Gender-Based Violence Clinical Trial
Official title:
Targeted Interventions to Address the Multi-level Effects of Gender-based Violence on PrEP Uptake and Adherence Among Adolescent Girls and Young Women in Siaya County, Kenya
This study is nested within the ongoing DREAMS (Determined, Resilient, Empowered, AIDS-free, and Safe) initiative in Siaya County, Kenya. It will test a pilot intervention that will address barriers to pre-exposure prophylaxis (PrEP) uptake and adherence in adolescent girls and young women (AGYW) to reduce their risk to HIV acquisition, with a focus on barriers stemming from male partners and gender-based violence.
This study is designed to assess feasibility, safety, and preliminary effects of a behavioral
intervention aimed at increasing pre-exposure prophylaxis (PrEP) uptake and adherence in
adolescent girls and young women (AGYW), with a focus on barriers stemming from male partners
and gender-based violence, through a pilot cluster randomized-controlled trial (RCT). This
study is nested within the ongoing DREAMS (Determined, Resilient, Empowered, AIDS-free, and
Safe) initiative in Siaya County, Kenya. Six DREAMS Safe Spaces and their catchment areas
will be randomized to receive this community-level intervention or standard of care. Primary
outcomes will include feasibility (recruitment, retention) and safety (ongoing or renewed
experience of GBV). The investigators will also determine whether the intervention shows
promise in increasing PrEP uptake, adherence, and persistence at 6 months. After the
intervention, small group discussions, in-depth interviews with male partners, and provider
questionnaires will explore acceptability and effects on PrEP decision making and use.
Population: AGYW ages 15-24 enrolled in the DREAMS Initiative in Siaya County, Kenya, and,
for in-depth interviews only, a subset of male partners of DREAMS participants.
Objectives: The goal of this work is to test the feasibility, acceptability, safety, and
preliminary effects of the intervention on PrEP uptake and adherence among AGYW.
The primary objectives are to assess:
1. Intervention safety
2. Feasibility of delivering the intervention within DREAMS operations
3. Acceptability of the intervention to participants, staff, and male partners.
The secondary objectives are to measure the intervention's effect on PrEP uptake, adherence,
and persistence at 6 months.
Endpoints: The endpoints for the primary objectives are:
1. Self-report of new or ongoing GBV, social harms, serious adverse events, or
unanticipated problems during study participation, in the intervention arm versus the
comparison arm.
2. Measures of feasibility including recruitment, retention, intervention participation,
and fidelity of intervention delivery.
3. Qualitative and quantitative reports of intervention acceptability among participants,
quantitative reports of acceptability among providers, and qualitative reports of
acceptability among male partners.
The endpoints for the secondary objectives are:
1. PrEP uptake: Among participants who are not on PrEP at study enrollment, the proportion
of who receive a PrEP prescription during follow-up in the intervention arm vs. the
control arm
2. PrEP adherence: Among participants who were dispensed PrEP during the study, the
proportion with >85% adherence over the duration of PrEP use and in the last month of
PrEP use, according to Wisepill data in the intervention arm vs. the control arm.
3. PrEP persistence: Among study participants who were dispensed PrEP during the study, the
proportion of scheduled PrEP refills that were dispensed, in the intervention arm
compared to the control arm.
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