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

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.

NCT Number	NCT05599581
Lead Sponsor	RTI International Collaborators: Impact Research & Development Organization, University of North Carolina, Chapel Hill
Conditions	IPV, HIV, PrEP
Enrollment	1,562 participants
Start Date	2022-09-29
Primary Completion	2026-03-23 (estimated)
Study Completion	2026-04-22 (estimated)
Updated on ClinicalTrials.gov	2026-08-07