"PrEP My Way": A Novel PrEP Delivery System to Meet the Needs of Young African Women
Phase: NA
Conditions: HIV/AIDS
Sponsor: Massachusetts General Hospital

PrEP My Way Study 
Protocol 
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Protocol 
 
“PrEP My Way”:  A Novel PrEP Delivery System to Meet  
the Needs of Young African Women 
 
 
Version 2.0 
 
20 January 2021 
 
Funding: 
US National Institute of Mental Health 
(R34MH122362) 
NCT04408729 

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Study team 
 
Massachusetts General Hospital/Harvard Medical School 
Jessica Haberer, MD, MS 
 
Kenya Medical Research Institute 
Elizabeth Bukusi, MBChB, MMed, MPH, PhD 
 
Emory University 
Aaron Siegler, PhD 
 
University of Washington 
Jared Baeten, MD, PhD 
 
 

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ACRONYMS  
ART 
 
Antiretroviral therapy 
CAB 
 
Community advisory board 
DBS 
 
Dried blood spots  
FDA 
 
Food and Drug Administration  
HIPAA  
Health Insurance Portability and Accountability Act of 1996 
HIV 
 
Human Immunodeficiency Virus  
MSM  
Men who have sex with men  
PEPFAR 
President’s Emergency Plan for AIDS Relief 
PrEP   
Pre-exposure prophylaxis  
RA 
 
Research assistant 
RCT 
 
Randomized controlled trial  
RCTP  
KEMRI Research Care and Training Program  
SMS 
 
Short message service 
STI 
 
Sexually transmitted infection 
SUS   
Systems usability scale 
TFV-DP 
Tenofovir diphosphate 
UTAUT  
Unified Theory of Acceptance and Use of Technology  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of Contents 
Abstract 
 
 
 
 
 
 
 
 
 
 
5 
Introduction/Background 
 
 
 
 
 
 
 
 
5 
Justification for study   
 
 
 
 
 
 
 
 
6 
General objectives 
 
 
 
 
 
 
 
 
 
8 
Specific objectives  
 
 
 
 
 
 
 
 
 
9 
Design and Methodology  
 
 
 
 
 
 
 
 
9 
Study procedures 
 
 
 
 
 
 
 
 
 
14 
Outcome measures 
 
 
 
 
 
 
 
 
 
17 
Ethical considerations 
 
 
 
 
 
 
 
 
19 
Potential risks and protections against risks  
 
 
 
 
 
21 
Expected application of results 
 
 
 
 
 
 
 
22 
Community advisory board (CAB) 
 
 
 
 
 
 
 
22 
Data safety and monitoring plan (DSMP) 
 
 
 
 
 
 
22 
Study records  
 
 
 
 
 
 
 
 
 
23 
Investigator roles 
 
 
 
 
 
 
 
 
 
23 
References 
 
 
 
 
 
 
 
 
 
 
24 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Abstract 
Young women in sub-Saharan Africa are a vulnerable population in terms of HIV acquisition 
with ~7,000 new infections occurring per week. Oral daily pre-exposure prophylaxis (PrEP) is a 
highly effective means of HIV prevention when taken regularly. Early experience with the global 
rollout of PrEP in this population indicates enthusiasm for PrEP, but also barriers to adherence 
and program retention.  
 
PrEP My Way is a novel PrEP delivery system consisting of clinic-based PrEP initiation, 
followed by peer-delivered kits for HIV self-testing, PrEP refills, vaginal swabs for gonorrhea and 
chlamydia self-sampling, pregnancy tests, and contraception refills, if desired. Based on Social 
Cognitive Theory, our overall hypothesis is that PrEP My Way will overcome critical stigma and 
structural barriers that currently limit PrEP use and thus empower young women to promote 
their sexual health.  
 
Introduction/Background 
We will first develop, tailor, and refine PrEP My Way for use with young women in Kisumu, 
Kenya (Aim 1). We will use a client-centered, iterative approach, involving individual interviews 
and focus group discussions to optimally design the PrEP My Way kit (with instructional 
materials) and peer delivery system (including communication and kit delivery plans). We will 
then test the intervention for feasibility, acceptability, and preliminary impact on PrEP adherence 
and program retention (Aim 2). We will randomize up to 150 Kenyan women to PrEP My Way 
versus standard of care (i.e., clinic-based delivery of PrEP and sexual health services) and 
follow them for 6 months. Feasibility will be assessed by receipt of the kit at 1, 3, and 6 months 
and ability to use its components per protocol. Acceptability will be determined through a mixed-
methods interview at 6 months. Preliminary impact will be evaluated by dried blood spot 
tenofovir levels (adherence) and kit use/clinic attendance at 6 months (retention) as primary 
outcomes. Mediators and moderators of PrEP use (e.g., empowerment and mental health) will 
be explored through questionnaires at baseline and 6 months. 
 
Design: Formative work, followed by a pilot randomized controlled trial (RCT) of PrEP My Way 
versus standard of care (1:1) 
 
Population: Young (16-24 years old) sexually active women who are interested in taking PrEP 
and own a phone 
 
Study site: Kisumu, Kenya 
 
Specific aims: 
1. Develop PrEP My Way. Using a client-centered approach, we will iteratively conduct 
individual interviews and focus group discussions with up to 70  Kenyan women (age 16-24) 
or other relevant community members to optimally design PrEP My Way (the kit with 
instructional materials) and peer delivery system (including phone communication and kit 
delivery plans).  
 
2. Assess PrEP My Way for feasibility, acceptability, and preliminary impact on PrEP adherence 
and program retention. We will randomize up to 150 Kenyan women (age 16-24) to PrEP My 
Way versus standard of care (i.e., clinic-based delivery of PrEP and sexual health services) 
and follow them for 6 months. Feasibility will be assessed by receipt of the kit at 1, 3, and 6 
months and ability to use its components per protocol. Acceptability will be determined 
through a mixed-methods interview. Preliminary impact will be evaluated by dried blood spot 
tenofovir levels (adherence) and kit use/clinic attendance at 6 months (retention). Potential 

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influencing and mediating socio-behavioral factors will be explored with questionnaires at 0 
and 6 months.  
 
Justification for the study  
Young women are a highly vulnerable population in terms of HIV acquisition given 1) limited 
access to sexual health information and services in many settings [1], 2) limited ability to 
negotiate condoms in many sexual relationships [2], 3) high risk for HIV acquisition in the setting 
of gender-based violence which can be very common [3], and 4) the 2-8X increased efficiency 
of HIV transmission from men-to-women compared to women-to-men [4]. Young women 
currently account for three-quarters of all new HIV infections in sub-Saharan Africa— a figure 
that translates to ~7,000 new infections occur per week [5]. Moreover, with the impending youth 
bulge, the adolescent population will reach >300 million by 2050 [6]. Clearly HIV prevention 
tools are needed for this population, and PrEP (current recommended as daily oral 300mg 
tenofovir/200mg emtricitabine) is in many ways an ideal option. It is safe and effective, it can be 
taken discretely, and it does not require negotiation with sexual partners [7]. And, young women 
want effective HIV prevention options as evidenced by 86-95% uptake of PrEP in two recent 
demonstration projects in southern Africa and Kenya [8, 9], as well as numerous advocacy 
campaigns [10]. 
 
Despite the advantages of PrEP, adherence and retention in PrEP programs have been 
challenging for young women. In two phase III clinical trials of PrEP, plasma tenofovir was 
detected in only 28-36% of women 18-25 years old [11, 12]. More recently, protective plasma 
levels of tenofovir were only seen in 38% of young women participating in a demonstration 
project in South Africa [13]. Additionally, only 10% of young women were still picking up PrEP at 
6 months in the above-noted Kenyan demonstration project, despite the high uptake [9]. Novel 
means to support ongoing use of PrEP and retention in care will be critical to successful HIV 
prevention efforts in this population. 
 
Two significant and unaddressed barriers to PrEP among young women in sub-Saharan Africa 
relate to stigma and structural barriers to PrEP access. Numerous implementation projects (e.g., 
through the PEPFAR-supported DREAMS Initiative) and academic studies are ongoing to 
address the important, fundamental need for information about PrEP and demand creation [14]. 
However, two additional barriers are significant impediments to the PrEP rollout among young 
women and warrant intervention development. Specifically, perceived stigma (e.g., being judged 
as promiscuous by older healthcare workers or in the community) and structural barriers (e.g., 
getting to clinics during regular business hours, funds for transportation) remain major factors 
that prevent women from accessing and persisting with PrEP [15]. These factors account for the 
majority of PrEP non-use in an ongoing study conducted by the investigators of this protocol 
(Monitoring PrEP for Young Adult Women [MPYA]; NCT02915367). 
 
Stigma and structural barriers have been a challenge among all populations worldwide, yet 
creative solutions have arisen. In the US, for example, access for men who have sex with men 
(MSM) has been improved through provider awareness and education [16], as well as a novel 
home PrEP delivery system [17]. The latter, called PrEP@Home includes tailored pictorial and 
video instructions for specimen self-collection, mail in kits for all recommended lab tests (i.e., 
HIV, syphilis, chlamydia, gonorrhea, creatinine), and a self-completed electronic survey to 
assess behavioral components of care, such as medication adherence and tolerance. 
PrEP@Home has been found to be acceptable and perceived as helpful for persistence with 
PrEP. Novel approaches are needed now for young women in sub-Saharan Africa. 
 

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PrEP uptake is also limited by the lack of concurrent provision of testing for other sexually 
transmitted infections (STIs) and contraception. Young women have many sexual health needs. 
Undergoing clinical exams to test for STIs and seeking contraception take time, which may be 
limited for many young women because of school, work, or family responsibilities. Moreover, 
young women may be hesitant to pursue these services because of fear of judgement (e.g., 
being seen as promiscuous). These barriers are in many ways the same as those for PrEP. And 
yet, women greatly desire STI testing and contraception. Indeed, they may be even more 
motivated to seek these services compared to PrEP [18, 19]. Several forms of “multi-purpose 
technologies” are under development to provide co-formulated PrEP and contraception [20]; 
however, co-provision of these services may serve a similar function and is possible with 
currently available products.  
 
Social Cognitive Theory provides a 
useful framework for developing 
effective interventions to overcome 
the barriers young women face. Social 
Cognitive Theory posits that people 
acquire and maintain particular 
behavioral patterns through the 
interaction of three factors: environment, 
personal factors, and behavior [21-23]. 
Behavior is not simply the result of the 
environment and the person, just as the 
environment is not merely a function of 
the person and behavior. In a review of 
theories underlying HIV prevention 
interventions for young people in sub-
Saharan Africa [24], Social Cognitive 
Theory was highlighted as favorable 
because it includes the influence of contextual and structural factors on an individual's behavior 
(unlike other commonly used theories, such as the Health Belief Model and Theory of Reasoned 
Action/Planned Behavior). As shown in Figure 1, PrEP My Way addresses the environmental 
factors (i.e., structural barriers and stigma) through personalized delivery of the kit at a time 
convenient for the young woman taking PrEP. Cognitive factors (i.e., self-empowerment and 
depression) are addressed through peer support and self-driven care; this approach has been 
effective in other peer-based, community delivery models to provide post-natal, HIV-related care 
in Uganda [25] and HIV testing among female sex workers in Uganda and Zambia [26, 27].  
Ultimately, these factors interact with each other and the behavior of PrEP adherence and 
retention in PrEP programs.  
 
Interventions are specifically needed for young women to persist with PrEP use and to reduce 
the burden of PrEP delivery in existing healthcare facilities. As shown in Figure 2, numerous 
recent demonstration projects and studies (e.g., PrIYA [28], LVCT Health [9]] have seen steep 
drop offs in PrEP use among young women after uptake. While many women make a very 
rational choice to discontinue PrEP (e.g., if they do not have an ongoing need for HIV 
prevention or they are adequately protected through some other prevention tool, like condoms), 
others want to continue with PrEP, but struggle due to factors such as stigma and structural 
barriers (see above). Much of this drop off could be attenuated through interventions aimed at 
PrEP persistence (i.e., adherence and program retention).  
Figure 1. Social Cognitive Theory underlying the PrEP My 
Way intervention 

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Moreover, the need and demand for PrEP 
among young women may well be 
overwhelming for traditional delivery structural. 
For example, PEPFAR estimated >250,000 
young women need effective HIV prevention 
interventions to facilitate epidemic control [29]. 
Given the safety and ease with which PrEP can 
be prescribed, methods to simplify its delivery 
are desirable and promising, including the use 
of HIV self-test kits to spread out clinic visits 
(as is being explored by the investigators of 
this protocol in another study, NCT03593629). 
Importantly, the largest expense involved with 
PrEP provision is staffing [30]; thus, 
community-based PrEP delivery through lay 
health workers (i.e., peers) has the potential to 
be cost-effective. Thus, interventions that 
simultaneously ease the burden on healthcare infrastructure and overcome environmental and 
cognitive barriers to PrEP persistence are well poised to have high impact on PrEP use and 
ultimately HIV prevention.  
  
Client-centered design increases the likelihood of the intervention uptake and use. Client-
centered design is a framework of processes in which user characteristics, usability goals, 
environment, tasks, and workflow of a product, service, or process are given extensive attention 
at each stage of the design process [31]. Client-centered design can be described as a multi-
stage problem-solving process that not only requires designers to analyze and envision the way 
users are likely to consume a product, but also to validate their assumptions with regard to the 
user behavior in real world tests. These tests are conducted with actual users at each stage of 
the process, ensuring that development proceeds with the client as the primary focus [32]. The 
overarching goal of this approach is to increase product usefulness and usability [33]. This 
protocol will therefore place the client at the center of the development process, thus promoting 
interest in PrEP and supporting persistence over time.  
 
In sum, young women need and want PrEP, yet stigma and structural barriers are inadequately 
addressed barriers that are limiting their ability to persist in PrEP use with high adherence and 
program retention. PrEP My Way is a young woman-centered intervention that helps make 
PrEP more accessible, while also promoting ready use of other desired sexual health services— 
STI testing and contraception. The intervention is grounded in Social Cognitive Theory, 
addressing key environmental and cognitive factors influencing PrEP adherence and program 
retention. PrEP My Way is thus poised to have high impact on HIV prevention among young 
women in sub-Saharan Africa by reducing the large drop offs in PrEP use seen in current 
implementation programs.  
 
General Objectives 
Overall design. We will first develop, tailor, and refine PrEP My Way for use with young women 
in Kenya (Aim 1). We will then test the intervention for feasibility, acceptability, and preliminary 
impact on PrEP adherence and program retention in a pilot RCT (Aim 2).  
 
 
 
 
Figure 2. Potential impact from an intervention 
aimed at PrEP persistence 

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Specific Objectives 
1. Develop PrEP My Way. Using a client-centered approach, we will iteratively conduct 
individual interviews and focus group discussions with up to 70 Kenyan women (age 16-
24) or other relevant community members to optimally design PrEP My Way (the kit with 
instructional materials) and peer delivery system (including phone communication and kit 
delivery plans).  
 
2. Assess PrEP My Way for feasibility, acceptability, and preliminary impact on PrEP 
adherence and program retention. We will randomize up to 150 Kenyan women (age 16-
24) to PrEP My Way versus standard of care (i.e., clinic-based delivery of PrEP and 
sexual health services) and follow them for 6 months. Feasibility will be assessed by 
receipt of the kit at 1, 3, and 6 months and ability to use its components per protocol. 
Acceptability will be determined through a mixed-methods interview. Preliminary impact 
will be evaluated by dried blood spot tenofovir levels (adherence) and kit use/clinic 
attendance at 6 months (retention). Potential influencing and mediating socio-behavioral 
factors will be explored with questionnaires at 0 and 6 months.  
 
Design and Methodology 
Study setting. Both aims of this protocol will take place in Kisumu, Western Kenya. This area is 
largely rural with an urban center and a total population of ~1,000,000. HIV prevalence is 21% 
among women. This study will be run under the KEMRI Research Care and Training Program 
(RCTP, a comprehensive HIV prevention, care and treatment program working in 100 clinics in 
Western Kenya). The RCTP is staffed by clinicians, pharmacists, counselors, community 
outreach officers, and laboratory technicians who are trained to provide routine health services, 
including HIV testing, PrEP, STI testing and treatment, and contraception. It has supported 
several projects focused on young women, as well as family planning/HIV integration studies 
(e.g., MPYA, PrIYA). 
 
The primary recruitment site for both aims will be Lumumba Sub-County Hospital (“Lumumba 
Clinic”), which is located next door to the RCTP. PrEP is included in the Kenyan National HIV 
Prevention Revolution Road Map [34], in which young women are identified as a priority 
population, and available at no charge through Lumumba Clinic and other public facilities. A 
total of 438 young women have received PrEP at this facility, making recruitment highly feasible. 
Contraception and STI testing/treatment (typically in the setting of symptoms, not routine 
screening) are also available free of charge. Recruitment may also occur through Kisumu 
County Hospital, which has a similar clinic and is located a 5 minutes-drive from our study 
offices.  
 
Aim 1. Develop the PrEP My Way intervention  
Overview. Using a client-centered approach, we will create a young woman-centered kit 
consisting of HIV self-testing, PrEP refills, STI self-sampling, and pregnancy tests and 
contraception (if desired), along with educational materials and kit delivery protocols for peer 
delivery in the community. We will hold individual interviews and focus group discussions with 
Kenyan women (age 16-24) in an iterative manner to optimally design PrEP My Way (the kit 
with instructional materials) and peer delivery system (including phone-based communication 
and kit delivery plans). 
 
The intervention. PrEP My Way will be developed through an iterative, client-centered process. 
However, we anticipate that it will involve one clinic-based visit to safely initiate PrEP and 
contraception per Kenyan national guidelines [35], followed by quarterly community-based peer 
delivery of a pre-packaged, visually-appealing kit with pictorial and video guidance (to be 

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modeled after PrEP@Home, noted above). The peer delivering the kit will be trained to provide 
basic education (e.g., anticipated side effects) and support use of the kit components (e.g., 
using the HIV test, collecting the vaginal swab). The peer will also have a smart phone to show 
the video if the participant does not have her own smart phone. Women taking PrEP My Way 
will communicate with peers via mobile phones (e.g., SMS, WhatsApp) to arrange for kit 
delivery via unmarked vehicles (typically motorbikes, called “boda bodas”) at home or a Safe 
Space (i.e., existing, designated community locations with private bathrooms, which are 
currently available in Kisumu through programs such as the PEPFAR-supported DREAMS 
initiative) during reasonable hours. Peers will not wear uniforms to avoid attention; they will also 
wear helmets on the motorbikes and only use pre-screened drivers for safety. Two-way mobile 
phone communication will also be used to convey test results and provide on-going support and 
empowerment. Follow-up with the clinic will occur annually and as needed (e.g., treatment for 
positive tests). 
 
Kit component. We anticipate the kit will include the following elements:  
• HIV self-testing. We will offer a choice of testing modalities. We will encourage the use of 
the finger prick test because of higher sensitivity; however, the oral test may be preferable to 
some.  
• The AtomoRapidTM HIV Test is an integrated HIV test of blood for the presence of 
antibodies to HIV-1/2.  It uses a contact-activated auto-retracting safety lancet to 
safeguard against needlesticks and cross contamination (all material and waste are within 
the kit itself). AtomoRapid’s interlocking features ensure each user step is performed in the 
correct sequence to help reduce user errors. Blood collection and delivery is controlled 
within the test which simplifies test procedures and improves blood volume accuracy. 
Testing takes ~15 minutes with a sensitivity of 99.8% and specificity of 100%. 
• The OraQuickTM In-Home HIV Test is the first FDA approved test (2012) that uses oral 
fluid to test for antibodies to HIV-1/2. The OraQuick In-Home HIV Test is a qualitative test 
that gives visually read results: preliminary positive, negative, or test not working (invalid) 
in about 20 minutes. The OraQuick oral fluid test has a sensitivity 91.7% and a specificity 
of 99.9%. 
• STI self-sampling for gonorrhea and chlamydia. Women will be instructed on how to 
collect vaginal swabs. In brief, a cotton swab (similar to a large Q-tip) will be inserted ~5 cm 
into the vagina and rotated gently for ~30 seconds. This approach has been shown to be 
feasible and acceptable in South Africa [36] Malawi [37], and Senegal [38]. Samples will then 
be transported to the Lumumba Clinic for processing by GeneXpert PCR test (Cepheid). 
• Pregnancy test 
• Contraception   
o Oral pills (e.g., Microgynon by Bayer Pharma AG, Germany) 
o Self-injection medroxyprogesterone (by DKT, India) 
o Condoms 
 
Other necessary testing for initiation of PrEP will not be included in the kit (i.e., creatinine and 
Hepatitis B), because it will be done at baseline in the clinic with PrEP initiation. An extra HIV 
test may be given for participants to use with their sexual partners if requested. 
 
Design of the kit and pictorial and video guidance. We will contract with ARK, a Nairobi-based 
design firm, to adapt PrEP@Home specifically for young women in Kenya. ARK is a full-service 
design firm that has over a decade of experience throughout the region and on the global stage. 
Their team brings vast expertise in design research, product design, filmmaking, and visual 
design, as well as a nuanced understanding of sexual health interventions in Kenya specifically. 

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Of particular relevance, ARK has worked in Kisumu to design technology to enhance efficiency 
in health sector service delivery for another client; ARK will build on this experience in facilitating 
the design of PrEP My Way. ARK staff involved with the study will undergo sensitivity training, 
including protections for human subjects in research; confidentiality of the study participants will 
be particularly emphasized. 
 
ARK will first solicit ideas from young women to produce an initial version of the PrEP My Way 
kit, pictorial and video guidance materials, and planned delivery protocol to use in the 
assessment process described below. They will then generate iterative versions of the kit, 
pictorial guidance, and video based on the feedback. The final version will be used for the pilot 
RCT in Aim 2. 
 
Recruitment, consent, and enrollment. We will identify young women to participate in the 
development of the intervention through Lumumba Clinic and Kisumu County Hospital. Eligibility 
criteria will be as follows:  
• 
Inclusion criteria 
o Young woman (age 16-24 years); we will enroll emancipated minors (e.g., those who 
have not yet attained the age of legal competency as defined by state law, but who 
are entitled to treatment as if they had by virtue of assuming adult responsibilities, 
such as self-support, marriage, or procreation) per Kenyan national guidelines [39]) 
or 16-17 year-olds with parental consent 
o Reported sexual activity within the past 3 months 
o Interest in taking PrEP (actual PrEP uptake is not a requirement for Aim 1)  
o Residence in the Kisumu region 
o Phone ownership 
o Ability to understand KiSwahili, DhoLuo, and/or English  
• 
Exclusion criteria- inability to provide informed consent (e.g., intoxication, mental 
disability) 
 
Participants will be approached randomly (e.g., the second client presenting on a given day) 
with stratification by age (16-20 versus 20-24 years). The study will be explained to potential 
participants, including a complete explanation of the benefits, risks, and procedures involved. 
Interested women will be asked to sign an informed consent form using the language of her 
choice (i.e., Swahili, Dholuo, or English). All activities will be conducted in a private setting. Only 
one participant will be enrolled per day to avoid clustering effects, as young women often 
present for PrEP services in groups [40], as seen in our MPYA study. A small incentive/thank 
you gift (worth ~300 Kenyan Shilling or $3 US) will be provided at the time of participation; 
transportation will be reimbursed if needed. 
 
If recommended by the participants, we may also conduct individual interview relevant 
community members for supplementary information, including clinicians, pharmacists, 
community organization leaders, and/or boda boda drivers. The only exclusion criterion for this 
group of participants would be the inability to provide informed consent (e.g., intoxication, 
mental disability).  
 
Design process. Using a client-centered design approach [31] as described above, the process 
will begin with individual interviews (typically 1-1.5 hours in duration) based on open discussion 
with no mock-ups to influence (e.g., anchor) the participants’ opinions (N.B., to maintain this 
open approach, ARK has intentionally not provided a mock up even for this protocol). 
Participants will have the opportunity to use each component of the kit. Our goal will be to find 
similarities in design preference and identify any previously missed opportunities. Individual 

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interviews will be utilized to avoid negative peer pressure and/or suppression of individual 
viewpoints. Attention will be paid to potential for stigma or other negative experiences in all 
aspects of the intervention. The overall guiding principal is to make PrEP My Way easy, 
engaging, and desirable for young women. Examples of solicited feedback are as follows:  
1) Kit: visual appearance and size 
2) Pictorial instructions: clarity of meaning, choice of cartoon figures 
3) Video guidance: clarity of meaning; choice of setting, actors, music 
4) Delivery protocol: peer characteristics, vehicles for delivery, setting and timing of 
delivery  
Later interviews will include evolving mock-ups of each of the physical components of the 
intervention and a story board for the video. After reaching saturation (anticipated by the 15th 
interview), we will conduct 2 focus group discussions with up to 5 women each to assess for 
group dynamics that might influence the design. Interviews and focus group discussions will be 
digitally recorded and transcribed for analysis. They will be conducted in KiSwahili, Dholuo, 
and/or English per the preferences of the participants (N.B., these three languages are 
commonly used together in this setting and will be spoken fluently by members of the local 
study team); language preferences will be considered in scheduling participants together. All 
written materials will be available in in KiSwahili, Dholuo, and English. The video will likely be 
produced in a commonly used combination of English and Swahili, called “Sheng”, pending 
input from the participants. 
 
Throughout this process, ARK will create a playbook (i.e., a detailed reference guide) to 
breakdown insights learned and explain the rationale of the process used. A workshop will also 
be held, involving clients, designers, and investigators together, to compile the final version of 
the intervention. During the workshop, participants will assume each other’s rolls to give new 
insights into their perspectives and needs. The final kit, pictorial instructions, and video will be 
produced once all input has been obtained.  
 
Analysis. To analyze the interviews and focus group discussions, we will use a framework 
approach, described in Richie and Spencer [41], which involves systematic coding to identify 
and define concepts, map the concepts, create typologies, find associations between concepts, 
and seek explanations from the data. We will use Dedoose (Version 8.0.35) for coding data. 
Double coding will ensure that interpretations of quotes are consistent, and that data quality is 
rigorous and transparent; differences between coding will be resolved by discussion involving 
other members of the research team. Recurring issues, concepts, and patterns will be identified 
using both inductive and deductive reasoning. Analyses will consider whether findings differ by 
age and/or language. 
 
Summary/deliverable. This aim will produce a young woman-centered kit with pictorial and video 
guidance for peer-delivery of PrEP, STI testing, and contraception that is ready for assessment 
in Aim 2. 
 
Aim 2. Assess PrEP My Way for feasibility, acceptability, and preliminary impact on PrEP 
adherence and program retention 
Overview. We will randomize up to 150 Kenyan women (age 16-24) to PrEP My Way versus 
standard of care (i.e., clinic-based delivery of PrEP and sexual health services) and follow them 
for 6 months. Feasibility will be assessed by receipt of the kit at 1, 3, and 6 months and ability to 
use its components per protocol. Acceptability will be determined through a mixed-methods 
interview at 6 months. Preliminary impact will be evaluated by dried blood spot tenofovir levels 
(adherence) and kit use/clinic attendance at 6 months (retention) as primary outcomes. 

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Figure 4. Participant flow for the pilot RCT of PrEP My Way versus standard of care 
Potential influencing and mediating socio-behavioral factors will be explored with questionnaires 
at enrollment and 6 months. See Figure 4 for an overview of the participant flow. 
Recruitment. We will identify young women to participate in the pilot RCT at the time they initiate 
PrEP at the Lumumba Clinic or Kisumu County Hospital. Participants may also be identified in 
the nearby community and invited to attend either facility to initiate PrEP and enroll in the study. 
Community recruitment will be done in areas such as hotspots, fish landing points, and within 
the general low end estates with the help of community health volunteers. These participants 
will be distinct from those engaged in the development of the intervention (Aim 1) to increase 
likelihood of generalizable findings. Similar to Aim 1, participants will be approached randomly 
(e.g., the second client seen on a given day) with stratification by age (16-20 versus 20-24). 
Only up to three participant will be enrolled per site per day to avoid clustering effects, as young 
women often present for PrEP services in groups [40].  
 
 
 
 
 
Consent, enrollment, and randomization. Eligibility criteria for the pilot RCT participants are as 
follows. All participants will have started PrEP within the past two weeks: 
• 
Inclusion criteria 
o Young woman (age 16-24 years); we will enroll emancipated minors (e.g., those who 
have not yet attained the age of legal competency as defined by state law, but who 
are entitled to treatment as if they had by virtue of assuming adult responsibilities, 
such as self-support, marriage, or procreation) per Kenyan national guidelines [39] or 
16-17 year-olds with parental/caregiver consent 
o Initiating PrEP (this criterion subsumes all necessary safety assessments for starting 
PrEP, including HIV-negative status, normal renal function, and lack of Hepatitis B 
infection) 
o Reported sexual activity in the past 3 months 
o Residence in the Kisumu region (maximum of 20 km from our study offices at RCTP) 
o Phone ownership 
o Ability to understand KiSwahili, DhoLuo, and/or English 
    Clients initiate PrEP per national guidelines in Lumumba Clinic (Kisumu) 
• 
Enrollment, consent, randomization occur 
• 
Baseline questionnaire administered 
PrEP My Way kit delivered at Month 1 
PrEP, STI testing/treatment, and contraception (if desired) 
delivered per standard of care in Lumumba Clinic at Month 1 
PrEP My Way kit delivered at Month 3 
PrEP, STI testing/treatment, and contraception (if desired) 
delivered per standard of care in Lumumba Clinic at Month 6 
• 
DBS collected for adherence 
• 
Mixed methods interview conducted 
PrEP, STI testing/treatment, and contraception (if desired) 
delivered per standard of care in Lumumba Clinic at Month 3 
PrEP My Way kit delivered at Month 6 
• 
DBS collected for adherence 
• 
Mixed methods interview conducted 

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• 
Exclusion criteria- inability to provide informed consent (e.g., intoxication, mental 
disability) 
Note: Participants may also be excluded at the discretion of the principal investigator (e.g., 
because of co-enrollment with a study that would compromise study aims or disruptive 
behavior).  
 
Participants will be consented as described in Aim 1, enrolled, and randomized (1:1) using a 
computer-generated simple randomization sequence to receive PrEP My Way or follow up as 
usual at Lumumba Clinic or Kisumu County Hospital over the next 6 months. The code creating 
the random allocation order will be generated and maintained by the study analyst (separate 
from the investigators). A variable size block randomization scheme will be implemented to 
produce the randomization list. Randomization will be implemented by transcribing onto paper 
within numbered envelopes. Thus, neither participants nor study staff will be blinded to each 
participant’s randomization arm assignment. Fidelity of randomization will be confirmed with 
tracking in REDCap. 
 
Study procedures (Some aspects of the planned procedures may change pending input from 
Aim 1 findings). Study procedures for both arms are summarized in Table 1.  
 
Clinic=Lumumba Clinic or Kisumu County Hospital; ^STI testing done only in the setting of symptoms; RA = research 
assistant; time and motion studies will also be done at the KEMRI Research Care and Training Program (i.e., the 
study site), Lumumba Clinic, and Kisumu County Hospital mid-way through the study period 
 
Intervention condition. A research assistant will administer a baseline demographic and socio-
behavioral questionnaire (see Table 2) at enrollment (Month 0) and exchange contact 
information with the participant. Tentative plans will be made for the first kit delivery at Month 1. 
The meeting will take place at the location, date, and time preferred by the participant; we 
anticipate the location will be private (e.g., home or a Safe Space) and should have a bathroom 
to facilitate hygienic sample collection. The meeting will occur during reasonable working hours 
to ensure the safety and comfort of peers and participants.  
Table 1. Summary of study procedures by arm. Each cell indicates how/where the procedure will take place. 
 
M0 
M1 
M3 
M6 
M0 
M1 
M3 
M6 
 
PrEP My Way 
Control 
Education (PrEP, sexual health) 
Clinic 
Peer 
Peer 
Peer 
Clinic 
Clinic 
Clinic 
Clinic 
HIV testing 
Clinic 
Kit 
Kit 
Kit 
Clinic 
Clinic 
Clinic 
Clinic 
PrEP 
Clinic 
Kit 
Kit 
Kit 
Clinic 
Clinic 
Clinic 
Clinic 
STI sampling 
Clinic^ 
Kit 
Kit 
Kit 
Clinic^ 
Clinic^ 
Clinic^ 
Clinic^ 
Pregnancy testing; contraception 
Clinic 
Kit 
Kit 
Kit 
Clinic 
Clinic 
Clinic 
Clinic 
Questionnaire administration 
RA 
-- 
-- 
RA 
RA 
-- 
-- 
RA 
Acceptability scale and interview 
-- 
-- 
-- 
RA 
-- 
-- 
-- 
-- 
DBS 
-- 
-- 
-- 
RA 
-- 
-- 
-- 
RA 
Table 2. Socio-behavioral data to be collected at enrollment and 6 months 
Demographics 
Age, residence type (urban/rural, with family/partner), employment/education 
Alcohol/substance use 
Rapid Alcohol Problems Screen-4* [42], use of marijuana and other drugs 
Depression 
PHQ-9*^ [43]  
Sexual behavior 
Number, type of partners (incl. HIV status), use of condoms, transactional,  
intimate partner violence [Pulerwitz, PLoS One 2018] 
HIV and PrEP stigma 
Perceived HIV stigma scale (modified Berger, adapted for Kenya)*^ [44]; PrEP 
stigma scale [45]#  
Belief in PrEP 
Knowledge about reduction in HIV risk due to PrEP, Belief in Medicines 
Questionnaire*^  [46]  
Self-esteem/efficacy 
Rosenberg Self-Esteem Scale*^  [47] 

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 * validated, ^utilized previously in Kenya, #this scale will be exploratory as it has not yet been used in the 
population 
 
At kit delivery, the peer will guide the participant through the pictorial materials for each aspect 
of the kit and show her the video. HIV test results will be available at the time of testing. The 
peer can be present to see the test results or not, per the participant’s preference. She will 
answer any questions regarding the kit and its components; any challenging questions will be 
brought back to clinical staff at the RCTP study site and answers relayed to the participant via 
phone. The peer may also provide weekly empowerment messages (e.g., “Remember- PrEP 
gives you control over your sexual health”) via phone; participants will be able to opt out of 
these messages, if desired (e.g., for privacy). The peer will obtain the HIV test results and 
document PrEP and contraception use. She will bring the vaginal swab back to the study site for 
processing. The peer will also dispose of any remaining materials, if desired by the participant. 
The peer will send an SMS or WhatsApp message indicating either normal results or the need 
for the participant to come to the study site for abnormal or indeterminate results within a few 
days. Explicit mention of STI testing will not occur in the messages to protect the participant’s 
privacy of the participants. Treatment and supportive counseling will then be provided by our 
staff per Kenyan national guidelines [35]. Arrangements will be made for prompt repeat HIV 
testing at our study site if any of the self-testing kits reveal a positive or indeterminant result; 
linkage to free antiretroviral therapy services will be facilitated in the event of a confirmed 
seroconversion. Participants will be offered repeat STI testing in the clinic if their self-collected 
samples are inadequate for testing. Follow-up for any other concerning situations (e.g., social 
harms) will be arranged by study staff as appropriate (see Human Subjects). 
 
At completion of the visit, the peer will make tentative plans for a repeat visit in two months 
(Month 3 of PrEP). She will remind the participant that she is available via mobile phone for any 
PrEP My Way-related questions and support. She will then contact the participant one week in 
advance of the tentative visit appointment to confirm it or make any necessary adjustments. 
Scheduling will aim to avoid any lapses in PrEP coverage and will occur in a private location 
during reasonable working hours, as described above.  
 
The above-noted procedures will be repeated at the Month 3 and Month 6 visit. Additionally, at 
the Month 6 visit, an RA will collect the following data either in the field or at the study site 
(within the next two weeks): 
• 
Dried blood spot for tenofovir concentration 
• 
Creatinine (point-of-care) 
• 
Socio-behavioral data (quantitative questionnaire; see Table 1) 
• 
Acceptability data (see below) 
 
Acceptability will be determined quantitatively with the Systems Usability Scale (SUS; [49]. This 
10-item Likert scale assesses domains including desired frequency of use, complexity, need for 
support, functionality, 
irregularities, ease of 
learning/use, time required for 
use, confidence, and training needed. 
Qualitatively, we will explore PrEP My 
Way in accordance with the Unified 
Theory of Acceptance and Use of 
Technology (UTAUT; Figure 5) in up to 
20 participants purposively selected to 
Empowerment 
Modified Sexual Relationship Power Scale [48]*^ 
Clinic satisfaction 
Patient-Healthcare Provider Relationship [Stall, JAIDS 2006]# 
Figure 5. Unified Theory of Acceptance and Use of Technology 

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reflect high and low usage of the kits. Questions for each model component are described in 
Table 3.   
 
All quantitative data will be recorded on encrypted tablets in REDCap. Qualitative interviews will 
be digitally recorded and transcribed. All data will be collected in a private space using the 
participant’s preferred language (KiSwahili, DhoLuo, or English). 
 
 
Participants will then be disenrolled from the study and linked back to the Lumumba Clinic, 
Kisumu County Hospital, or a similar clinic of their choice, for continuation of PrEP as desired. A 
small incentive/thank you gift (worth a minimum of ~500 Kenyan Shilling or $5 US) will be given 
at that time for transport and completion of study-related activities (not PrEP My Way utilization). 
The estimated time spent with the participant will be ~2 hours at enrollment, 30 minutes at 
Months 1 and 3, and ~1 hour at Month 6. 
 
Control condition. After randomization, a study research assistant (RA) will administer the 
baseline demographic and socio-behavioral questionnaire. Control participants will then 
continue to receive PrEP and any other desired sexual health services at Lumumba Clinic or 
Kisumu County Hospital. The study may provide or assist the clinics in obtaining necessary 
supplies for routine HIV/STI services in the event of supply chain stock outs. The RA will call the 
control participant in ~3 months to maintain accurate contact information and remind her that 
the RA will meet her at her 6-month PrEP appointment in the Lumumba Clinic or Kisumu County 
Hospital for the final study visit. The RA will make a reminder call one week in advance. If the 
control participant does not wish to continue PrEP or return to the Lumumba Clinic/Kisumu 
County Hospital, she may come to the RCTP study site for the final study procedures. The RA 
will then collect the following using the methods described above: 
• 
Dried blood spot for tenofovir concentration 
• 
Socio-behavioral data (quantitative questionnaire) 
• 
Review of Lumumba Clinic/Kisumu County Hospital chart records for HIV and STI 
testing and pick up of PrEP and contraception; participants may be asked for clarification 
if chart records are incomplete 
Control participants will then be disenrolled and provided with a small incentive/thank you (worth 
at least~500 Kenyan Shillings or $5 US) for completion of study-related activities. They will 
continue to receive PrEP and other sexual health services at Lumumba Clinic, Kisumu County 
Hospital, or another clinic as desired. 
 
Peer identification and hiring, and oversight. Peers will not be participants. They will be 
identified from PrEP programs in the Kisumu region. Peers will be 18-30 years old women who 
have themselves taken PrEP for at least 3 months and are fluent in KiSwahili, DhoLuo, and/or 
English. If they do not own a smart phone, the study will provide one for showing the PrEP My 
Way video guidance and enabling two-way communication with participants (e.g., SMS, 
WhatsApp). Although already experienced with PrEP, all peers will be trained about PrEP using 
Kenyan national guideline materials [35]. They will also undergo sensitivity training, including 
Table 3. Questions to be used in assessing PrEP My Way acceptability 
Model component 
Question content  
Performance expectancy 
Perceived usefulness, personal outcome expectations 
Effort expectancy 
Perceived effort needed to arrange delivery and use the kit 
components 
Social influence 
Perceived norms and stigma 
Facilitating conditions 
Kit delivery, instructional materials, role of the peer 
Behavioral intention to use 
Attitudes around current and anticipated future use/non-use 
Actual use 
DBS tenofovir concentration 

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protections for human subjects in research; confidentiality of the study participants will be 
particularly emphasized. Peers will receive a stipend of 20,000 Kenyan Shillings (~$200 US) per 
month, consistent with payment for peer/lay healthcare workers in other community-based 
health programs in the area. We will recruit three peers with each serving 15-20 participants. 
With the projected enrollment schedule over three months and the quarterly follow-up, this case 
load will amount to 8-16 clients per month, or 1 delivery every 1-2 work days (assuming ~20 
work days per month). This workload is reasonable, even if multiple attempts are needed to 
successfully deliver the kit. Participants will have options for engaging with peers, ranging from 
none beyond kit delivery to step-by-step support in using each component of the kit and follow-
up questions by phone. 
 
We will document the training process for the peers to promote reproducibility in future studies 
and/or program implementation.We will also observe the quality of the peer’s engagement with 
participants to document the content of their interactions, which can be accomplished during the 
planned time and motion studies (below).  
 
 
Cost. Because intervention effectiveness is not the aim of this study, we will not perform a 
formal cost-effectiveness analysis. However, we will collect costing data on the components of 
the intervention and perform time and motion studies over two-week periods in both the 
intervention and control arms of the study mid-way through the study period (i.e., when 
procedures are running smoothly). Up to 20 client interactions will be observed in each setting 
to capture the range of time and extent of effort required for PrEP, contraception, and STI 
services. An RA may observe the peers working with participants in the community, or the peer 
may perform the observation herself (per the preference of the participant). No identifiers of 
specific clients in the clinic will be recorded. This data will be used to formulate a preliminary 
sense of the costs of the PrEP My Way intervention relative to standard of care. 
 
Outcome measures 
Feasibility. Feasibility will be assessed by the following metrics: 1) receipt of the PrEP My Way 
kit at Months 1, 3, and 6, and 2) ability of the participant to use each aspect of the kit (i.e., the 
HIV self-test, use of the vaginal swab, and self-administration of medroxyprogesterone [if 
desired]) per protocol. The intervention will be considered feasible if >70% (35/50) participants 
1) receive a kit and 2) achieve a readable HIV test, usable vaginal swab, and self-injection of 
medroxyprogesterone, if desired, at >66% (2/3) of visits. 
 
Acceptability. The PrEP My Way intervention will be considered acceptable if >70% 
(35/50) participants rate 70% (7/10) items on the SUS as “very good” or higher. The qualitative 
interview will delve deeply into each of the four domains of the UTAUT model to provide in 
depth feedback on the intervention.  
 
Primary outcomes- Preliminary impact on PrEP adherence and program retention at 6 months.  
PrEP adherence will be assessed primarily by DBS for tenofovir diphosphate (TFV-DP) 
concentration. The TFV-DP concentration will provide an estimate of doses taken over the prior 
3 months (see Table 4; [11, 50]). Retention will be assessed by kit receipt in the intervention 
arm and clinic attendance per clinic records in the control arm at Month 6. Potential influencing 
and mediating socio-behavioral factors (Table 2) will be explored.  
 
Secondary outcomes. We will assess the following:  
Table 4. TFV-DP concentrations in DBS 
Estimated use 
Median fmol/punch (IQR) 

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*Exact value to be explored (see text) 
• Self-reported PrEP adherence at Months 
1, 3, and 6 (intervention arm) and Month 
6 (control arm). We will use the 3-item 
scale developed by Wilson et al, which 
involves different recall tasks (frequency, percent, and rating of adherence) over the 
prior 30 days [51]  
• PrEP persistence over the 6-month period 
• Rates of STI testing at Months 1, 3, and 6 
• Rates of pregnancy test and contraception pick up at Months 1, 3, and 6 
• Cost estimates 
 
Analysis 
Feasibility and acceptability. Feasibility metrics and the quantitative assessment of acceptability 
will be analyzed descriptively. We will use a content analysis approach to assess the qualitative 
acceptability data. Content analysis refers to systematic process for interpreting the content of 
textual data through coding and category construction [52]. We will develop a coding scheme 
through initial review of a randomly selected subset of 33% of interview transcripts. Sections of 
the transcripts that appear to address concepts of analytic interest (e.g., device design, stigma) 
will be assigned descriptive labels, or codes. Operational definitions will be developed for the 
codes to create a codebook, which will be used to code the data. We will use Dedoose software 
(version 8.0.23). We will then repeatedly sort and review codes to identify a broader set of 
concepts (e.g., social influences). The categories will be constructed from this second set of 
concepts by assignment of descriptive labels, formulation of operational definitions, and 
selection of illustrative citations from the data. We will review categories and summarize 
acceptance in the final, interpretive step of the analysis.  
 
Primary outcomes. Adherence (as determined by TFV-DP concentrations in DBS) and program 
retention at 6 months will be analyzed descriptively and then compared between the two study 
arms using Chi-square tests (i.e., comparing protective TFV-DP concentrations versus not; 
retained versus not). DBS will be shipped to the University of Cape Town in South Africa and 
some will be tested to measure TFV-DP concentrations. We will use an intention-to-treat 
approach for the primary outcomes but will also perform per protocol analysis. Because of the 
develop-mental nature of this R34 study and the small sample size, we will assess potential 
influencing factors on adherence and retention using logistic regression models. Thresholds 
from protective TFV-DP concentrations may be explored, as this is an active area of research 
[53, 54]. We will pre-specify variables to avoid overfitting the models as age, self-esteem, 
empowerment, stigma, depression, and alcohol/substance use. We will analyze study outcomes 
by peer to look for any clustering effects. We will also explore empowerment and depression as 
mediators of the relationship between the PrEP My Way intervention and adherence and 
retention outcomes, using the approach by Valeri and VanderWeele, which allows for logistic 
modeling, and sensitivity analyses around key assumptions per Imai.[55].  
 
Secondary outcomes. We will use descriptive statistics to understand self-reported adherence, 
PrEP persistence, early retention, and rates of STI testing, pregnancy testing, and contraception 
pick up. We will also explore trends for self-reported adherence within the intervention group 
with regression analysis. We will compare all secondary outcomes between intervention and 
control arms with Chi-square tests (categorical variables) and t-tests (continuous variables). As 
described above, we will also explore in the influence of age, self-esteem, empowerment, 
stigma, depression, and alcohol/substance use on any observed differences through logistic 
and linear regression models, for dichotomous and continuous variables, respectively.  
 
Protective* 
>1,250 
Moderate 
900-1,249 
Low 
<900 

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Cost analysis will follow the Clinton Health Access Initiative guidelines for costing HIV 
interventions [56, 57] and will reflect the provider perspective. We will conduct activity-based 
micro-costing to estimate the costs of the PrEP My Way intervention; data will be collected from 
the study budget, clinic expense reports, published information on labor costs, and staff 
interviews. These data will be used to complete cost worksheets. Costs will be categorized as 
fixed or variable. Variable costs indicate which costs could change (e.g., using free 
communication instead of standard 
telephone rates) and influence the 
estimates from the study. 
Power. We are estimating the power 
of the study sample based on PrEP 
adherence at 6 months. Based on 
prior studies (see Figure 2), we 
anticipate a 60% overall decrease in 
PrEP adherence from enrollment to 
Month 6. We estimate ~1/3 of that 
decrease will be due to appropriate 
rationale (e.g., no longer at risk for 
HIV acquisition or use of other HIV 
prevention methods such as 
condoms), in accordance with the 
concept of prevention-effective 
adherence [58]. We therefore believe 
2/3 of a 60% decrease or 40% 
decrease is an ideal target for this 
intervention. Of note, with prevention-effective adherence, PrEP adherence should be aligned 
with risk for HIV acquisition and lack of use of other effective means for HIV prevention. In this 
study, we will be following clients for the first six months of PrEP use. We are considering this 
period as a “season of risk” based on the client’s desire to initiate PrEP and will include the full 
six months in the denominator when calculating adherence and persistence. Future studies of 
PrEP My Way will include metrics of risk to determine prevention-effective adherence. We will, 
however, follow sexual behavior and reported risk to track the ongoing need for PrEP as a 
secondary analysis. 
 
Our power calculations are based on 80 participants, given an expected loss to follow-up of 
20% (estimated from our current MPYA study). As shown in Figure 6, assuming a standard 
deviation of 10%, 80 participants will have limited power to detect a difference of 20% between 
the study arms (e.g., ~40% power if the primary outcome is seen in 40% of the control group 
versus 60% in the intervention group; see the circled green dot). If a stronger effect is seen 
(e.g., closer to the ideal target of 40%), we may achieve >80% power. We believe this sample 
size is appropriate for the development of the PrEP My Way intervention. If the intervention is 
also found to be feasible and acceptable, we look forward to fully testing the intervention in a 
subsequent, fully powered study. 
 
Participant retention and withdrawal 
Participants will be tracked primarily through peers (intervention) and the clinic visits (standard 
of care). Individuals missing scheduled appointments will be contacted through study retention 
teams. Participants will be able to withdraw from the study at any time. 
 
Ethical Considerations 
Human subjects 
Figure 6. Estimate power for the study sample 
size

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This study will involve young Kenyan women in two sets of study procedures to develop and 
preliminarily test the PrEP My Way intervention.  
• 
Intervention development (Aim 1). We will use a client-centered approach, involving 
individual interviews and two focus group discussions with up to 25 Kenyan women to 
optimally design the PrEP My Way kit (with instructional materials) and peer delivery 
system (including communication and kit delivery plans).  
• 
Pilot randomized controlled trial (Aim 2). We will randomize 150 Kenyan women to PrEP 
My Way versus standard of care (i.e., clinic-based delivery of PrEP and sexual health 
services) and follow them for 6 months. These participants will be distinct from those 
participating in the intervention development aspects of the study. Feasibility will be 
assessed by receipt of the kit at 1, 3, and 6 months and ability to use its components per 
protocol. Acceptability will be determined through a mixed-methods interview at 6 
months. Preliminary impact will be evaluated by dried blood spot tenofovir levels 
(adherence) and kit use/clinic attendance at 6 months (retention) as primary outcomes. 
Mediators and moderators of PrEP use (e.g., empowerment and mental health) will be 
explored through questionnaires at baseline and 6 months.  
 
Inclusion of emancipated minors 
Per Kenyan national guidelines, 16 and 17-year old girls are considered to have reached the 
age of majority if they have been pregnant or diagnosed with an STI. They will therefore not 
require parental/guardian consent to participate in this study. As described below, study staff will 
host community events and meet with a community advisory board to allay potential concerns 
about studying sexual health in a young population.  
 
Pregnancy  
Available human and animal data suggest that tenofovir/emtricitabine does not increase the risk 
of major birth defects overall compared to the background rate [59]. Moreover, Kenyan national 
guidelines approve the use of PrEP during pregnancy. We will therefore not limit or change 
participation with regards to pregnancy. All pregnant participants will be encouraged to see 
appropriate pregnancy-related care through the Kenyan national healthcare system.  
 
Source of materials, recruitment of subjects and informed consent 
We will obtain institutional review board approval for this study through the Kenya Medical 
Research Institute and Partners HealthCare/Massachusetts General Hospital. Applications will 
cover recruitment, written and informed consent, enrollment, data collection, retention, study 
procedures, protection from risk, data safety, monitoring, and analysis. 
 
The study will recruit from the Lumumba Clinic and Kisumu County Hospital in Kisumu, Kenya, 
both of which has extensive experience with studies on HIV prevention and sexual health, 
including PrEP, STI testing, and contraception delivery, for young women. Study staff work 
closely with the community to provide informational sessions about all research activities, 
including drama activities in marketplaces, drama and interviews on radio stations, and activities 
as part of community events promoting HIV testing, treatment, care, and prevention.  
 
Written consent will be obtained for the prospective implementation of all study activities. The 
consenting process will take place in a private room and the consent form will comprehensively 
provide the following information: (a) introduction to the consent process, explaining the consent 
form and compliance with institution policy and country laws; (b) emphasis that participation is 
voluntary; (c) nature and purpose of the study; (d) explanation of study procedures; (e) potential 
discomforts and risks, as well as plans to protect participants from these risks; (f) potential 
benefits; (g) alternatives to participation in the study; (h) confidentiality, including how data will 

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be used and how it will be kept private; (i) refusal/withdrawal, including right to withdraw consent 
and leave the study at any time; and (j) rights and complaints.  After each major section, 
research staff obtaining consent will pause and check for understanding -- for example, by 
asking the potential participant to repeat, in their own words, what "the right to refuse" means.   
 
All recruitment, consent, and enrollment procedures, as well as all study procedures, will be 
conducted in the participant’s preferred language (i.e., Swahili, Dholuo, or English). 
 
Potential risks and protection against risk 
Study participants will face the following risks from the study procedures: 
1. Risk: Taking PrEP may be associated with some health risks. PrEP (300mg tenofovir, 
200mg emtricitabine) will be initiated in Lumumba Clinic and Kisumu County Hospital per 
Kenyan National Guidelines. It will be continued through those clinics for participants in 
the control arm and provided through the RCTP (study site) for those in the intervention 
arm. Risk communication about PrEP through study staff will be consistent Kenyan 
National Guidelines, which are also consistent with World Health Organization 
guidelines. In brief, mild side effects may occur in as many as 1 out of 10 people and 
include mild kidney function (only detected by laboratory tests), fatigue, upset stomach, 
vomiting, loose stools, and dizziness. More severe side effects are rare and may occur 
in less than 1 out of 100 people; these include rash, liver function problems, serious 
kidney damage and allergic reaction. Small changes in bone strength have been 
observed, but not associated with any fractures or symptoms. PrEP may interact with 
some other medications. 
Protection: Safety for PrEP initiation (e.g., HIV, creatinine, and Hepatitis B testing) will be 
performed at Lumumba Clinic/Kisumu County Hospital prior to enrollment in this study. 
For intervention participants, HIV testing will be provided with all PrEP My Way kits prior 
to PrEP refill, and creatinine will be tested at 6 months by the study staff at Lumumba 
Clinic/Kisumu County Hospital to evaluate kidney function. For control participants, HIV 
and creatinine testing will be available per Kenyan National Guidelines at routine follow-
up visits. Participants will be advised to call or come to the study clinic if they have 
unexplained increased or decreased urination, weight loss, cramps, muscle pain, 
dizziness, excessive fatigue, nausea, vomiting, or shortness of breath. Study staff will be 
available 24 hours a day/7 days a week to evaluate potential side effects from taking 
PrEP. A medical officer from the study team will perform any necessary examinations 
and determine if PrEP should be stopped and/or if further testing and care is needed. 
Participants will also be advised on potential drug-drug interactions.  
 
2. Risk: HIV acquisition and drug resistance may occur during study follow-up if a 
participant acquires HIV in spite of PrEP use, or during a break from PrEP and thereafter 
resumes PrEP. 
 
Protection: Per Kenyan national guidelines, participants in both study arms will receive 
standard counseling about HIV prevention through means other than PrEP (i.e., 
condoms, sexual partner reduction, and use of ART in any sexual partners who have 
HIV infection). Condoms will also be available free-of-charge. HIV testing will be 
performed prior to each disbursement of PrEP, as described above. Such frequent 
testing will decrease the potential for drug resistance to develop in the setting of acute 
HIV infection. If HIV seroconversion does occur, we will provide counseling for potential 
emotional trauma and assist with linkage to HIV treatment and care programs, which are 
widely available and free-of-charge through the Kenyan national healthcare system. 
 

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3.   Risk: Privacy may be lost through use of the PrEP My Way kit. 
 
Protection: We will advise participants on the potential for kit delivery to attract attention. 
We will minimize this risk by using unmarked vehicles (typically motorbikes that are 
commonly used for routine, day-to-day activities) and making deliveries at the preferred 
date, time, and location of the participants. Peers will also not wear uniforms, and they 
will be trained in human subjects protections, with emphasis placed on the importance of 
privacy and confidentiality. All samples will be labeled with the participant’s unique study 
ID number and date. This information will only be linked to identifiable information (e.g., 
the participant’s name) in databases that are stored securely with encryption and 
password or in locked cabinets (as described in the protocol). Samples will be 
transported in unmarked bags that will not indicate the name of the study, participants, 
or staff. Text and WhatsApp messages will not explicitly mention STI tests to protect the 
participant’s privacy of the participants. 
 
 
We will hire three peers to work with study participants. We believe the likelihood of a 
participant knowing all three is low. However, if she does know all the peers, she can 
decide to continue or not with study participation. We will also give each participant the 
option of changing peers at enrollment or during the course of the study per her 
preference (e.g., in case of interpersonal conflict). 
 
4.  Risk: Emotional discomfort, physical discomfort, bleeding, or rarely infection may occur 
from HIV self-testing, vaginal swab self-sampling for gonorrhea and chlamydia testing, 
and/or self-injection of medroxyprogesterone. 
 
Protection: All self-administered components in the PrEP My Way kit are licensed for 
routine clinical use and are generally considered safe. We will promote emotional and 
physical comfort with these components through client-centered design of all pictorial 
and video guidance. Peers will also be trained to support their use in person at the time 
of kit delivery, as well as through mobile phone interactions (e.g., SMS, WhatsApp).  
 
 
Group chats will be voluntary and participants will be informed of their right to opt out of 
them if they have any privacy or confidentiality concerns. This approach has worked well 
within the POWER study (conducted by Drs. Bukusi and Baeten) in the same study 
setting with no concerns reported. The WhatsApp or text messages between the peer 
and the participant will be closed (i.e., meaning no other individuals will be included). 
Peers will use password protected, encrypted phones to prevent loss of 
privacy/confidentiality and will receive training on the importance of 
privacy/confidentiality as noted above. Participants will be encouraged to use passwords 
on their personal phones and delete any message they do not want seen by others. 
 
5.   Risk: Privacy may be lost through security breaches with data collected through the 
study.  
 
Protection: All consent forms will be stored in locked cabinets at the research sites. All 
electronic data from interviews, focus group discussions, questionnaires, and test results 
will be stored securely on encrypted, password-protected devices and in REDCap 
(hosted at MGH), which is in compliance with HIPAA standards.  
 
6.   Risk: Some participants may experience fatigue from completing study interviews, focus 
group discussion, and/or questionnaires. 
 
Protection: We will keep all study procedures as short as possible to minimize the risk 
for fatigue. We will also allow participants to take breaks when needed.  

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Potential benefits and relation to risks 
During the study, participants will receive the same services available to them through the 
routine Kenyan healthcare clinics: HIV testing, PrEP, STI testing/treatment, pregnancy tests, 
and contraception. Participants in the intervention arm will have the added benefit of service 
delivery and peer support. All participants will receive an incentive (300 Kenyan Shillings, ~$3) 
for their time at enrollment and the 6-month follow-up visit.  
We feel the risks associated with the study are small. The benefits are consistent with cultural 
expectations and they follow the established standard with institutional review board approval in 
our other studies (e.g., MPYA as described above). We therefore believe the balance of benefit 
and risk is appropriate. 
 
Expected Application of the Results 
High persistent adherence and program retention are critical for achieving HIV prevention from 
PrEP, but are currently limited for young women in sub-Saharan Africa by stigma and structural 
barriers. PrEP My Way is a theory-based intervention to overcome these barriers and empower 
young women to achieve the benefits of PrEP, as well as STI management and contraception. 
This study will determine if PrEP My Way is feasible, acceptable, and likely to have impact on 
PrEP adherence and program retention. This knowledge is a critical step toward full testing of 
the intervention in a future R01 grant. If successful, PrEP My Way could help support the HIV 
prevention and sexual health needs of the millions of young women in the “youth bulge” that will 
affect Africa in the coming decade. 
 
Community advisory board (CAB) 
Lumumba Clinic maintains an active community advisory board with ten standing members 
representing the surrounding Kisumu region, as well as capacity for rotating members 
depending on the needs of each study. For this protocol, the CAB will be enriched with two 
young women taking PrEP. The study will be presented during the protocol development phase 
and at least annual thereafter for feedback and guidance on both implementation of study 
procedures and interpretation and dissemination of findings. 
 
Data and safety monitoring plan 
Drs. Haberer and Bukusi will work closely together to ensure that high quality data is collected 
and the safety of study participants is upheld. Dr. Bukusi will be responsible for oversight of the 
day-to-day activities in Kisumu. Drs. Haberer and Bukusi will communicate approximately 
weekly (e.g., by Skype/Zoom) with email more frequently as needed. Drs. Haberer will visit the 
site twice annually, and Drs. Siegler and Baeten will visit at least annually, to facilitate study 
operations, including trainings, monitoring, evaluation, and result dissemination. Reports on 
study progress will be generated at least monthly and shared among the investigators for 
discussion. Dr. Bukusi will communicate any adverse events to Dr. Haberer within 72 hours; all 
serious adverse events will be reported to the KEMRI and MGH institutional review boards 
according to their requirements (generally 7 days).  
 
ClinicalTrials.gov requirements 
Dr. Haberer will be responsible for registering and providing updated information about the 
clinical trial on ClinicalTrials.gov.  
 
Treatment for Injury 
Participants will be asked to inform the study staff if they feel they have been injured because of 
taking part in the study. Injuries may also be identified during laboratory testing, medical 
histories, and physical examinations. Treatment for adverse events related to study participation 

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will be provided by the study clinic at RCTP. If treatment is required that is beyond the capacity 
of the study clinic, the study doctors will refer the participant to appropriate services or 
organizations that can provide care for the injury. 
 
Study Records 
Site Investigators will maintain, and store in a secure manner, complete, accurate, and current 
study records throughout the study. The investigator will retain all study records for at least 
seven years after completion of the study. Study records include administrative documentation 
and regulatory documentation, as well as documentation related to each participant screened 
and/or enrolled in the study, including informed consent forms, questionnaires, notations of all 
contacts with the participant, logs linking participant name to study identification number and 
other identifying information in study files, and all other source documents. After seven years, 
these documents may be destroyed.  
 
Participants’ study information will not be released without their written permission, except as 
necessary for oversight by: 
• 
Study investigators 
• 
Study funders 
• 
Site institutional review boards 
• 
Massachusetts General Hospital 
• 
Kenya Medical Research Institute 
 
Investigator roles 
Dr. Haberer will be the overall PI for the study; she will be responsible for development of the 
study protocol, training and data collection materials, domestic regulatory approval, data 
management systems and quality control, data analysis, manuscript preparation, and result 
dissemination. 
 
Dr. Bukusi will serve as the site PI for the study; she will provide significant input on the study 
protocol, training and data collection materials, data analysis, manuscript preparation, and result 
dissemination. She will also oversee day-to-day staffing needs and data collection activities. 
 
Dr. Siegler serve as a co-investigator and will provide significant input on the design and use of 
the PrEP My Way kit, building on his experience with a similar intervention for men who have 
sex with men in the US. He will also assist with data analysis, manuscript preparation, and 
result dissemination. 
 
Dr. Baeten will be a consultant for this study, providing input regarding the protocol, analysis, 
manuscripts, and other dissemination activities. He has a well-established relationship with Drs. 
Haberer and Bukusi and will be readily available for consultation. 
 
Dr. Haberer will host monthly investigator calls to review study activities and facilitate input. She 
will also organize longer semi-annual meetings to reflect on study progress and impact; every 
other meeting will be held in Kenya. All investigators will be in regular communication via email.

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