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Studies

Interventional Active not recruiting

NCT07132905 on ClinicalTrials.gov

Mpata Yathu Trial for Young Women in Zambia

Official title: Randomized Pilot Trial of Church-Based Problem-Solving Therapy for Adolescent Girls and Young Women With a History of Gender-Based Violence in Zambia

  • Sponsor: University of California, San Francisco
  • Collaborators: University of California, Los Angeles
  • Enrollment: 180 (Estimated)
  • Study start: 2025-11-19 (Actual)
  • Primary completion: 2026-09-30 (Estimated)
  • Study completion: 2026-10-31 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: This is a two-arm, parallel assignment randomized controlled trial evaluating the effectiveness and implementation of Mpata Yathu, a church-based, lay counselor-delivered problem-solving therapy intervention for adolescent girls and young women (AGYW) in Zambia with a history of gender-based violence. Participants are randomized 1:1 to either an immediate intervention group (receiving six weekly PST sessions from baseline to 3 months) or a waitlist control group (receiving usual care from 0-3 months and the same intervention from 3-6 months). All participants are assessed at baseline, 3 months, and 6 months. The primary outcome is change in common mental disorder symptoms at 3 months. Implementation outcomes include feasibility, acceptability, and fidelity.
  • Masking: Single (Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief Summary

This randomized controlled trial evaluates Mpata Yathu ("Our Space"), a trauma-informed, church-based counseling intervention for adolescent girls and young women in Lusaka, Zambia who have experienced gender-based violence and are living with or at risk for HIV. The intervention is delivered by lay counselors who provide individual problem-solving therapy and referrals for mental health, HIV, and GBV-related services. Participants are assigned to receive counseling immediately or after a three-month waitlist period. The study examines mental health, HIV-related outcomes, and the feasibility, acceptability, and fidelity of delivering this community-based intervention.

Conditions

  • HIV
  • Common Mental Health Problems
  • PTSD - Post Traumatic Stress Disorder
  • Depression Disorder
  • Anxiety

Intervention / Treatment

  • Behavioral: Mpata Yathu ("Our Space")

Primary Outcome Measures

  • Change in symptoms of common mental disorders (CMDs) as measured by the Shona Symptom Questionnaire (SSQ-14) (Baseline and 3-month follow-up)
    The primary outcome is change in symptoms of common mental disorders (CMDs), measured using the Shona Symptom Questionnaire (SSQ-14), a 14-item screening tool used in Friendship Bench studies. Each item is scored as 0 or 1, with a total score range of 0-14. Higher scores reflect greater symptom severity. The primary analysis will compare mean SSQ-14 scores between the intervention and waitlist control arms at the 3-month follow-up, prior to the waitlist group receiving the intervention. SSQ-14 will also be measured at 6 months to assess within-group changes, but this is not part of the primary between-group analysis.

Countries

Zambia

Locations and Investigators

  • Not applicable (multi-site study), Lusaka, Zambia
  • Not disclosed for privacy reasons, Lusaka, Zambia

Study Officials