Addressing Cervical Cancer Disparity in South Florida: CBPR in Action
Phase: NA
Conditions: Cervical Cancer
Sponsor: University of Miami

 
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Protocol Title: Addressing Cervical Cancer Disparity in South Florida: CBPR in Action 
Version Date: 2/4/16 
NCT#02202109 
 
 
 
 
 
 
 
 

 
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1) 
Protocol Title 
Addressing Cervical Cancer Disparity in South Florida: CBPR in Action 
 
2) 
Principal Investigator 
Erin Kobetz, PhD, MPH 
 
3) 
Sub-investigator 
Olveen Carrasquillo, MD, MPH 
 
4) 
Study Contact 
Martine Poitevien, MBA 
 
5) 
Study Personnel 
(Listed on IRB7) 
 
6) 
IRB Review History 
N/A 
7) 
Objectives 
 
The study entitled “Health in Your Hands” will test the significance of community health worker 
participation by comparing Human Papilloma Virus (HPV) self-sampling provided by a community 
health worker and HPV self-sampling provided by mail. The study will enroll 700 participants in 
communities characterized by health disparities and lack of access to the formal healthcare 
system, such as Little Haiti, Hialeah, and South Dade.   
 
8) 
Background* 
 
In Miami, Florida, cervical cancer is a particular problem for Haitian and Caribbean Hispanic 
women. When compared to other racial/ethnic minority and immigrant groups in the Miami 
metropolitan area, Haitian and Hispanic women contribute disproportionately to cervical cancer 
incidence, morbidity and mortality, largely as a function of their underutilization of Pap smear 
screening. They do not undergo Pap smear screening for a myriad of reasons, including, but not 
limited to: poverty; language difficulties; limited access to health care; lack of knowledge about 
cancer and the importance of early detection; cancer fatalism or the belief that cancer implies 
death; and, cultural norms about health and disease prevention. The proposed project aims to 
overcome such barriers. 
 
With funding from the National Cancer Institute, we have documented the prevalence of lifetime 
and routine Pap smear among women living in our communities of interest.  Between March and 
May 2011, the community health workers approached approximately 200 women from various 
community venues across Little Haiti, Hialeah and West Perrine including Laundromats, health 
clinics, and churches. Of the participants, 71% reported having at least one Pap smear in their 
life. Of those with a history of screening (n=143), only 80% reported having a least one Pap smear 
in the past three years as recommended by national guidelines. There is not a direct comparison 
for our data, though in relation to national averages and data, the women in our sample appear 
to be under-screened.   
 
Following this data, a pilot study was conducted (funded by UM Sylvester and the University of 
Miami Institute for Women’s Health) to examine whether Haitian women consider self-sampling a 
culturally-acceptable alternative to the Pap smear.  A total of 250 women agreed to participate in 

 
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the study, which involved cervical self-sampling with the POI/NIH device (essentially a long q-tip 
with a protective sheath), as well as, completing a detailed survey.  Findings indicate that 
acceptability of the device is high, that the majority of women prefer the self-sampler to the 
traditional, physician speculum exam and find it easy and comfortable to use. In addition to such 
positive results, this pilot study helped to establish the infrastructure necessary for successfully 
carrying out the proposed study. 
 
 
 
9) 
Inclusion and Exclusion Criteria 
Rational for inclusion/exclusion criteria: our target population is ethnic minority females aged 30-
65 living in one of the three target communities who have not been screened for cervical cancer 
in the past three years (as per recent guidelines). 
To be eligible women must be:  
• 
Haitian, Hispanic, or African American 
• 
ages 30-65 years  
• 
report not having had a pap smear in the last three years  
• 
live in the cities of Miami/Little Haiti, Hialeah or unincorporated Southern Miami-Dade  
 
EXCLUSION CRITERIA: 
Women will not be included in the study if they:  
• 
report having had a hysterectomy  
• 
have a history of cervical cancer  
• 
plan to move outside of Miami-Dade county during the next six months  
• 
are enrolled in any other cancer prevention/outreach related study  
The study will exclude: 
• 
Adults unable to consent 
• 
Individuals who are not yet adults (infants, children, teenagers) 
• 
Pregnant women 
• 
Prisoners 
10) 
Number of Subjects 
700 
 
11) 
Study-Wide Recruitment Methods 
 
Participants will be recruited to participate in the study primarily through the efforts of Community 
Health Workers (CHWs), who are indigenous to the area, employed by our community partners 
and certified to conduct research by the University of Miami (UM) Institutional Review Board 
(IRB). The CHWs are not UM employees but are CITI-certified and are from either the Health 

 
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Choice Network, which includes the Citrus Health Network and Community Health of South 
Florida, Inc. (CHI), and the Center for Haitian Studies (CHS).  
 
The CHWs will be trained by the Principal Investigator and community partners about how to 
approach potentially eligible individuals and encourage their participation in the study. They will 
recruit participants from various community settings in Little Haiti, Hialeah, and South Dade, such 
as laundromats, flea markets, health clinics, local botanicas, and church gatherings, that have 
been identified through ethnographic community mapping as regularly frequented by the target 
population. The CHWs will also rely heavily on their own social networks and those of the 
community leaders, to identify potentially eligible participants.  
 
Although we recognize the inherent limitations in such non-probability approaches to sampling, 
our preliminary research in Little Haiti and Hialeah indicates that more random recruitment 
strategies engender suspicion and compromise overall participation. As a result, we must employ 
a non-probability, purposive quota-based sampling strategy to recruit participants. However, we 
will attempt to introduce randomness into this sample by using recruitment protocols that direct 
the CHWs to approach every Nth woman in socially salient community settings. We will compare 
study samples with data abstracted from the US census to better understand whether our sample 
is, in fact, representative of our target communities. 
 
Community Advisory Group members will also promote our research agenda through culturally-
appropriate communication channels, such as radio and print media. Radio is the primary news 
source for a majority of residents in our target communities, and can help generate community 
interest in, and support for the proposed research. 
 
12) 
Study Timelines 
An individual will participate in the study for six months (baseline interview at intake and a six-
month follow-up interview). We estimate the time necessary to enroll all study subjects will be 27 
months. The estimated date for completion of the study is May 1, 2017. 
 
13) 
Study Endpoints* 
 
Our primary endpoint is a returned HPV self-sampler kit. We have several planned subgroup 
analysis to help us understand if our intervention was more effective among certain population 
sub-groups. We therefore propose to examine whether the intervention was more efficacious 
among women with lower levels of educational attainment and those who are 
uninsured/underinsured.  We consider all these analysis to be hypothesis generating, rather than 
hypothesis testing, given limited power. We also plan to examine several secondary endpoints, 
including: a) Access to care (health insurance, having a usual source of care, and visit to provider 
in six months). These would be analyzed as binary variables and would help explore if HPV self-
sampling led to a decrease in access. b) Cervical cancer knowledge to help determine study 
fidelity. This is a continuous variable based on summed number of correct answers. c) Knowledge 
of test results and, for those with an abnormal screen, the proportion of women in each group 
who received appropriate initial follow-up within 30 days of the abnormal screen d) Acceptability 
of screening delivery.  
 
14) 
Procedures Involved* 
 

 
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Determination of eligibility The CHWs will screen potential participants for eligibility by asking 
whether they are 1) Haitian, Hispanic or African American, 2) 30-65 years of age or older, 3) have 
not had a Pap smear in the past three years, 4) has not had a hysterectomy, 5) has not been 
enrolled in a similar study (e.g. SUCCESS), 6) is not pregnant, 7) will not move in the next 6 
months. For those women who screen potentially eligible, the CHW will further describe the study. 
Potential participants will be told that we are conducting a research study to determine the best 
method to increase rates of cervical cancer screening among women in their community. They 
will be told that the study will involve a brief education session about cervical cancer prevention 
and treatment, as well as instructions on how to use the HPV self-sampler we will be providing 
them with.  
 
• 
Women who decline participation: For women who are potentially eligible but were not 
interested in participating, the brief demographic information collected during the eligibility 
screen (age, ethnicity) will be kept without any identifiable information. This data will be used 
to compare responders versus non-responders.  
• 
Women who agree to participate: The CHW will obtain signed informed consent from the 
women who are interested in participating. 
 
Informed Consent and Intake Survey: After obtaining consent, the CHW will proceed with the 
intake interview.  The intake interview will be conducted by our research assistants/community 
health educators (CHEs) to avoid introducing bias into our study design. Prior to beginning the 
intake survey, the CHE will first conduct another inclusion screen to verify that the potential 
participant still meets study inclusion criteria. The CHE will then re­explain the study to the 
potential participant and answer any questions she may have. If she is still agreeable to 
participating, the CHE will obtain signed informed consent.  After obtaining consent, the CHE 
will proceed with the intake interview.  The CHW will explain to participant that she will 
participate in two interviews 6 months apart, where each interview will take approximately 30 
minutes to complete. This home interview will be conducted using laptop computers with 
wireless cards allowing access to the Research Electronic Data Capture (REDCap) web­based 
platform (see below). Backup paper copies will be available in case the CHE experiences 
difficulty accessing the web. 
After completion of the intake survey, the participant will receive a $25 gift card for their time 
and participation.   
 
Randomization:  Once participants complete the screening intake, they will be randomized into 
one of two possible interventions. Participants will be provided randomization information via 
phone by the CHW. Randomization will be done by REDCap, a secure web-based and HIPPA 
compliant system that allows to manage online surveys, database and reporting.  
 
A custom allocation list has been created, which serves as a lookup table for deciding how to 
randomize subjects.  Randomization of subjects will occur on the data collection form where your 
randomization field. After a subject has been randomized, it will become permanently locked and 
unmodifiable. The randomization field will always be locked and unmodifiable both before and 
after randomization has occurred for a subject. When the user randomizes the subject, REDCap 
will check the allocation table and assign that subject's randomization field value, which will be 
derived from the next match in the table based upon the criteria. In this case, it will simply provide 
the subject with the very next value in the allocation table. 
Study personnel involved in accessing randomization data will include the Principal Investigator, 
Study Manager, REDCap Administrator, Research Associate/Data Manager and Statisticians.  A 
specific REDCap form will be used for randomization results. Randomization will occur on a 
weekly basis for all subjects whose data were uploaded that week. The CHEs will be blinded to 

 
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participants’ randomization assignment groups. The randomization group assignments will be 
accessed by the Study Manager, who will communicate the randomization results to the CHWs.  
 
In our research, we plan to use a self-sampling device developed by Preventive Oncology 
International (POI) and the National Institutes of Health (NIH). The POI/NIH self-sampler is 
considered a non-significant risk device and has been approved for research conducted by NIH 
faculty throughout the United States and in various international settings. This device is 
manufactured by Puritan Medical Products, and is thought to reflect an improvement over other 
self-samplers, given a larger Collection Swab tip, which enables a woman to collect cells from 
more of the cervix’s total surface area with less effort. The POI/NIH self-sampler is a 20 cm in 
diameter, which is similar to a regular-sized tampon. This sampler is easy to use.  A woman 
inserts the device into her vagina until she feels slight resistance. The participant then holds the 
paddle end of the Collection Swab and rotates it five times.  She then withdraws the Collection 
Swab. Once the Collection Swab is fully removed from the vagina, the participant places the 
Collection Swab into liquid cell preservative and rotates it five times. The participant can then 
dispose of the swab in a household trashcan and secure the vial lid. The vial can be placed back 
into the pre-addressed, stamped envelope and mailed to the SCCC for testing. The specimen can 
be stored at room temperature, and HPV testing can be effectively performed on this single 
specimen.  
 
The HPV self-sampler kit will include: 1) the HPV self-sampler (collection swab and the vial for 
collecting and storing the specimen; 2) a pre-addressed, stamped envelope for returning the vial 
to the SCCC laboratory for testing; 3) a postcard which includes a picture and information of the 
CHW that serves to re-orient the participant to the focus of the study; 4) an instructional sheet 
that visually depicts the steps for self-sampling; 5) information provided by our community partner 
in each site about their organization, the medical services provided, and how to schedule a Pap 
smear. We believe it is necessary for women to be exposed to information about Pap smears, 
given that they remain the standard for disease prevention throughout the life course.  At the six-
month follow-up interview, participants in this arm will be asked for detailed feedback about the 
kit and any recommendations for how to improve it.  
 
The CHW will call participants within a week, using the randomization phone script, to inform them 
of 1) randomization group allocation, 2) conduct brief health education over the phone, and 3) 
schedule a home visit (Group 1) or inform participant that kit will be mailed within one week (Group 
2).  
 
Within one week after completing the intake interview, women randomized to the intervention arm 
will receive a HPV self-sampling kit via mail (intervention arm- Group 2) or will be given a self-
sampling kit by the CHW (control arm- Group 1).  
 
Group 1: Control Group (CHW) - Participants receive HPV self-sampler at home visit: .  During 
the home visit, the CHW will provide the participant with brief health education and offer the HPV 
self-sampler accompanied by an instruction sheet on how to use the self-sampler. The education 
will include: 1) health education on the importance of cervical cancer screening using a short 
intervention/educational script and 2) motivation to encourage women to have screening using 
the HPV self-sampler. Women will also be informed of the following: 1) HPV infection usually is 
not detectable or harmful; 2) nearly everyone who has had sexual intercourse has been exposed 
to HPV and infection is very common; 3) a positive HPV test result does not indicate the presence 
of cancer and that not all women who test positive for an HPV infection will not develop advanced 

 
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cancer. It will also be stressed to women that if they have not seen a doctor recently they will still 
need to see a provider to address other health issues, which may include a gynecologic exam. 
They will also be advised that if HPV obtained through self-sampling is positive, they will need 
follow-up medical care at our clinical sites. The participant will have the option of self-sampling at 
home or mailing the kit back.  
 
Group 2: Intervention Group (Mail Self-Sampler Kit): Participants receive the kit via mail. The 
Study Manager mails the self-sampler kit to the participant. The CHW will also provide the 
participant with brief education via phone utilizing a short intervention/educational script. The 
participant will follow instructions on instruction sheet provided in the kit, and once self-sampling 
is completed, participant will mail the kit to UM/SCCC. 
 
Report of HPV Lab Results  
The Study Manager will receive test results from lab and provide information to CHWs. CHWs will 
call participants within 4-6 weeks to notify them of their test results when they are received. 
Participants who test negative will be encouraged to follow-up with their doctor and rescreen in 
36 months, based on the US Preventive Services Task Force (USPSTF) guidelines. Participants 
whose test results indicate insufficient sample (insufficient cellular quantity for analysis) would be 
asked if they had a hysterectomy. If no, the participant will provide a second sample, and an 
appointment will be scheduled by CHW. If answered yes, the HPV lab result will be reported to 
the Study Manager. Participants who test positive for HPV will be navigated to appropriate follow-
up care with our community partners and/or Jackson Memorial Hospital (JMH) within 30 days of 
receiving the result. JMH is the safety net hospital for Miami-Dade County and provides free and 
low cost care to indigent and medically underserved individuals in the Miami metropolitan area. 
The CHWs will work with JMH staff to ensure that women with abnormal findings receive timely 
follow up. The CHWs will follow up with participants who do not return the kit within 30 days. 
 
At 4 months, the CHW calls participants in both arms to verify contact information only.  
 
Exit Survey at 6 months:  The CHE will conduct an exit interview/ survey at 6 months with all 
who participated in the baseline procedures (Arms 1 and 2).  The survey will take approximately 
30 minutes. At exit, both arms will be offered the option of self-sampling at home or mailing the 
kit back. The participant on Arm 2 is offered the HPV self-sampler again to be done at home or 
the participant has the option of mailing it back, in case she did not have the opportunity to 
complete self-sampling. After completion of the intake survey, the participant will receive a $25 
gift card for their time and participation.  
 
15) 
Data and Specimen Banking 
 
. The Study Manager will take the specimens to the Oncogenomic Core Facility at UM Sylvester 
Comprehensive Cancer Center (SCCC) for high-risk HPV detection and HPV viral genotyping on 
a weekly basis. Specimens will be labeled with a number that matches the number assigned to 
the participant during the study intake. The specimens will be processed and Results will be 
reported back to Study Manager within 2 weeks, who will obtain signature from Dr. Carrasquillo. 
He will sign and date lab result sheet. Copies of results will be filed and kept in locked cabinet 
and uploaded to REDCap. The leftover samples will be banked in a secure freezer at the Sylvester 

 
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Comprehensive Cancer Center at the University of Miami, Miller School of Medicine for future 
analysis. 
 
16) 
Data Management 
 
All of the data collected via iPad or paper forms and supporting documentation will be uploaded 
and stored on REDCap, a web-based management application that is designed specifically for 
investigators and their research teams. It supports processes for participant recruitment, data 
collection, database management, reporting and study execution. A major strength for our 
proposal is that REDCap allows all study related information to be centralized yet be accessed 
through the internet from anywhere through encrypted and password protected access granted 
only to authorized UM personnel as designated by the study PIs.  It is easy to use, reliable, fully 
HIPPA complaint and secure. A major advantage of using this system is that UM provides this 
important resource to UM and associates (such as non UM community research partners) at no 
cost. This includes technical support and effort of REDCap team staff who provide technical 
assistance to investigators.  
 
17) 
Risks to Subjects 
 
Participants in the study will be asked a series of questions on health literacy, which involves an 
understanding of medical terms, access to health care, and cervical cancer knowledge, attitudes 
and beliefs. There is no risk of physical injury from answering these questions. However, 
participants may  feel uncomfortable by answering some questions about their personal feelings 
and beliefs. The educational portion with the CHWs may introduce a participant to health concepts 
that are discordant with their current beliefs. This may cause the participant confusion or 
frustration, as well as concern for herself, family members, and friends. The participant may also 
find herself opening up about health issues and concerns that she has previously kept private. 
This process may cause emotional discomfort.  
 
Regarding the cervical self-sampling device, the two most common problems of self- 
sampling were:  1) placing the sampler in an incorrect opening (e.g., the anus); and 2) Injury 
to the vagina or cervix due to aggressive sampling.  Also, you may experience cervical 
bleeding and inflammation from excessive pressure applied during the rotation of the device.  
If you experience continuous and heavy bleeding, stop using the device and contact the study 
team immediately.   However, both of these hazards are unlikely to occur with the current 
device.  In trials with more than 20,000 women when either problem has occurred, they did 
not cause serious injury. Rather, they resulted in minimal patient discomfort.  Thus, it is 
considered a non-significant risk device. If you decide that you do not wish to participate in 
the study after it has started, please tell the research assistant. There is no penalty imposed 
if you decide to end your participation early and/or refuse to answer any question. 
There are psychological risks associated with receiving an abnormal test result from self-
sampling. Participants may interpret an abnormal result as a diagnosis of cancer rather than an 
infection with HPV. The participant may feel hopeless in response to an abnormal result, believing 
that there is nothing that can help. As a member of an underserved, immigrant, minority group 
she may feel that adequate health services are not available or accessible to her. She may also 
feel guilty that she has done something wrong or someone has wished ill health upon her. She 

 
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may feel embarrassed to tell her friends, family, and other ones, fearful of how they may judge 
her and reflect upon her diagnosis. 
 
Adverse Experience Reporting: If any participant who chose to use the HPV self-sampler 
indicates to CHW that a discomfort is persistent or something else has occurred, CHW should 
contact directly the Principal Investigators of the study.  
 
18) 
Potential Benefits to Subjects 
 
A potential benefit for all participants is increased knowledge and awareness of one’s 
gynecological and sexual health, specifically information on cervical cancer and the opportunity 
to be screened. The information learned from this study will increase our understanding of 
effective ways to do cervical cancer outreach and screening to women who have not been 
screened. Sharing one’s understandings with other members of the community will also increase 
awareness on a larger scale.  
 
This study may help improve the relationship between the Little Haiti, Hialeah, and South Dade 
communities and health services. Participants may feel supported and cared for by our community 
partners.   
 
Women with normal test results will have peace of mind. Women with abnormal test results will 
hopefully be caught early enough where interventions that will help prevent more severe health 
issues, such as cervical cancer, are available. Those with abnormal test results whose follow up 
reveals cervical dysplasia and malignancy will be assisted in navigating the complex healthcare 
system for follow up care.  
 
19) 
Vulnerable Populations 
N/A 
 
20) 
Multi-Site Research 
N/A 
 
21) 
Community-Based Participatory Research 
 
Grant funding from the NIH enabled the creation of a University institute to address cancer health 
disparities. The institute, Jay Weiss Institute for Health Equity, previously known as South Florida 
Center for Reducing Cancer Disparities or SUCCESS, is focused on attenuating the excess 
burden of cervical cancer observed in Little Haiti, Hialeah, and West Perrine. For the past three 
years, the Jay Weiss team, comprised of diverse academic and community stakeholders, has 
been working to increase screening opportunity through outreach and education that reflects the 
unique cultural and linguistic needs of our target communities, and builds upon the assets of our 
extensive network of community partners. With the support and active participation of such 
partners, we have played a critical role in over 100 events held throughout Hialeah, Little Haiti, 
and West Perrine this year alone, and educated an estimated 5,474 people about cervical cancer 
and the importance of early detection of disease. This study provides an opportunity to extend 
our impact, and continue our work in our targeted communities. 

 
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22) 
Sharing of Results with Subjects 
 
CHWs will notify participants of their test results when they are received. Participants who test 
negative will be encouraged to follow up with their doctor and rescreen in 36 months, based on 
the US Preventive Services Task Force (USPSTF) guidelines. Participants whose test results 
indicate insufficient sample would be asked if they had a hysterectomy. If no, the participant will 
provide a second sample, and an appointment will be booked by CHW. If answered yes, the HPV 
lab result will be reported to the Study Manager.  Participants who test positive for high-risk strains 
of HPV will be navigated by the CHW to appropriate follow-up care with our community partners 
and/or Jackson Memorial Hospital (JMH) within 30 days of receiving the result. JMH is the safety 
net hospital for Miami-Dade County and provides free and low cost care to indigent and medically 
underserved individuals in the Miami metropolitan area. The CHWs will work with JMH staff to 
ensure that women with abnormal findings receive timely follow up. The CHWs will follow up with 
participants who do not return the kit within 30  days. 
 
23) 
Setting 
 
The CHWs will identify and recruit potential subjects at various community venues that they deem 
appropriate and at which women tend to congregate. These may include, but are not limited to 
laundromats, churches, health clinics, and flea markets in Little Haiti, Hialeah, and South Dade.  
Mailed specimens will be taken to the Oncogenomic Core Facility at UM Sylvester 
Comprehensive Cancer Center (SCCC) for high-risk HPV detection and HPV viral genotyping. 
 
24) 
Resources Available 
 
The current research study uses SUCCESS’ infrastructure to accomplish study aims and build 
necessary capacity to support future large scale, community-based interventions to address other 
areas of cancer disparity. SUCCESS has established Community Advisory Groups (CAGs) in 
Little Haiti and a steering Community Leadership Board (CLB). The CLB involves representation 
from members of all CAGs as well as other local experts in cancer prevention and control. The 
CLB meets quarterly to maximize information exchange between CAGs and also to ensure that 
key findings are disseminated to the community in a timely and appropriate manner. Additionally, 
SUCCESS is an active member of the Southeast Florida Cancer Control Collaborative, a group 
of more than 50 local organizations that collaborate on cancer prevention, education, and patient 
services, and may provide future opportunities for dissemination and expansion of the pilot 
intervention. 
 
25) 
Confidentiality 
 
Multiple steps will be taken to guarantee confidentiality. All paper-based surveys and forms will 
be entered and uploaded using Research Electronic Data Capture (REDCap). All REDCap data 
is securely hosted by the University of Miami’s IT Department. Research IT administers project 
creation, user account management, and movement of projects from development to production. 
Authentication is performed via CaneID Authentication Service (CAS), the same institution-wide 
system used for a variety of applications such as myUM.  Other electronic data will be stored in 

 
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password-protected files that only Dr. Kobetz and the Study Manager and study staff will be able 
to access. There are multiple levels of security once placed on the local network. Paper copies 
will similarly be stored in a locked file drawer that only Study Manager and the Data Manager will 
be able to access.  
 
All study personnel will be certified to conduct human subjects’ research by the University of 
Miami Institutional Review Board.  
 
All data will be inspected for quality assurance prior to analysis. Prior to performing statistical 
analyses on quantitative data, the data will be checked, screened and verified. Data checking is 
critical to ensure the integrity of the database. Range checks will be routinely performed, and 
random items from the raw data will be checked against the entered data so that mistakes can be 
identified. 
 
The study investigators and their staff will consider all records confidential to the extent permitted 
by law. The U.S. Department of Health and Human Services (DHHS) may request to review and 
obtain copies of any records.  Records may also be reviewed for audit purposes by authorized 
University employees or other agents who are bound by the provisions of confidentiality 
 
26) 
Consent Process 
Written Informed consent will be obtained by the CHW at the community venues where 
participants are being recruited for the study. We will be following the SOP HRP-090 
Informed Consent Process for Research when obtaining consent. Consent will be 
obtained in a private room from women who are eligible and agree to participate after the 
CHW describes the study. Potential participants will be told that we are conducting a 
research study to determine the best method to increase rates of cervical cancer 
screening among women in their community. They will be told that the study will involve a 
brief education session about cervical cancer prevention and treatment, as well as 
instructions on how to use the self-sampler we will be providing them with. The informed 
consent form will include a designated section “optional procedures” for participants to 
accept or decline biobanking of specimens for future analysis. Participants are given the 
opportunity to opt out of selected study procedures. 
Informed Consent will be provided in English, Spanish, and Creole, based on the 
participant’s language preference. 
 
27) Waiver of Signed Consent  
A waiver of signed consent is requested for screening activities. This research presents no more 
than minimal risk of harm to subjects and involves no procedures for which written consent is 
normally required outside of the research context.