Mpata Yathu Trial for Young Women in Zambia

NCT07132905 | Not Yet Recruiting

• 2 other identifiers: IRB-23-1685-AM-005UCLA-CDU CFAR grant AI152501
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to improve mental health and HIV-related outcomes among adolescent girls and young women (AGYW) in Zambia who have experienced gender-based violence (GBV). GBV includes physical, sexual, or emotional violence from partners or others and is known to increase the risk of depression, anxiety, post-traumatic stress, and HIV infection. In Zambia, access to mental health services is limited, especially for young women in low-resource communities. This study tests a counseling program called Mpata Yathu, which means "Our Space" in Chinyanja, designed to provide psychological support and improve well-being for young women who have faced violence and may be living with or at risk for HIV. Mpata Yathu is a culturally adapted version of the Friendship Bench, a lay counselor-delivered mental health intervention originally developed in Zimbabwe. In this adapted version, trained community lay counselors will deliver six individual problem-solving therapy (PST) sessions over a three-month period. Sessions will be delivered in private spaces within local Catholic churches in the Matero and Chawama areas of Lusaka, Zambia. Counseling sessions will also include referral options for participants who may need further support related to HIV care, GBV, or mental health concerns. The study is a two-arm randomized controlled trial. Participants will be randomly assigned to either:

1. 1.Immediate Intervention Group - Receives the Mpata Yathu intervention between baseline and 3-month follow-up
2. 2.Waitlist Control Group - Receives usual care for the first 3 months and then receives the Mpata Yathu intervention between 3- and 6-month follow-up

Conditions

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

Keywords

Gender-based violence; Problem-solving therapy; Adolescent girls and young women; Zambia; Lay counselors; Mental health; HIV treatment engagement; HIV prevention

Outcome Measures

Primary Outcomes (1)

• Change in symptoms of common mental disorders (CMDs) as measured by the Shona Symptom Questionnaire (SSQ-14)

  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.

  Baseline and 3-month follow-up

Secondary Outcomes (3)

• Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)

  Baseline, 3-month, and 6-month follow-up

• Change in anxiety symptoms as measured by the Generalized Anxiety Disorder-7 (GAD-7) scale

  Baseline, 3-month, and 6-month follow-up

• Change in PTSD symptoms as measured by the Child PTSD Symptom Scale (CPSS)

  Baseline, 3-month, and 6-month follow-up

Other Outcomes (5)

• HIV treatment engagement among participants living with HIV

  Baseline, 3-month, and 6-month follow-up

• HIV prevention readiness and behaviors among participants at risk for HIV

  Baseline, 3-month, and 6-month follow-up

• Attitudes toward gender-based violence (GBV) and recent GBV experiences

  Baseline, 3-month, and 6-month follow-up

Study Arms (2)

Immediate Mpata Yathu Intervention

EXPERIMENTAL

Participants randomized to this arm will receive the Mpata Yathu intervention immediately after enrollment. Mpata Yathu is a church-based, lay counselor-delivered adaptation of the Friendship Bench problem-solving therapy model. The intervention includes six weekly individual counseling sessions focused on structured problem-solving techniques and delivered in private spaces within local Catholic churches in Lusaka, Zambia. Counseling is provided by trained lay counselors who are pastors, teachers, peer navigators, and other trusted community members. Sessions are trauma-informed and survivor-centered, with integrated referrals for mental health, HIV, or GBV-related support services as needed. Follow-up assessments occur at 3 and 6 months.

Behavioral: Mpata Yathu ("Our Space")

Waitlist Control - Delayed Mpata Yathu Intervention

EXPERIMENTAL

Participants in this arm will receive usual care during the first three months after enrollment and will then receive the Mpata Yathu intervention between Months 3 and 6. Mpata Yathu is a church-based, lay counselor-delivered problem-solving therapy adapted from the Friendship Bench model. It consists of six weekly individual counseling sessions, delivered in church settings by trained lay counselors using a trauma-informed, survivor-centered approach. Sessions include structured problem-solving and optional referrals for HIV, GBV, or mental health services. Follow-up assessments are conducted at 3 months (pre-intervention) and again at 6 months (post-intervention).

Behavioral: Mpata Yathu ("Our Space")

Interventions

Mpata Yathu ("Our Space") BEHAVIORAL

Mpata Yathu is a church-based, lay counselor-delivered psychological intervention adapted from the Friendship Bench problem-solving therapy (PST) model. Designed for adolescent girls and young women in Zambia with a history of gender-based violence and elevated mental health symptoms, the intervention includes six weekly individual PST sessions delivered in private spaces within Catholic churches. Lay counselors are trained in trauma-informed, survivor-centered care and offer optional referrals to mental health, HIV, or GBV-related services. Mpata Yathu maintains the core structure of Friendship Bench but was adapted through community-partnered participatory research to meet the sociocultural needs of Zambian youth.

Also known as: Church-Based Problem-Solving Therapy, Lay counselor-delivered Problem-Solving Therapy

Immediate Mpata Yathu Intervention; Waitlist Control - Delayed Mpata Yathu Intervention

Eligibility Criteria

• Age: 15 Years - 24 Years
• Gender Eligibility Details: This study is limited to individuals who self-identify as female. Eligible participants must be adolescent girls and young women aged 15 to 24 who identify as female, regardless of their assigned sex at birth. Individuals of other gender identities are not eligible for this study.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• To be eligible for enrollment in the RCT, participants must meet the following criteria:
• aged 15 to 24 years;
• Speak Nyanja, Bemba, and/or English fluently;
• Reside in the Matero or Chawama constituency area during the time of recruitment;
• Report lifetime exposure to GBV, as assessed by the following sections of the WHO Multi-country Study on Women's Health and Domestic Violence Against Women instrument:
• Section 7 (Physical Violence by Intimate Partner): Reports of being slapped, pushed, hit with a fist, kicked, dragged, choked, or threatened/attacked with a weapon by a husband or partner.
• Section 8 (Sexual Violence by Intimate Partner): Reports of being physically forced to have sex, having sex out of fear, or being forced to engage in degrading sexual acts by a husband or partner.
• Section 9 (Emotional Abuse by Intimate Partner): Reports of being insulted, belittled, intimidated, or threatened by a partner.
• Section 10 (Physical Violence by Non-Partner): Lifetime experiences of being beaten or physically mistreated by someone other than a partner since age 15.
• Section 11 (Sexual Violence by Non-Partner): Forced sex or sexual acts since age 15 by a non-partner, and childhood sexual abuse before age 15.
• Exhibit moderate depressive symptoms indicated by a score of 10-14 on the 9-item Patient Health Questionnaire (PHQ-9), or common mental disorder (CMD) symptoms (e.g., depression, anxiety) as indicated by a score of 9 or higher on the 14-item Shona Symptom Questionnaire (SSQ-14); and
• Be living with HIV or demonstrate HIV risk behaviors, as defined by validated items from the World AIDS Foundation survey,25 including unprotected sex, multiple sexual partners, coerced sex, or transactional sex.

You may not qualify if:

• Women will be excluded if they:
• Require emergency treatment for any crisis (mental, physical, emotional) at the time of screening
• Report severe symptoms of depression (score \> 14 on PHQ-9) or no to mild depression symptoms (PHQ-9 score \<10), and/or severe anxiety symptoms using the Generalized Anxiety Disorder 7-item scale or GAD-7 (score \>14 on GAD-7)
• Have intellectual or cognitive disabilities that limit their ability to complete the screening tools, interact with a lay counselor and/or provide informed consent; and/or
• Are considered in immediate danger (e.g., reoccurring physical violence) during time of the study.
• Are currently receiving formal mental health counseling or psychotherapy (to avoid duplication of care and potential confounding effects).

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

Not applicable (multi-site study)

Lusaka, Zambia

Location

Related Publications (18)

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MeSH Terms

Conditions

Combat Disorders; Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Charisse V Ahmed, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moomba M Thornicroft, MPH

CONTACT

+260 97 4218181; mcpals4life@gmail.com

Charisse V Ahmed, PhD

CONTACT

charisse.ahmed@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, participants and lay counselors delivering the intervention will not be blinded to study arm assignment. However, quantitative outcome assessors conducting follow-up assessments at 3 and 6 months will be blinded to participants' group assignment to reduce bias in data collection. These assessors will not participate in intervention delivery and will be trained to avoid accessing materials or communication that could reveal arm status. Unblinding will only occur in the event of an adverse event or safety concern requiring knowledge of the participant's group assignment for appropriate clinical referral or management.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 20, 2025
• Study Start: September 22, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: De-identified IPD and supporting materials will be made available beginning 12 months after primary publication. Data will remain accessible indefinitely, as long as the Principal Investigator and study team are able to maintain secure and ethical data sharing processes. Access will be granted upon review of data access requests and completion of required approvals and agreements.
• Access Criteria: Data will be available to researchers with a methodologically sound proposal, subject to approval by the Principal Investigator and study team. Requestors must submit a data access application outlining research aims and methods. Access will be granted through a secure data-sharing platform or encrypted transfer, contingent on ethical approvals and signed data use agreements. Data will be de-identified to protect participant confidentiality.

Locations

ZA (1)