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

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 experience high rates of HIV and intimate partner violence (IPV). Experience of IPV is associated with higher HIV incidence and lower likelihood of PrEP initiation and persistence, 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 IPV and PrEP use among AGYW. The intervention includes three components delivered over 6 months: an eight-session support club for AGYW, community sensitization targeted toward male partners, and PrEP education events for couples. The parent study is evaluating the intervention in a 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 (Aim 3). However, the process evaluation does not collect data on the cost and affordability of intervention implementation. We propose a new Specific Aim (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.