A relationship-focused intervention to reduce intimate partner violence and increase PrEP uptake and adherence among adolescent girls and young women in Kenya

Research Triangle Institute, Durham NC

Investigators

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Abstract

This R01 application, led by an Early Stage Investigator, aims to test the effectiveness of a multilevel community-based intervention to increase uptake and adherence to oral pre-exposure prophylaxis (PrEP) among adolescent girls and young women in Kenya. Young women in this setting live in a context of unhealthy relationship dynamics and high risk of intimate partner violence and represent a large subpopulation who are uniquely susceptible to HIV acquisition. In addition to having higher HIV incidence, women experiencing intimate partner violence are less likely to initiate and persist with PrEP, limiting the protective benefit of this efficacious biomedical prevention intervention. Challenges to PrEP uptake and adherence occur at multiple levels of the socioecological model, including low individual self-efficacy, partner opposition, and community stigma. We propose to test a multi-level, community-based intervention designed specifically to address these challenges among adolescent girls and young women in Siaya County, Kenya. Designed by our team using participatory methods engaging local young women (R34MH114519), the intervention includes three components delivered over 6 months: an eight-session support club for participants, community sensitization targeted toward male partners, and PrEP education events for couples. Activities are designed to be integrated into youth-focused programming to ensure efficiency and sustainability. Results from a pilot cluster-randomized controlled trial conducted with 100 adolescent girls and young women at six sites indicate high feasibility and acceptability, and preliminary effectiveness: intervention arm participants had 2-fold higher PrEP uptake and adherence (p<0.05), with less frequent or severe intimate partner violence than control arm participants. The proposed study builds on these promising results and aims to evaluate the intervention in a fully powered cluster-randomized controlled trial across 22 administrative wards in Siaya County, Kenya, enrolling 72 adolescent girls and young women per ward (total N=1,584). The primary objectives (Aim 1) will be to test the effectiveness of the intervention on PrEP uptake and adherence immediately post-delivery (month 6 post-enrollment) and 6 months later (month 12). As secondary objectives we will test the intervention effect on intimate partner violence (Aim 2). A rigorous process evaluation will explore mechanisms of change, contextual factors, and implementation considerations to inform future refinement and scale-up, using programmatic data, participant questionnaires, and qualitative interviews with participants and providers (Aim 3). The proposed study builds directly on our prior intervention development work to develop the evidence base for this youth-designed, multi-level HIV prevention intervention. If effective, the intervention will be ideally positioned for sustainable integration into existing youth-focused programming to expand and support PrEP use in this important population.