# Tu'Washindi: A relationship-focused intervention to reduce GBV and increase PrEP uptake and adherence among Kenyan AGYW

> **NIH NIH R01** · RESEARCH TRIANGLE INSTITUTE · 2021 · $773,884

## Abstract

PROJECT SUMMARY
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 (AGYW) in Kenya. AGYW in this setting live in a context of heightened gender inequality
and risk of intimate partner violence (IPV) and represent a large subpopulation who are 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. Barriers to PrEP
uptake and adherence occur at multiple levels of the socioecological model, including low individual self-efficacy,
partner opposition, and community stigma. Tu'Washindi na PrEP (We are Winners with PrEP) is a multi-level,
community-based intervention designed specifically to address these challenges among AGYW in Siaya County,
Kenya. 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 100 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 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 AGYW 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 IPV and
relationship power (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 R34 intervention development work 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.

## Key facts

- **NIH application ID:** 10323074
- **Project number:** 1R01MH125671-01A1
- **Recipient organization:** RESEARCH TRIANGLE INSTITUTE
- **Principal Investigator:** Sarah Tyler Roberts
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $773,884
- **Award type:** 1
- **Project period:** 2021-08-19 → 2026-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10323074

## Citation

> US National Institutes of Health, RePORTER application 10323074, Tu'Washindi: A relationship-focused intervention to reduce GBV and increase PrEP uptake and adherence among Kenyan AGYW (1R01MH125671-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10323074. Licensed CC0.

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