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

NCT05599581 | Active Not Recruiting DMC

• 1 other identifier: R01MH12567
• Study Type: interventional
• Target: 1,562
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

IPV; HIV; PrEP

Keywords

Adolescent Girls and Young Women (AGYW); Human Immunodeficiency Virus (HIV); Intimate Partner Violence (IPV); Kenya; Pre-exposure prophylaxis (PrEP)

Outcome Measures

Primary Outcomes (2)

• Effective PrEP use (biomarker assessment)

  Percent of all study participants with biomarker tenofovir-diphosphate levels indicating consistent PrEP use (≥4 doses per week) for the past 2 months measured as concentrations in dried blood spots. Represents a composite outcome of PrEP initiation, persistence, and high execution to capture these steps in the HIV prevention continuum.

  6-month follow-up

• Effective PrEP use (biomarker assessment)

  Percent of all study participants with biomarker tenofovir-diphosphate levels indicating consistent PrEP use (≥4 doses per week) for the past 2 months measured as concentrations in dried blood spots. Represents a composite outcome of PrEP initiation, persistence, and high execution to capture these steps in the HIV prevention continuum.

  12-month follow-up

Secondary Outcomes (9)

• IPV prevalence

  3-month follow-up

• IPV prevalence

  6-month follow-up

• IPV prevalence

  12-month follow-up

• IPV severity

  3-month follow-up

• IPV severity

  6-month follow-up

Study Arms (2)

Tu'Washindi intervention plus usual HIV prevention services

EXPERIMENTAL

Participants in the intervention wards will receive the Tu'Washindi intervention plus access to evidence-based HIV prevention services offered throughout the county. These include PrEP delivery through the Ministry of Health, which is accessible to all AGYW.

Behavioral: Tu'Washindi

Standard of care HIV (Usual) prevention services only

NO INTERVENTION

Participants in the non-intervention (control) wards will have access to evidence-based standard of care HIV prevention services offered throughout the county. These include PrEP delivery through the Ministry of Health facilities, which is accessible to all AGYW.

Interventions

Tu'Washindi BEHAVIORAL

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.

Tu'Washindi intervention plus usual HIV prevention services

Eligibility Criteria

• Age: 15 Years - 24 Years
• Gender Eligibility Details: Females
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• RTI International: lead
• Impact Research & Development Organization: collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (2)

Impact Research and Development Organization (IRDO)

Kisumu, Kenya

Location

RTI International Africa Regional Office

Nairobi, Kenya

Location

Related Publications (1)

• Roberts ST, Minnis AM, Napierala S, Montgomery ET, Digolo L, Cottrell ML, Browne EN, Ndirangu J, Boke J, Agot K. Evaluation of the Tu'Washindi Na PrEP Intervention to Reduce Gender-Based Violence and Increase Preexposure Prophylaxis Uptake and Adherence Among Kenyan Adolescent Girls and Young Women: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2025 Apr 1;14:e55931. doi: 10.2196/55931.

  PMID: 40168655 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster-randomized controlled trial

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: October 31, 2022
• Study Start: September 29, 2022
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KE (2)