Empowering Adolescent Girls in Kenya to Improve Health Outcomes
Tu'Washindi Randomized Control Trial (RCT): A Relationship-focused Intervention to Reduce Gender-based Violence (GBV) and Increase Pre-exposure Prophylaxis (PrEP) Uptake and Adherence Among Kenyan Adolescent Girls and Young Women (AGYW)
This study is testing a new program in Kenya to see if it can help young girls use PrEP more and reduce violence from partners.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2132 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | RTI International Academic / other |
| Locations | 1 site (Kisumu) |
| Trial ID | NCT05599581 on ClinicalTrials.gov |
What this trial studies
This study tests the effectiveness of the Tu'Washindi intervention, designed by youth, to increase PrEP use and reduce intimate partner violence (IPV) among adolescent girls and young women (AGYW) in Kenya. It employs a cluster randomized controlled trial (cRCT) design, where 22 wards in Siaya County will be randomized to receive either the intervention plus usual HIV prevention services or usual services alone. Approximately 1,584 AGYW will be enrolled, with follow-up assessments at 3, 6, and 12 months to evaluate the intervention's impact on health outcomes and implementation challenges. The intervention includes empowerment-based support clubs, couple education events, and community sensitization efforts.
Who should consider this trial
Good fit: Ideal candidates for this study are female adolescents aged 15-24 who are currently in a sexual relationship and are vulnerable to HIV.
Not a fit: Patients who are not in a sexual relationship or do not meet the vulnerability criteria for HIV may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve PrEP uptake and adherence while reducing intimate partner violence among vulnerable adolescent girls and young women.
How similar studies have performed: Previous pilot studies of the Tu'Washindi intervention have shown promising results in improving PrEP uptake and reducing IPV, indicating potential for success in this larger trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Inclusion criteria AGYW participants: * Age 15-24 years * Female gender * Currently in a sexual relationship with a male partner for at least 1 month * Vulnerable 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. Inclusion criteria for male exit survey and in-depth interview (IDI) participants: * Aged 15 years or older * Male * Fluent in one of the study languages (English, Dholuo, or Kiswahili) * \[For exit surveys\]: attended a study Buddy Day or community sensitization event * \[For IDI participants\]: a male sexual partner of an AGYW clinical trial participant * \[For IDI participants\]: the AGYW participant must have provided permission for the study staff to contact the male partner * \[For IDI participants\]: (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. Inclusion criteria for healthcare providers: * Aged 18 years or older * Have been involved in delivering Tu'Washindi intervention activities to the AGYW clinical trial participants (e.g., mentors, community organizers, counselors, clinicians) * Fluent in one of the study languages (English, Dholuo, or Kiswahili) * Willing and able to provide informed consent. Exclusion Criteria: Exclusion criteria for AGYW participants: * Living with HIV (by self-report) * Planning any long-term travel or relocation in the next 12 months * Any condition that, in the opinion of the site PI or designee, would preclude informed assent/consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives. Exclusion criteria for men and healthcare providers: • Any condition that, in the opinion of the site PI or designee, would preclude informed assent/consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Where this trial is running
Kisumu
- Impact Research and Development Organization (IRDO) — Kisumu, Kenya (Recruiting)
Study contacts
- Study coordinator: Sarah T Roberts, PhD, MPH
- Email: sroberts@rti.org
- Phone: +15108494942
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.