Accepted for/Published in: JMIR Research Protocols
Date Submitted: Dec 30, 2024
Date Accepted: Feb 12, 2025
Evaluation of the Tu'Washindi na PrEP intervention to reduce gender-based violence and increase pre-exposure prophylaxis uptake and adherence among Kenyan adolescent girls and young women: Protocol for a cluster-randomized controlled trial.
ABSTRACT
Background:
Adolescent girls and young women (AGYW) constitute a priority population disproportionately affected by HIV, accounting for 25% of annual HIV incidence among adults in Kenya. Although oral PrEP is effective in reducing HIV acquisition, its protective benefit has been limited among AGYW in sub-Saharan Africa because of low uptake, adherence, and persistence. Intimate partner violence (IPV) and relationship power inequities are both widespread among AGYW and contribute to higher HIV incidence and lower PrEP utilization. Interventions are needed to support sustained PrEP use among AGYW by addressing IPV and relationship dynamics.
Objective:
This study aims to test the effectiveness of a Tu’Washindi na PrEP (We are Winners with PrEP), a multilevel community-based intervention, to increase uptake and adherence to PrEP and reduce IPV among AGYW in Siaya County, Kenya.
Methods:
The Tu’Washindi na PrEP intervention was co-designed by our team and AGYW using participatory methods and includes three components delivered over 6 months: an eight-session, empowerment-based support club for AGYW, community sensitization targeted toward male partners, and PrEP education events for couples. The intervention will be evaluated using cluster-randomized controlled trial across 22 administrative wards in Siaya County, Kenya, enrolling 72 AGYW per ward (total N=1,584). The primary objectives are 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 IPV. 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).
Results:
Data collection started in September 2022. As of December 2024, enrollment has been completed in 16 of 22 study wards, with 1150 of 1584 participants enrolled (73%). We anticipate that data collection will be completed in May 2026 and results will be available by mid-2027.
Conclusions:
The study builds directly on our promising formative and pilot research to develop the evidence base for this youth-designed, multi-level HIV prevention intervention. If effective, Tu’Washindi will be ideally positioned for sustainable integration into existing youth-focused programming to expand and support PrEP use in this priority population. Clinical Trial: Clinicaltrials.gov (NCT05599581); Current protocol: Version 7.0, 22 October 2024
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