High-yield HIV Testing, Facilitated Linkage to Care, and Prevention for Female Youth in Kenya (GIRLS)
Phase: NA
Conditions: HIV, Adolescent Behavior
Sponsor: Yale University

 
High-yield HIV testing, facilitated linkage to care, and 
prevention for female youth in Kenya (GIRLS Study) 
 
 
 
 
Clinical Trials identifier: NCT02735642 
 
September 9, 2016 
 
 
 

 
GIRLS Study Protocol            Version 1.0        September 9, 2016 
Page 1 of 110 
1.  
High-yield HIV testing, facilitated linkage to care, and 
prevention for female youth in Kenya (GIRLS Study) 
 
 
 
DAIDS Protocol Number: DAIDS ES #35125 
 
 
 
Sponsored by:  
US National Institutes of Health (NIH) 
National Institute of Allergy and Infectious Diseases (NIAID) 
Grant#: R01AI122797 
 
 
 
 
 
 
Principal Investigator, Protocol Chair: 
Ann Kurth, PhD, CNM, MPH 
Dean, School of Nursing 
Yale University 
New Haven, CT 
 
 Co-Principal Investigator, Protocol Co-Chair:  
Irene Inwani, MD, MPH 
Consultant Pediatrician, Assistant Director, Pediatrics and Child Health, Kenyatta 
National Hospital: University of Nairobi, Nairobi, Kenya 
 
 
Co-Principal Investigator, Study Site Chair:  
Kawango Agot, PhD, MPH 
Founder and Director, Impact Research and Development Organization 
Kisumu, Kenya 
 
 
 
 
Version 1.0 
 
 
 
September 9, 2016 
 

 
GIRLS Study Protocol            Version 1.0        September 9, 2016 
Page 2 of 110 
2. STATEMENT OF COMPLIANCE 
We, the principal investigators agree to conduct this study in compliance with this IRB approved 
protocol as it is described. We agree to comply with the ethical principles for the protection of 
human subjects as described in International Conference on Harmonization Good Clinical 
Practice E6 (ICH-GCP) and applicable ethical guidelines and regulatory requirements (outlined 
below). We, the principal investigators will assure no deviation from, or changes to, the protocol 
will occur without prior agreement from the sponsor and documented approval from the IRB 
(Kenyan and US), except where necessary to eliminate immediate hazard(s) to the participants. 
We, the principal investigators will promptly report to the IRB and the sponsor any changes in 
research activity and all unanticipated issues involving risks to human subjects.  
 
The signature below constitutes the approval of this protocol and the attachments, and provides 
the necessary assurances that this trial will be conducted according to all stipulations of the 
protocol, including all statements regarding confidentiality, and according to local legal and 
regulatory requirements and applicable U.S. federal regulations and ICH guidelines. 
 
 
Principal Investigator:  _____________Ann Kurth__________________________________ 
Print/Type 
 
Signed:  
Date: 
 
 
Name/Title 
 
 
 
 
Co-Principal Investigator:  __________Irene Inwani________________________________ 
Print/Type 
 
Signed:  
Date: 
 
 
Name/Title 
 
 
 
 
Co-Principal Investigator:  _________ Kawango Agot__________________________________ 
Print/Type 
 
Signed:  
Date: 
 
 
Name/Title 
 
 
 

 
GIRLS Study Protocol            Version 1.0        September 9, 2016 
Page 3 of 110 
3. TABLE OF CONTENTS 
1. 
HIGH-YIELD HIV TESTING, FACILITATED LINKAGE TO CARE, AND PREVENTION 
FOR FEMALE YOUTH IN KENYA (GIRLS STUDY) 
2. 
STATEMENT OF COMPLIANCE .................................................................................................................... 2 
3. 
TABLE OF CONTENTS ................................................................................................................................... 3 
4. 
PROTOCOL TEAM ROSTER .......................................................................................................................... 6 
5. 
LIST OF ABBREVIATIONS ............................................................................................................................. 8 
6. 
PROTOCOL SUMMARY ................................................................................................................................ 10 
7. 
BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ......................................................... 13 
7.1 
INTRODUCTION ........................................................................................................................................... 13 
7.2 
BACKGROUND ............................................................................................................................................ 14 
7.2.1 Preliminary studies; MP3 Youth Study Interventions for HIV Prevention .................................... 16 
7.2.1.1   HIV Testing Services (HTS), CD4 POC Testing, Viral Loads .................................................... 17 
7.2.1.2   Condoms ............................................................................................................................................ 18 
7.3 
GIRLS STUDY ........................................................................................................................................... 19 
7.4 
RATIONALE ................................................................................................................................................. 19 
8. 
STUDY OBJECTIVES..................................................................................................................................... 25 
9. 
STUDY DESIGN .............................................................................................................................................. 26 
9.1 
DESCRIPTION OF THE STUDY DESIGN ....................................................................................................... 26 
10. STUDY POPULATION .................................................................................................................................... 27 
10.1 
DESCRIPTION OF STUDY SITE AND STUDY POPULATION: ......................................................................... 27 
10.2 
TARGET SAMPLE SIZE ................................................................................................................................ 27 
11. STUDY INTERVENTIONS ............................................................................................................................. 29 
11.1 
RECRUITMENT ............................................................................................................................................ 29 
11.1.1 Recruitment strategy ........................................................................................................................... 29 
11.2 
INFORMED CONSENT (IC) .......................................................................................................................... 30 
Informed Consent (IC) Process .................................................................................................................. 31 
11.3 
ELIGIBILITY DETERMINATION (INCLUSION/EXCLUSION) AND ENROLLMENT .............................................. 32 
11.4 
TWO ‘SEEK’ RECRUITMENT STRATEGIES ................................................................................................... 32 
11.4.1 Community Based Recruitment Strategy ......................................................................................... 33 
11.4.2 Household Recruitment Strategy ...................................................................................................... 35 
11.5 
THREE ‘TEST’ STRATEGIES ........................................................................................................................ 36 
11.5.1 HIV Testing Services, POC CD4 Testing, and Viral Load Testing ............................................... 36 
Behavioral Baseline Interview (CAPI) ....................................................................................................... 39 
11.5.2 Condoms: Counseling and Distribution ............................................................................................ 39 
11.5.3 Referrals ............................................................................................................................................... 39 
11.6 
SCREENING AND COHORT ENROLLMENT PROCEDURES ............................................................................ 40 
11.6.1 Linkage to Care Intervention .............................................................................................................. 40 
11.6.2 Retention in Care ................................................................................................................................. 43 
11.6.3 Final Study Visit (for HIV+ and HIV- Cohorts) ................................................................................. 44 
11.7 
STUDY SUPPLIES, DISTRIBUTION, AND ACCOUNTABILITY .......................................................................... 45 
11.7.1 Study supplies storage. ...................................................................................................................... 45 
11.7.2 Study Accountability Procedures: ..................................................................................................... 46 
11.8 
ASSESSMENT OF PARTICIPANT COMPLIANCE WITH STUDY INTERVENTION(S) ........................................ 46 
12. OTHER STUDY PROCEDURES ................................................................................................................... 49 
12.1.1 Early Termination ................................................................................................................................ 49 
12.1.2 Pregnancy Visit .................................................................................................................................... 49 
12.1.3 Unscheduled Visits .............................................................................................................................. 49 

 
GIRLS Study Protocol            Version 1.0        September 9, 2016 
Page 4 of 110 
13. STATISTICAL CONSIDERATIONS ............................................................................................................. 50 
13.1 
OVERVIEW AND STUDY OBJECTIVES ......................................................................................................... 50 
13.2 
DESCRIPTION OF THE ANALYSES............................................................................................................... 50 
14. LABORATORY SPECIMENS AND BIOHAZARD CONTAINMENT ....................................................... 55 
14.1 
LOCAL LABORATORY SPECIMENS ............................................................................................................. 55 
15. SAFETY MONITORING STRUCTURE ........................................................................................................ 57 
15.1 
SAFETY MONITORING ................................................................................................................................ 57 
15.2 
LEVEL OF SEVERITY FOR ADVERSE EVENTS (AE) .................................................................................... 57 
15.3 
RECORDING/DOCUMENTATION OF AES .................................................................................................... 58 
15.4 
ANALYSIS/MANAGEMENT OF AES ............................................................................................................. 58 
15.5 
REPORTING PROCEDURES OF AES AND SAES ........................................................................................ 59 
15.5.1 Specific Serious Adverse Event Requirements .............................................................................. 59 
15.6 
TYPE AND DURATION OF THE FOLLOW-UP OF PARTICIPANTS AFTER ADVERSE EVENTS ........................ 60 
15.7 
HALTING RULES FOR THE PROTOCOL ....................................................................................................... 60 
15.8 
PREMATURE WITHDRAWAL OF A PARTICIPANT ......................................................................................... 60 
15.9 
SOCIAL HARMS MONITORING AND REPORTING ........................................................................................ 60 
15.10 APPROPRIATE METHODS AND TIMING FOR ANALYZING OUTCOME MEASURES. ...................................... 62 
15.11 SAMPLE SIZE CONSIDERATIONS ................................................................................................................ 62 
15.12 RANDOMIZATION ........................................................................................................................................ 63 
16. QUALITY CONTROL AND QUALITY ASSURANCE ................................................................................ 64 
17. ETHICS/PROTECTION OF HUMAN SUBJECTS ...................................................................................... 65 
17.1 
INSTITUTIONAL REVIEW BOARD/ETHICS COMMITTEE ............................................................................... 65 
17.2 
INFORMED CONSENT (IC) PROCESS ......................................................................................................... 65 
17.2.1 Minor Assent/ Informed Consent (IC) Process ............................................................................... 66 
17.3 
EXCLUSION OF WOMEN, MINORITIES, AND CHILDREN (SPECIAL POPULATIONS) .................................... 67 
17.4 
PARTICIPANT CONFIDENTIALITY ................................................................................................................ 67 
17.5 
POTENTIAL RISKS AND BENEFITS .............................................................................................................. 67 
17.5.1 Potential Risks ..................................................................................................................................... 67 
17.5.2 Potential Benefits ................................................................................................................................. 69 
17.6 
STUDY DISCONTINUATION ......................................................................................................................... 70 
18. DATA HANDLING AND RECORD KEEPING ............................................................................................ 71 
18.1 
DATA MANAGEMENT .................................................................................................................................. 71 
18.1.1 Screening IDs and Participant ID Numbers (PTIDs) ...................................................................... 71 
18.1.2 Procedures for Organization of Files ................................................................................................ 71 
18.1.3 Data Management Process ............................................................................................................... 73 
18.1.3.1 
Quality Assurance (QA)/Quality Control (QC) ........................................................................................ 73 
18.1.3.2 
Data Revision: ............................................................................................................................................. 73 
18.1.3.3 
Data Storage Process ................................................................................................................................ 73 
18.1.4 Confidentiality ....................................................................................................................................... 74 
18.2 
DATA CAPTURE METHODS ........................................................................................................................ 75 
18.2.1 Data Collection ..................................................................................................................................... 75 
18.3 
TYPES OF DATA ......................................................................................................................................... 76 
18.4 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS ..................................................... 76 
18.5 
TIMING/REPORTS ....................................................................................................................................... 77 
18.6 
STUDY RECORDS RETENTION ................................................................................................................... 77 
18.7 
PROTOCOL DEVIATIONS ............................................................................................................................ 77 
19. PUBLICATION POLICY ................................................................................................................................. 78 
APPENDIX A:   SCHEDULE OF PROCEDURES/EVALUATIONS .................................................................................. 79 
APPENDIX B:   LOGIC MODEL .................................................................................................................................. 80 
APPENDIX C: GIRLS STUDY (18+ AND MATURE MINORS) SAMPLE INFORMED CONSENT FORM ....................... 82 

 
GIRLS Study Protocol            Version 1.0        September 9, 2016 
Page 5 of 110 
APPENDIX D: GIRLS STUDY PARENTAL SAMPLE INFORMED CONSENT FORM FOR MINORS (15-17) ................ 88 
APPENDIX E: GIRLS STUDY MINOR (15-17) SAMPLE ASSENT FORM.................................................................. 94 
APPENDIX F: ORAL HIV SELF-TESTING INSTRUCTION SHEET ............................................................................. 100 
APPENDIX G: NASCOP HIV TESTING ALGORITHM ............................................................................................ 101 
20. SCIENTIFIC REFERENCES ........................................................................................................................ 104 
 
 
 

 
GIRLS Study Protocol            Version 1.0        September 9, 2016 
Page 6 of 110 
4. PROTOCOL TEAM ROSTER
U.S. Protocol Team Members 
Kenya Protocol Team Members 
 
 
Ann Kurth, PhD, CNM, MPH 
Principal Investigator 
Dean, School of Nursing 
Yale University 
300 Heffernan Dr. #C-28 
West Haven, CT  06516 
Ph: +1 203-785-2393 
Fax: +1 203-785-3554 
Skype: aekurth 
ann.kurth@yale.edu 
 
Irene Inwani, MD, MPH 
Principal Investigator 
Consultant Pediatrician, Assistant Director, 
Kenyatta National Hospital 
University of Nairobi 
P.O. Box 19676 
Nairobi, Kenya 
Ph: +254 722608483  
Skype: ireneinwani 
iinwani@yahoo.com 
Charles Cleland, PhD 
Consultant 
Associate Professor 
Division of Biostatistics 
Department of Population Health 
New York University School of Medicine 
 
Director, Transdisciplinary Research Methods 
Core, Center for Drug Use and HIV Research,  
NYU College of Global Public Health  
 
NYU Langone Health 
180 Madison Avenue, 17-51 
New York, NY  10016 
Skype: chuck.cleland 
Charles.Cleland@nyulangone.org 
 
Jared Baeten, MD, PhD 
 
Consultant, HIV Prevention Expertise  
Vice Chair, Global Health 
Professor 
 
University of Washington 
School of Public Health 
International Clinical Research Center 
908 Jefferson Street, Box 359927 
Seattle, WA  98104 
Ph: +1 206-520-3808 
Skype: jmbaeten 
jbaeten@u.washington.edu 
 
Kawango Agot, PhD, MPH  
Principal Investigator 
Director, Impact Research & Development 
Organization (IRDO) 
P.O. Box 9171  
Kisumu, Kenya 
 
Ph: +254 572020132  
kawango@impact-rdo.org 
mamagifto@yahoo.com 
 
Peter Cherutich, MBChB, PhD, MPH 
Co-Investigator 
Ministry of HealthP.O. Box 19361-00202  
Nairobi, Kenya 
 
Ph : +254 721924030 
Skype:pcheru 
pcheru2013@gmail.com 
 
Ruth Nduati, MD, MPH 
 
Co-Investigator 
Professor  
Kenyatta National Hospital 
University of Nairobi 
P.O. Box 19676 
Nairobi, Kenya 
 
Ph: +254 722 35323 
Skype: ruth.nduati 
ruth_nduati2000@yahoo.com 
 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 7 of 110 
 
 
Connie Celum, MD, MPH 
 
Consultant, HIV Prevention Expertise  
Professor  
University of Washington 
School of Public Health 
International Clinical Research Center 
325 Ninth Avenue, Box 359927 
Seattle, WA  98104 
Ph: +1 206-520-3825  
Skype: ccelum 
ccelum@u.washington.edu 
John Kinuthia, MD, MPH 
Co-Investigator 
Head, Research and Programs 
Obstetrician and Gynecologist 
Kenyatta National Hospital 
University of Nairobi  
P.O. Box 2590-00202 
Nairobi, Kenya 
Ph: +254 722 799052 
Skype: jkinuthia 
kinuthia@u.washington.edu 
 
 
Harsha Thirumurthy, PhD 
Consultant, Cost Effectiveness Analysis and 
Self-testing Expert 
Associate Professor  
Medical Ethics and Health Policy 
Perelman School of Medicine 
University of Pennsylvania 
Colonial Penn Center, 3641 Locust Walk 
Philadelphia, PA  19104 
Ph:+1  215-898-5611 
Skype: hthirumu 
 hthirumu@mail.med.upenn.edu 
Nok Chhun, MS, MPH 
Project Manager 
Yale School of Nursing 
300 Heffernan Drive  
West Haven, CT  06516 
Skype: nokmenee 
nok.chhun@yale.edu 
 
 
 
 
 
DAIDS Protocol Team Members 
 
 
Judi A. Miller 
Program Officer 
Prevention Sciences Program, DAIDS, NIAID, 
NIH, DHHS 
5601 Fishers Lane 
Bethesda, MD 20892-9831 
Ph: +1 301-496-1189 
jmillera@niaid.nih.gov 
Wairimu Chege MD, MPH 
Medical Officer 
Prevention Sciences Program, DAIDS, 
NIAID, NIH 
5601 Fishers Lane, Rm 8B38, 
Bethesda, MD 20892-9831 
Ph: + 1 240-292-4786 
wairimu.chege@nih.gov 
chegew@niaid.nih.gov 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 8 of 110 
 
 
5. LIST OF ABBREVIATIONS 
ACASI 
Audio Computer Assisted Self-interviews 
AE 
Adverse Event/Adverse Experience 
AIDS 
Acquired Immunodeficiency Syndrome 
ART 
Antiretroviral Therapy 
ARV 
Antiretroviral  
CAB  
Community Advisory Board 
CAPI 
Computer Assisted Personal Interview 
CCC 
Comprehensive Care Center 
CCT 
Conditional Cash Transfer 
CDC 
U.S. Centers for Disease Control and Prevention 
CRF 
Case Report Form 
DAIDS 
Division of AIDS 
DBS 
Dried blood spots 
ERC 
Ethics and Research Committee 
GCP 
Good Clinical Practice 
HAPI 
HIV and Pregnancy Intention 
HIV 
Human Immunodeficiency Virus 
HTS 
HIV Testing Services 
HPTN 
HIV Prevention Trials Network 
IC 
Informed Consent 
ICER 
Incremental Cost Effectiveness Ratio 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
IEC 
Independent or Institutional Ethics Committee 
IRB 
Institutional Review Board 
IRDO  
Impact Research and Development Organization 
KNH 
Kenyatta National Hospital 
MOH 
Ministry of Health 
MP3 
Methods for Prevention Packages Program 
N 
Number (typically refers to participants) 
NASCOP 
National AIDS and STI Control Programme 
NGO  
Non-Governmental Organization 
NIAID 
National Institute of Allergy and Infectious Diseases, NIH 
NIH 
National Institutes of Health 
OF HIVST 
Oral Fluid HIV Self-testing 
OHRP 
Office for Human Research Protections 
PEPFAR 
President’s Emergency Plan for AIDS Relief 
PI 
Principal Investigator 
PITC 
Provider-initiated Testing and Counseling 
PIMA Analyzer 
Pima CD4 test delivers an absolute count of T-helper cells from 
either a finger stick or venous whole blood sample within 20 
minutes 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 9 of 110 
 
 
PMTCT 
Prevention of mother–to-child transmission 
POC 
Point of Care 
PrEP 
Pre-Exposure Prophylaxis 
PSRC 
Prevention Science Review Committee 
PSRT 
Protocol Safety Review Team 
PTID  
Participant Identification Number 
RA 
Research Assistant 
RE 
Regulatory Entity 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event/Serious Adverse Experience 
SES 
Socioeconomic status 
SMC 
Safety Monitoring Committee 
SMS 
Short Message Service 
SOP 
Standard Operating Procedure 
SSA 
sub-Saharan Africa 
SSP  
Study-Specific Procedures (manual) 
STIs 
Sexually Transmitted Infections 
UCT 
Unconditional Cash Transfer 
UN 
United Nations 
UNAIDS 
The Joint United Nations Programme on HIV/AIDS 
UNICEF 
The United Nations International Children’s Emergency Fund 
UoN  
University of Nairobi 
USSD 
Unstructured Supplementary Service Data 
VCT 
Voluntary counseling and testing 
VL 
Viral Load 
VMMC 
Voluntary Medical Male Circumcision 
WHO 
World Health Organization 
 
 
 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 10 of 110 
 
 
6. PROTOCOL SUMMARY 
 
 
Full Title 
High-yield HIV testing, facilitated linkage to care, and prevention for female youth in Kenya 
Short Title 
GIRLS Study 
Principal 
Investigator(s) 
Ann Kurth, PhD, CNM, MPH, FAAN 
Irene Inwani, MD, MPH 
Kawango Agot, PhD, MPH 
Sample Size 
(N=1200). HIV positive cohort: (N≈108)a; Subset of HIV negatives (N≈185) 
 
a note that the positive cohort is an estimate based on expected HIV prevalence 
Study Population 
Female youth (aged 15-24) from Homa Bay County, Nyanza region, western Kenya 
Study Design 
 
 
The GIRLS study will rigorously compare two ‘seek’ recruitment strategies, three ‘test’ 
strategies, and two enhancements to an adaptive (SMART trial design) ‘linkage’ to care 
intervention, among young at-risk women, 15-24 years old, in Homa Bay County, western 
Kenya. Additionally, we will evaluate a scalable primary prevention messaging intervention to 
support identified HIV-negative young women in reducing HIV risk and adhering to HIV re-
testing recommendations. This study design will allow us to follow participants along both the 
prevention and care continua.   
Study Sites 
The study will take place in Homa Bay County, Nyanza region, Kenya. 
• 
Homa Bay municipality  
• 
Mbita sub-county 
• 
Ndhiwa sub-county 
Study Duration 
Anticipated 12 months of accrual with 12 months of follow-up.  
Study Intervention 
Description 
The following will be offered to all female youth (N=1200):  
(1) HIV Testing Services (HTS) via home-based or community based recruitment 
strategies 
(2) HIV testing approaches that females can choose from include: (a) oral fluid HIV self-
testing (OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test, OraSure Technologies) 
at their convenience; (b) staff-aided testing at home/mobile site; and (c) a referral to 
a health care facility where HIV testing will be done by a health care provider 
(standard facility-based HTS) 
(3) Behavioral survey at baseline visit 
(4) SMS HIV test experience satisfaction survey 
(5) Staff-administered questionnaire about self-testing for females who choose self-
testing option.  
 
For all HIV positive females: 
All HIV positive females will receive the following; 
(1) Point of care (POC) CD4 cell count at baseline   
(2) Viral load testing using dried blood spot (DBS) at 0 and 12 months 
(3) Referral for care and treatment; Adaptive linkage to care intervention. All HIV 
positive participants (N≈108) will be randomized to receive standard referral (N≈54) 
or standard referral plus SMS message (N≈54) to link to HIV care and treatment 
services; those who do not link to care within 2 weeks will be re-randomized in a ratio 
of 1:1 to a second SMS message or a one-time economic incentive to link to care. 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 11 of 110 
 
 
We will confirm linkage by self-report via phone call, and verified by medical record 
review.  
(4) ART adherence and treatment SMS reminders, combined with health status surveys 
at 3, 6, 9, and 12 months aligned to school holidays for those in school, when the 
participants would have access to phones. 
(5) Face-to-face (or telephone) interview on barriers and facilitators to seeking HIV care 
services after receiving a positive diagnosis at 12 months. If a phone interview is 
conducted, participant’s identity will be confirmed by asking the participant to provide 
three names used at enrollment as well as their current age, so that her identity may 
be ascertained correctly. 
 
For HIV negative females:  
All HIV negative females will receive the following: 
Risk assessment counseling, condoms, and referral for other prevention services 
(partner and family testing, PrEP, other family planning (contraception) methods, STI 
screening and treatment, drug use counseling, mental health services, social and 
nutritional support, legal services, sexual and gender based violence services and 
others that might be identified during the interview/risk assessment with participants). 
 
A subset of randomly selected high risk (risk score ≥2 as defined by eligibility criteria for high 
risk) HIV negative females (N≈185) will receive: 
(1) An SMS text at 6 and 12 months with a health promotion message;  
(2) SMS survey to collect HIV risk behaviors, condom use, and willingness to retest 
for HIV at 6 and 12 months;  
(3) HIV test at 12 months;  
(4) Face-to-face (or telephone) interview on barriers and facilitators to accessing HIV 
prevention services at 12 months. If a phone interview is conducted, participant’s 
identity will be confirmed by asking the participant to provide three names used 
at enrollment as well as their current age, so that her identity may be ascertained 
correctly.  
Primary Objectives 
 
(1) To determine the preferred recruitment venue and testing modality that targets and finds 
the highest number of HIV infected and at risk female youth aged 15-24 years in Homa Bay 
County, Nyanza region, western Kenya (Aim 1).  
• This will be determined by examining the uptake and yield of previously 
undiagnosed HIV infection of the two (2) ‘seek’ strategies (community or home-
based) and the three (3) ‘test’ strategies (self-testing, HTS in a home/mobile 
setting, or facility-based HTS) among female youth; 
 
(2) To conduct an economic evaluation, using cost effectiveness analyses to determine the 
relative utility of each seek, test, link, and prevention intervention (Aim 3). 
Secondary Objective 
(1) To pilot and evaluate an adaptive intervention to link newly diagnosed HIV-positive female 
youth to treatment and care services (Aim 2a);  
 
(2) To identify barriers and facilitators to seeking HIV care services after receiving a positive 
diagnosis (Aim 2b);  
 
(3) To identify barriers and facilitators to seeking HIV prevention services for high risk female 
youth after receiving a negative HIV test result (Aim 2c); 
 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 12 of 110 
 
 
(4) To provide an HIV prevention intervention to a randomly selected subset of high risk 
negatives (N≈185) (motivational text message, with referral for combination prevention 
interventions), and to re-test them at 12 months (Aim 2d). 
Primary Endpoint(s) 
Primary outcomes of interest for Aim 1 are based on the HIV prevention and treatment 
continua as outlined below:  
• 
Recruitment/Seek: Ability to identify and recruit female youth that are high risk for 
HIV infection using two seek strategies (home-based vs. community-based) 
o 
The proportion of youth in the community who accept study screening 
(estimated from total youth approached as the denominator);  
o 
The proportion of youth who accept study enrollment (estimated from youth 
screened and eligible as the denominator); 
• 
Testing:  
o 
Testing uptake by different testing modalities;  
o 
Completion of confirmatory testing;  
o 
Proportion that are positive;  
o 
Among those who are positive, completion of baseline collection of CD4 
and viral load tests. 
 
Outcomes of interest for Aim 3 economic evaluation to determine the comparative cost 
effectiveness of the seek, test, link, and prevention interventions are: 
• 
Compute the cost per HIV-infected female youth identified under each ‘seek’ 
strategy (home-based vs. community based); 
• 
Compute the cost per HIV-infected female youth identified under each ‘test’ strategy 
(self-testing, staff delivered HTS testing, standard facility-based HTS); 
• 
Calculate the incremental cost-effectiveness ratio of the adaptive linkage to care 
intervention among HIV positive female youth; 
• 
Compute the cost of the SMS prevention intervention among HIV negative female 
youth.  
Secondary 
Endpoint(s) 
Secondary outcomes of interest for Aim 2 are based on the HIV prevention and treatment 
continua as outlined below:  
 
• 
Linkage to Care:  
o 
Percent of females who tested positive that attended a first HIV care 
appointment at an HIV Comprehensive Care Center (CCC)  
o 
Time to link to care after positive confirmatory test result. 
• 
Retention in Care: 
o 
Completion of viral load testing at 12 months; 
o 
Reported appointment attendance via SMS and verification by study staff at 
3, 6, 9, and 12 months. 
• 
Primary Prevention (N≈185): 
o 
Proportion reporting HIV risk behaviors, and condom use, at 6 and 12 
months; 
o 
Proportion who re-tested at 12 months; 
o 
Proportion who tested positive at 12 months. 
 
 
 
 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 13 of 110 
 
 
7. 
BACKGROUND INFORMATION AND SCIENTIFIC 
RATIONALE 
7.1 Introduction 
Over three decades into the epidemic, sub-Saharan Africa (SSA) remains the region most heavily 
affected by HIV with nearly 70% of the 35.3 million people living with HIV globally, residing in the 
region (UNAIDS, 2013). Youth (15-24) bear the highest burden of new infections and in SSA 
account for 80% of the 2.3 million new infections each year (UNAIDS, 2013). Young females are 
twice as likely as their male counterparts to be infected, making females (15-24) in SSA the most 
at risk group for HIV infection.  
 
Despite this, the literature shows that programs for adolescent girls and young women are often 
uncoordinated and not evidence based. The incidence of HIV has declined in SSA, indicating 
efforts for HIV treatment and prevention (primary and secondary) have had an impact on curbing 
the epidemic. Although this improvement is encouraging, the incidence and prevalence of HIV 
continues to remain high, suggesting that innovative and effective HIV prevention and treatment 
is urgently needed. We propose an implementation science framework to address the HIV 
prevention and treatment continua that will inform best practices on how to identify, test, link, and 
retain female youth in HIV care, as well as primary HIV prevention in this vulnerable population. 
 
The major aims of the study entitled “High-yield HIV testing, facilitated linkage to care, and 
prevention for female youth in Kenya (GIRLS Study) are to: 
• 
Identify preferred recruitment venue and testing modality for female youth who are at 
highest risk for HIV in Homa Bay County, Nyanza region, western Kenya;  
• 
Pilot and evaluate an adaptive intervention to link newly diagnosed HIV-positive female 
youth to treatment and care services;  
• 
Deliver a primary HIV prevention intervention to high risk negative female youth; and 
• 
Conduct an economic evaluation, using cost effectiveness analyses to determine the 
relative utility of each seek, test, link, and prevention intervention. 
 
The focus will be to determine the preferred recruitment venue and testing modality that identifies 
the highest number of HIV infected and at-risk female youth (aged 15-24) in western Kenya. 
Knowledge of HIV status is a first step towards accessing HIV care, treatment, and prevention 
services. Particular care will be taken to protect minors who, in addition to their assent, will be 
required to have written parental or guardian informed consent (IC) in order to participate. This 
will add greatly to the science of how best to increase young women’s uptake of HIV prevention, 
testing, and linkage to care services in high-HIV burden settings, in order to optimize engagement 
in both the HIV prevention and care continua (McNairy & El-Sadr, 2012, 2014). Lessons learned 
will inform Government of Kenya, and other key policymakers, implementing partners and 
agencies throughout SSA that are exploring policies about appropriate scale up of these multiple 
seek, test, link, retain, and prevention strategies to realize the dream of an AIDS-free future for 
adolescent girls and young women. 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 14 of 110 
 
 
7.2 Background 
 
HIV in Kenyan Female Youth 
In Kenya, HIV prevalence is 5.9% among individuals aged 15-64 (NASCOP, 2014a), and 
estimated HIV incidence declined by 34% 2001-2011 (UNAIDS, 2012b). HIV prevalence has 
dropped since 2007 in most regions of Kenya but not in Nyanza region (NASCOP, 2014a), where 
this study will take place. The prevalence of HIV varies drastically per region in Kenya, with 
variations between 2.1-15.1% (NASCOP, 2014a). Children and youth aged 0-24 years form 66% 
of Kenya’s population. Surveillance data indicate that most new HIV infections occur among youth 
ages 15-24, when many are unaware of HIV status, condom and contraceptive use are low, and 
gender inequalities, concurrent sexual partnerships, and cultural value of childbearing enhance 
risk (Kenya National Bureau of Statistics (KNBS) and ICF Macro, 2010). The majority of Kenya’s 
population is at high risk for HIV infection and the rest of the population will be affected by reduced 
productivity, increased medical bills, and strained social support.   
 
Females between ages 20-24 
have a risk of HIV infection 
three times higher than males 
of the same age (NASCOP, 
2014a). 
The 
2010 
Kenya 
Demographic Health Survey 
(KDHS) 
showed 
that 
prevalence 
of 
HIV 
among 
females aged 15-19 is 2.7%, 
and 20-24 is 6.4%, whereas the 
prevalence 
of 
HIV 
among 
males aged 15-19 is 0.7%, and 20-24 is 1.5% (Kenya National Bureau of Statistics (KNBS) and 
ICF Macro, 2010). Young females have a much higher prevalence of HIV. Figure 1 shows HIV 
prevalence among women is higher than men from age 17 on and increases linearly with age, 
but for young men, remains lower and stable until age 24. This pattern underscores the need to 
focus on preventing HIV among 15-24 year old women. The UN and PEPFAR, among others, 
have emphasized the need to focus on disproportionately affected populations, such as young 
females, to have greater impact on HIV control (Birx, 2014a, 2014b). Exploration of sociocultural 
drivers of the HIV epidemic in Kenya highlights the need for age and gender-specific multi-level 
combination HIV prevention interventions that are delivered in youth-friendly mobile settings in an 
integrated services approach. Details of the mobile health event are outlined in the procedures 
section (section 7) and the rationale is in section 7.4. 
 
The Luo are the main cultural group in our study area of Homa Bay County, Nyanza region, the 
epicenter for HIV in Kenya, with the highest prevalence at 25.7% (NASCOP, 2014b); 23% of Luo 
females are HIV+. In Nyanza, 18.3% of young women and 27.2% of young men had sex before 
age 15.  By age 18, this is two-thirds of both young women and men. From these data, it is evident 
that there exists a crucial window between 15 and 18 years of age during which young people 
should be tested for HIV. PEPFAR lists HIV testing services (HTS) and creation of demand for 
clinical services, along with voluntary medical male circumcision (VMMC) and condoms, as high 
Figure 1: Gender-Age Specific HIV Prevalence (KAIS, 2014) 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 15 of 110 
 
 
impact interventions that should remain HIV prevention priorities (Birx, 2014a). This is especially 
important because among those who had their sexual debut before age 15, only 52.9% of young 
women and 33.7%% of young men used a condom at first sexual intercourse (NASCOP, 2014a). 
Only 65% of young Kenyan women (15-24 years) know where to find a condom, vs. 85% of young 
men.  Many young Kenyans say they know where to get an HIV test (85.2% of females and 84.2% 
of males aged 15-19) (KNBS and ICF Macro, 2010).  But only 55.6% of young women aged 15-
19 tested for HIV (vs. 44.7% of men) in 2012. In contrast, 91.6% and 67.3% of youth aged 20-24 
years have ever been tested for HIV (NASCOP, 2014a).  These data suggest that barriers exist 
that are keeping youth including girls from getting HIV tested.  Girls 15 to 24 years contribute 21% 
of all new infections in Kenya, with most at risk being post high school ages 18 to 24 (NASCOP, 
2014b). In these areas where high fertility, early coitarche, frequent intergenerational sex and low 
male circumcision put many young women at increased risk for HIV, it is critical to prioritize access 
to HIV testing, prevention, and treatment for this population.  Highlighting the urgency of 
increasing 
knowledge 
about 
HIV 
testing 
in 
Kenya is the fact that only 
47% of those people living 
with HIV know that they 
are HIV positive. Further 
along 
the 
HIV 
care 
continua (see Figure 2), 
only 42% of people living 
with HIV are enrolled in 
care, only 34% of people 
living with HIV receive 
ART, and adherence to 
ART, data suggest, is also 
low, as only 26% of 
people living with HIV have suppressed viral load (Birx, 2014a; NASCOP, 2014a; UNAIDS, 
2012a). Adolescent girls and young women are biologically and socially more susceptible to 
contracting HIV (more likely to have older sexual partners) and youth less often receive HIV 
testing (A. E. Kurth, Cleland, Chhun, et al., 2015; UNAIDS, 2012a; UNICEF, 2012). 
 
Female dominant risks 
While same-age sex also carries risk, cross-generational sex (age mixing) can expose younger 
women to older men with cumulative probability of HIV infection. KDHS 2003 found that women 
whose first partner was more than 10 years older had higher HIV (10%) than those whose first 
partner was less than 10 years older (8%) (CBS, MOH, & ORC Macro, 2003), whereas the KDHS 
2010 found that the rates of HIV among these groups converged at 7%. Studies show that HIV 
risk is greatest among couples where the female is aged 15-19 and the male partner is more than 
10 years older (13%). Girls with limited to no education were twice as likely to engage in cross-
generational age mixing as those who completed more schooling; age mixing needs to be 
addressed as an HIV prevention focus (Kenya National Bureau of Statistics (KNBS) and ICF 
Macro, 2010). Mathematical models have suggested that sexual age mixing across age and high 
and low prevalence groups, as well as concurrent sexual partnerships, may drive the sub-Saharan 
Figure 2: HIV Care Continuum (calculated from KAIS 2012 data) 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 16 of 110 
 
 
African epidemic (Goodreau et al., 2012; Hallett et al., 2010). In Nyanza, there are high levels of 
concurrent partnerships: 21% of marriages are polygynous (being one of 3 wives had OR 3.4 
for HIV, compared to single-spouse marriages) (K. Johnson & Way, 2006), and high reported 
concurrency (Kenya National Bureau of Statistics (KNBS) and ICF Macro, 2010; Voeten, Egesah, 
& Habbema, 2004).   
 
HIV serodiscordant couples are at high risk of HIV transmission within the relationship. Nearly 
half of all people living with HIV in sub-Saharan Africa in a relationship have a partner who is HIV 
negative (Curran et al., 2012). Of individuals in a discordant couple, half of the HIV negative 
partners are unaware that their partner is HIV positive (Curran et al., 2012). Among married or 
cohabiting couples in Kenya, approximately 6% are discordant. Among unmarried non-
cohabitating couples, approximately 10% are discordant. In Nyanza, 13% of all couples are 
discordant (Kenya National Bureau of Statistics (KNBS) and ICF Macro, 2010; NASCOP & CDC, 
2009). In sub-Saharan Africa, condom use is generally low, HIV testing services is low 
(particularly couples testing), partner disclosure of HIV positive status is low, and for those who 
are HIV positive and eligible for antiretroviral therapy (ART), uptake and adherence to 
antiretroviral medicine (ARV) is poor (Curran et al., 2012; Hughes et al., 2012; A. E. Kurth, Celum, 
Baeten, Vermund, & Wasserheit, 2011; UNAIDS, 2012b; WHO, 2011). There is a need to tailor 
HIV prevention strategies to recognize the vulnerability and gender sensitivity of discordant 
couples.  
 
Pregnancy 
Another factor increasing HIV risk among female youth is pregnancy, given the shared precursor 
of unprotected sex. Pregnancy is in the causal pathway for HIV acquisition and for vertical HIV 
transmission. Pregnancy itself increases HIV risk (Gray et al., 2005; Mugo et al., 2011) showed 
in a prospective cohort that pregnancy increases both male to female and female to male HIV risk 
2-fold.  The fertility rate in Kenya is 4.6 children per woman, a slight decrease since 2003 (Kenya 
National Bureau of Statistics (KNBS) and ICF Macro, 2010). Effective contraceptive use and 
women’s ability to negotiate condom use is low, thus unintended pregnancy rates are high. In 
Nairobi 95% of all abortions are to women under the age of 25 (Biddlecom, 2008) and are 
estimated to cause between 25 - 35% of maternal deaths (Hussain, 2012; Lema, Rogo, & Kamau, 
1996; Obare, van der Kwaak, & Birungi, 2012; Rogo, 1993; Shah & Ǻhman, 2010). New legislation 
passed in Kenya in 2010 permits abortion when “necessary”, but the majority of abortions remain 
unsafe and result in poor sexual and reproductive health outcomes, and death (Hussain, 2012). 
In Kenya the pressure for childbearing is a rite of passage to adulthood and is seen as necessary 
for a happy and productive life. These social values around childbearing often outweigh HIV 
concern, which increases HIV acquisition and vertical transmission in HIV+ pregnant females 
(Duflo, Dupas, Kremer, & Sinei, 2006; Ujiji, Ekström, Ilako, Indalo, & Rubenson, 2010).  Given 
the prevalence differential and other risk patterns, this study will focus on the 15-24 year 
old females as a highly-vulnerable group. 
7.2.1  Preliminary studies; MP3 Youth Study Interventions for HIV Prevention 
The GIRLS study builds upon the successes of the previous HIV prevention studies and offer an 
abridged version of a previous study entitled, “Gender-specific combination HIV prevention for 
youth in high-burden settings (MP3 Youth): A pilot study.” (R01AI094607; DAIDS Protocol 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 17 of 110 
 
 
Number 11989; Unpublished data). The focus of the GIRLS study is to find out the best strategies 
for reaching, recruiting, HIV testing and linking HIV infected female youth to care and treatment, 
and HIV negatives to prevention services. All services offered in the GIRLS study were partially 
informed by findings from the MP3 Youth study and were chosen because they were youth-
friendly, efficacious, and possible to implement in a mobile (community/venue-or home-based 
recruitment) setting. These services include HIV testing services (HTS), CD4 POC testing, viral 
load testing, and condoms. Referrals are made for ART, family planning (contraception), and 
other health service needs identified at the time of enrollment (e.g., partner and family testing, 
PrEP, STI screening and treatment, drug use counseling, mental health services, social and 
nutritional support, legal services, sexual and gender based violence services and others that 
might be identified during the interview/risk assessment with participants). Below, please see the 
basis of the interventions that will be offered in the GIRLS study. 
Interventions for HIV prevention 
There are numerous examples of individual HIV prevention interventions aimed at addressing the 
drivers of the HIV epidemic among youth. In the MP3 Youth study (data not yet published), we 
successfully reached 1740, recruited 1093 youth between the ages of 15-24 years old, carried 
out HIV testing for 1074, linked 69.7% of newly diagnosed HIV positives to care, and enrolled 284 
for follow-up (HIV positive cohort: 106; PrEP cohort: 28; CCT cohort: 50, and HIV negatives: 100). 
From MP3 Youth, we learnt that we can reach and recruit youth in a mobile health care setting. 
In the GIRLS study, we will learn whether we can reach and recruit female youth in a home-based 
setting as well. In MP3 Youth we demonstrated that we were able to successfully test youth in a 
mobile health event setting, but unlike in the GIRLS study, MP3 Youth did not offer alternative 
options to staff provided rapid HIV testing, such as self-testing or referral to a health facility. In 
addition, although we successfully linked HIV infected participants in the MP3 Youth study to care 
and treatment using a one-time economic incentive (i.e., bus fare), the MP3 Youth study did not 
have SMS reminders as a linkage strategy. We were able to successfully verify school enrollment 
for the CCT cohort and will use similar procedures in the GIRLS study for linkage verification.    
 
The Government of Kenya recently approved pre-exposure prophylaxis (PrEP) use as a national 
strategy for HIV prevention among key populations including high-risk females (Mukoma, 2016, 
NASCOP, 2015). PrEP is an HIV prevention method by which an uninfected individual takes 
antiretroviral drugs prior to HIV exposure to reduce the risk of infection (Plosker, 2013). Homa 
Bay is one of the selected counties that will offer PrEP, therefore, referrals will be made to 
government, private and NGO facilities offering the approved HIV prevention services, which 
includes PrEP. 
7.2.1.1   HIV Testing Services (HTS), CD4 POC Testing, Viral Loads 
 
HIV testing services (HTS) is a gateway for HIV prevention, care, and treatment.  Knowledge of 
HIV status is powerful. For individuals who are HIV negative, it is important to maintain a negative 
status and continue to practice risk reduction strategies.  For those who are positive, HTS is a 
critical entry point to life-sustaining care for people living with HIV, a key element of which is 
antiretroviral therapy (ART)/HIV treatment. Successful treatment is essential for prevention of 
secondary transmission, particularly from mother to child and to sex partners. Offering HTS to 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 18 of 110 
 
 
female youth (ages 15-24) is a way of addressing HIV transmission amongst this age group at 
high risk of HIV infection. The mobile setting increases accessibility to the interventions and 
reduces stigma by offering it in the context of a health event where other youth-friendly services 
are also being provided (J. K. B. Matovu et al., 2007; Sweat et al., 2011). In addition, offering HTS 
in a home-based setting increases knowledge of HIV status for those who would not otherwise 
come forward for testing due to HIV-testing stigma (Low et al., 2013). In the KAIS 2012 survey, 
among those who have not been tested for HIV, 36.7% of women aged 15-64 felt they did not 
need to be tested, and 17.5% of women were never offered an HIV test (NASCOP, 2014a). We 
will follow the current GoK guidelines for HTS, which includes educational risk reduction methods 
(NASCOP, 2015). 
 
CD4 testing.  We will use a point of care (POC) CD4 cell count assay in order to reduce the time 
between HIV+ test knowledge and seeking clinical relevant HIV care including ART.  An accurate 
CD4 count is needed for clinical staging, counseling and acceleration of treatment preparation of 
HIV+ patients.  
 
We will use the PIMA CD4 POC assay, which is being actively and successfully used in Kenya 
by NASCOP and with which our team has familiarity (TLC-IDU study, NIDA R01DA032080, PIs 
Kurth, Cherutich; MP3 Youth Study, NIAID R01AI094607, PIs Kurth, Inwani). The Kenya AIDS 
Indicator Survey (KAIS) used PIMAs for the last round of the survey. The PIMA assay uses a 
fingerstick specimen to count CD4 cells in 20 minutes, using a portable reader or analyzer.  The 
PIMA analyzer is designed for use in field settings like those we expect in Kenya. The PIMA 
analyzer has been evaluated against conventional systems including: the Beckman Coulter 
PLG/CD4 (Glencross, Coetzee, Lawrie, Stevens, & Osih, 2010), the BD FacsCalibur (Mtapuri-
Zinyowera et al., 2010), the BD FacsCount and  the Guva  instruments and compared well with 
conventional laboratory based CD4 testing in these studies.  
 
The MP3 Youth study measured participant CD4 at baseline and 12 months. However, WHO new 
Test and START guidelines recommends immediate treatment irrespective of CD4 count (WHO, 
2015). There is a priority shift from CD4 monitoring to scale-up of viral load testing as a more 
efficient indicator of adherence. Kenya is currently moving towards adopting these new 
recommendations, and we will ensure alignment with GoK national policies and will measure CD4 
levels only at baseline for clinical staging and treatment preparation and counseling purposes.   
 
Viral Load Testing. We will also collect specimens using dried blood spot (DBS) for HIV viral 
load (VL) testing at the mobile event or in the home for those found to be HIV-positive, and will 
repeat the VL at 12 months We have successfully used a DBS VL approach in the TLC-IDU (A. 
E. Kurth, Cleland, Des Jarlais, et al., 2015) and MP3 Youth studies in Kenya. 
 
Refer to the HTS section 11.5.1 under the intervention specific procedures section 11 for specific 
information on how HTS will be conducted. 
7.2.1.2   Condoms 
 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 19 of 110 
 
 
Male latex condoms are a barrier device that cover the penis and when used correctly and 
consistently during sexual intercourse can reduce unwanted/unplanned pregnancy and reduce 
the risk of contracting sexually transmitted infections (STIs), including HIV. Similarly, female 
condoms, made from thin, soft plastic called polyurethane (some are also made from latex), are 
worn inside the vagina, and when used correctly during vaginal sex, also help to protect against 
unwanted pregnancies and STIs. Condoms and counseling (that includes correct and consistent 
condom use and other safe sex practices) will be offered to female youth (15-24 years) who are 
recruited in either the community-based or home-based ‘seek’ strategies (Holmes, Levine, & 
Weaver, 2004). 
 
Although referrals will be made for other contraceptive methods for female youth, HTS counselors 
will also provide education about other available methods of birth control at the time of enrollment. 
Referrals for family planning will allow female participants to avoid unwanted or mistimed 
pregnancies, anticipate and attain their desired number of children as well as the spacing and 
timing of their births. A woman’s ability to space and limit her pregnancies has a direct impact on 
her health and well-being as well as on the outcome of each pregnancy. There is also increased 
risk for HIV acquisition and transmission during pregnancy (Gray et al., 2005; Mugo et al., 2011). 
 
We will ensure that the study staff is sensitive to lesbian, gay, bisexual, transgender, questioning 
(LGBTQ) issues in Kenya, which is a sensitive topic (Harper, 2013). We will ensure that 
counseling during all interventions, primarily HTS and condoms/contraception is both gender, age 
and sexuality appropriate where possible (Taegtmeyer et al., 2013). 
 
Refer to the condoms section 11.5.2 for specific information on how condoms will be distributed. 
 
7.3 GIRLS Study 
This study will inform best practices to increase young women’s, recruitment, uptake of HIV 
prevention, testing, and linkage for HIV to care services in a high-HIV burden African setting. As 
this study will be conducted within the framework of implementation science, data generated will 
help determine which study elements can be scaled-up to national level and will directly inform 
and support Kenya’s HIV epidemic control. 
 
7.4 Rationale 
 
Why focus on adolescent girls and young women? 
Adolescent girls and young women in sub-Saharan Africa are among the most vulnerable of 
populations globally. We will evaluate prevention-treatment continua interventions to increase 
uptake of HIV testing, linkage to care, retention and high-impact prevention among adolescents 
and young women. Kenya is a leader in developing evidence-based HIV care and prevention 
programs, and female youth in Nyanza are one of the highest priorities for HIV prevention and 
effective care (NASCOP & NACC, 2014). In sub-Saharan Africa girls 15-24 are 2-3 times more 
likely to be HIV+ than same-age males (Glynn et al., 2001; Kenya National Bureau of Statistics 
(KNBS) and ICF Macro, 2010; WHO, 2006). Girls’ education is low, cross-generational sex is 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 20 of 110 
 
 
high, condom negotiation is low, and girls are at a social, biomedical, and behavioral risk for HIV 
infection. 
Cross-sectional socio-demographic, HIV prevention, health services access, and other behavioral 
data will be collected at baseline from all females using a provider administered computer assisted 
personal interview (CAPI). Audio computer assisted self-interviews (ACASI) and CAPI surveys 
are being used successfully in Kenya (Osoti et al., 2014). The CAPI data will contribute to better 
understanding specific behavioral risks, HIV testing, and prevention intervention exposure for 
youth enrolled in the study. These data will serve as baseline for those subsets of study 
participants who are followed up in the HIV+ cohort and a subset of the HIV- females. The 
outcomes of this study will inform policymakers, implementing partners and agencies throughout 
sub-Saharan Africa that are (1) exploring HIV self-testing as a method for increasing knowledge 
of HIV status, and (2) wrestling with the urgent need to enhance the HIV prevention and treatment 
cascade for young women.   
 
Rationale for use of a mobile health delivery format 
The Government of Kenya (GoK) with implementing partners, including Impact Research and 
Development Organization (IRDO), have utilized mobile health teams and useful community 
engagement lessons have been learned (K. E. Johnson et al., 1989). Mobile health units have 
been successfully utilized in east Africa for rapid HIV assessment, HIV testing (J. K. Matovu & 
Makumbi, 2007), VMMC, and care including ART (Babigumira, Sethi, Smyth, & Singer, 2009; 
Chang et al., 2008) and palliative care (Downing & Kawuma, 2008). Adding mobile HIV testing to 
VCTs was found to be cost-effective in Kenya (Grabbe et al., 2010).  They have been used in 
other settings for HIV prevention including HIV/STI (Clark, Bowles, Song, & Heffelfinger, 2008; 
Cojan & Fanello, 2009; Grusky, Roberts, Swanson, Rhoades, & Lam, 2009; Liang et al., 2005; 
Liebman, Pat Lamberti, & Altice, 2002), screening and treatment (Ellen, Bonu, Arruda, Ward, & 
Vogel, 2003; Kahn, Moseley, Thilges, Johnson, & Farley, 2003), among youth (Auerswald, 
Sugano, Ellen, & Klausner, 2006), and syringe/needle exchange (Hebert et al., 2008; Miller et al., 
2002). They have been used to deliver contraceptive services to at-risk populations in other low-
income settings (Delvaux, Crabbe, Seng, & Laga, 2003; Desai & Tarozzi, 2011), and have been 
credited with being one of the reasons for high contraceptive use prevalence in Colombia ("Mobile 
family planning units," 1995). The President’s Emergency Plan for AIDS relief (PEPFAR) is 
implementing the DREAMS intervention in Kenya, focusing on identifying youth at risk for HIV 
and a mobile outreach strategy will also be used in many counties.  
 
The MP3-Youth study demonstrated that mobile health teams are an acceptable platform for 
delivery of gender-specific combination HIV prevention (data not yet published). As mentioned 
previously, the MP3 Youth study (data not yet published), successfully reached 1740, recruited 
1093 youth between the ages of 15-24 years old, carried out HIV testing for 1074, linked 69.7% 
of newly diagnosed HIV positives to care, and enrolled 284 for follow-up (HIV positive cohort: 106; 
PrEP cohort: 28; CCT cohort: 50, and HIV negatives: 100). Our partner NGO, the IRDO program, 
has successfully used mobile health teams to deliver HIV testing and VMMC outreach services 
delivery to >75,000 youth in Nyanza region since 2009. IRDO was able to recruit girls and young 
women to their health events by including information on life skills, along with reproductive and 
sexual health talks (Agot & Onyango, 2004). Given this track record, the GIRLS study will utilize 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 21 of 110 
 
 
a community-based recruitment strategy to seek female youth who are at highest risk for HIV in 
Homa Bay County.  
 
Rationale for home-based HIV testing services 
Additionally, a home-based strategy will also be utilized in order to assess preferences around 
recruitment venue, and to ascertain which seek strategy will identify the highest number of HIV 
positive female youths. Home-based HIV testing services has been provided in Kenya to 
individuals and families since 2006 and was piloted in Nyanza Province, with a high acceptance 
rate above 90% (NASCOP, 2008). Home-based testing is efficient and confidential, with high 
uptake. Over 80% of KAIS 2012 survey participants who had never tested for HIV, accepted 
home-based testing services; with 81.6% acceptance among female youth aged 15-19 years, and 
79.3 % in the 20-24 age group (NASCOP, 2014a). With any home-based approach, community 
entry procedures will be observed and we will follow home-based testing services protocols and 
guidelines that have been established by the Government of Kenya. Study team leadership are 
experienced in home-based HTS delivery in a rural setting (PIs: J. Kiarie, A. Kurth, Co-I: I. Inwani, 
R01HD058363). The home-based and community-based recruitment strategies used in the study 
is a departure from the more passive approach to HTS that is conducted in antenatal clinics, 
health facilities, and research clinic settings. HIV testing services and recruitment for research 
has traditionally been done in health facilities. Due to financial, health system, cultural, and 
knowledge barriers experienced by adolescents, young women are unlikely to access standard 
facility based HTS. Therefore, our study offers HIV testing and recruitment in different settings in 
order to inform best practices regarding HIV and recruitment strategies targeting this population.  
 
Rationale for self-testing 
HIV testing is a critical component in the control of the HIV epidemic and essential as an entryway 
into HIV treatment and care services. HIV testing has increased in Kenya, with 79.8% of adult 
women and 62.5% of men reporting in 2012 ever having been tested (NASCOP, 2014a). 
However, only 55.6% of young women aged 15-19 tested for HIV (vs. 44.7% of men) during this 
same year. In a study among young people in Uganda, 70% did not get tested because they 
feared stigmatization (Kitara & Aloyo, 2012). Currently available options for knowledge of HIV 
status in Kenya include voluntary counseling and testing (VCT), provider-initiated or facility testing 
(PITC), home-based testing services, and mobile testing campaigns. Self-testing has been 
studied in a series of studies (Kabiru, Sidze, Egondi, Osok, & Izugbara, 2014; Ann E. Kurth et al., 
2014; Ochako, Vu, & Peterson, 2014; Okal, Obare, Tun, & Matheka, 2014; Stankard, LeTouze, & 
Jones, 2014) overseen by the International Initiative for Impact Evaluation (3ie) organization for 
the GOK/MOH/NASCOP. Availability of oral fluid HIV self-testing (OraQuick ADVANCE® Rapid 
HIV-1/2 Antibody Test, OraSure Technologies) (A. E. Kurth, Cleland, Chhun, et al., 2015) is one 
of several options to increase access to testing especially in higher-risk subpopulations that may 
not access current forms of HIV testing, such as HIV-discordant couples, men who have sex with 
men (MSM), sex workers (SWs), people who inject drugs (PWID), and high-risk youth. 
 
Data from studies conducted in Malawi, Spain, Singapore, and the US show that self-testing in 
the general population is feasible, acceptable, and accurate (Napierala Mavedzenge, Baggaley, 
& Corbett, 2013; Pant Pai et al., 2013). Kenya has been a leader in innovative approaches to HIV 
prevention and care, and has demonstrated that HIV self-testing among health professionals 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 22 of 110 
 
 
(Kalibala et al., 2014) and the general population is feasible and acceptable (A. E. Kurth, Cleland, 
Chhun, et al., 2015).  
 
Youth are least likely to get HIV testing, and innovative strategies are needed to reach young 
women. Currently, oral fluid HIV self-tests kits are only available for research purposes and not 
accessible to the general public in Kenya. The acceptability of self-testing and use of this testing 
strategy among our target population of adolescent girls and young women have not been well 
documented. Therefore, this study provides an opportunity to expand the knowledge base of how 
HIV self-testing may contribute as an additional option for youth to know their status; uptake of 
HIV testing and hence self-knowledge of HIV status is low in this population (KAIS, 2014a). 
Offering self-testing as a testing option in this study will answer the question of acceptability and 
uptake of self-testing among young women. If we find that HIV self-testing is acceptable, with high 
uptake, this will add to available data that would inform strategies for increasing knowledge of HIV 
status in this population.  
 
Kenya is the first African country (and one of the first countries globally) to include HIV self-testing 
in their national guidelines (NASCOP, 2008). HIV self-testing is a confidential testing option that 
can increase testing uptake, especially for populations that choose not to receive HTS in a facility 
due to fear or stigma. The 2012 KAIS found that among adults who have ever tested for HIV, only 
3.5% of Kenyan adults reported using an HIV self-test kit; with more men (5.2%) than women 
(2.3%) reporting use. However, the low reported usage of these kits may be due to limited 
availability of these self-test kits for the general public. Among women aged 15-64 years surveyed 
on their willingness to use a self-testing kit, 67.3% reported that they were willing to use such a 
kit if it were available. HIV self-testing has the potential to be scaled-up and widely implemented, 
with minimal involvement of trained health professionals. HIVST could have an impact on the HIV 
epidemic in high burden countries, and can complement existing strategies, increase coverage of 
HIV testing and repeat testing, and provide earlier diagnosis for hard-to reach populations such 
as adolescents.  
Although there have been concerns related to QA/QC measures of HIV self-testing by 
adolescents, one of the appeals of self-testing is that the individual is empowered to conduct an 
HIV test to learn their status when they feel ready, in a setting of their choosing. Therefore, 
whether recruited in the home or in the community, participants who choose to self-test can 
perform the test at their convenience hence real-time monitoring would not be possible. A study 
conducted in Malawi found that uptake of self-testing was high, especially among adolescents, 
notably among young women aged 16-19 years old (Choko et al., 2015). Therefore, given this 
strong interest in using a self-test kit to learn their status, it seems highly unlikely that study 
participants would give their self-test kit away for someone else to use. Study staff include trained 
HTS counselors, and until there is evidence to the contrary, we will operate under the belief that 
the test kits distributed were used by study participants in which they were assigned. The lessons 
learned from this component of the study may inform the MoH about some of the challenges of 
making self-test kits available for the general public. One of these challenges may be ensuring 
that the kits are stored under optimal storage conditions. The option of HIV self-testing in our 
study needs to reflect real world use. Therefore, although we can ensure correct storage 
conditions per manufacture’s guidelines (please see section 11.7.1) when the kits are in our care, 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 23 of 110 
 
 
once distributed to participants, we cannot know the storage conditions prior to use. However, as 
previously mentioned, participants will be given information about the best way to store the kits 
and encouraged to call the study if they have any questions or concerns. In a self-testing study 
conducted in Kisumu, Kenya, where self-test kits were distributed, there were no reports of any 
issues related to storage or use of the test kits (Thirumurthy, Masters, Napierala Mavedzenge, 
Maman, Omanga and Agot, 2016).     
Rationale for short message service (SMS) for engagement and retention in care 
Offering linkage to care after a positive HIV test is critical – for risk reduction and lifesaving ART 
initiation. Data show that sexual risk behaviors decrease after a positive test and ART initiation, 
but over time these risky behaviors may begin all over again (Allen et al., 2003; Bunnell et al., 
2006; Colfax et al., 2002). Of Kenyans 15-64 years old self-reported as positive, 79.4% enrolled 
in care services within 90 days of diagnosis (NASCOP, 2014a). Previous studies in Uganda and 
South Africa showed 90% uptake of HTS and linkage among adults, but adolescents were not 
included; effective strategies need to be identified for them as barriers likely differ. Two strategies 
that were key to linkage were found to be POC CD4 and follow-up with participants (Barnabas et 
al., 2014). Evidence of SMS effectiveness for supporting linkage to and retention in HIV care 
exists (Finocchario-Kessler et al., 2014; Lester et al., 2010) for adults and we incorporate SMS 
elements in our study to assess impact for female youth. 
 
Kenya is developing a new electronic tracking system using SMS messaging to facilitate linkage 
and retention in care and adherence to ARVs for people living with HIV, and messages for high-
risk HIV-negatives. This national platform envisions use of mobile phones via the SMS platform 
for communication among facilities, health care workers, and patients to track and support 
linkage, treatment adherence, adherence to prevention interventions, and retention for improved 
outcomes. Data generated by this research in the use of SMS to engage participants (while 
maintaining their privacy and confidentiality) will inform this planned national platform and guide 
improvements of the system.  
Rationale for unconditional cash transfer 
A novel HIV prevention intervention that has been effective in sub-Saharan Africa is the cash 
transfer (CT), which can be conditional or unconditional. A conditional cash transfer (CCT) is a 
program that transfers pre-specified incentives (cash or goods) particularly to low-income 
households (individuals, caregivers, or schools), on the condition that they make investments in 
pre-specified conditions (Fiszbein, Schady, & Ferreira, 2009). However, unconditional cash 
transfers (UCT), which are not tied to any pre-specified behaviors, have also been found to be 
effective as an HIV prevention strategy (Baird, Garfein, McIntosh, & Özler, 2012).The National 
Government of Kenya, in collaboration with UNICEF and the World Bank, initiated a program in 
2002 called ‘the Kenya cash transfer programme for vulnerable children’. The program transfers 
$14-$28 USD per month (depending on the number of vulnerable children in the household)  to 
vulnerable youth in Kenya (Alviar & Pearson, 2009). Handa and colleagues evaluated the Kenya 
CT program and found a 31% reduction in sexual debut among young people (Handa, Halpern, 
Pettifor, & Thirumurthy, 2014). A randomized controlled cash transfer program examining the role 
of conditionality among adolescent girls in Malawi, found that although school attendance was 
lower in the unconditional cash transfer group, pregnancy and marriage rates were also 
significantly lower when compared to the conditional cash transfer group (Baird et al., 2012). 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 24 of 110 
 
 
These findings demonstrate that UCT can improve important outcomes such as delayed marriage 
and childbearing, but there may be a trade-off, between these desired behaviors and improved 
educational outcomes. In our study, we offer a one-time unconditional cash transfer for a subset 
of participants (i.e., those who do not link to care after the first randomization in the adaptive 
linkage to care pilot) because adolescents who test positive may experience structural barriers 
(i.e. transportation costs) in linking to care in a timely manner. Linkage is a one-time event and 
we assume that newly diagnosed HIV positive female youth will link to care within two weeks after 
the first randomization (standard referral vs. standard referral and SMS). The two-week timeframe 
for linkage to care is defined by the national government; those identified as HIV infected should 
be started on treatment during this period. In the study we will track if the participants have linked 
during this two-week time frame and will analyze time to linkage to HIV care and treatment 
services. We will also explore the use of the economic incentive for linkage during the face-to-
face (or telephone) exit interview which will be conducted at 12 months. If a phone interview is 
conducted, participant’s identity will be confirmed by asking the participant to provide three names 
used at enrollment as well as their current age, so that her identity may be ascertained correctly.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 25 of 110 
 
 
8. 
STUDY OBJECTIVES 
 
Primary Objectives 
 
(1) To determine the preferred recruitment venue and testing modality that targets and 
finds the highest number of HIV infected and at risk female youth aged 15-24 years 
in Homa Bay County, Nyanza region, western Kenya. This will be determined by 
examining uptake and yield of previously undiagnosed HIV infection of the two ‘seek’ 
strategies (community or home-based) and the three ‘test’ strategies (self-testing, 
HTS in a mobile/home setting, or facility-based HTS) among female youth; 
 
(2) To conduct an economic evaluation, using cost effectiveness analyses to determine 
the relative utility of each seek, test, link, and prevention intervention. 
 
Secondary Objectives 
 
(1) To pilot and evaluate an adaptive intervention to link newly diagnosed HIV-positive 
female youth to treatment and care services;  
 
(2) To identify barriers and facilitators to seeking HIV care services after receiving a 
positive diagnosis;  
 
(3) To identify barriers and facilitators to seeking HIV prevention services for high risk 
female youth after receiving a negative HIV test result; 
 
(4) To provide an HIV prevention intervention to a randomly selected subset of high-risk 
negatives (motivational text message with referral for combination prevention 
interventions), and to re-test them at 12 months. 
 
 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 26 of 110 
 
 
9. 
STUDY DESIGN 
 
9.1 Description of the Study Design 
The GIRLS study will rigorously compare two ‘seek’ recruitment strategies, three ‘test’ strategies, 
and two enhancements to an adaptive (SMART trial design) ‘linkage’ to care intervention, among 
young at-risk women, 15-24 years old, in Homa Bay County, western Kenya. Additionally, we will 
evaluate a scalable primary prevention messaging intervention to support identified high risk HIV-
negative young women in reducing HIV risk and adhering to recommended HIV re-testing 
recommendations. This study design will allow us to follow participants along both the prevention 
and care continua. Figure 3, summaries the study design. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 3: Study Design 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 27 of 110 
 
 
10. STUDY POPULATION 
10.1  Description of Study Site and Study Population: 
 
The study will be carried out in Homa Bay County, Nyanza region, western Kenya. HIV is a major 
crisis in Nyanza with ages 15-64 having an HIV prevalence of 15.1% compared to national 
prevalence of 5.6% (NASCOP, 2014a). Homa Bay County has a total population of 1,053,465 
and has the highest prevalence of HIV in Kenya, at 25.7% (NASCOP, 2014b). In addition, 
prevalence is higher among women (27.4%) than men (23.7%). Despite this high prevalence and 
the importance of HIV testing for prevention and treatment, 31% of people in Homa Bay still had 
never tested for HIV by 2009 (NASCOP, 2014b). High fertility, early coitarche, frequent 
intergenerational sex and low male circumcision put many young women at increased risk for HIV 
infection. It is therefore critical to prioritize access to HIV testing, prevention, and treatment for 
this population. This study will be conducted among female youth 15-24 years old (the highest 
risk age group). 
10.2  Target sample size 
 
We project to reach 1,200 female youth over an accrual period of up to 12 months, plus 
one year of follow-up. Therefore, in order to stay within the estimate 12 months of recruitment, 
we will put in place adequate field staff during the implementation phase of the project.  
 
Because Aim 1 of this study is not a clinical trial, but rather an exploration of differences in the 
yield of previously undiagnosed HIV infection across recruitment and testing strategies, we started 
with this large and feasible sample size and conducted power calculations to determine the size 
of effects detectable with at least 80% power. By recruiting 1200 female youth between the age 
of 15-24 years, we will have 80% power to detect an odds ratio of 1.67 when comparing 
recruitment strategies, on the proportion of previously undiagnosed female youth testing positive 
for HIV infection. And when comparing testing approaches within a recruitment strategy on that 
same outcome, an odds ratio of 2.01 can be detected with 80% power. These calculations, which 
are presented in more detail in section 15.11, show the proposed sample size (N=1200) is capable 
of detecting modest differences in the yield of previously undiagnosed HIV infection across both 
recruitment strategies and testing approaches.  
 
We expect large numbers of youth to participate through both venues (IRDO reaches tens of 
1000s of youth/year). Based on our experience with MP3 Youth (data not yet published) study 
(KNH/UON ERC P23/03/2011), which screened N=788 female youth and enrolled N= 690 female 
youth over a period of 8 months (November 19, 2014 – June 12, 2015) in the same county, we 
anticipate that we will be able to recruit 1,200 females over a period of 12 months with enhanced 
recruitment effort. We expect the sample accrual rate to be slower than in MP3 Youth, because 
we will be recruiting only female youth and mainly those out of school (a large proportion of 
younger MP3 Youth girls were in school and easier to recruit). In addition, we have two different 
recruitment strategies, and the home-based strategy may be more labor intensive and time 
consuming than a community mobile event. We therefore expect a somewhat lower accrual rate. 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 28 of 110 
 
 
The sample size for the linkage to care adaptive intervention pilot is an estimate of the number of 
female youth with previously undiagnosed HIV infection we anticipate reaching. The expected 
percentage of girls testing positive was based on our MP3 Youth pilot study (data not yet 
published), and we expect 9% of all tested girls to have HIV infection not previously diagnosed. 
Thus given a total sample size of 1,200 female youth, we anticipate enrolling about 108 previously 
undiagnosed HIV positive females in the adaptive intervention pilot to link HIV positive female 
youth to HIV treatment and care. 
 
Sampling method: We will stratify the sample by conveniently selected sub-counties; Homa Bay 
municipality, Mbita sub-county and Ndhiwa sub-county. Mapping of catchment areas surrounding 
health facilities will be used to establish relationships with referral clinics. We select a random 
starting point that is within walking distance (about 5km) of the catchment area of the health 
facility. Approximately four hundred (400) participants will be recruited from each stratum and for 
each stratum it is assumed that 200 participants will be recruited through each recruitment 
approach. Both recruitment strategies (household and mobile event) will run concurrently until the 
desired sample size is reached. If needed for sample size attainment, we will expand the sampling 
area to a 6 - 10 km circumference of the referral clinic. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 29 of 110 
 
 
11. STUDY INTERVENTIONS 
11.1  Recruitment 
11.1.1 Recruitment strategy 
We will work in partnership with the local community in conjunction with IRDO, our implementing 
partner. IRDO, has already successfully delivered combination HIV prevention services to youth 
in many counties in Nyanza, and most recently completed an HIV prevention study (MP3 Youth; 
R01AI094607; DAIDS Protocol Number 11989). 
Point of Entry:  
Local Mobilizers (Liaisons): Existing community mobilizers (outreach workers), who are 
affiliated with the implementing partner, will be the project liaisons for community entry. The 
individuals will facilitate meetings between the project staff and the local authorities (chiefs, 
community representatives, youth leaders, and health authorities). Community entry will begin by 
contacting local mobilizers who are well established in the target area through their established 
HTS efforts. 
Community Meetings: The study staff will request the local authorities for permission to 
participate in barazas (community meetings) or other organized community meetings where they 
will present the objectives of the study using a study-specific IRB-approved recruitment flier in an 
effort to sensitize the community to the study and to obtain the community’s permission to proceed 
with conducting the study.  
Meeting with Local Chief: In cases where there are no local mobilizers, the field site PI, field site 
coordinator, and study staff will first request a meeting with the respective chiefs of each site. The 
chiefs will then direct the study staff to the appropriate local partners (community representatives, 
youth leaders, and health authorities).   
 
Community Advisory Boards: We have identified community stakeholders in each of the study 
sites to engage as members of community advisory boards (CABs). We will form three CABs, 
one for each site. The CABs will act as the link between the study and the community/participants. 
We will train them on the study to enable them to address issues that could arise about the study 
in the community, or to contact study staff where needed. Given their vast knowledge of the study 
population and communities, the CAB members will review and give input on our recruitment 
strategies before we start and on an ongoing basis. 
 
Community Recruitment: The following areas were identified by female youths during the 
formative research phase of the MP3 Youth study (data not yet published) as venues where they 
would like to receive HIV testing services: (1) markets, (2) schools, (3) community organizations, 
non-governmental organizations, (4) community social events, (5) health facilities, and/or (6) 
churches. Therefore, these venues will serve as the sites for the community-based recruitment, 
where mobile health tents will be set up. Study staff will identify an appropriate location to set up 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 30 of 110 
 
 
the mobile tents that will ensure that study procedures can be conducted while protecting 
participant confidentiality. Information on other recruitment sites and approaches will be obtained 
from CAB members and study recruiters hired from the same communities. 
 
Home Based Recruitment: Households will be included if there is a female 15-24 years of age. 
Participants will be identified in their homes. RAs/Counselors/Study Staff will ensure that any 
other family members in the home understand the study is focusing on females, but the RA will 
be trained to make referrals for any other issues that he/she identifies within the home.  
Home-based and community-based recruitment will be carried out by GIRLS study staff, who will 
offer participation to a potential participant by reading them the IRB-approved recruitment script. 
If a potential participant declines to participate, they will be asked to fill out a refusal survey and 
thanked for their time. If willing to participate, they will be given a flier and if recruited via the 
community-based strategy will be directed to or taken to the mobile study tent area for IC. If 
recruited via the home-based strategy, they will undergo IC in a private area in their household. 
All participants will be informed that they will be contacted in 2 weeks in order to complete an 
SMS survey about their HIV testing experience.  
 
Offer of Participation 
IRB approved fliers will be used to recruit participants. The fliers will be distributed and posted in 
areas frequented by female youth (15-24), such as (1) markets, (2) schools, (3) community 
organizations, non-governmental organizations, (4) community social events, (5) health facilities, 
and/or (6) churches. 
 
All potential participants who are approached will be documented on the participant assessment 
tracking form. If the individual agrees to participate, then study staff will explain about the study 
and proceed with IC, eligibility determination, and registration. 
 
Individuals who do not consent/or withdraw consent, or who do not meet the study eligibility 
criteria will not be enrolled in the study but will receive onsite provision of standard services 
provided by IRDO program (not study) staff and referrals for whatever other services they request 
11.2  Informed Consent (IC) 
Participation of Minors & Emancipated Youth 
In order to participate in the GIRLS study, participants (18 and older or emancipated minors) must 
undergo written IC procedures. Consenting will be conducted by trained study staff and research 
counsellors. Participants under the age of 18 must bring the parent(s) or guardian(s) to give 
consent on behalf of minors who must also give assent. Emancipated minors (those who are 
married, have children, sexually active or have formally gone through a legal process of 
emancipation) can give their own consent. Upon completion, a copy of the informed consent will 
be provided to the participant. See appendices C-E for sample informed consent forms. 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 31 of 110 
 
 
Informed Consent (IC) Process 
All female youth enrolled in either the home or the community sites (potential participants) will be 
consented by RAs/Counselors/Study Staff, who will provide information about the study, explain 
study procedures, eligibility, and available options.  
 
1. The potential participant’s age will be determined as part of the eligibility determination 
(described in more detail in the next section) 
 
2. If the participant is less than 18 years old, and not an emancipated minor under Kenyan 
law, and if both youth and parent are present, then parental consent will be obtained and 
thereafter, participant assent will also be obtained. If the parent is not present, the potential 
participant will be required to return to the mobile event with a parent and then IC /assent 
procedures for parents of minors will commence. Both the parent and the youth will 
append their signature on the IC and assent form (on-site) respectively. Home consenting 
will not be done if the parent is not present, the study staff will make an appointment to 
visit the home when the parent/guardian are available. If youth are 18 years of age or older 
or an emancipated minor (married, has child, legally emancipated), IC procedures will 
continue.  
 
RAs/Counselors/Study Staff will provide the participant with the approved IC form in the 
participant’s language of choice: English, Dholuo or Kiswahili.  
 
RAs/Counselors/Study Staff will not assume a participant can read. Participants will be given the 
option of having the script read to them if they cannot read or feel more comfortable with the form 
being read to them. They will clarify the main points of the IC form with potential participants, to 
assess comprehension. This information includes: 1) purpose of study, 2) time commitment 
including follow up visit(s), 3) study procedures, 4) confidentiality, 5) incentive/payment, 6) 
eligibility assessment, and 7) voluntary nature of the study.  
 
RAs/Counselors/Study Staff will allow time for participants to ask questions about the study. Once 
all questions are addressed, they will verify that the potential participant is still interested in being 
in the study. If so, the RA will witness the participant and or parent sign and date the 
consent/assent form, or place left thumb print if participant/parent cannot write (an additional 
witnesses signature will be required on the form if this option is used). RAs/Counselors/Study 
Staff will then sign and date the consent form and provide the participant with a copy of the 
consent form. 
 
If a potential participant is unable to read (all will be given a small portion of the IC document to 
read to ascertain their literacy), an independent witness will be brought in to witness the 
consenting process. To qualify as an independent witness, the person must not be linked to the 
study in any way and must be over 18 years, literate and understand the language selected by 
the participant.  
 
▪ 
The potential participant will then be screened for eligibility. 
 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 32 of 110 
 
 
11.3 Eligibility Determination (Inclusion/Exclusion) and Enrollment 
 
Participants will be screened for eligibility by Research Assistants or other study staff. Participants 
must meet all inclusion criteria and may not meet any exclusion criteria in order to be eligible to 
participate in the study. 
 
Eligibility Requirements: 
 
Inclusion Criteria: 
▪ 
Female between the ages of 15-24. 
▪ 
Able to understand spoken English or Kiswahili or Dholuo. 
▪ 
Resides in Homa Bay County. 
▪ 
Not previously diagnosed as HIV positive. 
▪ 
Willing to give informed consent or if younger than 18 years of age and not an 
emancipated minor, has a parent or guardian willing to provide consent in 
addition to the minor’s assent. 
 
Exclusion Criteria: 
▪ 
Male. 
▪ 
Unable to understand spoken English, or Kiswahili or Dholuo. 
▪ 
Females who are older or younger than the ages of 15-24. 
▪ 
Resides outside of Homa Bay County. 
▪ 
HIV positive. 
▪ 
If under 18 and not an emancipated minor, unable to get parental consent. 
 
Enrollment 
 
After eligibility is assessed/confirmed, participants will be offered enrollment using the approved 
recruitment script. If she agrees, she will be taken through the following study enrollment 
procedures: (1) completing registration (to generate a study ID and to ensure single enrollment); 
and (2) completing the baseline behavioral survey using the tablet computer. Once enrolled, the 
participant will choose her preferred HIV testing options: (1) oral fluid HIV self-testing at her 
convenience, (2) HIV testing services (HTS) by study staff at the recruitment location, or (3) a 
referral to a health care facility for standard HTS. Participants who elect self-testing will be given 
the self-test kit and will be taken through the self-testing counseling using visual aids (either in 
the home or in the community). For participants who select staff administered HTS, the test will 
be conducted by the study staff.  For participants who request a referral for HTS at a health facility, 
they will be given a referral card with the name of a staffer (or other contact to be determined) at 
the facility. All participants will complete the participant assessment tracking form (this includes 
locator information for follow-up). 
11.4 Two ‘seek’ recruitment strategies 
Participants for this study will be recruited from either their homes or from a community-based 
venue. The purpose is to identify which recruitment venue gives the highest yield of HIV infected 
and at risk female youth. The sample will be stratified by the 3 selected sub-counties; Homa Bay 
municipality, Mbita and Ndhiwa sub-counties. Approximately four hundred (400) participants will 




*,5/66WXG\3URWRFRO9HUVLRQ6HSWHPEHU
3DJHRI


EH UHFUXLWHG IURP HDFK VWUDWXP DQG IRU HDFK VWUDWXP LW LV DVVXPHG WKDW DSSUR[LPDWHO\ 
SDUWLFLSDQWV ZLOO EH UHFUXLWHG WKURXJK HDFK UHFUXLWPHQW DSSURDFK %RWK UHFUXLWPHQW VWUDWHJLHV
KRXVHKROGDQGPRELOHFRPPXQLW\EDVHGHYHQWZLOOUXQFRQFXUUHQWO\XQWLOWKHGHVLUHGWDUJHWRI
1 IHPDOH\RXWKVDUHHQUROOHGLQRUGHUWRLGHQWLI\1§+,9SRVLWLYHIHPDOHV6HH)LJXUH
5HFUXLWPHQW6WUDWHJ\QRWHQXPEHUVDUHDQDSSUR[LPDWLRQ



)LJXUH5HFUXLWPHQW6WUDWHJ\
 &RPPXQLW\%DVHG5HFUXLWPHQW6WUDWHJ\

3RVVLEOH YHQXHV IRU FRPPXQLW\ EDVHG UHFUXLWPHQW LQFOXGH  PDUNHWV  VFKRROV 
FRPPXQLW\RUJDQL]DWLRQVQRQJRYHUQPHQWDORUJDQL]DWLRQVFRPPXQLW\VRFLDOHYHQWVQHDU
KHDOWK IDFLOLWLHV DQGRU  FKXUFKHV 7KHUHIRUH WKHVH YHQXHV ZLOO VHUYH DV WKH VLWHV IRU WKH
FRPPXQLW\EDVHGUHFUXLWPHQWZKHUHPRELOHKHDOWKWHQWVZLOOEHVHWXSVHH)LJXUHEHORZ
HQVXULQJWKDWVWXG\SURFHGXUHVFDQEHFRQGXFWHGZKLOHSURWHFWLQJSDUWLFLSDQWFRQILGHQWLDOLW\

Mobile 
Event
Tent 2
Research Initiation    
(IC, CAPI)
Tent 3
HTS, CD4, VL, 
Referrals
Tent 1
Reception Area
+RPD
%D\

0ELWD


1GKLZD

0RELOH(YHQW
+RXVHKROG
0RELOH(YHQW
+RXVHKROG
0RELOH(YHQW
+RXVHKROG
)LJXUH/D\RXWRI7HQWVDW0RELOH(YHQW

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 34 of 110 
 
 
Female youth will be screened and will then flow through the series of GIRLS study tents. Some 
interventions will require off-site follow-up (i.e., oral HIV self-testing option or referral to standard 
facility based HTS). 
Mobile Recruitment Layout 
This section describes the anticipated layout of the mobile health community based recruitment. 
The events will be akin to a health campaign/health event and will have music playing and a series 
of tents set up where the interventions will be delivered and through which participants will flow.  
Below is a description of the 3 areas to be set up at the mobile event. (See Figure 6 for details). 
 
Tent 1: 
Reception area where registration of interested potential female participants (15-
24 years) will occur.   
 
Tent 2: 
Research initiation tent where screening/eligibility, consenting, study ID allocation, 
and administration of CAPI behavioral questionnaire. 
 
Tent 3: 
HIV testing services if participant choose to be tested by study staff (per GoK HTS 
Guidelines, 2015), POC CD4, DBS for VL, condom demonstration. If participant 
chooses to receive HTS at a health facility, a referral card will be given at this time. 
For those who choose the self-testing option, she will be counseled on how to use 
the self-test including a demonstration by staff. She will also be given a 
pictographic instruction sheet in English, Kiswahili or Dholuo to use as reference. 
Referrals for other services as needed, such as FP/contraceptives and PMTCT. 
SMS survey demonstration.  
 
Figure 6: Mobile Event Layout 
 
 
 
 
Tent 1
Reception
•Reception, "Registration," 15-24 years, refer to research 
assistant (RA)
Tent 2
Research Initiation
•Consenting, eligibility, CAPI Baseline survey/decliners
Tent 3
HTC/CD4/VL/Referrals
•HTS, POC CD4, DBS for viral loads, condom demonstration. 
HIV positives enrollment in positive cohort; collect locator 
information. Get locator information from high risk HIV 
negatives for SMS survey at 6 and 12 months. Oral self-
testing demonstration for those who choose this testing 
option. SMS survey demonstration. Referrals to other 
services.

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 35 of 110 
 
 
Participant Flow at Mobile Event  
The mobile event receptionist in Tent 1 will register potential participants. The RA in Tent 2 will 
generate a study ID from the eligible and consented participant. The RA will write the participant’s 
name and date of birth in the link log, alongside the study ID information. Baseline behavioral 
survey and other data collection described below. The protection of these data is described in the 
data collection/management procedures (See section 18). Participant flow at the mobile event is 
described below: 
 
1. The mobile event receptionist will orient the participants to the ongoing study at “Tent 1” 
area. Receptionist will register participant and confirm age and gender. After registration, 
participant will be referred to Tent 2. 
 
2. If the participant is interested in the study, they will undergo the process of informed 
consent in Tent 2. If participant is not interested, they will be asked to fill out a refusal 
survey. After IC, eligibility is verified, and participant file opened as appropriate. Once 
enrolled, the interviewer will conduct the baseline interview (CAPI) and then participants 
will proceed to Tent 3.  
3. HIV testing services will take place in Tent 3. If participant chooses staff aided HTS, it will 
be done at this time. If participant chooses to self-test, she will be counseled on how to 
use the self-test including a demonstration from staff. If standard facility based HTS is 
chosen, she will be given a referral card (more details provided in HIV Testing Procedures 
section below). In addition, referrals to the district hospital or other facilities will be made 
for services not covered in the GIRLS study (e.g., partner and family testing, PrEP, other 
family planning (contraception) methods, STI screening and treatment, drug use 
counseling, mental health services, social and nutritional support, legal services, sexual 
and gender based violence services and others that might be identified during the 
interview/risk assessment with participants). Participants eligible for the HIV positive and 
negative cohorts will have their locator information collected at this time. 
11.4.2 Household Recruitment Strategy 
 
On arrival to the household, study staff will introduce him or herself and enquire if there are any 
females between the ages of 15-24 residing in the household. The research assistant (licensed 
HTS counselor) will ensure that any other family members in the home understand that the study 
is focusing on females, but the RA will be trained to make referrals for any other issues that he/she 
identifies within the home.  
 
If the female youth is not present, then RA will enquire the best time to return to the household. If 
female youth is present and interested in learning more about the study, RA will identify a private 
location in the household and explain the purpose of the study in more detail. Enrollment of 
participants will follow the same process of registration, consent, screening/eligibility, CAPI, HTS 
options, referrals etc., as participants enrolled via the community-based recruitment strategy as 
detailed above in Section 11.4.1. 
 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 36 of 110 
 
 
NOTE: Individuals who do not consent/or withdraw consent, or who do not meet the study 
eligibility criteria will not be enrolled in the study but will receive whatever services/referral to 
services they require. 
11.5  Three ‘test’ strategies 
Enrolled young women will be offered the following testing options 1) oral fluid HIV self-testing 
(OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test, OraSure Technologies), 2) staff-aided 
testing (HTS) using the recommended rapid HIV testing algorithm and 3) standard 
provider/facility-based testing. See Figure 7, HIV Testing Options. All participants will be sent a 
brief SMS satisfaction survey about their HIV test experience 2 weeks post enrollment, and will 
receive a small incentive (KSh 100) for airtime to fill out the survey. This is to ensure that we do 
not unintentionally bias an individual to choose a testing modality. 
 
 
Figure 7: HIV testing options 
This section describes the intervention specific procedures that will occur in the GIRLS Study as 
well as the off-site procedures that will occur for girls who choose the self-testing or standard 
facility based HTS. The interventions described in this section include: HTS testing options, 
condoms demonstration and distribution. Referrals will be given for other services, identified at 
the time of enrollment and not available within the study settings (partner and family testing, PrEP, 
other family planning (contraception) methods, STI screening and treatment, drug use counseling, 
mental health services, social and nutritional support, legal services, sexual and gender based 
violence services and others).  
11.5.1 HIV Testing Services, POC CD4 Testing, and Viral Load Testing 
• 
HTS sample target N=1200.  
Whether recruited in the home or in the community, after an individual has been consented, 
screened for eligibility and registered to participate in the GIRLS study, they will be offered three 
HIV Testing Options 
Oral fluid HIV self-testing  
at Participant’s 
Convenience 
Staff-Aided HIV Rapid 
Testing  
at Recruitment  
Standard HIV Rapid 
Testing  
at a Health Facility 
1. 
2. 
3. 
HIV Test Result Captured by: 
Encrypted photo of result 
(All positives, invalid, and proportion of 
negatives re-tested per GoK 
recommended algorithm by study staff) 
Staff at recruitment location 
Health facility 
Referrals tracked by card 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 37 of 110 
 
 
HIV testing options: staff-aided testing, self-testing, and referral to standard facility based HTS. 
The current government of Kenya HTS testing guidelines will be followed in all the cases. The 
government of Kenya has set standards on HIV self-testing (NASCOP, 2015), and we will follow 
these guidelines.  
 
Staff-aided testing 
The participant will receive: 
▪ 
Pre-test counseling, 
▪ 
HIV testing per GoK guidelines, 
▪ 
Post-test counseling, 
▪ 
PIMA–CD4 POC assay and viral load test (if positive), 
▪ 
Referral to services if applicable. 
 
This HTS process is based on the Kenyan National guidelines on rapid HIV testing; most recently 
updated August 2015 (See Appendix G). 
▪ 
Participants will undertake a screening rapid test. If positive a confirmatory test will be 
administered. A third rapid tie breaker will be done to confirm discordant results. This 
testing will be done sequentially by staff in the home or mobile setting. 
▪ 
Those who test negative will be reported as HIV negative. 
▪ 
Those who test positive on two rapid tests will be reported as HIV positive.  
 
For an individual who has an HIV positive test result, the CD4 and viral load samples will be taken 
immediately on site. The CD4 results will be communicated and the printout will be given to the 
participant. The viral load sample will be done using dried blood spot (DBS) which we have done 
successfully in our other studies through the CDC Kenya lab (Inzaule et al., 2013). The viral load 
results will be communicated after 2 weeks when the results are received from the lab. The HTS 
intervention will last approximately 35-45 minutes depending on the participant’s level of 
knowledge and engagement during the pre and post counseling sessions. 
 
Self-testing 
If an individual selects oral self-testing (Hurt & Powers, 2014) she will be counseled on how to 
use the self-test kit, including a demonstration by staff. In order to reduce false negatives, the 
demonstration will cover the following topics: (1) best way to store the test kit, and (2) how to 
collect the sample, stressing the importance of making sure they do not eat or drink anything less 
than thirty minutes before sample collection. She will also be given a pictographic instruction sheet 
in English, Kiswahili or Dholuo to use as reference (Appendix F). She can conduct the self-testing 
at her convenience within 2 weeks, but will be reminded that she can call the study contact number 
at any time if there are additional questions about how to administer the test. She will be informed 
that once she completes the test herself, she should take a picture of the result using the phone 
camera provided by the study (an anonymous barcode will be affixed to each kit and camera so 
as to confirm that the result links with participant). The participant will be instructed to page the 
number listed on the self-test kit so that she can immediately be sent the satisfaction survey via 
SMS and receive her incentive for completing the survey. Also, by paging the number listed, study 
staff will arrange for collection of the camera and used self-test kit, and conduct a brief interview 
on her experience with self-testing and interpretation of results. 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 38 of 110 
 
 
 
We will use pre-printed barcode labels, and each label will have a unique barcode number. At the 
time of kit and camera distribution to participant, study staff will affix one barcode label to the 
camera and one barcode label to the test kit. Study staffer will then record the barcode numbers 
on a tracking form to ensure that it links with the participant’s study identification number.  
 
If the participant does not page the number within a 2-week period, the RA will contact them by 
phone. If they still do not respond, we will trace them using the locator information provided at 
enrollment. For participants with a positive or indeterminate self-test result, the RA will ascertain 
a convenient location for conducting the confirmatory test in accordance with current government 
of Kenya HTS rapid testing algorithm. This may include home based or community, in line with 
the current recruitment strategy, or at a health care facility. Additionally, a randomly selected 
proportion (10%) of participants with a negative result will also undergo confirmatory testing for 
QA/QC purposes per current GoK HIV testing guidelines (NASCOP, 2015). Study staff will be 
trained and enrolled in the proficiency panel testing QA program with the MoH. When a participant 
requires confirmatory testing, the RA will follow the standard HTS guidelines for rapid HIV testing, 
which includes conducting two rapid tests and a tie-breaker if the results are discrepant. At this 
point if the HIV test is positive, CD4 and VL will be collected and the individual will be invited to 
enroll in the linkage intervention.  
Standard facility based HTS 
We will be working with Homa Bay County, Ndhiwa and Mbita health facilities. Participants who 
choose to test via standard facility based HTS will be given a card with the name of a research 
assistant/contact person at the facility. Additionally, the participant’s detailed locator information 
will be collected to ensure we can follow up with them as needed. HTS procedures will be 
conducted per Government of Kenya guidelines. If the participant tests positive, they will be 
invited to enroll in the linkage intervention.  
POC CD4 Testing  
At a mobile event, in the home, or facility, if a participant is confirmed positive for HIV, a portable 
PIMA CD4 analyzer (Alere, Inc., Waltham, Massachusetts, USA) will be used for a Point of Care 
(POC) CD4 count (Mwau et al., 2013). A finger stick specimen will be taken using an aseptic 
technique and processed in the PIMA analyzer. Results will be given verbally and in writing to the 
participant. The results will be used in the counseling for HIV-1 positives. Although WHO new 
Test and START guidelines recommends immediate treatment irrespective of CD4 count (WHO, 
2015), we will collect CD4 at baseline for clinical staging, counseling and treatment preparation 
purposes.  
 
Viral Load Testing 
Blood for viral load testing will be collected by finger prick and a DBS prepared for transportation 
to KEMRI CDC laboratory in Kisumu. The DBS will be stored at 4oC and transported to the 
laboratory once a week. We have used this method successfully with several studies in Kenya to 
enhance linkage and earlier ART initiation. The results will be returned to the participants/facilities 
where the care will be provided. We will use the viral load at baseline and 12 months as an 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 39 of 110 
 
 
adherence correlate comparing those suppressed and those with viral loads <1000, 
complemented by information from the surveys. 
Behavioral Baseline Interview (CAPI) 
The behavioral survey will be a provider administered computer assisted personal interview 
(CAPI) for all participants, regardless of recruitment strategy. Study team leadership have 
successfully administered CAPI surveys in a home-based setting (PIs: J. Kiarie, A. Kurth, Co-I: I. 
Inwani, R01HD058363). For sensitive questions (which we will identify in the survey), youth will 
be instructed that they can tap on the answer with the tablet facing away from the interviewer and 
the answer will not be visible after entry; this will incorporate elements of ‘ballot box response’ or 
ACASI approaches while reducing issues around lack of literacy and unfamiliarity with tablet 
computers  (Kelly et al., 2014). The behavioral baseline interview (CAPI) will collect the following 
types of information:  
• 
Basic demographic information 
• 
HIV risk behaviors 
• 
Sexual risk behaviors 
• 
Attitudes/knowledge about HIV transmission and prevalence 
• 
Knowledge and acceptability of specific HIV prevention interventions 
• 
Knowledge and acceptability of family planning methods 
 
Based on the responses to the key questions in the CAPI survey, we will use an algorithm to 
determine participants who are considered at “high risk”, i.e., they are sexually active AND meet 
at least one or more of the following: Sexual partner is HIV positive or of unknown HIV 
status, reports three or more sexual partners in the last month, or reports her sexual 
partner has multiple sexual partners. These “high risk” HIV uninfected females will be offered 
participation in the primary prevention component of the study. 
11.5.2 Condoms: Counseling and Distribution 
• 
Intervention delivery target (100%) to those enrolled (N =1200). 
 
Condoms (male and female) and counseling (that includes correct and consistent condom use 
and other safe sex practices) will be offered to female youth (15-24 years) in the home or at the 
mobile event. Condoms will be the brand approved for distribution by the government of Kenya.  
11.5.3 Referrals 
• 
Intervention delivery target (100%) to those enrolled (N =1200). 
 
Referrals are made for health service needs identified at the time of enrollment not available within 
the study (this may include referrals for ART, PrEP, family planning (contraception, PMTCT, STI 
screening, hepatitis, drug use counseling, etc. as per GOK HIV testing Guidelines 2015 page 21-
29).  
 
Accessing Services 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 40 of 110 
 
 
Whether recruited in the home or in the community, all services will be offered to eligible registered 
participants on the day of enrollment. These include HIV testing services (HTS), CD4 POC testing, 
viral load testing, and condoms. Participants will receive referrals for ART, PrEP, family planning 
(contraception), and other health service needs identified at the time of enrollment. These other 
health service needs may be partner and family testing, STI screening and treatment, drug use 
counseling, mental health services, social and nutritional support, legal services, sexual and 
gender based violence services and others that might be identified during the interview/risk 
assessment with participants.  Referrals will be made to the designated study clinics, Homa Bay 
County Referral Hospital, Mbita Health Centre, or Ndhiwa Health Centre. PrEP is approved for 
use among key populations, including high risk females (NASCOP, 2015). Homa Bay is one of 
the selected counties that will offer PrEP, therefore, referrals will be made for combination 
prevention interventions through approved government, private and NGO health facilities.  
11.6  Screening and cohort enrollment procedures 
   
HIV POSITIVE COHORT  
All participants who test HIV positive will be invited to enroll in the SMART design adaptive 
intervention pilot. Prior to enrollment in the linkage intervention, all participants who test HIV 
positive will be asked if they are willing to receive cell phone text messages to remind them to link 
to care, or if they would be willing to respond to cell phone text messages with no more than 15 
questions every 3 months for 12 months. If so, they will be given a low-cost cell phone.   
All participants who test HIV positive, give consent and are eligible, will be enrolled in the HIV 
positive cohort. 
 
HIV Positive Cohort Eligibility Requirements: 
Inclusion Criteria: 
▪ 
Meets general eligibility criteria. 
▪ 
Registered with the GIRLS study and assigned a valid Study ID number. 
▪ 
Previously signed IC or if younger than 18 years of age (and not an 
emancipated minor) has a parent or guardian who provided consent in 
addition to their individual assent.  
▪ 
Resides in the catchment area.  
▪ 
HIV positive by two (2) rapid tests. 
▪ 
Willing to receive SMS texts to link to HIV care and treatment services.  
11.6.1 Linkage to Care Intervention 
  
We will use an adaptive intervention/SMART trial design methodology to compare the success 
of a) short message service (SMS) text messaging and b) economic incentive (transport re-
imbursement worth KSh 400) systems in linking to HIV care and treatment services 
participants who test positive for HIV (expected N≈108) and require augmented linkage 
support. The initial intervention (first randomization) is that participants who test positive for 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 41 of 110 
 
 
HIV gets a standard referral or standard referral plus an SMS message with instructions on 
where to seek care. Some participants may engage in HIV care after receiving either the 
referral or referral plus SMS. Subsequently, the intervention will be tailored so those 
participants who are not linked to care within 2 weeks  after the initial intervention, who will be  
randomized again to receive either follow-up SMS with linkage encouragement, or a one-time 
economic incentive to seek care (shown to be effective in previous studies (Handa et al., 
2014)). All HIV positive participants enrolled for follow up will receive a motivational SMS with 
adherence to medication and care messages and an SMS survey at intervals of 3 months for 
12 months.  
 
At 12 months, we will follow-up with those participants that tested positive and enrolled in care 
to measure their viral load to determine whether they have been linked, retained in care and 
are adhering to treatment. We will also conduct an interview at 12 months to determine barriers 
and facilitators for linkage to care and treatment. 
  
We will be working with Homa Bay County, Ndhiwa and Mbita health facilities. Participants 
identified as HIV+ will be referred to Government of Kenya HIV Care centers referred to as 
Comprehensive Care Centers (CCC) for ART initiation. As previously stated, the GoK is 
moving towards adopting the WHO’s recommended Test and START guidelines; therefore, 
we will test for CD4 at baseline for clinical staging, counseling and treatment preparation 
purposes and collect sample (DBS) for viral load at the point of recruitment (community mobile 
event or home based) for those who test HIV-positive so as to enhance the motivation and 
information for the HIV+ female youth. Any HIV-positive female who self-reports that she is 
pregnant will be actively referred for PMTCT interventions and follow-up. Those eligible for 
ART/PMTCT referral but declining linkage intervention will be offered a declined intervention 
survey to examine reasons and will be referred to a facility of their choice and support group.  
 
Successful linkage to care is defined as date of first appointment at the HIV clinic (registering 
for care, and being assigned a patient number). We will work with existing structures at IRDO 
to verify if and when the participant reached the clinic and entered into care. 
 
Figure 8, Adaptive Intervention. 
 




*,5/66WXG\3URWRFRO9HUVLRQ6HSWHPEHU
3DJHRI


)LJXUH$GDSWLYH,QWHUYHQWLRQ

WKRVHQRWHQUROOHGLQWRWKH+,9SRVLWLYHFRKRUWZLOOEHUHIHUUHGIRUFDUHDQGWUHDWPHQWDWIDFLOLWLHVRIWKHLUFKRLFH

5DQGRPL]DWLRQ
1HZO\GLDJQRVHG+,9SRVLWLYHIHPDOHVLGHQWLILHGLQRXUVWXG\ZLOOEHUDQGRPL]HGWRUHFHLYH
VWDQGDUGUHIHUUDOWROLQNWRFDUHRUVWDQGDUGUHIHUUDOSOXV606PHVVDJHWROLQNWRFDUH7KRVH
WKDWGRQRWVXFFHVVIXOO\OLQNWRFDUHZLOOWKHQEHUHUDQGRPL]HGWRUHFHLYHHLWKHUDVHFRQG606
PHVVDJH RU DQ HFRQRPLF LQFHQWLYH :H ZLOO XWLOL]H DQ DSSURDFK FDOOHG SHUPXWHG EORFNV
UDQGRPL]DWLRQIRUSDUWLFLSDQWDVVLJQPHQWWRWKHLQWHUYHQWLRQ3HUPXWHGEORFNUDQGRPL]DWLRQ
KDVVHYHUDODGYDQWDJHVRQHRIZKLFKLVSURPRWLQJHTXDOGLVWULEXWLRQRISDUWLFLSDQWVLQHDFK
JURXS$OLVWRIUDQGRPDOORFDWLRQVZLOOEHJHQHUDWHGE\WKHVWXG\VWDWLVWLFLDQ LQUDQGRPO\
RUGHUHGSHUPXWHGEORFNVRIHLWKHURUDOORFDWLRQV7KHDOORFDWLRQOLVWZLOOEHVWRUHG
LQ D SDVVZRUG SURWHFWHG ILOH ZKLFK ZLOO RQO\ EH DFFHVVLEOH WR WKH VWXG\ VWDWLVWLFLDQ GDWD
PDQDJHURUSURMHFWPDQDJHU
7KHILHOG VWXG\ FRRUGLQDWRU ZLOO SURYLGH D OLVW RIVWXG\ ,' QXPEHUV RI SDUWLFLSDQWV QHHGLQJ
DOORFDWLRQ7KHVWXG\VWDWLVWLFLDQRUGDWDPDQDJHUZLOOUHFRUGWKHXQLTXHVWXG\LGHQWLILFDWLRQ
QXPEHUDQGWKHGDWHRIWKHDVVLJQPHQWRQWKHDOORFDWLRQOLVWDQGUHOD\WKHDVVLJQPHQWWRWKH
ILHOGVWXG\FRRUGLQDWRU$OWHUQDWLYHO\LIZHILQGWKDWWKLVLVQRWHIILFLHQWGXULQJLPSOHPHQWDWLRQ
RIRXUVWXG\ZHZLOOSXUVXHRWKHUPHWKRGVVXFKDVXVLQJVHTXHQWLDOO\ QXPEHUHGVHDOHG
HQYHORSHV FRQWDLQLQJ SDUWLFLSDQW DOORFDWLRQ WKDW PD\ EH SUHSDUHG EHIRUHKDQG 'RLJ 	
6LPSVRQ
:H DQWLFLSDWH D WRWDO RI  +,9 SRVLWLYH SDUWLFLSDQWV WR EH UDQGRPO\ DVVLJQHG WR HLWKHU
VWDQGDUGUHIHUUDORUVWDQGDUGUHIHUUDOSOXV606DWWKHILUVWUDQGRPL]DWLRQ3DUWLFLSDQWVQRW
OLQNHGWRFDUHDIWHUWKHILUVWUDQGRPL]DWLRQZLOOEHUHUDQGRPL]HGLQDUDWLRWRUHFHLYHHLWKHU
DQRWKHU606WH[WRUDQHFRQRPLFLQFHQWLYH

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 43 of 110 
 
 
11.6.2 Retention in Care 
• 
Offered to HIV positives who have successfully linked to HIV care (defined as date of 
first appointment at the HIV clinic (registering for care, and being assigned a patient 
number)).   
The goal is that at least 85% of young HIV+ women linked to treatment will stay engaged in 
care. Using the Weltel model (Lester et al., 2010), ART adherence and treatment engagement 
SMS reminders combined with health status surveys will be sent every 3 months, aligned to 
school holidays for those in school, when the participants have access to phones. We will get 
informed consent to look at records in the CCCs to confirm self-report of clinic attendance, 
though one of the primary outcomes is study collected viral load as a measure of adherence. 
 
HIV NEGATIVE COHORT  
A subset of participants who test negative, consent and are eligible will be enrolled in the HIV 
negative cohort. They will be given a low-cost cell phone. 
 
 
HIV Negative Cohort Eligibility Requirements: 
Inclusion Criteria: 
▪ 
Meets general eligibility criteria. 
▪ 
Registered with the GIRLS study and assigned a valid Study ID number. 
▪ 
Previously signed IC or if younger than 18 years of age (and not an 
emancipated minor) has a parent or guardian who provided consent in addition 
to their individual assent.  
▪ 
Resides in the catchment area. 
▪ 
HIV negative 
▪ 
Determined to be “high risk” for HIV, based on key responses to key questions 
in the baseline CAPI survey (sexually active AND meet at least one or more of 
the following: Sexual partner is HIV positive or of unknown HIV status, reports 
three or more sexual partners in the last month, or reports her sexual partner 
has multiple sexual partners) 
▪ 
Willing to receive SMS texts to assess HIV risk behaviors, condom use and 
HIV retesting behaviors and intentions. 
We will collect locator information (telephone contacts) from N≈185 randomly-selected youth who 
test HIV-negative and identified as “high risk”, to participate in a primary prevention messaging 
intervention to support HIV risk reduction and adherence to HIV re-testing recommendations. 
They will receive an SMS text at 6 and 12 months with a health promotion message and will also 
collect HIV risk behaviors, condom use, and assess their HIV retesting behaviors and intentions. 
At 12 months, we will re-test them for HIV and they will also complete a face-to-face (or telephone) 
interview on barriers and facilitators to accessing HIV prevention services. If a phone interview is 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 44 of 110 
 
 
conducted, participant’s identity will be confirmed by asking the participant to provide three names 
used at enrollment as well as their current age, so that her identity may be ascertained correctly.   
Those not enrolled into the cohort will be referred for prevention and other services (partner 
and family testing, PrEP, other family planning (contraception) methods, STI screening and 
treatment, drug use counseling, mental health services, social and nutritional support, legal 
services, sexual and gender based violence services and others that might be identified during 
the interview/risk assessment with participants). 
Follow Up SMS Surveys 
Participants will be educated on how to complete surveys on their phone at the time of enrollment. 
At this time, their cell phone number will be linked to their study ID. Each participant will be 
assigned a unique password/PIN code and a memory word. When they are sent the survey, they 
will need to enter their password to participate. If the participant forgets their password, they will 
be required to enter their memory word and if this fails, they will be required to visit the study site 
in person for identity verification and allocation of a new pass word.  Once study staff ensures 
that the phone user is the study subject, (receiving texts is free in Kenya) staff will then wirelessly 
transfer airtime, so the cohort participant can send surveys using short message service (SMS) 
texting (Kumar, Chen, Paik, & Subramanian, 2009). In this way we will ensure follow up with the 
cohort regardless of where they live (if they moved since baseline). The SMS surveys will collect 
the following types of information, including but not limited to: 
 
• 
HIV testing option and test experience 
• 
Successful linkage 
• 
Sexual risk behaviors 
• 
Retention in care 
• 
Adherence barriers and facilitators  
• 
Willingness to re-test (for subset of HIV negatives) 
• 
Status disclosure  
11.6.3 Final Study Visit (for HIV+ and HIV- Cohorts) 
 
The HIV+ cohort enrollees will be asked to come to the study site (Homa Bay County Referral 
Hospital, Mbita Health Centre, or Ndhiwa Health Centre) to get a repeat viral load specimen 
collection done. In fulfillment of Aim 2b, which is to identify barriers and facilitators (social 
demographic, clinical, health system related) to seeking HIV care services after receiving a 
positive diagnosis, all HIV positive cohort participants will be invited to an exit interview 
administered by study staff on computer tablets at the study sites. The purpose of the interview 
is to capture barriers and facilitators to HIV care and treatment services. These data will provide 
more contextual understanding of care seeking (i.e., different questions being assessed than by 
SMS) for young HIV+ women. We will interview all participants in the HIV positive cohort so that 
we are able to capture different linkage, retention, and ART adherence experiences. 
 
The HIV- cohort enrollees will be contacted to arrange for HIV re-testing. At this time, the HIV- 
cohort participants will be invited to an exit interview administered by study staff on computer 
tablets. The purpose of the interview is to capture barriers and facilitators to HIV prevention 
services. The data will be informative for understanding HIV prevention strategies. 




*,5/66WXG\3URWRFRO9HUVLRQ6HSWHPEHU
3DJHRI



7KH ILJXUH EHORZ VXPPDUL]HV *,5/6 VWXG\ IROORZXS WLPHOLQH DQG RXWFRPH PHDVXUHV DIWHU
VXFFHVVIXOOLQNDJHWRFDUH

)LJXUH)ROORZXSDQGRXWFRPHPHDVXUHVDIWHUOLQNDJHWRFDUH











6WXG\VXSSOLHVGLVWULEXWLRQDQGDFFRXQWDELOLW\
6WXG\VXSSOLHVVWRUDJH
x
+,9 7HVWLQJ 6HUYLFHV +,9 WHVW NLWV EDVHG RQ *R. +,9 WHVWLQJ DOJRULWKP FXUUHQWO\
'HWHUPLQH+,9IRUVFUHHQLQJ)LUVW5HVSRQVH+,9&DUHIRU&RQILUPDWRU\DQG
8QLJROGIRUWKH7LH%UHDNHU2UD4XLFN$'9$1&(5DSLG+,9$QWLERG\7HVWIRURUDO
IOXLG+,9VHOIWHVWLQJZLOOEHVWRUHGEHWZHHQ±&LQDGU\ORFDWLRQDZD\IURPGLUHFW
VXQOLJKW DQG DYRLGLQJ H[WUHPHV RI KRW RU FROG FRQGLWLRQV  DV SHU PDQXIDFWXUHU¶V
LQVWUXFWLRQVSURYLGHGLQWKHNLWLQVHUWDWVWXG\RIILFHDQGLQWKHPRELOHKHDOWKVHFXUHG
VXSSO\FKHVW.LWFRPSRQHQWVDUHVWDEOHXQWLOH[SLUDWLRQGDWHZKHQVWRUHGDVGLUHFWHG:H
Month 12
Month 9
Month 6
Month 3
Month 0
Baseline
+RPH%DVHG	
&RPPXQLW\
0RELOH(YHQW
5HFUXLWPHQW
$OOSDUWLFLSDQWV
&$3,%DVHOLQH
606WHVW
H[SHULHQFHVXUYH\
WKLVZLOOEHGRQH
ZHHNVSRVW
HQUROOPHQWVHOI
WHVWLQJVXUYH\IRU
WKRVHZKRFKRRVH
WKLVWHVWLQJRSWLRQ

+,9&RKRUW
EDVHOLQH&'DQG
9/WHVWVDQG
UDQGRPL]DWLRQ
LQFOXGHWKHZHHN
IROORZXSWR
HVWDEOLVKOLQNDJH



+,9±&RKRUW

5HWHQWLRQ
OLQNDJH606
VXUYH\
5HWHQWLRQ
OLQNDJH606
VXUYH\
5HWHQWLRQ
OLQNDJH606
VXUYH\
5HWHQWLRQOLQNDJH
6069/
IDFLOLWDWRUEDUULHU
WRFDUHH[LW
LQWHUYLHZ
3UHYHQWLRQ
3URPRWLRQ
606
VXUYH\
3UHYHQWLRQ
3URPRWLRQ606
VXUYH\+,9
UHWHVWLQJ
IDFLOLWDWRUEDUULHU
WRSUHYHQWLRQ
VHUYLFHVH[LW
LQWHUYLHZ

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 46 of 110 
 
 
will collect data on storage conditions (e.g., temperature tracking log), duration of storage, 
date self-test kit dispensed etc. We will also request that the meteorological department 
in Homa Bay provide data on average temperatures in the study locations during the study 
period. This information will not be used for weather prediction but as a proxy for 
temperature monitoring log for the test kits issued to participants. Meteorological data is 
part of QA for the test kits and will not be shared with participants. 
• 
PIMA CD4 cartridge will be stored at 2–30° temperature range (as per manufacturer’s 
instructions provided in the kit insert).  
• 
Condoms: Condoms will be stored at study office and in the mobile health secured 
supply-chest. 
11.7.2 Study Accountability Procedures: 
The designated study personnel supported by the field site coordinator will be responsible for 
tracking study test kits and supplies, and will be responsible for maintaining logs of study 
supplies/interventions administered to participants.  
• 
HIV Testing Services (HTS): Documentation of test kits (including PIMA CD4s) 
administered will be kept in the inventory log by the field study coordinator and in a log by 
the research assistants/nurses who conduct HTS.   
• 
Condoms: Documentation of condoms given will be kept in the inventory log by the field 
study coordinator/clinical officer and in a log by the research assistants/nurses who 
distribute condoms.   
 
11.8  Assessment of Participant Compliance with Study Intervention(s) 
 
Compliance with study interventions and recommendations will be assessed in the longitudinal 
cohorts.  
 
HIV positive Cohort: 
• 
We will be working with Homa Bay County, Ndhiwa and Mbita health facilities. Participants 
identified as HIV+ will be referred to Government of Kenya HIV Care centers referred to 
as Comprehensive Care Centers (CCC) via the intervention described for ART initiation 
for those who meet treatment criteria (See Figure 8, Adaptive Intervention). 
• 
We will have a database of all participants who tested positive so when a participant goes 
to the referral clinics (comprehensive care centers (CCCs)) she will be identified using the 
tracking card. After a girl has received a positive test result she will be given a card with 
the contact information of our study staff (or other contact to be determined) at the 
clinic. We will then check with the clinics to see if that participant has visited. 
• 
Among those that have successfully linked to care, adherence to antiretroviral medication 
and clinic visits will be assessed by self-report via an SMS text survey at 3, 6, 9 and 12 
months of follow-up, and a repeat of viral load measure at 12 months. We will also review 
her medical records at the CCC to confirm her self-report of clinic attendance. 
• 
All HIV positive girls will complete an exit interview at month 12 of follow up that will identify 
barriers and facilitators to seeking HIV care services after receiving a positive diagnosis. 
This exit interview will also capture information about the use of economic incentive for 
linkage. 
 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 47 of 110 
 
 
 
HIV negative Cohort: 
• 
Response rate to SMS survey at 6 and 12 months to collect HIV risk behaviors, condom 
use and willingness to retest for HIV among the approximately 185 HIV negative high risk 
girls on follow up. 
• 
At 12 months, whether or not we were able to re-test the participant for HIV at a site of 
their choice. 
• 
At 12 months, completion of face-to-face (or telephone) exit interview on barriers and 
facilitators to accessing HIV prevention services. If a phone interview is conducted, 
participant’s identity will be confirmed by asking the participant to provide three names 
used at enrollment as well as their current age, so that her identity may be ascertained 
correctly.   
 
We have included a flow chart below that brings all the interventions together, Figure 10. 
 
 
 
 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 48 of 110 
 
 
Recruitment 
(home-based or mobile event) 
Informed Consent 
(18-24 years old) 
Eligibility Assessment 
CAPI Behavioral Survey 
High risk HIV negatives identified 
HIV testing 
Oral fluid self-testing 
Staff-aided testing 
Referral for facility-based testing 
Locator Information Updated 
HIV positive 
(At baseline, all given standard 
referral for care and treatment, 
CD4 and VL collected. At 2 weeks 
given KSh 100 for completing SMS 
survey on testing experience) 
HIV negative 
(At baseline, all given referral for 
prevention and other services as 
necessary. At 2 weeks given KSh 
100 for completing SMS survey 
on testing experience) 
HIV positive cohort 
(All positives that consent to 
follow-up will undergo the first 
randomization: standard referral 
vs. standard referral plus SMS) 
HIV negative cohort 
(High risk negatives (randomly 
selected N≈185) identified from 
the CAPI questionnaire who 
consent to follow-up) 
2 weeks: contact self-
testers that have not 
communicated to 
make sure they 
completed testing 
w/in 2 weeks: collect 
camera and used test 
kit, administer self-
testing survey 
w/in 2 weeks: Retest 
self-testers who have 
a positive or 
indeterminate result 
and 10% of randomly 
selected negatives 
per GoK guidelines. 
Week 2: Verification of linkage to care and treatment  
Week 3: Second randomization for those not linked to 
care: SMS vs. economic incentive of KSh 400 
Month 3: (1) verification of enrollment/ health record 
review; (2) SMS survey with reimbursement of KSh 100 
Month 6: (1) verification of enrollment/ health record 
review; (2) SMS survey with reimbursement of KSh 100 
Month 6: Motivational health promotion survey 
with reimbursement of KSh 100 
Month 9: (1) verification of enrollment/ health record 
review; (2) SMS survey with reimbursement of KSh 100 
Month 12: (1) verification of enrollment/ health record 
review; (2) SMS survey with reimbursement of KSh 
100; (3) Exit survey with transport reimbursement of 
KSh 400; (4) viral load. 
Month 12: (1) Motivational health promotion 
survey with reimbursement of KSh 100; (2) HIV 
re-testing at site of their choice; (3) Exit interview 
with transport reimbursement of KSh 400. 
Figure 10.  A flow chart  
of study activities 
HIV positive 
per GoK guidelines 
Baseline, unless otherwise specified 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 49 of 110 
 
 
12. OTHER STUDY PROCEDURES  
12.1.1 Early Termination 
 
Early termination visit 
Participants may voluntarily withdraw from the study for any reason at any time. Field site 
investigators may withdraw a participant before their scheduled termination visit to protect their 
safety. Participants may be withdrawn if the study sponsors, government or regulatory authorities, 
IRBs/ERCs terminate the study prior to its planned end date. Site investigators are required to 
consult with the principal investigators prior to termination of any study participant. Study staff will 
record the reasons for all withdrawals in participants’ study records. There are no pharmaceutical, 
surgical or ongoing biomedical interventions; early termination will primarily be behavioral in 
nature. 
 
Voluntary Withdrawal 
If a participant voluntarily withdraws from the study, an exit questionnaire/debrief will be 
administered to determine reasons for withdrawal and risk behavior assessment as well as VL 
tests if HIV positive (as would normally be done at end of 12-month cohort). 
12.1.2 Pregnancy Visit 
Participants who become pregnant will be allowed to continue in the study. Our study does not 
include any pharmacological or surgical intervention. 
12.1.3 Unscheduled Visits 
 
Unscheduled visits will occur by sending an invitation SMS text to the participant, calling them, or 
locating them using their participant locator information (also known as locator tracking form), 
details can be found in the informed consent procedures section 11.2. Participant initiated 
unscheduled visits occur when a participant initiates an unscheduled visit by, texting, calling, or 
stopping by in person. 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 50 of 110 
 
 
13. STATISTICAL CONSIDERATIONS 
13.1  Overview and Study Objectives 
We will rigorously compare two ‘seek’ recruitment strategies, three ‘test’ strategies, and two 
enhancements to an adaptive (SMART trial design) ‘linkage to care intervention, among young 
at-risk women who are 15-24 years old. Additionally, we will evaluate a scalable primary 
prevention messaging intervention to support identified HIV-negative young women in reducing 
HIV risk and adhering to recommended HIV re-testing recommendations. This study design will 
allow us to follow participants along both the prevention and care continua. 
Primary Objectives:  
1. To determine the preferred recruitment venue and testing modality that targets and 
finds the highest number of HIV infected and at risk female youth aged 15-24 years in 
Homa Bay County, Nyanza region, western Kenya. This will be determined by 
examining the uptake and yield of previously undiagnosed HIV infection of the two 
‘seek’ strategies (community or home-based) and the three ‘test’ strategies (self-
testing, HTS in a home/mobile setting, or facility-based HTS) among female youth; 
2. To conduct an economic evaluation, using cost effectiveness analyses to determine 
the relative utility of each seek, test, link, and prevention intervention. 
Secondary Objectives:  
1. To pilot and evaluate an adaptive intervention to link newly diagnosed HIV-positive 
female youth to treatment and care services;  
 
2. To identify barriers and facilitators to seeking HIV care services after receiving a 
positive diagnosis; 
 
3. To identify barriers and facilitators to seeking HIV prevention services for high risk 
female youth after receiving a negative HIV test result; 
 
4. To deliver an HIV prevention intervention to a randomly selected subset of high risk 
negative female youth, and to re-test them at 12 months. 
13.2  Description of the Analyses 
See Table 1: Evaluation Plan for Data Management and Analysis.  
 
Baseline Data  
1. Basic demographic information 
2. Sexual risk behaviors 
3. HIV risk behaviors 
4. Attitudes/knowledge about HIV transmission and prevalence 
5. Knowledge and acceptability of specific HIV prevention interventions 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 51 of 110 
 
 
6. Knowledge and acceptability of family planning methods 
 
The primary endpoint for comparisons of recruitment and testing strategies is newly diagnosed 
HIV infection. The key outcomes we detail below are broken out by study aims and based on the 
HIV prevention and treatment continua, which organizes our outcomes of interest by recruitment 
strategies, testing, linkage, retention and primary prevention. 
 
Primary Endpoints 
Primary outcomes of interest for Aim 1 is based on the HIV prevention and treatment continua as 
outlined below:  
• 
Recruitment/Seek: Ability to identify and recruit female youths that are high risk for HIV 
infection using two seek strategies (home-based vs. community-based) 
o The proportion of youth in the community who accept study screening (estimated 
from total youth approached as the denominator);  
o The proportion of youth who accept study enrollment (estimated from youth 
screened and eligible as the denominator).  
• 
Testing:  
o Testing uptake by different testing modalities;  
o Completion of confirmatory testing;  
o Proportion that are positive;  
o Among those who are positive, completion of baseline collection of CD4 and viral 
load tests. 
 
Outcomes of interest for the Aim 3 economic evaluation include:  
• 
Compute the cost per HIV-infected female youth identified under each ‘seek’ strategy 
(home-based vs. community based); 
• 
Compute the cost per HIV-infected female youth identified under each ‘test’ strategy (self-
testing, staff delivered HTS testing, standard facility-based HTS); 
• 
Calculate the incremental cost-effectiveness ratio of the adaptive linkage to care 
intervention among HIV positive female youth; 
• 
Compute the cost of the SMS prevention intervention among HIV negative female youth.  
 
Secondary Endpoints 
• 
Linkage to Care:  
o Percent of females who tested positive that attended a first HIV care appointment 
at an HIV Comprehensive Care Center (CCC) 
o Time to link to care after positive confirmatory test result 
• 
Retention in Care: 
o Completion of viral load testing at 12 months; 
o Reported appointment attendance via SMS and verification by study staff at 3, 6, 
9, and 12 months. 
• 
Primary Prevention (N≈185): 
o Proportion reporting HIV risk behaviors, and condom use, at 6 and 12 months; 
o Proportion who re-tested at 12 months.   
o Proportion with a positive HIV test result for a sub-set of negatives at 12 months. 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 52 of 110 
 
 
Statistical Analyses 
Recruitment Strategy and Testing Modality: We will determine which HIV testing approaches are 
most preferred among all female youth and among higher risk female youth. We also will 
determine which recruitment and HIV testing approaches yield the highest rates of newly 
diagnosed HIV infection. Multinomial logistic regression (Hosmer & Lemeshow, 2004; Hosmer, 
Lemeshow, & Sturdivant, 2000) will be used to understand which testing approaches are most 
preferred/used by female youth. Preference for HIV testing at a health facility will be the reference 
category for the dependent variable. A model with only an intercept will be used to estimate the 
proportion of girls preferring each testing approach, and to test for pairwise differences in 
preferences (e.g., does a higher proportion of girls prefer staff-aided rather than self-testing?). In 
addition to overall preferences, we will consider age, risk behaviors, and HIV testing history as 
predictors of preferences by adding participant characteristics to the multinomial logistic 
regression analysis. Type of testing selected by participants, including refusal to test, will be 
regressed on predictors to estimate how characteristics of female youth impact HIV testing 
preferences. Model coefficients will describe the change in odds of preferring other types of 
testing relative to the reference category (facility-based testing).  
 
Logistic regression analysis will be used to determine which recruitment and HIV testing 
approaches yield the highest proportion of newly diagnosed HIV infection. HIV testing result 
(negative vs. positive) will be regressed on variables indicating recruitment strategy (home vs. 
community) and type of HIV testing (self, staff-aided, facility-based). With facility-based testing 
following community-based recruitment as a reference category, we will estimate how home-
based recruitment and other testing approaches change the odds of a positive test result. The 
interaction between recruitment strategy and HIV testing approach will be tested to determine 
whether the yield of each testing approach is conditional on recruitment strategy. If a significant 
interaction effect is found, simple main effects of testing approach within each recruitment strategy 
and simple main effects of recruitment strategy within each testing approach will be estimated. In 
addition to comparing yield by recruitment strategies and testing approaches, we will consider 
interaction effects with youth characteristics, such as age, risk behaviors, and HIV testing history, 
and type of testing. Similar logistic regression analyses will examine differences in the odds of 
completing all confirmatory testing by recruitment strategy and approach to testing. 
 
Home-based and community-based recruitment strategies will also be compared to determine 
which strategy is more effective in reaching higher risk female youth. Rates of acceptance of 
screening among potential participants offered screening and rates of enrollment among eligible 
participants will be compared by recruitment strategy using logistic regression. Risk will be 
characterized by number and serostatus of sex partners, concurrency, condom use, and patterns 
of HIV testing by the participant and any sex partners. 
 
A random selection of N≈185 girls with HIV negative tests will be followed-up. We will assess risk 
behaviors, condom use, additional HIV testing, linkage to prevention and any new HIV diagnoses 
over the year since study enrollment. Re-testing, prevention service use, and new HIV will be 
examined in relation to recruitment strategy, testing approach at enrollment, and participant risk 
behavior and other characteristics. 
 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 53 of 110 
 
 
Adaptive Intervention Pilot: Descriptive statistics and survival plots will be used to characterize 
occurrence and timing of linkage among girls responding to the initial SMS message and girls in 
each augmented treatment condition. Survival analysis (Singer & Willett, 2003; Therneau & 
Grambsch, 2000) will determine which approach to augmenting linkage – continued SMS or 
economic incentives – is more effective in linking female youth newly diagnosed with HIV to care 
sooner. Using the Cox Proportional Hazards Model, difference in the likelihood and timing of 
linkage between treatment conditions will be quantified with an interval estimate of the hazard 
ratio. Median time to linkage also will be estimated and compared across treatment conditions. 
 
Cost Effective Analysis 
In order to determine costs, we will conduct a micro-costing of the cost per HIV-infected person 
identified under each ‘seek’ and ‘test’ strategy. This will be followed by an incremental cost-
effectiveness analysis of the linkage to care interventions among HIV-infected, and a cost analysis 
of the SMS intervention among HIV-uninfected, women. These costs will include all costs required 
to deliver each intervention (home visits, staff time, supplies, and monitoring). Data will primarily 
utilize a micro-costing methodology that uses project expenditure and management records, 
employing structured costing spreadsheets that record each resource, category (e.g., personnel, 
supplies), quantity (e.g., hours), and unit costs. The cost data for the self-test group will include 
costs of obtaining a confirmatory test for those with positive self-testing results. The cost data will 
be stratified by HIV testing venue (home based, community based (mobile), or referral facility). 
With these cost data, we will calculate and compare the cost per HIV-infected person identified in 
each HTC strategy. We will also evaluate the costs of the linkage interventions per individual 
successfully linked to care. The results of the economic evaluation will allow us to identify the 
most efficient, affordable way to seek high risk young women and test them. For the linkage 
interventions, we will utilize the cost data as well as the effectiveness results to compute the ICER 
for the novel linkage intervention that is used. The ICER will reveal whether the costs of achieving 
the incremental gains from additional linkage intervention(s) suggest whether it is cost-effective 
or not. These results will provide novel data on the cost-effectiveness of linkage to care 
interventions for high-risk females in sub-Saharan Africa. 
 
Finally, we will conduct a novel economic evaluation, using a societal perspective, to compare 
the relative utility of the seeking, testing, and linkage to care strategies. This analysis will take into 
account the economic gains to individuals and households from early diagnosis of HIV and prompt 
initiation of ART. We will conduct a cost-benefit analysis that focuses on the societal level 
economic gains that result from individuals who are successfully linked and retained in HIV care 
and treatment (H. Thirumurthy et al., 2013). We will comprehensively evaluate and model the 
costs, morbidity averted, new infections averted, and the societal impact of increased household 
socioeconomic status (SES) resultant from being linked to care and receiving HIV treatment.  Data 
regarding costs will be collected using methods described above. Impacts on SES as a result of 
higher linkage to care and retention in care will be imputed from other studies we have conducted 
in Kenya and Uganda showing association between CD4 cell count and employment, income, 
and domestic (household) labor. We will also explore the possibility of collecting SES data from 
HIV-infected young women at the time they are enrolled in the linkage to care study and at 12 
months. Building on previous work which included a cost effectiveness analysis of HIV prevention 
interventions (Alsallaq R, Buttolph J, Cleland C, Hallett T, & A., 2013; A. E. Kurth, Inwani, I., Agot, 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 54 of 110 
 
 
K., Hallett, T., Cleland, C.M., Buttolph, J., Alsallaq, R, 2013) as well as economic evaluations of 
the effect of HIV treatment on the labor supply in Kenya (Harsha Thirumurthy, Zivin, & Goldstein, 
2008), we will expand the work to include the effect of different strategies for HIV seeking, testing, 
and linkage, which will complete the economic evaluation for the entire HIV continua of care. 
 
Other Analysis 
Logistic regression will be used to explore predictors of timely linkage to care among girls newly 
diagnosed with HIV infection. Potential predictors will include behavioral (e.g, number of sex 
partners), demographic (e.g., age), and clinical (e.g., baseline CD4) variables assessed at 
baseline. Interactions between these participant characteristics and treatment conditions of the 
adaptive intervention also will be explored.    
 
 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 55 of 110 
 
 
14. LABORATORY SPECIMENS AND BIOHAZARD 
CONTAINMENT 
14.1  Local Laboratory Specimens 
 
HIV infection  
• 
HIV testing 
• 
CD4 cell count  
• 
Viral load (VL) testing 
Local laboratory Kenya Medical research, CDC laboratory will perform testing for viral load and 
quality assurance for CD4 and rapid HIV tests. The CDC research lab in Kisumu has an elaborate 
internal and External Quality Assurance (EQA) programs.  
 
The study will adhere to standards of good laboratory practice, SSP manual, and local SOPs for 
proper collection, processing, labeling, transport, and storage of specimens. Specimen collection, 
testing, and storage at the local Lab will be documented using the Data Management System 
(LDMS) as described in the SSP Manual.  
 
Quality Control and Quality Assurance Procedures  
The CDC lab staff will follow up directly with site staff to resolve any QC or quality assurance (QA) 
problems identified through proficiency testing and/or on-site assessments. Throughout the 
course of the study, the lab will select a random sample of specimens to test for QA purposes.  
 
QC for HIV diagnostic testing  
Algorithms for HIV diagnostic testing are provided in the protocol and the SSP Manual. 
Participants will be tested for HIV infection status following current GoK guidelines. Participants 
with a positive or indeterminate result using the oral self-test kit will undergo confirmatory testing 
by study staff using a rapid blood test. In addition, a proportion of participants with a negative 
result from the oral self-test will also undergo confirmatory testing per current GoK guidelines for 
QA/QC purposes. HIV testing using blood samples will be subjected to quality assurance 
procedures. Proficiency panel testing from a proportion of tested samples will be done for both 
positive and negative per current GoK testing guidelines. We will follow these guidelines and will 
train our HTS staff on proficiency testing, i.e., staff conducting the tests will be subjected to testing 
of blinded panels of blood samples two or three times a year as part of quality assurance. 
 
QC for HIV RNA monitoring  
Quantitative HIV RNA (viral load) testing will be performed at Kisumu CDC lab at baseline and at 
12 month follow up in any subject with confirmed HIV infection.  QA for the VL testing will be done 
at the CDC lab and will fall under their QA system that has been established. 
 
QC for CD4 cell count determination   
For participants who test positive, CD4 cell count testing will be performed at the time when HIV 
infection is confirmed using PIMA POC machines which have been validated in Kenya and used 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 56 of 110 
 
 
for the recent national household KAIS survey. QA will be carried out by CDC lab, every third 
sample will be sent to the CDC lab for re-testing. 
 
Specimen Preparation, Handling and Shipping 
No specimens will be stored long-term. Specimens will be prepared according to the protocol and 
the WHO guidelines on biosafety. All containers will be clean. All containers will be appropriately 
labeled. Specimens that need to be transported to the CDC lab will be packaged in the triple 
packaging system. Specimens will be placed in the primary receptacle, then placed in leak-proof 
secondary containers, (boxes fitted with racks), and a third layer of outer packaging to protect the 
secondary container from damage. The box will be regularly decontaminated.  
 
Biohazard Containment  
As the transmission of HIV and other blood-borne pathogens can occur through contact with 
contaminated needles, blood, and blood products, appropriate blood and secretion precautions 
will be employed by all personnel in the drawing of blood and shipping and handling of all 
specimens for this study, as currently recommended by the U.S. CDC. All infectious specimens 
will be transported in leak proof containers. 
 
Sample storage  
Study site staff will store all DBS samples collected in this study, at -20oC or -80oC, until all 
protocol-related testing has been completed, including QC testing and other testing performed at 
the site.   
 
 
 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 57 of 110 
 
 
15. SAFETY MONITORING STRUCTURE 
 
15.1  Safety Monitoring 
 
In order to ensure participant safety, a multi-tiered communication network will be established 
between the study staff, field study coordinator, field site director, project manager, biostatistician, 
principal investigators, and NIAID project officer and medical officer to monitor participant safety 
and who will compose the Protocol Safety Review Team (PSRT). The PSRT will be chaired by 
the PIs. Regular (monthly and if needed more frequent) Skype calls will occur between the 
principal investigators, field site director, biostatistician, project manager and the field study 
coordinator and any issues will be communicated to the larger scientific team and brought 
immediately to the attention of the project officer and medical officer. Any serious adverse events 
(AEs) will be reported to the IRBs following protocols outlined below. The reports of safety issues 
will be reviewed by the study scientific team (PIs, biostatistician). Any SAE will be reported to 
NIAID, MoH, and IRBs as outlined in the next pages. The data manager will compile routine safety 
reports with the field study coordinator for review by the PSRT. The content, format, and frequency 
of the safety data reports will be agreed upon by the PSRT in advance of study implementation. 
 
 
15.2  Level of Severity for Adverse Events (AE) 
 
As with any evaluation involving medical interventions, potential adverse events (AEs) are 
expected. However, we expect that the risk of an adverse event as a result of study-related 
activities is minimal, our study does not involve a pharmacological agent. Possible adverse events 
in this population may include risk of distress and embarrassment during collection of personal 
data such as sexual risk behaviors. Taking a finger stick blood sample for HIV testing may cause 
a little pain, but poses minimal risk of infection because we will use sterile equipment and follow 
infection control and prevention procedures. All AEs reported by or observed in enrolled study 
participants will be documented regardless of severity and presumed relationship to study 
procedures. 
 
Adverse events 
An AE is any untoward medical occurrence in a participant for which there is a reasonable 
possibility that the experience may have been caused by the procedure; All AEs will be graded 
according to their intensity using the most recent DAIDS AE Grading Table available at: 
http://rsc.tech-res.com/safetyandpharmacovigilance.Serious Adverse Events (SAEs) (described 
below) will be recorded and reported to the Provincial Director of Health  and the regulatory bodies 
using both DAIDS AE grading table and the implementing partner’s AE severity scale (listed 
below). 
 
Serious Adverse Events (SAE): 
• 
Results in death, 
• 
Is life-threatening, 
• 
Requires inpatient hospitalization or prolongation of existing hospitalization, 
• 
Results in persistent or significant disability/incapacity, 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 58 of 110 
 
 
• 
Is a congenital anomaly/birth defect, or 
• 
Is an important medical event that may not be immediately life-threatening or result in 
death or hospitalization but may jeopardize the patient or may require intervention to 
prevent one of the other outcomes listed in the definition above. 
Adverse Events/Serious Adverse Events Severity Scale 
• 
Grade 1 (Mild): events require minimal or no treatment and do not interfere with the patient’s 
daily activities. 
• 
Grade 2 (Moderate): events result in a low level of inconvenience or concern with the 
therapeutic measures.  Moderate events may cause some interference with functioning. 
• 
Grade 3 (Serious): events interrupt a patient’s usual daily activity and may require systemic 
drug therapy or other treatment. Serious events are usually incapacitating. 
• 
Grade 4 (Life threatening): any adverse drug experience that places the patient or 
participant, 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. 
 
• 
Grade 5 (Death) 
15.3  Recording/Documentation of AEs 
Study staff will document in source documents and the appropriate AE Log CRF all AEs reported 
by or observed in enrolled study participants regardless of severity and presumed relationship to 
study procedures. AE severity will be graded per the DAIDS Table for Grading Adverse Events. 
If an adverse event is identified the adverse events form will be completed. If a serious adverse 
event is identified, the serious adverse events form will be completed. Serious Adverse Events 
(SAEs) will be recorded and reported to the Provincial Director of Health and the DAIDS Medical 
Officer.  All SAEs are being reported to review boards and sponsors per protocol.  
15.4  Analysis/Management of AEs 
Data will be obtained during the study visit, SMS text questionnaires, and through a study mobile 
number given to all participants to call for free if they feel that there are any complications due to 
an intervention they received.  
 
Study participants will be given specific instructions (a phone call card) for contacting the study 
staff to report any untoward medical occurrences they feel they may experience.  In the case of 
life-threatening events, participants will be instructed to seek immediate emergency care. 
 
Emergency follow-up visit 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 59 of 110 
 
 
Participants who reach out, request, or come in for an emergency follow-up visit will be seen as 
soon as possible.  
 
For all emergencies, the field coordinator/study staff will: 
• 
Ask the participant about the sequence of events since the intervention. Ask about: any 
problems; how problems developed; and any medication or other treatments obtained.  
• 
Plan treatment of any problems that can be handled on an outpatient basis.  
• 
Refer the participant to a higher level of care for treatment of potentially serious 
complications.  
• 
Ensure that the means of communicating with and timely transport to a higher level health 
facility are available  
• 
Note in the participant’s research record all problems and actions taken.  
15.5  Reporting Procedures of AEs and SAEs 
• 
All adverse events (AEs): will be recorded in the adverse events form and will be reported 
to: 
o The field study coordinator, who will then communicate the adverse events to the 
Principal investigators.  
o Relevant Ministry of Health authorities 
 
• 
Serious adverse events (SAEs): will be recorded on the serious adverse events form and 
reported to: 
o The field study coordinator, who will then communicate the adverse events to the 
Principal investigators.  
o The Provincial Director 
o DAIDS Medical Officer and Project Officer (sponsor).  
o Kenyan IRB and Yale IRB. 
15.5.1 Specific Serious Adverse Event Requirements 
 
All serious adverse events will be: 
• 
recorded on the appropriate serious adverse event case report form 
• 
followed through resolution by a study physician 
• 
reviewed by a study physician (Kenyan PI) 
 
Expedited Adverse Event Reporting Requirements 
N/A. Our study does not involve a pharmacological agent, therefore does not fulfill the 
requirements, definitions, and methods for expedited adverse event reporting as outlined in 
Version 2.0 of the DAIDS Expedited Adverse Event (EAE) Manual, which is available on the 
DAIDS 
Regulatory 
Support 
Center 
(RSC) 
website 
at 
http://rsc.tech-
res.com/safetyandpharmacovigilance.  
 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 60 of 110 
 
 
15.6 Type and Duration of the Follow-up of Participants after Adverse 
Events 
Participants who report any adverse event will be followed up weekly via SMS text or phone call 
until the adverse event is resolved. 
15.7  Halting Rules for the Protocol 
N/A. No pharmacologic or surgical interventions. 
15.8  Premature Withdrawal of a Participant 
See section 12.1.1. 
15.9  Social Harms Monitoring and Reporting 
It is possible that participants’ involvement in the study could lead to social harms such as 
stigmatization, discrimination, disruption to social support network, abuse (physical/verbal). Social 
harms will be monitored closely throughout the study. Information on social harms will be solicited 
from participants during follow-up visits to examine their experiences. This information will be 
recorded on case report forms. If a participant reports social harms, study staff will make every 
effort to provide appropriate counseling, care, and referrals if necessary. Any social harms that 
are deemed to be serious or unexpected will be reported to the IRBs and reported to DAIDs.  

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 61 of 110 
 
 
Table 1: Evaluation Plan 
Aims 1 and 2: Outcomes evaluated based 
on HIV prevention and treatment continua 
Measures (Sources) 
Data Collection Timeline 
Data Analysis 
N 
Recruitment/Seek: Ability to recruit female 
youths that are high risk for HIV infection 
using two seek strategies (home-based vs. 
community-based). The proportion of youth in 
the community who accept study screening; 
the proportion of youth who accept 
enrollment. 
CAPI baseline; (youth 
participants, total 
approached) 
Baseline 
 
 
Frequencies; differences in proportion by age, and 
recruitment strategy; which recruitment strategy yielded 
the highest rates of newly diagnosed HIV infection. 
Rates of acceptance of screening among potential 
participants offered screening and rates of enrollment 
among eligible participants will be compared by 
recruitment strategy using logistic regression. Risk will 
be characterized by number and serostatus of sex 
partners, concurrency, condom use, and patterns of HIV 
testing by the participant and any sex partners. 
N=1200 
Testing: Testing uptake; completion of 
confirmatory testing; proportion who are 
positive; among those who are positive, 
completion of baseline collection of CD4 and 
viral load tests. 
GIRLS study project 
database 
Baseline, 2 week SMS 
Satisfaction Survey. 
Frequencies; multiple logistic regression for which 
testing approach most preferred/used by females. Age, 
risk behaviors, HIV testing history as predictors of 
preferences; which testing approach yielded the highest 
rates of newly diagnosed HIV infection. 
N=1200 
Linkage to Care: Percent of females who 
tested positive that attended a first HIV care 
appointment at a CCC; time to link to care 
after positive confirmatory result. 
GIRLS study project 
database, medical record 
review at CCC, exit 
interviews. 
2 weeks after first 
randomization; 1 week to 
re-randomize; 2 weeks after 
second randomization (5 
weeks total from start of 
linkage pilot). Exit interview 
collected at 12 months. 
Descriptive statistics; survival plots for occurrence and 
timing of linkage. Cox proportional hazards model for 
differences in likelihood and timing of linkage between 
the two treatment conditions; median time to linkage. 
Predictors of successful linkage to care. 
N≈108 
Retention in Care: Completion of viral load 
testing one year after positive confirmatory 
test; self-report of appointment attendance. 
Review of medical records to confirm self-
report of clinic attendance. 
SMS surveys, medical 
record review, exit 
interviews. 
3, 6, 9, 12 months for SMS 
surveys. Medical record 
review to confirm clinic 
attendance self-report. Exit 
interview collected at 12 
months. 
Frequencies; assess number retained in care at 12 
months. Proportion who complete viral load testing at 12 
months. 
N≈108 
Primary Prevention: HIV risk behaviors, 
condom use, and HIV re-testing of a sub-
sample of high risk HIV negatives 
SMS surveys 
GIRLS study project 
database 
6 and 12 months for SMS 
surveys. At 12 months, exit 
interview and re-testing 
Descriptive statistics; new HIV diagnosis at 12 months. 
N≈185 
Aim 3 economic evaluation 
Measures (Sources) 
Data Collection Timeline 
Data Analysis 
 
Economic evaluation to determine the 
comparative cost effectiveness of the seek, 
test, link, and prevention interventions. 
GIRLS study project 
database 
Accrual and follow-up 
period.  
Micro-costing of the cost per HIV infected person under 
each seek and test strategy; incremental cost 
effectiveness of linkage to care intervention for HIV +; 
cost analysis of SMS intervention and re-testing for HIV 
negative females. 
 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 62 of 110 
 
 
15.10  Appropriate Methods and Timing for Analyzing Outcome 
Measures. 
See Table 1: Evaluation Plan. 
15.11  Sample Size Considerations 
Baseline sample size calculation 
Based on our experience with MP3 Youth (data not yet published), which screened N=788 female 
youth and enrolled N=690 female youth over a period of eight months (November 19, 2014 – June 
12, 2015), we expect we can recruit N=1200 female youth over a period of around twice that time. 
We expect the sample accrual rate to be slower than in MP3 Youth, because we will be recruiting 
only female youth and mainly those out of school (a large proportion of younger MP3 Youth girls 
were in school and easier to recruit). In addition, we have two different recruitment strategies, and 
the home-based strategy may be more labor intensive and time consuming than a community 
mobile event. We therefore expect a somewhat lower accrual rate. Therefore, in order to stay 
within the estimate 12 months of recruitment, we will increase our field staff during the 
implementation phase of the project. Sample size estimates are also based on IRDO’s program 
data and the estimated number of youth in Homa Bay. We expect large numbers of youth will be 
successfully recruited from the home and mobile events (IRDO reaches tens of thousands of 
youth/year) for a total sample size of ≥ 1200 female youth.  
 
Power Analysis 
Power calculations for Aim 1 are based on the yield of newly diagnosed HIV across recruitment 
strategies and testing options offered to female youth. Using version 12 of the PASS program 
(Hintze, 2013) for logistic regression, we did not approach this power analysis from the 
perspective of calculating a sample size needed to detect a particular effect size with at least 80% 
power. Rather, because this part of the study (Aim 1) is not a clinical trial but rather an exploration 
of preferences and yield of recruitment and participant-selected testing strategies, we started with 
the large, feasible sample size and determined the size of effects that could be detected with at 
least 80% power when comparing recruitment strategies and HIV testing approaches.  
 
The expected percentage of girls testing positive is based on our MP3 Youth pilot study. In that 
study, 55 of 636 female youth not previously diagnosed were found to have HIV infection (data 
not yet published). Thus, we expect about 9% of all tested females in this study to have HIV 
infection not previously diagnosed.  
 
With this estimate of the expected percentage of girls with newly diagnosed HIV infection, we 
asked how small of an increase in the odds of newly diagnosed HIV infection could be detected 
with 80% power when community-based recruitment is compared to home-based recruitment. 
With 600 youth recruited by each strategy, power is 80% to detect an odds ratio of 1.67, in other 
words, a modest increase from 9% to 14% newly diagnosed with HIV infection. When comparing 
testing approaches, and assuming an equal proportion of girls prefers each approach and testing 
approach does not interact with recruitment strategy, power is 80% to detect an odds ratio of 1.85. 
If there is an interaction between recruitment strategy and testing approach, when comparing 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 63 of 110 
 
 
testing approaches within a recruitment strategy (i.e., estimating simple main effects), power is 
80% to detect an odds ratio of 2.32.  
 
These calculations show the proposed sample size (N=1200) is capable of detecting modest 
differences in the yield of newly diagnosed HIV infection across both recruitment strategies and 
testing approaches.  
 
Among the approximately 108 female youth we expect to be newly diagnosed with HIV infection, 
about 20% are expected to successfully initiate HIV care at a health facility after a single SMS 
message. The remaining 80% (N=86) who are not linked to care after the initial SMS message 
will be randomly assigned to either continued SMS messages or to economic incentives. 
Assuming at least 60% are linked to care at some point during follow-up, survival analysis 
employing Cox regression will be able to detect a hazard ratio of 2.2 describing the impact of 
treatment condition (continued SMS vs. economic incentives) on the occurrence and timing of 
successful linkage to care at a health facility, with 80% power. 
15.12 Randomization 
Our study is observational in nature, but the Aim 2a adaptive linkage to care intervention does 
contain a randomization component. Newly diagnosed HIV-positive females identified in our study 
will be randomized to receive standard referral to link to care or standard referral plus SMS 
message to link to care. Those that do not successfully link to care will then be re-randomized to 
receive either an SMS message or an economic incentive. We will utilize an approach called 
permuted blocks randomization for participant assignment to the intervention. Permuted block 
randomization has several advantages, one of which is promoting equal distribution of participants 
in each group.  A list of random allocations will be generated by the study statistician in randomly 
ordered permuted blocks of either 2, 4, 6, 8 or 12 allocations. The allocation list will be stored in 
a password protected file which will only be accessible to the study statistician, data manager or 
project manager.  
The field study coordinator will provide a list of study ID numbers of participants needing 
allocation. The study statistician or data manager will record the unique study identification 
number and the date of the assignment on the allocation list, and relay the assignment to the field 
study coordinator. Alternatively, if we find that this is not efficient during implementation of our 
study, we will pursue other methods, such as using sequentially numbered, sealed envelopes 
containing participant allocation that may be prepared beforehand (Doig & Simpson, 2005). 
We anticipate a total of 108 HIV positive participants to be randomly assigned to either standard 
referral or standard referral plus SMS at the first randomization. Participants not linked to care 
after the first randomization will be re-randomized in a 1:1 ratio to receive either another SMS text 
or an economic incentive.  
See Section13: Statistical Considerations and Section 18: Data Handling and Record Keeping. 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 64 of 110 
 
 
16. QUALITY CONTROL AND QUALITY ASSURANCE 
A co-principal investigator who is a Kenyan physician with clinical research experience, the project 
manager, and IRDO internal research auditor who is a clinician (Clinical Officer) with extensive 
experience overseeing quality assurance in numerous clinical trials have been identified as the 
monitors to conduct Quality assurance/Quality control for the study. Following written standard 
operating procedures as they appear in the study specific operating procedures (SSP) and this 
protocol, the monitor will verify the study is conducted and data are generated, documented 
(recorded) and reported in compliance with the protocol, IRB, government of Kenya regulations, 
DAIDS and any other regulatory requirements. Details about data specific QA/QC are provided in 
the data management SOP. Also the study specific protocols contain built-in QA/QC procedures 
per intervention.  
 
 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 65 of 110 
 
 
17. ETHICS/PROTECTION OF HUMAN SUBJECTS 
 
17.1  Institutional Review Board/Ethics Committee 
The principal investigators will ensure that this study is conducted in a manner that protects 
human subjects.  
Prior to implementation of this protocol, and any subsequent full version amendments, each site 
will have the protocol and the protocol informed consent form(s) approved, as appropriate, by the 
local institutional review board (IRB)/ethics committee (EC) and any other applicable regulatory 
entity (RE). Upon receiving final approval, sites will submit all required protocol registration 
documents to the DAIDS Protocol Registration Office (DAIDS PRO) at the Regulatory Support 
Center (RSC). The DAIDS PRO will review the submitted protocol registration packet to ensure 
that all of the required documents have been received 
Following DAIDS approval, the Kenyatta National Hospital and Impact Research and 
Development Organization submit for review and approval the GIRLS Study protocol to their 
governing IRB in Kenya, Kenyatta National Hospital/University of Nairobi - Ethics and Research 
Committee (KNH-ERC). Once approval is granted from the local IRB (KNH-ERC) the approval 
and protocol are submitted to Yale University’s Human Research Protection Program. 
 
17.2  Informed Consent (IC) Process 
 
Site-specific informed consent forms (ICFs) WILL be reviewed and approved by the DAIDS PRO 
and sites will receive an Initial Registration Notification from the DAIDS PRO that indicates 
successful completion of the protocol registration process. A copy of the Initial Registration 
Notification should be retained in the site’s regulatory files. 
Upon receiving final IRB/EC and any other applicable RE approval(s) for an amendment, sites 
should implement the amendment immediately. Sites are required to submit an amendment 
registration packet to the DAIDS PRO at the RCC. The DAIDS PRO will review the submitted 
protocol registration packet to ensure that all the required documents have been received. Site-
specific ICF(s) WILL NOT be reviewed and approved by the DAIDS PRO and sites will receive 
an Amendment Registration Notification when the DAIDS PRO receives a complete registration 
packet. A copy of the Amendment Registration Notification should be retained in the site's 
regulatory files.  
For additional information on the protocol registration process and specific documents required 
for initial and amendment registrations, refer to the current version of the DAIDS Protocol 
Registration Manual. 
Informed consent is required to participate in the study (See Appendices C, D & E). 
 
All female youth coming to the mobile event site (potential participants) or recruited from the home 
will be consented by the trained RAs/Counselors/Study Staff who will explain more of the study, 
eligibility, and study procedures.  

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 66 of 110 
 
 
1. Potential participant’s age will be determined by asking them how old they were at 
their last birthday.  
2. If the participant is less than 18 years old and not an emancipated minor, then parental 
consent will be obtained and thereafter, participant assent will also be obtained. Both 
the parent and the youth will append their signature on the respective IC form (on-
site). 
3. If 18 years of age or older, or an emancipated minor by Kenyan standards, informed 
participant consent procedures will continue.  
 
RAs/Counselors/Study Staff will provide the participant with the approved IC form in the 
participant’s language of choice; English, Dholuo or Kiswahili. Participants will be given the option 
of having the script read to them if they cannot read or feel more comfortable with the form being 
read to them. RAs will not assume a participant can read. They will clarify the main points of the 
IC form with potential participants, to assess comprehension. This information includes: 1) 
purpose of study, 2) time commitment including follow up visit(s), 3) study procedures, 4) 
confidentiality, 5) incentive/payment, 6) eligibility assessment, and 7) voluntary nature of the 
study.  
 
RAs will allow time for participants to ask questions about the study. Once all questions have 
been addressed, they will verify that the potential participant is still interested in being in the study. 
If so, the RA will witness the participant and or parent sign and date the consent/assent form, or 
place left thumb print if participant/parent cannot write. (An additional witness signature will be 
required on the form if this option is used). RAs will then sign and date the consent/assent form 
and provide the participant with a copy of the consent/assent form.  The potential participant will 
then be screened for eligibility. Individuals who do not consent/or withdraw consent, or who do 
not meet the study eligibility criteria will not be enrolled in the study but will receive referrals for 
relevant services. 
 
17.2.1 Minor Assent/ Informed Consent (IC) Process 
 
In order to participate in the study, participants (18 and older or emancipated minors) must 
undergo written IC procedures. Participants under the age of 18 must bring parent(s) or 
guardian(s) to give consent on behalf of minors who must also give assent. Emancipated minors 
can give their own consent. Participants will sign the overall study IC document during registration.  
Upon accessing services, participants will provide the IC form to the provider.  Upon completion, 
a copy of the completed IC form will be provided to the participant. 
 
Participants under the age of 18 who choose staff-aided HTS, will have two options once the 
parent has consented to the test: (1) the youth can request that parent stays for the youth’s test 
results and post-test counseling or (2) the youth can request that her parent not see the test 
results, but if she tests positive for HIV, she must designate a guardian to whom she will disclose 
her results, in order to be able to receive treatment for HIV.  However, if the youth is considered 
an “emancipated minor”, that is she is under 18 years old, but is either married, pregnant or has 
an STI, she is exempt from the need to disclose her status to a parent or guardian. 
 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 67 of 110 
 
 
17.3 Exclusion 
of 
Women, 
Minorities, 
and 
Children 
(Special 
Populations) 
There are no special exclusions other than males as this study is focused on young females who 
have a higher HIV prevalence and have been identified by the Government of Kenya as being a 
highly vulnerable group. Innovative strategies across the HIV prevention care continua are 
needed to reach young women; programs already exist to reach men for voluntary medical male 
circumcision (VMMC). This underlies the scientific justification for the focus on young women in 
this study. 
 
17.4  Participant Confidentiality 
All study staff will be trained on participant confidentiality. All study staff will hold all aspects of the 
study (protocol documentation, and all other study related documents) in the strictest confidence. 
No information concerning the study or data will be released to any unauthorized third party, 
without written permission from the sponsor and the study participant. 
The study monitors (Yale, KNH, IRDO), other local, US, and international regulatory entities, and 
IRBs/ECs, or other authorized representatives of the sponsor (e.g., monitors, DAIDS, and OHRP) 
may inspect all documents and records required to be maintained by the Investigator, including 
but not limited to, medical records (office, clinic or hospital) for the participants in this study.  
See section 18: Data Handling and Record Keeping for additional information on participant 
confidentiality.  
We will ensure confidentiality with mobile phone usage confirming user identity for SMS 
messages as well as airtime incentive and digital cash transfers. (See data management 
responsibilities section). 
 
17.5 Potential Risks and Benefits 
 
17.5.1 Potential Risks 
Sensitive Information 
Surveys will be conducted on a staff administered computer assisted personal interview (CAPI) 
designed to collect and protect sensitive information. Computer assisted self-interviews (ACASI) 
has been found to have mixed results in terms of social desirability bias reporting of sensitive 
behaviors by Kenyan youth, suggesting a benefit to staff elaboration and support found in the 
CAPI. Only authorized study staff will have access to the participant’s questionnaire responses.  
SMS text surveys from the cohort will be sent over TCP/IP as encoded data without identifiers. 
HIV Testing – Adolescents 
 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 68 of 110 
 
 
HIV testing in adolescents poses special risks particularly for those who are still under the care of 
parents and guardians because of the fact that HIV can be sexually transmitted. This may result 
in adolescents refusing to test unless they are assured of confidentiality of the results. Study 
procedures will therefore ensure that all young people are provided with the opportunity to test in 
private. HIV testing will be accompanied by age appropriate, individualized HIV prevention 
messages for all adolescents whether testing HIV negative or positive.  Prevention with positives 
messaging and referrals will be incorporated into the post-test counseling, to include referral to 
appropriate PMTCT for those girls who test HIV+ and are pregnant. Youth may be embarrassed 
discussing their sexual history. Youth may become worried, anxious, or upset by learning the 
result of their HIV test is positive. Taking a finger stick blood sample for HIV testing poses minimal 
risk of infection because we will use sterile equipment. However, the finger stick may cause a little 
pain. 
 
Social Harms 
 
It is possible that involvement in the study could lead to stigmatization, discrimination, disruption 
to social support network, abuse (physical/verbal). We will monitor these and will protect 
confidentiality to reduce potential social harms.   
Stigma 
Adolescents who test positive may be particularly vulnerable to isolation, stigma and 
discrimination and will therefore be proactively linked to youth and other support groups in the 
community for ongoing psychosocial support. They will also be assisted with getting appointments 
at the nearest facility offering HIV care and treatment services in their catchment area. HIV labs 
and medications at these facilities are free, but sometimes transport costs are a barrier. 
Therefore, the study’s one-time financial incentive linkage arm is justified and not an 
undue incentive. 
Minimization of Risk 
All efforts will be made to minimize risks for participating in this study. Study staff are trained in 
human subjects’ protections. Study data will be collected, stored, and analyzed following strict 
security procedures.   
USSD or SMS text surveys from the cohort will be sent over TCP/IP as encoded data without 
identifiers. Data will be kept secure and minimal personal identification information will be 
collected, and will then be anonymized in the study database. Safeguards for protecting 
confidentially of questionnaires and other data will be strictly enforced. 
 
Physical risk protection 
 
The study staff responsible for obtaining fingerstick capillary blood samples will be trained in 
infection control and will use disposable gloves, alcohol swabs, sterile gauze, and retractable, 
disposable lancets so as to eliminate risk of contamination.  As part of the informed consent 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 69 of 110 
 
 
procedure, all eligible respondents will be told that the supplies that will be used are clean and 
sterile. 
 
Psychological risk protection 
 
All study staff will undergo training on HIV counseling and testing as per the Kenyan national 
curriculum and all HIV testing sessions will be conducted according to the Kenya guidelines for 
HIV testing. Several study members are specially trained clinicians able to handle crises situations 
due to any difficulties in coping with positive HIV test results. 
 
Protection of Minors  
 
In order to participate in the study, participants (18 and older or emancipated minors) must 
undergo written informed consent procedures for the study elements. Participants who are age 
15-17 and are not emancipated minors must bring parent(s) or guardian(s) to give consent on 
behalf of these minors who must also give assent. Emancipated minors can give their own 
consent.  Participants will sign the study informed consent documents during enrollment. One 
copy of the signed informed consent form will be provided to the participant. 
 
17.5.2 Potential Benefits 
Although HIV testing has inherent risks, knowledge of HIV status is a powerful tool for behavior 
change and is an entry point for care and treatment services for the HIV infected. Community-
based counseling and testing improves access to testing and is associated with high levels of 
acceptance and identification of a large proportion of previously undiagnosed HIV. However, the 
majority of Kenyans who desire to know their status have never had a HIV test. Youth in rural 
Kenya have limited opportunities to get a HIV test. This study will therefore be an important way 
of improving access to HIV testing for youth who are at high risk. 
All study subjects will benefit by receiving evidence-based HIV prevention services. High risk 
negative females will receive referral for PrEP, which the GoK has recently endorsed (January 
2016) as a national strategy for HIV prevention among key populations, including high-risk 
females. In addition, all HIV-positive youth identified during the study will be linked with community 
support groups as well as lifesaving care and treatment services for themselves. Those found 
pregnant will be supported to access prevention of mother-to-child transmission (PMTCT) 
services. Information regarding how to prevent infection or transmission of HIV to and from their 
sexual partners will also be offered. 
 
All participants will receive free HIV counseling and testing, information on the locations and 
operating times of the nearest HTS centers and other community-based HIV service 
organizations.  Those found to have HIV infection will be properly counseled and referred for 
appropriate follow-up at HIV care and treatment facilities in the area. Those randomized to 
additional linkage strategies (SMS, one-time cash transfer) will receive additional support for 
linking to care.  All HIV-negative girls will receive counseling around risk reduction, and those 
high-risk HIV-negative girls will receive referral for PrEP and SMS messages about the benefits 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 70 of 110 
 
 
of recommended re-testing, which may support HIV infection avoidance or early detection of HIV 
for treatment. 
 
The community will benefit from knowledge gained during interaction with the study staff on young 
peoples’ HIV and reproductive health.  Several recent studies in Kenya have documented that 
the community feels more HIV prevention services for youth are needed in western Kenya (Knopf, 
2012; Omanga et al., 2013). 
 
Importance of the Knowledge to be Gained 
The information gathered is expected to contribute to the literature by providing some of the first 
data on high yield seeking strategies combined with uptake of self-testing data, and an SMS 
based adaptive linkage to care intervention for young women in sub-Saharan Africa, who are 
among the highest HIV risk age-group globally. As such the lessons learned from the study are 
expected to be generalizable to the many similar settings where young people are at high risk of 
HIV acquisition. 
 
17.6  Study Discontinuation 
 
The principal investigators, sponsor, and the IRB/IEC, have the authority to discontinue or 
suspend the study. The Investigator will promptly inform the participants if the study is 
discontinued or suspended and will assure appropriate referrals. Furthermore, if the investigator 
discontinues or suspends the study, the institutions, sponsor and IRB will be promptly notified 
with a detailed written explanation. If the sponsor discontinues or suspends the study, the 
institutions and IRB will be promptly notified with a detailed written explanation. If the IRB 
discontinues or suspends the study, the institutions and sponsor will be promptly notified with a 
detailed written explanation. 
 
 
 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 71 of 110 
 
 
18. DATA HANDLING AND RECORD KEEPING 
18.1  Data Management 
18.1.1 Screening IDs, Participant ID Numbers (PTIDs), and unique barcodes 
Screening IDs will be assigned to all potential study participants who are approached for 
enrollment.  
• 
Screening IDs are assigned at the participant’s first screening visit, regardless of whether 
or not the potential participant completes screening for the study.     
• 
Participant Identification Numbers (PTIDs) are assigned at Enrollment and are separate 
from the Screening ID. 
• 
The Nairobi Office will provide both Screening IDs and PTIDs.  
 
Both Screening IDs and PTIDs ideally will be assigned in sequential order; however, it is 
recognized that deviations from sequential ordering occur from time to time, e.g., when several 
potential participants are approached for possible screening or enrollment at the same time.  
 
Pre-printed barcode labels will be procured from a vendor. Study staffer will place a pre-printed 
barcode label (with a unique barcode number) on the camera and on the self-test kit. Study staffer 
will then record the barcode numbers on a tracking form to ensure that it links with the participant’s 
study identification number. 
 
The Data Manager/Designee is responsible for maintaining the list of screening IDs and PTIDs 
and assigning screening IDs and PTIDs to potential participants. The Data Manager/Designee 
will also maintain the list of the unique barcodes affixed on the self-testing kit and the camera that 
is assigned to each participant who chooses the self-testing option. 
• 
The Data Manager will enter participant details (age, last-name) into the Participant 
Tracking Access Database after the participant visits and after he/she has reviewed the 
information for accuracy and completeness. 
• 
The Data Manager will enter the unique barcode number affixed to the test kit and camera 
into the Participant Tracking Access Database. He/she will ensure that the barcode 
numbers are linked to the correct participant identification number. Electronic photos from 
the camera will be uploaded to a study computer and labeled with the unique camera 
barcode number. No participant name or other identifier will be attached to these images.   
Additional information on organization, types of data, and storage of study files can be found in 
the SSP. 
18.1.2 Procedures for Organization of Files 
 
Screening Folders: Each participant who screens for the study will be assigned a Screening 
Folder.   

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 72 of 110 
 
 
• 
Screening folders will contain documents identified by the screening ID, and will not 
contain any documents with the participant names or identifiers.  
• 
Screening folders will be pre-assembled by the Data Manager, and will contain all forms 
necessary for the screening visits.  
• 
Hard copy screening folders will be stored in a lockable cabinet in the study office.  
• 
The hard copy and electronic screening folders of participants who do not enroll in the 
study will be stored separately.    
• 
Electronic screening data will be stored in a password protected database. 
 
Chart Note Binders 
• 
Enrolled participants will each have a chart-note binder.  
1. Participants will be identified only by Screening ID or PTID on documents in 
these binders.   
2. Forms from screening visits which do not contain participant names or 
identifiers will be transferred to the Chart Note Binders. 
 
• 
Name Charts 
1. Each participant will be given a Name Chart at the first screening visit, and will 
keep the same chart if he/she enrolls in the study.  
2. Name charts will be stored in a lockable cabinet in the Study Coordinator’s 
office.  
3. Name charts will be stored in cabinets which are separate from the Link Log, 
CRF binders, and Chart Note Binders.   
4. Documents in the Name Chart of screening participants will include: 
a) Screening Informed Consent Forms (ICFs) 
5. Documents in the Name Charts of enrolled participants will include the above 
and: 
a) Enrollment Informed Consent Forms 
b) Locator Forms (names and contact information) 
c) Tracer Forms  
6. As needed:  
a) Locator information updates 
b) Participant tracking forms 
c) Tracer forms (for calls and if no-response, or in person visits) 
d) Any other information about the participant that includes participant 
name 
 
• 
Link Log:  A paper Link Log will link the participant name and Screening ID/PTID.  
1. The link between participant name and PTID will also be stored in a password 
protected database (Participant Tracking Database).  
2. The paper Link Log will be stored in a lockable drawer in the Study 
Coordinator’s desk with limited access by study coordinator, principle 
investigators and representatives of the regulatory bodies only.  

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 73 of 110 
 
 
3. The Participant Tracking Database will be stored on a password protected 
computer in the Data Manager’s office.  
4. Only the Data Manager and Data Manager backup/Designee, Study 
Coordinator, and Principal Investigator will have access to the Participant 
Tracking Database.   
5. The electronic database will be backed up daily and kept on a separate digital 
storage (e.g., CD, encrypted thumb drive, etc.) in the data room.  We will also 
have a secure web based backup at Yale.  
6. A second back up copy will be kept offsite in a lockable drawer in the Principal 
Investigator's desk. This will be created daily; the digital storage will be 
transferred weekly to the PI.  
7. The Study Coordinator, Data Manager, IT Officer or Driver may transport the 
offsite back up digital storage in a secure fashion, not leaving it unattended at 
any time.   
8. Staff who transports the Offsite storage device will receive instruction on 
its proper transport. 
18.1.3 
Data Management Process 
18.1.3.1 Quality Assurance (QA)/Quality Control (QC) 
1. The SMS survey will be programmed so that it will be impossible to move from 
one question to the next unless all prior questions have been answered. The 
Data Manager will at the end of the week distribute a report on the quality and 
completeness of data received during the week. This information will be used 
to advise the field staffers on improvements that need to be made. 
18.1.3.2 Data Revision: 
1. No changes will be made to the Master Database.  All revisions, corrections, 
additions and deletions will be made using a Data Revision Script. The Data 
Manager will maintain the Data Revision Script, which will work by copying the 
Master Database then updating existing data, deleting erroneous data, and 
inserting missing data through standardized queries. 
2. In cases where study staff are not sure how to resolve a query, or when 
repeated attempts to resolve a query do not result in elimination of the query 
from the QC report, the Data Manager will contact the Database Administrator 
for guidance. 
18.1.3.3 
Data Storage Process 
• 
All study data — screening and on-study — will be stored securely as described in this 
protocol. All study data will be password security-protected. The data collected on the 
tablet or smartphone using CAPI will be encrypted in the field/within the software such that 
only password-authorized study staff can access the data. The cohort USSD - SMS text 
data will be attached only to an anonymous study ID and thus not contain any personally 
identifying information. 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 74 of 110 
 
 
1. All participant study files will be retained for at least five years after study 
completion unless otherwise specified by the Kenyatta National Hospital 
Administrative Office.   
2. All files will be retained on-site throughout the study period of performance.   
3. Arrangements for record storage after the study period of performance will be 
made in accordance with instructions to be provided by the Kenyatta National 
Hospital Administrative Office.  
 
• 
The Master Database and the Data Revision Script will be backed-up on a separate digital 
device at the end of each day and stored onsite. Weekly back-ups will be transported for 
offsite storage.  
 
• 
Information entered and stored in the Participant Tracking Database — which is not 
considered source data — will be backed-up on a separate digital device at the end of 
each day.  
1. This copy of the database will be overwritten with a new copy the following day.    
2. A second back up copy will be kept offsite in the Principal Investigator’s desk.   
3. The Study Coordinator, Data Manager, IT Officer or Driver may transport the 
offsite back up in a secure fashion, not leaving the CD unattended at any time.   
4. Staff who transports the Offsite digital device will receive instruction on its 
proper transport and a tracking log filled. 
18.1.4 Confidentiality 
• 
De-identified data: Participant study files will be stored as described in the previous 
sections.  
1. The use of participant names to identify study related documents will be 
minimized to the extent possible. All documents bearing participant names will 
be stored apart from documents bearing PTID or Screening ID or barcode 
numbers. In lieu of names, the study ID will be used so that the names will not 
appear on study documents.  
 
• 
Locked Cabinets: All files will be stored in locked cabinets in Homa Bay and Nairobi, with 
access limited to study staff.   
1. During working hours, the data room will be unlocked when the IT Officer is 
present to allow staff access to phones and other files to conduct participant 
visits and perform other required data management functions.  
2. If the IT Officer is away from the data room, the key for the data room will be 
left with the Study Coordinator, or other designated staff member. 
3.  At the end of the workday, the IT Officer will lock the data room.  The IT Officer 
will keep the key to the data room. One additional key to the data room will be 
kept at the study clinic by the Study Coordinator.  A set of spare clinic keys, 
including a data room key, will also be kept in a locked cabinet in the GIRLS 
Administrative Office.  
4. Only the PI, Study Coordinator, and Study Administrator/Designee will have 
access to this key.   

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 75 of 110 
 
 
5. Non staff members who may need to perform tasks in the data room such as 
carpentry or repairs will be allowed into the data room only when the IT Officer 
is present and care will be taken to ensure that participant records are not in 
view. 
 
• 
Access to the Participant Tracking Access Database, which contains names, PTID, 
Screening ID, barcode numbers and information about each study participant, will be 
limited to authorized study staff members through the use of password protections.  
1. The Data Manager, who will be responsible for printing out clinic schedules 
and reports from the database, will never print out reports that bear participant 
names.  
 
• 
No participant identifiers other than the Screening ID or PTID will be recorded on 
any CRF or other documents not in the name charts. 
1. Written permission will be obtained from participants prior to the release of any 
study-related information that personally identifies the participant outside of the 
study site. 
18.2  Data Capture Methods 
18.2.1 Data Collection 
All participants who are eligible, consented, and registered for the GIRLS study will be required 
to complete a baseline behavioral CAPI survey and an HIV testing experience satisfaction SMS 
survey. HIV positive participants who have successfully linked to care will complete SMS surveys 
every 3 months as described in the study procedures section. A subset of the HIV negative 
participants will also complete SMS surveys at 6 and 12 months. The HIV positive cohort and the 
HIV negative cohort will also complete a face-to-face (or telephone) interview at 12 months. If a 
phone interview is conducted, participant’s identity will be confirmed by asking the participant to 
provide three names used at enrollment as well as their current age, so that her identity may be 
ascertained correctly.   
 
Administering Computer Assisted Personal Interview (CAPI) Surveys – interviewer 
assisted. 
• 
Data Collection Setup 
1. The CAPI will be staff-administered on a tablet computer. 
2. All survey questions will be pre-programmed in tablet by the IT Officer and the 
Data Manager who will be responsible for training the field staffers and other 
study personnel on their use.  
3. The CAPI will be administered by the RAs/Counselors.  
4. Once a participant is enrolled in the study, her screening data will be entered 
into the main database in the study IT Office.   
• 
Data Collection Procedures 
1. Participants are required to complete the baseline survey. 
2. The behavioral CAPI survey will be administered after IC. The survey should 
be completed in one sitting.  

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 76 of 110 
 
 
3. For sensitive questions, the participant can input the answer without the 
interviewer viewing the screen, to reduce discomfort. 
4. Once complete, the RA will thank the participant for completing the survey.  
 
• 
Data Transfer Process 
1. All data will be temporarily saved on the hard-drive of the tablet.  
2. The data from the tablets will then be securely uploaded to the IT Office Data 
Computer and then securely transferred to the Data Manager’s office in Nairobi 
where the GIRLS study database will be housed. This transfer will occur within 
12 hours after completion of data collection.  
3. Data will not be deleted from the tablets before it is uploaded onto the IT 
Officer’s Data Computer and has been transmitted to Nairobi Office.  
4. The IT Officer will make a printout of all information on the tablets and file these 
hard copies in binders filed sequentially according to the Participant 
Identification Number (PTID) or Screening ID number and will be stored on 
shelves in lockable cabinets in the IT Office, separate from the Name Charts 
and Link Log (which will be stored in the Study coordinator’s office).  
5. Information in the tablets will be identified only by the Participant Identification 
Number (PTID) or Screening ID number.  
6. The RA assigned to the tablet will be responsible for it. When not in use, the 
tablet will be locked in a lock box. At the end of the day, tablets will be stored 
in lock boxes in the GIRLS study office in Homa Bay.  
 
SMS Survey data collection 
Participants in the HIV+ cohort will receive SMS text reminders to link to care and will also receive 
cell phone surveys regularly for follow-up data collection. The content of the surveys was 
previously described in section 11. USSD or SMS text surveys from the cohort will be sent over 
TCP/IP as encoded data without identifiers. Data will be kept secure and minimal personal 
identification information will be collected, and will then be anonymized in the study database. 
Safeguards for protecting confidentially of questionnaires and other data will be strictly enforced. 
Surveys will be automatically sent by the program used to push notifications. The responses will 
be saved in the GIRLS study database. The management of the SMS data will follow the same 
process as other forms of data for management and storage.   
 
18.3  Types of Data 
Examples of data to be collected include behavioral data, HIV testing modality uptake, HIV status, 
CD4 count, viral load level, linkage to care, and adverse events. See Table 1: Evaluation Plan, 
page 61 for detailed types of data collected. 
 
18.4  Source Documents and Access to Source Data/Documents 
The implementing partner, IRDO and clinical sites (Homa Bay County Referral hospital, Mbita 
and Ndhiwa Health centers) will maintain appropriate medical and research records for this study, 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 77 of 110 
 
 
in compliance with ICH-GCP, regulatory and institutional requirements for the protection of 
confidentiality of participants. The data management/analysis team (data managers and 
biostatistician), field study coordinator, project manager, and principal investigators will have 
access to the data. Once data are de-identified they can be shared with the rest of the scientific 
team as appropriate.  
The data management site will permit authorized representatives of the sponsor(s), NIAID, and 
other local, US, and international regulatory entities to examine (and when required by applicable 
law, to copy) clinical records for the purposes of quality assurance reviews, audits and evaluation 
of the study safety and progress. 
 
18.5  Timing/Reports 
See section 18 Data Handling and Record Keeping 
 Data Management. 
 
18.6  Study Records Retention 
See section 18 Data Handling and Record Keeping 
 Data Management. 
 
18.7  Protocol Deviations 
All protocol deviations will be immediately reported to the IRBs as well as the study sponsor (see 
section 16 Quality Control and Quality Assurance). Regular (monthly or more frequently as 
necessary) communication will provide a consistent and regular forum to examine protocol 
compliance (see section 15.1  Safety Monitoring). 
Intensive trainings on the study specific protocol and intermittent in-service trainings will be 
scheduled to ensure protocol compliance by all study staff.  
 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 78 of 110 
 
 
19. PUBLICATION POLICY 
 
Publication of the results of this trial will be governed by NIAID publication policies. All publications 
shall make the following acknowledgement as per the publication policy: 
 
Research reported in this publication was supported by the National Institute Of Allergy And 
Infectious Diseases of the National Institutes of Health under Award Number R01AI122797. The 
content is solely the responsibility of the authors and does not necessarily represent the official 
views of the National Institutes of Health 
 
Following completion of the study, the investigator may publish the results of this research in a 
scientific journal. The International Committee of Medical Journal Editors (ICMJE) member 
journals have adopted a trials-registration policy as a condition for publication.   
 
The study will be registered under ClinicalTrials.gov. We will undertake randomized comparison 
of interventions in the adaptive linkage to care pilot.  
 
ClinicalTrials.gov Identifier: NCT02735642 
Website: https://clinicaltrials.gov/ct2/show/NCT02735642 
 
 
 
 
 
 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 79 of 110 
 
 
Appendix A:   Schedule of Procedures/Evaluations 
 
Procedures (All Participants) 
Baseline 
2 weeks 
3 weeks 
3 months 
6 months 
9 months 
12 months 
Recruitment (at home or mobile 
event) 
x 
 
 
 
 
 
 
Signed Consent Form 
x 
 
 
 
 
 
 
Eligibility Assessment 
x 
 
 
 
 
 
 
CAPI Behavioral Survey 
x 
 
 
 
 
 
 
HIV Testing 
 
 
 
 
 
 
 
Enrollment for follow-up 
x 
 
 
 
 
 
 
ART/PMTCT referral 
x 
 
 
 
 
 
 
Condoms 
x 
 
 
 
 
 
 
Other referrals as appropriate 
x 
 
 
 
 
 
 
SMS HIV testing satisfaction 
survey (KSh 100) 
 
x 
 
 
 
 
 
Staff administered survey for 
participants who chose HIV 
self-testing 
 
x 
 
 
 
 
 
HIV Negative Cohort 
SMS primary prevention survey 
(KSh 100 each time complete 
survey) 
 
 
 
 
x 
 
x 
HIV re-test 
 
 
 
 
 
 
x 
Exit interview (KSh 400) 
 
 
 
 
 
 
x 
HIV Positive Cohort 
HIV test/confirmation 
x 
 
 
 
 
 
 
CD4 POC test 
x 
 
 
 
 
 
 
VL test 
x 
 
 
 
 
 
x 
Adaptive intervention pilot first 
randomization: standard 
referral or standard referral and 
SMS 
x 
 
 
 
 
 
 
Adaptive intervention pilot 
second randomization: SMS or 
economic incentive of KSh 400 
 
 
x 
 
 
 
 
Retention in care survey (KSh 
100 each time complete 
survey) 
 
 
 
x 
x 
x 
x 
Exit Interview (KSh 400) 
 
 
 
 
 
 
x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   (X) = as indicated/appropriate 
 
 
 
 
 
 
 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 80 of 110 
 
 
Appendix B:   Logic Model 
 
 
Study Objectives 
Resources/Inputs 
(what we invest) 
In order to accomplish 
our activities we will 
need the following: 
Activities 
(what we do) 
In order to address HIV 
prevention we will 
conduct the following 
activities: 
Outcomes (Outputs) for Aims 
1 and 2. 
We expect that once completed 
or under way, these activities will 
produce the following evidence 
along the HIV prevention and 
treatment continua: 
Outcomes for Aim 3 
Long-term Outcomes/ 
Impact 
We expect that once 
completed our study will 
have the following impact  
Aims 1 and 2 Objectives:  
 
(1) To determine the 
preferred recruitment venue 
and testing modality that 
gives the highest number of 
HIV infected and at risk 
female youth aged 15-24 
years in Homa Bay County, 
Nyanza region, western 
Kenya. This will be 
determined by examining 
uptake of the two ‘seek’ 
strategies (community or 
home-based) and the three 
‘test’ strategies (self-testing, 
HTC in a home/mobile 
setting, or facility-based 
HTC) among female youth; 
 
(2) To pilot and evaluate an 
adaptive intervention to link 
HIV-positive female youth 
to treatment and care 
services; and 
 
(3) To identify barriers and 
facilitators to seeking HIV 
care services after 
receiving a positive 
diagnosis. 
Funding 
Human Subjects 
Approval 
Aims 1 and 2 Outcomes: 
Aim 3 Outcomes: 
Increased HIV 
testing/counseling 
Community 
engagement 
Hire and train field staff 
Recruitment/Seek: Ability to 
identify and recruit female youths 
that are high risk for HIV infection 
using two seek strategies (home-
based vs. community-based) 
-The proportion of youth in the 
community who accept study 
screening (estimated from total 
youth approached as the 
denominator);  
-The proportion of youth who 
accept study enrollment 
(estimated from youth screened 
and eligible as the denominator); 
 
Conduct comprehensive 
economic evaluation to 
determine the comparative 
cost effectiveness of the 
seek, test, link, and 
prevention interventions. 
 
Increased correct and 
consistent condom use 
Scientific team 
Enroll participants. 
Testing:  
-Testing uptake by different 
testing modalities;  
-Completion of confirmatory 
testing;  
-Proportion that are positive;  
-Among those who are positive, 
completion of baseline collection 
of CD4 and viral load tests. 
 
Seek:  Compute the cost per 
HIV-infected female youth 
identified under each ‘seek’ 
strategy (home-based vs. 
community based) 
Increased treatment/ART 
adherence, reduced HIV 

 
 
 
GIRLS Study Protocol           Version 1.0             September 9, 2016 
Page 81 of 110 
 
 
(4) To deliver an HIV 
prevention intervention to a 
randomly selected subset 
of negatives. 
 
 
Aim 3 objectives: 
 
To conduct an economic 
evaluation, using cost 
effectiveness analyses to 
determine the relative utility 
of each seek, test, link, and 
prevention intervention. 
Established local 
implementing partner 
Pilot adaptive linkage 
intervention. 
Linkage to Care:  
-Percent of females who tested 
positive that attended a first HIV 
care appointment at an HIV 
Comprehensive Care Center 
(CCC)  
-Time to link to care after positive 
confirmatory test result. 
 
Test:  Compute the cost per 
HIV-infected female youth 
identified under each ‘test’ 
strategy (self-testing, staff 
delivered HTC testing, 
standard facility-based 
HTC); 
Increased use and familiarity 
with oral HIV self-testing 
kits. 
Protocol 
Follow up cohorts 
Retention in Care: 
-Completion of viral load testing 
at 12 months; 
-Self-report of appointment 
attendance via SMS at 3, 6, 9, 
and 12 months. 
-Medical record review to confirm 
self-report of clinic attendance. 
Link:  Calculate the 
incremental cost-
effectiveness ratio of the 
adaptive linkage to care 
intervention among HIV 
positive female youth; 
 
 
Training 
Disseminate results 
Primary Prevention: 
-HIV risk behaviors, and condom 
use, at 6 and 12 months for a 
subset of negatives (N≈185); 
-HIV re-testing for a sub-set of 
negatives (N≈185) at 12 months; 
-HIV status for a sub-set of 
negatives (N≈185) at 12 months. 
Prevention:  Compute the 
cost of the SMS prevention 
intervention among HIV 
negative female youth. 
 
Local clinics 
 
 
 
 

 
GIRLS Study Protocol        Version 1.0       September 9, 2016 
Page 82 of 110 
Appendix C: GIRLS Study (18+ and Mature Minors) Sample Informed Consent 
Form 
 
High-yield HIV testing, facilitated linkage to care, and prevention for female youth 
in Kenya (GIRLS Study) 
 
Introduction 
Hello, my name is --------------------. You are invited to take part in a research study. Before you decide 
whether to participate, you need to understand why the research is being done and what it would involve. 
Please take the time to read or to listen as I read the following information. You may talk to others about 
the study if you wish. Please stop me at any time and ask if there is anything that is not clear, or if you 
would like more information. When all of your questions have been answered and you feel that you 
understand this study, you will be asked if you wish to participate in the study, and if you decide to join this 
research study, we will then ask you to give your written consent. Your participation is completely voluntary 
and you can withdraw your participation at any time with no penalty.  
 
HIV testing services is an important gateway for HIV prevention, care, and treatment. Adolescent girls and 
young women in sub-Saharan Africa are the most at risk group for HIV infection. This is because of a 
number of reasons that include high fertility, young age at first sexual encounter, frequent intergenerational 
sex and low likelihood of partner circumcision. These reasons put many adolescent girls and young women 
at increased risk for HIV infection.  It is therefore important to prioritize HIV testing for this population. 
 
Purpose of the Study and Study Requirements 
 
What is the study about?  This study is being carried out by Impact Research and Development 
Organization in collaboration with Kenyatta National Hospital and Yale University. We are offering services 
to up to 1,200 female youth between the ages of 15-24 that help youth stay healthy and reduce chances of 
acquiring or transmitting HIV/AIDS.  The study is called the GIRLS Study. We would like to know which 
testing services female youth prefer and if they like receiving services at home, in the community outside 
the health facilities or in the health facilities. The ultimate goal of this study is to improve the health and 
well-being of female adolescents and young women like you.  
 
The study offers the following: 
• 
HIV Testing Services  
o 
For those who will turn out HIV positive, they will be assisted to access care and treatment 
in a government facility 
o 
For those who are at risk of HIV infection, they will be assisted to access prevention 
services  
 
• 
In addition, about 293 (about 185 negative and 108 positive) girls like you may be requested to be 
followed for one year. 
 
The testing, referral, and follow-up services will be delivered by health teams, made of nurses and 
counselors, among others.   
 
In order to participate in the GIRLS Study, you must be aged between 15 and 24 years. Because you are 
18 years or older or a ‘mature minor’ (if you are under the age of 18 years old but are married or pregnant 
or have a child), you must agree to participate voluntarily after getting all the necessary information. You 
will give your permission to participate in the study in writing. You will sign two copies of this form, and will 

 
GIRLS Study Protocol        Version 1.0       September 9, 2016 
Page 83 of 110 
be given a copy to take with you if you wish. One copy will remain with the study staff.  If you do not wish 
to take a copy with you, we will give you a piece of paper with information on whom to contact if you have 
questions about the study or your rights as a participant.  
 
To be a participant, you must also agree to provide information on where/how you can be reached by the 
study staff if needed. 
 
Why have I been invited to take part? You have been invited to take part because you are a young girl 
between the ages of 15-24 living in Homa Bay County where the study is taking place.   
 
What will happen if I take part?  If you agree to take part in the study today, the following things will 
happen: 
1.   You will be asked to agree to HIV counseling and rapid testing using a little blood from your finger or 
saliva. 
 
You can choose any of the following HIV testing approaches: 
a) Oral fluid HIV self-testing (OHIVST) at your convenience, where you carry out 
the test yourself using fluid from your mouth OR 
b) Staff-aided testing, where rapid testing using a little blood from your finger will 
be carried out either at home or at a mobile health event OR 
c)   You go to a health facility where rapid testing using a little blood from your 
finger will be done by a health provider (standard health facility based testing)  
 
You will be contacted in 2 weeks via SMS regardless of your testing choice. You will be asked to answer 
a few questions about your HIV test experience for which you will receive KSh 100 for your airtime and 
for time you will take to respond to the SMS.  
 
2. Study staff will ask you a few questions about yourself, your behaviors, and your knowledge of health 
promotion services and HIV prevention services using a questionnaire on a small hand-held computer 
called a tablet. This interview will be held in private where others cannot hear what you say and will 
take about 15 minutes.  
 
3. We will collect information of how we can locate/contact you in case we need to follow-up with you 
during the study (we will not reveal your identity to anyone outside the study).  
 
4. Once you receive the results of the HIV test, you will be told what additional services you may require 
and you will be offered appropriate referral. 
 
If the HIV test is positive:  If the oral fluid self-test, or staff-aided screening test, or facility-based screening 
test is positive, another test must be done to confirm the results. If one result is 
negative and one is positive, we will refer you to a health facility of your choice 
for HIV re-testing. If two HIV test results are positive, we will refer you to a local 
HIV care facility of your choice. We will also take blood (up to 4 mL, less than 1 
teaspoon) to see how strong the body’s defense system is (test your CD4 count) 
and how much of the virus is in your blood (HIV viral load level).   
 
If the test is positive and you are also pregnant, we will refer you to a health 
facility of your choice where you can get care for both the pregnancy and HIV 
and help prevent the unborn baby from getting HIV.  

 
GIRLS Study Protocol        Version 1.0       September 9, 2016 
Page 84 of 110 
All HIV infected girls will be invited to participate in a follow up for 12 months. 
We want to know what is the best way to support you in making sure that you 
receive the care you need. If you are positive and agree we will provide referral 
to a health care facility or referral plus SMS message to go for services, and after 
2 weeks we will check with you and with the clinic to see if you were able to get 
services. Among those who will not have gone to the clinic, they will be 
randomized (have a 50/50 chance) to receive either SMS text reminder to attend 
the clinic, or provided transport reimbursement. This is to help us understand the 
best approach to link young girls to HIV care. If you have linked to HIV care, we 
will send you SMS every three months to find out how you are doing and if you 
are keeping your appointments. We will confirm your self-report of clinic 
attendance by reviewing your medical records at the health facility. At 12 months, 
you will be contacted and invited to have blood taken for a repeat viral load test. 
At this time, all HIV positive girls will be invited to participate in an exit interview 
looking at what makes it easy or hard to go for HIV care among young girls. 
 
If the HIV test is negative:  If you test HIV negative, you may be asked if you would be willing to provide your 
phone number. A randomly selected number of girls (≈185) will receive an SMS 
at 6 and 12 months with a health promotion message and asked to answer a few 
questions on their behaviors, condom use, and willingness to retest for HIV. At 
12 months, they will be retested for HIV and also complete an exit interview on 
what makes it easy or hard to go for HIV prevention services. 
 
If you select OHIVST: 
If you choose this approach, you will be counseled/explained to on how to use 
the self-test and some paper with explanation and pictures on how to do the test 
given to you. Once you complete the test, you will be asked to take a picture of 
the result with a study camera (non-identifiable barcode (unique lines) will be 
placed on each kit and camera so as to confirm that the kit and camera links with 
your study number). You will be given a number that you can contact once you 
complete the self-test. You will be sent a few questions about your testing 
experience via SMS within 2 weeks and will receive KSh 100 for your airtime 
and for time you will take to respond to the SMS. Also, by sending a message or 
calling the number listed, study staff will arrange for collection of the camera and 
used self-test kit. At the time of kit and camera collection, study staff will conduct 
a brief interview on your experience with self-testing. (Note, you should not 
discard the test kit or camera, they will be collected by study staff).  
 
 
For those who have a positive or indeterminate test result with the self-test, and 
a randomly selected proportion of those who report testing negative, study staff 
will connect with you at a convenient location to help you get the confirmatory 
test. This may be at home, somewhere in the community, or at a health facility 
where you would be comfortable. 
 
Risks 
What are the risks of participating in the study? You may feel uncomfortable discussing your behaviors.  
Taking a finger stick blood sample for HIV testing may cause a little pain and poses minimal risk of infection, 
however we will use sterile equipment. We will ensure that infection control procedures are followed.   
 

 
GIRLS Study Protocol        Version 1.0       September 9, 2016 
Page 85 of 110 
HIV Testing Services: You may become worried, anxious, or upset by learning the result of your HIV test is 
positive. You will be counseled and referred for care and support.  
 
Social Harms: It is possible that your involvement in the study could lead to stigmatization, discrimination, 
disruption to social support network, and abuse (physical/verbal). We will monitor these and will protect 
confidentiality to reduce potential social harms.  We will also provide you with information on where you 
can get support services. In addition, you can call the Study Coordinator on the number provided at the end 
of this form to report any harm you may experience. 
 
Benefits 
 
What are the benefits of participating in the study?  
The direct benefits to you for participating in the study are that you will know your HIV status. If the test is 
negative, this will help you in making decisions on how to remain negative or live positively, depending on 
the results. You will also have access to HIV prevention services and health services that have been shown 
to help reduce HIV risks. You may learn a few things from the discussion that could help you protect yourself 
or others against HIV and other sexually transmitted infections. Also, the results of this study may contribute 
to the implementation of future intervention programs to reduce the risk of HIV in female adolescents and 
youth.  
 
Anyone found to be HIV positive will be linked with community support groups as well as life-saving care 
and treatment services for themselves. Those found pregnant will be supported to access prevention of 
mother-to-child transmission (PMTCT) services. Information regarding how to prevent infection or 
transmission of HIV to and from their sexual partners will also be offered.  
 
Confidentiality 
 
Will my participation in the study be kept confidential? We will take all steps necessary to ensure your 
privacy and confidentiality. Given that it is a mobile event/ home visit/ clinic visit, your attendance at any of 
these places may be known to other people. However, we will request all participants/ members of the 
homestead to keep information that they observe about others during the visit confidential and not to share 
it with anyone. The services will be offered in a place where other people cannot see you or hear what you 
say. 
 
You will be assigned a unique number and your name will not appear on any information like your responses 
on the computer or services accessed. Safeguards for protecting confidentially of questionnaires and other 
data will be strictly enforced. All data will be kept in a secure location at the Kenyatta National Hospital and 
Impact Research and Development Organization and destroyed at the end of the study. Each participant 
will be asked to respect the participation of others and the confidentiality of others they see. This point will 
be stressed throughout. 
 
Your study records (not your name) may be reviewed only by approved study staff and 
representatives of:  
• 
Yale University  
• 
Kenyatta National Hospital 
• 
Impact Research and Development Organization 
• 
Yale University Human Investigation Committee 
• 
Kenyatta National Hospital/University of Nairobi Ethics and Research Committee (KNH/UON-ERC) 
• 
National Institutes of Health USA 

 
GIRLS Study Protocol        Version 1.0       September 9, 2016 
Page 86 of 110 
• 
Office for Human Research Protections (OHRP) 
• 
Division of AIDS (DAIDS) 
• 
Ministry of Health Kenya 
• 
Other local, US, and international regulatory entities 
 
Voluntariness 
 
What are my rights as a research participant/subject? Your participation in this study is completely 
voluntary. Significant new findings developed during the course of the research which may affect your 
willingness to continue participation will be provided to you. If you decide not to participate, you will not lose 
any existing benefits you may receive from Impact Research and Development Organization or health 
facility. If you decide to take part, you are free to refrain from answering any questions and you may end 
your participation at any time without penalty or loss of existing benefits to which you are entitled.   
 
Involuntary Early Termination of Participation:  
The field site investigators may withdraw a participant before their scheduled termination visit to protect 
their safety. Participants may be withdrawn from the study if the study sponsors, government or regulatory 
authorities, ethical/institutional review boards stop the study before its planned end date. 
 
Voluntary Early Withdrawal: 
If someone voluntarily withdraws from the study, a few brief questions will be asked. We will offer HIV 
testing for those initially negative, and if HIV positive we will collect a small amount of blood sample to test 
how much of the virus is in your blood and refer you for services.  
 
Additional Information 
 
What will I receive for participating?  You will not be paid for your participation in the study. However, 
you will receive KSh 100 for your airtime and time taken in completing the SMS questions about your 
satisfaction with your HIV test experience.  
 
HIV-negative group: If you are HIV negative and selected to complete SMS questions at 6 and 12 months, 
you will receive KSh 100 for your airtime and time you will take to respond to the SMS. At 12 months, you 
will receive KSh 400 transport reimbursement when you retest for HIV and complete an exit interview about 
what made it easy or hard to access prevention services.  
 
HIV-positive group: You will receive KSh 100 for your airtime and time you will take completing SMS 
surveys. For participating in the exit interview about what made it easy or hard to access care, you will be 
compensated a total of KSh 400 for your time and travel. A randomly selected number of HIV positive youth 
will receive KSh 400 for transport to go for HIV care services. 
 
Will it cost me anything to participate? No, it will not cost you anything to participate.   
 
Please note that the U.S. National Institutes of Health (NIH) that is funding this study does not have a 
mechanism to provide direct compensation for research related injury. 
 
A description of this clinical trial will be available on www.ClinicalTrials.gov. This website will not include 
information that can identify you. At most, the website will include a summary of the results. You can search 
this website at any time. 
 

 
GIRLS Study Protocol        Version 1.0       September 9, 2016 
Page 87 of 110 
What will happen to the results of the research study? The results of the study will be discussed and 
presented in a report at team meetings or as a publication. The information may be presented at a 
conference with other studies that relate to youth health promotion, sexual health and HIV prevention and 
treatment. Neither the report nor the presentation will show your name.  
 
Who has reviewed the study for ethical issues? This study has been reviewed and approved by the 
Institutional Review Boards at both the Kenyatta National Hospital/ University of Nairobi (KNH/UON) 
and Yale University.  
 
What if I need more information?  For any information about the study, you may contact the Study 
Coordinator, Mr. Samwel Rao on 0713-687-399 at any time. 
 
What if there is a problem? Any complaint about the way you have been treated during the study or any 
possible harm you might suffer will be addressed. Please contact the Principal Investigator of the study, 
Dr. Irene Inwani from the Kenyatta National Hospital on 0202-726-300 or Professor Chindia, 
Secretary to the KNH/UON Ethics and Research Committee on 0202-726-300. 
 
At this time, I want to make sure you understand the study and see whether you have any additional 
questions.  After we discuss any questions you may have, we can discuss whether you are interested in 
participating in the study today. 
 
Are you willing to participate in the overall study (which includes HIV testing)? (Select one)    
 
No  ☐   (if no, stop here) 
 
 
 
 
 
 
 
Yes ☐   (if yes, continue below)     
SIGNATURE PAGE 
GIRLS Study Information and Informed Consent 
 
Participant: If you have read this consent form (or had it read and explained to you), all of your questions 
have been answered and you agree to take part in this study, please sign this form or make your mark to 
indicate your willingness to participate.  
 
Study staff who conducted informed consent discussion: I confirm that I have personally explained 
the nature and extent of the planned research, study procedures, potential risks and benefits, and 
confidentiality of personal information. 
 
 
Participant’s name (print) 
 
Participant’s 
signature/thumbprint 
and date 
 
 
Study 
staff 
conducting 
consent 
discussion (print) 
 
 
 
Study staff signature and date 
Witness’s name (print) (if appropriate)  
 
Witness’s signature and date (if 
appropriate) 
 

 
GIRLS Study Protocol        Version 1.0       September 9, 2016 
Page 88 of 110 
Appendix D: GIRLS Study Parental Sample Informed Consent Form for Minors 
(15-17) 
 
High-yield HIV testing, facilitated linkage to care, and prevention for female youth 
in Kenya (GIRLS Study) 
 
Introduction 
Hello, my name is --------------------. Your child is being invited to take part in a research study. Before you 
decide whether to allow your child to participate, you need to understand why the research is being done 
and what it would involve. Please take the time to read or to listen as I read the following information. You 
may talk to others about the study if you wish. Please stop me at any time and ask if there is anything that 
is not clear, or if you would like more information. When all of your questions have been answered and you 
feel that you understand this study, you will be asked if you will allow your child to participate in the study, 
and if you decide to allow your child to join this research study, we will then ask you to give your written 
consent. Your child’s participation is completely voluntary and you or your child can withdraw her 
participation at any time with no penalty.  
 
HIV testing services is an important gateway for HIV prevention, care, and treatment. Adolescent girls and 
young women in sub-Saharan Africa are the most at risk group for HIV infection. This is because of a 
number of reasons that include high fertility, young age at first sexual encounter, frequent intergenerational 
sex and low likelihood of partner circumcision. These reasons put many adolescent girls and young women 
at increased risk for HIV infection.  It is therefore important to prioritize HIV testing for this population. 
 
Purpose of the Study and Study Requirements 
 
What is the study about?  This study is being carried out by Impact Research and Development 
Organization in collaboration with Kenyatta National Hospital and Yale University. We are offering services 
to up to 1,200 female youth between the ages of 15-24 that help youth stay healthy and reduce chances of 
acquiring and transmitting HIV/AIDS. The study is called the GIRLS Study. We would like to know which 
testing services female youth prefer and if they like receiving services at home, in the community outside 
the health facilities or in the health facilities. The ultimate goal of this study is to improve the health and 
well-being of female adolescents and young women like your child. 
 
The study offers the following: 
• 
HIV Testing Services  
o 
For those who will turn out HIV positive, they will be assisted to access care and treatment 
in a government facility 
o 
For those who are at risk of HIV infection, they will be assisted to access prevention 
services  
 
• 
In addition, about 293 (about 185 negative and 108 positive) girls like your child may be requested 
to be followed for one year. 
  
The testing, referral, and follow-up services will be delivered by health teams, made of nurses and 
counselors, among others.   
 
In order to participate in the GIRLS Study, your child, who is under the age of 18 must bring a parent or 
guardian to give consent on their behalf, but they must also agree (give assent).  

 
GIRLS Study Protocol        Version 1.0       September 9, 2016 
Page 89 of 110 
You will give your permission for your child to participate in the study in writing. You will sign two copies of 
this form, and will be given a copy to take with you if you wish. One copy will remain with the study staff.  If 
you do not wish to take a copy with you, we will give you a piece of paper with information on whom to 
contact if you have questions about the study or your rights as a participant.  
 
You must also agree to provide information on where/how you can be reached by the study staff, if needed.   
 
Why has my child been invited to take part? Your child has been invited to take part because she is a 
young girl between the ages of 15-17 living in Homa Bay County where the study is taking place.   
 
What will happen if my child takes part?  If you allow your child to take part in the study today, the 
following things will happen: 
1. 
She will be asked to agree to HIV counseling and rapid testing using a little blood from her finger or 
saliva.  
 
Your child can choose from the following testing approaches: 
a) Oral fluid HIV self-testing (OHIVST) at her convenience, where she will carry 
out the test herself using fluid from her mouth OR 
b) Staff-aided testing, where rapid testing using a little blood from her finger will 
be carried out either at home or at a mobile health event OR 
c) She will go to a health facility where rapid testing using a little blood from her 
finger will be done by a health provider (standard health facility based testing)  
 
Your child will be contacted in 2 weeks via SMS regardless of her testing choice. She will be asked a 
few questions about her HIV test experience for which she will receive KSh 100 for her airtime and for 
time she will take to respond to the SMS. 
 
2. 
Study staff will ask your child a few questions about herself, her behaviors, and her knowledge of 
health promotion services and HIV prevention services using a questionnaire on a small hand-held 
computer called a tablet. This interview will be held in private where others cannot hear what your 
child says and will take about 15 minutes. 
 
3. 
We will collect information of how we can locate/contact your child in case we need to follow-up with 
your child during the study (we will not reveal your child’s identity to anyone outside the study). 
 
4. 
If your child chooses staff-aided HTS, she may choose to allow you to stay for her HIV test result. 
Once your child receives the results of the HIV test, she will be told what additional services she may 
require and she will be offered appropriate referral. If her test result is positive, she must name a 
parent or guardian to whom she will share her results in order to be able to receive treatment for HIV. 
 
If the HIV test is positive:  If the oral fluid self-test, or staff-aided screening test, or facility-based 
screening test is positive, another test must be done to confirm the results.  If 
one result is negative and one is positive, we will refer your child to a health 
facility of their choice for HIV re-testing. If two HIV test results are positive, we 
will refer your child to a local HIV care facility of their choice. We will also take 
blood (up to 4 mL, less than 1 teaspoon) to see how strong the body defense 
system is (test her CD4 count) and how much of the virus is in your child’s 
blood (HIV viral load level).  

 
GIRLS Study Protocol        Version 1.0       September 9, 2016 
Page 90 of 110 
If the test is positive and your child is also pregnant, we will refer your child to 
a health facility of her choice where they can get care for both the pregnancy 
and HIV and help prevent the unborn baby from getting HIV.  
 
All HIV infected girls will be invited to participate in a follow up for 12 months. 
We want to know what is the best way to support your child in making sure 
that she receives the care she needs. If your child is positive and she agrees, 
we will provide referral to a health care facility or referral plus SMS message 
to go for services, and after 2 weeks we will check with her and with the clinic 
to see if she was able to get services. Among those girls who will not have 
gone to the clinic, they will be randomized (have a 50/50 chance) to receive 
either SMS text reminder to attend the clinic, or provided transport 
reimbursement. This is to help us understand the best approach to link young 
girls to HIV care. If your child has linked to HIV care, we will send her SMS 
every three months to find out how she is doing and if she is keeping her 
appointments. We will confirm her self-report of clinic attendance by reviewing 
her medical records at the health facility. At 12 months, she will be contacted 
and invited to have blood taken for a repeat viral load test. At this time, all HIV 
positive girls will be invited to participate in an exit interview looking at what 
makes it easy or hard to go for HIV care among young girls. 
 
If the HIV test is negative:  If your child tests HIV negative, she may be asked if she would be willing to 
provide her phone number. A randomly selected number of girls (≈185) will 
receive an SMS at 6 and 12 months with a health promotion message and 
asked to answer questions on their behaviors, condom use, and willingness to 
retest for HIV. At 12 months, they will be retested for HIV and also complete 
an exit interview on what makes it easy or hard to go for HIV prevention 
services.  
 
If your child selects OHIVST: If your child chooses this approach, she will be counseled/explained to on 
how to use the self-test and some paper with explanation and pictures on how 
to do the test given to her. Once she completes the test, she will be asked to 
take a picture of the result with a study camera (non-identifiable barcode 
(unique lines) will be placed on each kit and camera so as to confirm that the 
kit and camera links with her study number).  She will be given a number that 
she can contact once she completes the self-test. She will be sent a few 
questions about her testing experience via SMS within 2 weeks and will 
receive KSh 100 for her airtime and for time she will take to respond to the 
SMS. Also, by sending a message or calling the number listed, study staff will 
arrange for collection of the camera and used self-test kit. At the time of kit 
and camera collection, study staff will conduct a brief interview on your child’s 
experience with self-testing. (Note: she should not discard the test kit or 
camera, they will be collected by study staff). 
 
 
If your child has a positive or indeterminate test result with the self-test, the 
study staff will connect with her at a convenient location to help her get the 
confirmatory test. Study staff will also administer a confirmatory test to a 
randomly selected proportion of girls who report testing negative with the self-

 
GIRLS Study Protocol        Version 1.0       September 9, 2016 
Page 91 of 110 
test. This may be at home, somewhere in the community, or at a health facility 
where she would be comfortable. 
Risks 
What are the risks of participating in the study? Your child may feel uncomfortable discussing her 
behaviors. Taking a finger stick blood sample for HIV testing may cause a little pain and poses minimal risk 
of infection, however we will use sterile equipment. We will ensure that infection control procedures are 
followed.    
 
HIV Testing Services: Your child may become worried, anxious, or upset by learning the result of her HIV 
test is positive. Your child will be counseled and referred for care and support.  
 
Social Harms: It is possible that your child’s involvement in the study could lead to stigmatization, 
discrimination, disruption to social support network, and abuse (physical/verbal). We will monitor these and 
will protect confidentiality to reduce potential social harms. We will also provide her with information on 
where she can get support services. In addition, she can call the Study Coordinator on the number provided 
at the end of this form to report any harm she may experience. 
 
Benefits 
What are the benefits of participating in the study?  
The direct benefits to your child for participating in the study are that she will know her HIV status and this 
will help her in making decisions on how to remain negative or live positively, depending on the results.  
She will have access to HIV prevention services and health services that have been shown to help reduce 
HIV risks. You may learn a few things from the discussion that could help your child protect herself or others 
against HIV and other sexually transmitted infections. Also, the results of this study may contribute to the 
implementation of future intervention programs to reduce the risk of HIV in female adolescents and youth.  
 
Anyone found to be HIV positive will be linked with community support groups as well as life-saving care 
and treatment services for themselves. Those found pregnant will be supported to access prevention of 
mother-to-child transmission (PMTCT) services. Information regarding how to prevent infection or 
transmission of HIV to and from others will also be offered.   
 
Confidentiality 
Will my child’s participation in the study be kept confidential? We will take all steps necessary to 
ensure your child’s privacy and confidentiality. Given that it is a mobile event/ home visit/ clinic visit, your 
child’s attendance at any of these places may be known to other people. However, we will request all 
participants/ members of the homestead to keep information that they observe about others during the visit 
confidential and not to share it with anyone. The services will be offered in a place where other people 
cannot see your child or hear what she says.  
 
Your child will be assigned a unique number and her name will not appear on any information like her 
responses on the computer or services accessed. Safeguards for protecting confidentially of questionnaires 
and other data will be strictly enforced. All data will be kept in a secure location at the Kenyatta National 
Hospital and Impact Research and Development Organization and destroyed at the end of the study. Each 
participant will be asked to respect the participation of others and the confidentiality of others they see. This 
point will be stressed throughout. 
Your child’s study records (not her name) may be reviewed only by approved study staff and 
representatives of:  
• 
Yale University  
• 
Kenyatta National Hospital 

 
GIRLS Study Protocol        Version 1.0       September 9, 2016 
Page 92 of 110 
• 
Impact Research and Development Organization 
• 
Yale University Human Investigation Committee 
• 
Kenyatta National Hospital/University of Nairobi Ethics and Research Committee (KNH/UON-ERC) 
• 
National Institutes of Health USA 
• 
Office for Human Research Protections (OHRP) 
• 
Division of AIDS (DAIDS) 
• 
Ministry of Health Kenya 
• 
Other local, US, and international regulatory entities 
 
Voluntariness 
What are my child’s rights as a research participant/subject? Your child’s participation in this study is 
completely voluntary. Significant new findings developed during the course of the research which may affect 
you and your child’s willingness to continue participation will be provided to you and your child. If you decide 
not to allow her to participate, she will not lose any existing benefits she may receive from Impact Research 
and Development Organization or health facility. If you decide to allow your child to take part, she is 
free to refrain from answering any questions and she may end her participation at any time without penalty 
or loss of existing benefits to which she is entitled.   
 
Involuntary Early Termination of Participation:  
The field site investigators may withdraw a participant before their scheduled termination visit to protect 
their safety. Participants may be withdrawn from the study if the study sponsors, government or regulatory 
authorities, ethical/institutional review boards stop the study before its planned end date. 
 
Voluntary Early Withdrawal: 
If someone voluntarily withdraws from the study, a few brief questions will be asked. We will offer HIV 
testing for those initially negative, and if HIV positive we will collect a small amount of blood sample to test 
how much of the virus is in your child’s blood and refer her for services.  
 
Additional Information 
What my child receives for participating?  Your child will not be paid for participation in the study. 
However, she will receive KSh 100 for her airtime and time taken in completing the SMS questions about 
her HIV test experience. 
 
HIV-negative group: If your child is HIV negative and selected to complete SMS questions at 6 and 12 
months, she will receive KSh 100 for her airtime and the time she will take to respond to the SMS. At 12 
months she will receive KSh 400 transport reimbursement when she retests for HIV and completes an exit 
interview about what made it easy or hard for her to access prevention services. 
 
HIV-positive group:  Your child will receive KSh 100 for her airtime and time she will take completing SMS 
surveys. For participating in the exit interview about what made it easy or hard for her to access care, your 
child will be compensated a total of KSh 400 for her time and travel. A randomly selected number of HIV 
positive youth will receive KSh 400 for transport to go for HIV care services.   
 
Will it cost me anything for my child to participate? No, it will not cost you anything for your child’s 
participation.   
 
Please note that the U.S. National Institutes of Health (NIH) that is funding this study does not have a 
mechanism to provide direct compensation for research related injury. 

 
GIRLS Study Protocol        Version 1.0       September 9, 2016 
Page 93 of 110 
A description of this clinical trial will be available on www.ClinicalTrials.gov. This website will not include 
information that can identify you. At most, the website will include a summary of the results. You can search 
this website at any time. 
 
What will happen to the results of the research study? The results of the study will be discussed and 
presented in a report at team meetings or as a publication.  The information may be presented at a 
conference with other studies that relate to youth health promotion, sexual health and HIV prevention and 
treatment. Neither the report nor the presentation will show your name or your child’s name.  
 
Who has reviewed the study for ethical issues? This study has been reviewed and approved by the 
Institutional Review Boards at the Kenyatta National Hospital/University of Nairobi (KNH/UON) and 
Yale University. 
 
What if I need more information?  For any information about the study, you may contact the Study 
Coordinator, Mr. Samwel Rao on 0713-687-399 at any time. 
 
What if there is a problem? Any complaint about the way your child has been treated during the study or 
any possible harm she might suffer will be addressed. Please contact the Principal Investigator of the 
study, Dr. Irene Inwani from the Kenyatta National Hospital on 0202-726-300 or Professor Chindia, 
Secretary to the KNH/UON Ethics and Research Committee on 0202-726-300. 
 
At this time, I want to make sure you understand the study and see whether you have any additional 
questions.  After we discuss any questions you may have, we can discuss whether you are interested in 
your child participating in the study today. 
 
Are you willing to permit your child to participate in the overall study (which includes HIV testing)? 
(Select one)    
 
No  ☐   (if no, stop here) 
 
Yes ☐   (if yes, continue below)   
SIGNATURE PAGE 
GIRLS Study Information and Parental Informed Consent 
 
Participant’s parent/guardian: If you have read this consent form (or had it read and explained to you), 
all of your questions have been answered and you agree to have your child take part in this study, please 
sign this form or make your mark to indicate your willingness to allow your child to participate.  
 
Study staff who conducted informed consent discussion: I confirm that I have personally explained 
the nature and extent of the planned research, study procedures, potential risks and benefits, and 
confidentiality of personal information. 
 
 
Participant’s 
parent/guardian 
name 
(print) 
 
Participant’s parent/guardian 
signature/thumbprint and date 
Study 
staff 
conducting 
consent 
discussion (print) 
 
 
Study staff signature and date 
Witness’s name (print) (if appropriate)  
 
Witness’s signature and date (if 
appropriate) 

 
GIRLS Study Protocol        Version 1.0       September 9, 2016 
Page 94 of 110 
Appendix E: GIRLS Study Minor (15-17) Sample Assent Form 
 
High-yield HIV testing, facilitated linkage to care, and prevention for female youth 
in Kenya (GIRLS Study) 
 
Introduction 
Hello, my name is --------------------. You are invited to take part in a research study. Before you decide 
whether to participate, you need to understand why the research is being done and what it would involve. 
Please take the time to read or to listen as I read the following information. You may talk to others about 
the study if you wish. In order to participate in the GIRLS Study, participants under the age of 18 must 
bring a parent or guardian to give consent on their behalf, but they must also agree (give assent). Before 
receiving services, your parent/guardian will be asked to give written permission for you to participate and 
you must also agree (give assent). Please stop me at any time and ask if there is anything that is not clear, 
or if you would like more information. When all of your questions have been answered and you feel that 
you understand this study, you will be asked if you wish to participate in the study, and if you decide to join 
this research study, we will then ask you to give your written assent. Your participation is completely 
voluntary and you can withdraw your participation at any time with no penalty.  
 
HIV testing services is an important gateway for HIV prevention, care, and treatment. Adolescent girls and 
young women in sub-Saharan Africa are the most at risk group for HIV infection. This is because of a 
number of reasons that include high fertility, young age at first sexual encounter, frequent intergenerational 
sex and low likelihood of partner circumcision. These reasons put many adolescent girls and young women 
at increased risk for HIV infection.  It is therefore important to prioritize HIV testing for this population. 
 
Purpose of the Study and Study Requirements 
 
What is the study about? This study is being carried out by Impact Research and Development 
Organization in collaboration with Kenyatta National Hospital and Yale University. We are offering services 
to up to 1,200 female youth between the ages of 15-24 that help youth stay healthy and reduce chances of 
acquiring or transmitting HIV/AIDS. The study is called the GIRLS Study. We would like to know which 
testing services female youth prefer and if they like receiving services at home, in the community outside 
the health facilities or in the health facilities. The ultimate goal of this study is to improve the health and 
well-being of female adolescents and young women like you. 
 
The study offers the following: 
• 
HIV Testing Services  
o 
For those who will turn out HIV positive, they will be assisted to access care and treatment 
in a government facility 
o 
For those who are at risk of HIV infection, they will be assisted to access prevention 
services  
 
• 
In addition, about 293 (about 185 negative and 108 positive) girls like you may be requested to be 
followed for one year. 
 
The testing, referral, and follow-up services will be delivered by health teams, made of nurses and 
counselors, among others.   
 

 
GIRLS Study Protocol        Version 1.0       September 9, 2016 
Page 95 of 110 
In order to participate in the GIRLS Study, you and your parent/guardian must agree for you to participate 
voluntarily after getting all the necessary information. You will give your permission to participate in the 
study in writing (undergo written assent procedures).  You will sign two copies of this form, and will be given 
a copy to take with you if you wish. One copy will remain with the study staff.  If you do not wish to take a 
copy with you, we will give you a piece of paper with information on whom to contact if you have questions 
about the study or your rights as a participant.  
  
To be a participant, you must also agree to provide information on where/how you can be reached by the 
study staff, if needed.   
 
Why have I been invited to take part? You have been invited to take part because you are a young girl 
between the ages of 15-17 living in Homa Bay County where the study is taking place.   
 
What will happen if I take part?  If you agree to take part in the study today, the following things will 
happen: 
1. 
You will be asked to agree to HIV counseling and rapid testing using a little blood from your finger or 
saliva.  
 
You can choose any of the following testing approaches: 
a) Oral fluid HIV self-testing (OHIVST) at your convenience, where you carry out 
the test   yourself using fluid from your mouth OR 
b) Staff-aided testing, where rapid testing using a little blood from your finger will 
be carried out either at home or at a mobile health event OR 
c) You go to a health facility where rapid testing using a little blood from your 
finger will be done by a health provider (standard health facility based testing) 
 
You will be contacted in 2 weeks via SMS regardless of your testing choice. You will be asked to 
answer a few questions about your HIV test experience for which you will receive KSh 100 for your 
airtime and for time you will take to respond to the SMS. 
 
2. 
Study staff will ask you a few questions about yourself, your behaviors, and your knowledge of health 
promotion services and HIV prevention services using a questionnaire on a small hand-held computer 
called a tablet. This interview will be held in private where others cannot hear what you say and will 
take about 15 minutes.  
 
3. 
We will collect information of how we can locate/contact you in case we need to follow-up with you 
during the study (we will not reveal your identity to anyone outside the study).  
 
4. 
If you choose staff-aided HTS, you may choose to allow your parent or guardian to stay for your HIV 
test result. Once you receive the results of the HIV test, you will be told what additional services you 
may require and you will be offered appropriate referral. If your test result is positive, you must name 
a parent or guardian to whom you will share your result in order to be able to receive treatment for 
HIV. 
 
If the HIV test is positive:  If the oral fluid self-test, or staff-aided screening test, or facility-based screening 
test is positive, another test must be done to confirm the results. If one result is 
negative and one is positive, we will refer you to a health facility of your choice 
for HIV re-testing. If two HIV test results are positive, we will refer you to a local 
HIV care facility of your choice. We will also take blood (up to 4 mL, less than 1 

 
GIRLS Study Protocol        Version 1.0       September 9, 2016 
Page 96 of 110 
teaspoon) to see how strong the body’s defense system is (test your CD4 count) 
and how much of the virus is in your blood (HIV viral load level).   
 
If the test is positive and you are also pregnant, we will refer you to a health 
facility of your choice where you can get care for both the pregnancy and HIV 
and help prevent the unborn baby from getting HIV.  
 
All HIV infected girls will be invited to participate in a follow up for 12 months. 
We want to know what is the best way to support you in making sure that you 
receive the care you need. If you are positive and agree we will provide referral 
to a health care facility or referral plus SMS message to go for services, and after 
2 weeks we will check with you and with the clinic to see if you were able to get 
services. Among those who will not have gone to the clinic, they will be 
randomized (have a 50/50 chance) to receive either SMS text reminder to attend 
the clinic, or provided transport reimbursement. This is to help us understand the 
best approach to link young girls to HIV care. If you have linked to HIV care, we 
will send you SMS every three months to find out how you are doing and if you 
are keeping your appointments. We will confirm your self-report of clinic 
attendance by reviewing your medical records at the health facility. At 12 months, 
you will be contacted and invited to have blood taken for a repeat viral load test. 
At this time, all HIV positive girls will be invited to participate in an exit interview 
looking at what makes it easy or hard to go for HIV care among young girls.  
 
If the HIV test is negative:  If you test HIV negative, you may be asked if you would be willing to provide your 
phone number. A randomly selected number of girls (≈185) will receive an SMS 
at 6 and 12 months with a health promotion message and asked to answer a few 
questions on their behaviors, condom use, and willingness to retest for HIV. At 
12 months, they will be retested for HIV. and also complete an exit interview on 
what makes it easy or hard to access HIV prevention services. 
 
If you select OHIVST:  
If you choose this approach, you will be counseled/explained to on how to use 
the self-test and some paper with explanation and pictures on how to do the test 
given to you. Once you complete the test, you will be asked to take a picture of 
the result with a study camera (non-identifiable barcode (unique lines) will be 
placed on each kit and camera so as to confirm that the kit and camera links with 
your study number). You will be given a number that you can contact once you 
complete the self-test. You will be sent a few questions about your testing 
experience via SMS within 2 weeks and will receive KSh 100 for your airtime 
and for time you will take to respond to the SMS. Also, by sending a message or 
calling the number listed, study staff will arrange for collection of the camera and 
used self-test kit. At the time of kit and camera collection, study staff will conduct 
a brief interview on your experience with self-testing. (Note, you should not 
discard the test kit or camera, they will be collected by study staff). 
 
 
For those who have a positive or indeterminate test result with the self-test, and 
a randomly selected proportion of those who report testing negative, study staff 
will connect with you at a convenient location to help you get the confirmatory 
test. This may be at home, somewhere in the community, or at a health facility 
where you would be comfortable.  

 
GIRLS Study Protocol        Version 1.0       September 9, 2016 
Page 97 of 110 
Risks 
What are the risks of participating in the study? You may feel uncomfortable discussing your behaviors.  
Taking a finger stick blood sample for HIV testing may cause a little pain and poses minimal risk of infection, 
however we will use sterile equipment. We will ensure that infection control procedures are followed. 
 
HIV Testing Services: You may become worried, anxious, or upset by learning the result of your HIV test is 
positive. You will be counseled and referred for care and support.  
 
Social Harms: It is possible that your involvement in the study could lead to stigmatization, discrimination, 
disruption to social support network, and abuse (physical/verbal). We will monitor these and will protect 
confidentiality to reduce potential social harms. We will also provide you with information on where you can 
get support services. In addition, you can call the Study Coordinator on the number provided at the end of 
this form to report any harm you may experience. 
 
Benefits 
What are the benefits of participating in the study?  
The direct benefits to you for participating in the study are that you will know your HIV status and this will 
help you in making decisions on how to remain negative or live positively, depending on the results. You 
will also have access to HIV prevention services and health services that have been shown to help reduce 
HIV risks. You may learn a few things from the discussion that could help you protect yourself or others 
against HIV and other sexually transmitted infections. Also, the results of this study may contribute to the 
implementation of future intervention programs to reduce the risk of HIV in female adolescents and youth.  
 
Anyone found to be HIV positive will be linked with community support groups as well as life-saving care 
and treatment services for themselves. Those found pregnant will be supported to access prevention of 
mother-to-child transmission (PMTCT) services.  Information regarding how to prevent infection or 
transmission of HIV to and from their sexual partners will also be offered. 
   
Confidentiality 
Will my participation in the study be kept confidential? We will take all steps necessary to ensure your 
privacy and confidentiality. Given that it is a mobile event/ home visit/ clinic visit, your attendance at any of 
these places may be known to other people. However, we will request all participants/ members of the 
homestead to keep information that they observe about others during the visit confidential and not to share 
it with anyone. The services will be offered in a place where other people cannot see you or hear what you 
say.  
 
You will be assigned a unique number and your name will not appear on any information like your responses 
on the computer or services accessed. Safeguards for protecting confidentially of questionnaires and other 
data will be strictly enforced. All data will be kept in a secure location at the Kenyatta National Hospital and 
Impact Research and Development Organization and destroyed at the end of the study. Each participant 
will be asked to respect the participation of others and the confidentiality of others they see. This point will 
be stressed throughout. 
 
Your study records (not your name) may be reviewed only by approved study staff and 
representatives of:  
• 
Yale University  
• 
Kenyatta National Hospital 
• 
Impact Research and Development Organization 
• 
Yale University Human Investigation Committee  

 
GIRLS Study Protocol        Version 1.0       September 9, 2016 
Page 98 of 110 
• 
Kenyatta National Hospital/University of Nairobi Ethics and Research Committee (KNH/UON-ERC) 
• 
National Institutes of Health USA 
• 
Office for Human Research Protections (OHRP) 
• 
Division of AIDS (DAIDS) 
• 
Ministry of Health Kenya 
• 
Other local, US, and international regulatory entities 
 
Voluntariness 
 
What are my rights as a research participant/subject? Your participation in this study is completely 
voluntary. Significant new findings developed during the course of the research which may affect your 
willingness to continue participation will be provided to you. If you decide not to participate, you will not lose 
any existing benefits you may receive from Impact Research and Development Organization or health 
facility. If you decide to take part, you are free to refrain from answering any questions and you may end 
your participation at any time without penalty or loss of existing benefits to which you are entitled.   
 
Involuntary Early Termination of Participation:  
The field site investigators may withdraw a participant before their scheduled termination visit to protect 
their safety. Participants may be withdrawn from the study if the study sponsors, government or regulatory 
authorities, ethical/institutional review boards stop the study before its planned end date. 
 
Voluntary Early Withdrawal: 
If someone voluntarily withdraws from the study, a few brief questions will be asked. We will offer HIV 
testing for those initially negative, and if HIV positive we will collect a small amount of blood sample to test 
how much of the virus is in your blood and refer you for services.  
 
Additional Information 
 
What will I receive for participating?  You will not be paid for your participation in the study. However, 
you will receive KSh 100 for your airtime and time taken in completing the SMS questions about your 
satisfaction with your HIV test experience. 
 
HIV-negative group: If you are HIV negative and selected to complete SMS questions at 6 and 12 months, 
you will receive KSh 100 for your airtime and time you will take to respond to the SMS. At 12 months, you 
will receive KSh 400 transport reimbursement when you retest for HIV and complete an exit interview about 
what made it easy or hard to access prevention services. 
 
HIV-positive group:  You will receive KSh 100 for your airtime and time you will take completing SMS 
surveys. For participating in the exit interview about what made it easy or hard to access care, you will be 
compensated a total of KSh 400 for your time and travel. A randomly selected number of HIV positive youth 
will receive KSh 400 for transport to go for HIV care services. 
 
Will it cost me anything to participate? No, it will not cost you anything to participate.   
 
Please note that the U.S. National Institutes of Health (NIH) that is funding this study does not have a 
mechanism to provide direct compensation for research related injury. 
 

 
GIRLS Study Protocol        Version 1.0       September 9, 2016 
Page 99 of 110 
A description of this clinical trial will be available on www.ClinicalTrials.gov. This website will not include 
information that can identify you. At most, the website will include a summary of the results. You can search 
this website at any time. 
 
What will happen to the results of the research study? The results of the study will be discussed and 
presented in a report at team meetings or as a publication. The information may be presented at a 
conference with other studies that relate to youth health promotion, sexual health and HIV prevention and 
treatment. Neither the report nor the presentation will show your name.  
 
Who has reviewed the study for ethical issues? This study has been reviewed and approved by the 
Institutional Review Boards at both the Kenyatta National Hospital/University of Nairobi (KNH/UON) 
and Yale University. 
 
What if I need more information?  For any information about the study, you may contact the Study 
Coordinator, Mr. Samwel Rao on 0713-687-399 at any time. 
 
What if there is a problem? Any complaint about the way you have been treated during the study or any 
possible harm you might suffer will be addressed. Please contact the Principal Investigator of the study, 
Dr. Irene Inwani from the Kenyatta National Hospital on 0202-726-300 or Professor Chindia, 
Secretary to the KNH/UON Ethics and Research Committee on 0202-726-300. 
 
At this time, I want to make sure you understand the study and see whether you have any additional 
questions.  After we discuss any questions you may have, we can discuss whether you are interested in 
participating in the study today. 
 
Are you willing to participate in the overall study (which includes HIV testing)? (Select one)    
 
No  ☐   (if no, stop here) 
 
Yes ☐   (if yes, continue below)    
SIGNATURE PAGE 
GIRLS Study Information and Informed Assent 
 
Participant: If you have read this assent form (or had it read and explained to you), all of your questions 
have been answered and you agree to take part in this study, please sign this form or make your mark to 
indicate your willingness to participate.  
 
Study staff who conducted informed assent discussion: I confirm that I have personally explained the 
nature and extent of the planned research, study procedures, potential risks and benefits, and confidentiality 
of personal information. 
 
Participant’s name (print) 
 
Participant’s 
signature/thumbprint 
and date 
 
Study 
staff 
conducting 
consent 
discussion (print) 
 
Study staff signature and date 
 
 
Witness’s name (print) (if appropriate)  
 
Witness’s signature and date (if 
appropriate) 

 
GIRLS Study Protocol        Version 1.0       September 9, 2016 
Page 100 of 110 
Appendix F: Oral HIV Self-testing Instruction Sheet 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
GIRLS Study Protocol        Version 1.0       September 9, 2016 
Page 101 of 110 
Appendix G: NASCOP HIV Testing Algorithm 
 
 
 
*Updated 13th August 2015 

 
GIRLS Study Protocol        Version 1.0       September 9, 2016 
Page 102 of 110 
 

 
GIRLS Study Protocol        Version 1.0       September 9, 2016 
Page 103 of 110 
 

 
GIRLS Study Protocol        Version 1.0       September 9, 2016 
Page 104 of 110 
20. SCIENTIFIC REFERENCES 
Agot, K., & Onyango, J. O. (2004). Youth-Friendly Services for HIV Prevention, Treatment, and 
Care: The Tuungane Youth Project, Kenya. From the Ground Up: Building 
Comprehensive HIV/AIDS Care Programs in Resource-Limited Settings, Volume 3: 
Developing Pathways and partnerships(Rolling Out and Scaling Up). 
http://ftguonline.org/ftgu-232/index.php/ftgu/article/view/2032/4060 Retrieved from 
http://ftguonline.org/ftgu-232/index.php/ftgu/article/view/2032/4060 
Allen, S., Meinzen-Derr, J., Kautzman, M., Zulu, I., Trask, S., Fideli, U., . . . Haworth, A. (2003). 
Sexual behavior of HIV discordant couples after HIV counseling and testing. AIDS, 
17(5), 733-740.  
Alsallaq R, Buttolph J, Cleland C, Hallett T, & A., K. (2013). Estimating the impact of combined 
prevention interventions based on HIV testing targeting 15-24 years-old men and women 
in Nyanza, Kenya.  . Paper presented at the 20th International Society for STD Research 
Conference, Vienna, Austria.  
Alviar, C., & Pearson, R. (2009). Cash Transfers for Vulnerable Children in Kenya: From 
Political Choice to Scale-Up. Retrieved from  
Auerswald, C. L., Sugano, E., Ellen, J. M., & Klausner, J. D. (2006). Street-based STD testing 
and treatment of homeless youth are feasible, acceptable and effective. Journal of 
Adolescent Health, 38(3), 208-212.  
Babigumira, J. B., Sethi, A. K., Smyth, K. A., & Singer, M. E. (2009). Cost effectiveness of 
facility-based care, home-based care and mobile clinics for provision of antiretroviral 
therapy in Uganda. Pharmacoeconomics, 27(11), 963-973.  
Baird, S. J., Garfein, R. S., McIntosh, C. T., & Özler, B. (2012). Effect of a cash transfer 
programme for schooling on prevalence of HIV and herpes simplex type 2 in Malawi: a 
cluster randomised trial. The Lancet(0). doi:10.1016/s0140-6736(11)61709-1 
Barnabas, R. V., van Rooyen, H., Tumwesigye, E., Murnane, P. M., Baeten, J. M., Humphries, 
H., . . . Celum, C. (2014). Initiation of antiretroviral therapy and viral suppression after 
home HIV testing and counselling in KwaZulu-Natal, South Africa, and Mbarara district, 
Uganda: a prospective, observational intervention study. Lancet HIV, 1(2), e68-e76. 
doi:10.1016/S2352-3018(14)70024-4 
Biddlecom, A. (2008). Unsafe Abortion in Kenya. Issues in brief (Alan Guttmacher Institute), 
4(1).  
Birx, D. (2014a). The Future of PEPFAR: Sustainable Results with Accountability, 
Transparency, and Impact Paper presented at the HPTN Meeting. 
http://www.hptn.org/web%20documents/AM2014Present/JP/08BirxPEPFAR18Jun14.pdf 
Birx, D. (2014b). SS-101 Global Health and PEPFAR. JAIDS Journal of Acquired Immune 
Deficiency Syndromes, 67, 74.  
Bunnell, R., Ekwaru, J. P., Solberg, P., Wamai, N., Bikaako-Kajura, W., Were, W., . . . 
Rutherford, G. (2006). Changes in sexual behavior and risk of HIV transmission after 
antiretroviral therapy and prevention interventions in rural Uganda. AIDS, 20(1), 85-92.  
CBS, MOH, & ORC Macro. (2003). Kenya Demographic and Health Survey 2003. Retrieved 
from Calverton, Maryland: http://www.measuredhs.com/pubs/pdf/FR151/FR151.pdf 
Chang, L. W., Kagaayi, J., Nakigozi, G., Packer, A. H., Serwadda, D., Quinn, T. C., . . . 
Reynolds, S. J. (2008). Responding to the Human Resource Crisis: Peer Health 
Workers, Mobile Phones, and HIV Care in Rakai, Uganda. AIDS Patient Care STDS, 
22(3), 173-174.  
Choko, A. T., MacPherson, P., Webb, E. L., Willey, B. A., Feasy, H., Sambakunsi, R., . . . 
Corbett, E. L. (2015). Uptake, Accuracy, Safety, and Linkage into Care over Two Years 

 
GIRLS Study Protocol        Version 1.0       September 9, 2016 
Page 105 of 110 
of Promoting Annual Self-Testing for HIV in Blantyre, Malawi: A Community-Based 
Prospective Study. PLoS Med, 12(9), e1001873. doi:10.1371/journal.pmed.1001873 
Clark, H. A., Bowles, K. E., Song, B., & Heffelfinger, J. D. (2008). Implementation of rapid HIV 
testing programs in community and outreach settings: perspectives from staff at eight 
community-based organizations in seven US cities. Public Health Reports, 123(Suppl 3), 
86.  
Cojan, B., & Fanello, S. (2009). Mobile screening unit for HIV and STI among seasonal workers 
in the ski resorts of Savoy, France: interest and perspectives]. Santé publique 
(Vandoeuvre-lès-Nancy, France), 21(3), 287.  
Colfax, G. N., Buchbinder, S. P., Cornelisse, P. G., Vittinghoff, E., Mayer, K., & Celum, C. 
(2002). Sexual risk behaviors and implications for secondary HIV transmission during 
and after HIV seroconversion. AIDS, 16(11), 1529-1535.  
Curran, K., Baeten, J. M., Coates, T. J., Kurth, A., Mugo, N. R., & Celum, C. (2012). HIV-1 
prevention for HIV-1 serodiscordant couples. Curr HIV/AIDS Rep, 9(2), 160-170. 
doi:10.1007/s11904-012-0114-z 
Delvaux, T., Crabbe, F., Seng, S., & Laga, M. (2003). The need for family planning and safe 
abortion services among women sex workers seeking STI care in Cambodia. 
Reproductive health matters, 11(21), 88-95.  
Desai, J., & Tarozzi, A. (2011). Microcredit, family planning programs, and contraceptive 
behavior: evidence from a field experiment in Ethiopia. Demography, 48(2), 749-782. 
doi:10.1007/s13524-011-0029-0 
Doig, G. S., & Simpson, F. (2005). Randomization and allocation concealment: a practical guide 
for researchers. J Crit Care, 20(2), 187-191; discussion 191-183. 
doi:10.1016/j.jcrc.2005.04.005 
Downing, J., & Kawuma, E. (2008). The impact of a modular HIV/AIDS palliative care education 
programme in rural Uganda. International Journal of Palliative Nursing, 14(11), 560-568.  
Duflo, E., Dupas, P., Kremer, M., & Sinei, S. (2006). Education and HIV/AIDS prevention: 
evidence from a randomized evaluation in Western Kenya. Retrieved from  
Ellen, J. M., Bonu, S., Arruda, J. S., Ward, M. A., & Vogel, R. (2003). Comparison of clients of a 
mobile health van and a traditional STD clinic. JAIDS Journal of Acquired Immune 
Deficiency Syndromes, 32(4), 388-393.  
Finocchario-Kessler, S., Gautney, B. J., Khamadi, S., Okoth, V., Goggin, K., Spinler, J. K., . . . 
Team, H. I. (2014). If you text them, they will come: using the HIV infant tracking system 
to improve early infant diagnosis quality and retention in Kenya. AIDS, 28 Suppl 3, S313-
321. doi:10.1097/QAD.0000000000000332 
Fiszbein, A., Schady, N. R., & Ferreira, F. H. (2009). Conditional cash transfers: reducing 
present and future poverty: World Bank Publications. 
Glencross, D., Coetzee, L., Lawrie, D., Stevens, W., & Osih, R. (2010). Encouraging point-of-
care PIMA CD4 testing performance in a laboratory setting: Johannesburg, South Africa. 
Paper presented at the 17th Conference on Retroviruses and Opportunistic Infections. 
Glynn, J. R., Caraël, M., Auvert, B., Kahindo, M., Chege, J., Musonda, R., . . . Buvé, A. (2001). 
Why do young women have a much higher prevalence of HIV than young men? A study 
in Kisumu, Kenya and Ndola, Zambia. AIDS, 15, S51-S60.  
Goodreau, S. M., Cassels, S., Kasprzyk, D., Montano, D. E., Greek, A., & Morris, M. (2012). 
Concurrent partnerships, acute infection and HIV epidemic dynamics among young 
adults in Zimbabwe. AIDS & Behavior, 16(2), 312-322. doi:10.1007/s10461-010-9858-x 
Grabbe, K. L., Menzies, N., Taegtmeyer, M., Emukule, G., Angala, P., Mwega, I., . . . Marum, E. 
(2010). Increasing access to HIV counseling and testing through mobile services in 
Kenya: strategies, utilization, and cost-effectiveness. Journal of acquired immune 
deficiency syndromes, 54(3), 317.  

 
GIRLS Study Protocol        Version 1.0       September 9, 2016 
Page 106 of 110 
Gray, R. H., Li, X., Kigozi, G., Serwadda, D., Brahmbhatt, H., Wabwire-Mangen, F., . . . Quinn, 
T. C. (2005). Increased risk of incident HIV during pregnancy in Rakai, Uganda: a 
prospective study. The Lancet, 366(9492), 1182-1188.  
Grusky, O., Roberts, K. J., Swanson, A.-N., Rhoades, H., & Lam, M. (2009). Staff strategies for 
improving HIV detection using mobile HIV rapid testing. Behavioral Medicine, 35(4), 101-
111.  
Hallett, T. B., Stover, J., Mishra, V., Ghys, P. D., Gregson, S., & Boerma, T. (2010). Estimates 
of HIV incidence from household-based prevalence surveys. AIDS, 24(1), 147. 
doi:10.1097/QAD.0b013e32833062dc. 
Handa, S., Halpern, C. T., Pettifor, A., & Thirumurthy, H. (2014). The Government of Kenya's 
Cash Transfer Program Reduces the Risk of Sexual Debut among Young People Age 
15-25. PLoS One, 9(1), e85473. doi:10.1371/journal.pone.0085473 
Harper, G. W. (2013). A socioecological model of sexual risk and resilience among gay/bisexual 
young men in Kenya: Avenues for prevention. Paper presented at the 141st APHA 
Annual Meeting (November 2-November 6, 2013). 
Hebert, M. R., Caviness, C. M., Bowman, S. E., Chowdhury, S. P., Loberti, P. G., & Stein, M. D. 
(2008). Backpack Needle Exchange: Background, Design, and Pilot Testing of a 
Program in Rhode Island. Journal of addictive diseases, 27(3), 7-12.  
Hintze, J. (2013). PASS 12. NCSS, LLC. Kaysville: Utah, USA.  
Holmes, K. K., Levine, R., & Weaver, M. (2004). Effectiveness of condoms in preventing 
sexually transmitted infections. Bulletin of the World Health Organization, 82(6), 454-
461.  
Hosmer, D. W., & Lemeshow, S. (2004). Applied logistic regression: John Wiley & Sons. 
Hosmer, D. W., Lemeshow, S., & Sturdivant, R. X. (2000). Introduction to the logistic regression 
model: Wiley Online Library. 
Hughes, J. P., Baeten, J. M., Lingappa, J. R., Magaret, A. S., Wald, A., de Bruyn, G., . . . 
Partners in Prevention, H. S. V. H. I. V. T. S. T. (2012). Determinants of per-coital-act 
HIV-1 infectivity among African HIV-1-serodiscordant couples. J Infect Dis, 205(3), 358-
365. doi:10.1093/infdis/jir747 
Hurt, C. B., & Powers, K. A. (2014). Self-Testing for HIV and Its Impact on Public Health. 
Sexually transmitted diseases, 41(1), 10-12.  
Hussain, R. (2012). Abortion and unintended pregnancy in Kenya. Issues in brief (Alan 
Guttmacher Institute)(2), 1.  
Inzaule, S., Yang, C., Kasembeli, A., Nafisa, L., Okonji, J., Oyaro, B., . . . Thomas, T. (2013). 
Field evaluation of a broadly sensitive HIV-1 in-house genotyping assay for use with 
both plasma and dried blood spot specimens in a resource-limited country. Journal of 
clinical microbiology, 51(2), 529-539.  
Johnson, K., & Way, A. (2006). Risk factors for HIV infection in a national adult population: 
evidence from the 2003 Kenya Demographic and Health Survey. JAIDS Journal of 
Acquired Immune Deficiency Syndromes, 42(5), 627-636.  
Johnson, K. E., Kisubi, W. K., Karanja Mbugua, J., Lackey, D., Stanfield, P., & Osuga, B. 
(1989). Community-based health care in Kibwezi, Kenya: 10 years in retrospect. Social 
Science & Medicine, 28(10), 1039-1051.  
Kabiru, C. W., Sidze, E. M., Egondi, T., Osok, D., & Izugbara, C. O. (2014). Understanding 
perceived social harms and abuses of oral HIV self-testing in Kenya: Key findings of a 
cross-sectional study. 3ie Grantee Final Report. Washington, DC: International Initiative 
for Impact Evaluation (3ie). Available at 
http://www.3ieimpact.org/media/filer_public/2014/07/18/understanding_perceived_social
_harms_tw2_1_18-june-2014-final.pdf. Accessed on December 12, 2015. .  

 
GIRLS Study Protocol        Version 1.0       September 9, 2016 
Page 107 of 110 
Kahn, R. H., Moseley, K. E., Thilges, J. N., Johnson, G., & Farley, T. A. (2003). Community-
based screening and treatment for STDs: results from a mobile clinic initiative. Sexually 
Transmitted Diseases, 30(8), 654-658.  
Kalibala, S., Tun, W., Cherutich, P., Nganga, A., Oweya, E., & Oluoch, P. (2014). Factors 
associated with acceptability of HIV self-testing among health care workers in Kenya. 
AIDS and behavior, 18(4), 405-414.  
Kelly, C. A., Hewett, P. C., Mensch, B. S., Rankin, J. C., Nsobya, S. L., Kalibala, S., & Kakande, 
P. N. (2014). Using Biomarkers to Assess the Validity of Sexual Behavior Reporting 
across Interview Modes among Young Women in Kampala, Uganda. Studies in Family 
Planning, 45(1), 43-58. doi:10.1111/j.1728-4465.2014.00375.x 
Kenya National Bureau of Statistics (KNBS) and ICF Macro. (2010). Kenya Demographic and 
Health Survey 2008-09. Retrieved from Calverton, Maryland: 
http://www.measuredhs.com/pubs/pdf/FR229/FR229.pdf 
Kitara, D. L., & Aloyo, J. (2012). HIV/AIDS Stigmatization, the Reason for Poor Access to HIV 
Counseling and Testing (HCT) Among the Youths in Gulu (Uganda). African Journal of 
Infectious Diseases, 6(1), 12-20.  
KNBS and ICF Macro. (2010). Kenya Demographic and Health Survey (KDHS) 2008-09. 
Retrieved from Calverton, Maryland: 
http://www.measuredhs.com/pubs/pdf/FR229/FR229.pdf 
Knopf, A. (2012). [FGD and survey results: Youth HIV preventino services]. 
Kumar, A., Chen, J., Paik, M., & Subramanian, L. (2009). ELMR: efficient lightweight mobile 
records. Paper presented at the Proceedings of the 1st ACM workshop on Networking, 
systems, and applications for mobile handhelds, Barcelona, Spain. 
Kurth, A. E., Celum, C., Baeten, J. M., Vermund, S. H., & Wasserheit, J. N. (2011). Combination 
HIV prevention: significance, challenges, and opportunities. Curr HIV/AIDS Rep, 8(1), 
62-72. doi:10.1007/s11904-010-0063-3 
Kurth, A. E., Cleland, C. M., Chhun, N., Sidle, J. E., Were, E., Naanyu, V., . . . Siika, A. M. 
(2015). Accuracy and Acceptability of Oral Fluid HIV Self-Testing in a General Adult 
Population in Kenya. AIDS Behav. doi:10.1007/s10461-015-1213-9 
Kurth, A. E., Cleland, C. M., Des Jarlais, D. C., Musyoki, H., Lizcano, J. A., Chhun, N., & 
Cherutich, P. (2015). HIV Prevalence, Estimated Incidence, and Risk Behaviors Among 
People Who Inject Drugs in Kenya. J Acquir Immune Defic Syndr, 70(4), 420-427. 
doi:10.1097/QAI.0000000000000769 
Kurth, A. E., Inwani, I., Agot, K., Hallett, T., Cleland, C.M., Buttolph, J., Alsallaq, R. (2013). 
Estimating the impact of combination prevention interventions targeting young men and 
women ages 15-24 years old in Nyanza, Kenya. Paper presented at the International 
HIV Treatment as Prevention (TasP) Workshop, Vancouver, BC.  
Kurth, A. E., Siika, A. M., Were, E., Naanyu, V., Emonyi, W., Sidle, J. E., . . . Chhun, N. (2014). 
Accuracy of Oral HIV Self-tests in Kenya: Grantee Final Report. Retrieved from  
Lema, V., Rogo, K., & Kamau, R. (1996). Induced abortion in Kenya: its determinants and 
associated factors. East African Medical Journal, 73(3), 164-168.  
Lester, R. T., Ritvo, P., Mills, E. J., Kariri, A., Karanja, S., Chung, M. H., . . . Najafzadeh, M. 
(2010). Effects of a mobile phone short message service on antiretroviral treatment 
adherence in Kenya (WelTel Kenya1): a randomised trial. The Lancet, 376(9755), 1838-
1845.  
Liang, T. S., Erbelding, E., Jacob, C. A., Wicker, H., Christmyer, C., Brunson, S., . . . Ellen, J. M. 
(2005). Rapid HIV testing of clients of a mobile STD/HIV clinic. AIDS Patient Care & 
Stds, 19(4), 253-257.  
Liebman, J., Pat Lamberti, M., & Altice, F. (2002). Effectiveness of a mobile medical van in 
providing screening services for STDs and HIV. Public Health Nursing, 19(5), 345-353.  

 
GIRLS Study Protocol        Version 1.0       September 9, 2016 
Page 108 of 110 
Low, C., Pop-Eleches, C., Rono, W., Plous, E., Kirk, A., Ndege, S., . . . Thirumurthy, H. (2013). 
The effects of home-based HIV counseling and testing on HIV/AIDS stigma among 
individuals and community leaders in western Kenya: evidence from a cluster-
randomized trial. AIDS Care, 25(Suppl 1), S97-107.  
Matovu, J. K., & Makumbi, F. E. (2007). Expanding access to voluntary HIV counselling and 
testing in sub‐Saharan Africa: alternative approaches for improving uptake, 2001–2007. 
Tropical Medicine & International Health, 12(11), 1315-1322.  
Matovu, J. K. B., Gray, R. H., Kiwanuka, N., Kigozi, G., Wabwire-Mangen, F., Nalugoda, F., . . . 
Wawer, M. J. (2007). Repeat voluntary HIV counseling and testing (VCT), sexual risk 
behavior and HIV incidence in Rakai, Uganda. AIDS and behavior, 11(1), 71-78. 
doi:10.1007/s10461-006-9170-y 
McNairy, M. L., & El-Sadr, W. M. (2012). The HIV care continuum: no partial credit given. AIDS, 
26(14), 1735-1738.  
McNairy, M. L., & El-Sadr, W. M. (2014). A Paradigm Shift: Focus on the HIV Prevention 
Continuum. Clinical Infectious Diseases, 59(Suppl 1), S12-15.  
Miller, C. L., Tyndall, M., Spittal, P., Li, M. K., Palepu, A., & Schechter, M. T. (2002). Risk-taking 
behaviors among injecting drug users who obtain syringes from pharmacies, fixed sites, 
and mobile van needle exchanges. Journal of Urban Health, 79(2), 257-265.  
Mobile family planning units. (1995). Profamilia, 13(26), 17-20.  Retrieved from 
http://www.ncbi.nlm.nih.gov/pubmed/12347403 
Mtapuri-Zinyowera, S., Chideme, M., Mangwanya, D., Mugurungi, O., Gudukeya, S., Hatzold, 
K., . . . Peter, T. (2010). Evaluation of the PIMA point-of-care CD4 analyzer in VCT 
clinics in Zimbabwe. JAIDS Journal of Acquired Immune Deficiency Syndromes, 55(1), 
1-7.  
Mugo, N. R., Heffron, R., Donnell, D., Wald, A., Were, E. O., Rees, H., . . . Kayintekore, K. 
(2011). Increased risk of HIV-1 transmission in pregnancy: a prospective study among 
African HIV-1 serodiscordant couples. AIDS (London, England), 25(15), 1887.  
Mukoma, W. (2016). Approval of Truvada a game changer in anti-HIV/Aids effort. 
http://www.theeastafrican.co.ke/OpEd/comment/Approval-of-Truvada-a-game-changer-
in-anti-HIV-Aids-effort-/-/434750/3027636/-/c45f1j/-/index.html. Accessed on February 
22, 2016.  
Mwau, M., Adungo, F., Kadima, S., Njagi, E., Kirwaye, C., Abubakr, N. S., . . . Hungu, J. (2013). 
Evaluation of PIMA™® Point of Care Technology for CD4 T Cell Enumeration in Kenya. 
PLoS One, 8(6), e67612.  
Napierala Mavedzenge, S., Baggaley, R., & Corbett, E. L. (2013). A review of self-testing for 
HIV: research and policy priorities in a new era of HIV prevention. Clin Infect Dis, 57(1), 
126-138. doi:10.1093/cid/cit156 
NASCOP. (2008). National Guidelines for HIV Testing and Counselling in Kenya. Retrieved 
from http://www.ilo.org/wcmsp5/groups/public/---ed_protect/---protrav/---
ilo_aids/documents/legaldocument/wcms_127533.pdf 
NASCOP. (2014a). Kenya AIDS Indicator Survey (KAIS) 2012 Final Report. 
http://www.nacc.or.ke/attachments/article/403/KAIS_II_2014_Final_Report.pdf Retrieved 
from http://www.nacc.or.ke/attachments/article/403/KAIS_II_2014_Final_Report.pdf 
NASCOP. (2014b). Kenya HIV County Profiles. Nairobi, Kenya: National AIDS Control Council.  
NASCOP, & NACC. (2014). Kenya HIV Prevention Revolution Road Map: Countdown to 2030.  
NASCOP (2015). The Kenya HIV Testing Services Guidelines. Available at 
https://aidsfree.usaid.gov/sites/default/files/hts_policy_kenya_2015.pdf 
Obare, F., van der Kwaak, A., & Birungi, H. (2012). Factors associated with unintended 
pregnancy, poor birth outcomes and post-partum contraceptive use among HIV-positive 
female adolescents in Kenya. BMC women's health, 12(1), 34.  

 
GIRLS Study Protocol        Version 1.0       September 9, 2016 
Page 109 of 110 
Ochako, R., Vu, L., & Peterson, K. (2014). Insights into potential users and messaging for HIV 
oral self-test kits in Kenya. 3ie Grantee Final Report. Washington, DC: International 
Initiative for Impact Evaluation (3ie). Available at 
http://www.3ieimpact.org/media/filer_public/2014/07/21/insights_into_potential_users-
final.pdf. Accessed on December 12, 2015.  
Okal, J., Obare, F., Tun, W., & Matheka, J. (2014). Possible channels for distribution of HIV oral 
self-test kits in Kenya. 3ie Grantee Final Report. Washington, DC: International Initiative 
for Impact Evaluation (3ie). Available at 
http://www.3ieimpact.org/media/filer_public/2014/08/04/possible_channels_for_distributi
on-test_study_final_report.pdf. Accessed on December 12, 2015.  
Omanga, E., Agot, K., Inwani, I., Walawanga, D., Ogange, L., Buttolph, J., & Kurth, A. (2013). 
Gender specific HIV prevention options for female youth: Which services, venues and 
information sources do they prefer?  . Paper presented at the University of Nairobi  HIV 
Collaborative Meeting, Nairobi.  
Organization, W. H. (2013). Consolidated guidelines on general HIV care and the use of 
antiretroviral drugs for treating and preventing HIV infection: recommendations for a 
public health approach.  
Osoti, A. O., John-Stewart, G., Kiarie, J., Richardson, B., Kinuthia, J., Krakowiak, D., & 
Farquhar, C. (2014). Home visits during pregnancy enhance male partner HIV 
counselling and testing in Kenya: a randomized clinical trial. AIDS, 28(1), 95-103 
110.1097/QAD.0000000000000023.  Retrieved from 
http://journals.lww.com/aidsonline/Fulltext/2014/01020/Home_visits_during_pregnancy_
enhance_male_partner.11.aspx 
Pant Pai, N., Sharma, J., Shivkumar, S., Pillay, S., Vadnais, C., Joseph, L., . . . Peeling, R. W. 
(2013). Supervised and unsupervised self-testing for HIV in high- and low-risk 
populations: a systematic review. PLoS Med, 10(4), e1001414. 
doi:10.1371/journal.pmed.1001414 
Plosker, G. L. (2013). Emtricitabine/tenofovir disoproxil fumarate: a review of its use in HIV-1 
pre-exposure prophylaxis. Drugs, 73(3), 279-291. doi:10.1007/s40265-013-0024-4 
Rogo, K. O. (1993). Induced abortion in sub-Saharan Africa. East African Medical Journal, 
70(6), 386-395.  
Shah, I., & Ǻhman, E. (2010). Unsafe abortion in 2008: global and regional levels and trends. 
Reproductive health matters, 18(36), 90-101.  
Singer, J. D., & Willett, J. B. (2003). Applied longitudinal data analysis: Modeling change and 
event occurrence: Oxford university press. 
Stankard, P., LeTouze, O., & Jones, M. (2014). How should HIV self-test kits be packaged in 
Kenya. 3ie Grantee Final Report. Washington, DC: International Initiative for Impact 
Evaluation (3ie). Available at 
http://www.3ieimpact.org/media/filer_public/2014/07/18/packaging_self-tests-
testing_report_q2_final_report_060614.pdf. Accessed on December 12, 2015.  
Sweat, M., Morin, S., Celentano, D., Mulawa, M., Singh, B., Mbwambo, J., . . . Coates, T. 
(2011). Community-based intervention to increase HIV testing and case detection in 
people aged 16–32 years in Tanzania, Zimbabwe, and Thailand (NIMH Project Accept, 
HPTN 043): a randomised study. The Lancet Infectious Diseases, 11(7), 525-532. 
doi:10.1016/s1473-3099(11)70060-3 
Taegtmeyer, M., Davies, A., Mwangome, M., van der Elst, E. M., Graham, S. M., Price, M. A., & 
Sanders, E. J. (2013). Challenges in providing counselling to MSM in highly stigmatized 
contexts: results of a qualitative study from Kenya. PLoS ONE, 8(6), e64527. 
doi:10.1371/journal.pone.0064527 
Therneau, T. M., & Grambsch, P. M. (2000). Modelling Survival Data: Extending the Cox Model. 
New York: Springer-Verlag. 

 
GIRLS Study Protocol        Version 1.0       September 9, 2016 
Page 110 of 110 
Thirumurthy H, Masters SM, Napierala Mavedzenge S, Maman S, Omanga E, Agot K. (2016). 
Promoting male partner HIV testing and safer sexual decision making through secondary 
distribution of self-tests by HIV-negative female sex workers and women receiving 
antenatal and post-partum care in Kenya: a cohort study. Lancet HIV 2016. 
http://dx.doi.org/10.1016/S2352-3018(16)00041-2 
Thirumurthy, H., Chamie, G., Jain, V., Kabami, J., Kwarisiima, D., Clark, T. D., . . . Havlir, D. V. 
(2013). Improved employment and education outcomes in households of HIV-infected 
adults with high CD4 cell counts: evidence from a community health campaign in 
Uganda. AIDS, 27(4), 627-634. doi:10.1097/QAD.0b013e32835c54d8 
Thirumurthy, H., Zivin, J. G., & Goldstein, M. (2008). The economic impact of AIDS treatment 
labor supply in Western Kenya. Journal of Human Resources, 43(3), 511-552.  
Ujiji, O. A., Ekström, A. M., Ilako, F., Indalo, D., & Rubenson, B. (2010). ‘I will not let my HIV 
status stand in the way.’Decisions on motherhood among women on ART in a slum in 
Kenya-a qualitative study. BMC women's health, 10(1), 1-10.  
UNAIDS. (2012a). Fact Sheet:  Adolescents, young people and HIV. UNAIDS. 
http://www.unaids.org/sites/default/files/en/media/unaids/contentassets/documents/facts
heet/2012/20120417_FS_adolescentsyoungpeoplehiv_en.pdf Retrieved from 
http://www.unaids.org/sites/default/files/en/media/unaids/contentassets/documents/facts
heet/2012/20120417_FS_adolescentsyoungpeoplehiv_en.pdf 
UNAIDS. (2012b). World AIDS day Report. Results. Geneva, Switzerland: UNAIDS. 
UNAIDS. (2013). Global Report: UNAIDS report on the global AIDS epidemic 2013. Geneva, 
Switzerland: UNAIDS.  
UNICEF. (2012). HIV/AIDS Issues: Preventing HIV infection among adolescents and young 
people. Eastern and Southern Africa.  Retrieved from 
http://www.unicef.org/esaro/5482_HIV_prevention.html 
Voeten, H. A., Egesah, O. B., & Habbema, J. D. F. (2004). Sexual behavior is more risky in rural 
than in urban areas among young women in Nyanza province, Kenya. Sexually 
Transmitted Diseases, 31(8), 481-487.  
WHO. (2006). WHO Department of Gender, Women and Health, WHO Department of 
HIV/AIDS. Retrieved from 
http://www.who.int/gender/documents/hiv/9241594594/en/index.html 
WHO. (2011). Global HIV/AIDS response: epidemic update and health sector progress towards 
universal access: progress report 2011. Geneva, Switzerland: World Health 
Organization.  
WHO. (2013). Consolidated guidelines on general HIV care and the use of antiretroviral drugs 
for treating and preventing HIV infection: recommendations for a public health approach. 
WHO. (2015). Guideline on when to start antiretroviral therapy and on pre-exposure prophylaxis 
for HIV. Available at 
http://apps.who.int/iris/bitstream/10665/186275/1/9789241509565_eng.pdf