Mpata Yathu Trial for Young Women in Zambia (NCT07132905) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Mpata Yathu Trial for Young Women in Zambia
Zambia180 participantsStarted 2025-11-19
Plain-language summary
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.
Who can participate
Age range
15 Years – 24 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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:
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in symptoms of common mental disorders (CMDs) as measured by the Shona Symptom Questionnaire (SSQ-14)
. 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).