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

HIV Prevention Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• HIV Prevention

• NCT number: NCT04982250
• Study type: Interventional
• Source: Fred Hutchinson Cancer Center
• Contact: Katrina F Ortblad, ScD, MPH
• Phone: 2066677267
• Email: kortblad@fredhutch.org
• Status: Recruiting
• Phase: N/A
• Start date: February 24, 2022
• Completion date: January 31, 2025