Church-based problem-solving therapy for adolescent girls and young women with a history of gender-based violence in Zambia: study protocol for a hybrid type 1 randomized controlled trial

Abstract

Background: Adolescent girls and young women (AGYW) in sub-Saharan Africa face a disproportionate burden of gender-based violence (GBV), HIV risk, and mental health challenges. Despite the demonstrated effectiveness of psychological interventions such as problem-solving therapy (PST), there is limited evidence on culturally adapted models for GBV-exposed AGYW that concurrently address HIV and mental health, particularly in settings with constrained mental health infrastructure.

Objective: This study outlines the protocol for a randomized controlled trial evaluating Mpata Yathu, a church-based adaptation of the Friendship Bench intervention, which delivers lay counselor-led PST to AGYW with a history of GBV in Lusaka, Zambia.

Methods: A hybrid implementation-effectiveness type 1 randomized controlled trial (intervention and waitlist control arms) will be conducted among 90 AGYW, aged 15 to 24, per arm with moderate depressive symptoms, lifetime GBV exposure, and HIV risk or diagnosis. The intervention comprises six individual PST sessions delivered over 3 months in church spaces. Implementation outcomes (feasibility, acceptability, fidelity), common mental disorder (CMD) symptoms (primary outcome), and exploratory outcomes (depression, anxiety, PTSD, HIV engagement, GBV attitudes, childhood adversity, coping self-efficacy) will be assessed at baseline, 3, and 6 months. The trial is powered to detect changes in CMD symptoms only. Mixed-methods data will inform feasibility, intervention refinement, and hypotheses regarding mental health as a mediator of HIV outcomes. Process evaluations will use the Consolidated Framework for Implementation Research (CFIR).

Conclusions: This trial will assess the potential of church-based PST to address the intersecting burdens of GBV, HIV, and mental health among AGYW in Zambia. Findings will offer insights into leveraging trusted community institutions (e.g., church and religious settings) for mental health and HIV care delivery in low-resource settings.

Trial registration: ClinicalTrials.gov NCT07132905. Prospectively registered on August 13, 2025.

Clinicaltrials: gov/study/NCT07132905.

Keywords: Adolescent girls and young women (AGYW); Church-based intervention; Gender-based violence (GBV); HIV prevention and treatment; Hybrid type 1 implementation-effectiveness trial; Implementation science; Lay counselors; Mental health; Problem-solving therapy (PST); Zambia.