About this trial
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. Immediate Intervention Group - Receives the Mpata Yathu intervention between baseline and 3-month follow-up 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
A total of 180 young women (90 per group) will participate in the trial. To be eligible, participants must be between the ages of 15 and 24, reside in the Matero or Chawama area, report lifetime GBV exposure, and show moderate depressive symptoms or symptoms of common mental disorders (CMDs). They must also be living with HIV or report behaviors that place them at risk for HIV.
The primary outcome is symptoms of CMDs, assessed using the Shona Symptom Questionnaire (SSQ-14). Secondary outcomes include depression, anxiety, and PTSD symptoms, as well as HIV-related outcomes such as clinic attendance, antiretroviral therapy (ART) adherence, and prevention behaviors such as condom use or PrEP readiness. The study will also measure feasibility, acceptability, and fidelity of the intervention.
Data will be collected through surveys at baseline, 3 months, and 6 months. The research team will also monitor how the intervention is implemented, how participants respond to counseling, and whether counselors follow the therapy protocol. Participants will receive a small stipend for their time and transport at each counseling session and follow-up visit.
This study is designed to test whether a trauma-informed, church-based mental health intervention can improve psychological well-being and HIV engagement among young women who are often underserved in traditional healthcare systems. If successful, this model could be expanded to other churches or schools in Zambia and similar settings. The results will inform future large-scale evaluations and could help shape new strategies for addressing GBV, mental health, and HIV among youth in sub-Saharan Africa.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Mpata Yathu ("Our Space")
BehavioralMpata 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
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.
Change in anxiety symptoms as measured by the Generalized Anxiety Disorder-7 (GAD-7) scale
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.
Change in PTSD symptoms as measured by the Child PTSD Symptom Scale (CPSS)
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
HIV treatment engagement among participants living with HIV
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.
HIV prevention readiness and behaviors among participants at risk for HIV
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.
Attitudes toward gender-based violence (GBV) and recent GBV experiences
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.
Change in coping self-efficacy as measured by the Coping Self-Efficacy Scale (CSE)
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.
Sponsors and contacts
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University of California, San Francisco
Lead sponsor
University of California, Los Angeles
Collaborator
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