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

NCT05599581 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1562

Last updated 2026-04-07

No results posted yet for this study

Summary

This study will test the effectiveness of a youth-designed multilevel intervention, Tu'Washindi, to increase PrEP use and reduce intimate partner violence (IPV) among Kenyan AGYW and to identify implementation challenges and strategies to facilitate future scale-up in programmatic settings to maximize public health impact.

Through a cluster randomized controlled trial (cRCT) design, twenty-two administrative wards in Siaya County, western Kenya will be randomized in a 1:1 ratio to receive either the 6-month Tu'Washindi intervention plus usual HIV prevention services or usual HIV prevention services alone. Approximately 72 AGYW will be enrolled from each ward (N= 1,584), with follow-up visits at months 3, 6, and 12 post-enrollment. A mixed methods process evaluation (not part of the clinical trial) will also be conducted using programmatic data, follow-up questionnaires from trial participants, approximately 500-1000 exit surveys with men, and approximately 100 qualitative interviews with AGYW participants, male partners, and intervention providers. These data will characterize fidelity and quality of intervention implementation, explore and test mechanisms of change, and capture contextual factors influencing intervention outcomes, with the goal of informing future refinement and implementation.

The population for this clinical trial study is AGYW ages 15-24 in Siaya County, Kenya.

Conditions

Interventions

BEHAVIORAL

Tu'Washindi

Tu'Washindi consists of 3 primary components: 1. PrEP Adherence Support Clubs: Eight 2-hour sessions that occur over the intervention period: twice per month for the first 2 months \& once per month for the remaining 4 months. Sessions will use structured \& unstructured activities designed to improve outcomes expectations, increase self-efficacy to use PrEP safely \& consistently, increase peer support for PrEP use, provide access to community IPV resources \& provide skills for healthy communication \& PrEP disclosure with male partners. 2. Community Male Sensitization conducted weekly over the first 3 months of the intervention period aimed to increase PrEP knowledge, reduce stigma, \& promote healthy relationship communication. 3. Buddy Days, which take place 3 months into the intervention period, designed to bring participants \& their male partners together to learn about PrEP, discuss community attitudes \& concerns regarding PrEP use, \& promote HIV prevention \& family well-being.

Sponsors & Collaborators

  • Impact Research & Development Organization

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • RTI International

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
24 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-29
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Kenya

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05599581 on ClinicalTrials.gov