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Tu'Washindi RCT: Adolescent Girls in Kenya Taking Control of Their Health
Sponsor: RTI International
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.
Official title: Tu'Washindi Randomized Control Trial (RCT): A Relationship-focused Intervention to Reduce Intimate Partner Violence (IPV) and Increase Pre-exposure Prophylaxis (PrEP) Uptake and Adherence Among Kenyan Adolescent Girls and Young Women (AGYW)
Key Details
Gender
FEMALE
Age Range
15 Years - 24 Years
Study Type
INTERVENTIONAL
Enrollment
1562
Start Date
2022-09-29
Completion Date
2026-07-31
Last Updated
2026-04-07
Healthy Volunteers
Yes
Interventions
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.
Locations (2)
Impact Research and Development Organization (IRDO)
Kisumu, Kenya
RTI International Africa Regional Office
Nairobi, Kenya