Tu'Washindi na PrEP: Adolescent Girls in Kenya Taking Control of Their Health
Condition: Gender-Based Violence
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Tu'Washindi intervention; Control
Intervention type(s): Behavioral; Other
Intervention description(s): The intervention includes the following components:
PrEP sensitization for men (community level). These activities will aim to provide men with basic information about PrEP and will be used to prepare men for more effective engagement in Buddy Days, described below.
"Buddy Days" (partner level). Buddy days will target male partner engagement by inviting couples to attend a community-wide event with health screenings, and PrEP sensitization, which aim to facilitate further communications about PrEP and increase men's support for AGYW's PrEP use.
Adherence support clubs (individual and peer levels). Support clubs will provide a forum for AGYW to discuss challenges and successes around PrEP use in relationships, including in the context of partner violence. Participation in these groups is hypothesized to increase self-efficacy for PrEP use by reducing social isolation and providing additional positive role-modeling from peer leaders.; Standard of care will include PrEP delivery according to the usual DREAMS procedures, including attendance at routine Safe Space meetings and routine PrEP provision at the Safe Space, if applicable.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: cluster randomized-controlled trial (RCT)
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Gender-Based Violence; PrEP (Pre-exposure Prophylaxis); AIDS Prevention; HIV Prevention