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. About 72 AGYW will be enrolled from each ward (total N= about 1,584), with follow-up visits at months 3, 6, and 12 post-enrollment. A mixed methods process evaluation will also be conducted using programmatic data, follow-up questionnaires from trial participants, about 500 exit surveys with men, and about 96 qualitative interviews with 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 study is AGYW ages 15-24 in Siaya County, Kenya; their male partners, ages 15 or older; and health providers delivering the intervention, ages 18 and above, who are working with this population.

Inclusion Criteria:Inclusion criteria AGYW participants:Age 15-24 yearsFemale genderCurrently in a sexual relationship with a male partner for at least 1 monthVulnerable 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 wardWilling and able to attend support clubs for over 6 monthsWilling and able to provide adequate contact information for retentionFluent 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 olderMaleFluent 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 olderHave 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 monthsAny 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