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Active, not recruiting

NCT Number: NCT07132905

Mpata Yathu Trial for Young Women 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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

15 year–24 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Not applicable (multi-site study), Lusaka, Zambia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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).

Treatment and study plan

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.

Other names: Church-Based Problem-Solving Therapy, Lay counselor-delivered Problem-Solving Therapy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • University of California, Los Angeles

Registry information

Official study 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

Acronym: MYT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2025
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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