Peer PrEP Referral + HIV Self-test Delivery for PrEP Initiation in Kenya

Study Overview
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Brief Summary
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Few young women at risk of HIV infection are initiating pre-exposure prophylaxis (PrEP) for HIV prevention in Kenya, thus we propose refining and testing a new model to increase PrEP initiation among young women at high HIV risk that has never been explored: peer PrEP referral + HIV self-test (HIVST) delivery. We conducted formative research to design of a model that is acceptable to young women and feasible to implement in Kenya. In this study, we will refine this model where young (≥16 to 24 years) female PrEP users refer their peers to PrEP and deliver HIVSTs in a pilot study and then test the refined model in a hybrid effectiveness-implementation trial. We hypothesize that relative to informal word-of-month peer PrEP referral (currently ongoing in Kenya), formalized peer PrEP referral + HIVST delivery will increase PrEP adoption (i.e., initiation, retention, and adherence) among peers, and be low cost and have high fidelity in Kenya.

Detailed Description
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Pre-exposure prophylaxis (PrEP) for HIV prevention is highly effective, but uptake remains low among young women in sub-Saharan Africa, one of the populations at greatest HIV risk. In Kenya, one of the target groups for HIV incidence reduction is young women (16-24 years), who account for 33% of the total of new HIV infections, yet comprise only 10% of the population. Barriers to PrEP initiation for this population are multi-faceted and include institutional (e.g., stigma associated with use) and intra-personal (e.g., lack of PrEP knowledge or self-efficacy) barriers. Thus, innovative PrEP delivery models that can help overcome these barriers are needed. The opinion of peers often influences the behaviors and preferences of young women, including those related to health and health care. Most young women who have initiated PrEP in Kenya to date have done so because of peer referral, thus formalized and enhanced peer referral has the potential to increase PrEP initiation among members of this population. HIV self-testing (HIVST) is a new technology that has the potential to enhance peer PrEP referral. Much of the emphasis on HIVST to date has been on identifying new individuals living with HIV and facilitating linkage to treatment, but the majority of individuals who self-test will test negative and may be interested in facilitated linkage to prevention services, like PrEP. We hypothesize that a formalized peer PrEP referral + HIVST delivery model can amplify PrEP initiation among young Kenyan women at HIV risk. We conducted formative qualitative research and stakeholder engagement to develop a model of formalized peer PrEP referral + HIVST delivery to increase PrEP initiation among young Kenyan women. We propose refining this model in a pilot study. In our pilot, we will recruit 16 young female PrEP users (i.e. peer providers) in Thika, Kenya to deliver the formalized peer PrEP referral + HIVST model to  4 peers (i.e., peer clients, =64 peer clients in total). At one month, we will quantitatively measure model adoption (e.g., peer referral, PrEP initiation) and feasibility (e.g., peer follow up) using surveys, and qualitatively measure acceptability using focus group discussions (FDGs) with those delivering and receiving the model (4-5 FDGs, 3-6 women/FDG). We then propose testing the refined model in hybrid effectiveness-implementation trial. In our trial, we will randomize 80 peer providers to: 1) formal peer PrEP referral + HIVST delivery, where they are encouraged to refer 4 peer clients to PrEP using an educational brochure, HIVSTs (2/peer, =8 total), and a MOH-style referral slip, vs. 2) informal peer PrEP referral, where they are encouraged to refer 4 peer clients to PrEP using word-of-mouth, as is ongoing in Kenya, and a MOH-style referral slip. All trial outcomes will be measured among peer clients, as reported by peer providers, three months later. Implementation outcomes will include acceptability, fidelity, and costs. The effectiveness outcomes will be PrEP initiation [primary], PrEP continuation (i.e., refilling), recent HIV testing use (past 3 months), and PrEP adherence, confirmed using dried blood spots. The results from this trial will address one of the greatest challenges to PrEP scale-up today and inform an R01 proposal for a community-randomized trial and budget impact analysis.

Official Title
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Peer PrEP Referral + HIV Self-test Delivery for PrEP Initiation Among Young Kenyan Women: Pilot Study & Randomized Trial

Conditions
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HIV Prevention

Intervention / Treatment
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* Behavioral: Formal peer PrEP referral + HIVST delivery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For peer providers (qualitative data, pilot): Age ≥16 to 24 years* Female Have been on PrEP for a minimum of three months Good adherence to PrEP (i.e., self-report take PrEP all the time) Willing to disclose PrEP use to their peers Able to identify up to 4 peers at risk of HIV infection Willing to participate in training with study counselors on PrEP referral and HIVST use Willing to refer peers to PrEP and deliver HIVSTs Good communication skills, determined by the study counselor Able and willing to provide written informed consent Per the discretion of the site investigator, no clear risks of social harm or inability otherwise to reasonably conduct HIVST at home in the context of PrEP delivery For peer providers (cRCT): Age ≥16 to 24 years* Female Must have refilled or initiated PrEP (i.e., been dispensed PrEP) Not currently enrolled in an HIV study Able to identify up to 4 peers with recent self-reported behaviors associated with risk of HIV acquisition Willing to participate in training with study counselors on PrEP referral and HIVST use Willing to refer peers to PrEP and deliver HIVSTs Good communication skills, determined by the study counselor Able and willing to provide written informed consent Willing to provide contact information for follow-up Willing to engage in all research activities including completion of questionnaires Per the discretion of the site investigator, no clear risks of social harm or inability otherwise to reasonably conduct HIVST at home in the context of PrEP delivery For peer clients (pilot, RCT): Age ≥16 to 24 years* Female Referred by peer (i.e., a PrEP users) to initiate PrEP Able and willing to provide informed consent Per the discretion of the site investigator, no clear risks of social harm or inability otherwise to reasonably conduct HIVST at home NOTE: We will only enroll young women ≥16 to 17 years into the study if they are emancipated minors and thus able to legally provide consent for participation in research. Kenyan law acknowledges women ages 14 to 17 who have become pregnant as emancipated minors. The PHRD site/UW collaboration has successfully enrolled emancipated minors into a number of prior studies, including PrEP clinical trials. In addition, Kenya's national policy guidelines explicitly permit PrEP use in this age group. Exclusion Criteria: For peer providers (qualitative data, pilot): Age ≥16 or >24 years Male Have not used PrEP for a minimum of three months Not willing to disclose PrEP use to their peers Not able to identify up to 4 peers at risk of HIV infection Not willing to participate in training with study counselors on PrEP referral and HIVST use Not willing to refer peers to PrEP and deliver HIVSTs Poor communication skills, determined by the study counselor Not able and willing to provide written informed consent For peer providers (cRCT): Age ≥16 or >24 years Male Have not used PrEP Currently enrolled in an HIV study Not able to identify up to 4 peers at risk of HIV infection Illiterate Not willing to participate in training with study counselors on PrEP referral and HIVST use Not willing to refer peers to PrEP and deliver HIVSTs Poor communication skills, determined by the study counselor Not able and willing to provide written informed consent For peer clients (pilot, cRCT): Age ≥16 or >24 years Male Not referred by peer (i.e., a PrEP users) to initiate PrEP Not able and willing to provide written informed consent

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The pilot study will be a single group model (N=104), and the RCT will be a parallel model (N=400).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Formal peer PrEP referral + HIVST delivery<br>After a brief training, young female PrEP users will be encouraged to refer up to 4 peers to PrEP using strategies gained from the training, PrEP educational materials (i.e., brochures), HIVST kits (2 kits/peer = 8 kits total), and Kenya MOH-style referral cards. | Behavioral: Formal peer PrEP referral + HIVST delivery<br>* After a brief training, young female PrEP users will be encouraged to refer up to 4 peers to PrEP using strategies gained from the training, PrEP educational materials (i.e., brochures), HIVST kits (2 kits/peer = 8 kits total), and Kenya MOH-style referral cards.<br>|
| No Intervention: Informal peer PrEP referral<br>Young female PrEP users will be encouraged to refer 4 peers to PrEP using informal word-of-mouth recruitment strategies and Kenya MOH-style referral cards. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PILOT: PrEP initiation [Number of peer clients] | Number of referred peer clients that initiated PrEP | 1 month | 
| PILOT: PrEP initiation [Proportion of peer clients] | Proportion of referred peer clients that initiated PrEP | 1 month | 
| cRCT: PrEP initiation | Proportion of referred peer clients that initiated PrEP | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PILOT: PrEP referral [Number of peer clients] | Number of peer clients referred to PrEP | 1 month | 
| PILOT: PrEP referral [Proportion of peer clients] | Proportion of peer clients referred to PrEP | 1 month | 
| PILOT: HIVST use [Number of peer clients] | Number of referred peer clients that used HIVST | 1 month | 
| PILOT: HIVST use [Proportion of peer clients] | Proportion of referred peer clients that used HIVST | 1 month | 
| PILOT: HIV risk [Number of peer clients] | Number of peers at HIV risk (scores >1/6 on the PrEP Rapid Assessment Screening Tool [RAST]) | 1 month | 
| PILOT: HIV risk [Proportion of peer clients] | Proportion of peers at HIV risk (scores >1/6 on the PrEP Rapid Assessment Screening Tool [RAST]) | 1 month | 
| cRCT: recent HIV testing | Proportion of referred peer clients who tested for HIV (any form, including HIVST) | 3 months | 
| cRCT: PrEP continuation | Proportion of peer clients that returned to a clinic to refill PrEP, among those who initiated PrEP | 3 months | 
| cRCT: PrEP adherence | Proportion of referred peer clients that returned for follow up and self-reported PrEP adherence (blood-level PrEP adherence measurements on random sample) | 3 months | 
| cRCT: HIV risk | Proportion of referred peers at HIV risk (scores >1/6 on the PrEP Rapid Assessment Screening Tool [RAST]) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kenya, adolescent girls and young women (AGYW), HIV pre-exposure prophylaxis (PrEP) delivery, HIV self-testing delivery