Competing Revision: Adding costing activities to the Tu'Washindi Study

Research Triangle Institute, Durham NC

Investigators

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Abstract

PROJECT SUMMARY/ABSTRACT The parent study to this competing revision application (R01MH125671) 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 (AGYW) in Siaya County, Kenya. This competing revision seeks to expand the scope of the parent study by adding a cost and economic evaluation. AGYW in this setting live in a context of heightened gender inequality and risk of intimate partner violence (IPV) and represent a large subpopulation uniquely vulnerable to HIV infection. In addition to having higher HIV incidence, women experiencing IPV are less likely to initiate and persist with PrEP, limiting the protective benefit of this efficacious biomedical prevention intervention. Tu’Washindi na PrEP (We are Winners with PrEP) is a multilevel, community-based intervention designed specifically to address these challenges among AGYW. Designed by our team using participatory methods engaging local AGYW (R34 MH114519), the intervention 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. 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 103 AGYW 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 IPV than control arm participants. The current study builds on these promising results to evaluate the intervention in a fully powered cluster-randomized controlled trial across 22 administrative wards in Siaya County, enrolling 72 AGYW per ward (N=1,584). The primary objectives (Aim 1) 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). A secondary objective is to test the intervention effect on IPV (Aim 2). A rigorous process evaluation is exploring 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, providers, and male partners (Aim 3). However, the process evaluation does not collect data on the cost and affordability of intervention implementation. During stakeholder engagement, it has become clear that intervention cost and affordability will be important considerations in determining whether Tu’Washindi is a good candidate for scale-up. Therefore, we propose a new Specific Aim to the current study (Aim 4): To measure the costs of implementing Tu’Washindi and perform a budget impact analysis to understand the resources required for successful implementation. The cost and budget impact data generated in this competing revision will complement data from our process evaluation to inform policy and practice and ensure that, if effective, Tu’Washindi can be rapidly and sustainably integrated into existing youth-focused HIV prevention programming to expand and support PrEP uptake and adherence in this priority population.