Mpata Yathu Trial for Young Women in Zambia (MYT)

August 7, 2026 updated by: University of California, San Francisco

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Adolescent girls and young women in Zambia experience intersecting risks related to gender-based violence (GBV), mental health concerns, and HIV. Exposure to physical, sexual, emotional, or controlling violence is associated with psychological distress and may also create barriers to HIV prevention, treatment engagement, medication adherence, and clinic attendance. Limited availability of specialized mental health providers creates a need for culturally relevant, community-delivered approaches that can expand access to psychological support.

Mpata Yathu is a culturally adapted, lay counselor-delivered problem-solving therapy intervention based on the Friendship Bench model originally developed in Zimbabwe. The intervention was adapted through community-partnered processes for adolescent girls and young women in Lusaka with experiences of GBV and HIV-related vulnerability. Adaptations include trauma-informed and survivor-centered counseling practices, training on responding to GBV-related concerns, participant choice of lay counselor when feasible, and structured referral pathways for mental health, HIV, and GBV services. The intervention does not replace clinical or emergency care; participants requiring services beyond the scope of lay counseling are referred to appropriate providers.

The study uses a hybrid type 1 implementation-effectiveness randomized controlled design. This design assesses preliminary intervention effects while also examining implementation in real-world community settings. Participants are randomly assigned in a 1:1 ratio, using permuted blocks stratified by HIV status, to the intervention or waitlist control conditions. Allocation is generated and concealed through REDCap after completion of baseline procedures. Because counseling participation is apparent to participants and lay counselors, masking is not possible for intervention delivery; however, follow-up outcome assessors remain unaware of study assignment when feasible.

Intervention participants are offered up to six individual problem-solving therapy sessions during the first three months after enrollment. Waitlist control participants receive available usual care during this period and are offered the same intervention after the 3-month assessment. Each counseling session lasts approximately 45-60 minutes. Although sessions are intended to occur weekly, participants may complete sessions within a three-month period to accommodate school, work, caregiving, mobility, illness, and other barriers to participation. Counseling is delivered in private spaces at participating churches in the Matero and Chawama areas of Lusaka.

Lay counselors receive training in problem-solving therapy, trauma-informed and survivor-centered care, research ethics, confidentiality, GBV response procedures, referral protocols, and recognition of concerns requiring escalation. Ongoing supervision and fidelity monitoring support consistent delivery of the intervention. Session completion, counselor adherence to intervention procedures, participant experiences, and contextual barriers and facilitators are documented throughout implementation.

Assessments occur at baseline and at 3- and 6-month follow-up. The three-month assessment serves as the primary comparison point between immediate-intervention and waitlist-control groups. By six months, both groups have been offered Mpata Yathu; analyses at this time focus on change over time and intervention implementation. Quantitative and qualitative process data are used to assess feasibility, acceptability, fidelity, retention, referral uptake, and factors influencing delivery within church-based settings. Findings will inform intervention refinement and the design of a future fully powered trial evaluating community-based mental health and HIV-support approaches for young women affected by GBV.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

To be eligible for enrollment in the RCT, participants must meet the following criteria:

  1. aged 15 to 24 years;
  2. Speak Nyanja, Bemba, and/or English fluently;
  3. Reside in the Matero or Chawama constituency area during the time of recruitment;

  4. 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.
  5. 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
  6. 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.

Exclusion Criteria:

Women will be excluded if they:

  1. Require emergency treatment for any crisis (mental, physical, emotional) at the time of screening
  2. 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)
  3. 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
  4. Are considered in immediate danger (e.g., reoccurring physical violence) during time of the study.
  5. Are currently receiving formal mental health counseling or psychotherapy (to avoid duplication of care and potential confounding effects).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Immediate Mpata Yathu Intervention
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")
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.
Other Names:
  • Church-Based Problem-Solving Therapy
  • Lay counselor-delivered Problem-Solving Therapy
Experimental: Waitlist Control - Delayed Mpata Yathu Intervention
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")
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.
Other Names:
  • Church-Based Problem-Solving Therapy
  • Lay counselor-delivered Problem-Solving Therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in symptoms of common mental disorders (CMDs) as measured by the Shona Symptom Questionnaire (SSQ-14)
Time Frame: 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.
Baseline and 3-month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Baseline, 3-month, and 6-month follow-up
Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire (PHQ-9), a widely used and validated screening tool for depression. Each item is scored from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 27. Higher scores indicate more severe depressive symptoms. Mean PHQ-9 scores will be compared between arms at 3-month follow-up, with additional within-group change explored at 6-month follow-up.
Baseline, 3-month, and 6-month follow-up
Change in anxiety symptoms as measured by the Generalized Anxiety Disorder-7 (GAD-7) scale
Time Frame: Baseline, 3-month, and 6-month follow-up
Anxiety symptoms will be measured using the 7-item GAD-7 scale. Each item is scored on a 0-3 scale, with a total possible score of 21. Higher scores reflect more severe anxiety symptoms. Mean scores will be compared across arms at 3-month follow-up and assessed for within-group change at 6 months.
Baseline, 3-month, and 6-month follow-up
Change in PTSD symptoms as measured by the Child PTSD Symptom Scale (CPSS)
Time Frame: Baseline, 3-month, and 6-month follow-up
PTSD symptoms will be measured using the Child PTSD Symptom Scale (CPSS), a 24-item self-report instrument designed to assess post-traumatic stress symptoms and related functional impairments in adolescents. The scale includes 17 items corresponding to DSM-IV PTSD symptom criteria and 7 items assessing functional impairment in areas such as school, family, and social life. Each symptom item is scored from 0 (not at all) to 3 (5 or more times a week), with a total symptom severity score ranging from 0 to 51. Scores will be compared between groups at 3-month follow-up, and within groups at 6-month follow-up.
Baseline, 3-month, and 6-month follow-up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HIV treatment engagement among participants living with HIV
Time Frame: Baseline, 3-month, and 6-month follow-up
Among participants living with HIV, treatment engagement will be assessed using self-reported clinic attendance and, where available, clinical data such as viral load, ART regimen, and pharmacy refills. Data will be collected at each follow-up to explore whether participation in Mpata Yathu is associated with improved treatment engagement. This outcome is exploratory and not powered for hypothesis testing.
Baseline, 3-month, and 6-month follow-up
HIV prevention readiness and behaviors among participants at risk for HIV
Time Frame: Baseline, 3-month, and 6-month follow-up
Among HIV-negative participants, HIV prevention readiness and behaviors will be assessed using survey questions on condom use, HIV testing, prevention self-efficacy, and PrEP awareness/readiness. Changes over time will be examined to explore potential effects of the Mpata Yathu intervention. This is an exploratory outcome.
Baseline, 3-month, and 6-month follow-up
Attitudes toward gender-based violence (GBV) and recent GBV experiences
Time Frame: Baseline, 3-month, and 6-month follow-up
Participants will complete validated measures assessing attitudes toward GBV, social norms, and recent experiences of emotional, physical, or sexual violence. These data will help explore whether Mpata Yathu influences GBV-related beliefs and exposures. This outcome is exploratory.
Baseline, 3-month, and 6-month follow-up
Change in coping self-efficacy as measured by the Coping Self-Efficacy Scale (CSE)
Time Frame: Baseline, 3-month, and 6-month follow-up
The CSE Scale assesses confidence in managing stress, emotions, and problem-solving. Items are scored 0-10, with higher scores indicating stronger coping ability. This exploratory outcome will be used to assess potential psychosocial changes resulting from the intervention.
Baseline, 3-month, and 6-month follow-up
Perceived social support as measured by the Oslo Social Support Scale (OSS-3)
Time Frame: Baseline, 3-month, and 6-month follow-up
The OSS-3 is a 3-item scale measuring the availability and perceived adequacy of social support. Scores range from 3 to 14. This outcome will be used to explore whether the Mpata Yathu intervention affects social support among participants.
Baseline, 3-month, and 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of California, Los Angeles

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Charisse V Ahmed, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 19, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-23-1685-AM-005
  • UCLA-CDU CFAR grant AI152501 (Other Grant/Funding Number: UCLA-CDU CFAR grant AI152501)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual-level quantitative data collected through participant surveys, including responses to validated mental health, HIV, GBV, and psychosocial measures, will be shared. No identifying information such as names, contact details, or GPS coordinates will be included. Audio recordings and qualitative interview transcripts will not be shared.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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