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

NCT ID: NCT03938818

Last Updated: 2020-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2019-12-13

Brief 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.

Conditions

Gender-Based Violence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: OTHER

Control

Intervention Type: OTHER

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.

Tu'Washindi intervention

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).

Group Type: EXPERIMENTAL

Tu'Washindi intervention

Intervention Type: BEHAVIORAL

The intervention includes the following components:

1. 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.

2. "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.

3. 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.

Interventions

Tu'Washindi intervention

The intervention includes the following components:

1. 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.

2. "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.

3. 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.

Intervention Type: BEHAVIORAL

Control

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Impact Research & Development Organization

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

RTI International

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Roberts, PhD

Role: PRINCIPAL_INVESTIGATOR

RTI International

Locations

Impact Research and Development Organization

Kisumu, , Kenya

Countries

Kenya

Other Identifiers

1R34MH114519-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MSU/DRPI/MUERC/00418/17

Identifier Type: -

Identifier Source: org_study_id