NCT05599581Completed
Tu'Washindi RCT: Adolescent Girls in Kenya Taking Control of Their Health
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)
Source: ClinicalTrials.gov · Last updated 7 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 1562 (actual)
- First submitted
- 26 Oct 2022
- Start date
- 29 Sept 2022
- Primary completion date
- 23 Mar 2026
- Lead sponsor
- RTI International
- Diseases
- HIV
- NCT number
- NCT05599581
What you commit to
- Study type: Interventional
- Participants enrolled: 1562
- From 29 Sept 2022 to the primary completion date, 23 Mar 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- To join the study potential AGYW participants must be:
- Age 15-24 years
- Female
- Currently in a sexual relationship with a male partner for at least 1 month
- Susceptible to HIV per modified Determined, Resilient, Empowered, AIDS-free, Mentored and Safe (DREAMS) eligibility score
- (a) Taking PrEP or (b) interested in PrEP (i.e., thinks she would benefit from PrEP but is not currently taking it)
- Resident of applicable ward
- Willing and able to attend support clubs for over 6 months
- Willing and able to provide adequate contact information for retention
- Fluent in one of the study languages (English, Dholuo, or Kiswahili)
- (a) If aged 18 and above: Willing and able to provide informed consent; or (b) if non-mature minor aged 15-17: willing and able to provide assent and parent or guardian willing and able to provide parental consent; or (c) 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.
Age in the registry: 15 years to 24 years · Sex: Female · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Impact Research and Development Organization (IRDO) Coordinator of this site? Confirm its status | Kisumu | Kenya | Unknown status |
| RTI International Africa Regional Office Coordinator of this site? Confirm its status | Nairobi | Kenya | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.