Fact CheckerSign in

NCT07132905Active, not recruiting

Mpata Yathu Trial for Young Women in Zambia

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

Source: ClinicalTrials.gov · Last updated 12 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
180 (estimated)
First submitted
13 Aug 2025
Start date
19 Nov 2025
Primary completion date
30 Sept 2026
Lead sponsor
University of California, San Francisco
Diseases
HIV
NCT number
NCT07132905

What you commit to

  • Study type: Interventional
  • Planned participants: 180
  • From 19 Nov 2025 to the primary completion date, 30 Sept 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Are currently receiving formal mental health counseling or psychotherapy (to avoid duplication of care and potential confounding effects).

Other illness

  • 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)

Other

  • Women will be excluded if they:
  • Require emergency treatment for any crisis (mental, physical, emotional) at the time of screening
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 15 years to 24 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Not disclosed for privacy reasons
Coordinator of this site? Confirm its status
LusakaZambiaUnknown status
Not applicable (multi-site study)
Coordinator of this site? Confirm its status
LusakaZambiaUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.