Impact of Cryotherapy Versus Loop Electrosurgical Excision Procedure (LEEP) on Recurrence of Cervical Intraepithelial Neoplasia and HIV-1 Cervical Shedding Among HIV-positive Women
Phase: NA
Conditions: Cervical Intraepithelial Neoplasia
Sponsor: University of Washington

 
 
 
 
 
 
 
 
Impact of Cryotherapy versus Loop 
Electrosurgical Excision Procedure (LEEP) 
on Recurrence of Cervical Intraepithelial 
Neoplasia and HIV-1 Cervical Shedding 
among HIV-positive Women 
 
Study Protocol 
Version 8.5 
 
 
Michael H. Chung, MD, MPH 
University of Washington 
November 20, 2015

Chapter 1 – Study Investigators 
 
Cervical Treatment Study 
2 
 
 
TABLE OF CONTENTS 
 
Chapter 1 - Study Investigators .............................................................................................. 1 
Chapter 2 - Introduction 
Summary and Objectives ............................................................................................... 6 
Background .................................................................................................................... 7 
Rationale ...................................................................................................................... 12 
Timeline and Dissemination ........................................................................................ 14 
Chapter 3 - Study Design 
Cervical Screening Organogram .................................................................................. 15 
Personnel ...................................................................................................................... 16 
Study Population & Recruitment ................................................................................. 30 
Study Procedures ......................................................................................................... 37 
Study Flow Diagram I (Enrollment thru Randomization) ........................................... 47 
Study Flow Diagram II (Randomization thru Exit) ..................................................... 48 
Study Flow Diagram III (Laboratory Tests) .............................................................. 488 
Loss to Follow-up & Mortality .................................................................................. 499 
Chapter 4 -Statistical Methods ............................................................................................. 53 
Chapter 5 - Data Management ............................................................................................. 55 
Chapter 6 - Laboratory Procedures ..................................................................................... 64 
Chapter7 - Ethics ................................................................................................................... 70 
Adverse Events ............................................................................................................ 83 
Data Safety and Monitoring Plan…………………………………………………….88 
Study Monitoring ......................................................................................................... 95 
Acronyms ............................................................................................................................. 9896 
Pre-Screening Talking Points for Clinic Staff ......................................................................... 98 
Screening Talking Points for Study Staff ................................................................................ 99 
Post-Medical Care Information ............................................................................................. 101 
Information for Spouses and Partners……………………………........................……. …..103 
Written Consent Forms…………………………………………………...………....… …..105 

Chapter 1 – Study Investigators 
 
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3 
 
ENROLLMENT .................................................................................................................... 140 
PAP SMEAR ......................................................................................................................... 144 
COLPOSCOPY ..................................................................................................................... 146 
RANDOMIZATION …………………………………………………………...…………. 150 
TREATMENT ....................................................................................................................... 153 
ADDRESS AND INTAKE .................................................................................................... 156 
SHEDDING ........................................................................................................................... 158 
PATIENT CONTACT ..................................................................................................... 164163 
VERBAL AUTOPSY ............................................................................................................ 166 
EXIT ...................................................................................................................................... 171 
CYTOLOGY REPORT ......................................................................................................... 173 
COLPOSCOPIC BIOPSY HISTOLOGY REPORT ............................................................. 176 
ENDOCERVICAL CURETTAGE HISTOLOGY REPORT…………….…………..…… 177 
LEEP BIOPSY HISTOLOGY REPORT .............................................................................. 178 
CD4 REPORT........................................................................................................................ 180 
FOLLOW-UP FORM ............................................................................................................ 181 
ADVERSE EVENT ............................................................................................................... 186 
RECRUITMENT FLYER…………………………………………………………………. 210 
COPTIC HOPE MEDICAL RECORD FORMS ................................................................... 214 
References .............................................................................................................................. 279 
 

Chapter 1 – Study Investigators 
 
Cervical Treatment Study 
1 
 
Study Investigators 
Principal investigator 
Michael H. Chung, MD, MPH, Assistant Professor, Department of Global Health, University 
of Washington 
325 Ninth Avenue, Box 359909, Seattle, WA 98104 U.S.A. 
Phone: (206) 543-4278 
Dr. Chung is the PI and will directly lead the planning, implementation, and analysis of the 
study.  He will meet weekly with the study team, direct the study, and guide the study 
coordinator.  He will check progress on enrollment and follow-up with the study coordinator 
and study doctor.  In addition, Dr. Chung will serve as the point person to explain the study 
and share data results with others and report adverse effects associated with the study.  The 
University of Washington will provide administrative, laboratory and data support to this 
project. 
 
Co-investigators 
Nelly Mugo, MBChB, MMed, MPH, Gynaecologist, Department of Obstetrics and 
Gynecology, Kenyatta National Hospital 
P.O. Box 19676, University of Nairobi, Nairobi, Kenya 
Phone: 271-4159 
Dr. Mugo is a Co-investigator of the study and will assist Dr. Chung in the study’s planning 
and implementation.  As a gynaecologist, she will ensure that the study medical staff will 
provide excellent care and maintain high clinical standards.  She will oversee the 
gynecological care and proper medical procedures by meeting regularly with the study doctor 

Chapter 1 – Study Investigators 
 
Cervical Treatment Study 
2 
 
and nurses.  Dr. Mugo will be involved in any gynecological complications related to the 
study. 
 
Samah Rafie Sakir, MBChB, Medical Director, Coptic Hospital of Kenya 
Ngong Road, Nairobi, Kenya 
Phone: 0733-392807 
As Medical Director of the Coptic Hospital, Dr. Sakir will work with Drs. Chung and Mugo 
to implement the study at the Coptic Hope Center for Infectious Diseases.  He and the Coptic 
Hospital will provide the clinical infrastructure where HIV patients will be enrolled and 
followed in the study.  Dr. Sakir will manage the health care workers at the Hope Center and 
ensure that clinical data that is collected from the Hope Center and shared with the study is 
accurate and timely.   
 
Grace John-Stewart, MD, PhD, Professor, Department of Medicine, University of 
Washington 
325 Ninth Avenue, Box 359909, Seattle, WA 98104 U.S.A. 
Phone: (206) 543-4278 
Dr. John-Stewart will lend her epidemiology expertise to the analysis of the study.  She has 
significant experience in conducting and examining randomized clinical trials in Kenya.  Dr. 
John-Stewart will help analyze the data, prepare any manuscripts, and give feedback on 
implementation of the trial.  
 
Barbra Richardson, PhD, Research Professor, Department of Biostatistics, University of 
Washington 
325 Ninth Avenue, Box 359909, Seattle, WA 98104 U.S.A. 

Chapter 1 – Study Investigators 
 
Cervical Treatment Study 
3 
 
Phone: (206) 543-4278 
Dr. Richardson will contribute statistical support to the study and will be deeply involved in 
statistical analysis of its findings.  She will prepare the method to randomize subjects and will 
analyze results of the study.  
 
Dr. Hugo De Vuyst, MD, PhD, epidemiologist, Infections and Cancer Epidemiology, 
International Agency for Research on Cancer (IARC-WHO). 
150 cours Albert Thomas; 69372 Lyon cedex 08 
Tel: +33 472 738521 
Dr. De Vuyst will contribute his expertise and epidemiological skills in issues of cervical 
cancer screening, HPV and HIV in developing countries.  He will help analyze the data and 
its association with HPV results. 
Silvia Franceschi, MD, Epidemiologist, Head of Infections and Cancer Epidemiology Group, 
IARC-WHO 
150 cours Albert Thomas; 69372 Lyon cedex 08 
Phone: +33 4728404 
Dr. Franceschi will contribute her extensive epidemiological expertise in the field of cervical 
cancer, HPV and HIV.   
 
Martin Steinau, PhD, Team Lead HPV DNA, Chronic Viral Diseases Branch (CVDB), 
Division of High-Consequence Pathogens and Pathology (DHCPP), National Center for 
Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and 
Prevention (CDC) 1600 Clifton Road, MS G41, Atlanta, GA 30329-4027 
Tel: +1-404-639-0561 

Chapter 1 – Study Investigators 
 
Cervical Treatment Study 
4 
 
Dr. Steinau will coordinate the HPV-related study activities and data-analysis. He will 
contribute his expertise and epidemiological skills in issues of cervical cancer screening, 
HPV and HIV in developing countries.  He will oversee the testing of HPV samples at CDC, 
ensure quality control, and help analyze the data and its association with HPV results. 
 
Elizabeth R. Unger, PhD, MD, Chief CVDB, DHCPP, NCEZID, CDC 
1600 Clifton Road, MS G41, Atlanta, GA 30329-4027 
Phone: +1-404-639-3533 
Dr. Unger will contribute her expertise in the field of cervical cancer, HPV and HIV.  She 
will supervise and manage the laboratory where the HPV sample testing will occur and help 
analyze the results of the study. 
 
Nelly Yatich, DrPH, MPH, Clinical Assistant Professor, Department of Global Health, 
University of Washington 
P.O. Box 250-00202, KNH, Nairobi 
Phone: +254-728-234-771 
E-mail: yatich@u.washington.edu 
Dr. Yatich will work closely with Drs. Chung and Mugo to implement the study at the Coptic 
Hope Center.  She will provide mentorship to the research team at weekly meetings, provide 
mentorship to the Data Manager in data analysis, and guide the study coordinator.  She will 
provide other on the ground support as needed.  
 
Dara A. Lehman, MHS, PhD, Staff Scientist, Human Biology, Fred Hutchinson Cancer 
Research CenterAffiliate Assistant Professor, Department of Global Health, University of 
Washington 

Chapter 1 – Study Investigators 
 
Cervical Treatment Study 
5 
 
Fred Hutchinson Cancer Research Center 
1100 Fairview Ave N  
C3-168 
Seattle, WA 98109 
Phone: +1 206 667 4147  
Email: dlehman@fhcrc.org 
 
Dr. Lehman will lead efforts to quantify the HIV-1 RNAlevels of cervical and plasma 
samples collectd from subjects enrolled in the study comparing cervical cancer treatments in 
HIV-positive women. 

Chapter 2 – Introduction 
 
Cervical Treatment Study 
6 
 
Summary and Objectives 
The recent scale-up of antiretroviral treatment programs in resource-limited settings 
provides an unprecedented opportunity to implement a comprehensive cervical cancer 
screening and treatment program for women who, by virtue of having HIV, are at significant 
risk for cervical disease.  Unfortunately, even if screening is offered free of charge to millions 
of women living with HIV, it is unclear which treatment modalityfor pre-cancerous cervical 
lesions will be most effective since HIV appears to affect outcomes of treatment by 
increasing the recurrence and severity of cervical disease.  Cervical treatment may also 
increase shedding of HIV from the cervix which may put discordant couples at risk and 
possibly spread HIV more widely.  This study proposes to randomize HIV-positive women 
with cervical intraepithelial neoplasia grade 2 and 3 (CIN 2 and 3) to cryotherapy vs. loop 
electrosurgical excision procedure (LEEP) and measure the recurrence of cervical disease in 
each group over 2-years of follow-up as well as HIV shedding from the cervix for 3 weeks 
after treatment.   
Our hypothesis is that compared to cryotherapy, LEEP is significantly more likely to 
prevent recurrence of cervical lesions over 2 years of follow-up and less likely to cause 
shedding of HIV-1 from the cervix over 3 weeks of follow-up.   
The objectives of this study are: 
1. To compare the rate of recurrence of cervical intraepithelial neoplasia among HIV-
positive women receiving cryotherapy versus LEEP over 2 years of follow-up 
2. To compare the shedding of HIV-1 from the cervix between HIV-positive women 
receiving cryotherapy versus LEEP over 3 weeks of follow-up 

Chapter 2 – Introduction 
 
Cervical Treatment Study 
7 
 
Background 
The introduction of antiretroviral medications on a large-scale in resource-limited 
settings through funding from agencies such as the President’s Emergency Plan for AIDS 
Relief (PEPFAR) has decreased the number of HIV-positive women dying from AIDS.  As a 
result, many HIV-positive women are leading longer, healthier lives.  However, despite 
immune reconstitution many are still at risk for diseases related to their HIV infection 
including cervical cancer.1  Cervical cancer is the leading cause of cancer death among 
women in resource-limited settings, and HIV-positive women are more likely to be infected 
with human papillomavirus (HPV), the primary cause of cervical cancer, and progress to 
invasive, life-threatening disease than those who are HIV-negative.2-6  Thus, although many 
women may be saved by antiretroviral therapy through PEPFAR support, they may later die 
of a disease that could have been detected and prevented at the same facilities where they 
received their antiretroviral treatment.7 
The importance of adequate cervical cancer screening among HIV-positive women is 
being recognized by the Kenya PEPFAR program, Office of the Global AIDS Coordinator 
(OGAC), and other clinics around the world which are treating HIV-positive women.8  While 
there is a body of published knowledge on the screening and treatment of women in 
resource-limited settings, very little has been studied on the relevance of these findings on 
HIV-positive women.9, 10  For example, it has been suggested that visual inspection with 
acetic acid (VIA) along with cryotherapy be recommended as a “screen and treat” approach 
on the same day for women located in resource-limited settings.11, 12 The benefits are 
obvious; VIA is simpler to administer than a Papanicolaou test (Pap smear), does not require 
laboratory support, and is up to 20 times less expensive.  Similarly, cryotherapy, a low 
technology treatment option, can be offered on the same day as VIA decreasing loss-to-

Chapter 2 – Introduction 
 
Cervical Treatment Study 
8 
 
follow-up due to referral and waiting times, and is cheaper and easier to administer than 
LEEP.  As a result, some HIV treatment programs in resource-limited settings are beginning 
to utilize this approach for their female patients.  As PEPFAR begins to consider supporting 
cervical cancer screening among HIV-positive women enrolled in its programs, it will be 
essential that decisions are grounded in scientific evidence since any approach may have 
tremendous consequences on morbidity, mortality, and transmission of HIV-1.13 
The issue is that there is no evidence that a “screen and treat” approach is as effective 
among HIV-positive women as it appears to be among HIV-negative women.  In fact, there 
is data to suggest that this approach may be problematic.  In HIV-negative women, VIA 
appears to be more sensitive but less specific compared to Pap smear.9, 14  HIV-infected 
women have a higher prevalence of aggressive cervical disease and are more likely to 
experience recurrent HPV and genital infections.5, 15  The presence of florid disease may alter 
the sensitivity and specificity of VIA in the presence of HIV disease, making it more 
sensitive but less specific than Pap smear.  VIA may therefore detect more cervical 
abnormalities in HIV-infected women that are not truly cancerous.  Coupled with 
cryotherapy, this may result in many HIV-positive women receiving unnecessary treatments 
that inflame the cervix and cause it to shed increased levels of HIV virus.16  Increasing 
cervical shedding of HIV after cryotherapy may increase HIV transmission and infectivity in 
a manner analogous to male circumcision which appears to increase the risk of female 
partners acquiring the disease.17 
The standard of care for screening and treatment in the US, according to the 
American Society for Colposcopy and Cervical Pathology (ASCCP), is based on Pap smears 
and excisional (cold-knife conization, loop electrosurgical excision procedures, laser 
conization, and electrosurgical needle conization) or ablative treatments (cryotherapy, laser 
ablation, electrofulguration, or cold coagulation).18  Women who are found to have high-

Chapter 2 – Introduction 
 
Cervical Treatment Study 
9 
 
grade lesions on cytology may either have their lesion treated right away with LEEP or have 
a colposcopy-directed biopsy.  If the woman has a biopsy and the histology results show a 
CIN 2 or 3 and the colposcopy is satisfactory, treatment may be undertaken with either 
ablative or excisional therapy.  If colposcopy is unsatisfactory or the CIN 2/3 is recurrent, 
treatment should be a diagnostic excisional procedure, which is an excisional procedure 
followed by a pathological examination of the sample tissue.  
According to the Kenyan Ministry of Health, cervical cancer screening and treatment 
practices include VIA and cryotherapy at the district level health centers and below, and Pap 
smears with follow-up colposcopy with biopsy and LEEP at tertiary and provincial level 
hospitals.19  In our study, participants will be screened using Pap smear with confirmatory 
histology and treated with cryotherapy or LEEP.  Our screening and treatment methods are 
consistent with standards of care set at Kenyan tertiary and provincial level facilities.  As 
mentioned above, one of the reasons to study cryotherapy and LEEP is to understand how to 
refer HIV-positive women for cervical treatment within the Kenyan government health 
system.  The reason we are utilizing cytology and histology as a screening method is the lack 
of evidence confirming the sensitivity and specificity of VIA among HIV-positive women.  
Given that the outcome of measurement in this study is recurrence of CIN, it is considered 
scientifically necessary and within Kenyan standards of care to use these accurate, evidence-
based tests. 
In terms of risk of serious complication, cryotherapy and LEEP are quite safe.  In a 
study from Zambia, Pfaendler, et al. found that the overall complication rate of LEEP to be 
3.7%, all of which was managed on-site in the clinic.20  Likewise, in a study of cryotherapy 
in India, the overall complication rate was found to be 3.0%.21  In a large study from Peru 
that followed 1,398 women, who underwent cryotherapy for a mean of 12 months, no serious 
complications, including pelvic inflammatory disease, severe cramps or bleeding, or 

Chapter 2 – Introduction 
 
Cervical Treatment Study 
10 
 
anaphylactic reactions, were found.22   In a comparison study between cryotherapy and 
LEEP, cryotherapy was found to have a 2% complication rate and LEEP, an 8% 
complication rate, and the difference was not significant.23 
There has been some controversy surrounding cervical treatment and whether or not it 
is associated with adverse pregnancy outcomes.   Sadler et al. showed in their retrospective 
analysis of 652 women that had undergone LEEP, laser ablation or laser conization that 
LEEP did not increase the incidence of preterm delivery.24  However, the authors did note a 
significant increase in premature rupture of membranes.  Acharya et al., in their matched 
cohort of 428 women undergoing LEEP,  also found no correlation between the procedure 
and premature delivery or low birth weight, but they did find a significantly higher number of 
women with pregnancy complications, which included premature contractions, infections and 
cervical incompetence.25 
Finally, there is evidence that cryotherapy may be less effective compared to LEEP in 
preventing the recurrence of cervical intraepithelial neoplasia though the literature is 
equivocal.  Overall, there have been few studies comparing the efficacy in treatment between 
cryotherapy and LEEP, especially in HIV-infected women.  Chirenje et al. found a 
significant difference in the failure rate of cryotherapy versus LEEP, however his numbers 
were small with only 6 high-grade recurrences in the cryotherapy arm (14.3%) and 2 in the 
LEEP arm (4%).26  Moreover, neither HIV nor HPV shedding was measured and follow-up 
time was only one year.  In another randomized study comparing cryotherapy and LEEP, this 
time a larger study in non-HIV-infected women, no significant difference was found between 
the two arms in terms of failure, defined as either recurrence or persistance.23  Additionally, 
in a 2000 Cochrane review, it was stated that “evidence suggests that there is no obviously 
superior surgical technique for treating cervical intra-epithelial neoplasia.”27 

Chapter 2 – Introduction 
 
Cervical Treatment Study 
11 
 
If cryotherapy is found to result in a greater number of failures, it may require more 
frequent and careful follow-up screening than LEEP, and therefore may not be as cost-
effective or therapeutic for the patient.  As a result, the individual and public health risks of a 
“screen and treat” approach for cervical cancer screening and treatment among HIV-positive 
women may be much greater than its benefits. 
 

Chapter 2 – Introduction 
 
Cervical Treatment Study 
12 
 
 
Rationale 
The University of Washington (UW) in collaboration with the Coptic Hope Center for 
Infectious Diseases has been providing cervical cancer screening to its female HIV positive 
patients in Kenya since 2006.  The UW/Coptic Hope Center has enrolled over 8,000 HIV-
positive women in its two Nairobi sites and offers a robust patient population for cervical 
screening.  The UW/Coptic Hope Center has already screened over 2,000 HIV-positive 
women for cervical cancer using both Pap smear and VIA, and has worked in partnership 
with Kenyatta National Hospital (KNH) to provide LEEP to those with detectable lesions.  
Most recently, the collaboration has received a grant from the Puget Sound Partners for 
Global Health to compare VIA versus Pap smear among women enrolled at the Hope Center 
and to examine HIV-1 cervical shedding in a small subset who receive cryotherapy.  
Unfortunately, funding is only available for one year and will not allow any comparison with 
LEEP or a study of cervical disease recurrence after intervention.   
Kenya is an appropriate site to conduct this study due to a high incidence of cervical 
cancer and lack of cervical screening coverage.  The incidence of cervical cancer in Kenya is 
much higher compared to the West and measures between 43 and 45 cases per 100,000 
compared to 8.4/100,000 in the USA.28, 29  Of 3,902 women who presented to KNH with 
reproductive tract malignancies between 1989 and 1998, 85% had invasive cervical cancer.28  
In a sampling of 1,353 patients at the same institution in Kenya, only 22% reported having 
received a previous Pap smear.30  Although the government of Kenya has advocated the use 
of VIA as a primary method to screen for cervical cancer, no specific recommendations are 
made concerning HIV-positive patients.  Cervical cancer screening for HIV-positive women 
in Kenya should be a high priority since HIV-infected women in Kenya with invasive 
cervical cancer are 10 years younger than HIV-negative women at initial presentation.6, 31 

Chapter 2 – Introduction 
 
Cervical Treatment Study 
13 
 
Based on the high incidence of cervical cancer in Kenya and building upon our 
programmatic and research work in cervical cancer screening among HIV-positive women, 
we propose to study the effect of LEEP versus cryotherapy on the recurrence of cervical 
intraepithelial neoplasia and the shedding of HIV-1 from the cervix.  Our hypothesis is that 
compared to cryotherapy, LEEP is significantly more likely to prevent recurrence of cervical 
lesions over 2 years of follow-up and less likely to shed HIV-1 from the cervix over 6-weeks 
of follow-up.  This evaluation will inform PEPFAR policies on the best method to treat pre-
cancerous lesions in HIV-positive women and elucidate the importance of cervical treatment 
interventions according to immune status and antiretroviral therapy.  Such information is 
directly relevant to the care of HIV-positive women in Kenya and other resource-limited 
countries which are significantly impacted by cervical cancer. 

Chapter 2 – Introduction 
 
Cervical Treatment Study 
14 
 
Timeline and Dissemination 
The duration of the evaluation activity is approximately6years from the beginning of 
the funding cycle.  It is estimated that it will take at least 3 years to screen at least 2,400 
women and randomize approximately 400 women with high grade intraepithelial lesions to 
LEEP vs. cryotherapy.  These randomized participants will be followed for 2 years after 
screening or randomization.  Including preparation and analysis, it is expected that it will take 
approximately 6years to complete this study.   
Results of the study will be shared directly with the USG/GOK technical teams 
through annual reports and regular e-mail contact with designated contacts at the CDC in 
Atlanta and Nairobi.  Reports will include analysis from regular DSMB meetings.  After 
initiation of the study, we will confer with the CDC on whom to report to in Kenya and 
Atlanta.  At that time, we will also determine how frequently the USG/GOK technical teams 
would like to be appraised of the study and its results.  At a minimum, we will seek to be in 
phone and/or e-mail contact with USG contacts quarterly to ensure that the study and its data 
is relevant to USG technical working groups and policies established around cervical cancer 
screening in PEPFAR-supported clinics.  Dissemination of study findings will also occur 
through public presentations and publication in internationally recognized journals.  CDC and 
USG staff/agents will not participate in the study as co-investigators or study collaborators.  
They will not participate directly in the study development, analysis, or manuscript 
preparation.

Chapter 3 – Study Design 
 
Cervical Treatment Study 
15 
 
Cervical Screening Organogram 
 
 
 
 
 
 
 
 
Principal & 
Co-Investigators 
Data Manager 
Study Coordinator 
Study Nurses 
Administrator 
Study Doctor 
Lab Assistant 
Data Clerk 
Lab Technologist 
Driver 
Receptionist 
 Community Health 
Worker 
Assistant Study 
Coordinator 

Chapter 3 – Study Design 
 
Cervical Treatment Study 
16 
 
Personnel 
Study Coordinator 
• Manage directly the Study Monitor, Data Manager, Study Doctor, Administrator, and Lab 
technologist around aspects of the PHE cervical treatment study and R01 resistance study 
• Monitor the progress of research activities and ensure the smooth and efficient day-to-day 
operation of research and data collection activities 
• Initiate and coordinate activities that improve the conduct and performance of the study 
• Conduct weekly clinic meetings that are led by Study Doctor with study staff  
• Conduct weekly data meetings that are led by the Data Manager to ensure data is 
collected in a timely fashion, is cleaned, and clearly analyzed 
• Conduct and lead weekly study-related administrative meetings  
• Directand be responsible for the study budget and petty cash that is managed by the 
administrator 
• Act as the primary administrative point of contact for research staff and as the principle 
operational liaison for Coptic administration and regulatory bodies 
• Analyze recruitment rates, determine if rates match expectations, and implement plans 
that will promote recruitment 
• Analyze retention rates and implement plans that will promote retention 
• 
Supervise and coordinate the provision of support services to investigators  
• Prepare periodic and ad hoc reports as required by investigators, funding agency, and/or 
regulatory bodies 

Chapter 3 – Study Design 
 
Cervical Treatment Study 
17 
 
• Be responsible for renewing, updating and modifying IRB applications at UW and KNH 
that are associated with this study 
• Be responsible for generating Adverse Events, protocol violations and deviations,  and 
unanticipated problems reports 
• Be responsible for liaising with the DMSB as needed 
• Perform any other duties and responsibilities that may be given by the PI or co-
investigator 
Assistant Study Coordinator 
• Assist the Study Coordinator in monitoring the progress of research activities and 
ensuring the smooth and efficient day-to-day operation of research and data collection 
activities 
• Implement and be responsible for renewing, updating, and modifying existing standard 
operating procedures (SOPs) and develop new ones as needed 
• Be responsible to ensure that all staff are following SOPs 
• Implement quality control procedures throughout the conduct of the study 
• Review the accuracy, completeness and timeliness of completed study related records, 
case report forms and other documents 
• Compare reported data with original source documents 
• Review study related processes relative to applicable regulatory requirements, including 
GCP and Human Subjects Protection regulations  
• Verify the following items for the study: protocol compliance (i.e. subject recruitment and 
eligibility criteria, informed consent and randomization procedures); that only designated 

Chapter 3 – Study Design 
 
Cervical Treatment Study 
18 
 
investigator(s) and/or appropriate research staff are performing study functions; that 
regulatory compliance is being maintained (i.e. that investigators are providing and 
maintaining all study related documents as required.)Be responsible for study compliance 
with all regulations 
• Communicate any serious deficiencies noted during monitoring to the Study Coordinator 
• Ensure that a record of all correspondence, monitoring reports and other written 
documentations are maintained by the Administrator 
• Participate in all study meetings  
• Organize and coordinate all training activities 
• Respond to and be responsible for implementing all matters that may arise from CDC and 
Study Monitor visits 
• Perform any other duties and responsibilities that may be given by the Study Coordinator 
•  
Study Doctor 
• Oversee and ensure that patients in the study are receiving good medical HIV care and 
inform the study coordinator of any complications 
• Identify subjects that require medical attention and refer them for care at the Hope Center 
• Draw blood or obtain specimens from patients if the lab assistant or lab technologist is 
unable or unavailable 
• Oversee the cervical screening clinic and ensure it is well-stocked with necessary medical 
supplies and equipment to perform the study 

Chapter 3 – Study Design 
 
Cervical Treatment Study 
19 
 
• Meet with the data clerk or data manager to correct data entry errors 
• Review and confirm eligibility of each patient for study  
• Administer questionnaires 
• Conduct gynecological examinations, HIV and HPV swabs, colposcopy, biopsies, and 
cryotherapy and LEEP  
• Assist the study nurses in performing their duties if they are unable or unavailable 
• Confer and communicate with Hope Center clinicians and medical staff if any questions 
or problems arise concerning medically related issues 
• Work closely with clinic staff at the Hope Center to ensure high recruitment for research 
study 
• Work with data manager and receptionist to analyze data and prepare reports  
• Present weekly summaries along with the study nurse and receptionist marking progress 
in enrollment and tracking of subjects in the study  
• Will be responsible for reporting adverse effects to the principal investigator and co-
investigators 
• Perform any other duties and responsibilities that may be given by the principal 
investigator or the study coordinator 
Study Nurses 
• Conduct gynecological examinations, HPV swabs, and Pap smears  

Chapter 3 – Study Design 
 
Cervical Treatment Study 
20 
 
• Check age, previous cervical screenings and gynecological history before enrollment into 
the program 
• Provide adequate knowledge and education about the study to patients so they can sign an 
Informed Consent 
• Administer the Informed Consent and store it safely 
• Administer questionnaires 
• Review and confirm eligibility of each patient for research study 
• Assist the study doctor in any medical procedures 
• Attend weekly clinic meetings 
• Maintain, and in the absence of the community health worker, clean and organize the 
cervical screening clinic 
• Transport equipment and supplies for cleaning and autoclaving 
• Meet with the data clerk or data manager to correct data entry errors 
• Draw blood or obtain specimens from patients if the lab assistant or lab technologist is 
unable or unavailable 
• Perform any other duties and responsibilities that may be given by the study coordinator 
or study doctor 
Administrator 
• Manage petty cash and study budget 
• Liaise with payroll administrators to ensure salaries are paid correctly and on time 

Chapter 3 – Study Design 
 
Cervical Treatment Study 
21 
 
• Make purchases, photocopy data collection tools, and keep inventories of supplies 
• Maintain communication between the clinic and office 
• Attend and take minutes at weekly administrative and clinic meetings and present them at 
the next meeting  
• Reconcile receipts to send to Seattle 
• Communicate with Seattle when more funds are needed 
• Manage the driver and arrange transportation 
• Arrange for study trainings in coordination with study coordinator 
• Maintain and organize files of personnel, correspondence, applications, IRB records, 
receipts, budget, inventories, etc… 
• Coordinate staff evaluation procedures 
• Oversee and record the attendance of office and clinic staff in coordination with the study 
nurse 
• Make monthly reports of project expenses 
• Facilitate in renewing personnel medical insurance and liaise between insurance and the 
hospital of matters of personnel appointment  
• Make weekly reports of administrative issues 
• Prepare IRB and government applications for the shipment of samples 
• Remind study coordinator when IRB renewals are due and work with study coordinator 
and principal investigator to submit, modify, and renew IRB applications 
• Ensure office tidiness 

Chapter 3 – Study Design 
 
Cervical Treatment Study 
22 
 
• Perform any other duties and responsibilities that may be given by the principal 
investigator or study coordinator 
Receptionist 
• Follow subjects enrolled in the study and ensure they are retained in the study and proper 
follow-up is done both at the research clinic and the Hope clinic 
• Keep track of all the patients enrolled and determine if any patient has missed 
appointment and take action to report and bring these patients back under care and 
supervision 
• Handle money given by the administrator and account for it by keeping the various logs 
(i.e. calling log, transport log and client transport reimbursement forms) and meet weekly 
with the administrator for reconciliation 
• Track Excel spreadsheet of patient appointments, recruitment, and follow-up in the study 
clinic 
• Develop report of clinic flow weekly for study clinic meetings 
• Present weekly summaries marking progress in enrollment and tracking of subjects in the 
study in coordination with the study doctor 
• Will work with the study doctor, lab assistant, and community health worker to follow-up 
subjects by phone and home visits 
• Perform any other duties and responsibilities that may be given by the principal 
investigator or study coordinator 
Data Manager 

Chapter 3 – Study Design 
 
Cervical Treatment Study 
23 
 
• Oversee the work of the data clerk as below and assume any of the duties of the clerk that 
may be required due to his absence or inability to perform 
• Manage the data clerk 
• Contribute to the design and modification of protocols, which define what and when data 
are to be collected 
• Design and approve forms on which data are collected 
• Be responsible for data collection forms and informed consents (both old and new) that 
are used in the study 
• Manage data information entered by the data clerk on study patients with Hope Center 
• Ensure that patient study files are properly filled, documented, and stored 
• Manage data backup on weekly basis 
• Coordinate the transfer of data with the Coptic Hope data manager to the research 
databases with the data clerk 
• Desingan SPSS database and manage both the SPSS and Access databases for the study 
• Ensure the databases meet requirements for the entry and reporting of clinical data 
• Maintain daily, weekly, and monthly work schedules for the data office with the data 
clerk and ensure their completion  
• Check for errors in the data, correct the errors, and maintain cleanliness of the data 
• Check and manage the data log book of errors produced by the data clerk 
• Coordinate the data-checking process and produce a monthly report on the data quality  

Chapter 3 – Study Design 
 
Cervical Treatment Study 
24 
 
• Thoroughly clean the data every 3 months to ensure cleansing of errors 
• Sort out any data entry or error problems weekly with the study doctor and study 
coordinator 
• Run frequencies and range checks to identify extreme values monthly 
• Present weekly and monthly reports of data analysis 
•  Assist the study doctor and receptionist in the presentation of weekly summaries marking 
progress in enrollment and tracking of subjects in the study  
• Assist the receptionist and study doctor in the preparation of monthly summary tables on 
number of  women enrolled in each study arm and to consolidate the weekly reports 
• Prepare laboratory shipping lists with the lab technologist 
• Be responsible for maintaining the security of the data 
• Generate study ID numbers 
• Be responsible for linking and de-linking data 
• Train clinical research staff to help improve the quality of the data being collected 
• Assist in standardizing data management procedures such as documentation for study 
operating procedures 
 
• Develop and maintain documentation and data management guidelines 
• Perform other duties that may be given by the principle investigator or study coordinator 
Data Clerk 
• Enter questionnaire data and laboratory testing information into a computer database 

Chapter 3 – Study Design 
 
Cervical Treatment Study 
25 
 
• Scan, verify, and check data in Teleform 
• 
Prepare new patient files and ensure all files contain the required questionnaires 
• Maintain Access, Excel, and SPSS computer databases for the study  
• Maintain daily, weekly, and monthly work schedules and ensure their completion 
• Conduct weekly data quality checks with guidance from the data manager 
• Check for errors in the data, correct the errors, and maintain cleanliness of the data 
• Inform the data manager and study coordinator and of any data entry problems on a 
weekly basis 
• Keep a data log book of data entry queries and inconsistencies 
• Back-up all data weekly (Friday) 
• Back-up all data to an off-site disk weekly (Friday) 
• Coordinate the timely movement of questionnaires, data forms, and information between 
the Hope Center, the Coptic research wing, and the KNH data office  
• Ensure that the computers, printers and scanner are in good order and free from viruses 
• Perform any other duties that may be given by the data manager, study coordinator, and 
principal investigator 
Lab Technologist 
• Oversee the work of the lab assistant as below and assume any of the duties of the lab 
assistant that may be required due to his absence or inability to perform 
• Manage the lab assistant 

Chapter 3 – Study Design 
 
Cervical Treatment Study 
26 
 
• Ensure enrolled patients have their blood samples and/or other specimens collected at all 
visits according the study schedule 
• Ensure equipment and supplies are available, working, and well maintained 
• Ensure the lab is maintaining good laboratory practices 
• Maintain and manage the inventory of laboratory supplies and equipment 
• Collect laboratory specimens (including blood) from study participants if the lab assistant 
is absent or unable to perform 
• Keep track of laboratory specimens by updating and maintaining the lab database 
• Prepare for the shipment of lab specimens (HIV and HPV)  
• Prepare media for collection of samples 
• Be responsible for maintaining appropriate freezer temperature  
• Monitor freezer temperature by keeping an accurate temperature chart if lab assistant is 
unavailable 
• Be responsible for and enact proper emergency procedures if the freezer is not 
functioning 
• Oversee and manage collection and storage of the following specimens: urine for 
pregnancy, HPV swab, HIV swab/CVL, Pap smear, and biopsy specimens 
• Coordinate the delivery of lab specimens (Pap smear and biopsy) and collection of results 
with the pathologist 
• Coordinate collection, delivery, and recording of CD4 counts 

Chapter 3 – Study Design 
 
Cervical Treatment Study 
27 
 
• Track specimens and results in lab book 
• Perform other duties that may be given by the study coordinator or principal investigator  
Laboratory Assistant 
• Collect laboratory specimens (including urine and blood) from study participants  
• Track CD4 results from the medical records office and update the CD4 results log in 
coordination with clinic lab tech, clinic data manager, and study senior data analyst 
• Ensure timely transportation of questionnaires and research files between Coptic and 
KNH offices 
• Assist the lab tech in the collection and storage of the following specimens: urine for 
pregnancy, HPV swab, HIV swab, Pap smear, and biopsy specimens 
• Assist the lab tech in the delivery of lab specimens (Pap smear and biopsy) and collection 
of results with the pathologist 
• Track specimens and results in lab book 
• Assist the lab tech in the delivery of specimens and collection of results 
• Assist the lab tech in the processing and freezing of samples 
• Monitor freezer temperature by keeping an accurate temperature chart and inform the lab 
technologist and study coordinator if there is a failure 
• Remove frost and clean the freezer 
• Record and present minutes at clinic research meetings if the administrator is not 
available 

Chapter 3 – Study Design 
 
Cervical Treatment Study 
28 
 
• Clean and help organize study clinic 
• Assist the receptionist in following subjects enrolled in the study and ensure they are 
retained in the study and proper follow-up is done both at the research clinic and the Hope 
clinic 
• Assist the receptionist in keeping track of all the patients enrolled and determine if any 
patient has missed appointment and take action to report and bring these patients back 
under care and supervision 
• Ensure completed questionnaires are delivered to the data clerk within 24 hrs  
• 
Will perform home visits as necessary in coordination with the receptionist and study 
doctor 
• 
Will help phone subjects for follow-up in coordination with the receptionist and study 
doctor 
• Perform other duties that may be given by the laboratory technologist, study coordinator, 
or principal investigator 
Community Health Worker 
• Accompany clients for possible enrollment from the Hope Center to the cervical 
screening clinic or study lab for urine testing 
• Accompany clients between the study lab, Coptic lab, and the cervical screening clinic 
• Help clients schedule appointments at the Hope Center 
• Clean and help organize study clinic 

Chapter 3 – Study Design 
 
Cervical Treatment Study 
29 
 
• Will perform home visits as necessary in coordination with the receptionist and study 
doctor 
• Will help phone subjects for follow-up in coordination with the receptionist and study 
doctor 
• Perform duties given by receptionist or study coordinator 
Driver 
• Transport specimens and data files 
• Assist the administrator in purchase of supplies and equipment 
• Maintain car and ensure it is running well and has fuel 
• 
Perform duties given by administrator or principal investigator 
• Pick supplies from the office to the clinic 

Chapter 3 – Study Design 
 
Cervical Treatment Study 
30 
 
Study Population & Recruitment 
The study will be a prospective randomized clinical trial enrolling HIV-positive 
women who receive care at the Coptic Hope Center for Infectious Diseases in Nairobi, 
Kenya.  The study clinic will screenat least 2,400 HIV-positive women from the Coptic Hope 
Center for cervical cancer and, of whom, approximately 400 will be enrolled and randomized 
to receive treatment.   
It is estimated that at least 2,400 women will need to be screened in order to identify 
400 women with high-grade intraepithelial lesions.  This is based on a prospective analysis of 
500 HIV-positive women who underwent Pap smear screening at the Hope Center between 
July and November 2009.  In this analysis, 187 (37%) women had normal cytological results, 
292 (59%) had abnormal cytological results, and 21 (4%) had results which were 
indeterminate due to inflammation, inadequate sample collection, or insufficient data.  
Abnormal cytological results included 77 women (15%) with atypical squamous cells of 
undetermined significance (ASCUS), 121 (24%) low-grade squamous intraepithelial lesions 
(LSIL), and 92 (18%) high-grade squamous intraepithelial lesions (HSIL).  
Adult HIV-positive women receiving care at the Coptic Hope Center who are not 
pregnant by clinical examination or history, have an intact cervix, have not received prior 
cervical treatment, do not have a history of a bleeding disorder, do not have any known 
allergy to study medications OR their alternatives, have initiated sexual intercourseand are 
above 18 years of age will be informed of the study by non-study clinicians and health care 
workers. Subjects will be excluded by the study at initial cervical cancer screening if they are 
HIV-negative, male, below 18 years of age, pregnant by clinical examination or history, post-
hysterectomy, post-cervical cancer treatment or have known allergies to study medications.   

Chapter 3 – Study Design 
 
Cervical Treatment Study 
31 
 
Potential participants will be identified by Hope Center clinical officers seeing 
patients as part of routine HIV medical care at the Hope Center.  Clinical officers will use 
“Pre-Screening Talking Points” to inform patients about the study.  If subjects are interested 
then they will be directed to the study clinic in a physically separate room staffed by study 
personnel. We will also use recruitment leaflets that will be distributed at the Hope Center 
Reception. The leaflets will have the contact information of the study staff.  At the study 
clinic, a study staff member will inform potential subjects of the study using “Screening 
Talking Points”.  If subjects remain interested and are eligible then they will be enrolled (see 
Study Flow I).  An appointment calendar will be kept by the study receptionist on an MS 
Access database to track who has attended the clinic and received screening.   
Interested women will be referred to the study clinic (Room A) which will be staffed 
by two study nurses trained to perform Pap smears on the same day after obtaining informed 
consent for screening.  Women who enrolled in the screening portion of the study and 
obtained a Pap smear will be asked to return to the study clinic (Room A) for results 2 weeks 
later.  If Pap result is positive for HSIL, the subject will be referred to a separate room (Room 
B) where a study doctor and a study nurse will obtain a biopsy to confirm CIN 2 and 3 by 
histology.  From this point, the subject will return to Room B and see the study doctor and 
nurse for further follow-up.  Four to sixweeks after biopsy, the subject will return for her 
results and to discuss treatment options.  At this point, study staff will obtain informed 
consent for randomization and follow-up, and the study doctor will randomize histology-
confirmed subjects (approximately 400 women) to LEEP or cryotherapy.  Criteria for being 
ineligible for cryotherapy include if a polyp or anatomic defect prevents access to the cervix 
and/or if the lesion size is >75% of the cervix or is larger than the cryoprobe tip, or if the 
lesion is not visible in its entire extend or extends more than 2 to 3 mm into the endocervical 
canal.  If any of these subjects are diagnosed with severe cervical disease confirmed by 

Chapter 3 – Study Design 
 
Cervical Treatment Study 
32 
 
histology at these later screening time points, they will be offered LEEP by the study or 
referred for appropriate care. 
Patients who require further care for cervical disease unavailable at the study clinic 
(eg. hysterectomy) or who decline to enroll in the treatment portion of the study will be 
referred to KNH.  Through patient tracing the study doctor and staff connected to the KNH 
gynecology department will make best efforts to assure that patients receive proper care.  
Referral notes and copies of results for histopathology, cytopathology, CD4 count, and HIV 
viral load will be sent with the patient during referral.  All study specific documentation 
including study numbers and title will be removed.  Only the subject’s name and age, as is 
relevant to the referral, will be on the documents sent for clinical care at KNH or Coptic 
Hospital. Subjects will receive government subsidized care at these sites but the study will 
not pay for these interventions or treatment. 
Study clinic visits will be conducted separately from regular medical visits a patient 
may make at the Hope Center.  Subjects will continue to follow-up with their doctors at the 
Hope Center, schedule their visits through the Hope receptionist, and pick up their 
medications at the clinic.  However, study clinic visits will be conducted by staff employed 
by the study in physically separate locations from routine medical visits.  Study appointments 
will not conflict with the HIV clinical care that patients receive through coordination between 
the study receptionist and the clinic receptionist.  Study doctors will not provide HIV care or 
treatment, and subjects will remain enrolled as patients at the Hope Center and receive the 
same care as prior to enrollment.  Before lab tests for the study are performed, confirmation 
from the subject (and if necessary, the laboratory) will be made to assure no tests, such as Pap 
smears ordered as standard of care or blood draws, are unnecessarily repeated.  

Chapter 3 – Study Design 
 
Cervical Treatment Study 
33 
 
Medical information collected by clinic staff at the Hope Center will be made 
available to the study team after written informed consent by the subject.  This will contain 
all information collected at the Hope Center including laboratory data.  Only clinic staff will 
collect medical information from subjects related to the management of their HIV disease.  
Study data for the PHE will be collected on separate forms and scanned, cleaned, and 
analyzed at a location unassociated with the clinic and its medical records.  Only study staff 
will collect study data on forms described in this protocol.  If institutional IRBs approve, we 
will make study data available to the clinic staff at the Hope Center after written informed 
consent is signed by the subject.  As soon as a participant’s results become available, the 
study staff will enter the results in a form that is stored in the participant’s Hope Fileas a 
means of communicating the results to the participant’s clinicians. This will be done in 
coordination with the medical records department at the Hope Center.  If clinical information 
is discovered about a subject that needs immediate attention, clinical staff will be available on 
site at all times to assist in care of the patient and will be informed by the study staff.In the 
event that a participant needs emergency care, the study clinical staff will be prepared to 
stabilize patients and emergency services are available at Coptic Hospital 24 hours a day.  
Moreover, clinical care is available at KNH at any time if needed or preferred by the patient.  
Participants will be given careful instruction as to which symptoms would necessitate them 
seeking additional medical care, especially after receiving treatment.  The participant will 
receive contact information of study staff whom they should contact in case of an emergency 
or if they need guidance as to how to manage a certain symptom or condition.  Study staff 
can share pertinent information with clinic staff in these situations by phone or in person as 
the study clinic is located on the hospital grounds. 
Participants will be consented for screening by study staff at their enrollment visit and 
for 
randomization 
and 
follow-up 
at 
their 
biopsy 
result 
visit.If 
an 

Chapter 3 – Study Design 
 
Cervical Treatment Study 
34 
 
exitedsubjectbecomeseligible for re-enrollment due to re-reading of cytology results (See 
QA/QC section), then re-enrollment consenting will be done at the disclosure visit for the 
new results.  All consenting study staff members will be able to describe study procedures in 
English, Kiswahili and possibly another local language.  Other nursing and study staff are 
available and should be contacted in the case of a participant who presents for enrollment but 
is not conversant in any of the languages the consenting staff member speaks.  Consent 
documents will be prepared in both English and Kiswahili at a basic reading level.  The 
English version will be used by study staff to produce the Kiswahili version and several 
members of the staff will review the document to assure its accuracy and readability. 
 
Participants will be encouraged to ask questions at any point during the consent 
process and will be given a copy of the document to review on their own.  If a participant has 
a question that cannot be answered by the consenting staff member, other study staff will be 
available for consultation.  The patient may also contact other study staff at her convenience.  
The participant may also interrupt the consent process at any time if she needs more time to 
consider her participation. 
 
Subjects with initial Pap smear results that areNormal or ASC-USwill be exited from 
thestudy after receiving their Pap smear results. Subjects with LSIL Pap smear results will be 
offered Colposcopy.  According to the 2012 ASCCP guidelines, participants found with LSIL 
in the absence of HPV co-testing should be recommended colposcopic evaluation and biopsy. 
These biopsy histology results will be treated the same as other study histology, including 
possible treatment randomization for CIN 2/3 and CIS. This will enable researchers to 
monitor lesions which may escalate from low-grade to high-grade in subjects who may be 
eligible for subsequent randomization.  Results from repeat Pap-smears will be treated the 
same as results from initial Pap smears: Women with Normal/ASC-US results will be exited 
from the study.  Subjects with HSIL/ASC-H/HSIL-invasion-not-ruled-out and results 

Chapter 3 – Study Design 
 
Cervical Treatment Study 
35 
 
suggestive of cervical carcinoma (i.e. high grade intra-epithelial lesions) will undergo 
colposcopy with biopsy, and may potentially be eligible for randomization upon confirmed 
histology results. If a subject with high grade intraepithelial lesions detected on study-related 
Pap smears is later found to have normal or ASCUS on a follow up Pap smear (study related 
or not) that occurs prior to or in lieu of a colposcopic evaluation, the subject will still be 
required to have a study related colposcopy and biopsy. 
Subjects who have biopsy-confirmed CIN 2, 3 or CIS will be eligible for the 
randomization and treatment portion of the study. They will be presented with the consent 
information upon receipt of biopsy result.  Subjects with biopsy results suggestive of cervical 
carcinoma will be exited from the study and referred for further evaluation and management 
at KNH.  Subjects with CIN I biopsy results will be asked to return to the clinic for repeat 
Pap smear in 6 months and will remain in the study.If a subject receives three consecutive 
CIN1histology results, she will be offered LEEP treatment by the study doctor.  These 
participants will be treated and followed the same as other non-randomized LEEP 
participants. 
 
Of note: Women with normal or with ASCUSPap smear results (that are exited from 
the study) will be referred for subsequent cervical screening follow-up at the Hope Center 
Cervical Cancer Screening Program (CCSP).  This program is administered by the Coptic 
Hospital and is supported by the Coptic Mission, PEPFAR, and other donor funding.  The 
CCSP offers free cervical cancer screening to HIV-positive women enrolled in the Coptic 
Hope Clinic. Currenttly, a single visit ‘screen-and-treat’ strategy for cervical cancer 
prevention and treatment will be used.The screen-and-treat method involves visual inspection 
of the cervix followed by treatment of precancerous lesions by cryotherapy at the same visit. 
Patients who cannot be treated with cryotherapyare referred to KNH for subsidized cervical 

Chapter 3 – Study Design 
 
Cervical Treatment Study 
36 
 
care and treatment.  As all study subjects are drawn from the Coptic Hope HIV clinic, they 
areall eligible to be screened, treated, and followed at the CCSP. 
If woman exited from her normal or ASCUS Pap smear result prefers to rescreen with 
the study, she may be re-enrolled using the re-enrollment consent form.

Chapter 3 – Study Design 
 
Cervical Treatment Study 
37 
 
Study Procedures 
1. SCREENING visit (at least 2,400 patients) (see Study Flow Diagram I, Enrollment) 
• At screening, subjects who agree to participation will:  
o Sign a written informed consent 
o Answer the “Enrollment” questionnaire which will ask her sociodemographic 
background,sexual history, and cervical cancer screening history. 
o Complete “Address and Intake” questionnaire. 
o Undergo a physical examination including a pelvic examination with a 
Papanicolaou smear of the cervix.  The results of the physical examination 
will be entered in the “Pap Smear” questionnaire 
o Women found to have evidence of an STI will undergo syndromic 
management according to the following algorithm: 
i. Vaginal discharge without abdominal pain 
1. Treat for vaginitis: 
a. Nystatin 1 pessary everyday x 5 days and 
b. Metronidazole 2g x 1 
2. If no improvement after 7 days, treat for cervicitis: 
a. Norfloxacin 800mg x 1 and 
b. Doxycycline 100mg BD x 7 days 
ii. Lower abdominal pain 
1. If due to surgical or gynecological causes, refer 

Chapter 3 – Study Design 
 
Cervical Treatment Study 
38 
 
2. If cervical motion tenderness, treat for pelvic inflammatory 
disease: 
a. Norfloxacin 800mg x 1 and 
b. Doxycycline 100mg BD x 7 days and 
c. Metronidazole 400mg BD x 10 days 
iii. Genital ulcer disease (GUD) 
1. If multiple lesions grouped together with a history of 
recurrence, treat for Herpes simplex genitalis: 
a. symptomatic treatment 
2. If other GUD, treat empirically: 
a. Erythromycin 500mg three times per day x 7 days and 
b. Benzathine penicillin 2.4 million U IM stat 
2. Two-week visit for RESULTS (at least 2,400 patients) 
• Patients will return to the clinic two weeks later for Pap smearresults which will be 
entered on the “Colposcopy” questionnaire.  We expect that an estimated 1,700 
women will have results (no dysplasia or ASCUS)that do not require study 
biopsy/colpo procedures.  These patients will be ineligible for randomization.   
• Women with no dysplasia or ASCUS Pap smear results will be exited from the study. 
They will be followed up at the Coptic Hope Cervical Cancer Screening Program 
(CCSP).  The Hope screening program offers free cervical screening through visual 
inspection with acetic acid (VIA).  Women who are screened and exited from this 
study with normal Pap smear results will be followed up at CCSP one year after initial 
screening.  Women who are screened and exited from this study with ASCUS Pap 
smear results will befollowed up at CCSP 6 months after initial screening. Women 
who have exited the study due to a cytologic diagnosis of no dysplasia or ASCUS will 

Chapter 3 – Study Design 
 
Cervical Treatment Study 
39 
 
be eligible to re-enroll in the study and obtain a study related screening pap smear, 
approximately 12 months after their last normal/ASCUS study related pap smear. 
• Women found with unsatisfactory results will have their Pap smear repeated. 
• Women with LSIL will be offered Colposcopy.  According to the 2012 ASCCP 
guidelines, participants found with LSIL in the absence of HPV co-testing should be 
recommended colposcopic evaluation and biopsy. 
• Any patient who receives a cytological diagnosis of high-grade intraepithelial lesion 
(HSILand ASC-H, and HSIL-invasion-not-ruled-out or SCC) (~18% of the patient 
population or approximately 400 patients), will be recommended to undergo 
colposcopy as per 2012 ASCCP guidelines. If a subject with high grade intraepithelial 
lesions detected on study-related Pap smears is later found to have normal or ASCUS 
on a follow up Pap smear that occurs prior to or in lieu of a colposcopic evaluation, 
the subject will still be required to have a study-related colposcopy and biopsy. Prior 
to participating in any cervical procedure, including biopsy, women will undergo a 
rapid pregnancy test.  Pregnant subjects will be exited from the study and followed-up 
in the CCSP. These women will also be referred for prevention of mother-to-child 
transmission (PMTCT) care at Hope Center. If the pregnancy result is negative, they 
will be referred to the study doctor for colposcopy-directed biopsy which will clarify 
the extent and severity of disease.  Results of the colposcopic examination will be 
entered in the “Colposcopy” questionnaire (see Study Flow I).For patients who have 
glandular epithelium abnormalities (AGC) on Pap or squamous epithelium 
abnormalities without visible lesions on colposcopy, endocervical sampling with 
curettage will be performed in order to identify possible abnormalities in the 
endocervical canal. 

Chapter 3 – Study Design 
 
Cervical Treatment Study 
40 
 
• After undergoing abiopsy, women will be given free condoms and advised to abstain 
from sexual activities for at least 10 days. 
3. 6-8-weekvisit for RANDOMIZATION (~400 patients) (see Study Flow II) 
• Subjects who have undergone biopsy will return four to six weeks later for a follow-
up visit to be giventhe results of the biopsy. Biopsy resultswill be entered in the 
“Treatment” questionnaire.   
• Those with biopsy results that are positive for a high grade pre-cancerous lesion (CIN 
2/ 3 or CIS) and if the lesion is amenable to cryotherapy or LEEP as per Kenyan 
national guidelines, will be eligible for randomization.  If they are willing to undergo 
informed consent for the treatment study, they will be randomized to receive either 
cryotherapy or LEEP (see Study Flow II).  Those who decline to participate in the 
treatment study will be exited and referred to KNH for treatment. Randomization 
questionnaire will also be completed during this visit. 
• Those patients who do not have lesions which are amenable to cryotherapy due to size 
or access will not be randomized but will be offered free LEEP and followed up every 
6 months for 2 years, the same way as randomized participants.  Those who 
havelesions that are neither amenable to LEEP nor cryotherapy due to size or severity 
of disease, or anatomy does not allow proper access to the cervix, will be referred to 
KNH for subsidized care at this government hospital.  The study will not pay for this 
treatment.  Patients will be given follow-up appointments in the study clinic after 
referral to determine outcomes.  They will have the option to continue to be followed 
at the CCSP. 

Chapter 3 – Study Design 
 
Cervical Treatment Study 
41 
 
• Those with CIN 1 will not be randomized or exited but will be asked to return to the 
study clinic after 6 months for a repeat Pap smear.   
• Those who show no dyplasia on histology will be exited from the study and referred 
to the CCSP for further follow-up. 
• It is expected that approximately 400 patients will be eligible for randomization.  
During randomization, a sealed envelope will be opened by the study doctor that will 
reveal the randomization arm that has been assigned to the study ID number.  
Randomization assignment will be performed on a computer by Dr. Barbra 
Richardson, the study statistician, in Seattle, and preparation of the envelopes will be 
performed by the study data manager in Nairobi in conjunction with Dr. Richardson. 
This is the standard used for all randomized clinical trials conducted by the University 
of Washington in Kenya. Study investigators and the study doctor will not have 
access to the randomization sequence.  Study investigators and staff will not be 
blinded to randomization. 
• Those eligible for randomization will have an HIV cervical viral level swab taken 
before treatment (LEEP or cryotherapy). 
• After receiving LEEP or cryotherapy, women will be given free condoms and advised 
to abstain from sexual activities for at least 4 weeks.  Women will also be offered an 
information sheet on the treatment procedure and abstinence information to take home 
for their spouse or partner.  Information includes treatment given, recommended 
abstinence period and reasons for abstaining from sexual intercourse.  These 
information sheets will be optional to maintain patient confidentiality and safety, 
especially for people who have not disclosed their status.   
• Patients undergoing randomization will have the following performed:  

Chapter 3 – Study Design 
 
Cervical Treatment Study 
42 
 
o Blood (10mls) will be drawn to check for HIV viral load and CD4 count 
o Cervix will be swabbed to assess the presence of Human Papillomavirus 
(HPV) prior to LEEP or cryotherapy 
o Cervix will be swabbed for HIV viral level prior to LEEP or cryotherapy 
o LEEP or cryotherapy performed based on randomization envelope 
o Those undergoing LEEP will have the LEEP piece taken for histology 
o “Randomization” questionnaire completed 
o  “Treatment” questionnaire completed 
4. First, second, and third-week visits for cervical HIV-1 SHEDDING after treatment (~400 
patients) (see Study Flow II) 
• Patients who have been randomized and received treatment (approximately 400 
patients)will be followed every 1 week for 3 weeks AFTER the treatment intervention 
to assess healing and measure HIV-1 viral shedding from the cervix.  These events 
can be called the 7-9, 8-10, and 9-11-week visit time points and will probably 
coincide with the eigth, ninth, and tenth week after enrollment.  However, for 
purposes of measuring HIV viral shedding, it is most important that these time points 
occur 1, 2, and 3 weeks after the treatment intervention.  These terms are consistent 
and are used for descriptive purposes.  They will return 3 times over a 3-week interval 
and have the following performed: 
o Blood (10mls) will be drawn to check for HIV viral load 
o Cervix will be swabbed to assess the presence of HIV-1 
o “Shedding” questionnaire completed 

Chapter 3 – Study Design 
 
Cervical Treatment Study 
43 
 
Shedding information will be considered valid if it is obtained ± 3 days of the 
scheduled visit. We will collect shedding information for the first three weeks after 
treatment but if a patient misses those visits but comes back within six weeks, we will 
still collect the samples just for comparison purposes. 
5. Six, twelve, eighteen, and twenty-four months after randomization visits for 
RECURRENCE (approximately 400 patients) (see Study Flow II) 
• After the 9-11-week visit, randomized participants and those who undergo LEEP but 
are not randomized because their lesions are not amenable to cryotherapy will return 
at 6, 12, 18, and 24 months after treatment is administered.  At the 24 month visit, the 
subject will be exited from the study.  At these 6-month interval visits, the following 
will be performed in order: 
o Pap smear to detect recurrence of cervical intraepithelial lesions 
o  Same Pap smear swab will be used to assess the presence of Human 
Papillomavirus (HPV) 
o Blood (5 mls) will be drawn to check for CD4 count 
o “Pap Smear” questionnaire completed 
• Pap smear results that are normal, ASCUS, will be filed in the participants file and 
disclosed at the next scheduled follow-up visit.  If pre-cancerous lesions by cytology 
have recurred then patient will be contacted to return to the study clinic to undergo 
colposcopic directed biopsy prior to treatment.  Results of the colposcopic 
examination will be entered in the “Colposcopy” questionnaire.. 
o If histology-confirmed lesians can be treated by LEEP, then the patient will 
receive a free LEEP and “Treatment” questionnaire will be filled.  
o If histology-confirmed lesions are too large or cancerous for LEEP then 
patient will be referred to KNH for subsidized care at this government 

Chapter 3 – Study Design 
 
Cervical Treatment Study 
44 
 
hospital.  The study will not pay for this treatment.  Patients will be given 
follow-up appointments in the study clinic after referral to determine 
outcomes. 
• Phone calls and home visits will be performed sequentially in the case of a subject 
who has been lost to follow-up (LTFU) after screening or randomization (see LTFU 
section).  LTFU will be prepared and discussed at weekly clinic meetings.  Written 
reports will be prepared from these meetings and sent to co-investigators.Home visits 
will be performed by community health workers trained to be discreet in their 
approach to finding patients.  They will not wear clothes that would identify them as 
health workers and will only use public transportation or unmarked private vehicles.  
They may ask about the participant’s health or whereabouts. 
6. Specimen transportation 
Blood samples will be processed at the study clinic and will be sent to the US for processing 
at a later date when enough samples have been collected, approvals have been obtained, and 
the laboratory is ready to receive the specimens.  The Pap smear and biopsy samples will be 
transported to the pathologist on a daily basis and the results will be brought back after 
processing.  HPV collection media will be stored at room temperature at the study clinic and 
may be transported outside of Kenya at a later date.  Biopsies will be transported to the 
pathologist and the results brought back within 2 weeks after processing.  The paraffin-
embedded tissue blocks remaining after the histology processing will be brought back and 
stored at the study clinic.  A transport log book will be used for this purpose. A results log 
will be kept to account for results received from the pathologist. 
7. Infection Control 

Chapter 3 – Study Design 
 
Cervical Treatment Study 
45 
 
Hand washing with soap, disinfecting used linen and equipment, proper waste disposal, 
single use needles and syringes, use of gloves and autoclaving of equipment at the Hope 
Center will be adhered to. 
8. Transport Fees 
No money for transport will be given on enrollment for this will be treated as a scheduled 
clinic day at the Hope Centre.  All subjects screened will get Ksh 300 on return to the clinic 
after initial enrollment and screening.  If a woman would like more time to consider entry 
into the study, she will be given money for travel at the time she returns with the intent to 
enroll in the study.  Subjects will receive travel money on presentation to the study office on 
their scheduled visit day and a list of subjects (by study ID) who get travel money will be 
maintained by the receptionist on daily basis.  The receptionist will be getting transport 
money from the administrator.  A top up will be done whenever the amount fall below Ksh 
3,000.  Maximum amount to be collected from the administrator at any given time will be 
Ksh 10,000. 
9. Notification of Results 
Cytology results: Subjects will be notified of their screening cytology results at a study visit 
scheduled two weeks after their screening visit. If on routine cytology QC re-readings, 
consensuscytology results are discordant from the initial reading and alternative management 
is required, subjects will be notified and called back for appropriate follow-up. Subjects with 
new cytology results of LSIL will be offered colposcopy and biopsy according to 2012 
ASCCP guidelines.If the new cytology results are HSIL, ASC-H, or HSIL cannot rule out 
invasion, patients will be presented with evaluation, treatment and follow-up options,which  
includes continuation in the study (even if previously exited). Subjects will be given consent 
information to re-enroll into the study. A Colposcopy form will be completed at this visit.  
Cytology results from bi-annual follow-up visits for randomized participants and non-

Chapter 3 – Study Design 
 
Cervical Treatment Study 
46 
 
randomized LEEP participants will be disclosed at the next scheduled follow-up visit if the 
result is Normal of ASCUS.  If pre-cancerous or cancerous lesions by cytology have recurred 
then patient will be contacted to return to the study clinic to undergo colposcopic directed 
biopsy prior to treatment. 
Histology results: If the participant needs a biopsy (i.e., HSIL, ASC-H, HSIL cannot rule out 
invasion, or ICC), they will need to return 4-6 weeks later for histology results. If study staff 
or a participant feel that having a counselor present at any of these visits would help facilitate 
the conversation, this can be arranged though utilization of Hope Center counseling staff. 
Participants who do not come to their scheduled appointments will be called or visited at 
home using the contact information provided at enrollment (process described thoroughly 
below in the Loss to Follow-up & Mortality section).   
10.  Exit 
Subjects will exit the study after an interview with the study doctor or study nurse.  An “Exit” 
form will be completed.  Participants will be notified that if they wish to know the final 
results of the study, they may contact the study office 6 months or a year after their 
participation is complete. 
 

Chapter 3 – Study Design 
 
Cervical Treatment Study 
47 
 
 
Study Flow Diagram I (Enrollment thru Randomization) 
ENROLLMENT 
• Informed consent 
• Enrollment form 
• Pap smear 
• Pap smear  form 
• Address & Intake 
form 
Pregnant  
Colposcopy  form 
• 
Exit form 
• 
Exit study 
• 
Refer to PMTCT 
Same day 
Same day 
4-6 week interval 
Same day 
2 week interval 
CRYOTHERAPY 
(see Study Flow II) 
LEEP(with biopsy) 
(see Study Flow II) 
CIN II & III & CIS (no AGC): 
(no squamous disease in 
endocervical canal if curettage 
done)  
 
• 
Informed consent 
• 
Randomization form 
• 
Treatment form 
• 
Randomize subject 
• 
Blood CD4 & HIV 
• 
Cervical swab HPV &  HIV 
RESULTS 
• 
Read biopsy results 
• Read curettage results 
• 
HSIL +ASC-H + HSIL 
cannot rule out 
carcinoma, LSIL 
• 
Pregnancy test 
•
Colposcopy form
No dysplasia, or ASCUS 
• 
Colposcopy  form 
• 
Exit form 
• 
Exit study 
RESULTS 
• Read Pap results 
Cryotherapy 
ineligible (Including 
Curretage result 
CIN1-3 or CIS)– 
• Informed Consent 
• Randomization form 
but no randomization 
of the subject 
• Treatment form 
• Blood CD4 & HIV 
Cervical swab HPV & 
HIV before treatment
CIN I 
Repeat Pap smear after 6 
months 
Patients with discordant 
results after Cytology QC 
HSIL not visible on 
Colpo or AGC 
• 
Pregnancy test 
• 
Colposcopy form 
• 
Endocervical 
Curettage  
• 
Curettage form 
Curettage resultCeCa or 
Glandular lesions 
• 
Refer to KNH 
• 
Exit form 
• 
Exit study 

Chapter 3 – Study Design 
 
Cervical Treatment Study 
48 
 
Study Flow Diagram II (Randomization thru Exit) 
 
RANDOMIZATION 
• 
Informed consent 
• 
Randomization form 
• 
Treatment form 
• 
Randomize subject 
• 
Blood CD4 & HIV 
• 
Cervical swab for HPV & HIV before 
treatment
1 week interval 
SHEDDING 1 @ 1 weekafter Rx 
• 
Shedding form 
• 
Cervical swab & Blood HIV 
1 week interval 
SHEDDING 2 @ 2 weeks after RX 
• 
Shedding form 
• 
Cervical swab & Blood HIV 
SHEDDING 3 @ 3 weeks after Rx 
• 
Shedding form 
• 
Cervical swab & Blood HIV 
1 week interval 
PAP SMEAR & RESULTS @ 6 months 
• 
Pap smear and HPV swab 
• 
Blood CD4 & HIV 
• 
LEEP Histology result disclosure 
• 
Pap smear form 
• 
Results 
• 
Colposcopy form 
PAP SMEAR & RESULTS @ 12 months 
• 
Pap smear and HPV swab 
• 
Blood CD4 & HIV 
• 
Pap smear form 
• 
Results 
• 
Colposcopy form 
PAP SMEAR & RESULTS @ 18 months 
• 
Pap smear and HPV swab 
• 
Blood CD4 & HIV 
• 
Pap smear form 
• 
Results 
• 
Colposcopy form 
PAP SMEAR & RESULTS @ 24 months & EXIT 
• 
Pap smear and HPV swab 
• 
Blood CD4 & HIV 
• 
Pap smear form 
• 
Results 
• 
Colposcopy form 
• 
Exit form 
• 
Exit study 
6 month interval 
6 month interval 
6 month interval 
6 month interval 
Not Amenable to 
Cryotherapy 

Chapter 3 – Study Design 
 
Cervical Treatment Study 
49 
 
Study Flow Diagram III (Study Tests) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CYTOLOGY 
Normal/ASCUS 
AGC 
HSIL/ASC-
H/HSIL 
INRO/ SCC / 
LSIL 
Inadequate Pap 
Exit, advise to 
repeat Pap or VIA 
after 6 -12 mos 
Colposcopy 
AND ECC 
Repeat Pap 
smear 
Refer to KNH 
as required 
HISTOLOGY 
Atypical Squamous 
Metaplasia/ NIL 
CIN 1 
CIN 2, CIN 3 CIS 
Carcinoma 
Exit, advise to 
repeat Pap or VIA 
after 6 -12 mos 
Not exited, 
repeat Pap after 
6 mos 
Randomize to either 
LEEP or 
Cryotherapy and 
follow up as per the 
protocol 
Refer to KNH  
Refer to KNH  

Chapter 3 – Study Design 
 
Cervical Treatment Study 
50 
 
Loss to Follow-up & Mortality 
Tracing of randomized participants 
If a randomized subject fails to appear for a scheduled study clinic visit then she will 
be contacted by phone the next day by the receptionist.  If the first phone call after a missed 
visit does not reach the patient or someone who is in contact with the patient, then calls will 
be repeated at least twice a week for two weeks.If the patient is reached by phone, another 
visit will be scheduledas soon as possible within one month.  If the patient also fails to return 
for this rescheduled visit, the receptionist will call again the following day.  If again the 
patient does not return for the next rescheduled visit (the third scheduled visit of its kind), or 
if at least 4 calls have been unsuccessful in reaching the subject, an attempt will be made to 
visit her at home by a community health worker.    If a home visit is unsuccessful in reaching 
the subject, or if home-visit is successful but the subject fails to return to the study, then she 
will be considered lost to follow-up (LTFU).  If a phone call or home visit reaches the 
subject, then an appointment will be made for the subject to return to the study clinic.  (See 
Study Tracing Diagram for randomized patients).   
Tracing of non-randomized participants 
If a non-randomized subject fails to appear for a scheduled visit, including 6-month 
repeat Pap smear visit after a prior LSIL or CIN1 resultshe will be contacted by phone the 
next day by the receptionist.  If the phone call does not reach the patient or someone who is in 
contact with the patient, then a second call will be made the following week.  If both calls are 
unsuccessful in reaching the subject, or if the visit is rescheduled but the subject again fails to 
show up, thenher Coptic Hope file will be flagged, and she will be considered LTFU.  If a 

Chapter 3 – Study Design 
 
Cervical Treatment Study 
51 
 
phone call or home visit reaches the subject, then an appointment will be made for the subject 
to return to the study clinic.   
Tracing of patients with new QA/QC Cytology results 
Both enrolled participants and patients who have been exited from the study may need 
to be contacted to receive new cytology results based on laboratory QA/QC.  Women whose 
final QA/QC cytology result has been downgraded from the initial result that was disclosed to 
them, or women whose final results do not require treatment (Normal, ASCUS) will be 
followed in the same manner as non-randomized subjects: two weekly phone calls and 
flagged Hope file.  These patients will be operationally considered lost at this same point.   
Women whose final results have been upgraded to ASC-H, HSIL, or SCC, and 
women whose final results are unsatisfactory but had at least one reading of ASC-H, HSIL, 
or SCC, will receive additional follow-up efforts.  This includes at least 6 phone calls over 4 
weeks, with at least one call over the weekend.  Home visits will also be conducted for these 
patients when possible.  These subjects will be defined as LTFU on a case-by-case basis 
when all efforts to contact them have been completed.   
Tracing of patients with cancer 
 
Any woman who receives an initial or final laboratory result of SCC (cytology) or 
ICC (histology), whether she is randomized, non-randomized, or exited, will receive the same 
extensive follow-up efforts as noted above,  This includes at least 6 phone calls over 4 weeks, 
including a phone call over the weekend, and a home visit when possible.  These subjects will 
be defined as LTFU on a case-by-case basis when all efforts to contact them have been 
completed.   
Documentation of tracing 

Chapter 3 – Study Design 
 
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All attempts at contacting the patient either through phone call or home visits will be 
documented in the participant’s chart notes.  All attempts at home visit will be recorded on 
the “Patient Contact” form.  If a subject is LTFU, this will be recorded on the “Patient 
Contact” form, in addition to reasons for loss.  If a subject withdraws or asks to dis-enroll 
from the study, the “Exit” form will be completed.    If a subject is determined to have died 
through phone call or home visit, then the “Verbal Autopsy” form will be completed.  
Information on loss or death will be shared with the Hope clinic team and social worker so 
that they may update their files. 
Statistical considerations for LTFU 
Those who are LTFU or dropout after randomization will contribute time and data to 
the outcomes of measurement for as long as they have remained in the study.  They will 
continue to remain in the arm to which they have been randomized and analyses comparing 
interventions will include these participants.  If, for example, they reach the 6 month time 
point but did not appear at 12 or 24 months, then data from this subject will be included until 
6 months after randomization in a survival analysis.The study coordinator and study doctor 
will oversee loss and mortality data in coordination with the receptionist. 

Chapter 3 – Study Design 
 
Cervical Treatment Study 
53 
 
Study Tracing Diagram for Randomized Participants 
 
 
 
 
If Ppt. misses 2 rescheduled visits  
(3 missed visits in a row, 
including the initial missed visit) 
Phone calls (2/week 
for 2 weeks) 
Reschedule visit 
(w/in 1mo) 
Ppt. not reached 
Ppt. reached 
Participant missed visit 
Home visit 
Ppt. not reached 
Ppt. reached but 
declines to return 
Ppt. reached   
Withdrawn 
LTFU 
(Flag Hopefile) 
Ppt. attends visit 
Ppt. misses visit 
Reschedule visit 
(w/in 1mo) 
Ppt. attends visit 
Ppt. misses visit 

Chapter 4 – Statistical Methods 
 
Cervical Treatment Study 
54 
 
 
 
Statistical Methods 
The sample size was calculated to detect a 10% difference in treatment outcomes 
between LEEP and cryotherapy (4% versus 14%)26 with 80% power and a 0.05 significance 
level.  Accounting for the possibility of a 20% loss-to-follow-up rate over two years, we 
estimated that 400 women with high grade lesions would need to be enrolled in the study 
with 200 women randomized to each arm.  It is estimated that 200 women in each arm will 
allow detection of a 0.25 log10 HIV virus level difference in cervical shedding between the 
two arms with greater than 90% power.  Based on results from an ongoing cervical cancer 
screening study implemented at the Hope Center in 2009, our estimation of the prevalence of 
high-grade intraepithelial lesions is about 18%.  Given this estimate and the number of 
women who are likely to be eligible for randomization, we calculate that we need to enroll 
2,400 women for initial screening. 
The primary analysis of the study will be to compare treatment outcomes between the 
LEEP and cryotherapy intervention arms in an intent-to-treat analysis.  Treatment outcomes 
will be measured by Pap smears taken every 6 months during two-year follow-up.  Pap 
smears demonstrating high-grade intraepithelial lesions will be considered positive and 
compared against negative or low-grade intraepithelial lesions.  A Chi-square test will be 
used to compare the percentage of positive Pap smears between the intervention arms at 6, 
12, 18, and 24 months.  Secondary analyses will compare cervical HIV-1 RNA viral shedding 
between the treatment arms.  A comparison of the average area under the curve (AAUCMB) of 
long-transformed HIV-1 RNA cervical viral loads will be performed between the two arms 
using an analysis of covariance (ANCOVA) model.  
Our analysis will include contraceptive history as a potential confounder.  While there 
has been some suggestion in the literature that HIV infectivity among women on oral 

Chapter 4 – Statistical Methods 
 
Cervical Treatment Study 
55 
 
contraceptives is increased,33, 34 a recent study from the UW did not show a significant 
increase in  levels of HIV RNA in cervical samples obtained from women on hormonal 
contraception.35  A more recent multicenter randomized controlled trial performed in Asia 
and Africa also did not find an association between hormonal contraceptive use and increased 
HIV transmission.36  However, increased viral shedding due to hormonal contraceptive use 
remains an important and interesting question and one that we will examine in our study. 
The analysis will control for immunological status through measurement of CD4 
count as well as presence of and duration on antiretroviral medications.  Given that the study 
will recruit patients from an antiretroviral treatment clinic, it is expected that the majority of 
subjects will be on antiretroviral medications (~75%).  Type and duration of antiretroviral 
drugs (ARVs) will be obtained through accessing clinical medical files and CD4 count 
measurements will be obtained regularly during study follow-up.  The impact of ARVs on 
recurrence of cervical intraepithelial lesions is unclear and may have minimal effect.37, 38  
Also, despite ARV use, HIV shedding has still been detected in the genital tract.39  Therefore, 
we are confident that the sample size will still be adequate to detect differences between 
treatment modalities among women on antiretroviral medications. 

Chapter 5 – Data Management 
 
Cervical Treatment Study 
56 
 
Data Management 
Introduction 
Data will be captured on paper forms or electronically using Open Data Kit (ODK) 
application which has a data collection component to be used on a mobile device, and a 
centrally managed data store component. ODK  is supported by the University of Washington 
(UW). Data will be cleaned, and analyzed at UW project offices located at KNH in Nairobi, 
Kenya.  This office, which supports several UW studies, will provide administrative and 
database management support to this research project.  Study data will be collected separately 
from Hope clinic data and will not be linked to the Hope dataset. The forms have been used 
in a recent cervical screening study and improvements have been made as a result.  Analysis 
of the data will be conducted using SPSS version 16.0 (SPSS Inc, Chicago, Illinois, USA) by 
UW statisticians and epidemiologists associated with the study.  Data will be managed by the 
Data Manager and the data clerk.  
 
See Appendix B for data collection forms 
Facilities 
Cervical Cancer Screening room at Coptic Hope Center for Infectious Diseases 
The on-site facilities available for cervical cancer screening include two examination beds, one office 
desk, and one computer, and at least one tablet PC.  Electronic and paper data collection forms and 
paper informed consent forms will be administered here.  The address and intake form, which 
captures patient identifier data will be completed on paper forms only.  
UW study clinic and laboratory at Coptic Hope Center for Infectious Diseases 

Chapter 5 – Data Management 
 
Cervical Treatment Study 
57 
 
At this site, there is one clinic room and laboratory dedicated to this study.  The clinic will 
have one examination bed, one desk, and one computer.  Data collection forms will be filled 
out at the study clinic and in the Cervical Cancer Screening room. Any paper data forms, 
including address and intake and lab request forms will be sent to the UW offices in KNH for 
scanning daily but returned for storage at this site, while the lab forms will be sent to the 
Lancet laboratory.  
UW data and administrative offices at Kenyatta National Hospital 
The study has an administrative and a  data management office in the UNITID building at 
KNH.  There are five computers, one laser printer,  one scanner and a one copier.  All 
computers except the data computer have internet access.  All computers have antivirus 
software which is kept up to date by the data manager.  Only non-identifiable data will be 
collected electronically and stored on a local ODK Aggregate (server) which is maintained by 
NASCOP.  All data collected using the ODK will be downloaded from the nNASCOP  server 
onto the data computer and converted in  SPSS format.   
Databases 
The study data will be recorded in SPSS, MS Access, or written notebooks and include: 
Data Collection Forms – this SPSS database includes all questionnaires that are 
electronically and manually filled at the study.clinic   In total there are 16 questionnaires to 
be filled  
• Enrollment 
• Pap Smear  
• Colposcopy 
• Randomization 

Chapter 5 – Data Management 
 
Cervical Treatment Study 
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• Treatment 
• Address and Intake 
• Shedding 
• Patient Contact 
• Verbal Autopsy 
• Exit 
• Cytology Report 
• Colposcopic Biopsy Histology Report 
• Endocervical Curettage Histology Report 
• LEEP Biospsy Histology Report 
• CD4 Report 
• Follow-up Form 
Cervical Cancer Screening Appointment and Tracking – this MS Access database will track 
patients from the Hope Center who are referred to the study clinic by scheduling 
appointments and recording dates that screening tests are performed. 
Laboratory – this database contains an inventory of all specimens collected, stored, and 
analyzed.  
Specimen Collection – a written notebook provides a written record that tracks when the 
specimens have been collected and where they are going.  Specimens include: 
• Blood for CD4 count 
• Blood for HIV viral level 
• Cervical swab for HIV viral level 
• Cervical swab for HPV 

Chapter 5 – Data Management 
 
Cervical Treatment Study 
59 
 
• Pap smear 
• Colposcopy-directed biopsy 
• Endocervical curettage specimen 
• LEEP specimen 
Storage – a written notebook which tracks specimens which are stored in the freezer and 
where they are kept.  Stored specimens include: 
• Cervical swab for HIV 
• Cervical swab for HPV 
• Blood plasma and cells for HIV 
Laboratory Results – a written notebook which tracks the results of laboratory analyses that 
are performed in Kenya.  Results tracked include: 
• CD4 count 
• Pap smear result 
• Colposcopy-directed biopsy result 
• LEEP biopsy result 
• Endocervical curettage biopsy result 
Management 
Entry  
   

Chapter 5 – Data Management 
 
Cervical Treatment Study 
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The data collection forms will be completed either manually on paper forms or electronically 
on ODK. The following collection forms will be completed manually in paper forms: , 
address and intake form (which captures patient identifier data), Cytology Report, 
Colposcopic Biopsy Histology Report, Endocervical Curettage Histology Report, LEEP 
Biospsy Histology Report and CD4 report, all of which serves as lab request forms.  
Each subject has a folder in which all paper forms and questionnaires are stored.  These 
folders are stored in a locked cabinet at the UW study clinic at Coptic.  Newly filled-out 
questionnaires are brought to the UW KNH data office from the study clinic daily.  
Questionnaires are scanned into the computer database the same afternoon, and folders are 
returned to the clinic the following morning.  Scanned data is verified by Cardiff Teleform 
software and later cross-checked against the paper questionnaire on the same day by the data 
clerk after it is exported into SPSS.    
For data captured electronically, only non-identifiable data will be collected electronically 
and stored on a local ODK Aggregate (server) maintained by NASCOP. The Address and 
Intake form which collects the patients identifiable information will be completed on paper, 
sent to the UW office in KNH for scanning daily, and returned for storage in the Coptic study 
clinic where they will be kept in a locked cabinet. Once the data is collected using the 
encrypted electronic forms, it will be transmitted to the Nascop server through an encrypted 
path.. As an added layer of security, all electronic data forms (even though they contain no 
identifiable data) are encrypted on the data collection devices prior to transmission to the 
local server. The Principal Investigator,  the Data Manager and the data collectors will have 
access to the ODK server  with different rights.Quality 
The data clerk maintains a data logbook where all the data entry queries or errors encountered 
during data entry are recorded.  Data entry queries or errors are then discussed with the study 

Chapter 5 – Data Management 
 
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staff at least once a week.  Discussions are held with both study staff and data clerk together 
at the study clinic and corrections are made to the database by the data clerk upon returning 
to the data office.  The data manager ensures that all errors are attended to on a regular basis. 
The data manager ensures that all the data is clean at all times.  Questionnaire (Address and 
Intake) data is checked for entry accuracy at the time of scanning.  In addition, data checking 
is done on the databases every week and the data manager takes responsibility for organizing 
the data checking process.   A summary report on the data quality and data entry accuracy is 
then produced by the data manager and distributed to the project investigators.  
Data checking is done using the following methods: 
Ranges and Validity rules  
A range of acceptable values and skip patterns (checks) has been inbuilt for all the 
appropriate variables during the programming of the data collection form using the xml form.  
Any values that fall outside this range cannot be accepted by the database.  Validity rules are 
also set where certain variables can only be entered if they comply with a particular rule.  For 
example, the database does not allow outside limit or blank entries for the patient 
identification numbers and all unreal dates are rejected.  The data manager works with the 
data clerk to identify any inconsistent data on a weekly basis.  Inconsistency checks are done 
when the files are in SPSS.  The manager then consults with study clinicians to resolve the 
inconsistencies.  
Line listings for data captured non-electronically  
The main objectives of line listings include:  
• identifying any errors made during data entry  

Chapter 5 – Data Management 
 
Cervical Treatment Study 
62 
 
• estimating the accuracy rate of the data clerk, monitor and asses his/her data entry 
performance  
The data manager produces 10% line listings of all the enrollment and follow-up files on a 
quarterly basis. The data team members then check the line listings against the hard copy 
questionnaires. Errors are highlighted on the line listings and the error rate approximated 
thereafter.  If the error rate is higher than 0.3% then the whole database should be checked.  
After the checking has been completed, the data manager lists all the corrections that need to 
be done in the patient charts on the data entry sheet; this helps the data entry clerk easily 
identify the corrections that need to be done.  
 
Missing values  
Restrictions have been put on all questions that are required to be answered. These checks 
prevent the interviewer from skiping any question that requires a response. 
Safety, Security, & Storage 
Data security in ODK 
 All data collection devices( Tablets) will have a security code for unlocking  to prevent 
unauthorized users 
 All the electronic forms will be encrypted before loading to the ODK collect 
 The data will be uploaded to Nascop server   through a secured pathPrivate key will be used 
to decrypt the data. ONLY the Data manager will have access to the private key 
 Once the data is decrypted , it will be converted into SPSS format.  
 All databases are backed up every Friday by saving the most current files on two CD 
disks and external harddrive and uploaded to the UW-server.  All computers are 
password-protected, preventing access by any unauthorized persons.  Data is backed 

Chapter 5 – Data Management 
 
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63 
 
up on a weekly basis by the data clerk and the data manager.  Data is saved on an 
external hard-drive that remains in the office as well as on a CD that is kept off-site.  
All data on CD disks will be password protected by the data clerk.    All patient 
records are filed according to numerical order of the patients' identification.  Folders 
are kept in a locked storage cabinet at the study clinic for reference by research 
personnel.  Once the subject completes the study or is lost to follow-up, her records 
are brought to the KNH office for storage.  Participant study ID will be generated by 
the  data manager who will be responsible for linking and de-linking data. 
Schedule 
Daily 
Electronic questionnaire entry – The nurses will complete the forms electronically and upload 
(send) the data to the ODK server. The data will then be downloaded from the server and 
saved onto the data computer in SPSS format 
Specimen entry – Specimens that are collected in clinic are entered into the Clinic Specimen 
CollectionBook.  Results are entered in the CD4 Results Book, Pap Smear Results Book, and 
Biopsy Results Book. 
 
 
 
 
 
 

Chapter 5 – Data Management 
 
Cervical Treatment Study 
64 
 
 
 
. 

Chapter 6 – Laboratory Procedures 
 
Cervical Treatment Study 
65 
 
Laboratory Procedures 
Sample collection  
• Study nurse will collect Pap smear specimens and cervical swabs for HPV and HIV 
• Study doctor will collect cervical biopsy specimen under colposcopy and perform 
endocervical curettage when necessary 
• Study nurse or lab assistant will collect blood specimens 
• Specimens will be gathered in the laboratory before transfer 
• Lab assistant or technologist will record details in lab book.  Information includes: 
o Specimen Study ID 
o Date  
o Visit type 
o Time sample was collected 
• Pap smear, cervical biopsy, and endocervical curettage specimens will be placed in a cool 
box and transported to the designated laboratory before 4 pm by the lab assistant or 
technologist.  Designated laboratory will record reception of samples in a book including: 
specimen study ID, date, time, and number of specimens.  Results will be filled in the 
relevant “Histology Report” and “Cytology Report”.   
• One set of blood samples will be sent to the Coptic Hospital for CD4 count.  These results 
will be filled in the “CD4 Report”. 
• One set of blood samples will be centrifuged at the study laboratory by the lab 
technologist located at the Hope Center and frozen in a -80OC freezer for storage.  
Shipment of samples for analysis of viral levels will be performed on these samples. 
• Cervical swabs for HIV will be prepared in the study laboratory and frozen in a -80OC 
freezer for storage.  Cervical swabs for HPV will be stored in storage medium 

Chapter 6 – Laboratory Procedures 
 
Cervical Treatment Study 
66 
 
(preservCyt) at <25 C.  Shipment of samples for viral analysis will be performed on 
these samples. 
Pap smear and cervical tissue biopsy 
• Papanicolaou test: after the application of a speculum, a cervex brush will be inserted to 
its full length into the endocervical canal so that the shorter outer brush hairs are in 
contact with the ectocervix. The cervex brush will then be gently pushed whilst being 
turned 5 times in an anticlockwise direction (2.5 complete turns), in order to collect cells 
from both the endo- and ecto-cervix. Care will be taken not to touch the tip of the brush in 
order to avoid cross-contamination. Using the brush, a Pap smear will then be prepared by 
smearing the brush on a clean glass slide and fixing immediately with 95% isopropyl 
alcohol for at least 30 minutes at the study clinic.  The slide will then be transported to the 
laboratory to be stained, and the cytology will be reported by a study pathologist from 
Aga Khan University Hospital using the Bethesda classification. 
• Samples from the colposcopy-directed biopsy of the cervix, endocervical curettage 
specimen and the LEEP specimen will be fixed in 10% buffered formaldehyde solution 
and transported for haematoxylin-eosin staining.  The histopathology results will be read 
by a study pathologist from Aga Khan University Hospital, and the biopsy samples will 
subsequently be preserved and fixed in paraffin.  Biopsy blocks will be collected and may 
be sent to the IARC for further analysis. 
Cervical swabs for HIV and HPV 
• Dacron swabs will be used to collect samples for HIV from the cervix.  Endocervical 
secretions will be collected by rotating the swab 360 degrees in the outer part of the 
endocervix.   
• For HIV-1 DNA testing, the dry swab will be stored as such in the -80OC freezer. 

Chapter 6 – Laboratory Procedures 
 
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• For HIV RNA testing, the swabs will be collected in a cryovial containing 1 ml of 
freezing media and then stored at -80OC. 
• Cervical samples for HPV will be taken using cervex brush. The brush will be inserted to 
its full length into the endocervical canal so that the shorter outer brush hairs are in 
contact with the ectocervix. The cervex brush will then be gently pushed whilst being 
turned 5 times (2.5 complete turns), in order to collect cells from both the endo- and ecto-
cervix. Care will be taken not to touch the tip of the brush in order to avoid cross-
contamination.The brush containing cervical cellular material will be placed in a vial 
containing PreservCyt media (Cytyc Corporation) and labeled with the subject 
identification number of the participant. The brush will be fully rinsed in the media by 
pressing 10 times against the bottom of the vial, forcing the brush hairs to separate. 
Finally the brush will be vigorously shaken in the media to remove any residual cells. The 
brush will NOT be left in the vial, but discarded. It is very important to close the vial very 
tightly to avoid possible leakage during transport. Cell samples will be stored at the Hope 
Center at <25 C, and then later transported to the US or to IARC in Europe. 
Shipping 
• The UW has extensive experience measuring HIV-1 viral RNA from cervical swabs and 
plasma.  While measuring plasma HIV-1 RNA viral levels is available in Kenya, HIV-1 
RNA analysis from cervical swabs has not been performed here.  In order to maintain 
high quality standards, samples will be analyzed in Seattle.  Plasma HIV-1 RNA will also 
be analyzed in the same laboratory so that the results, taken from two different body 
compartments on the same day, are comparable.  The KNH IRB has approved laboratory 
analysis of cervical samples in Seattle for a current study on cervical cancer screening and 
is therefore expected to approve similar testing for this study.  Analysis of samples locally 

Chapter 6 – Laboratory Procedures 
 
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68 
 
is dependent on significant funding to develop a laboratory locally that could perform 
PCR analysis. 
• Samples for HPV testing will be shipped to the IARC in France and then to the 
Netherlands or to the US directly where the PCR testing will be conducted.  The KNH 
IRB has also approved laboratory analysis of cervical samples in Europe for a current 
study (mentioned above) and is therefore expected to approve similar testing for this 
study.   
 
Analysis for HIV-1 viral levels 
• HIV swabs will be stored at -80°C until shipment to Seattle.  The swabs will be tested for 
HIV RNA using a Gen-Probe HIV-1 viral load assay (San Diego, California, USA) which 
has been validated for use in Kenyan HIV subtypes.40  The assay has a lower limit of 50 
copies/swab in genital secretions.  HIV-1 DNA will be examined in the cervical swabs by 
detecting proviral DNA using a nested PCR for the viral gag region which should detect 
as little as 1 copy of DNA.  This technique has been validated in a number of other 
studies.39, 41 
Analysis for HPV subtypes 
• Frozen pellets of exfoliated cervical cells collected in PreservCyt will be extracted and 
tested following standard operating procedures of the HPV Laboratory at CDC as 
implemented under the ongoing Quality Management System.  The Linear Array HPV 
Genotyping Test (Roche Diagnostics), based on L1 consensus PCR with type-specific 
hybridization, will be used.  The assay detects 37 HPV types: HPV6, 11, 16, 18, 26, 31, 
33, 35, 39, 40, 42, 45, 51, 52, 53, 54, 55, 56, 58, 59, 61, 62, 64, 66, 67, 68, 69, 70, 71, 72, 
73, 81, 82, 83, 84, 89, and IS39. The probe for HPV 52 (called XR) cross reacts with 

Chapter 6 – Laboratory Procedures 
 
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HPV 33, 35, and 58.  If the XR band and any cross-reacting types are identified, HPV 52 
will be identified with a type-specific quantitative PCR assay.  Samples negative for both, 
beta-globin and all HPV types will be reported as negative.  Results will be recorded in 
database and securely transmitted to Dr. Chung for linking to epidemiologic and clinic 
data.  
Quality Assurance and Quality Control (QA/QC) for Cytology and Histology Specimens 
A Cytology and Histology QA/QC procedures document is attached to the protocol as an 
addendum. 
• Loss of slides or blocks: If any cytology or histology slides or blocks are misplaced 
during the course of QA/QC procedures, the patient will be contacted to return for repeat 
Pap smear or biopsy, as necessary.   
Quality Assurance/Quality Control of Study Procedures 
• LEEP: The senior gynecologist on the study will work closely with the study doctor to 
ensure quality procedures with a low rate of complications through regular weekly 
meetings and contact through cell phone and e-mail. The complication rate and type will 
be reviewed on a bi-monthly basis.  This information will be collected by the “Adverse 
Event” form which hasbeen added.  All LEEP specimens will also be evaluated by 
histopathology with confirmatory reads as detailed above. 
• Cryotherapy: As with LEEP, the study doctor will be well trained and mentored by the 
study gynecologist to perform quality procedures with low rates of complications, and the 
complication rate and type will be reviewed on a bi-monthly basis. This information will 
be collected by the “Adverse Event” form which hasbeen added.   

Chapter 6 – Laboratory Procedures 
 
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• Colposcopy and endocervical curettage: The study gynecologist will supervise the study 
doctor to conduct colposcopy with biopsy and curettage.  He will receive support and in-
service trainings as deemed necessary.   
 

Chapter 7 – Ethics & Safety 
 
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Ethics 
A. INTRODUCTION 
Field and laboratory procedures will be performed in 
Nairobi, Kenya, while data analysis will be done in both 
Nairobi and Seattle, Washington.  The study will be reviewed 
by the Institutional Review Board (IRB) at the University of 
Washington and the Kenyatta National Hospital (KNH) Ethical 
Review Committee (ERC).  The study will not recruit subjects 
prior to approval from both the University of Washington IRB 
and the KNH ERC.  In accordance with the International 
Conference on Harmonisation Good Clinical Practices (ICHGCP) 
section 4.5.4, the investigators may deviate from protocol 
prior to IRB approval in order to eliminate immediate hazard 
to trial subjects.    
B. DECEPTION 
If any deception or withholding of complete information is required for this activity, 
explain why this is necessary and attach a protocol explaining if, how, when, and by 
whom subjects will be debriefed. 
No deception or withholding of complete information is 
required for this activity. 
C. SUBJECTS 
1.  How many subjects will you need to complete this study?  

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     Number: approximately 400                  Age range: above 18 
2.  Explain how you will achieve equitable subject representation in the following categories.  
If not applicable, justify exclusions. 
     a.  Age (minors, elderly):  N/A.Sexually active women are at greatest 
risk for cervical cancer.  Adolescents will be excluded 
due to their high rate of regression of cervical lesions, 
with 90% clearing the HPV virus by 24 months.  In terms of 
cervical dysplasia, it was been shown that in adolescents 
with high grade lesions, a majority will clear these 
lesions within 1 to 3 years.  The current ASCCP guidelines 
state that wome with HSIL cytologyshould be managed with 
colposcopy. 
     b.  Gender:  N/A. Cervical cancer affects the female reproductive 
system only 
c.  Ethnic and racial minority populations:  N/A.Study is performed in Kenya 
where the majority of the population is black 
3.  What characteristics (inclusion criteria) must subjects have to be in this study?  (Answer 
for each subject group, if different.)   
HIV-positive, female, over the age of 18, intact cervix, 
initiation of sexual intercourse 
4.  What characteristics (exclusion criteria) would exclude subjects who are otherwise 
eligible from this study?  (Answer for each subject group, if different.) 
HIV-negative, male, below 18 years of age, pregnant by 
clinical history or physical examination, post-hysterectomy, 

Chapter 7 – Ethics & Safety 
 
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post-cervical cancer treatment, history of a bleeding 
disorder, no prior initiation of sexual intercourse 
5.  Describe the subject recruitment strategies you will use for each group of subjects.  
(Attach advertisements, flyers, contact letters, telephone contact protocols, Health 
Sciences recruitment web site template, etc.) 
Adult female subjects who attend the Hope Center for 
Infectious Diseases will be informed by a doctor at the 
clinic of the study and their potential eligibility using 
the attached form (Pre-Screening Talking Points).  If the 
subject expresses interest, the doctor will contact the 
study nurse who will accompany the subject to the study 
clinic located less than 50 yards away. We will also use 
recruitment leaflets that will be distributed by the study 
staff at the Hope Center Reception. The leaflets will have 
the contact information of the study staff.   
6.  Explain who will approach subjects to take part in the study and how this will be done to 
protect subjects’ privacy. 
Doctors from the Hope Center who see the subjects at a 
medical follow-up or screening visit will approach subjects 
to take part in the study in a confidential, private room. 
We 
will 
also 
use 
recruitment 
leaflets that 
will 
be 
distributed by the study staff at the Hope Center Reception. 
The leaflets will have the contact information of the study 
staff.   

Chapter 7 – Ethics & Safety 
 
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7.  Explain what steps you will take during the recruitment process to minimize potential 
coercion or the appearance of coercion.  
Doctors or study staff who inform subjects of the study will 
follow the “Pre-Screening Talking Points” and let them know 
that their decision whether to participate in the study or 
not will not affect their clinical care at the Hope Center.  
In addition, women who wish to be screened but do not want 
to enter the study will receive free screening.  The study 
nurse will reiterate these points during the informational 
interview using the “Screening Talking Points” to gauge the 
interest of the patient before signing an informed consent.  
Talking Points are enclosed in the Appendix. 
8.  Will you give subjects gifts, payments, services without charge, or extra course credit?  
 No    
 Yes   If yes, explain:   
Subjects will receive free treatment for pre-cancerous 
lesions amenable to cryotherapy or LEEP.  Medical personnel 
will 
provide 
free 
medical 
services, 
gynecological 
examination, treatment, and free condoms.  Randomized 
subjects will also receive money for transportation to 
return to clinic. 
9.  Will any of the subjects or their third-party payers be charged for any study procedures?    
 No  
 Yes   If yes, explain: 
10. Where will the study procedures be carried out?  

Chapter 7 – Ethics & Safety 
 
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The study will be carried out in Nairobi, Kenya at the 
Coptic Hospital.  IRB approval for this PHE has been granted 
by Kenyatta National Hospital (KNH) in Kenya and the 
University of Washington (UW). 
D. RISKS AND BENEFITS 
1.  Describe nature and degree of risk of possible injury, stress, discomfort, 
invasionofprivacy, and other sideeffects from all study procedures, drugs and devices 
(standard and experimental), interviews and questionnaires.  Include psycho-social risks as 
well as physiological risks.  Include risks of withholding standard care or procedures if this 
is the case.  Do not reference the consent form.     
The study may collect personal information that may be 
embarrassing for the subject to talk about.  As part of the 
study, the subject may meet other patients from this clinic 
whom she may know from outside the clinic.  We will be 
collecting blood samples using a needle and syringe.  The 
puncture of the needle may be uncomfortable and leave a 
bruise and may cause infection or fainting.  Collection of 
biopsy samples through the pelvic exam may cause: mild 
discomfort as the subject is examined, small amount of 
bleeding from the vagina for 1-2 days, and mild to moderate 
cramping for 5 minutes that is similar to mild menstrual 
pain.  If the subject undergoes cryotherapy or LEEP, then 
she may experience mild abdominal cramps for less than 10 
minutes, discharge from the vagina for about 2 weeks, and/or 
bleeding for several days. Possible serious complications 

Chapter 7 – Ethics & Safety 
 
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include excessive bleeding or infection.  Additionally, some 
studies have shown that cervical treatment is associated 
with pregnancy complications including premature rupture of 
membranes, premature contractions, infections and cervical 
incompetence.  
If the subject undergoes a biopsy, she is requested not have 
sex for 10 days.  The reason is that if her partner is not 
infected with HIV, then he may be at greater risk of 
becoming infected with HIV after the biopsy procedure 
because of a possibility of increased HIV shedding from the 
cervix.  The participant may also be at increased risk of 
infection at the site of the biopsy.  If the subject has 
received cryotherapy or LEEP, then, for the same reasons as 
the biopsy, we suggest that she not have sex for 4 weeks 
after it is performed. 
Subjects will be prescribed antibiotics to protect against 
infection after cervical treatment or as treatment for an 
sexually transmitted infection or other vaginal infection 
discovered on pelvic exam.  Possible side-effects from 
antibiotic use include (but are not limited to) nausea or 
anorexia, 
vomiting, 
diarrhea, 
photosensitivity, 
rash, 
anaphylaxis possibly leading to death, dizziness, headache, 
confusion, tinnitus or hearing loss, seizures, arrhythmias, 
neutropenia, thrombocytopenia, hyper/hypoglycemia, tendon 

Chapter 7 – Ethics & Safety 
 
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rupture, liver disease, kidney disease and peripheral 
neuropathy. 
2.  Explain what steps you will take to minimize risks of harm and to protect subjects’ rights 
and welfare.  (If you will include protected groups of subjects (minors, fetuses in utero, 
prisoners, pregnant women, decisionally impaired or economically or educationally 
disadvantaged subjects) please identify the group(s) and answer this question for each 
group.) 
The clinical procedures of collecting blood, fluid, and 
tissue samples will only be performed by certified medical 
staff trained in these tasks.  Any complications arising 
from these procedures will be handled by a doctor and 
covered by the study.  
Study 
investigators 
may 
decide 
to 
withdraw 
a 
study 
participant from the study if they find further enrollment 
may expose the participant to harm or the investigator 
determines the participant will not be able to abide by 
study safety requirements, e.g. in the case of mental health 
problems or drug/alcohol dependency problems. 
 3.  Is it possible that you will discover a subject’s previously unknown condition (disease, 
suicidal intentions, genetic predisposition, etc.) as a result of study procedures?    
 No   
 Yes   If yes, explain how you will handle this situation. 
The intent of this cervical cancer screening study is to 
detect pre-cancerous and cancerous lesions of the cervix 
which may not be known to the subject and then treat those 

Chapter 7 – Ethics & Safety 
 
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lesions free of charge.  If the lesions are too large or are 
cancerous then we will refer them to the neighboring 
government hospital for subsidized care. 
4.  Describe the anticipated benefits of this research for individual subjects in each subject 
group.  If none, state “None.”   
The benefit of this research for the individual is that we 
may be able to detect and treat pre-cancerous disease of the 
cervix before 
it 
becomes 
cancerous 
and 
deadly. 
 
By 
participating in this study, an individual may avoid the 
development of a life-threatening disease. 
5.  Describe the anticipated benefits of this research for society, and explain how the benefits 
outweigh the risks.  
The benefit of this research for society is that it may 
identify the most effective method to treat cervical 
dysplasia in HIV-positive women who are at much higher risk 
for cervical cancer and who number in the millions in 
resource-constrained settings around the world.  Results of 
this research may impact international guidelines and the 
way millions of dollars of donor funding is spent on the 
care of HIV-positive women. 
As discussed above, the medical care offered through the 
research conforms to the standard of care established by the 
Kenyan MOH at tertiary care and provincial level health care 
facilities.  Options are available to clients enrolling in 
the study to obtain Pap smears at these locations along with 

Chapter 7 – Ethics & Safety 
 
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cryotherapy and LEEP treatment.  At the same time, the 
treatment interventions that are being offered in the study 
do not offer unreasonable risks and provide likely clinical 
benefit.  Both procedures are widely recommended in both 
developing and developed settings and one method is not 
known to be better than the other among HIV-positive women.  
As previously discussed, given the paucity of evidence-based 
literature there is scientific and medical equipoise in 
addressing this question and offering these two treatment 
methods. 
The benefits of the procedures being offered outweigh the 
risks.  The risks of LEEP and cryotherapy are low.  In the 
study previously mentioned from Zambia, Pfaendler, et al. 
found that the overall complication rate of LEEP to be 3.7%, 
all of which was managed on-site in the clinic.20  Likewise, 
in a study of cryotherapy in India, the overall complication 
rate was found to be 3.0%.21  Both LEEP and cryotherapy may 
result in infection or bleeding, though the rates are low 
and the great majority can be managed in the clinic where 
the procedure was performed.  Pfaendler et al. found 
bleeding as a complication in 14/697 (2.0%) and infection in 
12/697 (2.0%) while performing LEEP.  Nene et al. in the 
study from India mentioned above had 9 (1.9%) cases of mild 
bleeding and infection in 8 (1.4%) cases.  The benefits of 
treatment through LEEP and cryotherapy, on the other hand, 

Chapter 7 – Ethics & Safety 
 
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are very high.  It has long been known that HIV-positive 
women are at higher risk of cervical disease and faster 
progression of lesions.42, 
43  From preliminary studies 
performed on our HIV-positive patient population, we have 
found that the prevalence of high-grade lesions is around 8% 
in 
women 
30-39 
years 
old 
and 
taking 
antiretroviral 
medications.44  Additionally, studies have shown that either 
method of treatment is extremely effective in treating CIN.27 
E. CONFIDENTIALITY OF RESEARCH DATA 
1.  Will you record any direct subject identifiers (names, Social Security numbers, patient, 
hospital, laboratory or claim numbers, addresses, telephone numbers, locator information, 
etc.)  
No   
 Yes   If yes, explain why this is necessary and describe the coding system 
you will use to protect against disclosure.   
We will be recording names and assigning a study number that 
will be used on all study visits.  This is to ensure 
accurate follow-up of study participants.  This will be 
handled by the senior data analyst. 
2.  Will you retain a link between study code numbers and direct identifiers after the data 
collection is complete?  
No   
 Yes   If yes, explain why this is necessary and for how 
long you will keep this link.   
The link between the study participant’s name and study 
number is necessary to facilitate follow-up during the 1 
month study period.  This link will no longer be needed 
after follow-up is completed and will be removed after 5 

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years.  This will be handled by the senior data analyst.  
Data and specimens will be stored for 10 years after 
completion of study follow-up before being destroyed. 
3.  Describe how you will protect data against disclosure to the public or to other researchers 
or non-researchers.  Explain who (other than members of the research team) will have 
access to data (e.g., sponsors, advisers, government agencies, etc.).          
All names and numbers will remain in confidential files that 
are accessible only to the investigators and study staff.  
Computer 
databases 
containing 
information 
about 
study 
subjects will be protected by passwords which allow access 
to only the investigators.    
Notebooks, folders and CDs will move between the study 
clinic site and the KNH data office in a direct manner to 
minimize handling of data.  Information will be transported 
by private vehicle used by the study.  There will be two CDs 
to back up study data, one to be kept with the administrator 
at an off-site location and one with the senior data 
analysis in a locked closet at KNH.  Data files on the 
computer and CDs will be password protected, accessible only 
by data staff.  Additionally, patient identifying data will 
be kept in a separate, locked folder from the clinical data 
to maximize confidentiality when reading clinical materials.  
All 
data, 
including 
physical 
medical 
files, 
will 
be 
physically locked when not in transport – both at the study 
site and at the office at KNH – to assure that only 

Chapter 7 – Ethics & Safety 
 
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designated staff will have access to the files.  The study 
coordinator 
will 
be 
responsible 
for 
ensuring 
patient 
confidentiality for both electronic data and the medical 
files. 
4.  Will you place a copy of the consent form or other study information in the subject’s 
medical or other personal record?   
 No   
 Yes.  If yes, explain why this is necessary. 
5.  Do you anticipate using any data (information, specimens, etc.) from this study for other 
studies in the future?   
 No  
 Yes If “Yes,” explain and include this information in the consent form.    
Specimens may be tested for HPV at a later date.  Data and 
specimens are requested to be stored from the participant 
for 10 years following enrollment for possible use in other 
HIV and cervical studies in the future.  Approval from the 
UW and KNH IRBs will be obtained before any of these studies 
are performed. 
F. ADDITIONAL INFORMATION 
1.  If the study will involve radiation exposure to subjects, e.g., X-rays, radioisotopes:  
 Pending   
 Approved 
 NA 
2.  Will you need access to subjects’ medical, academic, or other personal records for 
screening purposes or during this study?   
 No   
 Yes.  If yes, specify types of records, what information you will take from the 
records and how you will use them.   

Chapter 7 – Ethics & Safety 
 
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Subjects will be enrolled at the Hope Center for their HIV 
care and their medical records contain information on what 
type of treatment they have received and the severity of 
their condition.  We will access these records to determine 
what type of antiretroviral treatment they’ve been exposed 
to 
and 
their 
clinical 
status 
according 
to 
medical 
examination and laboratory values including CD4 count.  This 
information is included in the consent form. 
3.  Will you make audio-visual or tape recordings or photographs of subjects?  
 No   
 
Yes.  If yes, explain what type of recordings you will make, how long you will keep them, 
and if anyone other than the members of the research team will be able to see them. 
4.  Will your study involve use of equipment involving energy input to the subjects (EMG, 
EKG, MRI, ultrasound, etc.)? 
 No   
 Yes.  If yes, attach documentation that all equipment will be tested regularly or 
describe safety testing procedures you will use. 
G. REPORTING OF ADVERSE EVENTS 
1.  Describe how unanticipated adverse events related to study participation will be reported 
to the local IRB/Ethics Committee.     
The IRBs of host institutions and the sponsor, CDC, will be 
notified of adverse events by the PI within 72 hours of his 
becoming aware if the adverse events fall into one of two 
categories: 
1. related to research procedures and unexpected and severe 

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2. related to research procedures and expected, but more 
severe or occurring at a greater frequency than expected 
Severe adverse events related to the study include any death, 
any 
non-HIV-related 
hospitalization, 
severe 
infection 
including PID, severe bleeding or cramping and severe cervical 
stenosis.  Any adverse events will be recorded by study staff 
on Adverse Events Reporting Forms at the time of the incident 
or at the next study visit.  Documenation of severe adverse 
events which meet the criteria listed above will be brought to 
the attention of study PIs within 24 hours by the study doctor 
and/or study nurse via phone or email, and be assessed. 
Other Adverse Events that do not meet the criteria above will 
be reported to the IRBs as per their specific guidelines..  
All serious and non-serious adverse events will be reported to 
the DSMB during its regular meetings.  All Adverse Event 
reports that are sent to the IRBs and DSMB will also be sent 
to the study sponsor.   

Chapter 7 – Ethics & Safety 
 
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Adverse Events 
Specification of Safety Parameters 
Safety parameters for this study will include signs and symptoms of local genital 
irritation and of systemic effects that could be related to either Pap smear screening or study 
treatment procedures (LEEP or cryotherapy), side effects from any medications prescribed as 
part of this study, and any other health complications that subjects may experience while 
enrolled in this study.  Methods and Timing for Assessing, Recording, and Analyzing Safety 
Parameters. 
Adverse Events (AEs) 
An AE is any untoward medical occurrence or unintended clinical sign, including an 
abnormal laboratory finding, symptom or disease,in a clinical investigation subject that 
occurs during the course of the study. The occurrence is considered an AE whether it is 
associated with the use of a medical treatment or procedure, or considered unrelated to that 
medical treatment or procedure. The occurrence of an AE may come to the attention of study 
personnel in various ways--during study visits, during interviews of a study participant 
presenting for medical care, or during a review by a study monitor.  
All AEs will be: 
• recorded on the appropriate AE CRFby the study physician and nurses 
• summarized by the data team 
• followed through resolution by a study clinician 
• reviewed and evaluated by a study clinician 
• Study-related SAEs will be immediately reported to the host IRBs and ERCs, 
and to the study sponsor. 
In this study, the following situations will be considered AEs: 
1. Occurrences related to Pap smear, LEEP or cryotherapy procedures: 

Chapter 7 – Ethics & Safety 
 
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Symptoms such as abdominal pain that lasts longer than 2-3 days, vaginal bleeding 
and/or discharge, fever, or chills will be assessed at each study visit after obtaining either Pap 
smear or cervical biopsy.   
2. Occurrences related to side effects from prescribed medications related to the study: 
If a medication(s) are prescribed for treatment of an infection, subjects will be 
assessed for any potential side-effects at each visit.  These symptoms may include: upset 
stomach, vomiting or diarrhea, sensitivity to light, rash, severe allergic reaction that could 
cause death, dizziness, headache, confusion, ringing in the ears or hearing loss, seizures, 
heart problems, blood disorders, problems with blood sugar, liver disease, kidney disease, 
and pain or numbness in the arms or legs.   
3. New medical problem(s) or worsening of an existing medical problem(s) 
 
 
Study staff will inquire about any new medical problem or worsening of an existing 
medicalproblem since the subject’s last visit.  
Any medical condition that is present at the time of the Enrollment Visit should be 
considered as the baseline for this pre-existing condition and not reported as an adverse 
event.  However, if there is an increase in the frequency or severity of the condition, it will be 
recorded as an adverse event.  Anticipated day-to-day fluctuations of pre-existing conditions, 
which do not represent clinically significant exacerbation, will not be considered adverse 
events. 
All AEs will be graded for severity and relationship to study procedures or treatment.  
 
Classification of Severity of Adverse Event: 

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For adverse events that do not fall under the three categories listed above (occurrences 
related to study procedures, medications, or new or worsening existing medical problems), 
the following guidelines will be used to quantify severity: 
Mild: adverse events that require minimal or no treatment and do not interfere with the 
patient’s daily activities. 
Moderate: adverse events that result in a low level of inconvenience for the patient’s daily 
activities or concern with the study treatment or procedures.  Moderate events may cause 
some interference with functioning. 
Severe: adverse events that interrupt a patient’s usual daily activity and may require systemic 
drug therapy or other treatment.  Severe events are usually incapacitating. 
Life threatening:  any adverse event that places the patient or subject, in the view of the 
investigator, at immediate risk of death from the reaction as it occurred, i.e., it does not 
include a reaction that, had it occurred in a more severe form, might have caused death. 
Changes in the classification of severity of an AE should be documented to allow an 
assessment of the duration of the event at each level of intensity.  Adverse events 
characterized as intermittent require documentation of onset and duration of each episode. 
All AEs will be categorized by the study physician.   
 
Relationship of Adverse Event to Study Procedures: 
All AEs must have their relationship to study procedures assessed by the study 
clinician.  
The terms used to assess the relationship of an AE to the study procedures are: 

Chapter 7 – Ethics & Safety 
 
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1. Related- There is a reasonable possibility that the AE may be related to the study 
agent. 
2. Not Related- There is not a reasonable possibility that the AE is related to the 
study agent. 
When an AE is assessed as “not related” to study agent(s), and alternative etiology, 
diagnosis, or explanation for the AE should be provided.   
 
Outcome of Adverse Event: 
 
All AEs must have their outcome assessed as either “resolved without sequelae”, 
“resolved with sequelae”, “ongoing”, “death”, “unknown.”  The study clinican is responsible 
for assessing outcomes and recording them on the appropriate CRF.   
Definition of Serious Adverse Event (SAE) 
An SAE is defined as an AE that meets one of the following conditions: 
• Death during the period of protocol defined surveillance 
• Life-threatening event (defined as a subject at immediate risk of death at the time of 
the event) 
• An event requiring inpatient hospitalization or prolongation of existing hospitalization 
during the period of protocol defined surveillance  
• Results in congenital anomaly or birth defect 
• Results in a persistent or significant disability/incapacity 
• Any other important medical event that may not result in death, be life threatening, or 
require hospitalization, may be considered a serious adverse experience when, based 

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upon appropriate medical judgment, the event may jeopardize the subject and may 
require medical or surgical intervention to prevent one of the outcomes listed above. 
 

Chapter 7 – Ethics & Safety 
 
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Data Safety and Monitoring Plan 
Introduction 
The data safety and monitoring board (DSMB) will act in advisory capacity to the 
CDC, UW, KNH, UoN, Coptic Hospital, and IARC – WHO to monitor patient safety and 
evaluate treatment interventions for this study.  Dr. Scott McClelland (UW) will be Chairman 
of the DSMB. 
After its first meeting around study initiation, the DSMB will be responsible for 
reviewing interim safety and efficacy analyses at five time points during the 3 year study 
period. These meetings and reviews of interim analyses are expected to occur at 
approximately 4, 9, 15, 21, and 27 months after study initiation. 
1) The first meeting will take place when 100 participants have received the study 
intervention, and this is expected to occur around 4 months after study initiation.   
2) The second meeting will take place when 75 participants have received Month 6 
Pap smear results, and this is expected to occur around 9 months after study 
initiation.   
3) Thereafter, DSMB meetings and interim analyses will occur every 6 months after 
this second meeting or approximately at 15, 21, and 27 months after study 
initiation. 
 
The DSMB will have the following responsibilities: 
1. Review the research protocol and plans for data safety and monitoring; 

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2. Evaluate the progress of the trials, participant recruitment, accrual and retention, 
participant risk versus benefit, and other factors that can affect study outcome; 
3. Protect the safety of the study participants and review interim or cumulative data for 
evidence of  adverse events; 
4. Review safety and progress report from an unblinded statistician who will use both 
blinded and unblinded data; 
5. Make recommendations to the institutions involved and the PIs concerning 
continuation, termination or other modifications of the trials based on the observed 
beneficial or adverse effects of the treatment under study; 
6. Review report on interim analysis of efficacy in accordance with stopping rules 
which are clearly defined in advance of data analysis and have the approval of the 
DSMB; 
7. Ensure the confidentiality of the trial’s data and the results of monitoring; and 
8. Review issues that have been identified by the study team and upon request by the 
study team, review problems that are identified by the monitors in relation to patient 
safety. 
 
DSMB Recommendations 
The DSMB may conclude each review with recommendations to continue the trial 
without change, modification of the trial, or termination of the trial based on pre-defined 
criteria established at the beginning of the trial. 
Recommendations for modification of the design and conduct of the trial may 
include: 
1. Modifications of the study protocol based upon the review of the safety data; 

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2. Suspension or early termination of the study because of serious concerns about 
subjects' safety, inadequate performance or rate of enrollment; 
3. Suspension or early termination of the study because study objectives have been 
obtained according to pre-established statistical guidelines; 
4. Optional approaches for trial design when the DSMB determines that the 
incidence of primary study outcomes is substantially less than expected, such as 
recommendations to increase the number of trial centers or extend the recruitment 
period/follow-up period; and, 
Confidentiality 
Confidentiality will be maintained during all phases of DSMB review and 
deliberations. Only voting members of the DSMB will have access to interim analyses of 
outcome data by treatment group. Exceptions may be made when the DSMB deems it 
appropriate. DSMB members must maintain strict confidentiality concerning all privileged 
trial results ever provided to them. The DSMB will review data only by masked study group 
(such as ‘Intervention 1’ versus ‘Intervention 2’ rather than cryotherapy versus LEEP) unless 
the DSMB determines that the identities of the groups are necessary for their decision-
making. Any request to unmask data must be made in writing.  
Membership 
The DSMB will be composed of four members chosen from both the U.S. and Kenya. 
The members include: 
1. 
R. Scott McClelland, MD, MPH, Associate Professor of Medicine, 
Epidemiology and Global Health, UW; 
2. 
Elizabeth Brown, ScD, Associate Member, FHCRC, Research Associate 
Professor, Department of Biostatistics, UW; 

Chapter 7 – Ethics & Safety 
 
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3. 
James Kiarie, MBChB, MMed, MPH, Professor of Obstetrics/Gynecology, 
KNH; and  
4. 
David Eschenbach, MD,  Professor, Women's Health, Chairman, Department 
of Obstetrics and Gynecology, UW 
5. 
Ad hoc specialists may be invited to participate as non-voting members at any 
time if additional expertise is desired. 
Meetings 
The first meeting will take place either prior to trial initiation or early after the trial 
has been initiated to discuss the protocol. A designated DSMB member and the PIs will 
prepare the agenda to  review initiation of the trial and reporting of adverse events. The 
DSMB will also review monitoring guidelines and approve or give recommendations.. 
Once the trial has been initiated, the DSMB will meet, as outlined above, to examine 
the accumulated safety and enrollment data, review study progress and discuss other factors 
(internal or external to the study) that might impact continuation of the trials as designed. A 
DSMB meeting may be requested by DSMB members or the Principal Investigators at any 
time to discuss safety concerns, and includes the occurrence of any Significant Adverse 
Event (SAE) that is associated with the study. The study team will provide the logistical 
management and support of the DSMB meetings. The meetings will be convened by 
teleconference to decrease travel cost. An emergency meeting of the DSMB may be called at 
any time should questions of patient safety arise. 
Meeting Format 
The meetings will mainly be open sessions. These sessions will be attended by the 
Principal Investigators or designee. Other research staff may attend the open sessions but this 
is up to the discretion of the PI. Issues discussed at open sessions will include conduct and 

Chapter 7 – Ethics & Safety 
 
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progress of the study, including patient accrual, compliance with protocol, and problems 
encountered. Patient-specific data and treatment group data will not be presented in these 
sessions. 
Closed sessions may be requested by the DSMB at any time and will be attended by 
voting DSMB members and the unblinded statistician. Any other trial staff may be requested 
to attend by the DSMB. All safety and efficacy data will be presented at this session. The 
discussion at the closed session is completely confidential. 
Should the DSMB decide to issue a termination recommendation, the full vote of the 
DSMB will be required. In the event of a split vote, majority vote will rule and a minority 
report will be appended. An appeal may be filed by study PIs if a termination decision is 
made. 
Study Stopping Criteria 
The DSMB may recommend stopping the study for the following reasons: 
• The data show a significantly increased risk of serious adverse effects in one of the 
treatment arms.   
• Interim efficacy analyses show significant treatment benefits or futility in the one 
treatment group.  The interim efficacy analyses are based on pre-specified stopping 
boundaries for the primary endpoint of the study which preserve the study wide Type 
I error rate.    
• It becomes clear that successful completion of the study is not feasible (e.g. there is 
an excess of patient dropout, missing data, lack of recruitment etc). 
Interim Efficacy Analyses 

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This study will employ interim analyses to assess accumulating study data for early evidence 
of treatment efficacy.  The primary outcome, recurrence of cervical intraepithelial neoplasia 
grade 2 or 3, will be compared between groups at the following approximate times: months 9, 
15, 21 and 27, and for DSMB safety, upon cumulative enrollment and intervention of 
100patients.  The decision criteria for stopping the study at each interim analysis are based on 
O’Brien-Fleming superiority boundary with Type I error controlled at alpha-levelα = 0.05. In 
the event that interim analyses are conducted at times other than the preplanned times (e.g. 
unequal information accrual) the stopping criteria will be adjusted to maintain overall type I 
error rate of α=0.05.  We will use Lan-DeMets alpha spending approach,to make the 
necessary adjustments. The decision criteria for stoppage are based on a power of 80%to 
detect a treatment group difference at the end of study. 
Report 
A formal report prepared by an assigned administrator will be reviewed and approved 
by the DSMB chair, who will prepare a summary. The minutes and summary will be sent to 
the full DSMB within three weeks of the meeting. Once approved by the DSMB, the chair of 
the DSMB will sign on behalf of the board and the report will be forwarded to the 
participating institutions within 4 weeks of each meeting. The PIs will submit the results of 
these meetings to the UW Institutional Review Board (IRB),the KNH Ethics Review 
Committee (ERC), and the Centers for Disease Control (CDC) which  is the study sponsor. 
Each report will conclude with a recommendation to continue or to terminate the study. This 
recommendation will be made by formal majority vote. A termination recommendation may 
be made by the DSMB at any time by majority vote. The report will not include un-blinded 
data or any discussion of the un-blinded data. 

Chapter 7 – Ethics & Safety 
 
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Any new findings discovered by the DSMB during the course of the study that may 
affect the willingness of subjects to remain in the study will be shared by the study doctor or 
nurse through direct discussions and printed pamphlets.   

Chapter 7 – Ethics & Safety 
 
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Sponsor Monitoring 
As the study sponsor, the Centers for Disease Control (CDC) may conduct monitoring 
or auditing of study activities to ensure the scientific integrity of the study and to ensure the 
rights and protection of study participants.  Monitoring and auditing activities may be 
conducted by: 
• CDC staff (“internal”) 
• authorized representatives of CDC (e.g., a contracted party considered to be 
“external”) 
• both internal and external parties 
 
Monitoring or auditing may be performed by means of on-site visits to the 
Investigator’s facilities or through other communications such as telephone calls or written 
correspondence.  The visits will be scheduled at mutually agreeable times, and the frequency 
of visits will be at the discretion of CDC.  During the visit, any study-related materials may 
be reviewed and the Investigator along with study staff should be available for discussion of 
findings. 
The study may also be subject to inspection by regulatory authorities (national or 
foreign) as well as the IECs/IRBs to review compliance and regulatory requirements. 
 
 
 

Acronyms 
 
Cervical Treatment Study
 
 
98 
 
Acronyms 
AIDS – Acquired Immunodeficiency Syndrome 
CCSP – Cervical Cancer Screening Program, Coptic Hope Center for Infectious Diseases 
CDC – Centers for Disease Control 
CIN – Cervical Intraepithelial Neoplasia 
CIS – Carcinoma in situ 
CVL – Cervicovaginal Lavage 
HIV – Human Immunodeficiency Virus 
HPV – Human Papillomavirus 
IRB – Institutional Review Board 
KNH – Kenyatta National Hospital 
LEEP – Loop Electrosurgical Excision Procedure 
OGAC – Office of the Global AIDS Coordinator 
Pap – Papanicolaou 
PEPFAR – President’s Emergency Plan for AIDS Relief 
PHE – Public Health Evaluation 
RNA – Ribonucleic Acid 
UNITID – University of Nairobi Institute of Tropical and Infectious Diseases 

Acronyms 
 
Cervical Treatment Study
 
 
99 
 
UoN – University of Nairobi 
USA – United States of America 
USG – United States Government 
UW – University of Washington 
VIA – Visual Inspection with Acetic Acid

Pre-screening Talking Points – Version 4.0 December 1, 2010 
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Pre-Screening Talking Points for Clinic Staff 
Dr. Michael Chung is conducting a research study at the Hope Center.  This study 
examines what methods may best treat disease in a woman’s private parts called the cervix.  
This disease is like a wound on the skin and can go away by itself.  But in some cases, 
especially in women who have HIV, these wounds might become cancer.  The study wants to 
see how treatment can prevent this problem from becoming cancer and how treatment might 
affect HIV.  Those patients who enroll in the study will be given free screening for cervical 
disease that may develop into cancer and will also provide free treatment.  Dr. Chung and 
other doctors from the University of Washington in America, the University of Nairobi, and 
Coptic Hospital are leading this study.  You appear to be eligible to be in this study and can 
possibly enroll in this trial if you like.  The study offers free screening for cervical disease 
and if treatment is received, further follow-up free testing and treatment over 2 years. 
Participation in the research study is voluntary and does not affect your medical care 
at the Hope Center in any way.    Free screening for cervical disease is also available at the 
Hope Center Cervical Cancer Screening Program even if you do not participate in this study. 
The study may help you detect cervical disease that may be treated and prevent 
cervical cancer in the future.  Are you interested in learning more about the study from the 
study nurse or doctor?  They can explain the study in more detail if you are interested.  If you 
are, we will send you to the study clinic right now.  If not, you may go home or continue 
receiving care here from the pharmacy and laboratory. 
 

Screening Talking Points– Version 4.0 – December 1, 2010 
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Screening Talking Points for Study Staff 
You are being invited to participate in a research study at the Hope Center.  
The study is being conducted by Dr. Michael Chung and other doctors from the 
University of Washington in America, Kenyatta National Hospital, and the Coptic 
Hospital.  This study examines what methods may best treat disease of the female 
private parts called the cervix, and how treatment affects HIV levels.  This disease is 
like a wound on the skin and can go away by itself.  But in some cases, especially in 
women who have HIV, these wounds might become cancer.   
You do not have to join the study.  Whether or not you join the study will not 
impact your care at the Hope Center in any way.  If you are eligible and participate in 
the study, you will receive free screening and treatment that will help detect and 
remove disease from your cervix that may lead to cancer.  You will be asked 
questions and undergo a pelvic examination where our doctor and nurse can examine 
you to detect any areas that look like disease.  After undergoing screening, we will 
ask you to return in 2 weeks to receive the results from the test.  Most likely you will 
not need further treatment or tests after this.  If, however, we find a result that might 
be disease, we will conduct another test to confirm the disease and the need for 
follow-up treatment.   
If you are positive for cervical disease, you may enroll in a study to receive 
treatment. If you do, we will ask you to return every week for 3 weeks to examine you 
and test for any HIV that may be shed from your cervix after treatment.  We will 
follow you for the next 2 years at 6 months intervals to test if there is any further 
disease.  If it does, we will treat you.  We will also draw blood from you in order to 

Screening Talking Points– Version 4.0 – December 1, 2010 
Cervical Treatment Study 
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see how much HIV is in your blood and what is your CD4 count.  All of this is free of 
cost. 
 Free screening for cervical disease is also available at the Hope Center 
Cervical Cancer Screening Program regardless of whether you participate in this 
study or not.You are referred to us because the clinical officer has determined that 
you are a woman who may be eligible for this study. 
• Are you over 18 years of age? 
• Are you pregnant? 
• Have you had a hysterectomy? 
• Have you ever received treatment for cervical disease? 
• Have you ever had a problem with bleeding? 
• Have you initiated sexual intercourse? 
If you are interested in the study, I will explain more about it from the 
informed consent form which I will give or read to you.  If you still want to be in the 
study after reading or being read the informed consent, you can sign the form and we 
can enroll you in the study 

Post-Medical Care Information—Version 1.0 – August 01, 2011 
 
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103 
 
Post-Medical Care Information 
Cervical Cancer Screening 
 
 
Pap smear or biopsy 
 
After receiving a Pap smear or biopsy, you may have any of the following symptoms which 
are normal: 
 
• 
Slight belly discomfort (like menstrual cramps, should not last more than 1-2 days) 
• 
Slight bleeding from the vagina 
 
We recommend you take paracetamol or ibuprofen for pain or cramps. 
 
It is very uncommon to have severe problems but if you experience any of the following, 
please notify the clinic or screening staff (see contacts below) right away: 
 
• 
Pain in the belly that lasts longer than 2-3 days 
• 
Much bleeding from the vagina  
• 
Bleeding from the vagina that is increasing in amount, or comes with belly pain 
• 
Fever, chills 
 
After a biopsy, it is important to wait 10 days before having sex. This will protect you and 
your partner from infection. (Please discuss with the screening nurse or doctor if you cannot 
wait and don’t forget to take condoms!) 
 
 
Treatment (cryotherapy or LEEP) 
 
After receiving treatment, you may have any of the following symptoms which are normal: 
 

Post-Medical Care Information—Version 1.0 – August 01, 2011 
 
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104 
 
• 
Belly pain like during your period (should not last longer than 1-2 days) 
• 
Slight bleeding from the vagina for up to 1 week 
• 
Clear fluid from the vagina (as long as 2 weeks) 
 
The following symptoms are not normal and you should contact screening staff and have 
medical attention as soon as possible if you have: 
 
• 
Severe belly pain 
• 
Bleeding from the vagina that continues or is a large amount  
• 
Fever, chills 
• 
Cloudy (white) fluid from the vagina 
 
 After treatment, it is important to wait 4 weeks before having sex. This will protect you and 
your partner from infection. (Please discuss with the screening nurse or doctor if you cannot 
wait and don’t forget to take condoms!) 
Medications 
You may receive medications (antibiotics) after treatment or to treat an infection found during 
your exams. Please follow the directions about how to take the medications carefully. If you 
have a severe problem after taking the medication or have any of the follow symptoms, please 
stop the medication and contact screening staff: 
• 
upset stomach, vomiting 
• 
severe diarrhea or diarrhea with blood 
• 
sensitivity to light, rash 
• 
dizziness, severe headache, confusion, ringing in the ears or hearing loss  
• 
seizures (uncontrolled jerking of the body) 
• 
heart problems 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Screening Staff Contacts: 
 
**EMERGENCY NUMBERS (24 HOURS):  020-272-2710 or 0733-771-288 
• 
Office 1: 0728-456-540 
• 
Office 2: 020-271-2947 
• 
Dr. Michael Chung:  020-271-2947 
• 
Dr. Nelly Mugo:  020-273-6744 
• 
Dr. Samir Sakr:  020-272-4737 

Information for Spouses—Version 1.0 – August 01, 2011 
 
Cervical Treatment Study 
105 
 
 
Information for Spouses and Partners 
Cervical Cancer Screening and Treatment 
 
Treatment (cryotherapy or LEEP) 
Your wife or partner has undergone the following treatment as part of a cervical cancer 
screening and treatment program: 
Cryotherapy 
 
 
 
LEEP 
 
 
 After treatment, it is important to wait 4 weeks before having sex. This is because HIV 
shedding may increase substantially (but temporarily) at the site of cryotherapy or LEEP. This 
shedding may increase the risk of HIV transmission to an uninfected partner or lead to HIV 
re-infection. If abstinence is impossible during the healing period, it is important to use a 
condom every time you have sex for at least 4 weeks after treatment. 
 
 
 
 
 
 
 
 
 
 
 
Screening Staff Contacts: 
If you need more information, you may call the following numbers Mon-Fri 
between 8am and 5pm: Office 1: 0728-456-540 
• 
Office 2: 020-271-2947 
• 
Cell: 0721-289-733 
• 
Dr. Samir Sakr:  020-272-4737 
 

Maelezo kwa mabwana na wapenzi– Toleo 1.0 – August 1, 2011 
 
Cervical Treatment Study 
106 
 
Maelezo kwa mabwana na wapenzi. 
Ukaguza na matibabu ya saratani ya mlango wa kizazi. 
Matibabu ya Cryotherapy au LEEP 
Mke au mpenzi wako amefanyiwa matibabu yafuatayo kama mojawapo wa mpangilio wa 
ukaguzi na matibabu ya saratani ya mlango wa kizazi: 
 
 
 
 Cryotherapy 
 
 
 
LEEP 
Baada ya matibabu ni muhimu usionane kimwili na mke au mpenzi wako kwa mda wa wiki 
nne. Hi ni kwa sababu idadi ya virusi vinanyosababisha ukimwi inaweza kuongezeka ( kwa 
muda tu) katika sehemu iliyofanyiwa Cryotherapy au LEEP. Ongezeko la idadi ya virusi kwa 
mlango wa kizazi inaweza kuongezea hadhari ya kuambukiza mpenzi ambaye 
hajaambukizwa, au ongezeko la uambukizi mpya wa virusi vinavyosababisha ukimwi.Iwapo 
haiwezekani kujinyima kufanya mapenzi wakati huu ambapo mke au mpenzi wako 
anaendelea kupata nafuu, ni muhimu kutumia mpira wa kondomu kila wakati mnapoonana 
kimwili kwa mda wa wiki nne, baada ya kupokea matibabu. 
 
 
 
 
Numbari za mawasiliano : 
Iwapo ungependa kupewa maelezo zaidi, unaweza 
kupiga simu kwa numbari zifuatazo Jumatatu hadi 
ijumaa kuuanzia saa mbili asubuhi mpaka saa kumi 
na moja jioni. 
Afisi 1: 0728-456-540 
Afisi  2: 020-271-2947 
• 
Rununu: 0721-289-733 
 

Screening Consent Form- Initial Consent– Version 8.1 – September 27, 2012 
Cervical Treatment Study 
Page 1 of 6 
 
STUDY WRITTEN CONSENT FORM 
Cervical Treatment Study: Screening  
INITIAL CONSENT 
 
Full Title: 
Impact of Cryotherapy versus Loop Electrosurgical Excision Procedure (LEEP) on Recurrence of Cervical 
Intraepithelial Neoplasia and HIV-1 Cervical Shedding among HIV-positive Women 
Study Investigators:  
Michael H. Chung, MD, MPH, Assistant Professor, Department of Global Health, University of Washington, 
020 271-2947 
Nelly Mugo, MBChB, MMed, MPH, Gynecologist, Department of Obstetrics and Gynecology, Kenyatta 
National Hospital, 020 273-6744 
Samah Sakr, MBChB, Medical Director, Coptic Hospital of Kenya, 020 272-4737 
Hugo De Vuyst, MD, PhD, Epidemiologist, International Agency for Research on Cancer, World Health 
Organization, +33-472738521 
Silvia Franceschi, MD, Epidemiologist, International Agency for Research on Cancer, World Health 
Organization, +33-4728404 
Barbra Richardson, PhD, Research Professor, Department of Biostatistics, University of Washington, +1-206-
731-2425 
Grace John-Stewart, MD, PhD, Professor, Department of Medicine, University of Washington, +1-206-543-
4278 
Emergency telephone number staffed 24 hours a day: 020 271 2947, 0723 914 057 or 0721 289 733 
Ethical Review Committee Chairperson: Professor A. N. Guantai, 020 2726300, Ext. 44102, 4435544355, 
can be contacted for questions about research subject rights 
 
Researchers’ Statement 
 
We are asking you to be in a research study.  The purpose of this consent form is to give you 
information so you can decide if you want to be in the study.  Please read the form carefully.  You may ask 
questions about the purpose of the research and what we would ask you to do for the study.  You may ask 
about possible risks and benefits, your rights as a volunteer, and anything else about the research or this form.  
You may ask questions at any time (before, during, and after the study) about anything.  When we have 
answered all your questions, you can decide if you want to be in the study or not.  This process is called 
‘informed consent.’  If you wish, we will give you a copy of this form.  Please let us know if you would rather 
use the Kiswahili consent form. 
Purpose of the Study 

Screening Consent Form- Initial Consent– Version 8.1 – September 27, 2012 
Cervical Treatment Study 
Page 2 of 6 
 
 
The reason we are doing this research project is to screen for disease which may lead to cervical 
cancer. Participation in this project lasts for up to 1 month.  You were asked to participate in this project 
because you are:  
• 
HIV-positive,  
• 
currently receiving care at the Hope clinic,  
• 
not pregnant,  
• 
do not have a history of problems with bleeding, 
• 
have not had a hysterectomy (an operation to remove the uterus), 
• 
and have initiated sexual intercourse. 
Cervical cancer is the most common cancer among young and middle-aged women in Kenya.  More 
women who have HIV get cervical cancer than those who do not have HIV.  Even in HIV-infected women, 
cervical cancer is not common.  However, in HIV-infected women, cervical disease that is not cancer is 
common.  This disease is caused by a virus called the human papillomavirus (HPV). It is very important to 
find this disease and treat it before it becomes cancer. This study will screen you for cervical disease.  If you 
screen positive for cervical disease, you may choose to enroll in a treatment study, or you will be referred 
elsewhere for treatment.  The treatment study will be explained to you in detail before you decide.  This 
screening study will have over 2,400 participants.  By doing this study, we hope to provide free and 
comprehensive screening for HIV-positive women to prevent cervical cancer. 
 
Procedures (see Appendix) 
All participants will be asked to come for 1 to 3 visits over 1 month.  All study visits will take from 20 to 40 
minutes  (Visit 1: consent process – 10 minutes, Pap smear – 20 minutes; Visit 2: review of Pap smear results 
– 10 minutes, colposcopy and biopsy  – 30 minutes; Visit 3: review of biopsy results and discussion of 
treatment options – 30 minutes) 
Visit 1: 
If you agree, you will first undergo a pelvic exam with a Pap smear to see if you have a something 
like a wound (called a lesion).  This lesion may possibly develop into cancer.  A pelvic exam means that a 
doctor or nurse will examine your female parts.  The Pap smear involves brushing the cervix with a small 
brush to collect material that can be looked at under a microscope (like a large magnifying glass).   
Visit 2: 
You will then return to this clinic 2 weeks later to find out the results of this test.  Most of the time the 
results will show no disease or that we just have to repeat the Pap smear or visual inspection (VIA) every 6 
months.  If this is the case, then you will exit the study at this point and receive further follow-up at the Coptic 
Hope Cervical Cancer Screening Program (CCSP) or be asked to come back to the study clinic for a repeat 
Pap smear after 6 months.  If we find lesions that need to be treated at these visits, we will discuss your 
treatment options with you in detail. 

Screening Consent Form- Initial Consent– Version 8.1 – September 27, 2012 
Cervical Treatment Study 
Page 3 of 6 
 
 If you are screened and we find a lesion that needs to be looked at carefully, you will first have a 
pregnancy test. If you are pregnant, nothing more will be done until after you deliver.  We will send you for 
special care at the Hope center to make sure you do not pass HIV to your baby (this care is called PMTCT), 
and you will exit the study and receive further follow-up at the CCSP. If you are not pregnant, we will look at 
your cervix with a type of magnifying lens called a colposcope.  We will look closely at the cervix and take a 
piece out, about the size of a grain of rice.  This is called a biopsy.  We will look at this tissue biopsy under a 
microscope and share the results with you 4-6weeks later.  This test is very good and will help us decide 
whether you need to have treatment. 
There are some cells found in the cervix and the lining of the uterus.  These are called ‘glandular 
cells.’  When Pap smear results show that your glandular cells are abnormal, the doctor will perform a 
procedure referred to as ‘Endocervical Curettage (ECC).’  This is a procedure where a spoon-shaped 
instrument called a ‘curette’ is used to scrape abnormal material from the passageway between the cervix and 
the uterus.  This procedure obtains a small sample, which is then sent to the lab to be examined for abnormal 
cells.  ECC is performed during colposcopy and takes just a few minutes to perform.  You can expect to feel 
mild cramping, much like menstrual cramps following the procedure.  If you are found to have abnormal cells 
but the doctor cannot see them by means of a colposcope, you will undergo ECC as described above.   
Visit 3:  You will return to this clinic in 4-6weeks for the biopsy results.  If we find cervical disease that 
needs treatment, we will discuss your treatment options with you.  You may choose to enroll in a further 
treatment study, which will be explained in detail at this time.  If you prefer not to enroll in another study, you 
will be referred for treatment at Kenyatta National Hospital (KNH) and standard care at Coptic Hope Center.  
Whether you choose to accept study treatment or referral, you will be exited from this screening study at your 
third visit.    
Contacting Participants 
 
We will ask you to give us contact information like a phone number so we can call you if you do not 
come to a scheduled visit.  We may ask about your health or where you are during these calls.  It is important 
for you to come to all of your scheduled visits.  If we cannot contact you by phone, we may try to visit you at 
your house.  If this happens, we will not wear clothes that show we are health workers.  You should tell us if 
you do not want to be contacted in this way.  If you do not return for your Pap smear or biopsy results, we 
will also “flag” your Coptic Hope file so that you can be notified that you have available study results at your 
next clinic visit.   
If study quality control procedures indicate that your Pap smear result is discordant from the original 
result you were given, we will ask you to return to the clinic to receive your new results and to discuss 
potential treatment options.  At this point, you may be asked if you would like to re-enroll in the study.   
 
 
 
Risks and discomforts of being in the study 
This is an explanation of problems you may have through your participation in this study.  Other problems not 
listed may happen as well. 
Screening 
Collection of samples through the pelvic exam may cause:  

Screening Consent Form- Initial Consent– Version 8.1 – September 27, 2012 
Cervical Treatment Study 
Page 4 of 6 
 
• 
mild discomfort as you are examined,  
• 
a small amount of bleeding from the vagina for 1-2 days afterwards and  
• 
mild to moderate cramping for around 5 minutes that is similar to mild period pain.   
If you receive a biopsy, we ask that you do not have sex for 10 days.  The reason is that if you are 
HIV-infected and your partner is not, then he may be at greater risk of becoming infected with HIV.  If your 
partner is HIV positive, he may be at greater risk of getting re-infected with resistant HIV.  Also, you need 
time to heal and will put yourself at higher risk of infection unless you give yourself this time.  If you need 
help talking about these issues with your partner, a nurse, doctor or counselor can help you.  We will give you 
free condoms to use if it is impossible for you to not have sex.  
Another possible discomfort you may face is the worry or anxiety that you may have disease on your 
cervix.  You may talk about this with a study nurse or doctor or if you would like talk to a counselor, we can 
help to arrange this. 
We may find on screening that you have an infection.  In this case we will give you a prescription for 
antibiotics.  Side effects of these antibiotics may include: upset stomach, vomiting or diarrhea, sensitivity to 
light, rash, severe allergic reaction that could cause death, dizziness, headache, confusion, ringing in the ears 
or hearing loss, seizures (jerking of the body), heart problems, blood disorders, problems with blood sugar, 
liver disease, kidney disease and pain or numbness in your legs or arms.  If you experience any of these 
problems, please report to study staff right away. 
Confidentiality 
The study staff will ask you for personal information that may be embarrassing to talk about like how 
many sexual partners you have had.  You may choose not to answer any question.  As part of the study, you 
may meet other patients from this clinic whom you know from outside the clinic.  We have no plans to release 
your information to anyone other than the study researchers or appointed monitors.  Sometimes committees 
that oversee research will examine study information to make sure nothing illegal or unethical is being done.  
Your personal information will be protected if this happens and will not be shown to anyone outside of this 
review. As the study sponsor, CDC may monitor or audit study activities. The reason for this would be to 
make sure that the study is being done the way it is supposed to be done. It would also make sure that your 
rights and health are protected. Your personal medical information will be kept confidential. 
 
Alternative to taking part in this study 
 
If you choose not to take part in this study, you will continue to receive medical care at the Coptic 
Hope Center and free antiretroviral medications.  You may also receive free cervical cancer screening at this 
clinic without having to enroll in this study. 
 
Benefits of the study 
 
Your participation will help us understand more about cervical disease.  By participating in this study, 
you receive free screening for cervical disease.  If you would like to know the results of the study you can 
contact the study office 6 months or 1 year after you leave the study. 

Screening Consent Form- Initial Consent– Version 8.1 – September 27, 2012 
Cervical Treatment Study 
Page 5 of 6 
 
Compensation for injury 
There is no cost to you for participating in this study other than your time.  The study will pay for all 
screening costs for tests provided at the study clinic.  If any physical injuries happen to you as a result of 
study participation, the study will cover the costs of care.  If you think you have an injury or illness related to 
this study, contact the study staff (Dr. Michael Chung (020-272-2710) or Dr. Nelly Mugo (020-273-6744) or 
Dr. Evans Malava (0721 289 733) right away.  They will treat you or refer you for treatment. 
Specimen and Data Storage and Use of your Samples for Future Studies   
We would like to save your medical information and Pap smear, colposcopy and endocervical 
curettage samples in Kenya at the Coptic Hospital and Kenyatta National Hospital for future research.  This 
research may be done by the University of Washington or by other researchers who are working with us on 
this study for ten years after the end of follow-up in the study.  We will use these data and samples only for 
research related to cervical cancer and HIV.  Before your samples leave the clinic, they will be assigned a 
code.  Your name will not be on them.  Your name will be linked to the code only for five years after the 
study is completed.  After that time, the link between your name and the code on your samples and data will 
be destroyed.  The Institutional Review Boards are committees that watch over the safety and rights of 
research participants at Kenyatta National Hospital and the University of Washington.   They must approve 
any future research studies using your samples.  If you do not want to have your samples saved for future 
research, you can still be in this study and your samples will be destroyed once testing for the study is 
completed.  If you agree to store your samples now, but change your mind before the end of the study, let the 
study staff know and we will make sure that your samples do not get stored for future research.  We will not 
sell your samples. Tests done on your samples may lead to a new invention or discovery.  We have no plans 
to share any money or other benefits resulting from this invention or discovery with you.   
Other information 
 
Your medical information is confidential (or kept secret) and we will keep your records in a locked 
office.  Your medical records and information about your participation in the research will be available to you 
and to the study team but not to anyone outside of the study without your agreement.  If you agree, we will 
share the information from this study with your doctors at the Hope Center.  This information may help them 
treat your HIV and give you better care.  All of your records will be kept in locked areas and all computer 
information will be password protected.   
 
University of Washington staff sometimes review studies such as this one to make sure they are being 
done safely and legally.  If a review of this study takes place, your records may be examined.   
You 
may 
refuse to participate or may leave from the study at any time without penalty or loss of benefit or help to 
which you have a right to.  We will tell you if there is any new information about the treatments we are 
studying so you can decide if you want to leave the study.  Your relationship with staff and services at Coptic 
Hope Center for Infectious Diseases will not be affected in any way if you do or do not participate or if you 
enter the program and leave later.   Please inform study staff if you decide you would like to leave the study.  
You may be asked to give some final samples but you may refuse. 
 
Study staff may decide to take you out the study if they find you may be harmed if you continue to 
participate.  You may also be taken out of the study if the staff think you will not be able to follow study 
safety requirements. 
 
 

Screening Consent Form- Initial Consent– Version 8.1 – September 27, 2012 
Cervical Treatment Study 
Page 6 of 6 
 
 
Please contact  Dr. Michael Chung (020 271-2947), Dr. Samah Sakr (020 272-4737), or Dr. Nelly 
Mugo (020 273-6744) for questions about the study or to report any problems. 
 
Signature of study staff_______________________________ Date ______________ 
 
Printed name of study staff_______________________________ 
 
Subject's statement 
 
This study has been explained to me.  I volunteer to take part in this research.  I give permission to 
the researchers to use my medical records as described in this consent form.  I have had a chance to ask 
questions.  If I have questions later about the research, I can ask one of the researchers listed above.  If I have 
questions about my rights as a research subject, I can call the Ethical Review Committee at Kenyatta National 
Hospital 726-300.  I will receive a copy of this consent form if I would like one. 
Please mark, initial and date one option:  
_____I DO agree to store my samples and data for future research  
 
_____I DO NOT agree to store my samples and data for future research    
 
Signature or thumbprint of participant _________________________________ Date ________________ 
 
Printed name of participant____________________________________ 
Copies to: Investigator and Subject 
 
 

Screening Consent Form- Re-Enrollment Consent– Version 8.1 – September 27, 2012 
Cervical Treatment Study 
Page 1 of 6 
 
STUDY WRITTEN CONSENT FORM 
Cervical Treatment Study: Screening  
RE-ENROLLMENT CONSENT 
 
Full Title: 
Impact of Cryotherapy versus Loop Electrosurgical Excision Procedure (LEEP) on Recurrence of Cervical 
Intraepithelial Neoplasia and HIV-1 Cervical Shedding among HIV-positive Women 
Study Investigators:  
Michael H. Chung, MD, MPH, Assistant Professor, Department of Global Health, University of Washington, 
020 271-2947 
Nelly Mugo, MBChB, MMed, MPH, Gynecologist, Department of Obstetrics and Gynecology, Kenyatta 
National Hospital, 020 273-6744 
Samah Sakr, MBChB, Medical Director, Coptic Hospital of Kenya, 020 272-4737 
Hugo De Vuyst, MD, PhD, Epidemiologist, International Agency for Research on Cancer, World Health 
Organization, +33-472738521 
Silvia Franceschi, MD, Epidemiologist, International Agency for Research on Cancer, World Health 
Organization, +33-4728404 
Barbra Richardson, PhD, Research Professor, Department of Biostatistics, University of Washington, +1-206-
731-2425 
Grace John-Stewart, MD, PhD, Professor, Department of Medicine, University of Washington, +1-206-543-
4278 
Emergency telephone number staffed 24 hours a day: 020 271 2947, 0723 914 057 or 0721 289 733 
Ethical Review Committee Chairperson: Professor A. N. Guantai, 020 2726300, Ext. 44102, 44355, can be 
contacted for questions about research subject rights 
 
Researchers’ Statement 
 
We are asking you to be in a research study.  The purpose of this consent form is to give you 
information so you can decide if you want to be in the study.  Please read the form carefully.  You may ask 
questions about the purpose of the research and what we would ask you to do for the study.  You may ask 
about possible risks and benefits, your rights as a volunteer, and anything else about the research or this form.  
You may ask questions at any time (before, during, and after the study) about anything.  When we have 
answered all your questions, you can decide if you want to be in the study or not.  This process is called 
‘informed consent.’  If you wish, we will give you a copy of this form.  Please let us know if you would rather 
use the Kiswahili consent form. 
Purpose of the Study 

Screening Consent Form- Re-Enrollment Consent– Version 8.1 – September 27, 2012 
Cervical Treatment Study 
Page 2 of 6 
 
 
The reason we are doing this research project is to screen for disease which may lead to cervical 
cancer. Participation in this project lasts for up to 1 month.  You were asked to participate in this project 
because you are:  
• 
HIV-positive,  
• 
currently receiving care at the Hope clinic,  
• 
not pregnant,  
• 
do not have a history of problems with bleeding, 
• 
have not had a hysterectomy (an operation to remove the uterus), 
• 
and have initiated sexual intercourse. 
Cervical cancer is the most common cancer among young and middle-aged women in Kenya.  More 
women who have HIV get cervical cancer than those who do not have HIV.  Even in HIV-infected women, 
cervical cancer is not common.  However, in HIV-infected women, cervical disease that is not cancer is 
common.  This disease is caused by a virus called the human papillomavirus (HPV). It is very important to 
find this disease and treat it before it becomes cancer. This study will screen you for cervical disease.  If you 
screen positive for cervical disease, you may choose to enroll in a treatment study, or you will be referred 
elsewhere for treatment.  The treatment study will be explained to you in detail before you decide.  This 
screening study will have over 2,400 participants.  By doing this study, we hope to provide free and 
comprehensive screening for HIV-positive women to prevent cervical cancer. 
 
Procedures (see Appendix) 
All participants will be asked to come for 1 to 3 visits over 1 month.  All study visits will take from 20 to 40 
minutes  (Visit 1: consent process – 10 minutes, Pap smear – 20 minutes; Visit 2: review of Pap smear results 
– 10 minutes, colposcopy and biopsy  – 30 minutes; Visit 3: review of biopsy results and discussion of 
treatment options – 30 minutes) 
Visit 1: 
If you agree, you will first undergo a pelvic exam with a Pap smear to see if you have a something 
like a wound (called a lesion).  This lesion may possibly develop into cancer.  A pelvic exam means that a 
doctor or nurse will examine your female parts.  The Pap smear involves brushing the cervix with a small 
brush to collect material that can be looked at under a microscope (like a large magnifying glass).   
Visit 2: 
You will then return to this clinic 2 weeks later to find out the results of this test.  Most of the time the 
results will show no disease or that we just have to repeat the Pap smear or visual inspection (VIA) every 6 
months.  If this is the case, then you will exit the study at this point and receive further follow-up at the Coptic 
Hope Cervical Cancer Screening Program (CCSP) or be asked to come back to the study clinic for a repeat 
Pap smear after 6 months.  If we find lesions that need to be treated at these visits, we will discuss your 
treatment options with you in detail. 

Screening Consent Form- Re-Enrollment Consent– Version 8.1 – September 27, 2012 
Cervical Treatment Study 
Page 3 of 6 
 
 If you are screened and we find a lesion that needs to be looked at carefully, you will first have a 
pregnancy test. If you are pregnant, nothing more will be done until after you deliver.  We will send you for 
special care at the Hope center to make sure you do not pass HIV to your baby (this care is called PMTCT), 
and you will exit the study and receive further follow-up at the CCSP. If you are not pregnant, we will look at 
your cervix with a type of magnifying lens called a colposcope.  We will look closely at the cervix and take a 
piece out, about the size of a grain of rice.  This is called a biopsy.  We will look at this tissue biopsy under a 
microscope and share the results with you 4-6 weeks later.  This test is very good and will help us decide 
whether you need to have treatment. 
There are some cells found in the cervix and the lining of the uterus.  These are called ‘glandular 
cells.’  When Pap smear results show that your glandular cells are abnormal, the doctor will perform a 
procedure referred to as ‘Endocervical Curettage (ECC).’  This is a procedure where a spoon-shaped 
instrument called a ‘curette’ is used to scrape abnormal material from the passageway between the cervix and 
the uterus.  This procedure obtains a small sample, which is then sent to the lab to be examined for abnormal 
cells.  ECC is performed during colposcopy and takes just a few minutes to perform.  You can expect to feel 
mild cramping, much like menstrual cramps following the procedure.  If you are found to have abnormal cells 
but the doctor cannot see them by means of a colposcope, you will undergo ECC as described above.   
Visit 3:  You will return to this clinic in 4-6 weeks for the biopsy results.  If we find cervical disease that 
needs treatment, we will discuss your treatment options with you.  You may choose to enroll in a further 
treatment study, which will be explained in detail at this time.  If you prefer not to enroll in another study, you 
will be referred for treatment at Kenyatta National Hospital (KNH) and standard care at Coptic Hope Center.  
Whether you choose to accept study treatment or referral, you will be exited from this screening study at your 
third visit.    
Contacting Participants 
 
We will ask you to give us contact information like a phone number so we can call you if you do not 
come to a scheduled visit.  We may ask about your health or where you are during these calls.  It is important 
for you to come to all of your scheduled visits.  If we cannot contact you by phone, we may try to visit you at 
your house.  If this happens, we will not wear clothes that show we are health workers.  You should tell us if 
you do not want to be contacted in this way.  If you do not return for your Pap smear or biopsy results, we 
will also “flag” your Coptic Hope file so that you can be notified that you have available study results at your 
next clinic visit.   
If study quality control procedures indicate that your Pap smear result is discordant from the original 
result you were given, we will ask you to return to the clinic to receive your new results and to discuss 
potential treatment options.  At this point, you may be asked if you would like to re-enroll in the study.   
 
 
 
Risks and discomforts of being in the study 
This is an explanation of problems you may have through your participation in this study.  Other problems not 
listed may happen as well. 
Screening 
Collection of samples through the pelvic exam may cause:  

Screening Consent Form- Re-Enrollment Consent– Version 8.1 – September 27, 2012 
Cervical Treatment Study 
Page 4 of 6 
 
• 
mild discomfort as you are examined,  
• 
a small amount of bleeding from the vagina for 1-2 days afterwards and  
• 
mild to moderate cramping for around 5 minutes that is similar to mild period pain.   
If you receive a biopsy, we ask that you do not have sex for 10 days.  The reason is that if you are 
HIV-infected and your partner is not, then he may be at greater risk of becoming infected with HIV.  If your 
partner is HIV positive, he may be at greater risk of getting re-infected with resistant HIV.  Also, you need 
time to heal and will put yourself at higher risk of infection unless you give yourself this time.  If you need 
help talking about these issues with your partner, a nurse, doctor or counselor can help you.  We will give you 
free condoms to use if it is impossible for you to not have sex.  
Another possible discomfort you may face is the worry or anxiety that you may have disease on your 
cervix.  You may talk about this with a study nurse or doctor or if you would like talk to a counselor, we can 
help to arrange this. 
We may find on screening that you have an infection.  In this case we will give you a prescription for 
antibiotics.  Side effects of these antibiotics may include: upset stomach, vomiting or diarrhea, sensitivity to 
light, rash, severe allergic reaction that could cause death, dizziness, headache, confusion, ringing in the ears 
or hearing loss, seizures (jerking of the body), heart problems, blood disorders, problems with blood sugar, 
liver disease, kidney disease and pain or numbness in your legs or arms.  If you experience any of these 
problems, please report to study staff right away. 
Confidentiality 
The study staff will ask you for personal information that may be embarrassing to talk about like how 
many sexual partners you have had.  You may choose not to answer any question.  As part of the study, you 
may meet other patients from this clinic whom you know from outside the clinic.  We have no plans to release 
your information to anyone other than the study researchers or appointed monitors.  Sometimes committees 
that oversee research will examine study information to make sure nothing illegal or unethical is being done.  
Your personal information will be protected if this happens and will not be shown to anyone outside of this 
review. As the study sponsor, CDC may monitor or audit study activities. The reason for this would be to 
make sure that the study is being done the way it is supposed to be done. It would also make sure that your 
rights and health are protected. Your personal medical information will be kept confidential. 
 
Alternative to taking part in this study 
 
If you choose not to take part in this study, you will continue to receive medical care at the Coptic 
Hope Center and free antiretroviral medications.  You may also receive free cervical cancer screening at this 
clinic without having to enroll in this study. 
 
Benefits of the study 
 
Your participation will help us understand more about cervical disease.  By participating in this study, 
you receive free screening for cervical disease.  If you would like to know the results of the study you can 
contact the study office 6 months or 1 year after you leave the study. 

Screening Consent Form- Re-Enrollment Consent– Version 8.1 – September 27, 2012 
Cervical Treatment Study 
Page 5 of 6 
 
Compensation for injury 
There is no cost to you for participating in this study other than your time.  The study will pay for all 
screening costs for tests provided at the study clinic.  If any physical injuries happen to you as a result of 
study participation, the study will cover the costs of care.  If you think you have an injury or illness related to 
this study, contact the study staff (Dr. Michael Chung (020-272-2710) or Dr. Nelly Mugo (020-273-6744) or 
Dr. Evans Malava (0721 289 733) right away.  They will treat you or refer you for treatment. 
Specimen and Data Storage and Use of your Samples for Future Studies   
We would like to save your medical information and Pap smear, colposcopy and endocervical 
curettage samples in Kenya at the Coptic Hospital and Kenyatta National Hospital for future research.  This 
research may be done by the University of Washington or by other researchers who are working with us on 
this study for ten years after the end of follow-up in the study.  We will use these data and samples only for 
research related to cervical cancer and HIV.  Before your samples leave the clinic, they will be assigned a 
code.  Your name will not be on them.  Your name will be linked to the code only for five years after the 
study is completed.  After that time, the link between your name and the code on your samples and data will 
be destroyed.  The Institutional Review Boards are committees that watch over the safety and rights of 
research participants at Kenyatta National Hospital and the University of Washington.   They must approve 
any future research studies using your samples.  If you do not want to have your samples saved for future 
research, you can still be in this study and your samples will be destroyed once testing for the study is 
completed.  If you agree to store your samples now, but change your mind before the end of the study, let the 
study staff know and we will make sure that your samples do not get stored for future research.  We will not 
sell your samples. Tests done on your samples may lead to a new invention or discovery.  We have no plans 
to share any money or other benefits resulting from this invention or discovery with you.   
Other information 
 
Your medical information is confidential (or kept secret) and we will keep your records in a locked 
office.  Your medical records and information about your participation in the research will be available to you 
and to the study team but not to anyone outside of the study without your agreement.  If you agree, we will 
share the information from this study with your doctors at the Hope Center.  This information may help them 
treat your HIV and give you better care.  All of your records will be kept in locked areas and all computer 
information will be password protected.   
 
University of Washington staff sometimes review studies such as this one to make sure they are being 
done safely and legally.  If a review of this study takes place, your records may be examined.   
You 
may 
refuse to participate or may leave from the study at any time without penalty or loss of benefit or help to 
which you have a right to.  We will tell you if there is any new information about the treatments we are 
studying so you can decide if you want to leave the study.  Your relationship with staff and services at Coptic 
Hope Center for Infectious Diseases will not be affected in any way if you do or do not participate or if you 
enter the program and leave later.   Please inform study staff if you decide you would like to leave the study.  
You may be asked to give some final samples but you may refuse. 
 
Study staff may decide to take you out the study if they find you may be harmed if you continue to 
participate.  You may also be taken out of the study if the staff think you will not be able to follow study 
safety requirements. 
 
 

Screening Consent Form- Re-Enrollment Consent– Version 8.1 – September 27, 2012 
Cervical Treatment Study 
Page 6 of 6 
 
 
Please contact  Dr. Michael Chung (020 271-2947), Dr. Samah Sakr (020 272-4737), or Dr. Nelly 
Mugo (020 273-6744) for questions about the study or to report any problems. 
 
Signature of study staff_______________________________ Date ______________ 
 
Printed name of study staff_______________________________ 
 
Subject's statement 
 
This study has been explained to me.  I volunteer to take part in this research.  I give permission to 
the researchers to use my medical records as described in this consent form.  I have had a chance to ask 
questions.  If I have questions later about the research, I can ask one of the researchers listed above.  If I have 
questions about my rights as a research subject, I can call the Ethical Review Committee at Kenyatta National 
Hospital 726-300.  I will receive a copy of this consent form if I would like one. 
Please mark, initial and date one option:  
_____I DO agree to store my samples and data for future research  
 
_____I DO NOT agree to store my samples and data for future research    
 
Signature or thumbprint of participant _________________________________ Date ________________ 
 
Printed name of participant____________________________________ 
Copies to: Investigator and Subject 

Randomization Consent– Version  8.1 –September 27, 2012 
 
Cervical Treatment Study 
Page 1 of 7 
 
STUDY WRITTEN CONSENT FORM 
Cervical Treatment Study: Cryotherapy vs. LEEP 
Full Title: 
Impact of Cryotherapy versus Loop Electrosurgical Excision Procedure (LEEP) on Recurrence of Cervical 
Intraepithelial Neoplasia and HIV-1 Cervical Shedding among HIV-positive Women 
Study Investigators:  
Michael H. Chung, MD, MPH, Assistant Professor, Department of Global Health, University of Washington, 
020 271-2947 
Nelly Mugo, MBChB, MMed, MPH, Gynecologist, Department of Obstetrics and Gynecology, Kenyatta 
National Hospital, 020 273-6744 
Samah Sakr, MBChB, Medical Director, Coptic Hospital of Kenya, 020 272-4737 
Hugo De Vuyst, MD, PhD, Epidemiologist, International Agency for Research on Cancer, World Health 
Organization, +33-472738521 
Silvia Franceschi, MD, Epidemiologist, International Agency for Research on Cancer, World Health 
Organization, +33-4728404 
Barbra Richardson, PhD, Research Professor, Department of Biostatistics, University of Washington, +1-206-
731-2425 
Grace John-Stewart, MD, PhD, Professor, Department of Medicine, University of Washington, +1-206-543-
4278 
Emergency telephone number staffed 24 hours a day: 020 271 2947, 0723 914 057 or 0721 289 733 
Ethical Review Committee Chairperson: Professor A. N. Guantai, 020 2726300, Ext. 44102, 4435544355, 
can be contacted for questions about research subject rights 
 
Researchers’ Statement 
 
We are asking you to be in a research study.  The purpose of this consent form is to give you 
information so you can decide if you want to be in the study.  Please read the form carefully.  You may ask 
questions about the purpose of the research and what we would ask you to do for the study.  You may ask 
about possible risks and benefits, your rights as a volunteer, and anything else about the research or this form.  
You may ask questions at any time (before, during, and after the study) about anything.  When we have 
answered all your questions, you can decide if you want to be in the study or not.  This process is called 
‘informed consent.’  If you wish, we will give you a copy of this form.  Please let us know if you would rather 
use the Kiswahili consent form. 
Purpose of the Study 
 
The reason we are doing this research project is to find the best treatment of disease which may lead 
to cervical cancer. Participation in this project lasts for 2 years.  You were asked to participate in this project 
because 
you 
are:

Randomization Consent– Version  8.1 –September 27, 2012 
 
Cervical Treatment Study 
Page 2 of 7 
 
 
• 
HIV-positive,  
• 
currently receiving care at the Hope clinic,  
• 
not pregnant,  
• 
do not have a history of problems with bleeding, 
• 
have not had a hysterectomy (an operation to remove the uterus), 
• 
have initiated sexual intercourse 
• 
have not received treatment for cervical disease in the past 
• 
and have received a positive result for cervical disease from Pap smear and biopsy screening. 
Cervical cancer is the most common cancer among young and middle-aged women in Kenya.  More 
women who have HIV get cervical cancer than those who do not have HIV.  Even in HIV-infected women, 
cervical cancer is not common.  However, in HIV-infected women, cervical disease that is not cancer is 
common.  This disease is caused by a virus called the human papillomavirus (HPV). It is very important to 
find this disease and treat it before it becomes cancer. This study will compare two ways of treating cervical 
disease: cryotherapy and loop electrosurgical excision procedure (LEEP).  Both treatments are commonly 
done for women around the world and are not new.  We will explain these treatments for you.  This study will 
have 400 participants.  By doing this study, we hope to find the best way to treat HIV-positive women to 
prevent cervical cancer. 
 
Procedures (see Appendix) 
All participants will be asked for come for 5 to 8  visits over 2 years.  All study visits will take from 15 to 40 
minutes. 
 
Randomization (Visit 1: review of biopsy results – 10 minutes, randomization and treatment– 30 minutes) 
 
 Based on your Pap smear and biopsy results, we have found cervical disease that needs treatment.  If 
you decide to participate in this study, we will offer you one of two common and effective treatment methods.  
One method is called cryotherapy. It is a procedure which will freeze and remove the diseased part of your 
cervix.  We freeze by touching your cervix with a small stick that is very cold.  For cryotherapy, you will be 
offered an oral painkiller. The other method is called LEEP and uses a heated wire to do the same thing after 
the cervix is numbed by medication.  The heated wire will scoop out the disease from the cervix.   
You will be randomly assigned to one of these methods.  Random assignment is like “flipping a 
coin.” You have an equal chance of receiving either of these methods.  We won’t know which treatment you 
will receive until we open an envelope that has a sheet of paper telling us which treatment you will get.  
Neither of us will choose your treatment.  We are randomly assigning one of these methods because we do 
not 
know 
if 
one 
treatment 
is 
better 
than 
another 
for 
women 
who 
have 
HIV. 

Randomization Consent– Version  8.1 –September 27, 2012 
 
Cervical Treatment Study 
Page 3 of 7 
 
If we see that the diseased part of your cervix or ‘lesion’ is too large and cannot be treated well by 
cryotherapy, then we will not randomize you and will choose to treat you with LEEP.  You will receive LEEP 
treatment free of charge and we will follow you every 6 months for 2 years.  If the lesion cannot be treated 
well by either cryotherapy or LEEP, then we will refer you to Kenyatta National Hospital (KNH).  At KNH 
you can receive different types of treatments at the lower cost of a government hospital.    We will send 
copies of forms with you that will be important for your care.  These forms will not show that you are part of 
a study.  We will provide follow-up for you for 2 years after your care at KNH. If you agree to be treated by 
either cryotherapy or LEEP at the study clinic, 2 teaspoons (10 mls) of your blood will be taken with a needle 
from your arm.  We will check a CD4 count and the levels of HIV in your blood.  We will also brush your 
cervix and later test the sample for levels of HIV and for HPV.  We would like to look at your medical 
records at the Hope Center.  We want to gather a full picture of your prescribed medications and medical 
condition, the results of your laboratory tests, and your attendance in clinic.   
Follow-up after Randomization (Visits 2-8: review results and cervical swab – 30 minutes) 
 
If you are randomized to cryotherapy or LEEP, we will ask you to return again at the 1, 2, and 3-week 
visits after treatment.  At these visits, we will draw 2 teaspoons (10mls) of blood and again brush your cervix 
to see how much HIV is there.  We will want to see whether the level of virus is increased in your cervix after 
treatment and when it returns to usual levels.   
If you are randomized or offered LEEP but not randomized, we will also ask you to return at 6, 12, 
18, and 24 months after treatment for repeat Pap smears.  This is to make sure that the diseased part of your 
cervix was completely removed and/or no new abnormal tissue has formed. We will also brush your cervix to 
test for HPV at this time and take 2 teaspoons (10 mls) of blood to measure your CD4 count and HIV viral 
levels.  If we find more abnormal lesions at this time, we will treat you with LEEP or refer you for further 
care at KNH.  The study will not pay for care you receive at KNH. 
Contacting Participants 
 
We will ask you to give us contact information like a phone number so we can call you if you do not 
come to a scheduled visit.  We may ask about your health or where you are during these calls.  It is important 
for you to come to all of your scheduled visits.  We want to follow you carefully to find and treat any cervical 
disease you might have or develop later on.  If we cannot contact you by phone, we may try to visit you at 
your house.  If this happens, we will not wear clothes that show we are health workers.  You should tell us if 
you do not want to be contacted in this way. 
 
 
Risks and discomforts of being in the study 
This is an explanation of problems you may have through your participation in this study.  Other problems not 
listed may happen as well. 
Treatment 
There may be risks or discomforts from receiving treatment.  If you have cryotherapy, then you may 
have: 
• 
mild abdominal (or belly) cramps (usually last less than 10 minutes),  
• 
fluid from the vagina for about 2 weeks (may last longer),

Randomization Consent– Version  8.1 –September 27, 2012 
 
Cervical Treatment Study 
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• 
bleeding,  
• 
infection that we will need to treat here at the clinic or in rare cases, at the hospital.  Infection 
may cause fevers, chills, night sweats, or white fluid from the vagina.  
If you have LEEP, you may develop: 
• 
bleeding during or after the procedure (you may have to return to the clinic if the bleeding starts 
and continues after the procedure is done) 
• 
infection.  
All of these complications can be treated with medications or treatments that will be provided free of 
charge by the clinic.  Possible treatments may include: 
• 
antibiotic medications to treat infection, 
• 
packing the vagina with bandages to stop bleeding, 
• 
putting stitches in the cervix to stop bleeding or 
• 
hospitalization for severe infection or bleeding. 
Please tell us if you have any of these problems after treatment.  If you have received cryotherapy or 
LEEP, then we ask that you do not have sex for 4 weeks after it is performed.  The reason is the same that 
your partner may be at greater risk of becoming infected with HIV.  Also, you may be at greater risk of 
getting an infection.  We can help you to discuss this with your partner.  
All participants who have treatment (cryotherapy or LEEP) will get a prescription for antibiotics.  
These antibiotics include doxycline, metronidazole or norfloxacin. 
Effects of these antibiotics may include upset stomach (must avoid alcohol for 2 days), vomiting or 
diarrhea, sensitivity to light, rash, dizziness, headache, confusion, seizures (jerking of the body), heart 
problems, blood disorders, problems with blood sugar, problems, liver disease and pain or numbness in your 
legs or arms.  Any reaction to medications should be reported right away to study staff. 
After having the treatment, there is a small chance that you may have problems later with pregnancy.  
After having LEEP, some women have problems when they are pregnant including infections, early 
contractions or problems with the cervix.  Some women develop a tightened opening of their cervix that must 
be stretched.  Other women have had their water break early or had babies born early possibly because of the 
operation on their cervix.  
Blood draw 
We will be collecting blood samples, 2 teaspoons (10 mls), from you using a new needle and syringe.  
The puncture of the needle may be uncomfortable and leave a bruise. It may also cause infection or fainting.   
Confidentiality 
The study staff will ask you for personal information that may be embarrassing to talk about like how 
many sexual partners you have had.  You may choose not to answer any question.  As part of the study, you 

Randomization Consent– Version  8.1 –September 27, 2012 
 
Cervical Treatment Study 
Page 6 of 7 
 
may meet other patients from this clinic whom you know from outside the clinic.  We have no plans to release 
your information to anyone other than the study researchers or appointed monitors.  Sometimes committees 
that oversee research will examine study information to make sure nothing illegal or unethical is being done.  
Your personal information will be protected if this happens and will not be shown to anyone outside of this 
review. As the study sponsor, CDC may monitor or audit study activities. The reason for this would be to 
make sure that the study is being done the way it is supposed to be done. It would also make sure that your 
rights and health are protected. Your personal medical information will be kept confidential. 
 
Alternative to taking part in this study 
 
If you choose not to take part in this study, you will continue to receive medical care at the Coptic 
Hope Center and free antiretroviral medications.  You may also receive free cervical cancer screening at this 
clinic without having to enroll in this study.  The Coptic Hope Clinic can provide you with Cryotherapy 
treatment even if you do not enroll in this study.  We can also refer you to Kenyatta National Hospital for 
different types of treatments at the lower cost of a government hospital.     
 
Benefits of the study 
 
Your participation will help us understand more about cervical disease.  This may change the way 
cervical disease is found and treated in developing countries like Kenya.  If you would like to know the 
results of the study you can contact the study office 6 months or 1 year after you leave the study. 
 
Compensation for injury 
There is no cost to you for participating in this study other than your time.  The study will pay for all 
screening and treatment costs for tests and therapy provided at the study clinic.  If any physical injuries 
happen to you as a result of study participation, the study will cover the costs of care.  Treatment includes 
antibiotics, pain relief, and methods to stop bleeding.  If you think you have an injury or illness related to this 
study, contact the study staff (Dr. Michael Chung (020-272-2710) or Dr. Nelly Mugo (020-273-6744) or Dr. 
Evans Malava (0721 289 733) right away.  They will treat you or refer you for treatment. 
 
Specimen and Data Storage and Use of your Samples for Future Studies   
We would like to save your medical information and samples of your blood and cervix in Kenya at 
the Coptic Hospital and Kenyatta National Hospital for future research.  This research may be done by the 
University of Washington or by other researchers who are working with us on this study for ten years after the 
end of follow-up in the study.  We will use these data and samples only for research related to cervical cancer 
and HIV.  Before your samples leave the clinic, they will be assigned a code.  Your name will not be on them.  
Your name will be linked to the code only for five years after the study is completed.  After that time, the link 
between your name and the code on your samples and data will be destroyed.  The Institutional Review 
Boards are committees that watch over the safety and rights of research participants at Kenyatta National 
Hospital and the University of Washington.   They must approve any future research studies using your 
samples.  If you do not want to have your samples saved for future research, you can still be in this study and 

Randomization Consent– Version  8.1 –September 27, 2012 
 
Cervical Treatment Study 
Page 6 of 7 
 
your samples will be destroyed once testing for the study is completed.  If you agree to store your samples 
now, but change your mind before the end of the study, let the study staff know and we will make sure that 
your samples do not get stored for future research.  We will not sell your samples. Tests done on your samples 
may lead to a new invention or discovery.  We have no plans to share any money or other benefits resulting 
from this invention or discovery with you.   
 
Other information 
 
Your medical information is confidential (or kept secret) and we will keep your records in a locked 
office.  Your medical records and information about your participation in the research will be available to you 
and to the study team but not to anyone outside of the study without your agreement.  If you agree, we will 
share the information from this study with your doctors at the Hope Center.  This information may help them 
treat your HIV and give you better care.  Some of your samples including blood and samples from the cervix 
may be sent to the USA or Europe for testing.  Your information and samples will still be protected if this 
happens.  All of your records will be kept in locked areas and all computer information will be password 
protected.   
 
University of Washington staff sometimes reviews studies such as this one to make sure they are 
being done safely and legally.  If a review of this study takes place, your records may be examined.   
 
You may refuse to participate or may leave from the study at any time without penalty or loss of 
benefit or help to which you have a right to.  We will tell you if there is any new information about the 
treatments we are studying so you can decide if you want to leave the study.  Your relationship with staff and 
services at Coptic Hope Center for Infectious Diseases will not be affected in any way if you do or do not 
participate or if you enter the program and leave later.   Please inform study staff if you decide you would like 
to leave the study.  You may be asked to give some final samples but you may refuse. 
 
Study staff may decide to take you out the study if they find you may be harmed if you continue to 
participate.  You may also be taken out of the study if the staff think you will not be able to follow study 
safety requirements. 
 
Transportation costs of Ksh 300 will be given to you when you return to the clinic for a study-related 
visit.  You will receive transport money from the study receptionist.  
 
Please contact  Dr. Michael Chung (020 271-2947), Dr. Samah Sakr (020 272-4737), or Dr. Nelly 
Mugo (020 273-6744) for questions about the study or to report any problems. 
Signature of study staff_______________________________ Date ______________ 
 
Printed name of study staff_______________________________ 
 
Subject's statement 
 
This study has been explained to me.  I volunteer to take part in this research.  I give permission to 
the researchers to use my medical records as described in this consent form.  I have had a chance to ask 
questions.  If I have questions later about the research, I can ask one of the researchers listed above.  If I have 

Randomization Consent– Version  8.1 –September 27, 2012 
 
Cervical Treatment Study 
Page 6 of 7 
 
questions about my rights as a research subject, I can call the Ethical Review Committee at Kenyatta National 
Hospital 726-300.  I will receive a copy of this consent form if I would like one.

Randomization Consent– Version  8.1 –September 27, 2012 
 
Cervical Treatment Study 
Page 7 of 7 
 
 
 
Please mark, initial and date one option:  
_____I DO agree to store my samples and data for future research  
 
_____I DO NOT agree to store my samples and data for future research    
 
Signature or thumbprint of participant _________________________________ Date ________________ 
 
Printed name of participant____________________________________ 
 
Copies to: Investigator and Subject 
 
 
 
 
 

Kiswahili Screening Consent-Initial Consent– Version 8.1 – September 27, 2012 
Cervical Treatment Study 
Page 1 of 7 
 
MAKUBALIANO YA PAMOJA 
KISWAHILI CONSENT FORM 
MATIBABU YA SARATANI YA MLANGO WA KIZAZI: UCHUNGUZI 
IDHINI YA AWALI 
WATAFITI 
Michael H Chung, MD. MPH, Mkufunzi, Idara ya utabibu, Chuo Kikuu cha Washington 272-
2710 
Nelly Mugo, MBChB, MMed, MPH, Gainakolojia, Mhadhiri, Idara ya Ukunga na 
Gainakologia, Hospitali kuu ya Kenyatta, 020-273-6744 
Sarah Sakr, MBChB, Msimamizi wa afya, Hospitali ya Coptic, Kenya 020-272-4737 
Hugo De Vuyst, MD, PhD, Epidemiologisti, Idara ya Kimataifa ya Utafiti wa Saratani, Shirika la 
Afya la Dunia (WHO), +33-472738521 
Silvia Franceschi, MD, Epidemiologisti, Idara ya Kimataifa ya Utafiti wa Saratani, Shirika la Afya la 
Dunia (WHO), +33-4728404 
Barbara Richardson, PhD, Profesa Msaidizi katika Utafiti, Idara ya Biostatistiki, Chuo Kikuu 
cha Washington, +1-206-731-2425 
Grace John Stewart, MD, PhD, Profesa, Kitivo Cha Utabibu, Chuo Kikuu Cha Washington, 
+1-206-543-4278 
 
Nambari za simu ya dharura; 072-2710 au 0733-711-288 
Mwenyekiti wa kamati ya uchunguzi wa maadili; Proffesa A. N. Guantai, 020 2726300, Ext. 
44102, 44355unaweza kuwasiliana naye kwa maswala ya utafiti na maadili ya washiriki wa 
utafiti huu. 
 
Ujumbe wa Watafiti 
 
Tunakuuliza kushiriki katika utafiti huu wa kitaalamu. Lengo la fomu hii ya idhini ni 
kukupa habari itakayokufahamisha na kukusaidia kuamua kama ungelipenda kushiriki katika 
utafiti huu au la. Tafathali soma maelezo haya kwa makini. Unaweza kuuliza maswali kuhusu 
nia/kusudi ya utafiti huu; unavyohitajika kufanya katika  utafiti, uwezekano wa kuwepo na 
madhara au manufaa yeyote, haki yako kama aliyejitolea, na mambo mengine kuhusu utafiti 
huu au chochote usicho elewa kwenye fomu hii. Tukishajibu maswali yako yote, unapaswa 
kuamua kushiriki kwenye utafiti huu au la. Kukubali kushiriki kwenye utafiti huu kwa hiari 
yako kunamaanisha kuwa umeelezwa na umeelewa yote yanayohusika na kukubaliana nayo. 
Ukipenda, tutakupa nakala ya fomu hii kujihifadhia. Tafadhali tujulishe iwapo ungependa 
kutumia lugha ya Kingereza. 

Kiswahili Screening Consent-Initial Consent– Version 8.1 – September 27, 2012 
Cervical Treatment Study 
Page 2 of 7 
 
Lengo la Utafiti huu. 
 
Mathumuni  ya mradi huu wa utafiti ni kukupima njia yako ya uzazi kuthibitisha 
ikiwa una dalili inayoashiria kuwa unaweza kupata saratani ya mlango wa uzazi (cervical 
cancer). Umeulizwa kushiriki katika utafiti huu kwa sababu; 
• 
Umeambukizwa maradhi ya UKIMWI 
• 
Unapata matibabu katika kituo cha matibabu cha Hope 
• 
Hauna Mimba 
• 
Hauna historia ya shida ya kuvuja damu 
• 
Haujapata kutolewa sehemu yako ya uzazi (uterasi) 
• 
Umewahi fanya ngono 
 
Saratani ya aina hii huambukiza wanawake wengi wenye umri mdogo na hata wa 
makamu nchini Kenya. Wanawake walioambukizwa na virusi vinavyosababisha ukimwi 
(HIV) wana  hatari kubwa ya kuambukizwa saratani ya mlango wa kizazi (cervical cancer), 
kuliko wanawake wengine ambao bado hawajaambukizwa na HIV. Hata hivyo, kwa 
wanawake walioambukizwa na virusi vinavyosababisha ukimwi, saratani ya mlango wa 
kizazi si ya kawaida. Lakini katika wanawake walioambukizwa na virusi vinavyosababisha 
ukimwi, maambukizo ya mlango wa kizazi usio saratani ya mlango wa kizazi ni wa kawaida. 
Maambukizo haya  husababishwa na virusi vya “Papiloma” (HPV). Ni muhimu kutambua na 
kutibu maambukizo haya kabla hayajageuka kuwa saratani ya mlango wa kizazi. 
 
Utafiti huu  utakupima mlango wako wa uzazi. Iwapo wachunguzi wakipata chembe 
chembe zisizo za kawaida ambazo zinahitaji kutibiwa katika kiwango hiki, unaweza kujiunga 
na utafiti wa matibabu ya ugonjwa unaosababisha saratani ya mlango wa uzazi, ama unaweza 
kutumwa upate matibabu kwingine.Tutakuelezea njia za matibabu kabla hujaamua kujiunga 
na utafiti huo. Katika utafiti huu, tutakuwa na washiriki takriban 2,400. Utafiti huu 
utatuwezesha kupima wanawake bila malipo  ili kuwawezesha wale wanoishi na virusi 
vinavyosababisha ukimwi (HIV) kuishi maisha bila saratani ya mlango wa kizazi. 
 
Hatua ya kushiriki katika utafiti 
Washirika wote watahitajika kutembelea kiliniki mara 1 au 2 au 3. Kila mara, mshirika 
atatumia dakika 20 hadi 40 katika kiliniki. 
 
Uteuzi; (Kutembelea kiliniki Mara Ya 1;Makubaliano - dakika 10, Pap Smear-dakika 20; 
Kutembelea kiliniki Mara Ya 2; Marejeleo ya Matokeo ya Pap Smear- dakika 10, Colposcopy 
na Biopsy (ikihitajika)- dakika 30; Kutembelea kiliniki mara ya 3; Marejeo ya matokeo ya 
biopsy na kujadili juu ya njia za matibabu- dakika 30) 
 
Kutembelea kiliniki mara ya 1:  
Ukikubali kushiriki katika utafiti huu, kwanza utahitajika kuchunguzwa fupanyonga (Pelvic 
exam) kwa kupanguzwa sehemu yako ya siri kutumia burashi ili kuthibitisha ikiwa una dalili 

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inayoashiria kuwa na virusi vinavyoweza kusababisha saratani ya mlango wa uzazi (Pap 
Smear). Kuchunguzwa fupanyonga, kunamaanisha kuwa muuguzi atakagua sehemu zako za 
siri (uke wako). Pap smear itajumuisha utumiaji wa burashi ndogo iingizwayo kwenye kizazi 
ili kuchukua chembe chembe zitakazochunguzwa kwa kutumia “mikroskope”. Kisha 
utahitajika kurudi katika kiliniki baada ya majuma mawili ili kuchukua matokeo ya uchunguzi 
huu.  
Kutembelea kiliniki mara ya 2:  
Utarejea kwenye kiliniki baada ya wiki mbili ili kupata matokeo ya pap smear. Mara nyingi, 
matokeo huwa ni sawa (hakuna kasoro) na mtu hahitaji matibabu ya ziada, ila kurudia “Pap 
smear” tena baada ya kila miezi sita au kufanyaukaguzi na asidi asetiki (VIA) baada ya miezi 
sita. Ikiwa hujambo utaondoka utafitini katika kiwango hiki na kupokea matibabu mengine 
katika Kiliniki ya ukaguzi wa Ugonjwa wa saratani ya mlango wa kizazi ya Coptic Hope 
Centre, [Coptic Hope Cervical Cancer Screening Program (CCSP)] ampapo utapokea VIA, 
au utaulizwa kurudi katika kiliniki ya utafiti baada ya miezi sita  ili kurudia “Pap smear”. 
Wachunguzi wakipata chembe chembe  zisizo za kawaida ambazo zinahitaji kutibiwa katika 
kiwango hiki, watakuelezea juu ya matibabu. 
 
Lakini watafiti wakigundua chembe chembe zisizo za kawaida, watachunguza sehemu yako 
ya siri kwa makini. Kwanza utapimwa kama wewe ni mjamzito. Kama wewe ni mjamzito, 
Hakuna utafiti mwingine utaendelea hadi utakapojifungua mtoto. Watafiti watakutuma kupata 
matibabu ya dharura katika kituo cha Hope  ili kuhakikisha hauambukizi mtoto wako virusi 
vinavyosababisha ukimwi (PMTCT). Kisha utaondoka utafitini katika kiwango hiki na 
kupokea matibabu mengine katika Kiliniki ya ukaguzi wa Ugonjwa wa saratani ya mlango wa 
kizazi ya Coptic Hope Centre,[ Coptic Hope Cervical Cancer Screening Program (CCSP)]. 
Ikiwa wewe si mjamzito,  watafiti wakigundua chembe chembe zisizo za kawaida, 
watachunguza sehemu yako ya siri kwa makini wakitumia chombo kiitwacho “colposcope”, 
ili kuchukua tishu, kiwango kama kipande kimoja cha mchele, utarabu huu unajulikana kama 
“Biopsy”. Tishu iliyochukuliwa, itachunguzwa kwa mikroskope na utajulishwa matokeo 
baada ya wiki nne hadi sita. Mwenendo huu wa kupima ambao majibu yake huwa ni sahihi 
utatuwezesha kujua kana kwamba unahitaji matibabu. 
Kuna chembe chembe za ndani ya njia ya kizazi katikati ya mlango wa kizazi na 
kizazi na pia zinaendelea mpaka ndani ya kizazi. Hizi chembe chembe zinaitwa ‘glandular 
cells’. Ikiwa majibu ya pap smear itaonyesha ‘glandular’ cells si kawaida, daktari ata gwaruza 
kwa njia ya kizazi kutumia chombo chenye umbo cha kijiko ili sampuli ndogo ipatikane ya 
kukaguliwa. Utaratibu huu unaitwa ‘Endocervical curettage (ECC)’. Kukwaruza inafanywa 
wakati ‘colposcopy’ na inachukuwa dakika chache. Unaweza pata maumivu ya tumbo kidogo 
kama wakati unapo pata damu ya mwezi. Pia, kama chembe chembe za mlango wa kizazi 
kwa pap smear inaonyesha si kawaida na mabadiliko ya ugonjwa  kwa mlango wa kizazi 
wakati wa colposcopy haionekani, hii kukwaruza itafanywa kama vile imeelezwa hapo 
mbeleni.  
Kutembelea kiliniki mara ya 3:  

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Utarejea kwenye kiliniki kati ya wiki nne na wiki sitaili kupata matokeo ya biopsy. Iwapo 
tutagundua maambukizi yanayohitaji matibabu, tutakujulisha matibabu ambayo unaweza 
pata. Unaweza kujiunga na utafiti wa matibabu ya ugonjwa unaosababisha saratani ya mlango 
wa uzazi, ama unaweza chagua matibabu kwingine, au tunaweza kukutuma Hospitali Kuu ya 
Kenyatta (KNH) na uendelee kupokea matibabu yako ya kawaida katika Coptic Hope 
Center.Ukichagua kuendelea na utafiti wa matibabu au la, katika kiwango hii, tutakuondoa 
katika utafiti wa kupimwa mlango wa kizazi.    
Tutatumia rekodi zako za afya ziliko HOPE Center ili kukusanya habari zote kuhusu 
afya yako ili kuelewa vyema dawa ambazo umekuwa ukitumia, hali ya afya yako kwa sasa na 
majibu ya vipimo kutoka maabara na pia jinsi umekuwa ukihudhuria kliniki. 
 
 
Kuwasiliana na Washiriki 
 
Tutakuuliza utupatie jinsi ya kuwasiliana nawe kama vile nambari yako ya simu ili tuweze kukupigia 
usipotembelea kiliniki kama ilivyopangwa. Tunaweza kukuuliza kuhusu afya yako au ulipokuwa katika 
mawasiliano haya. Ni muhimu kwako kutembelea kiliniki kama ilivyopangwa. Iwapo hatuwezi kuwasiliana 
nawe kwa njia ya simu, tunaweza kukutembelea kwako nyumbani. Iwapo tutakutembelea kwako nyumbani, 
hatutavalia mavazi yatakayoashiria kuwa sisi ni wahudumu katika hospitali. Unaweza kutuarifu iwapo 
hupendi njia hii ya mawasiliano.Usiporejea kupokea matokeo yako ya pap smear au biospy, tutawasiliana na 
wafanyi kazi wa mapokezi ya Coptic waweke mawaidha kwa faili yako ili unaporejea kwa matibabu yako ya 
kawaidia, utakumbushwa kupitia kwenye kiliniki ya utafiti kupokea matokeo yako.  
Kamataratibu zakudhibiti ubora wautafitizinaonyesha 
kuwaPapsmearyakomatokeonitofautinamatokeoya awali uliyo pewa,tutakuuliza 
urudiklinikikupokeamatokeo yakompya nakujadilimatibabu inayowezekana.Katika hatua hii,unaweza 
kuulizwakamaungependakujiandikisha tena katikautafiti. 
 
 
Athari na usumbufu wa kushiriki kwenye utafiti huu. 
Haya ni maelezo ya athari na usumbufu unayoweza kukumbana nayo kwa kushiriki katika utafiti huu. 
Athari na usumbufu mwingine ambao haujatajwa unaweza kutokea pia. 
 
Kiingilio (Screening) 
Kuchukua sampuli kutoka kwenye fupanyonga (pelvic) kwaweza sababisha; 
• kukerwa kidogo wakati ukaguzi ukiendelea, 
•  kutokwa na damu kidogo kwenye uke wako baadaye kwa siku moja au mbili, na 
• kupata uchungu mdogo wa tumbo kama ule wa damu ya mwezi kwa dakika tano hivi.  
 

Kiswahili Screening Consent-Initial Consent– Version 8.1 – September 27, 2012 
Cervical Treatment Study 
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Ukifanyiwa uchunguzi wa “Biopsy” kwenye fupanyonga (Pelvic), tunakusihi usishiriki ngono 
kwa muda wa siku kumi. Hii ni kwa sababu ikiwa una virusi vinavyosababisha ukimwi na 
(HIV) ili hali mpenzio hana, atakuwa katika hatari kubwa zaidi ya kuambukizwa na virusi 
hivi vya ukimwi. Ikiwa mpenzi wako ana virusi vinavyosababisha ukimwi, atakuwa katika 
hatari kubwa ya kuambukizwa tena na virusi stahimilivu vinavyosababisha ukimwi. Pia, 
wewe unahitaji muda wa kupona na utajiweka katika hatari ya maambukizi usipojipatia muda 
huu. Iwapo unahitaji msaada wowote wa kuongelea mambo haya na mpenzi wako, muuguzi, 
daktari au mshaurikatika hospital atakusaidia. Tutakupatia mipira ya kondomu bila malipo 
iwapo hutaweza kutoshiriki katika ngono. 
Athari nyengine unayoweza kukumbana nayo ni wasiwasiya kuwa una ugonjwa katika 
mlango wako wa uzazi. Unaweza kuongea kuhusu jambo hili na muuguzi wa kitafiti, daktari, au 
ukitaka kuongea na mshaurikatika hospitali, tutakusaidia kupanga haya. 
Tunaweza kugundua katika kiingilio kuwa una maambukizo. Iwapo utapatikana na 
maambukizo, tutakupa maagizo ya kupata dawa. Madhara ya dawa hizi yanaweza kuwa kuumwa na 
tumbo, kutapika na kuharisha, usikivu wa mwangaza, mwasho, mzio mkali mmenyuko unaoweza 
kusababisha kifo, kizunguzungu, kuumwa na kichwa, kuchanganyikiwa, kupigapiga kwenyemasikio 
au kupoteza usikivu, mshtuko wa mwili (jerking of the body), maumivu ya moyo, machafuko ya 
damu, shida ya kisukari, ugonjwa wa maini, ugonjwa wa figo na uchungu au kuganda kwenye 
mikono na miguu. Ikiwa utahisi mojawepo ya athari hizi, mfahamishe mkaguzi katika utafiti huu 
mara moja. 
Uwekaji wa siri 
Wahudumu katika utafiti huu,watakusanya habari ya binafsi na waweza kuona aibu kuongea 
kuhusu habari zako za ndani kama vile; idadi ya wapenzi ambao ushakuwa nao. Unaweza kuchagua 
kutojibu maswali yoyote. Pia, ukija kiliniki, waweza kukutana na wagonjwa wengine ambao 
umewajua mbeleni.Hatuna mpango wa kupeana habari yako ya kibinafsi kwamtu yeyote nje ya utafiti 
huuisipokuwa watafiti au wachunguzi walioteuliwa.Wakati mwingine kamati inayosimamia utafiti 
huu watachunguza habari ya utafiti huu ili kuhakikisha hakuna jambo lolote ambalo ni kinyume na 
sheria au kinyume na maadili litakalotendwa.  Habari yako ya kibinafsi italindwa ipasavyo ikiwa 
hayo yatatendeka na hakuna mtu yeyote atakayeona habari hiyo nje ya uchunguzi 
huu.Kamamdhamini wautafiti, CDC wanaweza kufuatiliaaukukaguashughuli zautafiti.Sababu 
hiiitakuwakuhakikishakuwa utafitiunafanyika kwanjiainayotakiwa, napia kuhakikishakwamba 
hakiyakonaafya yako inalindwa.Matibabuyakotaarifa binafsiitakuwasiri. 
Mbadala wa kujiunga na utafiti huu 
Ukichagua kutoshiriki kwenye utafiti huu, utaendelea kuhudumiwa kikamilifu na 
kupata matibabu na dawa za ART kutoka “Coptic Hope Centre” bila malipo. Unaweza pia 
kupata uchunguzi wa saratani ya mlango wa nyumba ya uzazi bila malipo yeyote katika 
kiliniki hii bila kushiriki katika utafifi huu. 
Manufaa kutokana na utafiti huu 
Kushiriki kwako katika utafiti huu, kutatuwezesha kuelewa zaidi kuhusu ugonjwa wa mlango 
wa nyumba ya uzazi. Kwa kujiunga na utafiti huu, utapata kupimwa mlango wako wa uzazi 
bila malipo. Kama ungependa kujua matokeo ya utafiti huu, unaweza kuwasiliana na ofisi ya 
utafiti huu miezi sita au mwaka mmoja baada ya kumaliza utafiti huu. 
 

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Gharama na Fidia ya Majeraha 
Hakuna gharama yoyote ya kushiriki katika utafiti huu, ila muda wako pekee. Utafiti huu 
utalipia gharama ya uchanguzi wowote utakayopokea kwenye kiliniki ya utafiti. Ikiwa Utapata 
majereha kutokana na kushiriki katika utafiti huu, utafiti huu utafidia gharama yote ya malipo ya 
utunzaji. Ikiwa unafikiri kuwa umepata jeraha ama maumivu kutokana na utafiti huu, wasiliana na 
wahudumu wa utafiti huu, (Daktari Michael Chung (020-272-2710) au Daktari Nelly Mugo (020-
273-6744) au Daktari Evans Malava (0721 289 733)) mara moja.  Watakuhudumia kwa matibabu au 
kukupendekeza kwa matibabu. 
Kuhifadhi kwa Sampuli na Data na Matumizi ya sampuli hizi kwa utafiti wa baadaye  
Tungependa kuhifadhi habari yako ya matibabu na sampuli za pap smear na biopsy katika 
Hospitali ya Coptic na katika Hospitali kuu ya Kenyatta kwa madhumuni ya utafiti wa baadaye. 
Utafiti huu waweza kufanywa na Chuo kikuu cha Washington au na watafiti wengine wanaofanya 
kazi nasi katika utafiti huu kwa muda wa miaka kumi baada ya mwisho wa kufuatiliwa katika utafiti.  
Tutatumia data na sampuli hizi kwa minajili ya utafiti unaoegemea na saratani ya mlango wa kizazi 
na UKIMWI. Kabla sampuli yako kutoka kwenye kiliniki, itapewa kifichomaalumu Jina lako 
halitakuwemo. Jina lako litahusishwa na kificho hiki kwa miaka mitano pekee yake baada ya 
kukamilisha utafiti huu. Baada ya muda huu, kihusishi baina ya jina lako na kificho kilichoko katika 
sampuli na data kitaangamizwa. Bodi za taasisi ya mapitio ni kamati zinazoagalia usalama na haki za 
washiriki wa utafiti katika Hospitali kuu ya Kenyatta na Chuo kikuu cha Washington. Lazima 
ziidhinishe utafiti wowote wa baadaye utakaotumia sampuli na data yako.  Ikiwa hupendi sampuli 
zako zihifadhiwe kwa minajili ya utafiti wa baadaye, unaweza kushiriki katika utafiti huu na sampuli 
zako zitaharibiwa mara tu uchunguzi utakapokamilika.  Ukikubali uhufadhi wa sampuli zako leo, 
kisha ubadilishe nia yako baadaye kabla ya utafiti kukamilika, wafahamishe watafiti ambao 
watahakikisha kuwa sampuli zako hazitahifadhiwa kwa minajili ya utafiti wa baadaye. Hatutauza 
sampuli zako. Uchunguzi utakao fanya kwenye sampuli zako waweza kutuelekeza katika uvumbuzi 
mpya. Hatuna mpango wowote wa kugawana nawe pesa zozote au faida  nyinginezo zitakazotokana 
na uvumbuzi huu - 
Maelezo ya ziada 
Habari kuhusu utambuzi wa ugonjwa wako ni siri na tutaweka rekodi ya afya yako kwa afisi 
inayofungwa. Habari kuhusu uchunguzi na ushiriki wako kwenye utafiti huu utatolewa kwako na 
kikundi cha watafiti pekee wala si mtu mwengine yeyote nje ya utafiti huu bila idhini yako.  Ikiwa 
utapeana idhini, tutawafahamisha habari yako daktari wa Coptic Hope Center. Habari hii inaweza 
kuwasaidia kukupa matibabu na huduma bora ya UKIMWI.Rekodi zako zote zitahifadhiwa katika 
sehemu zilizofungwa na kifuli na tarakilishi zote zitakuwa zina neno la siri la kuhakikisha ulinzi. 
 
Wakati mwengine, wafanyikazi wa chuo kikuu cha Washington wanakagua utafiti kama huu 
ili kuhakikisha unafanywa kwa njia inayofaa na iliyo halali. Ikiwa ukaguzi wa utafiti huu  utafanyika, 
rekodi zako zaweza kuchunguzwa. 
Waweza kukataa kushiriki au waweza kuondoka kwenye 
utafiti huu wakati wowote bila kuadhibiwa au kupoteza faida iliyokuwa haki yako. Tutakueleza ikiwa 
kuna habari geni zinazohusu matibabu ambayo tunatafiti ili uweze kuamua iwapo utajiondoa kwenye 
utafiti huu. Uhusiano wako na wafanyikazi wa huduma za Coptic Hope Centre for infectious diseases,  
hautaadhiriwa kwa vyovyote ikiwa utakubali kushiriki kwenye utafiti huu ama ukiingia kwenye 
mpangilio halafu baadaye uondoke kabla ya kumaliza uchunguzi. Tafadhali wafahamishe wahudumu 

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wa utafiti huu ikiwa utaamua kuondoka katika utafiti huu. Unaweza kuulizwa kupeana sampuli za 
mwisho lakini waweza kukataa. 
 
Wahudumu katika utafiti huu wanaweza kuamua kukuondoa kwenye utafiti huu wakigundua 
kuwa unaweza kupata madhara ukiendelea kushiriki. Unaweza kuondolewa kwenye utafiti huu ikiwa 
wahudumu watagundua kuwa huwezi kufuata masharti ya usalama. 
 
Maswali yeyote kuhusu utafiti huu, ama athari mbaya kutokana na uchunguzi huu 
yapaswa kuelekezwa kwa mtafiti anayekuhudumia au Daktari Michael Chung (272-2710), 
Daktari Samah Sakr (272-4737), au Daktari Nelly Mugo (273-6744). 
 
Je, una maswali yeyote? 
Sahihi ya mtafiti…………………………               Tarehe………………….. 
 
Jina la Mtafiti…………………………… 
Muhusika 
 
Nimeelezwa juu ya utafiti huu. Najitolea kwa hiari kushiriki kwenye utafiti huu. 
Nimewapa watafiti ruhusa ya kutumia  rekodi zangu za utabibu kama ilivyopendekezwa 
kwenye fomu hii ya makubaliano. Nimekuwa na fursa ya kuuliza maswali. Nikiwa na 
maswali yeyote kuhusu utafiti huu baadaye, naweza kumuuliza mojawapo wa watafiti 
waliotajwa kwenye fomu hii. Nikiwa na maswali kuhusu haki yangu kama mhusika kwenye 
utafiti , naweza piga simu kwa kamati ya uchunguzi wa maadili walioko Hospitali kuu ya 
Kenyatta kwa kutumia nambari 020-726-300. Nikitaka, nitapewa nakala ya fomu hii yangu 
binafsi. 
Tafadhali tia alama , ufupi wa jina na anwani katika chaguo moja:  
_____Nimekubali kuweka sampuli na data kwa minajili ya utafiti wa baadaye   
 
_____Sijakubali kuweka sampuli na data kwa minajili ya utafiti wa baadaye   
 
Sahihi au alama ya kidole cha gumba cha mshiriki _________________________________  
 
Tarehe________________ 
 
Jina la Mshiriki lililochapishwa____________________________________ 
 
Nakala kwa Mtafiti na Mshiriki 

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MAKUBALIANO YA PAMOJA 
KISWAHILI CONSENT FORM 
MATIBABU YA SARATANI YA MLANGO WA KIZAZI: UCHUNGUZI 
UANDIKISHAJI UPYA 
WATAFITI 
 
Michael H Chung, MD. MPH, Mkufunzi, Idara ya utabibu, Chuo Kikuu cha Washington 272-
2710 
Nelly Mugo, MBChB, MMed, MPH, Gainakolojia, Mhadhiri, Idara ya Ukunga na 
Gainakologia, Hospitali kuu ya Kenyatta, 020-273-6744 
Sarah Sakr, MBChB, Msimamizi wa afya, Hospitali ya Coptic, Kenya 020-272-4737 
Hugo De Vuyst, MD, PhD, Epidemiologisti, Idara ya Kimataifa ya Utafiti wa Saratani, Shirika la 
Afya la Dunia (WHO), +33-472738521 
Silvia Franceschi, MD, Epidemiologisti, Idara ya Kimataifa ya Utafiti wa Saratani, Shirika la Afya la 
Dunia (WHO), +33-4728404 
Barbara Richardson, PhD, Profesa Msaidizi katika Utafiti, Idara ya Biostatistiki, Chuo Kikuu 
cha Washington, +1-206-731-2425 
Grace John Stewart, MD, PhD, Profesa, Kitivo Cha Utabibu, Chuo Kikuu Cha Washington, 
+1-206-543-4278 
 
Nambari za simu ya dharura; 072-2710 au 0733-711-288 
Mwenyekiti wa kamati ya uchunguzi wa maadili; Proffesa A. N. Guantai, 020 2726300, Ext. 
44102, 44355unaweza kuwasiliana naye kwa maswala ya utafiti na maadili ya washiriki wa 
utafiti huu. 
 
Ujumbe wa Watafiti 
 
Tunakuuliza kushiriki katika utafiti huu wa kitaalamu. Lengo la fomu hii ya idhini ni 
kukupa habari itakayokufahamisha na kukusaidia kuamua kama ungelipenda kushiriki katika 
utafiti huu au la. Tafathali soma maelezo haya kwa makini. Unaweza kuuliza maswali kuhusu 
nia/kusudi ya utafiti huu; unavyohitajika kufanya katika  utafiti, uwezekano wa kuwepo na 
madhara au manufaa yeyote, haki yako kama aliyejitolea, na mambo mengine kuhusu utafiti 
huu au chochote usicho elewa kwenye fomu hii. Tukishajibu maswali yako yote, unapaswa 
kuamua kushiriki kwenye utafiti huu au la. Kukubali kushiriki kwenye utafiti huu kwa hiari 
yako kunamaanisha kuwa umeelezwa na umeelewa yote yanayohusika na kukubaliana nayo. 
Ukipenda, tutakupa nakala ya fomu hii kujihifadhia. Tafadhali tujulishe iwapo ungependa 
kutumia lugha ya Kingereza. 

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Lengo la Utafiti huu. 
 
Mathumuni  ya mradi huu wa utafiti ni kukupima njia yako ya uzazi kuthibitisha 
ikiwa una dalili inayoashiria kuwa unaweza kupata saratani ya mlango wa uzazi (cervical 
cancer). Umeulizwa kushiriki katika utafiti huu kwa sababu; 
• 
Umeambukizwa maradhi ya UKIMWI 
• 
Unapata matibabu katika kituo cha matibabu cha Hope 
• 
Hauna Mimba 
• 
Hauna historia ya shida ya kuvuja damu 
• 
Haujapata kutolewa sehemu yako ya uzazi (uterasi) 
• 
Umewahi fanya ngono 
 
Saratani ya aina hii huambukiza wanawake wengi wenye umri mdogo na hata wa 
makamu nchini Kenya. Wanawake walioambukizwa na virusi vinavyosababisha ukimwi 
(HIV) wana  hatari kubwa ya kuambukizwa saratani ya mlango wa kizazi (cervical cancer), 
kuliko wanawake wengine ambao bado hawajaambukizwa na HIV. Hata hivyo, kwa 
wanawake walioambukizwa na virusi vinavyosababisha ukimwi, saratani ya mlango wa 
kizazi si ya kawaida. Lakini katika wanawake walioambukizwa na virusi vinavyosababisha 
ukimwi, maambukizo ya mlango wa kizazi usio saratani ya mlango wa kizazi ni wa kawaida. 
Maambukizo haya  husababishwa na virusi vya “Papiloma” (HPV). Ni muhimu kutambua na 
kutibu maambukizo haya kabla hayajageuka kuwa saratani ya mlango wa kizazi. 
 
Utafiti huu  utakupima mlango wako wa uzazi. Iwapo wachunguzi wakipata chembe 
chembe zisizo za kawaida ambazo zinahitaji kutibiwa katika kiwango hiki, unaweza kujiunga 
na utafiti wa matibabu ya ugonjwa unaosababisha saratani ya mlango wa uzazi, ama unaweza 
kutumwa upate matibabu kwingine.Tutakuelezea njia za matibabu kabla hujaamua kujiunga 
na utafiti huo. Katika utafiti huu, tutakuwa na washiriki takriban 2,400. Utafiti huu 
utatuwezesha kupima wanawake bila malipo  ili kuwawezesha wale wanoishi na virusi 
vinavyosababisha ukimwi (HIV) kuishi maisha bila saratani ya mlango wa kizazi. 
 
Hatua ya kushiriki katika utafiti 
Washirika wote watahitajika kutembelea kiliniki mara 1 au 2 au 3. Kila mara, mshirika 
atatumia dakika 20 hadi 40 katika kiliniki. 
 
Uteuzi; (Kutembelea kiliniki Mara Ya 1;Makubaliano - dakika 10, Pap Smear-dakika 20; 
Kutembelea kiliniki Mara Ya 2; Marejeleo ya Matokeo ya Pap Smear- dakika 10, Colposcopy 
na Biopsy (ikihitajika)- dakika 30; Kutembelea kiliniki mara ya 3; Marejeo ya matokeo ya 
biopsy na kujadili juu ya njia za matibabu- dakika 30) 
 
Kutembelea kiliniki mara ya 1:  
Ukikubali kushiriki katika utafiti huu, kwanza utahitajika kuchunguzwa fupanyonga (Pelvic 
exam) kwa kupanguzwa sehemu yako ya siri kutumia burashi ili kuthibitisha ikiwa una dalili 

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inayoashiria kuwa na virusi vinavyoweza kusababisha saratani ya mlango wa uzazi (Pap 
Smear). Kuchunguzwa fupanyonga, kunamaanisha kuwa muuguzi atakagua sehemu zako za 
siri (uke wako). Pap smear itajumuisha utumiaji wa burashi ndogo iingizwayo kwenye kizazi 
ili kuchukua chembe chembe zitakazochunguzwa kwa kutumia “mikroskope”. Kisha 
utahitajika kurudi katika kiliniki baada ya majuma mawili ili kuchukua matokeo ya uchunguzi 
huu.  
Kutembelea kiliniki mara ya 2:  
Utarejea kwenye kiliniki baada ya wiki mbili ili kupata matokeo ya pap smear. Mara nyingi, 
matokeo huwa ni sawa (hakuna kasoro) na mtu hahitaji matibabu ya ziada, ila kurudia “Pap 
smear” tena baada ya kila miezi sita au kufanyaukaguzi na asidi asetiki (VIA) baada ya miezi 
sita. Ikiwa hujambo utaondoka utafitini katika kiwango hiki na kupokea matibabu mengine 
katika Kiliniki ya ukaguzi wa Ugonjwa wa saratani ya mlango wa kizazi ya Coptic Hope 
Centre, [Coptic Hope Cervical Cancer Screening Program (CCSP)] ampapo utapokea VIA, 
au utaulizwa kurudi katika kiliniki ya utafiti baada ya miezi sita  ili kurudia “Pap smear”.  
Wachunguzi wakipata chembe chembe  zisizo za kawaida ambazo zinahitaji kutibiwa katika 
kiwango hiki, watakuelezea juu ya matibabu. 
 
Lakini watafiti wakigundua chembe chembe zisizo za kawaida, watachunguza sehemu yako 
ya siri kwa makini. Kwanza utapimwa kama wewe ni mjamzito. Kama wewe ni mjamzito, 
Hakuna utafiti mwingine utaendelea hadi utakapojifungua mtoto. Watafiti watakutuma kupata 
matibabu ya dharura katika kituo cha Hope  ili kuhakikisha hauambukizi mtoto wako virusi 
vinavyosababisha ukimwi (PMTCT). Kisha utaondoka utafitini katika kiwango hiki na 
kupokea matibabu mengine katika Kiliniki ya ukaguzi wa Ugonjwa wa saratani ya mlango wa 
kizazi ya Coptic Hope Centre,[ Coptic Hope Cervical Cancer Screening Program (CCSP)]. 
Ikiwa wewe si mjamzito,  watafiti wakigundua chembe chembe zisizo za kawaida, 
watachunguza sehemu yako ya siri kwa makini wakitumia chombo kiitwacho “colposcope”, 
ili kuchukua tishu, kiwango kama kipande kimoja cha mchele, utarabu huu unajulikana kama 
“Biopsy”. Tishu iliyochukuliwa, itachunguzwa kwa mikroskope na utajulishwa matokeo 
baada ya wiki nne hadi sita. Mwenendo huu wa kupima ambao majibu yake huwa ni sahihi 
utatuwezesha kujua kana kwamba unahitaji matibabu. 
Kuna chembe chembe za ndani ya njia ya kizazi katikati ya mlango wa kizazi na 
kizazi na pia zinaendelea mpaka ndani ya kizazi. Hizi chembe chembe zinaitwa ‘glandular 
cells’. Ikiwa majibu ya pap smear itaonyesha ‘glandular’ cells si kawaida, daktari ata gwaruza 
kwa njia ya kizazi kutumia chombo chenye umbo cha kijiko ili sampuli ndogo ipatikane ya 
kukaguliwa. Utaratibu huu unaitwa ‘Endocervical curettage (ECC)’. Kukwaruza inafanywa 
wakati ‘colposcopy’ na inachukuwa dakika chache. Unaweza pata maumivu ya tumbo kidogo 
kama wakati unapo pata damu ya mwezi. Pia, kama chembe chembe za mlango wa kizazi 
kwa pap smear inaonyesha si kawaida na mabadiliko ya ugonjwa  kwa mlango wa kizazi 
wakati wa colposcopy haionekani, hii kukwaruza itafanywa kama vile imeelezwa hapo 
mbeleni.  
Kutembelea kiliniki mara ya 3:  

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Utarejea kwenye kiliniki kati ya wiki nne na wiki sitaili kupata matokeo ya biopsy. Iwapo 
tutagundua maambukizi yanayohitaji matibabu, tutakujulisha matibabu ambayo unaweza 
pata. Unaweza kujiunga na utafiti wa matibabu ya ugonjwa unaosababisha saratani ya mlango 
wa uzazi, ama unaweza chagua matibabu kwingine, au tunaweza kukutuma Hospitali Kuu ya 
Kenyatta (KNH) na uendelee kupokea matibabu yako ya kawaida katika Coptic Hope 
Center.Ukichagua kuendelea na utafiti wa matibabu au la, katika kiwango hii, tutakuondoa 
katika utafiti wa kupimwa mlango wa kizazi.    
Tutatumia rekodi zako za afya ziliko HOPE Center ili kukusanya habari zote kuhusu 
afya yako ili kuelewa vyema dawa ambazo umekuwa ukitumia, hali ya afya yako kwa sasa na 
majibu ya vipimo kutoka maabara na pia jinsi umekuwa ukihudhuria kliniki. 
 
 
Kuwasiliana na Washiriki 
 
Tutakuuliza utupatie jinsi ya kuwasiliana nawe kama vile nambari yako ya simu ili tuweze kukupigia 
usipotembelea kiliniki kama ilivyopangwa. Tunaweza kukuuliza kuhusu afya yako au ulipokuwa katika 
mawasiliano haya. Ni muhimu kwako kutembelea kiliniki kama ilivyopangwa. Iwapo hatuwezi kuwasiliana 
nawe kwa njia ya simu, tunaweza kukutembelea kwako nyumbani. Iwapo tutakutembelea kwako nyumbani, 
hatutavalia mavazi yatakayoashiria kuwa sisi ni wahudumu katika hospitali. Unaweza kutuarifu iwapo 
hupendi njia hii ya mawasiliano.Usiporejea kupokea matokeo yako ya pap smear au biospy, tutawasiliana na 
wafanyi kazi wa mapokezi ya Coptic waweke mawaidha kwa faili yako ili unaporejea kwa matibabu yako ya 
kawaidia, utakumbushwa kupitia kwenye kiliniki ya utafiti kupokea matokeo yako.  
Kamataratibu zakudhibiti ubora wautafitizinaonyesha 
kuwaPapsmearyakomatokeonitofautinamatokeoya awali uliyo pewa,tutakuuliza 
urudiklinikikupokeamatokeo yakompya nakujadilimatibabu inayowezekana.Katika hatua hii,unaweza 
kuulizwakamaungependakujiandikisha tena katikautafiti. 
 
 
Athari na usumbufu wa kushiriki kwenye utafiti huu. 
Haya ni maelezo ya athari na usumbufu unayoweza kukumbana nayo kwa kushiriki katika utafiti huu. 
Athari na usumbufu mwingine ambao haujatajwa unaweza kutokea pia. 
 
Kiingilio (Screening) 
Kuchukua sampuli kutoka kwenye fupanyonga (pelvic) kwaweza sababisha; 
• kukerwa kidogo wakati ukaguzi ukiendelea, 
•  kutokwa na damu kidogo kwenye uke wako baadaye kwa siku moja au mbili, na 
• kupata uchungu mdogo wa tumbo kama ule wa damu ya mwezi kwa dakika tano hivi.  
 

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Ukifanyiwa uchunguzi wa “Biopsy” kwenye fupanyonga (Pelvic), tunakusihi usishiriki ngono 
kwa muda wa siku kumi. Hii ni kwa sababu ikiwa una virusi vinavyosababisha ukimwi na 
(HIV) ili hali mpenzio hana, atakuwa katika hatari kubwa zaidi ya kuambukizwa na virusi 
hivi vya ukimwi. Ikiwa mpenzi wako ana virusi vinavyosababisha ukimwi, atakuwa katika 
hatari kubwa ya kuambukizwa tena na virusi stahimilivu vinavyosababisha ukimwi. Pia, 
wewe unahitaji muda wa kupona na utajiweka katika hatari ya maambukizi usipojipatia muda 
huu. Iwapo unahitaji msaada wowote wa kuongelea mambo haya na mpenzi wako, muuguzi, 
daktari au mshaurikatika hospital atakusaidia. Tutakupatia mipira ya kondomu bila malipo 
iwapo hutaweza kutoshiriki katika ngono. 
Athari nyengine unayoweza kukumbana nayo ni wasiwasiya kuwa una ugonjwa katika 
mlango wako wa uzazi. Unaweza kuongea kuhusu jambo hili na muuguzi wa kitafiti, daktari, au 
ukitaka kuongea na mshaurikatika hospitali, tutakusaidia kupanga haya. 
Tunaweza kugundua katika kiingilio kuwa una maambukizo. Iwapo utapatikana na 
maambukizo, tutakupa maagizo ya kupata dawa. Madhara ya dawa hizi yanaweza kuwa kuumwa na 
tumbo, kutapika na kuharisha, usikivu wa mwangaza, mwasho, mzio mkali mmenyuko unaoweza 
kusababisha kifo, kizunguzungu, kuumwa na kichwa, kuchanganyikiwa, kupigapiga kwenyemasikio 
au kupoteza usikivu, mshtuko wa mwili (jerking of the body), maumivu ya moyo, machafuko ya 
damu, shida ya kisukari, ugonjwa wa maini, ugonjwa wa figo na uchungu au kuganda kwenye 
mikono na miguu. Ikiwa utahisi mojawepo ya athari hizi, mfahamishe mkaguzi katika utafiti huu 
mara moja. 
Uwekaji wa siri 
Wahudumu katika utafiti huu,watakusanya habari ya binafsi na waweza kuona aibu kuongea 
kuhusu habari zako za ndani kama vile; idadi ya wapenzi ambao ushakuwa nao. Unaweza kuchagua 
kutojibu maswali yoyote. Pia, ukija kiliniki, waweza kukutana na wagonjwa wengine ambao 
umewajua mbeleni.Hatuna mpango wa kupeana habari yako ya kibinafsi kwamtu yeyote nje ya utafiti 
huuisipokuwa watafiti au wachunguzi walioteuliwa. Wakati mwingine kamati inayosimamia utafiti 
huu watachunguza habari ya utafiti huu ili kuhakikisha hakuna jambo lolote ambalo ni kinyume na 
sheria au kinyume na maadili litakalotendwa.  Habari yako ya kibinafsi italindwa ipasavyo ikiwa 
hayo yatatendeka na hakuna mtu yeyote atakayeona habari hiyo nje ya uchunguzi 
huu.Kamamdhamini wautafiti, CDC wanaweza kufuatiliaaukukaguashughuli zautafiti.Sababu 
hiiitakuwakuhakikishakuwa 
utafitiunafanyika kwanjiainayotakiwa, napia kuhakikishakwamba 
hakiyakonaafya yako inalindwa.Matibabuyakotaarifa binafsiitakuwasiri. 
Mbadala wa kujiunga na utafiti huu 
Ukichagua kutoshiriki kwenye utafiti huu, utaendelea kuhudumiwa kikamilifu na 
kupata matibabu na dawa za ART kutoka “Coptic Hope Centre” bila malipo. Unaweza pia 
kupata uchunguzi wa saratani ya mlango wa nyumba ya uzazi bila malipo yeyote katika 
kiliniki hii bila kushiriki katika utafifi huu. 
Manufaa kutokana na utafiti huu 
Kushiriki kwako katika utafiti huu, kutatuwezesha kuelewa zaidi kuhusu ugonjwa wa mlango 
wa nyumba ya uzazi. Kwa kujiunga na utafiti huu, utapata kupimwa mlango wako wa uzazi 
bila malipo. Kama ungependa kujua matokeo ya utafiti huu, unaweza kuwasiliana na ofisi ya 
utafiti huu miezi sita au mwaka mmoja baada ya kumaliza utafiti huu. 
 

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Gharama na Fidia ya Majeraha 
Hakuna gharama yoyote ya kushiriki katika utafiti huu, ila muda wako pekee. Utafiti huu 
utalipia gharama ya uchanguzi wowote utakayopokea kwenye kiliniki ya utafiti. Ikiwa Utapata 
majereha kutokana na kushiriki katika utafiti huu, utafiti huu utafidia gharama yote ya malipo ya 
utunzaji. Ikiwa unafikiri kuwa umepata jeraha ama maumivu kutokana na utafiti huu, wasiliana na 
wahudumu wa utafiti huu, (Daktari Michael Chung (020-272-2710) au Daktari Nelly Mugo (020-
273-6744) au Daktari Evans Malava (0721 289 733)) mara moja.  Watakuhudumia kwa matibabu au 
kukupendekeza kwa matibabu. 
Kuhifadhi kwa Sampuli na Data na Matumizi ya sampuli hizi kwa utafiti wa baadaye  
Tungependa kuhifadhi habari yako ya matibabu na sampuli za pap smear na biopsy katika 
Hospitali ya Coptic na katika Hospitali kuu ya Kenyatta kwa madhumuni ya utafiti wa baadaye. 
Utafiti huu waweza kufanywa na Chuo kikuu cha Washington au na watafiti wengine wanaofanya 
kazi nasi katika utafiti huu kwa muda wa miaka kumi baada ya mwisho wa kufuatiliwa katika utafiti.  
Tutatumia data na sampuli hizi kwa minajili ya utafiti unaoegemea na saratani ya mlango wa kizazi 
na UKIMWI. Kabla sampuli yako kutoka kwenye kiliniki, itapewa kifichomaalumu Jina lako 
halitakuwemo. Jina lako litahusishwa na kificho hiki kwa miaka mitano pekee yake baada ya 
kukamilisha utafiti huu. Baada ya muda huu, kihusishi baina ya jina lako na kificho kilichoko katika 
sampuli na data kitaangamizwa. Bodi za taasisi ya mapitio ni kamati zinazoagalia usalama na haki za 
washiriki wa utafiti katika Hospitali kuu ya Kenyatta na Chuo kikuu cha Washington. Lazima 
ziidhinishe utafiti wowote wa baadaye utakaotumia sampuli na data yako.  Ikiwa hupendi sampuli 
zako zihifadhiwe kwa minajili ya utafiti wa baadaye, unaweza kushiriki katika utafiti huu na sampuli 
zako zitaharibiwa mara tu uchunguzi utakapokamilika.  Ukikubali uhufadhi wa sampuli zako leo, 
kisha ubadilishe nia yako baadaye kabla ya utafiti kukamilika, wafahamishe watafiti ambao 
watahakikisha kuwa sampuli zako hazitahifadhiwa kwa minajili ya utafiti wa baadaye. Hatutauza 
sampuli zako. Uchunguzi utakao fanya kwenye sampuli zako waweza kutuelekeza katika uvumbuzi 
mpya. Hatuna mpango wowote wa kugawana nawe pesa zozote au faida  nyinginezo zitakazotokana 
na uvumbuzi huu ..   
Maelezo ya ziada 
Habari kuhusu utambuzi wa ugonjwa wako ni siri na tutaweka rekodi ya afya yako kwa afisi 
inayofungwa. Habari kuhusu uchunguzi na ushiriki wako kwenye utafiti huu utatolewa kwako na 
kikundi cha watafiti pekee wala si mtu mwengine yeyote nje ya utafiti huu bila idhini yako.  Ikiwa 
utapeana idhini, tutawafahamisha habari yako daktari wa Coptic Hope Center. Habari hii inaweza 
kuwasaidia kukupa matibabu na huduma bora ya UKIMWI.Rekodi zako zote zitahifadhiwa katika 
sehemu zilizofungwa na kifuli na tarakilishi zote zitakuwa zina neno la siri la kuhakikisha ulinzi. 
 
Wakati mwengine, wafanyikazi wa chuo kikuu cha Washington wanakagua utafiti kama huu 
ili kuhakikisha unafanywa kwa njia inayofaa na iliyo halali. Ikiwa ukaguzi wa utafiti huu  utafanyika, 
rekodi zako zaweza kuchunguzwa. 
Waweza kukataa kushiriki au waweza kuondoka kwenye 
utafiti huu wakati wowote bila kuadhibiwa au kupoteza faida iliyokuwa haki yako. Tutakueleza ikiwa 
kuna habari geni zinazohusu matibabu ambayo tunatafiti ili uweze kuamua iwapo utajiondoa kwenye 
utafiti huu. Uhusiano wako na wafanyikazi wa  huduma za Coptic Hope Centre for infectious 
diseases,  hautaadhiriwa kwa vyovyote ikiwa utakubali kushiriki kwenye utafiti huu ama ukiingia 
kwenye mpangilio halafu baadaye uondoke kabla ya kumaliza uchunguzi. Tafadhali wafahamishe 

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wahudumu wa utafiti huu ikiwa utaamua kuondoka katika utafiti huu. Unaweza kuulizwa kupeana 
sampuli za mwisho lakini waweza kukataa. 
 
Wahudumu katika utafiti huu wanaweza kuamua kukuondoa kwenye utafiti huu wakigundua 
kuwa unaweza kupata madhara ukiendelea kushiriki. Unaweza kuondolewa kwenye utafiti huu ikiwa 
wahudumu watagundua kuwa huwezi kufuata masharti ya usalama. 
 
Maswali yeyote kuhusu utafiti huu, ama athari mbaya kutokana na uchunguzi huu 
yapaswa kuelekezwa kwa mtafiti anayekuhudumia au Daktari Michael Chung (272-2710), 
Daktari Samah Sakr (272-4737), au Daktari Nelly Mugo (273-6744). 
 
Je, una maswali yeyote? 
Sahihi ya mtafiti…………………………               Tarehe………………….. 
 
Jina la Mtafiti…………………………… 
Muhusika 
 
Nimeelezwa juu ya utafiti huu. Najitolea kwa hiari kushiriki kwenye utafiti huu. 
Nimewapa watafiti ruhusa ya kutumia  rekodi zangu za utabibu kama ilivyopendekezwa 
kwenye fomu hii ya makubaliano. Nimekuwa na fursa ya kuuliza maswali. Nikiwa na 
maswali yeyote kuhusu utafiti huu baadaye, naweza kumuuliza mojawapo wa watafiti 
waliotajwa kwenye fomu hii. Nikiwa na maswali kuhusu haki yangu kama mhusika kwenye 
utafiti , naweza piga simu kwa kamati ya uchunguzi wa maadili walioko Hospitali kuu ya 
Kenyatta kwa kutumia nambari 020-726-300. Nikitaka, nitapewa nakala ya fomu hii yangu 
binafsi. 
Tafadhali tia alama , ufupi wa jina na anwani katika chaguo moja:  
_____Nimekubali kuweka sampuli na data kwa minajili ya utafiti wa baadaye   
 
_____Sijakubali kuweka sampuli na data kwa minajili ya utafiti wa baadaye   
 
Sahihi au alama ya kidole cha gumba cha mshiriki _________________________________  
 
Tarehe________________ 
 
Jina la Mshiriki lililochapishwa____________________________________ 
 
Nakala kwa Mtafiti na Mshiriki 

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MAKUBALIANO YA PAMOJA 
KISWAHILI CONSENT FORM 
MATIBABU YA SARATANI YA MLANGO WA KIZAZI; CRYOTHERAPY AU 
LEEP 
WATAFITI 
Michael H Chung, MD. MPH, Mkufunzi, Idara ya utabibu, Chuo Kikuu cha Washington 272-
2710 
Nelly Mugo, MBChB, MMed, MPH, Gainakolojia, Mhadhiri, Idara ya Ukunga na 
Gainakologia, Hospitali kuu ya Kenyatta, 020-273-6744 
Sarah Sakr, MBChB, Msimamizi wa afya, Hospitali ya Coptic, Kenya 020-272-4737 
Hugo De Vuyst, MD, PhD, Epidemiologisti, Idara ya Kimataifa ya Utafiti wa Saratani, Shirika la 
Afya la Dunia (WHO), +33-472738521 
Silvia Franceschi, MD, Epidemiologisti, Idara ya Kimataifa ya Utafiti wa Saratani, Shirika la Afya la 
Dunia (WHO), +33-4728404 
Barbara Richardson, PhD, Profesa Msaidizi katika Utafiti, Idara ya Biostatistiki, Chuo Kikuu 
cha Washington, +1-206-731-2425 
Grace John Stewart, MD, PhD, Profesa, Kitivo Cha Utabibu, Chuo Kikuu Cha Washington, 
+1-206-543-4278 
 
Nambari za simu ya dharura; 072-2710 au 0733-711-288 
Mwenyekiti wa kamati ya uchunguzi wa maadili; Proffesa A. N. Guantai, 020 2726300, Ext. 
44102, 44355 unaweza kuwasiliana naye kwa maswala ya utafiti na maadili ya washiriki wa 
utafiti huu. 
 
Ujumbe wa Watafiti 
 
Tunakuuliza kushiriki katika utafiti huu wa kitaalam. Lengo la fomu hii ya idhini ni 
kukupa habari itakayokufahamisha na kukusaidia kuamua kama ungelipenda kushiriki katika 
utafiti huu au la. Tafathali soma maelekezo haya kwa makini. Unaweza kuuliza maswali 
kuhusu nia/kusudi ya utafiti huu; unavyohitajika kufanya katika  utafiti, uwezekano wa 
kuwepo na madhara au manufaa yeyote, haki yako kama aliyejitolea, na mambo mengine 
kuhusu utafiti huu au chochote usichoelewa kwenye fomu hii. Tukishajibu maswali yako 
yote, unapaswakuamua kushiriki kwenye utafiti huu au la. Kukubali kushiriki kwenye utafiti 
huu kwa hiari yako kunamaanisha kuwa umeelezwa na umeelewa yote yanayohusika na 
kukubaliana nayo. Ukipenda, tutakupa nakala ya fomu hii kujihifadhia. Tafadhalu tujulishe 
iwapo ungependa kutumia lugha ya Kingereza. 
Lengo la Utafiti huu.

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Mathumuni  ya mradi huu wa utafiti, ni kutafuta njia iliyo bora ya kutibu ugonjwa 
unaosababisha saratani ya mlango wa kizazi (cervical cancer). Umeulizwa kushiriki katika 
utafiti huu kwa sababu; 
• 
Umeambukizwa maradhi ya UKIMWI 
• 
Unapata matibabu katika kituo cha matibabu cha Hope 
• 
Hauna Mimba 
• 
Hauna historia ya shida ya kuvuja damu 
• 
Haujapata kutolewa sehemu yako ya uzazi (uterasi) 
• 
Umewahi fanya ngono 
• 
Haujawahi kupata matibabu yoyote ya mlango wa kizazi hapo mbeleni 
• 
Umepatikana kuwa na chembe chembe zisizo za kawaida kwa mlango wa uzazi 
kwenye pap smear ua biopsy. 
 
Saratani ya aina hii huambukiza wanawake wengi wenye umri mdogo na hata wa 
makamo nchini Kenya. Wanawake walioambukizwa na virusi vinavyosababisha ukimwi 
(HIV) wana  hatari kubwa ya kuambukizwa saratani ya mlango wa kizazi (cervical cancer), 
kuliko wanawake wengine ambao bado hawajaambukizwa na HIV. Hata hivyo, kwa 
wanawake walioambukizwa na virusi vinavyosababisha ukimwi, saratani ya mlango wa 
kizazi si ya kawaida. Lakini katika wanawake walioambukizwa na virusi vinavyosababisha 
ukimwi, maambukizo ya mlango wa kizazi usio saratani ya mlango wa kizazi ni wa kawaida. 
Maambukizo haya  husababishwa na virusi vya “Papiloma” (HPV). Ni muhimu kutambua na 
kutibu maambukizo haya kabla hayajageuka kuwa saratani ya mlango wa kizazi. 
 
Utafiti huu utalinganisha namna mbili za ukaguzi wa mlango wa kizazi; Cryotherapy 
na LEEP (loop electrosurgical excision procedure). Njia hizi mbili hutumika sana kwa 
wanawake wengi duniani na sio geni. Tutakuelezea njia hizi mbili za utabibu. Katika utafiti 
huu, tutakuwa na washiriki 400. Utafiti huu utatuwezesha kutambua matibabu bora 
itakayowawezesha wanawake wanaoishi na virusi vinavyosababisha ukimwi (HIV) kuishi 
maisha bila saratani ya mlango wa kizazi. 
 
Hatua ya kushiriki katika utafiti 
Washirika wote watahitajika kutembelea kliniki mara 5 au 8 kwa muda usiozidi miaka 2. Kila 
mara, mushirika atatumia dakika 15 hadi 40 katika kiliniki. 
 
 
 
Utaratibu wa kupeana matibabu bila mapendeleo (Randomization) 
(Marejeleo ya Matokeo ya Biopsy  – dakika 10, Utaratibu wa kupeana matibabu bila 
mapendeleo (ikihitajika) – dakika 30) 
 

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Matokeo ya pap smear na biopsy yameonyesha ya kuwa  uko na maambukizo 
yanayohitaji matibabu. ukiamua kujiunga na utafiti huu,  tutatumia mojawapo ya njia mbili 
ambazo ni za kutumainika. Njia moja inaitwa “Cryotherapy”. Njia hii inatia barafu sana 
(freeze) kwenye sehemu  yako ya uzazi iliyoambukizwa na ugonjwa. Unaweza pewa dawa ya 
kumeza kupunguza maumivu baada ya Cryotherapy. Njia ya pili inajulikana kama, “LEEP”. 
Njia hii inatumia chuma kidogo kilichopashwajoto  ili kutoa sehemu iliyoambukizwa baada 
ya kugandishwa kwa dawa. Utahudumiwa kwa njia mojawapo ya hizi bila mapendeleo ili 
kudhibitisha ni njia ipi iliyo bora kuliko nyengine.  
Njia ya kuchagua matibabu bila mapendeleo ni kama “kuzungusha peni”, kila upande 
wa peni una uwezo uliyo sawa, kama ilivyo njia hizi mbili za matibabu. Hatujui kwa hakika 
ni njia gani ya matibabu utakayopata hadi tutakapofungua bahasha iliyo na kijikaratasi 
kitakachotujulisha ni njia gani ya matibabu utakayopata. Sio sisi wala wewe utakayechagua 
njia ya matibabu, bali ni bahasha iliyo na vijikaratasi vitakavyo tuelekeza ni njia ipi 
itakayotumika baada ya kufungua ile bahasha. Tutakuashiria kutumia mojawapo ya njia hizi 
mbili bila mapendeleo (kuegemea njia moja) kwa sababu hatujui ni njia ipi iliyo bora 
kutumiwa na wanawake walioambukizwa na virusi vinavyosababisha ukimwi (HIV). 
Tukigundua kuwa sehemu ya kizazi iliyoambukizwa ni kubwa mno, na haiwezi 
kutibika sawa sawa kwa “Cryotherapy”, tutakutibu tukitumia njia ya “LEEP”. Utapata 
matibabu ya LEEP bila malipo yoyote. 
 Ikiwa sehemu iliyoambukizwa haiwezi kutibika vizuri kwa “Cryotherapy” au 
“LEEP”, utaondoka kwenye utafiti huu na kuelekezwa kwenye hospitali kuu ya Kenyatta 
(KNH) utakapopata matibabu ya aina nyengine ya matibabu kwa bei nafuu katika hospitali ya 
serikali. Watafiti watakupatia fomu zako za matibabu ambazo ni muhimu kwa matibabu yako. 
Hizi fomu hazitaonyesha kuwa wewe ni mshirika wa utafiti huu. Baada ya matibabu 
utakayopokea kutoka KNH, tutakufuatilia kwa miaka 2 na kukupa matibabu. 
Tukikupa njia mojawapo ya matibabu yaliyotajwa (Cryotherapy au LEEP), vijiko 
viwili vya chai (tea spoons [10mls]) vya damu vitatolewa ili kuhesabu chembe chembe za 
CD4 na kuthibitisha kiwango cha virusi vinavyosababisha  ukimwi (HIV) katika damu yako 
kwa wakati huu. Kisha tutapanguza kwa burashi sehemu yako ya kizazi na kukagua kiwango 
cha virusi vinavyosababisha  ukimwi. Mwisho, tutapangusa sehemu yako ya kizazi ili 
kukagua kiwango cha virusi vya “Papiloma” (HPV) ambavyo ni viini vinavyoambukiza 
sehemu ya kizazi na kusababisha saratani ya uzazi (Cervical cancer). 
Tutatumia rekodi zako za afya ziliko HOPE Center ili kukusanya habari zote kuhusu 
afya yako ili kuelewa vyema dawa ambazo umekuwa ukitumia, hali ya afya yako kwa sasa na 
majibu ya vipimo kutoka maabara na pia jinsi umekuwa ukihudhuria kiliniki. 
 
Mpangilio baada ya kupata matibabu bila mapendeleo 
(Kutembelea kiliniki Mara Ya 2-8;Marejeleo ya Matokeo na usufi wa mlango wa kizazi- 
dakika30) 

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Ukipata  mojawapo ya matibabu (Cryotherapy au LEEP) bila mapendeleo, watafiti 
watakuuliza urudi kwenye kiliniki tena wiki ya kwanza (1), pili (2) na tatu (3) baada ya 
matibabu. 
 
Kila  mara utakaporudi kiliniki, vijiko viwili vidogo vya damu vitatolewa na kisha 
kupanguza sehemu yako ya kizazi ili kuthibitisha kiwango cha virusi vinavyosababisha 
ukimwi (HIV). Tungependa kujua kama kiwango hiki kimeongezeka baada ya matibabu na 
kitarudi katika hali yake ya kawaida lini? 
 
Ukipata mojawapo ya matibabu (Cryotherapy au LEEP), tutakuuliza kurudi kiliniki 
ya utafiti mwezi wa sita (6), kumi na mbili (12), kumi na nane (18) na pia mwezi wa ishirini 
na nne (24) baada ya matibabu yako ya kwanza ili kurejelea “Pap smear” kudhibitisha Ikiwa 
sehemu yako ya kizazi iliyoambukizwa imeondolewa kabisa na hakuna tishu iliyojitenga au 
isiyo ya kawaida iliyojitengeza. Tutapanguza sehemu yako ya kizazi (cervix), ili kukagua 
virusi vya “Papiloma” (HPV) kwa wakati huu na kutoa vijiko viwilividogo vya damu ili 
kuhesabu chembe chembe za CD4 na kudhibitisha viwango vya virusi vinavyosababisha 
ukimwi (HIV). Tukigundua hali isiyo ya kawaida, tutakutibu kwa kutumia LEEP, kisha 
tutakuelekeza katika hospitali kuu ya Kenyatta (KNH) kwa matibabu ya ziada yaliyo nafuu. 
 
Kuwasiliana na Washiriki 
 
Tutakuuliza utupatie jinsi ya kuwasiliana nawe kama vile nambari yako ya simu ili tuweze 
kukupigia usipotembelea kiliniki kama ilivyopangwa. Tunaweza kukuuliza kuhusu afya yako au 
ulipokuwa katika mawasiliano haya. Ni muhimu kwako kutembelea kiliniki kama ilivyopangwa. 
Tunataka kukufuatilia vyema na kwa makini ili kutibu ugonjwa wowote katika mlango wa kizazi ulio 
nao sasa au utakaoupata baadaye. Iwapo hatuwezi kuwasiliana nawe kwa njia ya simu, tunaweza 
kukutembelea kwako nyumbani. Iwapo tutakutembelea kwako nyumbani, hatutavalia mavazi 
yatakayoashiria kuwa sisi ni wahudumu katika hospitali. Unaweza kutuarifu iwapo hupendi njia hii 
ya mawasiliano.  
 
Athari na usumbufu wa kushiriki kwenye utafiti huu. 
Haya ni maelezo ya athari na usumbufu unayoweza kukumbana nayo kwa kushiriki katika utafiti huu. 
Athari na usumbufu mwingine ambao haujatajwa unaweza kutokea pia. 
 
Matibabu 
 
Kuna uwezekano wa madhara au maumivu u kipata matibabu haya. Ukishiriki 
katikautibabu wa “Cryotherapy”, waweza kuhisi; 
• maumivu madogo ya tumbo kwa muda unaopungua dakika kumi, 
•  kutokwa na majimaji kwenye uke wako kwa muda wa wiki mbili (au zaidi).  
• Kuvuja damu 
• Maambukizo ambayo tunaweza kutibu hapa katika kiliniki au katika hospitali kwa 
nadra sana. Maambukizo haya yanaweza kusababisha homa,baridi, kutokwa na jasho 
usiku, au majimaji meupe kutoka kwenye uke wako. 

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Ukitibiwa kwa LEEP, unaweza; 
• kuvuja damu baada au wakati matibabu haya yanapoendelea. (Unashauriwa kurudi 
kiliniki Ikiwa uvujaji huu wa damu utaanza, kisha kuendelea baada ya matibabu kwa 
ukaguzi wa ziada.) 
•  Kuna uwezekano wa kuambukizwa kwenye eneo la matibabu.  
Madhara haya yote yanaweza kutibiwa bila malipo yeyote katika kiliniki hii. Matibabu haya 
yanaweza kuwa; 
• 
kupewa dawa ya kuuguza maambukizi.  
• 
Kuingiza pamba kwenye uke wako kuzuia kuvuja damu, 
• 
Kushona kwenye mlango wako wa uzazi ili kuzuia kuvuja kwa damu au 
• 
Kulazwa hospitalini kwa makali ya maambukizo au uvujaji wa damu. 
Tafadhali tufahamishe ikiwa una madhara haya baada ya matibabu. 
 
Baada ya kupokea matibabu ya “Cryotherapy”, au LEEP tunakusihi usishiriki katika 
kitendo cha gono kwa muda wa juma nne, sababu ni kuwa waweza kumwambukiza mwenzio 
kwa urahisi. Pia kuna uwezekano wa wewe kupata maambukizo. Tunaweza kukusaidia 
kuongelea jambo hili na mpenzi wako. 
Washiriki wote watakaopata matibabu ya “Cryotherapy” au “LEEP” watapata maagizo ya 
dawa ya “antibiotiki”. Dawa hii ya antibiotiki itashirikisha doxycline, metronidazole or norfloxacin.  
Madhara ya dawa hizi yanaweza kuwa usumbufu wa tumbo (Lazima usikunywe 
tembo/pombe kwa siku 2) kutapika na kuharisha usikivu wa mwangaza, mwasho, mzio mkali 
mmenyuko unaoweza kusababisha kifo, kizunguzungu, kuumwa na kichwa, kuchanganyikiwa, 
kupigapiga kwenyemasikio au kupoteza usikivu, mshutuko wa mwili (jerking of the body), maumivu 
ya moyo, machafuko ya damu, shida ya kisukari, ugonjwa wa maini, ugonjwa wa figo na uchungu au 
kuganda kwenye mikono na miguu. Ikiwa utahisi mojawepo ya athari hizi, mfahamishe mkaguzi 
katika utafiti huu mara moja. 
Baada ya kupata matibabu haya, kuna uwezekano wa kupata matatizo utakapobeba mimba 
baadaye. Baada ya kupata matibabu ya “LEEP”, wanawake wengine wamepata matatizo wanapobeba 
mimba kama vile;maumivu ya mapema wakati wa kujifunguaau shida katika mlango wa mfuko wa 
uzazi.Katika Wanawake wachache, mlango wa mfuko wa uzazi huziba na inabidi ulegezwe. 
Wanawake wengine huvuja majimaji ya uzazi kabla ya muda ufaao wa kuzaa mtoto pengine kutokana 
na operesheni ya mlango wa mfuko wa uzazi (cervix). 
Utoaji wa damu 
 
Tutakusanya sampuli za damu, vijiko 2 (10 mls),  kutoka kwako kwa kutumia 
shindano na “sirinji”. Kudungwa shindano kwaweza kuwa chungu na yaweza kuacha alama 
kidogo kwa muda mfupi. Yaweza kusababisha maambukizo au kuzirai. 
Uwekaji wa siri

Kiswahili Randomization Consent- version 8.1- September 27, 2012 
 
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Wahudumu katika utafiti huu,watakusanya habari ya binafsi na waweza kuona aibu kuongea 
kuhusu habari zako za ndani kama vile; idadi ya wapenzi ambao ushakuwa nao. Unaweza kuchagua 
kutojibu maswali yoyote. Pia, ukija  kiliniki, waweza kukutana na wagonjwa wengine ambao 
umewajua mbeleni.Hatuna mpango wa kupeana habari yako ya kibinafsi kwamtu yeyote nje ya utafiti 
huuisipokuwa watafiti au wachunguzi walioteuliwa. Wakati mwingine kamati inayosimamia utafiti 
huu watachunguza habari ya utafiti huu ili kuhakikisha hakuna jambo lolote ambalo ni kinyume na 
sheria au kinyume na maadili litakalotendwa.  Habari yako ya kibinafsi italindwa ipasavyo ikiwa 
hayo yatatendeka na hakuna mtu yeyote atakayeona habari hiyo nje ya uchunguzi 
huu.Kamamdhamini wautafiti, CDC wanaweza kufuatiliaaukukaguashughuli zautafiti.Sababu 
hiiitakuwakuhakikishakuwa utafitiunafanyika kwanjiainayotakiwa, napia kuhakikishakwamba 
hakiyakonaafya yako inalindwa.Matibabuyakotaarifa binafsiitakuwasiri. 
Mbadala wa kujiunga na utafiti huu 
Ukichagua kutoshiriki kwenye utafiti huu, utaendelea kuhudumiwa kikamilifu na kupata matibabu na 
dawa za ART kutoka “Coptic Hope Centre” bila malipo. Unaweza pia kupata uchunguzi wa saratani 
ya mlango wa nyumba ya uzazi bila malipo yeyote katika kiliniki hii bila kushiriki katika utafifi huu. 
Unaweza kutibiwa na Cryotherapi katika Hospitali ya kiliniki ya Hope hata ukichagua kutojiunga na 
utafiti huu. Pia, tunaweza kukutuma kupewa huduma katika hospitali kuu ya Kenyatta, ambapo 
malipo ni kama ya hospitali za serikali.   
 
Manufaa kutokana na utafiti huu 
Kushiriki kwako katika utafiti huu, kutatuwezesha kuelewa zaidi kuhusu ugonjwa wa mlango 
wa nyumba ya uzazi.Pia, kushiriki kwako katika utafiti huu kutachangia katika elimu ya 
nyanja hii ambayo yaweza kutoa mabadiliko katika jinsi ya ugonjwa wa saratani ya mlango 
wa uzazi unavyogunduliwa na kutibiwa. Kwenye nchi inayoendelea kama Kenya.Kama 
ungependa kujua matokeo ya utafiti huu, unaweza kuwasiliana na ofisi ya utafiti huu miezi 
sita au mwaka mmoja baada ya kumalizika utafiti huu.  
Gharama na Fidia ya Majeraha 
Hakuna gharama yeyote ya kushiriki katika utafiti huu, ila muda wako pekee. Utafiti huu 
utalipia gharama ya uchaguzi na matibabu yoyote utakayopokea kwenye kiliniki ya utafiti. Ikiwa 
Utapata majereha kutokana na kushiriki katika utafiti huu, utafiti huu utafidia gharama yote ya malipo 
ya utunzaji. Matibabu yatahusisha dawa zinazopambana na vidudu vilivyo hai (antibiotics), dawa 
zinazopunguza maumivu na njia zinazoachisha kuvuja damu. Ikiwa unafikiri kuwa umepata jeraha 
ama maumivu kutokana na utafiti huu, wasiliana na wahudumu wa utafiti huu, (Daktari Michael 
Chung (020-272-2710) au Daktari Nelly Mugo (020-273-6744) au Daktari Evans Malava (0721 289 
733)) mara moja.  Watakuhudumia kwa matibabu au kukupendekeza kwa matibabu. 
Kuhifadhi kwa Sampuli na Data na Matumizi ya sampuli hizi kwa utafiti wa baadaye  
Tungependa kuhifadhi habari yako ya matibabu na sampuli za damu yako na mlango mfuko 
wa uzazi, Kenya  katika Hospitali ya Coptic na katika Hospitali kuu ya Kenyatta kwa madhumuni ya 
utafiti wa baadaye. Utafiti huu waweza kufanywa na Chuo kikuu cha Washington au na watafiti 
wengine wanaofanya kazi nasi katika utafiti huu kwa muda wa miaka kumi baada ya mwisho wa 
kufuatiliwa katika utafiti.  Tutatumia data na sampuli hizi kwa minajili ya utafiti unaoegemea na 

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saratani ya mlango wa kizazi na UKIMWI. Kabla sampuli yako kutoka kwenye kiliniki, itapewa 
kifichomaalumu Jina lako halitakuwemo. Jina lako litahusishwa na kificho hiki kwa miaka mitano 
pekee yake baada ya kukamilisha utafiti huu. Baada ya muda huu, kihusishi baina ya jina lako na 
kificho kilichoko katika sampuli na data kitaangamizawa. Bodi za taasisi ya mapitio ni kamati 
zinazoangalia usalama na haki za washiriki wa utafiti katika Hospitali kuu ya Kenyatta na Chuo 
kikuu cha Washington. Lazima ziidhinishe utafiti wowote wa baadaye utakaotumia sampuli na data 
yako.  Ikiwa hupendi sampuli zako zihifadhiwe kwa minajili ya utafiti wa baadaye, unaweza kushiriki 
katika utafiti huu na sampuli zako zitaharibiwa mara tu uchunguzi utakapokamilika.  Ukikubali 
uhifadhi wa sampuli zako leo, kisha ubadilishe nia yako baadaye kabla ya utafiti kukamilika, 
wafahamishe watafiti ambao watahakikisha kuwa sampuli zako hazitahifadhiwa kwa minajili ya 
utafiti wa baadaye. Hatutauza sampuli zako. Uchunguzi utakao fanya kwenye sampuli zako waweza 
kutuelekeza katika uvumbuzi mpya. Hatuna mpango wowote wa kugawana nawe pesa zozote au faida  
nyinginezo zitakazotokana na uvumbuzi huu ..   
Maelezo ya ziada 
Habari kuhusu utambuzi wa ugonjwa wako ni siri na tutaweka rekodi ya afya yako kwa afisi 
inayofungwa. Habari kuhusu uchunguzi na ushiriki wako kwenye utafiti huu utatolewa kwako na 
kikundi cha watafiti pekee wala si mtu mwengine yeyote nje ya utafiti huu bila idhini yako.  Ikiwa 
utapeana idhini, tutawafahamisha habari yako daktari wa Coptic Hope Center. Habari hii inaweza 
kuwasaidia kukupa matibabu na huduma bora ya UKIMWI. Baadhi ya sampuli zako ikiwa ni pamoja 
na sampuli za damu na sampuli kutoka kwenye mlango wa mfuko wa uzazi zaweza kutumwa USA au 
Uropa kwa uchunguzi. Habari yako na sampuli zako zitalindwa ikiwa haya yatatendeka. Rekodi zako 
zote zitahifadhiwa katika sehemu zilizofungwa na kifuli na tarakilishi zote zitakuwa zina neno la siri 
la kuhakikisha ulinzi. 
 
Wakati mwengine, wafanyikazi wa chuo kikuu cha Washington wanakagua utafiti kama huu 
ili kuhakikisha unafanywa kwa njia inayofaa na iliyo halali. Ikiwa ukaguzi wa utafiti huu  utafanyika, 
rekodi zako zaweza kuchunguzwa. 
Waweza kukataa kushiriki au waweza kuondoka kwenye 
utafiti huu wakati wowote bila kuadhibiwa au kupoteza faida iliyokuwa haki yako. Tutakueleza ikiwa 
kuna habari geni zinazohusu matibabu ambayo tunatafiti ili uweze kuamua iwapo utajiondoa kwenye 
utafiti huu. Uhusiano wako na wafanyikazi wa huduma za Coptic Hope Centre for infectious diseases,  
hautaadhiriwa kwa vyovyote ikiwa utakubali kushiriki kwenye utafiti huu ama ukiingia kwenye 
programu halafu baadaye uondoke kabla ya kumaliza uchunguzi. Tafadhali wafahamishe wahudumu 
wa utafiti huu ikiwa utaamua kuondoka katika utafiti huu. Unaweza kuulizwa kupeana sampuli za 
mwisho lakini waweza kukataa. 
 
Wahudumu katika utafiti huu wanaweza kuamua kukuondoa kwenye utafiti huu wakigundua 
kuwa unaweza kupata madhara ukiendelea kushiriki. Unaweza kuondolewa kwenye utafiti huu ikiwa 
wahudumu watagundua kuwa huwezi kufuata masharti ya usalama. 
Utarejeshewa gharama ya usafiri ya Ksh 300 mara utakaporudi katika kiliniki kwa 
sababu zinazohusiana na utafiti huu. Utapata pesa za usafiri kutoka kwa mhudumu wa 
mapokezi. 
 
 
Maswali yeyote kuhusu utafiti huu, ama athari mbaya kutokana na uchunguzi huu 
yapaswa kuelekezwa kwa mtafiti anayekuhudumia au Daktari Michael Chung (272-2710), 
Daktari Samah Sakr (272-4737), au Daktari Nelly Mugo (273-6744). 
 
Je, una maswali yeyote? 

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Sahihi ya mtafiti…………………………               Tarehe………………….. 
 
Jina la Mtafiti…………………………… 
Muhusika 
 
Nimeelezwa juu ya utafiti huu. Najitolea kwa hiari kushiriki kwenye utafiti huu. 
Nimewapa watafiti ruhusa ya kutumia  rekodi zangu za utabibu kama ilivyopendekezwa 
kwenye fomu hii ya makubaliano. Nimekuwa na fursa ya kuuliza maswali. Nikiwa na 
maswali yeyote kuhusu utafiti huu baadaye, naweza kumuuliza mojawapo wa watafiti 
waliotajwa kwenye fomu hii. Nikiwa na maswali kuhusu haki yangu kama mhusika kwenye 
utafiti , naweza piga simu kwa kamati ya uchunguzi wa maadili walioko Hospitali kuu ya 
Kenyatta kwa kutumia nambari 020-726-300. Nikitaka, nitapewa nakala ya fomu hii yangu 
binafsi.Tafadhali tia alama , ufupi wa jina na anwani katika chaguo moja:  
_____Nimekubali kuweka sampuli na data kwa minajili ya utafiti wa baadaye   
 
_____Sijakubali kuweka sampuli na data kwa minajili ya utafiti wa baadaye   
 
Sahihi au alama ya kidole cha gumba cha mshiriki _________________________________  
 
Tarehe________________ 
 
Jina la Mshiriki lililochapishwa____________________________________ 
 
Nakala kwa Mtafiti na Mshiriki 
 
 
 
 
 
 
 
 

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ENROLLMENT 
 
Study ID Number__ __ __ Hope ID Number __ __ __ __Interviewer Number_ 
 
Date of interview (day/month/year) 
___ ___/___ ___/___ ___ ___ ___ 
Agreed to store samples: Yes  
No 
Don’t know     
Other, specify  
 
A: SOCIODEMOGRAPHIC 
1. Date of birth (day/month/year)  
___ ___/___ ___/___ ___ ___ ___ 
2. Age  
 
 
 
 
____________ years 
3. How many years of education did you complete? 
____________ years 
4. What is highest education level you have completed? None  
 
Primary 
 
 
 
 
 
 
 
 
 
Secondary 
 
 
 
 
 
 
 
Higher education/ University  
Don’t know     
Refused  
 
 
 
 
 
 
 
 
Other, specify 
 
5. Marital status (tick one): 
 
Married (monogamous) 
 
Married (polygamous) 
 
Single  
 
 
 
Divorced/Separated 
 
 
Widowed 
 
 
 
Refused  
 
 
                                                                              Cohabiting                                    
 
 
 
 
 
 
Other, specify 
 
6. Employment (tick one): 
 
Salaried job 
 
 
 
Self-employed  
 
 

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141 
 
Housewife 
 
 
 
Unemployed          
 
 
Casual laborer                        
Refused  
 
 
 
 
 
 
 
 
Other, specify 
7. Household income per month (tick one): None  
 
 
 
< 5000 Ksh 
 
 
5001 – 10000 Ksh 
 
 
10001 – 15,000 Ksh 
 
 
>15,000 Ksh 
 
 
 
Don’t know 
 
 
 
Refused 
 
 
 
 
B: SEXUAL HISTORY  
8. How old were you when you first had vaginal intercourse? 
__ __   Don’t know 
refused    never         Other, specify 
9. How many sex partners have you ever had? __ __ 
Don’t know refused   
Other, specify __________________________ 
 
10. How many different sex partners did you have in the last year? 
__ __
 
Don’t know   refused   Other, specify 
 
 
11. Have you had sex in the last month? (If no, don’t know, refused, skip to 14)  
Yes  
No 
  Don’t know  
Refused   Other, specify  
 
12. How often have you used condoms during sex in the last month? 
Always  (100%) 
 
Most of the time (75-99%) 
 
Half of the time  (50%-74%) 
 
Sometimes (25-49%) 
 
 
Rarely (1-25%)  
 
Never (0%) 
 
 
Refused  
Don’t know   
Other, specify 
 
13. Do you think you may be currently pregnant? Yes 
 
No 
  Don’t 
know  
Refused   Other, specify 

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C: CERVICAL CANCER SCREENING HISTORY 
14. Have you been previously screened for cervical cancer?  Yes  
No 
  
Don’t know   Refused   Other, specify 
 
If no,don’t know or refused skip to 20. 
15. What cervical cancer screening test did you undergo most recently (tick one)? 
 
  
  Pap smear 
 
  
  Visual inspection with Acetic acid 
 
  
  HPV 
  Other, specify: ______________________ 
 Don’t know  
 
 
 
Refused 
16. Where was the most recent test performed? 
 
 
  Coptic 
 KNH 
 Refused 
 Don’t know 
 
 
  Other, specify 
17. When was the test performed? 
 Don’t know  
 
18. What were the results? 
 
 
  Normal 
 
 
  Abnormal, specify ____________________ 
 Don’t know  
 Refused 
19. Did you receive any cervical treatment or surgery as a result of this test? 
 
      Yes 
No 
Don’t know       Refused  
  Other, specify _____________ 
 
If yes, specify ____________________________ 

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20. Was Pap Smear performed today?  
Yes          No  
If no, explain Refused   Don’t know 
21. Comments.

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PAP SMEAR 
 
Study ID Number 
__ __ __ 
 
 
 
Interviewer Number __ __ 
 
 
 
Date of interview (day/month/year) 
___ ___/___ ___/___ ___ ___ ___ 
 
Visit (tick one)  Initial Visit   Repeat    Month 6 FU 
 Month 12 FU 
 Month 18 
FU 
 Month 24 
Other, specify ____________________________ 
 
A: PHYSICAL EXAMINATION 
1. Temperature 
__ __ __°C 
2. Is there inguinal node enlargement Yes         No  
3. Is there abdominal tenderness 
 
Yes         No  
4. Are there any abdominal masses        Yes         No  
5. Were there any other abnormalities found on general physical exam Yes         No  
If yes, specify 
B: PELVIC EXAMINATION 
6. What was found on the external genital exam (tick all that apply)? 
  Abnormal visible discharge at introitus 
  Ulcers 
  Excoriations  
 
 
 
  Vesicles 
  Oedema 
 
 
 
 
  Papules 
  Sores 
 
 
 
 
  Normal 
  Other (Specify) ____________________________________ 
7. Were there any perineal warts on external genital exam? 
Yes         No  
If yes, specify  
a. Size 
__ __ mm 
b. Number of warts 
__ __ 
c. Location of warts 
______________ 
8. Did the cervix appear abnormal on gross pelvic exam? 
Yes         No  
If yes, tick all that apply 
  Abnormal discharge 
 
  Warts 
  Bleeds easily on touch 
 
Cervicitis 
  Visible lesion 
 
 
Condylomata 

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  Bloody discharge 
 
  Ulcers 
 
 
 
  Fungating mass 
  Leukoplakia 
 
 
Cervical polyp 
Bartholian cysts 
 
 
Blisters 
Overt cervical cancer 
 
  Other abnormality, specify 
9. Did you palpate the uterus? Yes         No  
If yes, then specify 
a. Estimated uterine size __ __ . __ cm 
 
b. Was the uterus tender? Yes         No  
c. Were there possible fibroids? 
Yes         No  
10. Was there any adnexal tenderness? Yes         No  
If yes, specify location      
Right Left          Both   
C: Pap 
11. Were you able to take an adequate Pap smear? 
Yes         No  
a. If no, specify why 
Patient discomfort 
Excessive bleeding 
Excessive discharge or inflammation 
Other, specify 
D: DIAGNOSIS 
12. Normal exam 
 
 
 
Yes         No  
13. Candidiasis  
 
 
Yes         No  
14. Cervicitis  
 
 
 
Yes         No  
15. Pelvic inflammatory disease  
Yes         No  
16. Vulval warts 
 
 
 
Yes         No  
17. Vaginal warts 
 
 
 
Yes         No  
18. Genital ulcerations  
 
Yes         No  
19. Lower genital tract infection 
Yes         No  
20. Other 
 
 
 
 
Yes         No  
If others, specify 
E: OTHER 
21. Did you give any treatment to the participant? Yes          No  
If yes, specify (treatment 
22. Did you give referal to the participant? Yes          No  
If yes, specify (diagnosis and referral institution) 
23. Comment.

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COLPOSCOPY 
 
Study ID Number 
__ __ __ 
 
 
Interviewer Number __ __ 
 
 
 
Date of interview (day/month/year) 
___ ___/___ ___/___ ___ ___ ___ 
 
Visit (tick one)  Initial Visit   Month 6 FU  Month 12 FU 
 Month 18 FU 
 
 Month 24 FU 
LSIL FU  
CIN 1 FU       Other, specify _________________ 
A: PAP SMEAR DIAGNOSIS 
1. What date was the Pap smear performed? 
2. What was the Pap smear diagnosis (tick all that apply)? 
 
 No dysplasia (NIL) 
 
 ASCUS 
 
 LSIL (CIN 1) 
 
 HSIL (CIN 2 & 3) 
ASC-H 
 
 Invasive carcinoma 
 
 ACG (Atypical Glandular Cells) 
 
 Cervicitis 
 
 Yeast infection 
 
 Indeterminate/insufficient sample 
 
 Other, specify 
 
 Unknown, specify reason 
3. Is cervical biopsy with colposcopy indicated based on Pap smear cytology?
 
 
Yes         No  
If no,skip to Q24 and fill exit form where necessary 
If yes, and colposcopy had been done previously,skip to Q24. 

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If yes and colposcopy had not been done previously, do a pregnancy test 
     4. Result of pregnancy test:  Pregnant 
  Not Pregnant  
 
           (If pregnant fill exit form, If not pregnant refer for colposcopy) 
Not pregnant  
B: PHYSICAL EXAMINATION 
5. Temperature 
__ __ __ °C 
6. Is there inguinal node enlargement 
Yes         No  
7. Is there abdominal tenderness 
 
Yes         No  
      8. Are there any abdominal masses        Yes         No  
 
9. Were there any other abnormalities found on general physical exam 
Yes         No  
If yes, specify 
 
C: PELVIC EXAMINATION 
10. What was found on the external genital exam (tick all that apply)? 
  Abnormal visible discharge at introitus 
  Ulcers 
  Excoriations 
 
 
 
 
  Vesicles 
  Oedema  
 
 
 
 
  Papules 
  Sores 
 
 
 
 
 
  Normal 
         11. Were there any perennial warts on external genital exam? 
Yes         No  
If yes, specify  
d. Size 
__. __ __ mm 
e. Number of warts 
__ __ 
f. Location of warts 
______________ 
12. Did the cervix appear abnormal on gross pelvic exam? Yes         No  
If yes, tick all that apply 
  Abnormal discharge  
  Warts 
  Bleeds easily on touch 
 
Cervicitis 
  Visible lesion 
 
 
Condylomata 
  Bloody discharge 
 
 
  Ulcers 
 
 
 
  Fungating mass 
  Leukoplakia  
 
Cervical polyp 
 
 
 
Blisters 

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Overt cervical cancer 
13.  Did you palpate the uterus? 
Yes         No  
  If yes, the specify     
a.  Estimated uterine size 
__ __ . __ cm 
b.  Was the uterus tender? 
Yes         No  
c.  Were there possible fibroids? 
Yes         No  
 
d.  Was there any adnexal tenderness? 
Yes         No  
d(i)  If yes, specify location  
Right  
Left        Both    
 
D: COLPOSCOPIC BIOPSY 
15.  Did you see the entire squamocolumnar junction (SCJ)? 
Yes         No  
16. Was it a satisfactory colposcopy? 
 
Yes         No  
If no, specify 
17. Were there colposcopic findings within the transformation zone?  Yes         No  
If yes, specify (tick all that apply) 
  Flat acetowhite epithelium 
  Micropapillary or microconvoluted acetowhite epithelium 
  Leukoplakia 
  Punctation 
  Mosaic 
  Atypical vessels 
  Iodine-negative epithelium 
􀂉 Lesion extended into endocervix 
18. Draw SCJ (acetowhite, punctation, mosaics, atypical vessels, and other lesions): 
19. Were there any other colposcopic findings?  
Yes         No  
If yes, specify (tick all that apply) 
􀂉 Mucosal bleeding easily induced 
􀂉 Purulent cervicitis 
􀂉 Opaque discharge 
􀂉 Yellow discharge 
􀂉 Other, specify: 
20.  Were there colposcopic findings consistent with invasive carcinoma? 
Yes         No  

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E: COLPOSCOPY DIAGNOSIS 
21.  Is patient eligible for cryotherapy if necessary? Yes         No  
If no, indicate reason (tick all that apply) 
 Lesion >75% of cervix 
 Lesion is larger than cryoprobe tip 
 Lesion suspicious for cancer 
 Polyp or anatomic defect preventing access to cervix 
 Previous treatment with cryotherapy in this study 
 Other, specify 
22. What was your diagnosis based on colposcopy examination (tick all that apply)? 
􀂉 Normal colposcopic findings 
􀂉 Unsatisfactory, specify:  
􀂉 Inflammation/infection, specify 
􀂉 Leukoplakia 
􀂉 Condyloma 
􀂉 LSIL (CIN 1) 
􀂉 HSIL (CIN 2 & 3) 
􀂉 Invasive cancer 
􀂉 Other, specify:  
 
D: SPECIMEN COLLECTION 
23. Was a biopsy taken?  Yes         No  
a. If yes, how many biopsies were taken __ __ 
b. Draw: (mark site(s) with an ‘X’ on colposcopy drawing) 
c. If no, specify why biopsy was not taken 
 
E: Treatment 
24.  Was any treatment given to the patient ? Yes          No  
          If yes, specify treatment 
25. Was a referral given to the patient? Yes          No  
          If yes, specify diagnosis, and the referral institution 

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26.Comments: 
 

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RANDOMIZATION 
 
Study ID Number__ __ __ Hope ID Number __ __ __ __ 
Randomization Number_ _  
Interviewer Number_ 
Date of interview (day/month/year) 
___ ___/___ ___/___ ___ ___ ___ 
 
A: CURRENT MEDICAL HISTORY 
1. Do you have pain when passing urine?  
Yes 
 
No 
 Other, 
specify Refused   Don’t know 
2. Do you have any lower abdominal pain? Yes 
 
No 
 Other, specify 
Refused   Don’t know 
3. Do you have any abnormal vaginal discharge?  Yes 
         No  
 Other, 
specify Refused   Don’t know 
   4. Have you noticed any growths around your vagina? 
Yes          No         
Don’t know  Other, specify Refused   Don’t know 
 
B: REPRODUCTIVE HEALTH 
5. How old were you when you had your first menstrual period? __ __  Don’t know 
  refused   Other, specify 
6. Date of last menstrual period (day/month/year) ___ ___/___ ___/___ ___ ___ ___ 
Don’t know   refused   Other, specify 
7. Do you have history of abnormal vaginal bleeding  
Yes 
 
No 
 
Don’t know     
Refused  
Other, specify 
If yes specify the type of bleeding 
  
  Irregular 
  
  Heavy 
  
Menorrhagia   
  Other, specify 
 Don’t know 
 Refused 
 

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8. Have you ever used any form of family planning  method? Yes   
No   
Don’t know    
Refused   
Other, specify ________ 
If yes, specify (tick all that apply) 
 
 
Injectable 
 
IUCD  
 
Natural 
 
 
 
Condoms 
 
OCP 
 
 
Norplant/ Implant 
 
BTL                  
others, specify ______________________ 
9. Are you using any form of family planning method now? 
 
 
 
Yes 
 
No 
Don’t know    Refused 
 
Other, specify  ______________________________________ 
 
If yes, specify (tick all that apply) 
 
Injectable 
 
IUCD  
 
Natural 
 
 
Condoms 
 
OCP 
 
 
Norplant/ Implant
 
 
 BTL                  
others, specify ____________ 
 
10. How many times have you been pregnant? 
__ __  Refused   Don’t know  
Other  
11. How many times have you had live births? 
__ __ Refused   Don’t know  
Other  
12. How many abortions, miscarriages, and/or stillbirths have you had? __ __
 
Refused   Don’t know  Other  
13. Have you ever been admitted to the hospital with a gynecological problem?  
Yes 
 
No 
  Don’t know   Refused   Other, specify 
14. Have you ever had abdominal surgery? Yes 
 
No 
   Refused   
Don’t know  Other, specify 
15. Have you ever had vaginal surgery? 
 
Yes 
 
No 
    
Refused   Don’t know  Other, specify 
16. Do you currently smoke cigarettes 
 
 
Yes 
 
No 
 
Refused   Don’t know  Other, specify 
 
C: HIV HISTORY 
17. When were you diagnosed as having HIV? (day/month/year) ___ ___/___ 
___/___ ___ ___ ___    
18.1. How was HIV detected? (tick only one) 

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- At the occasion of a VCT:  
 
 
Yes 
 
 
- During pre-natal check-up:  
 
 
Yes 
 
 
- Because of a sickness, specify:________________ Yes 
 
 
- Other, specify:_________________________ 
 
 
 
- Don’t know:  
 
 
 
 
 
 
 
- Refused: 
 
 
 
 
 
 
 
 
19. Are you currently on antiretroviral medications? 
Yes 
 
No 
 
Don’t know     
Refused  
Other, specify 
If yes,  
 
a) specify current medications: ___________________________ 
 
b) original start date: ___ ___/___ ___/___ ___ ___ ___  Don’t know   
 
c) Do you know why you were started on antiretroviral medication? 
 
 - because of sickness, specify: _____________________  Yes 
 
 
 - because of low CD4 count:  
 
 
 
Yes 
 
 
 
- because of high viral load:  
 
 
 
Yes 

 
- Other, specify: _________________________ 
 
 
 
 
- Don’t know:  
 
 
 
 
 
 
 
 
- Refused: 
 
 
 
 
 
 
 
 
 
20. Comment 

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TREATMENT 
 
Study ID Number 
__ __ __ 
 
 
Interviewer Number __ __ 
 
 
 
Date of interview (day/month/year) 
___ ___/___ ___/___ ___ ___ ___ 
 
Visit (tick one)  Initial Visit   Month 6 FU  Month 12 FU 
 Month 18 FU 
 
 Month 24 FU 
 CIN 1 FU 
Other, specify _______________ 
Does the patient have any known allergies to medications or antibiotics?Yes          No  
If yes, specify 
A: DIAGNOSIS 
1. What date was the cervical biopsy performed? ___ ___/___ ___/___ ___ ___ ___ 
2. What was the result of cervical biopsy histopathology (tick all that apply)? 
 
No dysplasia (NIL) 
 
CIN 1 
 
CIN 2 
 
 CIN 3 
 CIS 
 
 AGC (Atypical Glandular Cells) 
 
 Invasive carcinoma 
 
 Cervicits 
 
 Unknown, specify reason 
 
 Other, specify 
3. Has patient previously received treatment as part of this study? 
Yes          No  
If yes, skip to 7 
 
B: RANDOMIZATION 

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4. Is patient indicated for LEEP or cryotherapy treatment based on histopathology?
 
Yes         No  
If no, continue to 14 
5. Is patient’s lesion amenable to cryotherapy? 
Yes          No  (If yes, go to 
question 6) 
 5(i)If no, indicate reason (tick all that apply) 
 Lesion >75% of cervix 
 Lesion is larger than cryoprobe tip 
 Invasive cervical cancer on histology 
 Lesion suspicious for cancer 
 Polyp or anatomic defect preventing access to cervix 
 Patient declines procedure 
 Other, specify 
5(ii)If no, is patient’s lesions amenable to LEEP? 
Yes          No  
If yes, skip to 7 
If no, skip to 14 
6. Was patient randomized to LEEP or cryotherapy today?  
Yes          No  
 
If yes, to which treatment? 
LEEP  Cryotherapy   
 
If no, why? 
 
 
 Patient refuses 
 
 
 Patient not eligible for treatment, specify reason 
 
 
 Other, specify 
 
C: TREATMENT 
7. Did you perform LEEP or cryotherapy today?  (tick one)   
LEEP  
 
Cryotherapy   
Neither, explain  
(If neither, explain, skip to Q14) 
8. Did you visualize the full extent of lesion? 
 
Yes         No  
9. Was the squamocolumnar junction fully visualized? 
Yes         No  
10. Draw position of lesion and treatment performed: 
11. Did the patient experience any pain during the procedure? 
Yes         No  
12. Was analgesia provided? 
 
 
 
Yes         No  
13. Were there any complications?  
 
Yes         No  

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If yes, specify 
14. Was any antibiotics given?    Yes         No  
If yes, specify 
 
 
 
 
D: OTHER 
15. Was the patient referred for further treatment at another institution?  Yes         
No  
If yes, specify institution and reason 
16. Was treatment or a referral given for something other than cervical disease? Yes          No  
If yes, specify (give diagnosis and treatment) 
17. Comments

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157 
 
ADDRESS AND INTAKE 
 
Study ID number __ __ __ 
 
 
 
Interviewer number ____  ____ 
 
Date of interview (day/month/year) 
___ ___/___ ___/___ ___ ___ ___ 
 
Format(tick one) 
 
New  
 
Update (fill only updated info) 
 
A.  PERSONAL INFORMATION 
1. What is your name? 
a. First name 
b. Middle name 
c. Last name 
2. How are you called in your home area? 
3. What is the current physical location where you live? 
a. District 
b. City 
c. Village 
d. Estate 
e. Plot number 
f. Door number 
g. Road name  
 
4. Public Transportation to the house: 
      4a. Type:  Ͱ Bus   Ͱ Boda boda    Ͱ Matatu    Ͱ Taxi   Ͱ Other (specify) 
      4b. Route number: 
      4c. Stage Name  
      4d. General Name of the Area  
5. Walking directions to house from the stage?  
6. Landmarks that aide in locating the household: (Names of schools, churches, 
businesses etc.) 
7. Can you be reached by phone?  
 
Yes 
 
No 
 
 
If yes,  
7 (i)What is the phone number 1? 
7 (ii)What is the phone number 2? 
 
7iii. Who carries the phone (tick one)  
  self  
  other, specify 
 

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158 
 
B.  SIGNIFICANT CONTACT 
8. Is there another person who is ware of your HIV status that we can contact through phone 
if we are unable to reach you directly? 
 
If no, skip to 9. 
9. What is the name of this contact person? 
a. First name 
b. Middle name 
c. Last name 
10. What is the relationship of this person to you? 
11. (a)What is the phone number 1? 
      (b) What is the phone number 2? 
 
C.  UPCOUNTRY INFORMATION 
12. Do you have an upcountry home? 
 
Yes 
 
No 
 
If no, skip to 19 
13. What is the physical location of your upcountry home? 
a. District 
b. City 
c. Village 
d. Estate 
e. Plot number 
f. Door number 
14. Specific directions to residence 
15. Is there person located in your upcountry home whom we can contact if we are unable to 
reach you directly?  
Yes 
 
No 
 
If no, skip to 19 
16. What is the name of this contact person? 
a. First name 
b. Middle name 
c. Last name 
17. What is the relationship of this person to you? 
18. Does this contact have a phone number? 
Yes 
 
No 
 
If yes, specify: phone number 1, phone number 2 
 
D.  OTHER 
Comment:

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SHEDDING 
 
Study ID Number 
__ __ __ 
 
 
Interviewer Number __ __ 
 
 
 
Date of interview (day/month/year) 
___ ___/___ ___/___ ___ ___ ___ 
 
Visit (tick one)  Week 1 FU  Week 2 FU  Week 3 FUOther, specify ________ 
 
A: MEDICAL HISTORY 
1. Has the patient experienced any lower abdominal pain since the last visit? 
Yes          No  
If yes, indicate: 
a. Duration 
__ __ days 
b. Severity (scale from 1 to 5; 5 being most severe) __ __ 
 
2. Has the patient experienced any vaginal bleeding since the last visit? 
Yes          No  
If yes, indicate: 
a. Duration __ __ days 
b. Volume 
  Stain pants 
 
  Requires sanitary pad 
 
  Other, specify                   
3. Has the patient experienced any vaginal discharge since the last visit?    
Yes          No  
If yes, indicate: 
c. Duration __ __ days 
d. Color 
  Yellow  
 
 
  Brown                       
 
  White 
 
 
 
 
  Clear         
 
 

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  Other, specify                   
e. Smell 
 
  Malodorous 
 
  No odor 
 
  Other, specify                   
f. Volume  
  Stain pants 
 
  Requires sanitary pad 
 
  Other, specify                   
4. Has the patient experienced any fever after the last visit? 
 
Yes          No  
 
If yes, specify duration __ __ days 
5. Did the patient seek medical care for these or other complaints? 
Yes          No  
 
If yes, specify what complaint prompted the participant to seek care: 
  Abdominal pain 
 
  Fever 
  Vaginal Bleeding 
 
  Vaginal discharge 
a.  Other, specify                   
 
If yes, specify where the participant sought care: 
  Study clinic 
 
  Hope Center 
  Coptic Hospital 
 
  KNH 
b.  Other, specify                
6. Was the participant’s condition possibly due to a study procedure? (Ask if any of 
questions 1-4 is yes) 
Yes          No  

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If any question 1-4 is Yes and the condition is not expected as per study protocol, or is 
more severe than expected, fill an AE form. 
 
 
7. Date of last menstrual cycle (dd/mm/yyyy)  
8.     Have you ever had vaginal sex since treatment? Yes          No  Refused   
 
Other (specify)  ___________________________ 
 
8 (a). If yes, how many times? __ 
 
8(b) If you have had vaginal sex since treatment, how often did you use condoms during 
sex? 
Always  (100%)  
Most of the time (75-99%)   
Half of the time  (50%-74%)   Sometimes (25-49%)   
Rarely (1-25%)  
Never (0%)   
Refused    Don’t know  
Other, specify_______________ 
 
9. Do you think you may be currently pregnant? Yes          No  
10. Are you currently on antiretroviral medications? 
        Yes              Refused         Other, specify  
        No                Don’t know  
If No, Refused, or Don’t Know, skip to Q14 
        If yes, specify current medications and original start date. 
  d4t, 3tc, nvp 
    d4t, 3tc, efv 
  azt, 3tc, nvp 
   azt, 3tc, efv 
  Other specify 
  Original ARV start date (dd/mm/yyyy) 
11. During the last 7 days, how many antiretroviral pills did the patient MISS taking?  
12. During the last 30 days, how many antiretroviral pills did the patient MISS taking?  
(If Q11 and Q12 patient did not MISS taking any pills skip to Q14) 

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13. If the patient missed any doses, please specify reasons (check all that apply) 
  Toxicity/ side effect 
    Share with others 
    Forgot 
c.  Felt better 
  Too ill 
   Stigma, disclosure or privacy issues 
    Drug out of stock 
  Patient lost or ran out of pills 
  Delivery /travel problem 
  Inability to pay 
  Alcohol 
  Depression 
d.  Other specify 
 
 
B: DIAGNOSIS 
14. Is there any new infection that was related to the procedure since the last visit? 
Yes          No  
 
If yes, specify and fill an Adverse Event questionnaire: 
15. Were there any new complications diagnosed today related to the treatment?  
Yes          No  
 
If yes, specify and fill an Adverse Event questionnaire: 
 
C: TREATMENT 
16. Was any treatment provided today? Yes          No  
If yes, specify 
17. Was the  patient referred for further cervical treatment at another institution?   
Yes         No  
17 (i)If yes, specify institution  

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17(ii)If yes, specify reason for referral 
 
 
D: SPECIMEN COLLECTION 
18. Did you collect cervical HIV swab? Yes          No  
If no, specify reason: 
19. Did you collect blood? 
 
 
Yes          No  
If no, specify reason: 
 
E: ACCEPTABILITY OF TREATMENT 
20. Please complete the items listed below by placing a checkmark on the box next to 
each question that best indicates how the client feels about the treatment she received.  
 
 
 
 
 
Strongly 
Disagree 
Disagree, Neutral, 
Agree 
strongly 
agree 
(i) I find this treatment an 
acceptable way of dealing with 
cervical lesions 
 
 
 
 
 
(ii) I would be willing to use 
this procedure if I were to 
develop more lesions 
 
 
 
 
 
(iii) I would recommend this 
procedure to someone with 
cervical lesions 
 
 
 
 
 
(iv) overall, I have a positive 
reaction to this treatment 
 
 
 
 
 
 
F: OTHER 
22.  
__ 
 
23.  
24. Comments:

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PATIENT CONTACT 
 
Study ID Number 
__ __ __ 
 
 
 
Interviewer Number __ __ 
 
 
 
Date of contact (day/month/year) 
___ ___/___ ___/___ ___ ___ ___ 
1. Date of last Hope clinic visit (day/month/year) 
2. Date of last study clinic visit (day/ month/year) 
3. Was patient or patient contact reached by phone or home visit? 
 
 Ͱ Phone 
Ͱ Home visit 
 
Ͱ Other, specify 
 
4. Did you talk to the patient or patient contact?   
    Ͱ Yes, talked to patient  (Go to 6) 
    Ͱ Yes, talked to patient contact  (Go to 5) 
    Ͱ No (Go to 4) 
 
5. If talked to patient contact, who was the source of information (tick one)  
    Ͱ Clinician / clinic staff 
 
    Ͱ Mother or Father 
 
Ͱ Neighbor 
    Ͱ Spouse or Partner    
    Ͱ Employer  
 
Ͱ Caregiver 
 
    Ͱ Family member / Relative     Ͱ Friend 
 
 
Ͱ Treatment supporter 
 
 
 
 
 
 
 
 
 
Ͱ Other (specify) 
 
 
 
 
 
 
5a. Did the source of information have credible knowledge for whether the patient was alive or dead? 
          Ͱ Yes, credible and patient confirmed alive  (Go to 4) 
          Ͱ Yes, credible and patient confirmed dead  (Go to 7 and complete Verbal Autopsy form) 
          Ͱ Source did not know whether patient was dead or alive  (Go to 4) 
Ͱ Source not credible  (Go to 7 and complete Verbal Autopsy form) 
 
 

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6. Reasons for missed study appointment (tick all that apply) 
   Ͱ N/A, did not reach patient or patient contact             
Ͱ Unable attend because health problem 
   Ͱ No longer willing to be in study  
Ͱ Family problems      
   Ͱ Wait time too long in clinic 
Ͱ Client will go to faith healer 
 
 
   Ͱ Conflict with work 
Ͱ Unwilling to disclose 
 
 
   Ͱ Financial problems 
Ͱ No longer willing attend Hope Clinic 
   Ͱ Client moved or relocated 
Ͱ Other (specify) 
 
 
 
7. If talked to patient, did the patient wish to remain in the study?   
 
Ͱ Yes  (Go to 7a) 
Ͱ No   (Go to 8 and complete Exit Form)     
            Ͱ N/A, did not talk to patient  (Go to 9) 
 
7a. Did the patient schedule a study appointment?  Ͱ Yes   Ͱ No  (If Yes go to 7b, If No go to 7c)   
 
7b. If yes, date of scheduled appointment (DD/MM/YYYY)  ͰͰ/ͰͰ/ͰͰͰͰ 
 
 
7c. If no, why did the patient not schedule an appointment (tick all that apply) 
            Ͱ Unable to attend because of health problems 
            Ͱ Family problems      
 
            Ͱ Conflict with work 
 
 
 
            Ͱ Financial problems  
 
            Ͱ Client moved or relocated 
 
            Ͱ Client lives too far away 
 
            ͰOther (specify)     
 
 
 
8. If the patient does not wish to return to the study, specify why (tick all that apply) 

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     Ͱ Not willing to attend Hope Clinic 
 
Ͱ Not willing to be in study 
     Ͱ Attend clinic closer to home  
     Ͱ Wait time too long 
     Ͱ Conflict with work 
     Ͱ Financial problems 
     Ͱ Unwilling to attend because of health problems  
     Ͱ Family problems 
     Ͱ Client will go to a faith healer  
     Ͱ Not willing to disclose HIV status  
 
 
     Ͱ Referred else where 
 
 
 
 
Ͱ Other (specify)   
     Ͱ Unknown  
 
 
 
 
 
 
9. Comments 
 
 
 
 

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VERBAL AUTOPSY 
 
Study ID Number 
__ __ __ 
 
 
 
Interviewer Number __ 
__ 
 
 
 
Date of interview (day/month/year) 
___ ___/___ ___/___ ___ ___ ___ 
1.  Age at death    ͰͰͰ years 
 
2. Date of death (DD/MM/YYYY)  ͰͰ/ͰͰ/ͰͰͰͰ  
 
3. Place of death 
4. The information source for the cause of death was  (tick all that apply)  
    Ͱ Partner/spouse 
 
 
    Ͱ Mother or Father 
 
 
Ͱ Friend 
    Ͱ Hospital records/staff   
 
    Ͱ Other family member/relative 
Ͱ Care giver
 
 
    Ͱ Neighbor  
 
 
    Ͱ Unknown  
Ͱ Other (specify) 
 
5.  Was the deceased seeking other medical treatment (other than Hope Center) during the last 
3 months before his/her death?      Ͱ Yes  
    Ͱ No Ͱ Unknown 
 
If yes go to 
5a, if no go to 6 
 
 
5a.  If yes, where specifically was the deceased receiving other medical care?   
 
Name of facility:_______________________________________ 
 
 
5b.  What type of care was the deceased receiving at the these other facilities? (Tick 
all that apply) 
 
     Ͱ General medical care 
 
Ͱ TB 
 
 
 
 
Ͱ STD 
     Ͱ HIV/AIDS  
 
Ͱ Malaria 
 
 
 
Ͱ Other infectious disease(s) 
     Ͱ Other care (specify all types of care 
received:___________________________________________) 
 

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6.  Respondent’s detailed account of the illness of the deceased: 
 
7.  Did a health care worker tell you the cause of death?  Ͱ Yes      Ͱ No Ͱ Unknown 
 
 
 
 
 
 
 
 
 
If yes go to 7a, if no 
go to 8 
 
 
7a. What did the health care worker say was the cause of 
death?__________________________ 
 
8.  Did s/he have any operation for the illness?  Ͱ Yes  
    Ͱ No Ͱ Unknown 
 
 
 
 
 
 
 
 
 
If yes go to 8a, if no go to 9 
 
8a.  How long before the death was the operation? _____days 
 
8b.  On what part of the body was the operation?   
Ͱ Abdomen  Ͱ Chest  ͰHead   Ͱ Other(Specify_______________) 
 
9.  Has spouse or other sexual partner(s) of the deceased died in the past 5 years?    
Ͱ Yes      Ͱ No Ͱ Unknown 
 
 
If yes go to 9a, if no 
go to 10 
 
 
9a.  If yes, what is the believed cause(s) of death of the partner(s) 
 
 
9a1. Partner 1:_____________________________ 
 
 
9a2. Partner 2:_____________________________    
 
Injury/accident/suicide 
 
10.  Did s/he suffer from any injury or accident that led to her death?  Ͱ Yes   Ͱ No 
Ͱ 
Unknown 
If yes go to 10a, if no go to 11 
10a.  What kind of injury or accident did the deceased suffer? 

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Ͱ Road traffic accident Ͱ Fall  
 
Ͱ Drowning 
 
Ͱ Poisoning 
 
Ͱ Burns 
 
Ͱ Violence/assault 
Ͱ 
Other:________________________ 
Ͱ Unknown 
 
10b.  Was the injury or accident intentionally inflicted by someone else?  Ͱ Yes   Ͱ 
No  Ͱ Unknown 
 
10c.  Do you think that s/he committed suicide? Ͱ Yes    Ͱ No 
   Ͱ Unknown      
Skip to Q.12 
 
11.  Did s/he suffer from any animal/insect bite that led to her/his death?   
Ͱ Yes    Ͱ 
No 
   Ͱ Unknown  
 
11a.  If yes, what type of animal/insect?________________________ 
 
History of previously known medical conditions 
 
12.  Did the deceased suffer from any of the following conditions? 
 
a.  High blood pressure  
 
 
Ͱ Yes      Ͱ No Ͱ Unknown 
b.  Diabetes 
 
 
 
 
 
Ͱ Yes      Ͱ No Ͱ Unknown 
c.  Asthma 
 
 
 
 
 
Ͱ Yes      Ͱ No Ͱ Unknown 
d.  Epilepsy 
 
 
 
 
 
Ͱ Yes      Ͱ No Ͱ Unknown 
e.  Malnutrition   
 
 
 
 
Ͱ Yes      Ͱ No Ͱ Unknown 
f.  Cancer   
 
 
 
 
 
Ͱ Yes      Ͱ No Ͱ Unknown  
f1.  If yes, specify type of cancer or site:_____________ 
g.  Tuberculosis  
 
 
 
Ͱ Yes      Ͱ No Ͱ Unknown 
h.  Any other medically diagnosed illness?         Ͱ Yes      Ͱ No Ͱ Unknown 
h1.  If yes, specify:______________________ 

Verbal Autopsy – Version 2.3 – April 26, 2011 
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13.  Signs, symptoms, and their severity during the last illness: 
 
Unexpected vaginal bleeding or discharge 
ͰNo    Ͱ Yes 
2 weeks    Ͱ >2 weeks    Ͱ Unknown 
Pelvic or vaginal pain 
ͰNo    Ͱ Yes 
2 weeks    Ͱ >2 weeks    Ͱ Unknown 
 
Symptom/ Signs 
Symptom 
present? 
If present, duration of symptom 
a.  Fever 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
b.  Loss of weight 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
c.  Diarrhea 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
d.  Vomiting/associated abdominal pain 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
e.  Constipation/associated abdominal pain 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
f.  Cough 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
g.  Cough followed by vomiting 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
h.  Breathing trouble (chest indrawing/difficult/rapid/wheezing) ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
i.  Neck stiffness 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
j.  Unconscious episodes 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
k.  Fits 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
l.  Jerking of individual limbs 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
m.  History of epileptic illness in earlier years 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
n.  Paralysis of limbs 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
o.  Rigid body stiffness, unable to open mouth 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
p.  Red and sore eyes 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
q.  Skin rash and itching 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
r.  Herpes Zoster (at any time in life) 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
s.  Abscesses/body sores 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
t.  White patches on the inside of mouth and tongue 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
u.  Oedema 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
v.  Hair changes 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
w.  Yellowing of eyes or passing of brown urine 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
x.   Chest pain 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
y.  Other (Specify:                                                      ) 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 

Verbal Autopsy – Version 2.3 – April 26, 2011 
Cervical Treatment Study 
171 
 
14.  Records available in home, e.g., death certificate (extract findings): 
15. Comment

Exit – Version 2.4 – September 27, 2012 
Cervical Treatment Study 
172 
 
EXIT 
 
Study ID Number:  ___  ___  ___ 
 
 
 
Interviewer Number: ____  
____ 
 
Date of visit (day/month/year) ___ ___ / ___ ___ / ___ ___ ___ ___ 
 
1. Is the patient exiting the study because she has completed the study protocol and qualifies 
as per study guidelines to exit the study at this time? 
 
Ͱ Yes     Ͱ No  (If Yes, go to 
9, If No go to 2) 
2. Date of last study visit (DD/MM/YYYY)   ͰͰ/ͰͰ/ͰͰͰͰ 
3. Date last seen by study staff (DD/MM/YYYY)   ͰͰ/ͰͰ/ͰͰͰͰ 
4. Has the patient accessed care at the Hope Clinic in the past year?  Ͱ Yes     Ͱ No 
 
5. Did you talk to the patient?    Ͱ Yes   Ͱ No   (If Yes go to 6, If No go to 5a) 
 
      5a. If no, who was the source of information (tick one)  
        Ͱ Clinician / clinic staff 
 
     Ͱ Employer  
Ͱ Treatment supporter 
 
 
        Ͱ Spouse or Partner   
 
     Ͱ Friend 
 
 
Ͱ Other (specify) 
        Ͱ Family member / Relative 
     Ͱ Neighbor  
 
        Ͱ Mother or Father  
     Ͱ Caregiver  
6.  Has the patient transferred HIV care to another program?   Ͱ Yes     Ͱ No  (If Yes go to 6a, 
If No go to 7) 
 
 
6a. If yes, where is the patient transferring care to (tick one) 
 
    Ͱ Transferred to another non-Hope clinic, specify 
 
 
 
 
    Ͱ Transferred to Industrial area clinic   
 
 
 
    Ͱ Transferred to Maseno clinic 
 
 
 

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7.  Has Hope Clinic asked the patient to Exit or leave the program?  Ͱ Yes    Ͱ No (If Yes go 
to 7a, If No go to 8) 
              7a. Reasons for being Exited from the program (tick all that apply)  
 
    Ͱ Client has not returned to clinic for 1 year 
 
 
 
 
 
 
    Ͱ Poor Adherence 
 
 
 
 
 
 
    Ͱ Poor Clinic Attendance 
 
    Ͱ Not willing to disclose HIV status  
 
 
 
    Ͱ Referred else where 
 
 
 
 
    Ͱ Tested Negative 
 
    Ͱ Other (specify)   
 
    Ͱ Unknown  
 
 
 
 
8.  Has the patient asked to be Unenrolled from the study?  Ͱ Yes    Ͱ No  (If Yes go to 8a, If 
No go to 9) 
 
8a. Reasons patient is asking to Unenroll from the study (tick all that apply)  
 
    Ͱ Not willing to attend  
 
    Ͱ Waiting  time too long 
 
    Ͱ Conflict with work 
 
    Ͱ Financial problems 
 
    Ͱ Unwilling to attend because of health problems  
 
    Ͱ Family Problems 
 
    Ͱ Client will go to a faith healer  
 
    Ͱ Not willing to disclose HIV status  
 
 
 
    Ͱ Referred else where 
 
 
 
 
    Ͱ Other (specify)   
 
    Ͱ Unknown  
9. At what point was the patient exited?  Ͱ After Pap smear  ͰAfter Biopsy     Ͱ Mortality Ͱ 
Withdrawn from study ͰOther  ( If other specify)  
 
 
10. Comment

Cytology – Version 2.6 – September 27, 2012 
Cervical Treatment Study 
174 
 
CYTOLOGY REPORT 
First read  
Re-read 1 
Consensus reading 
Study ID Number__ __ __ 
Test/ Visit code___ ___ ___ ___Hope ID Number ___ ___ ___ ___ 
 
 
 
 
 
Visit (tick one)  Initial Visit   Repeat    Month 6 FU 
 Month 12FU  
 Month 18 
FU 
 
 Month 24 FU 
Other, specify 
Interviewer number __ __ __ 
 
 
 
 
 
Patient Age 
1. Date sample was collected in clinic (day/month/year)  ___ ___/___ ___/___ ___ ___ 
___ 
2. Time sample was collected in clinic 
3. Date sample was received in laboratory (day/month/year) ___ ___/___ ___/___ 
___ ___ ___ 
4. Time sample was received in laboratory 
5. When was the Pap smear preparation processed? (day/month/year) ___ ___/___ ___/___ 
___ ___ ___ 
6. When was the Pap smear preparation reported? (day/month/year) ___ ___/___ ___/___ 
___ ___ ___ 
7. Quality of specimen:                                  Satisfactory             Unsatisfactory 
(If unsatisfactory, fill Q8 and skip to Q13) 
8. Quality limitations in sample?                           Yes                          No 
       If “Yes”, specify limitations: 
  No endocervical components   
 
 
- Not enough cellular material  
 
 
- Air dried 
 
 
 
 
- Bad fixation  
 
 
 
- Too much blood  
 
 
 
- Too much pus  
 
 
 
 
- Other specify……………………………………………………………………… 

Cytology – Version 2.6 – September 27, 2012 
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9. Any microbiological findings?                        Yes                             No 
       If “Yes”, specify findings: 
               Lactobacilli 
 
 
 
Mixed flora                                                   
 
    Bacterial vaginosis 
 
 
 
 
   Candida 
 
 
 
 
 
   Trichomonas vaginalis 
 
 
 
   Actinomyces  
 
 
 
   Schistosoma  
 
               Herpes simplex 
 
 
 
Other, specify…………………  
 
10. Any reactive changes observed?                           Yes                              No 
       If “Yes”, specify findings 
 
               Metaplasia 
 
 
 
               Inflammatory changes  
 
 
 
   Follicular cervicitis 
 
 
 
 
   Parakeratosis  
 
 
 
 
   Atrophy 
 
 
 
 
 
   Other reactive changes                                  
 
                             If “Yes”, specify………………………………………………………… 
 
11. Squamous epithelium: 
 Normal                                  Abnormal   
              If “Yes”, specify findings     
 
 
ASC-US 
 
 
 
   Yes                                     No 
 
 
ASC-H  
 
 
 
   Yes                                    No 
Low grade SIL  
 
 
   Yes                                    No 
 
 
    - With koilocytosis        
 
   Yes                                    No       

Cytology – Version 2.6 – September 27, 2012 
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High grade SIL  
 
 
    Yes                                   No 
 
 
HSIL invasion not ruled out 
 
    Yes                                   No    
 
Squamous cell carcinoma 
 
     Yes                                  No   
 
Others, specify _____________________________________________ 
 
12. Glandular epithelium:                                 Normal                                           
abnormal  
                If “Yes”, specify findings                                              
          Abnormal presence of endometrial cells 
  Yes                          No                       
          Atypical glandular cells, pref. neoplastic   Yes                          No   
Adenocarcinoma in situ  
 
  Yes                          No   
                       Adenocarcinoma                                           Yes                          No   
       - Endometrial 
 
 
  Yes                           No   
        - Endocervical 
 
 
  Yes                           No   
Others, specify ____________________________________________ 
13. Other 
remarks................................................................................................................. 
Interviewer number of pathologist          
Date: ___________ 
 

Colposcopic Biopsy Histology Report – Version 2.6 – September 27, 2012Cervical Treatment 
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177 
 
COLPOSCOPIC BIOPSY HISTOLOGY REPORT 
First read  
Re-read 1 
Consensus reading Tie-break 
Study ID Number__ __ __ 
 
 
 
Hope ID Number ___ ___ ___ ___ 
Test/ Visit code________ 
Visit (tick one)  Initial Visit   Month 6 FU  Month 12 FU 
 Month 18 FU 
 
 Month 24 FU 
Other, specify 
Interviewer number ---  ----Patient Age ______________ 
1. Date sample was collected in clinic (day/month/year)  ___ ___/___ ___/___ ___ ___ 
___ 
2. Time sample was collected in clinic 
3. Date sample was received in laboratory (day/month/year) ___ ___/___ ___/___ 
___ ___ ___ 
4. Time sample was received in laboratory 
5. When was the biopsy processed? (day/month/year) ___ ___/___ ___/___ ___ ___ ___ 
6. When was the biopsy reported? (day/month/year) ___ ___/___ ___/___ ___ ___ ___ 
7. Was the amount of sample adequate for reading? Ͱ Yes    Ͱ No  Other, specify 
8. What was the histology result of the cervical biopsy (tick one)? 
 
No dysplasia (NIL)  
CIN 1  
 
CIN 2 
 
 
CIN 3 
 
Invasive carcinoma 
 
 
Indeterminate/ 
CIS 
 
Other, specify 
9. Was there evidence of cervicitis? Ͱ Yes    Ͱ No  Other, specify 
10. Who read the biopsy and gave this histology result? 
Pathologist Interviewer number ___ 
 
11. Comments: 
 

ECC Biopsy Histology Report – Version 1.2 – September 27, 2012 Cervical Treatment Study 
 
178 
 
ENDOCERVICAL CURETTAGEHISTOLOGY REPORT 
First read  
Re-read 1 
Consensus readingTie-break 
Study ID Number__ __ __ 
 
 
 
Hope ID Number ___ ___ ___ ___ 
Test/ Visit code_______ 
Visit (tick one)  Initial Visit   Month 6 FU  Month 12 FU 
 Month 18 FU 
 
 Month 24 FU 
Other, specify 
Interviewer number ---  ----Patient Age ______________ 
1. Date sample was collected in clinic (day/month/year)  ___ ___/___ ___/___ ___ ___ 
___ 
2. Time sample was collected in clinic 
3. Date sample was received in laboratory (day/month/year) ___ ___/___ ___/___ 
___ ___ ___ 
4. Time sample was received in laboratory 
5. When was the biopsy processed? (day/month/year) ___ ___/___ ___/___ ___ ___ ___ 
6. When was the biopsy reported? (day/month/year) ___ ___/___ ___/___ ___ ___ ___ 
7. Was the amount of sample adequate for reading? Ͱ Yes    Ͱ No  Other, specify 
8. What was the histology result of the Endocervical Curettage biopsy (tick one)? 
 
No dysplasia (NIL)  
CIN 1  
 
CIN 2 
 
 
CIN 3 
 
Invasive carcinoma 
 
 
Indeterminate/ 
CIS 
 
Other, specify 
9. Was there evidence of cervicitis? Ͱ Yes    Ͱ No  Other, specify 
10. Who read the biopsy and gave this histology result? 
Pathologist Interviewer number ___ 
 
11. Comments: 

LEEP Biopsy Histology Report – Version 2.6 – September 27, 2012 Cervical Treatment 
Study 
 
179 
 
LEEP BIOPSY HISTOLOGY REPORT 
First read  
Re-read 1 
Consensus reading Tie-break 
Study ID Number__ __ __ 
 
 
 
Hope ID Number ___ ___ ___ ___ 
Test/ Visit code__________ 
 
Visit (tick one)  Initial Visit   Month 6 FU  Month 12 FU 
 Month 18 FU 
 
 Month 24 FU 
Other, specify 
Patient Age ______________ Interviewer number --- ---- 
 
1. Date sample was collected in clinic (day/month/year)  ___ ___/___ ___/___ ___ ___ 
___ 
2. Time sample was collected in clinic 
3. Notes:  
 
 
4. Date sample was received in laboratory (day/month/year) ___ ___/___ ___/___ 
___ ___ ___ 
5. Time sample was received in laboratory 
6. When was the LEEP specimen processed? (day/month/year) ___ ___/___ ___/___ ___ __ 
7. When was the LEEP specimen reported? (day/month/year) ___ ___/___ ___/___ ___ ___  
8. Was the amount of sample adequate for reading? Ͱ Yes    Ͱ No  Other, specify 
9. What was the histology result of the LEEPcervical biopsy (tick one)? 
 
No dysplasia (NIL)  
CIN 1  
 
CIN 2 
 
 
CIN 3 
 
Invasive carcinoma 
 
 
Indeterminate/ 
CIS 
 
Other, specify 
10. Was there evidence of cervicitis? Ͱ Yes    Ͱ No  Other, specify 
11. Who read the biopsy and gave this histology result? 

LEEP Biopsy Histology Report – Version 2.6 – September 27, 2012 Cervical Treatment 
Study 
 
180 
 
Pathologist Interviewer number ___ 
 
12. Comments:

CD4 Report – Version 2.5 – September 27, 2012 
Cervical Treatment Study 
 
181 
 
CD4 REPORT 
 
Study ID Number__ __ __ 
 
 
 
Hope ID Number ___ ___ ___ ___ 
 
 
 
Visit (tick one)  Randomization/LEEP Visit   Month 6FU   Month 12FU  
 Month 18 
FU 
 Month 24 FU 
Other, specify 
 
 
Patient Age                                                                        Interviewer number  
 
1. Date sample was collected in clinic (day/month/year)  ___ ___/___ ___/___ ___ ___ 
___ 
2. Time sample was collected in clinic 
3. Date sample was received in laboratory (day/month/year) ___ ___/___ ___/___ 
___ ___ ___ 
4. Time sample was received in laboratory 
5. When was the CD4 count run? (day/month/year) ___ ___/___ ___/___ ___ ___ ___ 
6. What was the result of the CD4 count?  ___ ___ ____ ____ 
7. Who ran the CD4 count and gave this CD4 result? Coptic lab Ͱ     Other, specify 
 
 
8. Comments: 
 
 
 
 
 
 
 

Follow Up – Version 1.1 – May 30, 2012 
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182 
 
FOLLOW-UP FORM 
 
Study ID Number__ __ __ 
Hope ID Number __ __ __ __Interviewer Number_ 
 
Date of interview (day/month/year) 
___ ___/___ ___/___ ___ ___ ___ 
Visit (tick one)  Month 6 FU  Month 12 FU 
 Month 18 FU 
 
 Month 24 FU 
Other, specify  
A: MEDICAL HISTORY 
1. Did you consult a doctor or clinical officer between today and your previous study visit?
 
 
 
 
 
Yes  
 
 
 
No  
 
 
(go to question 2) 
Don’t know  
 
(go to question 2) 
Refused  
 
(go to question 2) 
 
 
If yes: 
1.1. How many consultations? 
___ ___ 
Don’t know  
 
(go to question 2) 
Refused  
 
(go to question 2) 
 
1.2. Why did you consult?      
1.2.1. Visit 1: 
Reason for consultation 
 
Routine check-up visit not study related 
|__|    yes 
Sickness……………….………………. 
|__|    yes 
Other, specify ………………………. 
|__|    yes 
Do not recall the reason 
|__|    yes 
Refused 
|__|    yes 
 
1.2.2. Visit 2: 
Reason for consultation 
 
Routine check-up visit not study related 
|__|    yes 
Sickness……………….………………. 
|__|    yes 
Other, specify ………………………. 
|__|    yes 
Do not recall the reason 
|__|    yes 
Refused 
|__|    yes 
 
1.2.3. Visit 3: 
Reason for consultation 
 
Routine check-up visit not study related 
|__|    yes 
Sickness……………….………………. 
|__|    yes 
Other, specify ………………………. 
|__|    yes 
Do not recall the reason 
|__|    yes 
Refused 
|__|    yes 

Follow Up – Version 1.1 – May 30, 2012 
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                          1.2.4   Visit 4 
Reason for consultation 
 
Routine check-up visit not study related 
|__|    yes 
Sickness……………….………………. 
|__|    yes 
Other, specify ………………………. 
|__|    yes 
Do not recall the reason 
|__|    yes 
Refused 
|__|    yes 
 
                         1.2.5   Visit 5 
Reason for consultation 
 
Routine check-up visit not study related 
|__|    yes 
Sickness……………….………………. 
|__|    yes 
Other, specify ………………………. 
|__|    yes 
Do not recall the reason 
|__|    yes 
Refused 
|__|    yes 
 
                          1.2.6    Visit 6 
Reason for consultation 
 
Routine check-up visit not study related 
|__|    yes 
Sickness……………….………………. 
|__|    yes 
Other, specify ………………………. 
|__|    yes 
Do not recall the reason 
|__|    yes 
Refused 
|__|    yes 
 
 
 
(For those previously not on ARVs- please refer to enrollment form) 
2. Have you initiated anti-retroviral medication since the last visit? 
                                                             Yes  
 
 
 
                                                              No  
 
 
                                                          Don’t know  
 
                                                              Refused  
 
 
 
          If yes: 
          2.1. Which date did you initiate ARV’s     --/ --/ ---- 
          2.2. Specify current regimen 
 
 3. Are you still on ARVs? (For those previously on ARVs-please refer to enrollment form) 
                                                             Yes  
 
 
                                                             No 
 
                                                              NA                    
 
 
 
 
 
(If NA go to Q4) 
 
                  3.1 If no, reasons for not being on ARVs 
                                - Poor adherence 
                                - Side effect 
                                - Stigma 
                                -Concurrent illness  
                                - Other (specify)   
 
                   3.2 If yes, has your anti-retroviral medication changed since last cervical 
treatment visit?  

Follow Up – Version 1.1 – May 30, 2012 
Cervical Treatment Study 
184 
 
 
 
 
 
 
Yes  
 
 
 
No  
 
 
(go to question 4) 
Don’t know  
 
(go to question 4) 
Refused  
 
(go to question 4) 
 
 
If yes: 
3.2.1. On which date was it changed: ___ ___/___ ___/___ ___ ___ ___ 
3.2.2. What was the reason for changing your antiretroviral medication? (Check all 
that apply) 
a) Because of low CD4 counts: 
 
 
 
 
Yes  
b) Because of high viral load: 
 
 
 
 
Yes  
c) Because of clinical symptoms:  
 
 
 
Yes  
f) Other, specifiy: ___ ___ ___ ___ ___ ___ 
 
 
Yes  
e) Don’t know: 
 
 
 
 
 
 
Yes  
d) Refused: 
 
 
 
 
 
 
Yes  
 
3.2.3 Specify current medications: 
___________________________ 
 
4. Did you receive any cervical treatment other than what we offered?  
 
 
 
 
 
Yes  
 
 
 
No  
 
 
(go to part B) 
Don’t know  
 
(go to part B) 
Refused  
 
(go to part B) 
 
 
If yes: 
4.1. On which date was this: ___ ___/___ ___/___ ___ ___ ___ 
4.2. Which treatment did you receive? 
a) Cryotherapy: 
 
 
 
 
 
 
Yes  
b) LEEP:  
 
 
 
 
 
 
Yes  
c) Cold knife exconisation: 
 
 
 
 
Yes  
d) Hysterectomy:   
 
 
 
 
 
Yes  
f) Other, specifiy: ___ ___ ___ ___ ___ ___ 
 
 
Yes  
e) Don’t know: 
 
 
 
 
 
 
Yes  
d) Refused: 
 
 
 
 
 
 
Yes  
 
B. SEXUAL HISTORY 
5. Have you had sex in the last 6 months?  
 
 
 
 
 
Yes  
 
 
 
No  
 
 
(go to Q6) 
Don’t know  
 
(go to Q6) 
Refused  
 
(go to Q6) 
 
 
If yes: 
 
5.1. With your regular partner?  Yes  
 
 
 
    No   
 
(go to Q5.2) 
If yes, 
5.1.1. How often have you used condoms during sex with your regular 
partner in the last 6 months? 
Always (100%)  
 
 
 
 
 
Most of the time (75-99%)  
 
 

Follow Up – Version 1.1 – May 30, 2012 
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185 
 
Half of the time (50%-74%)  
 
 
 
Sometimes (25-49%)   
 
 
Rarely (1-25%)  
 
 
 
 
 
Never (0%)  
 
 
 
 
Don’t know  
 
 
 
 
 
 
Refused to answer  
 
 
 
 
 
 
5.1.2. Do you suspect that your partner has had other sexual partnersduring 
the last 6 months? 
Yes  
 
 
 
No  
 
 
 
Don’t know  
 
Refused  
 
 
 
 
5.2. Did you have sex with any other partner(s) than your regular partner during the 
last 6 months?    
 
 
 
Yes  
 
 
 
No  
 
 
(Go to Q6) 
Don’t know  
 
(Go to Q6) 
Refused  
 
(Go to Q6) 
 
If yes: 
5.2.1. How many other different sexual partners besides your regular partner did 
you have in the last 6 months?  
___ ___ 
Don’t know  
 
Refused  
 
 
 
5.2.2. How often have you used condoms during sex with these other partner(s) 
in the last 6 months? 
 
Always (100%)  
 
 
 
 
 
Most of the time (75-99%)  
 
 
Half of the time (50%-74%)  
 
 
 
Sometimes (25-49%)   
 
 
Rarely (1-25%)  
 
 
 
 
 
Never (0%)  
 
 
 
 
Don’t know  
 
 
 
 
 
 
6. Refused to answer   
 
 
 
7. Comment 

 
186 
 

Adverse Events – Version 2.5 – September 27, 2012 
Cervical Treatment Study 
187 
 
ADVERSE EVENTS 
Study ID Number 
__ __ __ 
 
 
Interviewer Number__ __ 
 
 
 
Date of visit (day/month/year) ___ ___/___ ___/___ ___ ___ ___ 
Visit (tick one)   
 Shedding1    
 Shedding2    
 Shedding3 
 
 
 
 Month 6 FU  
 Month 12 FU 
 Month 18 FU 
 Month 24 FU 
 
Other, specify ____________________ 
 
Adverse Event 
Start 
Date(DD/MM/Y
YYY) 
End Date 
(DD/MM/YYYY) 
Severity 
1= Mild 
2= Moderate 
3= Severe 
4= Life 
Threatening 
Relationship to Study 
procedures 
1= Related 
2= Notrelated 
 
Outcome 
1= Resolved without 
sequelae 
2= Resolved with sequelae 
3= Ongoing 
4= Death 
5= Unknown 
Serious 
0= No 
1= Yes** 
1 
 
 
 
 
 
 
 
2 
 
 
 
 
 
 
 
3 
 
 
 
 
 
 
 
4 
 
 
 
 
 
 
 
 

Adverse Events – Version 2.5 – September 27, 2012 
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188 
 
Comments: ___________________________________________________________________________________________________________ 
_____________________________________________________________________________________________________________________ 
** If Serious Adverse Event, contact a PI immediately after filling this form.** 
PI Contacts:  Dr. Michael Chung – 020-271-2947, 0722-579-963,  Dr. Nelly Mugo – 020-273-6744 
 
 
 
 

Enrollment- Kiswahili – Version 2.6 – February 14, 2012  
Cervical Treatment Study 
189 
 
UANDIKISHAJI 
 
Study ID Number__ __ __ Hope ID Number __ __ __ __Interviewer Number_ 
 
Date of interview (day/month/year) 
___ ___/___ ___/___ ___ ___ ___ 
 
Ulikubali kuhifadhi sampuli : Ndio  
La 
Sijui     
Nyingine, eleza  
 
A: SOCIODEMOGRAPHICS 
 Tarehe ya kuzaliwa (siku/mwezi/mwaka) 
 
___ ___/___ ___/___ ___ 
___ ___ 
 Miaka   
 
 
 
____________ years 
 Ulikamilisha miaka ngapi ya elimu? 
____________ years 
 Elimu ya juu zaidi uliyokamilisha? 
Hakuna  
 
 
Msingi  
 
 
 
 
 
 
 
 
Sekondari 
 
 
 
 
 
 
 
Elimu ya juu/ Chuo Kikuu 
 
Sijui     
Amekataa 
 
 
 
 
 
 
 
 
 
Nyingine, eleza 
 
 Hali ya ndoa (jibu moja) 
 
Ndoa  (mke mmoja )            
 
Ndoa (wake wengi) 
 
Pekee  
 
 
Talaka/Tenganishwa  
Mjane  
 
 
Amekataa 
 
 
Kuishi pamoja  
 
 
 
 
 
 
 
Nyingine eleza 
 
 
 Ajira (jibu moga): 
 
 
Kazi inayokupa mshahara 
 
Kujiajiri 
 
 
 

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Mama wa nyumbani  
 
Hujaajiriwa          
 
 
Mfanyikazi wa kawaida           
Amekataa 
 
 
 
Nyingine, eleza  
 
 
 
 Kipato cha kaya kwa mwezi (jibu moja): Hakuna  
 
 
 
< 5000 Ksh 
 
 
5001 – 10000 Ksh 
 
 
10001 – 15,000 Ksh 
 
 
>15,000 Ksh 
 
 
 
Sijui 
 
 
 
 
Amekataa 
 
 
 
 
B: HISTORIA YA KUFANYA MAPENZI  
8. Ulikuwa na miaka mingapi ulipofanya ngono ya uke mara ya kwanza?__ __   
SijuiAmekataa    Hujawahi            Nyingine, eleza 
 
9. Umewahi kuwa na wapenzi wangapi wa ngono? __ __ Sijui Amekataa   
Nyingine,eleza    __________________________ 
 
10. Umekuwa na wapenzi wangapi tofauti wa ngono mwaka wa mwisho? 
__ 
__ 
Sijui   Amekataa   Nyingine, eleza 
 
11. Umefanya ngono katika mwezi wa mwisho? (If no, don’t know, refused, skip to 
14)  Ndio 
 
La 
  Sijui  
Amekataa   Nyingine, eleza  
 
12. Ni mara ngapi umetumia mpira wakati wa ngono katika mwezi uliopita? 
Kila wakati  (100%) 
 
Wengi wa wakati huo (75-99%)   
Nusu ya mudu   (50%-74%)  Wakati mwingine (25-49%) 
 
Mara chache (1-25%)             Kamwe (0%)  
Amekataa                             Sijui                                          
 
Nyingine, eleza 
 
13. Je, unafikiri unaweza kuwa ma mimba sasa? Ndio  
La 
  Sijui  
 
Amekataa   Nyingine, eleza 
 
 

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C: SARATANI YA UZAZI HISTORIA YA UCHUNGUZI  
14. Hapo awali, umewahi kupimwa saratani ya uzazi? Ndio 
 
La 
  
Sijui    Alikataa   Nyingine, eleza 
 
 
If no,don’t know or refused skip to 20. 
15. Uchunguzi gani wa saratani ya uzazi uliofanyiwa hivi karibuni? (jibu moja) 
 
  
  Pap smear 
 
  
  Ukaguzi na asetiki aside  
 
  
  HPV 
  Nyingine, eleza : ______________________ 
 Sijui 
 
 
Amekataa 
16. Uchunguzi huu wa hivi karibuni ulifanyiwa wapi?  
 
 
 
  Coptic 
 KNH 
 AmekataaSijui 
 
 
  Nyingine, eleza 
17. Uchunguzi huu ulifanyiwa wapi? 
 sijui  
 
18. Majibu yalikuwa nini? 
 
 
  Kawaida 
 
 
  Usiokuwa ya kawaida, eleza  ____________________ 
 Sijui 
 Amekataa 
19. Ulipokea matibabu yoyote ya kizazi au upasuaji kwasababu ya majibu ya hii 
uchunguzi?   
      Ndio 
La 
Sijui       Amekataa    Nyingine, eleza _____________ 
 
Kama ni ndio, eleza ____________________________ 
 
20. Pap Smear ilifanywa leo?  
Ndio          La Amekataa   Sijui 
Kama ni la, fafanua  
21. Maoni

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UBAHATISHAJI 
 
Study ID Number__ __ __ Hope ID Number __ __ __ __ 
 
Randomization Number_ _  
Interviewer Number_ 
 
Date of interview (day/month/year) 
___ ___/___ ___/___ ___ ___ ___ 
 
 
A: HISTORIA YA SASA YA MATIBABU  
1. Je, unauchungu unapopitisha mkojo? Ndio 
 
La 
 Nyingine, eleza 
Amekataa   Sijui 
 
2. Je, una uchungu sehemu ya chini ya tumbo? 
Ndio  
La 
 
Nyingine, eleza Amekataa   Sijui 
 
3. Je, unatokwa na uchafu yasiyo ya kawaida katika uzazi wako wa kike?  Ndio 
 
La 
 Nyingine, eleza   Amekataa   Sijui 
 
   4.Je, umeona uvimbe yoyote katika uzazi wako wa kike? Ndio  
La 
 
Nyingine, eleza   Amekataa   Sijui 
 
B: AFYA YA UZAZI 
5. Ulikuwa na miaka mingapi ulipopata damu ya mwezi? __ Amekataa  Sijui   
Nyingine, eleza 
 
6. Tarehe ya mwisho ya kupata damu yako ya mwezi ? (dd/mm/yy) ___ ___/___ 
___/___ ___ ___ ___ Sijui   Amekataa   Nyingine eleza 
 
7. Je, una historia ya kutokwa na damu isiyo ya kawaida sehemu ya uke? Ndio 
 
La 
 Sijui    Amekataa  Nyingine, eleza 
 
Kama ndio, eleza aina ya damu 
  
  Isiyo mara kwa mara 
  
  Nzito 
  
Kutokwa na damu nzito sana wakati wako wa mwezi 
  
  Nyingine, eleza 
 Sijui 

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 Amekataa 
 
8. Je, umewahi kutumia njia yoyote ya kupanga uzazi? Ndio   La   
Sijui    
Amekataa  
Nyingine, eleza ________ 
Kama ndio, eleza  (chagua yote yanayotumuka) 
 
 
Sindano 
 
IUCD  
 
Asili 
 
 
 
 
Mpira  
Tembe  
 
Norplant/Implant 
 
BTL                
Nyingine, eleza ______________________ 
9. Je, sasa hivi unatumia njia yoyote ya kupanga uzazi? 
 
ndio 
 
la 
Sijui    Amekataa 
 
Nyingine, eleza ______________________________________ 
 
Kama ndio, eleza  (chagua yote yanayotumika) 
 
Sindano 
 
IUCD  
Asili 
 
 
 
Mpira  
Tembe  
 
Norplant/Implant 
 
 BTL                 
Nyingine, eleza ____________ 
 
10. Je, umekuwa na mimba mara ngapi? 
__ __  Amekataa   Sijui  Nyingine  
 
11. Je, umekuwa na watoto walioishi mara ngapi? __ __ Amekataa   Sijui  
Nyingine  
 
12. Je, umetoa mimba ngapi au kupoteza mimba au mtoto kufia kabla kuzaliwa ?
 
__ __ Amekataa   Sijui  Nyingine  
 
13. Je, umewahi kulazwa hospitalini na tatizo yoyote ya gynecologia? 
 
Ndio 
 
La 
  Sijui   Amekataa   Nyingine, eleza 
14.Je, umewahi kupasuliwa tumbo? 
Ndio  
La 
   Amekataa   
Sijui  Nyingine, eleza 
 
15. Je, umewahi kupasuliwa uke?  
Ndio  
La 
    Amekataa   
Sijui  Nyingine, eleza 
 
16. Sasa hivi, unavuta sigara? 
 
 
Ndio  
La 
    
Amekataa   Sijui  Nyingine, eleza 

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C: HISTORIA YA HIV 
17. Ulijulikana uko na HIV lini? (dd/mm/yyyy) ___ ___/___ ___/___ ___ ___ ___    
 
18.1. HIV ilitambuliwa aje? (jibu moja pekee) 
 
- Ulipotembelea kituo cha VCT: 
 
 
Ndio  
 
- Kwa kliniki ya wajawazito  : 
 
 
 
Ndio  
 
- Kwasababu ya ugonjwa , eleza:________________ 
Ndio  
 
- Nyingine, eleza:_________________________ 
 
 
 
- Sijui:  
 
 
 
 
 
 
 
- Amekataa: 
 
 
 
 
 
 
 
 
19. Je, sasa hivi unatumia madawa ya kurefusha maisha? Ndio  
La 
 
Sijui     
Amekataa 
 
Nyingine, elezaKama 
ndio,  
 
a) Eleza madawa unayotumia sasa : 
___________________________ 
 
b) tarehe ya awali uliyoanza ___ ___/___ ___/___ ___ ___ ___  sijui   
 
c) Je, unajua sababu ulioanzishwa madawa ya kurefusha maisha?  
 
 - Kwasababu ya ugonjwa, eleza: _____________________  Ndio  
 
 - Kwasababu ya CD4 kuwa chini : 
 
 
 
Ndio  
 
- Kwasababu ya viwango vya virusi kuwa juu: 
 
Ndio  
 
- Nyingine, eleza: _________________________ 
 
 
 
 
- Sijui:  
 
 
 
 
 
 
 
 
- Amekataa 
 
 
 
 
 
 
 
 
 
20. Maoni 
 

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ANUANI NA ULAJI 
Study ID number __ __ __ 
__ __ __ 
 
Interviewer number ____  ____ 
 
Date of interview (day/month/year) 
___ ___/___ ___/___ ___ ___ ___ 
 
Format(tick one) 
 
New  
 
Update (fill only updated info) 
A.  YA KIBINAFSI 
19. Jina Lako Nani? 
a. Jina la kwanza 
b. Jina la katikati 
c. Jina la mwisho 
 
20. Wajulikana kwa jina lipi eneo unako ishi? 
21. Jina kamili ya eneo unako ishi. 
a. Wilaya 
b. Mji 
c. Kijiji 
d. Mtaa 
e. Nambari ya ploti 
f. Nambari ya mlango 
g. Jina la barabara 
 
22. Usafiri wa umma hadi kwako nyumbani: 
      4a. Aina:  Ͱ Bus   Ͱ Boda boda    Ͱ Matatu    Ͱ Taxi   Ͱ Mengine(Fafanua) 
      4b. Numbari ya gari iendako eneo unakoishi: 
      4c. Jina la kituo cha kuabiria magari? 
      4d. Jina inalojulikana eneo unakoishi.  
23. Maelezo ya njia kutoka kwako hadi kituo cha kuabiria magari?  
24. Alama ya kuwa msaidizi katika kuuweka kaya: (Majina ya shule, makanisa, 
biashara nk) 
25. Je, unaweza  kufikiwa kwa njia ya simu?  
Ndiyo  
La 
 
 
Kama ndiyo, 
 (i) Nambari ya simu yako 1? 
 (ii) ) Nambari ya simu yako 2? 
 
iii. Nani anaye beba simu hiyo (Weka alama kwa moja)  
  Mimi     Mwingine, 
fafanua 
 
B.   MAWASILIANO MUHIMU 
26. Je, kuna mtu mwingine ambaye anjua   hali yako ya HIV ambaye  tunaweza kuwasiliana 
kwa njia ya simu kama hatuwezi kufikia wewe moja kwa moja? If no skip to 9.  

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27. Jina  lake ni nani? 
a. Jina la kwanza 
b. Jina la katikati 
c. Jina la mwisho 
28. Uhusiano gani upo kati yako na mtu huyu ? 
29. (a)Nambari yake ya simu1? 
      (b) Nambari yake ya simu2? 
 
C.  MAWASILIANO KUHUSU KWAKO MASHAMBANI 
30. Je, una nyumbani bara? 
 
Ndiyo  
La 
If no, skip to 19 
31. Ni wapi kwako Bara? 
a. Wilaya 
b. Mji 
c. Kijiji 
d. Mtaa 
e. Nambari ya ploti 
f. Nambari  ya mlango 
32. Maelekezo maalum kwa makazi 
33. Je, kuna mtu u ko  bara  ambaye tunaweza kuwasiliana kama hatuwezi kufikia wewe 
moja kwa moja? 
 
Ndiyo  
La 
 
If no, skip to 19 
34. Jina lake huyu mtu ni nani? 
a. Jina la kwanza 
b. Jina la katikati 
c. Jina la mwisho 
35. Uhusiano gani upo kati yako na mtu huyu ? 
36. Je huyu mtu ako na simu? Ndiyo  
La 
Iwapo ndiyo ,  fafanua  
(a)Nambari yake ya simu1? 
       (b) Nambari yake ya simu2? 
 
D.  ANDRA 
Maoni 
 

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SHEDDING 
 
Study ID Number 
__ __ __ 
 
 
Interviewer Number __ __ 
 
 
 
Date of interview (day/month/year) 
___ ___/___ ___/___ ___ ___ ___ 
 
Visit (tick one)  Week 1 FU  Week 2 FU  Week 3 FU    Other, specify ________ 
 
A: MEDICAL HISTORY 
 
1.  Unasikia maumivu ya tumbo ya chini? 
 
  ndio        la  
(Ndio,fafanua) 
a. muda wa __ __ (siku) 
b. Ukali(kidogo 1-5, 5 kuwakali zaidi ) 
 
9.  Umekuwa na historia ya kutokwa na damu ambaye si yakawaida? Fafanua 
 
Ndio          La  
(Ndio,fafanua) 
 
g. muda wa__ __ siku 
h. kiasi 
doasuruali) 
 
Inahitajipediya usafi 
 
Mwingine,eleza 
 Unatokwa na majimaji ya uke yasiyo ya kawaida? 
10.  
Ndio          la 
                          (Ndio,fafanua) 

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i. 
 muda wa __ __ siku) 
j. 
rangi ya 
  Majano  
 
hudurungi  
  nyeupe    
 
wazi 
 
 
 
 
  Nyingine ,fafanua                  
k. harufu 
 
  Harufu mbaya 
 
Hakunaharufu 
 
Mengine,eleza 
l. 
kiasi 
  inadoasuruali 
 
Inahitajipediya usafi 
 
Mengine,eleza 
11. Mgonjwa amekuwa nahoma yoyotebaada ya ziara yamwisho? 
Ndio          la 
 
kama ndio, fafanua    muda….siku 
12. Je,mgonjwaametafutahuduma zamatibabu kwa ajili yahaya aumalalamiko mengine? 
Ndio          La 
 
If yes, specify what complaint prompted the participant to seek care: 
  Uchungu wa tumbo ya chini 
 
  Homa 
  Damu kutoka uzazi wa kike 
 
  Uchafu unaotoka katika uzazi wa kike 
e.  Mengine, fafanua 
 
If yes, specify where the participant sought care: 
  Study clinic 
 
  Hope Center 

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  Coptic Hospital 
 
  KNH 
f.  Other, specify                
13. Was the participant’s condition possibly due to a study procedure? (Ask if any of 
questions 1-4 is yes) 
Yes          No  
 
If yes, fill out a Complications questionnaire. 
 
 
 
14. Damu yako ya mwezi ya mwisho ilikuwa lini? (dd/mm/yyyy) 
 
15. Umewahi fanya ngono uke tangu utibiwe?      Ndio        la Kataa 
 
 Nyingine fafanua___________________________ 
 
8 (a). Ndio, mara ngapi?__ 
 
8(b) Kamawamefanya mapenziuketangumatibabu,je,ni mara ngapikutumia 
kondomuwakati wa         ngono?              
 
 
Kila wakati  (100%) 
 
Wengi wa wakati huo (75-99%)   
Nusu ya mudu   (50%-74%)  Wakati mwingine (25-49%) 
 
Mara chache (1-25%)             Kamwe (0%)  
Amekataa                             Sijui                                          
 
Nyingine, eleza 
 
 
9. Unafikiri unaweza kuwa mjamzito 
Ndio          la 
10.  Kwa sasa unatumia madawa ya kupungua makali ya virusi 
 
  Ndio            Kataa        Nyingine,fafanua 
La              Sijui 
        Ndio, fafanua madawa unayo tumia sasa na tarehe uliyo yaanza 

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  d4t, 3tc, nvp 
    d4t, 3tc, efv 
  azt, 3tc, nvp 
   azt, 3tc, efv 
  zingine, fafanua 
Tarehe ya kuanzaARV awali  (dd /mm /yyyy) 
11 Katika siku7 ya mwisho , mgojwa alikosa kumeza tembe ngapi za dawaza kurefusha 
maisha? 
12 Katika siku 30 ya mwisho30, mgonjwa alikosa kumeza tembe ngapi za dawaza kurefusha 
maisha? 
(If Q11 and Q12 patient did not MISS taking any pills skip to Q14) 
13. If the patient missed any doses, please specify reasons (check all that apply) 
  Toxicity/ side effect 
    Share with others 
    Forgot 
g.  Felt better 
  Too ill 
   Stigma, disclosure or privacy issues 
    Drug out of stock 
  Patient lost or ran out of pills 
  Delivery /travel problem 
  Inability to pay 
  Alcohol 
  Depression 
h.  Other specify 
 
 
B: DIAGNOSIS 
14. Is there any new infection that was related to the procedure since the last visit? 

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Yes          No  
 
If yes, specify and fill a Complications and/or Adverse Event questionnaire: 
15. Were there any new complications diagnosed today related to the treatment?  
Yes          No  
 
If yes, specify and fill a Complications and/or Adverse Event questionnaire: 
 
C: TREATMENT 
16. Was any treatment provided today? Yes          No  
If yes, specify 
17. Was the  patient referred for further cervical treatment at another institution?   
Yes         No  
17 (i)If yes, specify institution  
17(ii)If yes, specify reason for referral 
 
 
D: SPECIMEN COLLECTION 
18. Did you collect cervical HIV swab? Yes          No  
If no, specify reason: 
19. Did you collect blood? 
 
 
Yes          No  
If no, specify reason: 
 
 
 
 
 
 
 
E: ACCEPTABILITY OF TREATMENT 
20. Please complete the items listed below by placing a checkmark on the box next to 
each question that best indicates how the client feels about the treatment she received.  
 
 
 
 

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SIKUBALI 
KAMWE 
 
haukubaliani 
 
kadri, 
 
kukubaliana 
 
sanakukubaliana 
 
(i) Naona hii njia ni 
mwafaka kwa 
kukabiliana na 
magonjwa ya njia 
ya uzazi) 
 
 
 
 
 
(ii) Naweza tumia 
haya ya matibabu 
nikipatamagonjwa 
kama haya siku  ya 
mbeli 
 
 
 
 
 
(iii) ningependekeza 
haya matibabu kwa 
mtu mwingine 
 
 
 
 
 
(iv) kwa jumla 
nakubaliana na 
haya matibabu) 
 
 
 
 
 
 
F: OTHER 
 
 
 
 
24. Comments:  
 

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VERBAL AUTOPSY 
Study ID Number 
__ __ __ 
 
 
 
Interviewer Number __ 
__ 
 
 
 
Date of interview (day/month/year) 
___ ___/___ ___/___ ___ ___ ___ 
1.  Umriwakati was kifo Ͱ years  
2.  Tarehe yakifo ͰͰ/ͰͰ/ͰͰͰͰ   
3. Mahaliya kifo 
4. The information souce for the cause of death was (tick all that apply) 
    Ͱ Partner/spouse 
    Ͱ Mother or Father      Ͱ Friend 
    Ͱ Hospital records/staff  Ͱ Other family member/relative 
           Ͱ Care giver 
    Ͱ Neighbor  
 Ͱ Unknown 
Ͱ Other (specify) 
5.  Was the deceased seeking other medical treatment (other than Hope Center) during the last 
3 months before his/her death?      Ͱ Yes  
    Ͱ No Ͱ Unknown 
 
If yes go to 
5a, if no go to 6 
 
 
5a.  If yes, where specifically was the deceased receiving other medical care?   
 
Name of facility:_______________________________________ 
 
 
5b.  What type of care was the deceased receiving at the these other facilities? (Tick 
all that apply) 
 
     Ͱ General medical care 
 
Ͱ TB 
 
 
 
 
Ͱ STD 
     Ͱ HIV/AIDS  
 
Ͱ Malaria 
 
 
 
Ͱ Other infectious disease(s) 
     Ͱ Other care (specify all types of care 
received:___________________________________________) 
 
6.  Respondent’s detailed account of the illness of the deceased: 
 

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7.   Je,mfanyakazi wahuduma za afya alikuambiasababu ya kifo?    NdioͰ   
  la  Ͱ 
 
sijuiͰ   
If yes go to 7a, if no go to 8 
7a. Ninimfanyakazi wahuduma za afyawanasemakilichosababisha kifo? 
8.  Alifanyiwa upasuaji wowote kwa sababu ya ugonjwa?    NdioͰ   
    LaͰ  sijuiͰ  
 
 
 
If yes go to 8a, if no go to 9 
8a.  Upasuaji ulikuwa muda ganikabla ya kifo?_____siku 
8b.  Sehemu gani ya mwili alifanyiwa upasuahi? 
Ͱ tumbo Ͱ Kifua  Ͱkichwa)   Ͱ Mengine(fafanua) _______________) 
9. Mpenzi(wapenzi)wa marehemu wowote wamekufakatikakipindi cha miaka 5 iliyopita? 
NdioͰ      La  Ͱ  Haijulikani Ͱ   
If yes go to 9a, if no go to 10 
 
 
9a. Kama ndiyo, ni nini waliamini kilichosababisha  kifo champenzi(s) 
 
 
 
 
9a1. Partner 1:_____________________________ 
 
 
9a2. Partner 2:_____________________________    
 
Injury/accident/suicide 
 
10. Je alikabiliwa namajerahayoyoteauajaliambayo imesababishakifo chake?  NdioͰ   LaͰ
 
sijuiͰ  
If yes go to 10a, if no go to 11 
10a.  Ni aina gani yamajerahaauajalimarehemualiteseka nayo? 
 
Ͱ Barabara yaajaliza barabaranii   Ͱ 
kuanguka 
 
Ͱ kuzama 
 
Ͱsumu 
 
Ͱ kuungua 
 
 
Ͱ magombano   Ͱ Mengine  Ͱ Haijulikani 
10b.   Majeruhi au ajali ilikuwa ya makusudi au ilifanywa na mtu mwingine) ndioͰ    LaͰ  
sijuiͰ  
 
 

Verbal Autopsy- Kiswahili – Version 2.3 – February 14, 2012 
 
Cervical Treatment Study 
205 
 
10c.   
Je, unafikirikwambayeye alijiua?) ndioͰ    LaͰ  sijuiͰ  
11.  Je,yeye aliumwa na mnyama/mdudu yeyote  iliyosababishakifo chake? 
NdioͰ     
LaͰ  
   SijuiͰ   
 
11a. Kama ndiyo, niaina yamnyama/mdudu? 
 
History of previously known medical conditions 
 
12.  Did the deceased suffer from any of the following conditions? 
 
a.  High blood pressure  
 
 
Ͱ Yes      Ͱ No Ͱ Unknown 
b.  Diabetes 
 
 
 
 
 
Ͱ Yes      Ͱ No Ͱ Unknown 
c.  Asthma 
 
 
 
 
 
Ͱ Yes      Ͱ No Ͱ Unknown 
d.  Epilepsy 
 
 
 
 
 
Ͱ Yes      Ͱ No Ͱ Unknown 
e.  Malnutrition   
 
 
 
 
Ͱ Yes      Ͱ No Ͱ Unknown 
f.  Cancer   
 
 
 
 
 
Ͱ Yes      Ͱ No Ͱ Unknown  
f1.  If yes, specify type of cancer or site:_____________ 
g.  Tuberculosis  
 
 
 
Ͱ Yes      Ͱ No Ͱ Unknown 
h.  Any other medically diagnosed illness?         Ͱ Yes      Ͱ No Ͱ Unknown 
h1.  If yes, specify:______________________ 
 
13.  Signs, symptoms, and their severity during the last illness: 
Symptom/ Signs 
Symptom 
present? 
If present, duration of symptom 
a.  Fever 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
b.  Loss of weight 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
c.  Diarrhea 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
d.  Vomiting/associated abdominal pain 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
e.  Constipation/associated abdominal pain 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
f.  Cough 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 

Verbal Autopsy- Kiswahili – Version 2.3 – February 14, 2012 
 
Cervical Treatment Study 
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Unexpected vaginal bleeding or discharge 
ͰNo    Ͱ Yes 
2 weeks    Ͱ >2 weeks    Ͱ Unknown 
Pelvic or vaginal pain 
ͰNo    Ͱ Yes 
2 weeks    Ͱ >2 weeks    Ͱ Unknown 
 
14.  Records available in home, e.g., death certificate (extract findings): 
15. Comment 
 
 
g.  Cough followed by vomiting 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
h.  Breathing trouble (chest indrawing/difficult/rapid/wheezing) ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
i.  Neck stiffness 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
j.  Unconscious episodes 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
k.  Fits 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
l.  Jerking of individual limbs 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
m.  History of epileptic illness in earlier years 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
n.  Paralysis of limbs 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
o.  Rigid body stiffness, unable to open mouth 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
p.  Red and sore eyes 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
q.  Skin rash and itching 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
r.  Herpes Zoster (at any time in life) 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
s.  Abscesses/body sores 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
t.  White patches on the inside of mouth and tongue 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
u.  Oedema 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
v.  Hair changes 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
w.  Yellowing of eyes or passing of brown urine 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
x.   Chest pain 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 
y.  Other (Specify:                                                      ) 
ͰNo    Ͱ Yes Ͱ <2 weeks    Ͱ >2 weeks    Ͱ Unknown 

Exit- Kiswahili – Version 2.3 – February 14, 2012 
 
Cervical Treatment Study 
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EXIT 
 
Study ID Number:  ___  ___  ___ 
 
 
 
Interviewer Number: ____  
____ 
 
Date of visit (day/month/year) ___ ___ / ___ ___ / ___ ___ ___ ___ 
 
1. Is the patient exiting the study because she has completed the study protocol and qualifies 
as per study guidelines to exit the study at this time? 
 
Ͱ Yes     Ͱ No  (If Yes, go to 
9, If No go to 2) 
2. Date of last study visit (DD/MM/YYYY)   ͰͰ/ͰͰ/ͰͰͰͰ 
3. Date last seen by study staff (DD/MM/YYYY)   ͰͰ/ͰͰ/ͰͰͰͰ 
4. Has the patient accessed care at the Hope Clinic in the past year?  Ͱ Yes     Ͱ No 
 
5. Did you talk to the patient?    Ͱ Yes   Ͱ No   (If Yes go to 6, If No go to 5a) 
 
      5a. If no, who was the source of information (tick one)  
        Ͱ Clinician / clinic staff 
 
     Ͱ Employer  
Ͱ Treatment supporter 
 
 
        Ͱ Spouse or Partner   
 
     Ͱ Friend 
 
 
Ͱ Other (specify) 
        Ͱ Family member / Relative 
     Ͱ Neighbor  
 
        Ͱ Mother or Father  
     Ͱ Caregiver  
6.  Je, mgonjwa anahamisha huduma ya HIV kwa mpangilio mwingine?   Ͱ Ndiyo     Ͱ La     
(If Yes go to 6a, If No go to 7) 
 
 
6a. If yes, where is the patient transferring care to (tick one) 
 
    Ͱ Kuhamishiwa kliniki ingine ambayo siya HOPE, elezea 
 
 
 
 
    Ͱ Kuhamishiwa kliniki ya Industrial area 
 
 
 
 
    Ͱ Kuhamishiwa kliniki yaMaseno 
 
 
 

Exit- Kiswahili – Version 2.3 – February 14, 2012 
 
Cervical Treatment Study 
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7.  Has Hope Clinic asked the patient to Exit or leave the program?  Ͱ Yes    Ͱ No (If Yes go 
to 7a, If No go to 8) 
              7a. Reasons for being Exited from the program (tick all that apply)  
 
    Ͱ Client has not returned to clinic for 1 year 
 
 
 
 
 
 
    Ͱ Poor Adherence 
 
 
 
 
 
 
    Ͱ Poor Clinic Attendance 
 
    Ͱ Not willing to disclose HIV status  
 
 
 
    Ͱ Referred else where 
 
 
 
 
    Ͱ Tested Negative 
 
    Ͱ Other (specify)   
 
    Ͱ Unknown  
 
 
 
 
8.  Has the patient asked to be Unenrolled from the study?  Ͱ Yes    Ͱ No  (If Yes go to 8a, If 
No go to 9) 
 
8a. Reasons patient is asking to Unenroll from the study (tick all that apply)  
 
Ͱ Kutokuwa na nia ya kuhudhuria 
 
    Ͱ Muda wa kusubiri kuwa mrefu sana 
 
    Ͱ Kutoambana na kazi 
 
 
    Ͱ Matatizo ya fedha 
 
    Ͱ Kukosa nia ya kuhudhuria kwa sababu ya matatizo ya kiafya 
 
    Ͱ Matatizo ya familia 
 
    Ͱ Mteja kwenda kwa mganga waimani 
 
Ͱ Kutokuwa tayari kusema hali yake ya Ukimwi  
 
 
 
    Ͱ Kutumwa kwingine 
 
 
 
 
    Ͱ Nyingine (taja)  
 
    Ͱ Haijulikani  
9. At what point was the patient exited?  Ͱ After Pap smear  ͰAfter Biopsy  
ͰMortality    ͰWithdrawn from studyͰOther  ( If other specify)   
 
10. Comment 
 

Adverse Events- Kiswahili – Version 2.3 – February 14, 2012 
 
Cervical Treatment Study 
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English Recruitment Flyer – Version 1.0 – August 01, 2011 
Cervical Treatment Study 
210 
 
CERVICAL TREATMENT STUDY 
 
What is a Pap smear? 
A Pap smear is a simple test to check your cervix to make sure it is healthy. Your cervix is the 
opening of the uterus, and is at the top of your vagina (see the diagram below). A Pap smear 
takes only a few minutes and is not painful. Having a Pap smear every two years is the best 
way to prevent cancer of the cervix. 
 
 
 
Why have a Pap smear? 
A Pap smear can show the early warning signs of cancer of the cervix. Sometimes the cells of 
the cervix change from healthy to unhealthy (abnormal). A Pap smear can find abnormal cells 
before cancer develops. 
 
What causes cervical cancer? 
An infection with a virus called HPV (human Papillomavirus) is the cause of almost all 
cervical cancers. There are over 100 different types of HPV. Two of these types are known to 
cause most of the cervical cancer cases. HPV is very common. Most people (four out of five) 
will have HPV at some time in their lives. Anyone who has ever had sex can have HPV. 
 
In most cases, HPV clears up by itself in a few years. Sometimes the virus can stay in your 
body longer, and can lead to cervical cancer. This usually takes a long time – about 10 years. 
A Pap smear every two years can find cell changes caused by HPV before they turn into 
cancer. Your doctor, nurse or health worker can then make sure your health is monitored and 
that you get treatment if you need it, so you can stay healthy. 
 
How is a Pap smear done? 
First the doctor or nurse asks you to undress from the waist down and to lie on your back for 
the examination. You can ask for a female doctor or nurse. Next the doctor or nurse will use a 
speculum (medical instrument) to open your vagina so your cervix can be seen more clearly. 
Some cells are gently wiped from your cervix with a small brush or spatula (a small plastic or 
wooden stick). The cells are placed on a glass slide and sent to a laboratory where they are 
looked at under a microscope. 
 
 
What does it feel like? 
Sometimes having a Pap smear can be a little embarrassing. Remember, for the person doing 
the smear, this is just part of their everyday work and they are not embarrassed. The 

English Recruitment Flyer – Version 1.0 – August 01, 2011 
Cervical Treatment Study 
211 
 
procedure might be a bit uncomfortable, but it shouldn’t hurt. If it hurts, tell your doctor, 
nurse or health worker straight away. 
 
What if my results are not normal? 
If your results are not normal this does not mean you have cancer. Very often it will be that 
you have something simple like an infection that will clear up naturally. Sometimes a woman 
may need to have a Pap smear more often. Some types of abnormal cells may need to be 
treated by a specialist. Make sure you talk to your doctor, nurse or health worker about what 
is best for you. 
 
HIV and cervical cancer 
HIV-positive women are more likely to be infected with human Papillomavirus (HPV), the 
primary cause of cervical cancer, and progress to invasive, life-threatening disease than those 
who are HIV-negative.  
Note: Being on HIV medication does NOT reduce your risk of cervical cancer. 
 
Cervical Treatment Study 
Researchers from the University of Washington in the USA, Kenyatta National Hospital, 
WHO and Coptic Hospital are conducting a study to see how treatment can prevent abnormal 
cells from becoming cancer, and how treatment might affect HIV.  Those patients who enroll 
in the study will be given free screening for cervical disease that may develop into cancer and 
will also receive free treatment if they are found to have abnormal cells.   
 
For more information about the study, contact: 
1. Peter Juma:  
 
0721-898-785 
2. Elizabeth Makena:  
0728-456-540 
3. Dr. Evans Malava: 
0721-289-733 

Kiswahili Recruitment Flyer – Version 1.0 – August 01, 2011 
Cervical Treatment Study 
212 
 
CERVICAL TREATMENT STUDY 
 
Je Pap Smear ni nini? 
Pap Smear ni kupimwa njia yako ya uzazi kwa njia rahisi kuhakikisha ni salama. Njia ya 
uzazi ni mlango wa nyumba ya mototo tumboni na iko kwa ndani juu ya sehemu yako ya siri 
(angalia mchoro hapo chini). Kupimwa njia ya uzazi huchukuwa dakika chache tu na si 
uchungu. 
Kupimwa njia ya uzazi kila baada ya miaka miwili ndio njia bora zaidi ya kuzuia saratani ya 
njia ya uzazi. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Kwa nini upimwe njia ya uzazi? 
Kupimwa njia ya uzazi kunaweza kuonyesha dalili za saratani ya njia ya uzazi. Wakati 
mwingine hali ya njia ya uzazi hubadilika, na kuwa na hitilafu. Ukipimwa njia ya uzazi 
inaweza kujulikana kama ina hitilafu kabla haijabadilika kuwa saratani. 
 
Nini kinachosababisha Saratani wa njia ya uzazi? 
Kuambukizwa kwa virusi vinavyoitwa HPV (humanpapillomavirus) kunasababisha karibu 
saratani zote za njia ya uzazi. Kuna zaidi ya aina 100 tofauti za HPV. Aina mbili za HPV 
zinajulikana kusababisha saratani kwa karibu wote wanaougua njia za uzazi. Virusi vya HPV 
vinapatikana kwa wingi. Watu wengi (wanne kwa watano) watakuwa na HPV wakati mmoja 
maishani mwao. Yeyote ambaye ashawahi kufanya ngono anaweza kuwa na HPV. 
 
Mara nyingi, virusi vya HPV hutoweka vyenyewe baada ya miaka michache. Mara nyingine 
hivi virusi vinaweza vikakaa mwilini na vinaweza kusababisha saratani ya njia ya uzazi. Hii 
huchukuwa mda mrefu – kama miaka 10. Kupimwa njia ya uzazi kila baada ya miaka miwili 
kunaweza kufanya mabadiliko ya njia ya uzazi yajulikane kabla hayajasababisha saratani. 
Daktari wako, muuguzi au mfanya kazi kutoka kituo cha afya anaweza kuhakikisha kuwa 
afya yako inafuatiliwa na unapata matibabu kama unayahitaji ili uwe na afya bora. 
 
Je mtu hupimwaje njia ya uzazi? 
Kwanza daktari au muuguzi anakuuliza uvue nguo kutoka kiunoni kwenda chini na ulale chali 
ili akupime. Unaweza kuuliza upimwe na daktari au muuguzi wa kike. Halafu daktari au 
Mfereji wa kupitisha 
mayai ya mwanamke 
Sehemu mayai ya 
mke 
yanapotengenezwa 
Nyumba ya mtoto tumboni 
Mlango wa nyumba ya mtoto 
au njia ya uzazi 
Juu ya sehemu ya siri ya mke 

Kiswahili Recruitment Flyer – Version 1.0 – August 01, 2011 
Cervical Treatment Study 
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muuguzi atatumia chombo cha kupimia kufungua sehemu yako ya siri ili njia ya uzazi 
ionekane vyema zaidi. Atapangusa ukuta katika njia yako ya uzazi na brashi ndogo au 
chombo cha kupima (kijiti kidogo ama kipande cha mpira kidogo). Kilichopanguswa kutoka 
njia ya uzazi, wataweka kwenye kioo kidogo na kupelekwa maabara (lebu) watakakotazama 
wakitumia darubini. 
 
Je mtu husikiaje? 
Wakati mwingine kupimwa njia ya uzazi ni jambo la kutahayari au kuonea aibu. Kumbuka, 
kuwa 
anayekupima njia ya uzazi, hii ni kazi yake ya kawaida na hatahayari au kuona aibu. 
Unapopimwa, unaweza kusikia ovyo, lakini haina uchungu. Ukisikia uchungu, mwambie 
daktari wako, muuguzi au mfanyakazi kwenye kituo cha afya hapohapo. 
 
Je kama majibu yangu sio sawa au salama? 
Kama majibu yako sio sawa, haimaanishi uko na saratani. Mara nyingi itakuwa una jambo 
dogo kama kuambukizwa ambako huisha kwenyewe bila kutibiwa. Mara nyingine 
mwanamke anahitaji kupimwa njia ya uzazi mara kwa mara. Hali nyingine zisizo za kawaida 
zahitaji matibabu maalum. Hakikisha umeshauriana na daktari wako, muuguzi au mfanya kazi 
wa kituo cha afya ili akufahamishe kilicho bora kwako. 
 
Uhusiano wa UKIMWI na saratani ya njia ya uzazi 
Wanawake wanaougua ugonjwa wa UKIMWI wanauwezekano mkubwa kuliko wale ambao 
hawana UKIMWI kuambukizwa virusi vya human Papillomavirus (HPV), vinavyosababisha 
saratani ya njia ya uzazi, na iendelee hadi ivaamie mwili na iwe, kitisho kwa maisha.  
Kumbuka: Kutumia dawa ya UKIMWI haiwezi kupunguza hatari ya saratani ya njia 
ya kizazi. 
 
Utafiti wa matibabu ya njia ya kizazi (Cervical Treatment Study) 
Watafiti kutoka Chuo Kikuu cha Washington huko Marekani, Hospitali Kuu ya Kenyatta, 
Shirika la Afya Duniani na Hospitali ya Coptic wanafanya utafiti kuona jinsi gani 
tiba inaweza kuzuia chembe chembe zisizo za kawaida isiwe saratani ya njia ya kizazi, na 
jinsi tiba inaweza kuathiri ugonjwa wa UKIWMI.  Wagonjwa ambao watahusika katika utafiti 
huu watapewa uchunguzi (Pap smear) wa bure na pia watapata matibabu ya bure 
wakipatikana na chembe chembe zisizo za kawaida. 
 
Kwa habari zaidi kuhusu utafitii huu, wasiliana na: 
1. Peter Juma:  
 
0721-898-785 
2. Elizabeth Makena:  
0728-456-540 
3. Dr. Evans Malava: 
0721-289-733 

Hope Medical Record Forms – Version 2.0 – May 5, 2010 
Cervical Treatment Study 
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COPTIC HOPE MEDICAL RECORD FORMS 
ADDRESS AND INTAKE
1. Gender
Male
Female
2. Age  (Years)
Month
Interviewer number
Today's Date (DD.MM.YYYY)
/
/
3. Date Of Birth (DD/MM/YYYY)
/
/
Name ( First, Middle,Last)
5. Email
6. Physical Address
Site Code
4a. If Nairobi province, specify area: (tick one)
Langata/Kibera
Starehe
Dagoretti
Makadara
Embakasi
Westlands
Kasarani
Kamukunji
Eastland/ Industrial Area
Other (specify)
Hope version 5.0
Modified December 2009
Coptic Hope Center
4. In which region does the client reside(stay)?
Nairobi province (see 4a)
Nyanza Province (see 4b)
Western Province (see 4b)
Central Province
Rift Valley Province
North Eastern Province
Eastern Province
Coast Province
Other country (specify)
4b. If western or Nyanza, specify area: (tick one)
Kisumu Rural
Siaya
Vihiga
Kakamega
Luanda
Maseno
Chulaimbo
Lela
Other (Specify)
HOPE ID Number
Page 1
 
 

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Emergency contact (in case we cannot reach the patient)
11. Name (Last, First, Middle)
For the data use only (tick after scanning the form)
  Scanned               Date ___ / ___ / _________  Name of data person
10a. Relationship to phone owner (tick one)
Self
Relative
Friend
Employer
Other (specify)
11a. Relationship to client (tick one)
Self
Relative
Friend
Employer
Other (specify)
Husband/Wife
ADDRESS AND INTAKE
Clients transferring from Pediatric Clinic
12. Pediatric Hopeid
9a. Relationship to phone owner (tick one)
Self
Relative
Friend
Employer
Other (specify)
8. How long does the client plan to stay at this residence?
Less than a year
Greater than a year
7. How long has the client stayed at this residence?
Less than a year
Greater than a year
9. Phone number  (Cell) 
10. Phone number (Landline) 
11b. Phone No.
 
 
 
 

Hope Medical Record Forms – Version 2.0 – May 5, 2010 
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216 
 
 
COUNSELING ADHERENCE #1
Modified   December 2009
Coptic Hope Clinic
Version   5.0
Checklist
Tick
Explain about HIV and how it affects the body
Explain about CD4 cells and why it is necessary to measure the CD4 count
Explain the difference between HIV and AIDS.
Explain about ARV.
Explain ARV is not a cure.
Explain the cause of resistance.
Explain treatment failure
Explain importance of adherence.
Explain problem of side effects.
Have patient think about life long commitment of therapy.
Have patient think about ability to follow up care
Notes/Remarks
Interviewer number
.
Explore patient support system
Discuss adherence promotion strategies e.g. treatment buddy, pill diary e.t.c
For the data use only (tick after scanning the form)
  Scanned               Date ___ / ___ / _________  Name of data person
2. Identify barriers to adherence (tick all that apply)
Poor Communication
Low literacy
Inadequate understanding about HIV/AIDS
Lack of social support
Failure to disclose status
Alcohol/ Drug use
Mental State
Stigma
None
Others (specify)
Today's date (DD.MM.YYYY)
/
/
Site Code
3. Does the patient need to move forward with the protocol or to repeat counselling adherence #1 ?
Move forward
Repeat Counselling Adherence # 1
HOPE ID Number
 
 

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COUNSELING ADHERENCE #2
Modified   December 2009
Coptic Hope Clinic
Version   5.0
Question
Rationale
Score
1. What do you know about ARVs?
Assess whether information given in Counseling Adherence#1 has been understood.
2. What are the names of any ARVs?
Assess the client's knowledge of basic ARV action (especially that ARV is not a cure for
HIV infection.)
3. How do ARVs work?
Assess client's knowledge of side effects related to his/her ARV regimen and the appropriate
response to deal with side effects.
4 What side effects are associated with
ARVs? What do you know about them?
Assess whether client knows ARV is life long treatment.
5. How long should you normally take
ARVs?
Assess whether client understands the problem of resistance given ARV interruptions.
6. What happens if you dont take ARVs
consistently?
Assess whether client knows that CD4 count is a laboratory indicator for monitoring the
effect of ARV
7. What is the purpose of CD4 counts?
8. What are your expectations from
ARVs?
Assess whether client has realistic expectations, e.g., prolonging life, keeping them well
enough from their family, e.t.c. Assess for false expectations, e.g., a cure for HIV, e.t.c
Interviewer number
Score scale:               1-Poor  2-Fair  3-Good
Today's date (DD.MM.YYYY)
/
/
Site Code
Section A: Knowledge Assessment
Assess the client knows that AZT, NVP, etc. are ARVs, but septrin is not
9. Can someone still transmit HIV while
taking ARVs?
Assess/review need for continued prevention e.g. condom use.
If total score is less than 18, patient has failed section A
If total score is 18 or above, the patient passes section A
Total Score:
Question
Rationale
10. Assess for barriers that help
determine capability for followup
Assess whether client can attend HIV clinic for follow up medical and counselling care
12. On a scale of 1 to 5 (5 being most
ready, 1 being least), please rate the
client's ability to adhere to medications
Score 1: Patient will adhere to the ARVs very poorly (Misses more than half the doses)
Score 2: Patient will likely miss doses of ARVs ona regular basis (misses up to 50% of doses)
Score 3: Patient will only miss some doses of ARVs (1 dose a month at most)
Score 4: Patient will rarely miss a dose of ARVs (1 dose every 6 months at most)
Score 5: Patient will almost never miss any doses (1 dose every year at most)
Score
Section B: Counselor Assessment
11. Ask the client whether s/he has a
relative/friend whom s/he can rely on to
support her/him taking ARV
If total score is 2 or below on question 12, patient fails section B
If total score is 3 or above question 12, patient passes section B
Assess availability of support from home
HOPE ID Number
Page 1
 
 
 
 

Hope Medical Record Forms – Version 2.0 – May 5, 2010 
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218 
 
Notes/Remarks
For the data use only (tick after scanning the form)
  Scanned               Date ___ / ___ / _________  Name of data person
Question
Rationale
13.Ask the client if s/he can come to
HIV clinic for regular follow-up?
YES or NO answer
Score
Section C: Participant Assessment
14. Do you want to start ARV
treatment now?
If any answers in this section are
"NO" then patient fails Section C
YES or NO answer
Section D: Final Assessment
a) Did the patient pass section A, B and C?
Yes
No
b) If NO, is the patient scheduled to repeat counseling?
Yes
No
(Patient moves forward)
Yes
No
Yes
No
15.
COUNSELING ADHERENCE #2
 

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219 
 
COUNSELING ADHERENCE #3
Modified   December 2009
Hope Clinic
Version  5.0
To be performed 1 month after starting ARVs
Question
Rationale
1. What do you know about ARVs?
Assess whether information given in Counseling Adherence#1 has been understood.
2. What are the names of your
medications and dosage?
Assess whether the client knows his/her medication and dosage.
3. How do ARVs work?
Assess the client's knowledge of basic ARV action (especially that ARV is not a cure for
HIV infection.)
4. What side effects are assosiated with
ARVs and what do you do if you have
side effects?
Assess client's knowledge of side effects related to his/her ARV regimen and the appropriate
response to deal with side effects.
5. How long should you normally take
ARVs?
Assess whether client knows ARV is life long treatment.
6. What happens if you don't take your
ARVs consistently?
Assess whether client understands the problem of resistance given ARV interruptions.
7. What is the purpose of CD4 counts?
Assess whether client knows that CD4 count is a laboratory indicator for monitoring the
effect of ARV
8. What are your expectations from
ARVs?
Assess whether client has realistic expectations, e.g. prolonged life, keeping them well enough
from thier family, etc. Assess for false expectations, e.g., a cure for HIV, etc.
Assess review need for continued prevention e.g. condom use
Notes/Remarks
Interviewer number
9. How can someone still transmit HIV
while taking ARVs?
For the data use only (tick after scanning the form)
  Scanned               Date ___ / ___ / _________  Name of data person
Score scale:               1- poor  2-Fair  3-Good
Score
Today's date (DD.MM.YYYY)
/
/
Site Code
Section A: Knowledge Assessment
Total Score
Question
Rationale
10. During the last 7 days how many
pills did the patient MISS taking?
Get exact number of pills missed
11. On a scale of 1 to 5 (5 being most
ready, 1 being least), please rate the
client's ability to adhere to
medications?
Score 1: Patient will adhere to the ARVs very poorly (Misses more than half the doses)
Score 2: Patient will likely miss doses of ARVs ona regular basis (Misses up to 50% of doses)
Score 3: Patient will only miss some doses of ARVs (1 dose a month at most)
Score 4: Patient will rarely miss a dose of ARV (1 dose every 6 months at most)
Score 5: Patient will almost never miss any doses (1 dose every year at most)
Score
Section B: Counselor Assessment
HOPE ID Number
 

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PHONE NUMBER AND ADDRESS UPDATE FORM
1. Has the client's phone number changed?
Yes
No
Interviewer number
Today's Date (DD.MM.YYYY)
/
/
Name (First, Middle,last)
5. Physical Address
Site Code
(For Maseno, check 2nd, 3rd and where applicable 4th column)
6. In which region does the client now reside (stay)
Nairobi province
Nyanza province
Western province
Central province
Rift Valley province
North Eastern province
Eastern province
Coast province
(See 6a)
(See 6b)
(See 6b)
6a. If Nairobi province, specify area: (tick one)
Langata/Kibera
Starehe
Dagoretti
Makadara
Embakasi
Westlands
Kasarani
Kamukunji
Eastlands/Industrial Area
Other(Specify)
6b. If western or Nyanza, specify area: (tick one)
Kisumu Rural
Siaya
Vihiga
Kakamega
Luanda
Maseno
Chulaimbo
Lela
Other(specify)
2a. Relationship to phone owner (tick one)
Self
Husband or wife
Relative
Friend
Employer
Other (specify)
3a. Relationship to phone owner (tick one)
Self
Husband or wife
Relative
Friend
Employer
Other (specify)
4. Has the client moved?
Yes
No
Modified  December 2009
Hope Clinic
Version   5.0
(If Yes go to 2, If No go to 4)
(If Yes go to 5, If No go to 7)
Page 1
HOPE ID Number
2. Phone number  (Cell) 
3. Phone number (Landline) 
 
 
 

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Emergency contact (in case we cannot reach the patient)
10a. Relationship to client (tick one)
Self
Relative
Friend
Employer
Other (specify)
Husband/Wife
10. Name (Last, First, Middle)
For the data use only (tick after scanning the form)
  Scanned               Date ___ / ___ / _________  Name of data person
8. Email
7. Has the client's email changed?
Yes
No
9. Has the client's emergency contact changed?
Yes
No
(If Yes go to 8, If No go to 9)
(If Yes go to 10)
PHONE NUMBER AND ADDRESS UPDATE FORM
10b. Phone No.
 

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PATIENT PHONE CONTACT FORM
Interviewer number
Today's Date (DD.MM.YYYY)
/
/
Site Code
2. Did you talk to the patient or patient's contact?
Yes, talked to patient
Yes, talked to patient's contact
No
(Go to 4)
(Go to 3)
(Go to 4)
3. If talked to patient's contact, who was the source of  information (tick one)
Clinician/clinic staff
Spouse or partner
Family member/Relative
Employer
Friend
Mother/Father
Neighbour
Caregiver
Treatment supporter
Other (specify)
3a. Did the source of information have credible knowledge for whether the patient was alive or dead?
Yes, credible and patient confirmed alive
Yes, credile and patient confirmed dead
Source did not know whether patient was dead or alive
(Go to 4)
(Go to 9 and complete Mortality form)
(Go to 4)
4. What was the reason for calling or contacting the patient or patient's contact?
Patient missed clinic appointment
Patient missed pharmacy pickup
(Go to 5)
(Go to 6)
5. Reasons for missed clinic appointment (tick all that apply)
N/A, did not reach patient or patient's contact
No longer willing to attend
Wait time too long
Conflict with work
Financial problems
Client moved or relocated
Unable to attend because of health problems
Family problems
Client will go to faith healer
Unwilling to disclose
Other (specify)
6. Reasons for missed pharmacy pick up (tick all that apply)
Got medication somewhere else
Conflict with work
Financial problems
Client moved or relocated
Unable to attend because of health problems
Family problems
Client will go to faith healer
Unwilling to disclose
Other (specify)
N/A, did not reach patient
1. Date of phone contact (DD/MM/YYYY)
/
/
Modified  December 2009                                                 Hope Clinic                                                                                   Version   5.0
HOPE ID Number
Other (specify)
(Go to 7)
Page 1
 
 

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For the data use only (tick after scanning the form)
  Scanned               Date ___ / ___ / _________  Name of data person
7. If talked to patient, did the patient wish to remain in the clinic?
Yes
No
N/A, did not talk to patient
(Go to 7a)
(Go to 8 and complete Exit form)
(Go to 9)
7a. Did the patient schedule a clinic appointment?
Yes
No (If YES go to 7b, If NO go to 7d)
7d. If NO, why did the patient not schedule an appointment (tick all that apply)
Conflict with work
Financial problems
Client moved or relocated
Unable to attend because of health problems
Family problems
Client lives too far away
Other (specify)
8. If the patient does not wish to return to the clinic, specify why (tick all that apply)
Attend clinic closer to home
Not willing to attend
Wait time too long
Conflict with work
Financial problems
Referred elsewhere
Unwilling to attend because of health problems
Family problems
Client will go to faith healer
Not willing to disclose HIV status
Other (specify)
Unknown
 Comments
7b. If YES, date of scheduled appointment (DD/MM/YYYY)
/
/
9.Did you refer the client to any of the following (tick all that apply)
Clinic
Counselor
Nutritionist
HBC
None
 

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Counseling  General Session
Notes
What was the focus of the session? (tick all that apply)
Pretest
Hygiene
Family planning
Crisis
Discordance
Sex and sexuality
Post-test
PMTCT
Child(ren)
Opportunistic infection
Welfare
Drug therapy
HIV/STD Prevention
Nutrition
Bereavement
Spirituality
Disclosure
Other (specify)
Modified   December 2009
Coptic Hope Clinic
Version   5.0
Interviewer number
For the data use only (tick after scanning the form)
  Scanned               Date ___ / ___ / _________  Name of data person
Site Code
Today's Date (DD/MM/YYYY)
/
/
HOPE ID Number
Child transfer to Adult Clinic
 

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COUNSELOR SCREENING
Interviewer number
Today's date (DD.MM.YYYY)
/
/
Site Code
Page 1
1. How many children do you have or care for?
If = 0 go to 2
Test Result
Receiving HIV care?
Receiving HAART?
Recieving HAART and/or
HIV care at Hope Clinic?
1a. Describe HIV test results and HIV care for each child.
Positive
Negative
Unknown
Not tested
Yes
No
Unknown
N/A
Yes
No
Unknown
N/A
Positive
Negative
Unknown
Not tested
Yes
No
Unknown
N/A
Yes
No
Unknown
N/A
Yes
No
Unknown
N/A
Positive
Negative
Unknown
Not tested
Yes
No
Unknown
N/A
Yes
No
Unknown
N/A
Yes
No
Unknown
N/A
Positive
Negative
Unknown
not tested
Yes
No
Unknown
N/A
Yes
No
Unknown
N/A
Yes
No
Unknown
N/A
Yes
No
Unknown
N/A
1
2
3
4
2. Have you revealed your serostatus to:
a. Spouse(s) or steady partner(s)
All
Some
None
Has no spouse
b. Casual  or non-casual partner(s)
All
Some
None
Has no partner
c. Parents
All
Some
None
Has no parents
e. Children
All
Some
None
Has no children
f. Friends
All
Some
None
Has no friends
g. Others 
All
Some
No one else
Specify
d. Siblings
All
Some
None
Has no siblings
3. Who forms your closest social support (tick one)
Spouse/steady partner
Mother
Father
Friend
Sibling
Other (specify)
No social supporter
3a. Have you informed this person of your serostatus?
Yes
No
N/A
Modified   December 2009
Hope Clinic
Version   5.0
HOPE ID Number
 
 
 

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4. Have you ever had sex?
Yes
No
(If YES, go to 5, If NO go to 13)
5. How many spouse(s) or steady partner(s) do you have?
(If = 0 go to 6)
5a. Describe HIV test results and HIV care for each spouse(s) or steady partner(s)
Relationship
Test Result
Receiving HIV care?
Receiving HAART?
Recieving HAART and/or
HIV care at Hope Clinic?
Spouse
Steady partner
Positive
Negative
Unknown
not tested
Yes
No
Unknown
N/A
Yes
No
Unknown
N/A
Yes
No
Unknown
N/A
Spouse
Steady partner
Positive
Negative
Unknown
Not tested
Yes
No
Unknown
N/A
Yes
No
Unknown
N/A
Yes
No
Unknown
N/A
Spouse
Steady partner
Positive
Negative
Unknown
Not tested
Yes
No
Unknown
N/A
Yes
No
Unknown
N/A
Yes
No
Unknown
N/A
1
2
3
Spouse
Steady partner
Positive
Negative
Unknown
not tested
Yes
No
Unknown
N/A
Yes
No
Unknown
N/A
Yes
No
Unknown
N/A
Spouse
Steady partner
Positive
Negative
Unknown
Not tested
Yes
No
Unknown
N/A
Yes
No
Unknown
N/A
Yes
No
Unknown
N/A
Spouse
Steady partner
Positive
Negative
Unknown
Not tested
Yes
No
Unknown
N/A
Yes
No
Unknown
N/A
Yes
No
Unknown
N/A
4
5
6
 
 
 

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6. How many diffrerent casual or non-steady partner(s) did you have in the past year?
7. In the past year, how many different sexual partners have you had, including your spouse(s) and steady partner(s)?
8. During your lifetime have you had sex with
Men Only
Women Only
Both
None
Refused to answer
a.Spouse(s) or steady partiners
Never
Sometimes
Always
No sex in past 12 months
No spouse/steady partner
(Tick one)
10. Did you use a condom during your last sexual encounter 
No
Yes
Refused to answer
(Tick one)
9. Describe your condom use in the past 12 months todate:-
b.Non- steady partiners.
Never
Sometimes
Always
No sex in past 12 months
No Non-steady partner
11a. Are you able to say NO to sex if your spouse or steady partner will not use a condom?
No
Yes
No spouse/steady partner
Refused to answer
Don't know
12. Are you able to talk about condoms with your casual or non-steady partner(s)?
Yes
No
No non-steady partner(s)
Refused to answer
Don't know
12a. Are you able to say NO to sex if your casual or non-steady partner(s) will not use a condom?
No
Yes
No non-steady partner(s)
Refused to answer
Don't know
11. Are you able to talk about using condoms with your spouse(s) or steady partner(s)?
No
Yes
Refused to answer
No spouse/steady partner
Dont know
15. Counselor, does the client need a treatment supporter?
Yes
No
(If yes go to 15a, if no go 16)
Client requests treatment supporter
Physically disabled
Mentally disabled
15a. If YES why? specify (Tick all that apply)
Other (specify)
14. Do you feel neglected by anyone (tick all that apply)
Family
Friends
Health care workers
None
Others (specify)
13. Are you Circumcised ?
Yes
No
Refused to answer
Female client
(Ask Male client only)
 
 

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16. Counselor is this client recommended for homecare?
Yes
No
16a. If YES, specify why? (Tick all that apply)
Physically or mentally disabled adult
Adult dependent on care-giver
Client requests a home visit
Disclosure (patient would like help disclosing status to family members)
Family testing (client would like other family members to be tested)
Other (specify)
Checklist
  Tick
(if Yes)
1. Overview of HOPE Center Program and Services
2. Importance of commitment to the program
3. Policy for adherence and clinic attendance
4. Patients enrollment status in other programs or facilities
5. Patients long term goals for health management at our program
17. Have you explained/discussed or checked the following with the Client?
Notes / Assessment
For the data use only (tick after scanning the form)
  Scanned               Date ___ / ___ / _________  Name of data person
  Tick
(if No)
 

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ADULT LOCATOR FORM
Interviewer number
Today's Date (DD/MM/YYYY)
/
/
Site Code
1. Name (Last, First, Middle)
2. Gender
Male
Female
3. Age  (Years)
CLIENT'S RESIDENTIAL AND TELEPHONE CONTACT INFORMATION
4. Public Transportation to the house:
4a. Type
Bus
Citi Hoppa
Matatu
Taxi
Other(specify)
4b. Number
4c. Stage Name
4d. General name of the area
5. Walking directions to house from the stage?
6. Landmarks that aide in locating the household: (Schools, churches, businesses etc.)
7. How is the Client or Caregiver called or refered to in home area:
8. Primary Telephone Contact:
Mobile
Landline
Unknown
Modified   December   2009                            Hope Clinic                                                   Version   5.0
HOPE ID Number
Page 1
 
 

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For the data use only (tick after scanning the form)
  Scanned               Date ___ / ___ / _________  Name of data person
8a. Line belongs to:
Client
Parent
Caregiver
Other household member
Relative
Friend
Neighbour
Nerby Simu ya Jamii
Guardian Institution or organisation
Other(specify)
8b. If the phone is not the client's does the owner know of the client's status?
Yes
No
Unknown
9. Secondary Telephone Contact:
Mobile
Landline
Unknown
9a. Line belongs to:
Client
Parent
Caregiver
Other household member
Relative
Friend
Neighbour
Nearby Simu ya Jamii
Guardian Institution or organisation
Other(specify)
9b. If the phone is not the client's does the owner know of the client's status?
Yes
No
Unknown
10a. This residence is:
Permenent
Temporary
Unknown
10. How long has the client been living at this residence:
Years
Months
 

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ADULT MEDICAL FOLLOW-UP
Interviewer number
Modified   December 2009
Version   5.0
Hope Clinic
HISTORY OF PRESENT ILLNESS
MEDICAL  REVIEW
1. Does the patient currently have Extra pulmonary TB? 
Yes
No
Today's Date (DD.MM.YYYY)
/
/
Site Code
Page 1
2a. If YES, what was the diagnosis based on (tick all that apply)
Chest X-ray
Sypmtoms (persistent cough >2 weeks, fever, night sweats, etc)
Failure to respond to empirical antibiotics
Sputum
Other (specify)
Unknown
3. Is the patient currently on treatment for TB(PTB & ETB)
Yes
No
Unknown
(If YES go to 3a, If NO or Unknown go to 4)
3b. If YES, specify treatment
EH
RHZ
RHZE
RH
SHRZE
unknown
Other (specify)
3c. Is the patient currently being treated for TB at coptic? 
Yes
No
3d. If NO, specify where:
Private hospital
Public hospital
Other government facility
Other (specify)
4. In the past month, has the patient experienced any of the following? (tick all that apply)
Urethral discharge
Genital sores or ulcers
Painful micturation(Dysuria)
Dysparenuia
Vaginal itching/burning
Vaginal discharge
Testicular pain or swelling
Lower Abdominal pain 
None
3a. If yes, specify treatment start date (DD.MM.YYYY)
/
/
(If YES go to 4, If NO go to 3d)
2.Does the Patient  have Pulmonary TB?
Yes 
No (If YES go to 2a, If NO go to 4)
S=streptomycine
H=Isoniazid
R=Rifampicin
Z=Pyrazinamid
E=Ethambutol
HOPE ID Number
 
 

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MEDICATIONS
5. Is the patient currently taking HAART or ARVs, excluding PMTCT & PEP?
Yes
No
5a. If yes, specify (tick one)
AZT-3TC-EFV
AZT-3TC-NVP
AZT-3TC-LPV/rit
d4T(30mg)-3TC-EFV
d4T(30mg)-3TC-NVP
d4T(30mg)-DDI-LPV/rit
d4T(40mg)-DDI-LPV/rit
TDF 3TC EFV
TDF 3TC NVP
TDF-ABC-LPV/rit
Unknown
Other (specify)
(If YES go to 5a, If NO go to 7)
5b. Has the patient had any recent side effects due to HAART or ARV medications?
Yes
No(If Yes go to 5c, If NO go to 6)
5c. If YES, describe the symptoms and severity of possible side effects (Tick for each symptom)
Symptom
Frequency of Symptom
If YES, severity of symptom
a. Nausea or vomiting
b. Rash
c. Fat changes
d. Diarrhea
e. Anemia
f. Cough
g. Fatigue
h. Abdominal pain
i. CNS - dizzininess, anxiety, nightmares
j. Headache
k. Jaundice
l. Difficulty breathing
m. Burning/numbness/tingling
n. Fever
o. Heartburn
p. Other (specify)
Sometimes
Often
Sometimes
Often
Sometimes
Often
Sometimes
Often
Sometimes
Often
Sometimes
Often
Sometimes
Often
Sometimes
Often
Sometimes
Often
Sometimes
Often
Sometimes
Often
Sometimes
Often
Sometimes
Often
Sometimes
Often
Sometimes
Often
Sometimes
Often
Mild
Moderate
Severe
Mild
Moderate
Severe
Mild
Moderate
Severe
Mild
Moderate
Severe
Mild
Moderate
Severe
Mild
Moderate
Severe
Mild
Moderate
Severe
Mild
Moderate
Severe
Mild
Moderate
Severe
Mild
Moderate
Severe
Mild
Moderate
Severe
Mild
Moderate
Severe
Mild
Moderate
Severe
Mild
Moderate
Severe
Mild
Moderate
Severe
Mild
Moderate
Severe
 
 

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6a. If patient MISSED doses, please specify reasons (tick all that apply).
Toxicity/side  effect
Share with others
Forgot
Felt better
Too ill
Stigma, disclosure or privacy issues
Drug stock out - dispensary
Patient lost or ran out of pills
Delivery/travel problems
Inability to pay
Alcohol
Depression
Other (specify)
6. During the last 7 days how many ARV pills did the patient MISS taking? (tick one)
None
Very Few
Half
Most
All
7. Is patient taking any of the following medications? (tick all that apply)
Cotrimoxazole
Dapsone
Fluconazole
Antimalarial medications
Herbal traditional medications
Multivitamin supplements
None of the above
8. What other medications is patient currently taking?
Medication
Dose (mg)
Frequency (per day)
Start date
1.
2.
3.
Stop date
9. PHYSICAL   EXAMINATION
Temp (F)
.
HR
BP
/
RR
Wt (Kg)
.
Sa O2
HGT
.
BMI
BMI>18.5
BMI<18.5
BMI Unknown
Nurse number
System (tick one)
Normal
Abnormal
Not done
Findings (if abnormal)
General
Skin
Lymph nodes
HEENT
Lungs
Cardiovascular
Abdomen
Genitourinary
Extremities
Musculoskeletal
Neurological
Psychological
10.
Gender
MALE
Female
 
 
 

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ASSESSMENT AND PLAN
11. What diagnoses does the patient have on today's visit (tick all that apply)?
Dementia
Candidiasis (thrush) - oral
Ulcers - oral
Other (specify)
URTI
HSV - genital
Asthma
Malaria
Soft tissue infection
Diarrhea
Dermatitis
Conjuctivitis
Side effects due to ARV
Zoster
IRIS
Chancroid
Anaemia
Hypertension
Peptic Ulcer disease
Gonorrhea
Candidiasis (thrush) - vaginal
Syphilis
Genital Ulcer disease
None
13. If pulmonary TB suspected, what is the suspected pulmonary TB based on (tick all that apply)?
Abnormal X-ray
Symptoms (persistent cough >2 weeks, fever, night sweats, etc)
Failure to respond to empirical antibiotics
Recent contact with people with Pulmonary TB
Other (specify)
13a. Will the patient be sent for pulmonary TB testing?
Yes
NO
(If NO TB go to 15)
14. If Pulmonary TB is diagnosed today, what is it based on(tick all that apply)?
Abnormal X-ray
Symptoms (persistent cough >2 weeks, fever, night sweats, etc)
Failure to respond to empirical antibiotics
Sputum
Other (specify)
14a. Specify treatment to be started:
RHZE
RHZ
Other (specify)
SHRZE
EH
12. What is the patients current Pulmonary TB diagnosis?
Pulmonary TB suspected
Pulmonary TB diagnosed today
Currently on pulmonaryTB treatment
Previously diagnosed with TB, not on Treatment
No Pulmonary TB
Other(specify)
(If suspected go to 13)
(If diagnosed go to 14)
(If currently on TB treatment go to 15)
(If yes, go to 13b, if no go to 15)
(Go to 15)
Neuropathy 
Myalgia
UTI
Extra Pulmonary TB
Pneumonia
13b. If YES, which of the following tests will the patient be sent for:
Sent for sputum
Sent for X-ray
Other (specify)
S=streptomycine
H=Isoniazid
R=Rifampicin
Z=Pyrazinamid
E=Ethambutol
(skip to 14a)
 
 
 

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Section B: Female Patients Only (If Male go to 19)
15. Is the patient currently pregnant?
Yes
No
Unknown
(If YES, complete Pregnancy Monitoring Form)
16. Is the patient currently breastfeeding?
Yes
No
(If NO,refer patient to Nutritionist)
16b. If YES, has she had a session with the nutritionist since she started breast feeding?
Yes
No
16a. If yes, specify what type of breastfeeding (tick one)
Exclusive breastfeeding
Mixed feeding
(Child given ONLY mother's milk and NO water, tea, formula, cow's milk or food of any kind)
(Child given mother's milk and water, tea formula, cow's milk or food)
18.Is the patient being referred for Cervical Cancer screening at Hope?
Yes
No
18a. If NO, reasons why patient  NOT referred for Cervical Cancer Screening  (tick all that apply)
Patient is younger than 18 years
Patient has had total hysterectomy, LEEP or cryotherapy
Patient is currently pregnant
Patient does not accept screening
Patient has had a screening test in the last year
Patient wishes to defer until a later time
No service  available at this time
Other(specify)
(If yes go to 19, If NO go to 18a)
Specify reason
Specify reason
(If YES,go to 16a,if no go to 17)
17.Has the patient delivered in the past 18 Months?
Yes
No
17b.Age of the child
Months
Days
17c. If not currently breastfeeding,at what age did the child stop breastfeeding?
Months
Days
Unknown
NA,Child never breastfed
17d.Has the child ever had a PCR test?
Yes
No
17f. Will an Infant PCR test be ordered today?
Yes
No
(If yes go to 17a,If No go to 18)
17a.If yes, is this the first time the patient has returned to the Hope Center since delivery?
Yes
No
(If yes, compelete pregnancy Close -Out form)
(Complete Infant PCR form;If Q17e is HIV Negative,Indeterminate or Result not yet available)
17e.If Yes, what was the result of the last PCR test?
HIV Positive
HIV Negative
Indeterminate
Result not yet available
(Go to 18)
Child not Alive
 
 

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19. Is the Client currently on HAART, excluding PMTCT and PEP?
Yes
No
19a. If yes, did you continue current HAART?
Yes
No
19a1. If no, did you change or stop HAART today?
Changed
Stopped
(If YES go to 19a, If No go to 19b)
(If YES go to 20 ,If No go to 19a1)
19a2. Specify why HAART was changed or stopped   (Tick all that apply)
Toxicity / Side effects
Pregnancy
Risk of pregnancy
Newly diagnosed TB
New drug available
Drug not available
Clinical treatment failure
Immunologic treatment failure
Virologic treatment failure
Poor adherence
Illness, hospitalization
Patient lacks finances
Other (specify)
(Skip to 20)
19c. Did you initiate HAART/ARV treatment at this clinic visit, excluding PMTCT and PEP?
Yes
No
19c2. If NO, specify:
Patient has not completed HAART protocol
Patient preference
Patient currently on drugs which may interact with HAART/ARV
Patient too ill to begin HAART today
Other (specify)
19b1. If ELIGIBLE for therapy then by what criteria  (tick all that apply)?
CD4 count
WHO Clinical Stage
CD4 %
Date (DD/MM/YYYY) 
/
/
1
2
3
4
Viral Load
19b. If no, is patient ELIGIBLE for therapy?
Yes
No
Not yet determined
(If Eligible go to 19b1; if NOT
eligible or NYD go to 22)
Patient on HAART/ARV in past
20. Has the patient completed HAART protocol?
Yes
No
21. What ARV medications were prescribed or continued today
AZT-3TC-EFV
AZT-3TC-NVP
AZT-3TC- LPV/rit
d4T(30mg)-3TC-EFV
d4T(30mg)-DDI-LPV/rit
d4T(30mg)-3TC-NVP
TDF-ABC -LPV/rit
TDF 3TC EFV
TDF 3TC NVP
None
Other (specify)
19c1.If yes,what was the WHO stage
1
2
3
4
(If YES go to 19c1 If No go to 19c2
 
 
 

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22a. If no, why?
Side effects/ toxicity
Stockout/drug supply interruption
Patient  preference
Other (Specify)
Dapsone
Fluconazole
Multivitamin supplement
None of the above
22. Did you initiate or continue Cotrimoxazole today?
Yes
No (If YES go to 23, If NO go to 22a)
23. Did you initiate or continue any of the following medications today (tick all that apply)?
24. Other medications prescribed during this visit
Medication
Dose (mg)
Frequency (per day)
Start date
1.
2.
3.
4.
Comments
25. What laboratory tests were ordered today (tick all that apply)
cd4
ALT
Hgb
LFT
Viral Load
Complete Blood Count
Creatinine
HIV ELISA Confirmatory test
Other (specify)
None
Chest X-ray
Widal Test
Urinalysis
For the data use only (tick after scanning the form)
  Scanned               Date ___ / ___ / _________  Name of data person
Lactic Test
 

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ADULT MEDICAL SCREENING
Interviewer number
Modified   December 2009
Version   5.0
Hope Clinic
HISTORY OF PRESENT ILLNESS
PAST MEDICAL HISTORY
1. Has the patient ever had pulmonary TB in the past?
Yes
No
Unknown
(If YES go to 1a, If NO or unknown go to 2)?
Today's date (DD.MM.YYYY) 
/
/
Date started (DD/MM/YYYY) 
/
/
Date stopped (DD/MM/YYYY) 
/
/
Never completed full treatment
Doesn't know if received full treatment
Completed Full Treatment
Site Code
Page 1
(If YES go to 1c, If NO or unknown go to 2)
1d. If YES, did the patient (tick one)?
1b. Was the patient treated
Yes
No
Unknown
1a. If YES, what was the diagnosis based on (tick all that apply)
Chest X-ray
Sypmtoms (persistent cough >2 weeks, fever, night sweats, etc)
Failure to respond to empirical antibiotics
Sputum
Other (specify)
Unknown
2. Does the patient currently have Extra pulmonary TB? 
Yes
No
1c. If YES, specify treatment
EH
RHZ
RHZE
RH
SHRZE
unknown
Other (specify)
S=streptomycine
H=Isoniazid
R=Rifampicin
Z=Pyrazinamid
E=Ethambutol
HOPE ID Number
 
 

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6. Has the patient ever had or been told he/she had a sexually transmitted infection?
Yes
No
Unknown
6a. If yes, specify (tick all that apply)
Chlamydia
Syphilis
Herpes
Chancroid
 Neisseria gonorrhea 
Trichomonas vaginalis
Other specify
Unknown
5. In the past month, has the patient experienced any of the following? (tick all that apply)
Urethral discharge
Genital sores or ulcers
Painful micturation(Dysuria)
Dysparenuia
Vaginal itching/burning
Vaginal discharge
Testicular pain or swelling
Lower Abdominal pain 
None
3.Does the Patient  have Pulmonary TB?
Yes 
No
Chest X-ray
3a. If YES, what was the diagnosis based on (tick all that apply)
Sypmtoms (persistent cough >2 weeks, fever, night sweats, etc)
Failure to respond to empirical antibiotics
Sputum
Other (specify)
Unknown
4. Is the patient currently on treatment for TB  (either PTB or EPTB)
Yes
No
Unknown
(If YES go to 4a If NO or Unknown go to 5)
4a. If yes, specify treatment start date (DD.MM.YYYY)
/
/
4c. Is the patient currently being treated for TB at coptic? 
Yes
No
(If YES go to 5, If NO go to 4d)
4d. If NO, specify where:
Private hospital
Public hospital
Other government facility
Other (specify)
(If YES go to 3a, If NO go to 4)
4b. If YES, specify treatment
EH
RHZ
RHZE
RH
SHRZE
unknown
Other (specify)
S=streptomycine
H=Isoniazid
R=Rifampicin
Z=Pyrazinamid
E=Ethambutol
 
 

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7. Does the patient currently have, or has the patient ever had, any of the following conditions (tick all that apply)
WHO stage 4
Candidiasis (Esophageal, Bronchi, Trachea, or lungs)
Cryptococcosis, Extrapulmonary
Cryptosporidosis with Diarrhea (> 1 month duration)
Herpes Simplex (mucocutaneous > 1 months, or visceral or any duration)
HIV Encephalopathy
HIV Wasting Syndrom
Kaposi's Sarcoma (KS)
Lymphoma
Atypical Mycobacteriosis, Disseminated
Tuberculosis, Extrapulmonary
Progressive Multifocal Leukoencephalopathy (PML)
Mycosis, disseminated endemic (i.e., histoplasmosis, cocciodiomycosis)
Pneumocystis Carinii Pneumonia (PCP)
Salmonella Septicemia, Non-typhoid
Toxoplasmosis, CNS
WHO stage 3
Severe Bacterial infections (i.e Pneumonia, pyomysitis )
Oral Candidiasis (Thrush)
Unexplained chronic diarrhea (> 1 month)
Unexplained Prolonged Fever (intermittent or constant, > 1 month)
Oral Hairy Leukoplakia
Tuberculosis, Pulmonary (within last 12 months from today)
Weight loss > 10% of body weight
Asymptomatic HIV infection
Herpes Zoster (within last 5 years)
Minor Mucocutaneous Manifestations
Recurrent Upper Resiratory Infections
Weight loss < 10% of Body weight
Persistent generalized lymphadenopathy (PGL)
WHO stage 1
WHO stage 2
8. What is the WHO Clinical Stage of the patient? (tick one)
1
2
3
4
 
 
 

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9b. Last Viral load
undetectable
Unknown
Not tested
Unknown
10a. If YES, specify history below
MEDICATIONS
First regimen
Second regimen
Third regimen
Other (Specify)
Truvada
TDF
LPV/
rit
NVP
EFV
AZT
DDI
ABC
3TC
d4T
First
regimen
Second
regimen
Third
regimen
Other (Specify)
CD4 count at
time of regimen
initiation
(if known)
Adherence
(1=V. poor,
2=poor, 3=Fair,
4= Good,
5=Excellent)
Date started
(DD/MM/YYYY)
Generic
Brand
Unknown
Generic
Brand
Unknown
Generic
Brand
Unknown
Unknown
Unknown
Unknown
Did patient
stop?
If yes,
Date stopped
(DD/MM/YYYY)
Yes
No
Yes
No
Yes
No
First
regimen
Second
regimen
Third
regimen
Costs
Side
effects
Failure of
therapy
New
diagnosis
TB
Drug out
of stock
Doctor
orders
Unknown
10. Has the patient ever taken or is the patient presently on HAART excluding for the purpose of PMTCT and PEP?
Yes
No
(If YES go to 10a, if NO go to 11)
9c. Last viral load date (DD.MM.YYYY) 
/
/
/
/
/
/
/
/
/
/
/
/
/
/
9. Last CD4 count
Unknown
Not  tested
Unknown
9a. Last CD4 count date (DD.MM.YYYY) 
/
/
If stopped why? (tick all that apply)
Generic or
brand
(tick one)
Medication (tick all that apply)
 
 
 

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11. Is patient taking any of the following medications? (tick all that apply)
Cotrimoxazole
Dapsone
Fluconazole
Antimalarial medications
Herbal traditional medications
Multivitamin supplements
None of the above
12. What other medications is patient currently taking?
Medication
Dose (mg)
Frequency (per day) Start date
1.
2.
3.
13. PHYSICAL EXAMINATION
Temp (F)
.
HR
BP
/
RR
Wt (Kg)
.
System (tick one)
Normal
Abnormal
Not done
Findings (if abnormal)
General
Skin
Lymph nodes
HEENT
Lungs
Cardiovascular
Abdomen
Genitourinary
Extremities
Musculoskeletal
Neurological
Psychological
Stop date
Height (cm)
Sa O2
BMI
BMI>18.5
BMI<18.5
BMI Unknown
Nurse number
14.
Gender
MALE
Female
 
 

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ASSESSMENT AND  PLAN
15. What new diagnoses does the patient have on today's visit (tick all that apply)?
(If suspected go to 17)
(If diagnosed go to 18)
(If currently on TB treatment go to 19)
(If NO TB go to 19)
(If YES, go to 17b, If NO go to 19)
Pneumonia
Dementia
Candidiasis (thrush) - oral
Ulcers - oral
Other (specify)
URTI
HSV - genital
Malaria
Soft tissue infection
Diarrhea
Dermatitis
Conjuctivitis
Side effects due to ARV
Zoster
IRIS
Chancroid
Anaemia
Hypertension
Peptic Ulcer disease
Asthma
Candidiasis (thrush) - vaginal
Ulcers genital
Syphilis
Genital Ulcer disease
Gonorrhea
Extra Pulmonary TB
None
16. What is the patients current TB diagnosis?
TB suspected
TB diagnosed today
Currently on pulmonaryTB treatment
No TB
Other(specify)
17. If TB suspected, what is the suspected TB based on (tick all that apply)?
Abnormal X-ray
Symptoms (persistent cough >2 weeks, fever, night sweats, etc)
Failure to respond to empirical antibiotics
Recent contact with people with TB
Other (specify)
17a. Will the patient be sent for TB testing?
Yes
NO
18. If TB is diagnosed today, what is it based on(tick all that apply)?
Abnormal X-ray
Symptoms (persistent cough >2 weeks, fever, night sweats, etc)
Failure to respond to empirical antibiotics
Sputum
Other (specify)
(Go to 19)
Myalgia
Neuropathy 
UTI
17b. If YES, which of the following tests will the patient be sent for:
Sent for sputum
Sent for X-ray
Other (specify)
18a. Specify treatment to be started:
EH
RHZE
RHZ
SHRZE
Other (specify)
 
 

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SECTION B: FEMALE PATIENTS ONLY
19. In the past, has the patient ever taken any antiretroviral drugs for PMTCT?
Yes
No
Unknown (If YES go to 19a, If NO or Unknown go to 20)
19a. If YES, how many times did the patient take PMTCT?
19b. Specify history for each pregnancy in which the patient had PMTCT, beginning with the youngest child:
Date of delivery (DD/MM/YYYY)
Regimen
Location of
delivery
Mode of delivery
1.
2.
AZT
Hospital
Home
Other (specify)
Hospital
Home
Other (specify)
C-section
Unassisted vaginal
Assisted vaginal 
C-section
Unassisted vaginal
Assisted vaginal 
/
/
/
/
(use of forceps or
vacuum)
(use of forceps or vacuum)
Antepartum
Labor & Delivery
Postpartum
Specify when the
drug was taken
(Tick all that apply
3TC
Antepartum
Labor & Delivery
Postpartum
NVP
Antepartum
Labor & Delivery
Postpartum
HAART
Antepartum
Labor & Delivery
Postpartum
Other (Specify)
Antepartum
Labor & Delivery
Postpartum
AZT
3TC
NVP
HAART
Other (Specify)
Antepartum
Labor & Delivery
Postpartum
Antepartum
Labor & Delivery
Postpartum
Antepartum
Labor & Delivery
Postpartum
Antepartum
Labor & Delivery
Postpartum
Antepartum
Labor & Delivery
Postpartum
Unknown
Unknown
 
 
 

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Date of delivery (DD/MM/YYYY)
Regimen
Location of
delivery
Mode of delivery
3.
4.
Hospital
Home
Other (specify)
Hospital
Home
Other (specify)
C-section
Unassisted vaginal
Assisted vaginal 
C-section
Unassisted vaginal
Assisted vaginal 
/
/
/
/
(use of forceps or vacuum)
(use of forceps or vacuum)
Specify when
the drug was
taken (Tick all
that apply
AZT
3TC
NVP
HAART
Other (Specify)
Antepartum
Labor & Delivery
Postpartum
Antepartum
Labor & Delivery
Postpartum
Antepartum
Labor & Delivery
Postpartum
Antepartum
Labor & Delivery
Postpartum
Antepartum
Labor & Delivery
Postpartum
AZT
3TC
NVP
HAART
Other (Specify)
Antepartum
Labor & Delivery
Postpartum
Antepartum
Labor & Delivery
Postpartum
Antepartum
Labor & Delivery
Postpartum
Antepartum
Labor & Delivery
Postpartum
Antepartum
Labor & Delivery
Postpartum
Unknown
Unknown
 
 

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22b. If NO, is patient ELIGIBLE for therapy?
Yes
No
Not  yet  determined
22b1. If ELIGIBLE for therapy then by what criteria (tick all that apply)?
CD4 count
WHO Clinical Stage
Date (DD/MM/YYYY)
/
/
(If Eligible=NO or NYD >>24)
1
2
3
4
Viral Load
copies
(If YES, go to 22a, If NO go to 22b)
(If YES, go to 23, If NO go to 22a1)
(Go To 23)
Patient on HAART/ARV in past
(If YES go to 23, If NO go to 22c1)
22. Is the patient currently on HAART, excluding PMTCT and PEP?
Yes
No
22a. If yes, did you continue current HAART today?
Yes
No
22a1. If no, did you change or stop HAART today?
Changed
Stopped
22a2. Specify why HAART was changed or stopped (Tick all that apply) :
Toxicity / Side effects
Pregnancy
Risk of pregnancy
Newly diagnosed TB
New drug available
Drug not available
Clinical treatment failure
Immunologic treatment failure
Virologic treatment failure
Poor adherence
Planned treatment interruption
Illness, hospitalization
Patient lacks finances
Other (specify)
22c. Did you initiate HAART/ARV treatment at this clinic visit, excluding PMTCT and PEP?
Yes
No
22c1. If NO, specify:
Patient has not completed HAART protocol
Patient preference
Patient currently on drugs which may interact with HAART/ARV
Patient too ill to begin HAART today
Patient pregnant
Other (specify)
21b. If YES, has she had a sesson with the nutritionist since she started breastfeeding.
Yes
No (If NO refer to Nutritionist)
23. What ARV medications were prescribed or continued today
AZT-3TC-EFV
AZT-3TC-NVP
AZT-3TC- LPV/rit
d4T(30mg)-3TC-EFV
d4T(30mg)-DDL-LPV/rit
d4T(30mg)-3TC-NVP
TDF-ABC -LPV/rit
TDF 3TC EFV
TDF 3TC NVP
None
Other (specify)
21a. If yes, specify what type of breastfeeding (tick one)
Exclusive breastfeeding
Mixed feeding
(Child given ONLY mother's milk and NO water, tea, formula, cow's milk or food of any kind)
(Child given mother's milk and water, tea formula, cow's milk or food)
20. Is the patient currently pregnant?
Yes
No
Unknown (If YES also complete Pregnancy Monitoring Form)
21. Is the patient currently breastfeeding?
Yes
No (If YES go to 21a, if NO go to 22)
 
 
 
 

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26. Other medications prescribed during this visit
For the data use only (tick after scanning the form)
  Scanned               Date ___ / ___ / _________  Name of data person
Medication
Dose (mg)
Frequency (per day)
Start date
1.
2.
3.
Stop date
4.
5.
Additional Comments
27. What laboratory tests were ordered today (tick all that apply)
cd4
ALT
Hgb
LFT
Viral Load
Complete Blood Count
Creatinine
HIV ELISA Confirmatory test
Other (specify)
None
Chest X-ray
Widal Test
Urinalysis
Lactic Test
24. Did you initiate or continue Cotrimoxalzole today?
Yes
No (If yes go to 25, if no go to 24a)
24a. If no, why?
Side effects/ toxicity
Stockout/drug supply interruption
Patient preference
Other (Specify)
Dapsone
Fluconazole
Multivitamin supplement
None of the above
25. Did you initiate or continue any of the following medications today (tick all that apply)?
 

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VERBAL AUTOPSY FORM
Interviewer number
Today's Date (DD.MM.YYYY)
/
/
Site Code
Page 1
1. Gender
Female
Male
2. Age at death
Years
4. The information source for the cause of death was (Tick all that apply)
Partner/Spouse
Hospital records/Staff
Neighbour
Mother or Father
Other family member/relative
Unknown
Friend
Caregiver
Other (Specify)
5. Was the deceased seeking other medical treatment (other than Hope Center) during that last 3 months before his/her death?
Yes
No
Unknown
(If YES go to 5a, If NO go to 6)
5a. If YES, where specifically was the deceased receiving other medical care?
5b. What type of care was the deceased receiving at these other facilities? (Tick all that apply)
General medical care
HIV/AIDS
TB
Malaria
STD
Other infectious disease(s)
Other (Specify)
Name of facility: 
6. Respondent's detailed account of the illness of the deceased:
7. Did a health care worker tell you the cause of death?
Yes
No
Unknown
(If YES go to 7a, If NO go to 8)
3. Date of death (DD/MM/YYYY)
/
/
Modified   December , 2009
Version   5.0
Coptic Hope Clinic
HOPE ID Number
 
 

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8. Did s/he have any operation for the illness?
Yes
No
Unknown
(If YES go to 8a, If NO go to 9)
8a.How long before the death was the operation? :
Months
8b. On what part of the body was the operation?
Abdomen
Chest
Head
Other(specify)
9. Has the deceased's spouse or partner died in the past in the past 5 years?
Yes
No
Unknown
Had no spouse
9a. If YES, what is the percieved cause(s) of death of the partner(s)
9a1. Partner 1:
9a2. Partner 2:
Injury/accident/suicide
10. Did s/he suffer from any injury or accident that led to her/his death?
Yes
No
Unknown
(If YES go to 10a, If NO go to 11)
10a. What kind of injury or accident did the deceased suffer?
Road traffic accident
Burns
Unknown
Fall
Violence/assault
Drowning
Poisoning
Other:
10b. Was the injury or accident intentionally inflicted by someone else?
Yes
No
Unknown
10c. Do you think that s/he committed suicide?
Yes
No
Unknown
7a. What did the health care worker say was the cause of death?
(If YES go to 9a, If NO go to 10)
 
 

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Page 3
History of previously known conditions
11. Did the deceased suffer from any of the following conditions?
Yes
No
Unknown
Yes
No
Unknown
Yes
No
Unknown
Yes
No
Unknown
a. High blood pressure
b.Diabetes
c. Asthma
d. Epilepsy
e. Malnutrition
f. Cancer
Yes
No
Unknown
Yes
No
Unknown
g. Tuberculosis
Yes
No
Unknown
f1. If YES, specify type or site
h. Any other medically diagnosed illness?
Yes
No
Unknown
h1. If YES, specify 
 
 
 

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12. Signs, symptoms and their severity during the last illness:
Symptom
If present, duration of symptom
Symptom present?
a. Fever
b. Loss of weight
c. Diarrhea
d. Vomiting/associated abdominal pain
e. Constipation/associate abdominal pain
f. Cough
g. Cough followed by vomiting
h. Breathing trouble (chest indrawing/difficult
/rapid/wheezing)
i. Neck stiffness
j. Unconscious episodes
k. Fits
l. Jerking of individual limbs
m. History of epileptic illness in earlier years
n. Paralysis of limbs
o. Rigid body stiffness, unable to open mouth
p. Red and sore eyes
q. Skin rash and itching
r. Herpes zoster (at any time in life)
s. Abscesses/body sores
t. White patches on the inside of mouth and
tongue
Yes
No
unknown
=<2 weeks
>2 weeks
Unknown
=<2 weeks
>2 weeks
Unknown
=<2 weeks
>2 weeks
Unknown
=<2 weeks
>2 weeks
Unknown
=<2 weeks
>2 weeks
Unknown
=<2 weeks
>2 weeks
Unknown
=<2 weeks
>2 weeks
Unknown
=<2 weeks
>2 weeks
Unknown
u. Oedema
v. Hair changes
w. Yellowing of eyes or passing of brown urine
x. Chest pain
y. Other (specify)
Yes
No
Unknown
Yes
No
Unknown
Yes
No
Unknown
Yes
No
Unknown
Yes
No
Unknown
Yes
No
Unknown
Yes
No
Unknown
Yes
No
Unknown
Yes
No
Unknown
Yes
No
Unknown
Yes
No
Unknown
Yes
No
Unknown
Yes
No
Unknown
Yes
No
Unknown
Yes
No
Unknown
Yes
No
Unknown
Yes
No
Unknown
Yes
No
Unknown
Yes
No
Unknown
Yes
No
Unknown
Yes
No
Unknown
Yes
No
Unknown
Yes
No
Unknown
Yes
No
Unknown
=<2 weeks
>2 weeks
Unknown
=<2 weeks
>2 weeks
Unknown
=<2 weeks
>2 weeks
Unknown
=<2 weeks
>2 weeks
Unknown
=<2 weeks
>2 weeks
Unknown
=<2 weeks
>2 weeks
Unknown
=<2 weeks
>2 weeks
Unknown
=<2 weeks
>2 weeks
Unknown
=<2 weeks
>2 weeks
Unknown
=<2 weeks
>2 weeks
Unknown
=<2 weeks
>2 weeks
Unknown
=<2 weeks
>2 weeks
Unknown
=<2 weeks
>2 weeks
Unknown
=<2 weeks
>2 weeks
Unknown
=<2 weeks
>2 weeks
Unknown
=<2 weeks
>2 weeks
Unknown
=<2 weeks
>2 weeks
Unknown
 
 
 
 

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For the data use only (tick after scanning the form)
  Scanned               Date ___ / ___ / _________  Name of data person
14. Records available in home e.g. death certificate (extract findings):
z. unexpected vaginal bleeding or discharge
aa.Pelvic or vaginal pain
Yes
No
Unknown
Yes
No
Unknown
Women only:
Comments (if the form is incomplete or any other comments)
=<2 weeks
>2 weeks
Unknown
=<2 weeks
>2 weeks
Unknown
 

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ADULT NURSING SCREENING
Interviewer number
Today's date (DD.MM.YYYY)
/
/
Site Code
Section A: All Patients
Hope VCT 
Other VCT
PMTCT
CCC Clinic or HIV Clinic
Hope TB clinic
Other TB clinic
Self-referral
Child welfare Clinic
Family member, spouse or friend
Other patients
NGO
Coptic ward
Other hospital ward (specify)
Coptic Pharmacy
Private doctor
Other (specify)
1. Who referred patient here? (tick one)
2. Does the client have a NASCOP referral number? 
Yes
No
(If YES go to 2a, If NO go to 3)
2a. If Yes, specify the client's NASCOP referral number with date
NASCOP Referral Number
NASCOP referral number unknown
3. Has client ever been  on antiretroviral drugs, excluding for PMTCT and PEP? 
Yes
No
3a. If YES, where did the client receive antiretroviral drugs ?
CCC Clinic or HIV Clinic
Private Doctor
Hospital ward
NGO
Other (specify)
3b. What is the reason for transfer of care (tick all that apply)
Financial
Client's preference
Distance to clinic
Doctors advice
Poor management
Client was asked to leave
Facility unable to provide long term care
Other (specify)
(If YES go to 3a, If NO go to 4)
Modified   December 2009                                                              Hope Clinic                                                      Version   5.0
Page 1
Refferal Date (DD/MM/YYYY)
/
/
HOPE ID Number
4. In the past, has the patient ever taken any antiretroviral drugs for PMTCT?
Yes
No
Unknown
N/A,Male Client
4a. If YES, how many times did the patient take PMTCT?
 
 

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5. Has the patient been tested for HIV? 
Yes
No
(If Yes go to 5a, If NO  go to 6)
5a. If yes, where was the test performed? (Tick one)
PITC  (ProviderInitiated HIV Testing and Counseling)
VCT
PMTCT
Postnatal Clinic
CWC(Child welfare Clinic)
TB clinic
Other (Specify)
(If PITC, go to 5ai, else  go to 5b)
5ai. Where was the PITC done ? 
Coptic Hospital-Outpatient
Hope TB clinic
Hope Home-base care program
Muangalizi Program
Coptic Hospital-inpatient
Private Hospital
Public Hospital
Other(specify)
5c. What were the test results?
Positive
Negative
Unknown
5b. When was the test done (DD/MM/YYYY)
/
/
6. Has the patient been hospitalized in the last 1 year? 
Yes
No
6a. If yes, how many times? 
Yes
No
Dont Know
Yes
No
Dont Know
Yes
No
Dont Know
9a. If yes, please specify 
(Medical and non-medical allegies)
(If Patient ticked any "YES" in Q7, 8 or 9 highlight allergy in chart)
7. Does patient have Penicillin allergy?
8. Does patient have Sulfa allergy?
9. Does the patient have any other
 
 

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13. Is the patient or partner using any form of family planning?
Yes
No
Section B: Female  patients only [If Male go to 12]
10. How many times has the patient been pregnant? 
11. How many children has patient given birth to? 
12a) What is the age of the first child? Years
12b) What is the age of the last child? Years
Month
Month
IF = 0 go to 13
12. How many of the children the patient has given birth to are alive? 
IF = 0 go to 13
IF = 0 go to 13
13a. If YES (tick all that apply)
Condoms
Intrauterine device
Oral contraceptive pills
Injectable/implantable hormones
Diaphram/Cervical cap
Vastectomy/tubal ligation/hysterectomy
Natural method (specify)
Other (specify)
Other Comments
 Scanned               Date ___ / ___ / __  Name of data person
Weeks
Weeks
 

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1. Anthropometric Assessment
Weight 
.
Height 
 
Kgs
cm
Hip Circ.
cm
Waist circ.
cm
Waist:Hip ratio
.
cm
BMI
.
2. Medical
NUTRITION FOLLOW - UP
Interviewer number
Modified   December 2009
Hope Clinic
Version   5.0
Medication
Time
with food?
Time
with food?
Time
with food?
MUAC
.
cm
Today's date (DD.MM.YYYY)
/
/
4. Is the client on food supplement?
Yes
NO
3. Is the client currently on multivitamins?
Yes
NO
3a. If yes, did you continue the multivitamins today?
Yes
NO
4a. If yes, which type of food supplement?
First Food
Advantaged
Foundation
Other (specify)
4b. If yes, what is the qualifying criteria
BMI < 18.5
Pregnant
Breastfeeding mother
Other (specify)
Site Code
5. Is the client initiating food supplements today?
Yes
No
5a. If yes, why?
BMI < 18.5
Pregnant
Breastfeeding mother
Other (specify)
6. Is the client exiting food supplement today?
Yes
No
(If YES go to 3a, If NO go to 4)
(If YES go to 4a, If NO go to 5)
(If YES go to 6a, If NO go to 7)
6a. If yes, Why?
BMI >20
Defaulter
Dead
No longer breast feeeding
Non recoveries
Recovered
Transfer
Other (specify)
(If YES go to 5a, If NO go to 6)
5b. If yes, which type of food supplement?
First Food
Advantaged
Foundation
Other (specify)
HOPE ID Number
5c. If yes, has the patient been on food supplement before?
Yes
No
Page 1
 
 
 

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8. Assessment and Recommendations
7.How would you Classify today's case?
Severe Cases
Moderate/Mild Cases
For the data use only (tick after scanning the form)
  Scanned               Date ___ / ___ / _________  Name of data person
(Q7. applies to those initiated/or already  on food supplement )
 

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1. Anthropometric Assessment
Height 
cm
Hip Circ.
cm
2. Medical
Waist circ.
cm
Waist:Hip ratio
.
cm
BMI
.
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
Medications?
Yes
No
No
Yes
No
Yes
No
Yes
No
Yes
Nausea
Diarrhoea
Weight loss greater than  10%
Poor appetite
Swallow difficulty
Constipation
Vomiting
Chewing/teeth problem
Taste changes
NUTRITION   SCREENING
Interviewer number
(specify)
Weight 
.
Kgs
MUAC  
.
cm
Other medical conditions
No
Yes
If patient has other medical conditions, specify
1
2
3
4
Today's date (DD.MM.YYYY)
/
/
Medication
Time
with food?
Time
with food?
Time
with food?
Page 1
3. Social History
Permanent housing
No
Yes
Adequate food resoures
No
Yes
Adequate cooking facilities
No
Yes
Activity/excercise
No
Yes
Smoking
No
Yes
Alcohol
No
Yes
Drugs
No
Yes
Site Code
4. Dietary History
4a. Number of meals or snacks per day
4b. Times per week eat out
specify
specify
specify
HOPE ID Number
Version   5.0
Modified   December 2009
Hope Clinic
 
 

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5. Is the client currently on multivitamins?
Yes
NO
5a. If YES, did you continue the multivitamins today?
Yes
NO
6. Is the client on food supplement?
Yes
NO
6a. If YES, which type of food supplement?
First Food
Advantaged
Foundation
Other (specify)
6b. If YES, what is the qualifying criteria
BMI < 18.5
Pregnant
Breastfeeding mother
Other (specify)
4d. Special or alternative diets
No
Yes
4e. Food intolerances or allergies
No
Yes
No
Yes
4f. Food likes
No
Yes
4g. Food dislikes
specify
specify
specify
specify
4c. Who prepares food?
Spouse
Self
Relative
Caregiver
Other (specify)
Neighbour
Child/children
(If YES go to 5a, If NO go to 6)
(If YES go to 6a, If NO go to 7)
8. Is the client initiating food supplements today?
Yes
No (If YES go to 8a, If NO go to 10)
8b. If YES, which type of food supplement is client initiating today?
First food
Advantaged
Foundation
Other (specify)
8a. If yes, why?
BMI < 18.5
Pregnant
Breastfeeding mother
Other (specify)
8c. If yes, has the patient been on food supplement before?
Yes
No
9.How would you Classify today's case?
Severe Cases
Moderate/Mild Cases
(Q9. applies to those initiated/or already  on food supplement )
10. Assessment and Recommendations
For the data use only (tick after scanning the form)
  Scanned               Date ___ / ___ / _________  Name of data person
7. 24 hour recall /usual diet
B/Fast
M. Morning
Lunch
M. Afternoon
Dinner
 

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SOCIAL WORK SCREENING
Interviewer number
Today's date (DD/MM/YYYY)
/
/
Site Code
Page 1
Client's Residential and Telephone Contact Information
1. Public Transport to the House:
Ia. Type
Bus
Citi Hoppa
Matatu
Taxi
Other(specify)
Ib. Number
Ic. Stage Name
Id. General name of the area
2. Walking directions to house from the stage?
3. Landmarks that aid  in locating the household: (Names of schools, Churches, businesses etc.)
4. How is the client called or referred to in the home area:
4a. How is the caregiver called or referred to in the home area:
N/A
IIa. Type
Bus
Citi Hoppa
Matatu
Taxi
Other(specify)
IIb. Number
IIc. Stage Name
IId. General name of the area
Second trip
First trip
Modified   December 2009
Hope Center Clinic
Version   5.0
HOPE ID Number
 
 

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5. Does the patient have a treatment supporter?
Yes
No (If yes, go to 5a, if no go to 6)
5a. Treatment supporter name(Last, First, Middle)
5d. Treatment supporter number  (Cell) 
.
5e. Treatment supporter number  (Landline) 
.
6. Upcountry name for the client?
N/A
6a. Upcountry contact home address?
N/A
6b. Upcountry contact postal address?
N/A
6c. Upcountry contact phone number (Cell) 
.
6d. Upcountry contact phone number (Landline) 
.
N/A
N/A
7. During the last year from today,have you been hit, slapped, Kicked, or hurt by someone?
Yes
No
Refused to answer
7a. If yes Who?
Spouse
Casual Partner
Parent
Steady Partner
Sibling
Other(specify)
5b. Treatment supporter home address
5c. Treatment supporter postal address (P.O Box)
 
 

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8. During the last year from today,have you ever hit, slapped, Kicked, or hurt someone?
Yes
No
Refused to answer
8a. If yes Who?
Spouse
Casual Partner
Parent
Steady Partner
Sibling
Other(specify)
9. In the past 12 months have you:
9a1. Smoked?
Yes
No
Refused to answer
9a2. If yes, number of cigarretes per day
9c1. Smoked marijuana ?
Yes
No
Refused to answer
9c2. If yes, number of times per month
9d1. Used cocaine?
Yes
No
Refused to answer
9d2. If yes, number of times per month
9d3. If yes, how?
Sniff
smoke
Inject
Other (specify)
9e1. Used intravenous drugs?
Yes
No
Refused to answer
9e2. If yes, number of times per month
9e3. If yes, do you share needles?
yes
No
Refused to answer
9b1. Chewed Miraa
Yes
No
Refused to answer
9b2. If yes, number of times per month
 
 

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10a. If yes, number of drinks per week
10b. In the last month, how often did you get drunk?
Never
Daily
Weekly
1-3 times a month
11. Can you use a condom during sex after you have been drinking or taking drugs?
Yes
No
Do not drink or use drugs
Refused to answer
10c.In the last month, have you experienced any of the following after drinking alcohol?
Gotten in to a fight
Had accident/ Injured
Been arrested
Been raped(sex was forced on you)
Sexually assaulted someone
No
Yes
Refused to answer
No
Yes
Refused to answer
No
Yes
Refused to answer
No
Yes
Refused to answer
No
Yes
Refused to answer
12. What is your Current Marital Status (tick one)
Married (monogamous)
Married (Polygamous)
Cohabiting(come we stay)
Divorced
Separated
Widowed
Single
13. What is your occupation?
Unemployed
Employed
Self-employed
Housewife
Causal labourer
Student
14. Housing roof type?
Corrugated iron sheet
Tiles
Concrete
Grass
Makuti
Asbestos
Tin
Other (specify)
10. Do you drink alcohol?
Yes
No
 
 

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15.How many adults live in the home?
16. How many children live in the home?
17. How much do you or your spouse earn in one month? (Ksh)
0 - 2,000 Ksh
2,001 - 5000 Ksh
5,001 - 10,000 Ksh
10,001 - 20,000 Ksh
20,001 - 30,000 Ksh
30,001 - 50,000 Ksh
> 50,001 Ksh
Refused to answer
18. What is your highest level of education?(Tick one)
No education
Lower primary education (< 5years education)
Five to eight years of primary education
Some secondary education
Beyond secondary education
Hours
Minutes
19. How long does it take for you to travel to the clinic from home one way (Hrs/ Minutes)
20.Do you have piped water in your home?
Yes
No
21. Do you have electricity at home?
Yes
No
22. What is your main source of cooking at home?
Electricity
Paraffin
Firewood
Solar Energy
Other (Specify)
23. Social worker, does the client require home assessment
Yes
No
Physically or mentally disabled adult
Adult dependent on care-giver
Client requests a home visit
Disclosure (patient would like help disclosing status to family members)
Family testing (patient would like other family members to be tested)
23a. If YES, why?
Other (specify)
For the data use only (tick after scanning the form)
  Scanned               Date ___ / ___ / _________  Name of data person
 

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ADULT TRACING AND HOME CARE FOLLOW-UP FORM
Interviewer number
Today's Date (DD.MM.YYYY)
/
/
Site Code
Modified   December 2009                                 Hope Clinic                                                              Version   5.0
1a. This visit is taking place at the client's
Place of residence
Place of work or school
Central market, shop or other public meeting place
Hospital due to client's admission
1. What is the reason for today's follow-up visit, as specified by previous visit (Check all that apply)
REASONS FOR FOLLOW-UP VISIT
Clinic attendance and/or ART adherence monitoring
Follow-up on physical health, HBC or first aid
Follow-up on psyco-social issue or refferal made(specify refferal)
Monitoring consistency of caregiver
Homebased counseling for patient or caregiver/household members 
Patient
Counseling for the Caregiver/Household
ART and Adherence
Management of side effects
Disclosure
General counseling
Hygiene
Client basic care
Nutrition
HIV prevention
Other (specify)
Care and support for PLWHA
General HIV: Prevention, Transmission and management
knowing HIV status: Testing and care options
Management of side effects for client needs
ART and Adherence
Disclosure
General counseling
Hygiene
Nutrition
PMTCT and Family Planning
Other (specify)
(Specify all that apply):
HOPE ID Number
Counseling
Social work
Clinic
Pharmacy
PMTCT Client
Lost to folow up client
Hospital Admission
Page 1
 
 
 

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ADULT TRACING AND HOME CARE FOLLOW-UP FORM
PHYSICAL HEALTH MONITORING
Stable and self dependent
2. During this visit how would you describe the client's physical condition/health?
Sought medical attention for health complaints from previous visit
Did not seek medical attention for health complaints from previous visit
Presenting new health complaints at this visit
(Specify outcome)
(Specify outcome)
(Specify in question 3)
Condition improving
No change
Condition worsening
Condition improving
No change
Condition worsening
3. Current symptoms or complaints assessed during this visit:
None
Minor Health Complaints
Severe Health Complaints
Low grade fever (below 38)
Headaches
Fatigue
Nausea and or occasinal vomiting
Mild diarrhea (occasinal and loose stool)
Abdominal pain
Cough
Fat changes
Bedridden/immobile
Severe coughing (2 weeks or more) with difficulty breathing
Severe Burning/tingling in extremities
Poor feeding
Severe Diarrhea (frequent and watery)
Severe vomiting
Burning tingling in extremities
Skin rush
Persistent or high grade fever (above 39)
Jaundice
Sores or skin lesions
Mental confusion/Dementia
4. How many meals does the client eat per day?
One
Two
Three
More than three
None
Immobile
Other (specify)
Other (specify)
 
 

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ADULT TRACING AND HOME CARE FOLLOW-UP FORM
CAREGIVER/HOUSEHOLD MONITORING
5. Has the caregiver changed since the last visit?
Yes
No
5a. If YES, specify reason
No longer able or willing to care for the patient
Found more suitable long term caregiver
Patient refused care from this person
Patient's condition no longer requires the need of a caregiver
Patient's condition now requires the help of a caregiver
Other (Specify)
(If NO, go to Q6)
5b. If YES, who is the new caregiver?
Self (No caregiver needed)
Parent
Spouse
Relative
Neighbour
Friend
Social worker/Institution
Other (Specify)
5c. If YES, is the new caregiver aware of the clients HIV status?
Yes
No
6. At this visit are there areas of counseling or education which are needed in the household? (Tick all that apply)
Patient
Counselling for the Caregiver/Household
ART and Adherence
Management of side effects
Disclosure
General counselling
Hygiene
Client basic care
Nutrition
HIV prevention
Care and support for PLWHA
General HIV: Prevention, Transmission and management
Management of side effects for client needs
ART and Adherence
Disclosure
General counseling
Hygiene
Nutrition
PMTCT and Family Planning
Knowing HIV status: Testing and care options
Other (specify)
Other (specify)
Opportunistic Infections and STIs
Opportunistic Infections and STIs
 
 

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ADULT TRACING AND HOME CARE FOLLOW-UP FORM
PSYCO-SOCIAL MONITORING
7. Was referral made at the previous visit?
Yes
No (If NO go to Q8)
7a. If YES, specify
Domestic violence
Drug or Alcohol abuse
Sexual violence
Food Insecurity
Legal aid
Other (Specify)
7b. If YES did the client seek referral services?
Yes
No
Transportation costs
Client refused to go
Client went but was turned away
Forgot or lost referral slip
Other (specify)
8. Have there been any noticeable changes from the last visit in the psycho-social issues that were identified?
No noticeable change
Improvement
Issues are worsening
Cannot assess
9. During this visit were there any concerns in the household regarding any of the following? (Tick all that apply)
Physical abuse
Sexual abuse
Emotional abuse
Alcohol abuse
Drug abuse
Potential to self-inflict harm
Depression
Stigma and isolation
Food insecurity
Neglect by caregiver
NO CONCERNS
Client Reported
Client Reported
Staff Assessed
Household Reported
Staff Assessed
Staff Assessed
Staff Assessed
Staff Assessed
Staff Assessed
Staff Assessed
Staff Assessed
Staff Assessed
Staff Assessed
Staff Assessed
Client Reported
Client Reported
Client Reported
Client Reported
Client Reported
Client Reported
Client Reported
Client Reported
Client Reported
Household Reported
Household Reported
Household Reported
Household Reported
Household Reported
Household Reported
Household Reported
Household Reported
Household Reported
Household Reported
 
 
 

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ADULT TRACING AND HOME CARE FOLLOW-UP FORM
CLINIC ATTENDENCE AND ADHERENCE MONITORING
10. Is the client on ARVs?
Yes
No
11. Since the last visit has the client refilled their prescription?
Yes
No (If YES go to Q 12)
11a. If NO specify reason:
Client was not due for a refill since the last home visit
Unable to get to clinic due to transport costs
Unable to get to the clinic due to illness or weakness
Lacked someone to assist to clinic
Forgot
Refused to go
Other (specify)
Travelled
12. Since the last visit, has the client missed any doses?
One
Two
Three
More than three
None
12a. If doses were missed specify reason:
Refused to take medications
Doses were administered by caregiver who did not give
Ran out of medication and could not refill prescription
Was stopped by physician
Forgot
Side effects
Other (specify)
Felt too ill or too weak to take
Medications lost or stolen
13. Is the client/caregiver able to recall critical information related to thier ARV regime?
Drug names
Doses
Times taken
Side effects
Food related indications
All
All
All
All
All
Some
Some
Some
Some
Some
None
None
None
None
None
14. Client adherence since the last visit has
No change
Improved
Worsened
Refer to clinician for review
Sharing medications with others
Felt better and decided to stop
Stigma,disclosure or privacy issues
Drug or alcohol use affecting adherence
 
 
 

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ADULT TRACING AND HOME CARE FOLLOW-UP FORM
15a. If NO, Specify
Too ill to come
Forgot
Lost appointment card
Stigma within the household related to disclosure or privacy
Could not afford transport
Alcohol or drug use affected ability to come
Depression
Refused to come or continue with program
Need assistance from care-giver and none was available
Was seen at another clinic
Other (specify)
15. Since the last visit, has the client attended all their scheduled clinic visits?
Yes
No
Not due for visit
FOLLOW - UP PLAN
16. Is the client eligible for discharge from the tracer and home care services
Yes
No
16a. If NO, Next visit scheduled for:
One week
Two weeks
One month
Two months
16b. What actions will be taken as follow-up to this visit?
Follow-up counseling in the home for client or caregiver/household
Follow-up on physical health
Adherence monitoring
Follow-up and monitoring of social conditions and actions previously taken
Organization referral or accompaniment
Refferal for household member for site based VCT services
Accompany client to clinic
Counselor assisted disclosure
Home based VCT for household member
Alert authorities for further investigation of neglect, sexual or domestic violence
Refferal for suspected TB of client or household member
Specify date of next visit((DD/MM/YYYY)
/
/
PMTCT
Organise Hospital ambulatory services for immediate and urgent medical needs
HIV positive Family /Household member for  HIV/AIDS management
Work
Traveled
No Action
 
 

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17. During this visit, was an appointment booked for the client at the clinic?
Yes
No
If YES, specify the appointment type:
Doctor
Counselor
Pharmacy
Social worker
Nutritionist
For the data use only (tick after scanning the form)
  Scanned               Date ___ / ___ / _________  Name of data person
ADULT TRACING AND HOME CARE FOLLOW-UP FORM
Comments
If YES, Specify date of next appointment((DD/MM/YYYY))
/
/
 

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ADULT TRACING AND HOME CARE SCREENING FORM
Interviewer number
Today's Date (DD.MM.YYYY)
/
/
Site Code
1. The reason for this client to be monitored trhough the tracer and Home Care program is
Adult on ARVs not adhering to medications or clinc appointments
Adult dependent on care-giver
Post-partum mother
Staff reffered for other reason: (Specify)
1a. This visit is taking place at the client's
Place of residence
Place of work or school
Central market, shop or other public meeting place
Hospital due to client's admission
PHYSICAL HEALTH ASSESSMENT
2. At this initial screening in what physical condition did you find the client?
Stable , mobile and able to take care of self
Weak but mobile and able to take care of self
Immobile or needs assistance to walk or move, reliant on caregiver
2a. Current symptoms or complaints assessed during this visit:
Skip to Question 4 if the residence is an institution/organisation
None
Minor Health Complaints
Severe Health Complaints
Low grade fever (below 38)
Headaches
Fatigue
Nausea and or occasional vomiting
Mild diarrhea (occasional and loose stool)
Abdominal pain
Cough
Fat changes
Bedridden/immobile
Severe coughing (2 weeks or more) with difficulty breathing
Servere Burning/tingling in extremities
Poor feeding
Severe Diarrhea (frequent and watery)
Severe vomiting
Burning tingling in extremities
Skin rash
Persistent or high grade fever (above 39)
Jaundice
Sores or skin lesions
Mental confusion/Dementia
Other(specify)
Modified   December 2009                                   Hope Clinic                                                                    Version  5.0
Page 1
HOPE ID Number
Lost to folow up client
 
 

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3a. Who is the head of the household
Patient (Self)
Patient's mother
Both parents
Patient's sibling (Specify age)
Patient's relative (Aunt, Uncle, grandparent, cousin)
Patient's Father
Neighbour
Friend
Other (Specify)
years
HOUSEHOLD ASSESSMENT
3. Describe the type of residence this is:
Private residential home
Institution/organization (specify name):
( Skip to Question 4 if the residence is an institution/organisation)
3b. How many individuals living in the household?
3b1. Adults (Age 15 and over) :
3b2. Children (Age 14 and below) :
3c. Number or rooms in the house:
One
Two
Three
More than three
3d. Does the house have electricity?
Yes
No
3e. What is the household's water source?
Piped to the house
Water tank and piping to the house
Communal water tap within the vicinity
Communal water tank within the vicinity
Water from river, pool or open water source
No water source in the vicinity
3f. What is the household's sanitation system?
Own flash toilet in the house
Private pit latrine
Shared toilet in vicinity of house
Shared pit latrine in vicinity of house
None
3g. What is the source of Energy for cooking?
Gas
Wood
Charcoal
Paraffin
Electricity
None
4. Does the patient have any special needs?
Yes
No
Unknown
Page 2
 
 
 

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4a. If YES specify:
Advanced illness
Physically handicapped or disabled
Mentally handicapped or disabled
Emotionally/psychologically unstable or unwell
Other(specify)
4b1. If YES specify
Spouse
Partner
Parent
Relative
Friend
Neighbour
Social worker/local community health worker
Other(specify)
4b. If YES does the client currently have a caregiver?
Yes
No
Unknown
5. Is the client living in an environment where hygiene is neglected?
Yes
No
5a. If YES specify:
Foul smell in the room where the client is staying
Client is sleeping in soiled beddings
Client has not had a bath for more than 2 days
Other(Specify)
6. How many meals is the client eating per day?
One
Two
Three
More than three
None
7. Does the client have access to food?
Always
Sometimes
Never
NO CONCERNS
Page 3
4a. If YES specify:
 
 
 

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8. Are there there any concerns in the household regarding any of the following? (Tick all that apply)
Physical abuse
Sexual abuse
Emotional abuse
Alcohol abuse
Drug abuse
Potential of self-inflict harm
Depression
Stigma and isolation
Food insecurity
Neglect by caregiver
NO CONCERNS
Client Reported
Client Reported
Staff Assessed
Household Reported
Staff Assessed
Staff Assessed
Staff Assessed
Staff Assessed
Staff Assessed
Staff Assessed
Staff Assessed
Staff Assessed
Staff Assessed
Staff Assessed
Client Reported
Client Reported
Client Reported
Client Reported
Client Reported
Client Reported
Client Reported
Client Reported
Client Reported
Household Reported
Household Reported
Household Reported
Household Reported
Household Reported
Household Reported
Household Reported
Household Reported
Household Reported
Household Reported
9. Is the client aware of his or her status?
Yes
No
Unknown
9a. If NO, is the caregiver willing to begin the disclosure process with the patient?
Yes
No
Unknown
COUNSELLING AND DISCLOSURE ASSESSMENT
10. If the client has a caregiver, is the current caregiver aware of the patient's status?
Yes
No
Unknown
There is no caregiver
11. Are other household members aware of the client's status?
All
Some
None
11a. If NO, is the patient/caregiver willing to begin the disclosure process with other household members?
Yes
No
10a. If NO, is the patient willing to begin the disclosure process with the caregiver?
Yes
No
Unknown
12. Is there a need for HIV counseling and testing of other household members? (Tick all that apply)
Mother
Father
Siblings
Other household members of unknown status in need of testing
None
Spouse/Partner
Page 4
 
 
 

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13. What areas of counsellling and education are necessary for the Patient and household?
PMTCT and family planning
Care and support for PLWHA
Knowing HIV status: Testing and care options
Patient
ART and Adherence
Management of side effects
Disclosure
General counselling
Hygiene
Client basic care
Nutrition
HIV prevention
Other (specify)
Counselling for the Caregiver/Household
General HIV: Prevention, Transmission and management
Management of side effects for client needs
ART and Adherence
Disclosure
General counseling
Hygiene
Nutrition
Other (specify)
CLINIC  ATTENDANCE AND ARV ADHERENCE ASSESSMENT
14. Is the client on ARVs?
Yes
No (If NO, skip to question 16)
14a. If yes,isthe client able to tell you the following information?
Drug names
Doses
Times taken
Side effects
Food related indications
All
All
All
All
All
Some
Some
Some
Some
Some
None
None
None
None
None
Page 5
 
 

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14b. During the last 7 days, how many doses did the client miss?
One
Two
Three
More than three
None
14c. During the last 30 days, how many doses did the client miss?
One
Two
Three
More than three
None
14c1. If the patient missed any doses, please specify reasons (Check all that apply)
Refused to take medication
Forgot
Doses are administered by caregiver who did not give
Ran out of medication and could not refill prescription
Was stopped by physician
Side effects
Felt too ill or too weak to take
Medications lost or stolen
Sharing medications with others
Felt better and decided to stop
Stigma, disclosure or privacy issues
Other (specify)
Drug or alcohol use affecting adherence
14d. When is the client due for a refill (check prescription)
Date passed in a previous month
Within the current month
Next month
Last month
2 months or more
No prescription available to confirm
15. Has the client/caregiver missed the client's last clinic visit?
Yes
No
15a. If YES, what reason did the client/caregiver fail to return to the clinic for your appointments?
Too ill to come
Forgot
Lost appointment card
Stigma within the houosehold related to disclosure or privacy
Could not afford transport
Need assistance from care-giver and none was available
Other (specify)
Page 6
work
Travel
Alcohol or drug use affected ability to come
Depression
Refused to come or continue with program
Was seen at onother clinic
 
 
 

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For the data use only (tick after scanning the form)
  Scanned               Date ___ / ___ / _________  Name of data person
Modified
March 2008
Hope
Clinic
Version
FINAL ASSESSMENT AND FOLLOW-UP PLAN
16. Based on this initial assssment, what actions will be taken as follow-up to this visit? (check all that apply)
Follow-up counseling for client or caregiver/household
Follow-up on physical health
Adherence monitoring
Follow-up and monitoring of social conditions and actions previously taken
Organization referral or accompaniment
Refferal for household member for site based VCT services
PMTCT
HIV+ family/household member for HIV/AIDS management
Accompany client to clinic
Counselor assisted disclosure
Organize hospital ambulatory services for immediade and urgent medical needs
Home based VCT for household member
Alert authorities for further investigation of neglect, sexual or domestic violence
17. Next home visit scheduled for:
One week
Two weeks
One month
Two months
Refferal for suspected TB of client/household member
Specify date of next home visit((DD/MM/YYYY))
/
/
18. During this visit, was an appointment booked for the client at the clinic?
Yes
No
If YES, specify the appointment type:
Doctor
Counselor
Pharmacy
Social worker
Nutritionist
If YES, Specify date of next appointment((DD/MM/YYYY))
/
/
Comments
Page 7
(refer to Question 13)
For the data use only (tick after scanning the form)
  Scanned               Date ___ / ___ / _________  Name of data person
No Action
 
 

References 
Cervical Treatment Study 
279 
 
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