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

NCT03938818 | Completed DMC

• 2 other identifiers: MSU/DRPI/MUERC/00418/171R34MH114519-01
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Gender-Based Violence

Keywords

Gender-Based Violence; PrEP (Pre-exposure Prophylaxis); AIDS Prevention; HIV Prevention

Outcome Measures

Primary Outcomes (8)

• Intervention safety - survey tool

  Self-report of experience of social harms in the past 3 months and violence or controlling behavior using an adapted version of the World Health Organization's questions on violence against women. Behaviors are reported for every experience in the past 3 months and frequency of experience (e.g., once, few times, many times).

  3 months

• Intervention safety - survey tool

  Self-report of experience of social harms in the past 3 months and violence or controlling behavior using an adapted version of the World Health Organization's questions on violence against women. Behaviors are reported for every experience in the past 3 months and frequency of experience (e.g., once, few times, many times).

  6 months

• Intervention safety - form

  Reports of new or ongoing gender-based violence (GBV), social harms, serious adverse events, or unanticipated problems during study participation. Information will be self-reported using an specially-developed form

  Throughout the study, approximately 6 months

• Feasibility of the behavioral intervention - Process Indicators

  Measures of feasibility including recruitment timelines and numbers enrolled, retention rates, intervention participation measured by attendance at support club sessions and other intervention activities, and fidelity of intervention delivery measured through documented observations of intervention delivery capturing activities administered and ratings of quality.

  Throughout the study, approximately 6 months

• Acceptability of the behavioral intervention - qualitative data from participants

  Acceptability measures include qualitative reports of intervention acceptability among participants. These will include in-depth interviews covering topics such as satisfaction with content, delivery, and length of the intervention, as well as reported impact on the participant's life.

  6 months

• Acceptability of the behavioral intervention - quantitative data from participants

  Quantitative reports of intervention acceptability among participants. Satisfaction with intervention content, delivery, length using the client satisfaction questionnaire and as measured on a likert scale response and as open-ended response options.

  6 months

• Acceptability of the behavioral intervention - quantitative data from providers

  Satisfaction with intervention content, delivery, length using the client satisfaction questionnaire and as measured on a likert scale response and as open-ended response options.

  6 months

• Acceptability of the behavioral intervention - qualitative data from male partners

  Qualitative reports of intervention acceptability among male partners. These will include in-depth interviews covering topics such as satisfaction with content, delivery, and length of the intervention, as well as reported impact on the male partner's life.

  6 months

Secondary Outcomes (3)

• Pre-Exposure Prophylaxis (PrEP) uptake

  6 months

• Proportion of participants with Pre-Exposure Prophylaxis (PrEP) adherence > 85% at six months

  Throughout the study, approximately 6 months

• Pre-Exposure Prophylaxis (PrEP) persistence among participants at six months

  6 months

Study Arms (2)

Control

OTHER

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

Other: Control

Tu'Washindi intervention

EXPERIMENTAL

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).

Behavioral: Tu'Washindi intervention

Interventions

Tu'Washindi intervention 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.

Tu'Washindi intervention

Control 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.

Control

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \) Age 15-24 years (inclusive);
• \) HIV-negative, by self-report;
• \) 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;
• \) Fluent in English, Dholuo, or Swahili;
• \) Enrolled in DREAMS (defined by having a DREAMS identification (ID) number);
• \) Lives within the Safe Space catchment area - 7) Willing and able to attend support groups over the 6-month period;
• \) Potentially interested in PrEP and/or using PrEP already;
• \) Able and willing to provide adequate locator information, as defined in site standard operating procedures (SOPs);
• )If aged 18 and above: Willing and able to provide informed consent;
• )If non-mature minor aged 15-17: Willing and able to provide assent and parent or guardian willing and able to provide parental consent;
• )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.

You may not qualify if:

• )Planning to relocate away from the study catchment area in the next 6 months;
• )Planning to travel away from the study catchment area for a time period that would interfere with study participation; or
• \) 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.

Sponsors & Collaborators

• RTI International: lead
• Impact Research & Development Organization: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Impact Research and Development Organization

Kisumu, Kenya

Location

Study Officials

• Sarah Roberts, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: cluster randomized-controlled trial (RCT)

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: May 6, 2019
• Study Start: April 15, 2019
• Primary Completion: December 13, 2019
• Study Completion: December 13, 2019
• Last Updated: January 14, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)