Tu'Washindi na PrEP: Adolescent Girls in Kenya Taking Control of Their Health

RTI International

Status: Completed

Conditions: Gender-Based Violence

Treatments: Other: Control; Behavioral: Tu'Washindi intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03938818

MSU/DRPI/MUERC/00418/17

1R34MH114519-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 103 patients

Sex: Female

Ages: 15 to 24 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 1. Age 15-24 years (inclusive);
• 2. HIV-negative, by self-report;
• 3. At high risk for acquiring HIV, as defined by the 2016 Guidelines on Use of Antiretroviral Drugs for Treating and Preventing HIV Infections in Kenya;
• 4. Fluent in English, Dholuo, or Swahili;
• 5. Enrolled in DREAMS (defined by having a DREAMS identification (ID) number);
• 6. Lives within the Safe Space catchment area - 7) Willing and able to attend support groups over the 6-month period;
• 8. Potentially interested in PrEP and/or using PrEP already;
• 9. Able and willing to provide adequate locator information, as defined in site standard operating procedures (SOPs);
• 10)If aged 18 and above: Willing and able to provide informed consent;
• 11)If non-mature minor aged 15-17: Willing and able to provide assent and parent or guardian willing and able to provide parental consent;
• 12)If mature minor aged 15-17: Willing and able to provide informed consent or to provide assent and parent or guardian consent, per participant choice.

Exclusion criteria

• 1)Planning to relocate away from the study catchment area in the next 6 months;
• 2)Planning to travel away from the study catchment area for a time period that would interfere with study participation; or
• 3. Has any condition that, in the opinion of the site PI, would preclude informed assent/consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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103 participants in 2 patient groups

Control

Other group

Description:

Standard of care will include PrEP delivery according to the usual DREAMS procedures

Treatment:

Other: Control

Tu'Washindi intervention

Experimental group

Description:

Standard of care will include PrEP delivery according to the usual DREAMS procedures. The Tu'Washindi intervention includes the following components: 1. PrEP sensitization for men (community level). 2. "Buddy Days" (partner level). 3. Adherence support clubs (individual and peer levels).

Treatment:

Behavioral: Tu'Washindi intervention