HIVMYTNCT07132905
Mpata Yathu Trial for Young Women in Zambia
A study testing Mpata Yathu ("Our Space") in people with HIV and Common Mental Health Problems, run by University of California, San Francisco at 2 sites in Zambia.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 24 years, women only
- Conditions the study is for
- HIV, Common Mental Health Problems, PTSD - Post Traumatic Stress Disorder
- What is being tested?
- Mpata Yathu ("Our Space")
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesZambia
- Study dates
- 19 Nov 2025to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
Zambia2 sites
Not applicable (multi-site study)
Lusaka
Not disclosed for privacy reasons
Lusaka
About this study
Official 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
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.
Read the 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.
- Conditions
- HIV, Common Mental Health Problems, PTSD - Post Traumatic Stress Disorder, Depression Disorder, Anxiety
- Being tested
- Mpata Yathu ("Our Space")
- Keywords
- Gender-based violence, Problem-solving therapy, Adolescent girls and young women, Zambia, Lay counselors, Mental health, HIV treatment engagement, HIV prevention
- Medical subject headings
- Combat Disorders, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mpata Yathu ("Our Space")Behavioural
Also called Church-Based Problem-Solving Therapy, Lay counselor-delivered Problem-Solving Therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Mpata Yathu Intervention | Experimental | 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. Receives: Behavioral: Mpata Yathu ("Our Space") |
| Waitlist Control - Delayed Mpata Yathu Intervention | Experimental | 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). Receives: Behavioral: Mpata Yathu ("Our Space") |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 3-month follow-up
Secondary outcomes (3)
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.
Measured: Baseline, 3-month, and 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.
Measured: Baseline, 3-month, and 6-month follow-up
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.
Measured: Baseline, 3-month, and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start19 Nov 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm, parallel assignment randomized controlled trial evaluating the effectiveness and implementation of Mpata Yathu, a church-based, lay counselor-delivered problem-solving therapy intervention for adolescent girls and young women (AGYW) in Zambia with a history of gender-based violence. Participants are randomized 1:1 to either an immediate intervention group (receiving six weekly PST sessions from baseline to 3 months) or a waitlist control group (receiving usual care from 0-3 months and the same intervention from 3-6 months). All participants are assessed at baseline, 3 months, and 6 months. The primary outcome is change in common mental disorder symptoms at 3 months. Implementation outcomes include feasibility, acceptability, and fidelity.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Charisse V Ahmed, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132905
- Sponsor's protocol ID
- IRB-23-1685-AM-005
- Other IDs
- UCLA-CDU CFAR grant AI152501
- Acronym
- MYT
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
White SJ, Sin J, Sweeney A, Salisbury T, Wahlich C, Montesinos Guevara CM, Gillard S, Brett E, Allwright L, Iqbal N, Khan A, Perot C, Marks J, Mantovani N. Global Prevalence and Mental Health Outcomes of Intimate Partner Violence Among Women: A Systematic Review and Meta-Analysis. Trauma Violence Abuse. 2024 Jan;25(1):494-511. doi: 10.1177/15248380231155529. Epub 2023 Feb 24.
PubMed 36825800Stein C, Flor LS, Gil GF, Khalil M, Herbert M, Aravkin AY, Arrieta A, Baeza de Robba MJ, Bustreo F, Cagney J, Calderon-Anyosa RJC, Carr S, Chandan JK, Chandan JS, Coll CVN, de Andrade FMD, de Andrade GN, Debure AN, DeGraw E, Hammond B, Hay SI, Knaul FM, Lim RQH, McLaughlin SA, Metheny N, Minhas S, Mohr JK, Mullany EC, Murray CJL, O'Connell EM, Patwardhan V, Reinach S, Scott D, Spencer CN, Sorensen RJD, Stockl H, Twalibu A, Valikhanova A, Vasconcelos N, Zheng P, Gakidou E. The health effects associated with physical, sexual and psychological gender-based violence against men and women: a Burden of Proof study. Nat Hum Behav. 2025 Jun;9(6):1201-1216. doi: 10.1038/s41562-025-02144-2. Epub 2025 Apr 10.
PubMed 40210704Kuchukhidze S, Panagiotoglou D, Boily MC, Diabate S, Eaton JW, Mbofana F, Sardinha L, Schrubbe L, Stockl H, Wanyenze RK, Maheu-Giroux M. The effects of intimate partner violence on women's risk of HIV acquisition and engagement in the HIV treatment and care cascade: a pooled analysis of nationally representative surveys in sub-Saharan Africa. Lancet HIV. 2023 Feb;10(2):e107-e117. doi: 10.1016/S2352-3018(22)00305-8. Epub 2022 Dec 1.
PubMed 36463914Ahmed CV, Thornicroft M, Chileshe K, Ntebeka BM, Dovel K, Bogart LM, Chavez NR, Bwalya FT, Brooks MJ, Swendeman D. Church-based problem-solving therapy for adolescent girls and young women with a history of gender-based violence in Zambia: study protocol for a hybrid type 1 randomized controlled trial. Trials. 2026 Apr 10;27(1):370. doi: 10.1186/s13063-026-09625-3.
PubMed 41957660Means AR, Kemp CG, Gwayi-Chore MC, Gimbel S, Soi C, Sherr K, Wagenaar BH, Wasserheit JN, Weiner BJ. Evaluating and optimizing the consolidated framework for implementation research (CFIR) for use in low- and middle-income countries: a systematic review. Implement Sci. 2020 Mar 12;15(1):17. doi: 10.1186/s13012-020-0977-0.
PubMed 32164692Dworkin ER, Weaver TL. The impact of sociocultural contexts on mental health following sexual violence: A conceptual model. Psychol Violence. 2021 Sep;11(5):476-487. doi: 10.1037/vio0000350.
PubMed 34631201Li Y, Marshall CM, Rees HC, Nunez A, Ezeanolue EE, Ehiri JE. Intimate partner violence and HIV infection among women: a systematic review and meta-analysis. J Int AIDS Soc. 2014 Feb 13;17(1):18845. doi: 10.7448/IAS.17.1.18845. eCollection 2014.
PubMed 24560342Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
PubMed 19664226Chibanda D, Mesu P, Kajawu L, Cowan F, Araya R, Abas MA. Problem-solving therapy for depression and common mental disorders in Zimbabwe: piloting a task-shifting primary mental health care intervention in a population with a high prevalence of people living with HIV. BMC Public Health. 2011 Oct 26;11:828. doi: 10.1186/1471-2458-11-828.
PubMed 22029430Maddoux J, Symes L, McFarlane J, Koci A, Gilroy H, Fredland N. Problem-solving and mental health outcomes of women and children in the wake of intimate partner violence. J Environ Public Health. 2014;2014:708198. doi: 10.1155/2014/708198. Epub 2014 Nov 11.
PubMed 25435885Devries KM, Mak JY, Bacchus LJ, Child JC, Falder G, Petzold M, Astbury J, Watts CH. Intimate partner violence and incident depressive symptoms and suicide attempts: a systematic review of longitudinal studies. PLoS Med. 2013;10(5):e1001439. doi: 10.1371/journal.pmed.1001439. Epub 2013 May 7.
PubMed 23671407Conroy AA, Jain JP, Sheira L, Frongillo EA, Neilands TB, Cohen MH, Wilson TE, Chandran A, Adimora AA, Kassaye S, Sheth AN, Fischl MA, Adedimeji A, Turan JM, Tien PC, Weiser SD. Mental Health Mediates the Association Between Gender-Based Violence and HIV Treatment Engagement in US Women. J Acquir Immune Defic Syndr. 2022 Feb 1;89(2):151-158. doi: 10.1097/QAI.0000000000002848.
PubMed 34723926Leddy AM, Weiss E, Yam E, Pulerwitz J. Gender-based violence and engagement in biomedical HIV prevention, care and treatment: a scoping review. BMC Public Health. 2019 Jul 8;19(1):897. doi: 10.1186/s12889-019-7192-4.
PubMed 31286914Cabral A, M Baeten J, Ngure K, Velloza J, Odoyo J, E Haberer J, Celum C, Muwonge T, Asiimwe S, Heffron R; Partners Demonstration Project Team. Intimate Partner Violence and Self-Reported Pre-exposure Prophylaxis Interruptions Among HIV-Negative Partners in HIV Serodiscordant Couples in Kenya and Uganda. J Acquir Immune Defic Syndr. 2018 Feb 1;77(2):154-159. doi: 10.1097/QAI.0000000000001574.
PubMed 29076883Cluver L, Meinck F, Toska E, Orkin FM, Hodes R, Sherr L. Multitype violence exposures and adolescent antiretroviral nonadherence in South Africa. AIDS. 2018 May 15;32(8):975-983. doi: 10.1097/QAD.0000000000001795.
PubMed 29547438
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07132905
- Acronym / sponsor ID
- MYT / IRB-23-1685-AM-005
- Conditions
- HIV, Common Mental Health Problems, PTSD - Post Traumatic Stress Disorder, Depression Disorder, Anxiety
- Keywords
- Gender-based violence, Problem-solving therapy, Adolescent girls and young women, Zambia, Lay counselors, Mental health, HIV treatment engagement, HIV prevention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a two-arm, parallel assignment randomized controlled trial evaluating the effectiveness and implementation of Mpata Yathu, a church-based, lay counselor-delivered problem-solving therapy intervention for adolescent girls and young women (AGYW) in Zambia with a history of gender-based violence. Participants are randomized 1:1 to either an immediate intervention group (receiving six weekly PST sessions from baseline to 3 months) or a waitlist control group (receiving usual care from 0-3 months and the same intervention from 3-6 months). All participants are assessed at baseline, 3 months, and 6 months. The primary outcome is change in common mental disorder symptoms at 3 months. Implementation outcomes include feasibility, acceptability, and fidelity.
| Arm | Type | Receives |
|---|---|---|
| Immediate Mpata Yathu Intervention | Experimental | Behavioral: Mpata Yathu ("Our Space")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. |
| Waitlist Control - Delayed Mpata Yathu Intervention | Experimental | Behavioral: Mpata Yathu ("Our Space")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). |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mpata Yathu ("Our Space")Also: Church-Based Problem-Solving Therapy, Lay counselor-delivered Problem-Solving TherapyMpata 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. | Behavioural | Immediate Mpata Yathu Intervention, Waitlist Control - Delayed Mpata Yathu Intervention |
Primary outcome
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.
3 secondary outcomes
Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: 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
Change in PTSD symptoms as measured by the Child PTSD Symptom Scale (CPSS)
Time frame: Baseline, 3-month, and 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background: PubMed 36825800White SJ, Sin J, Sweeney A, Salisbury T, Wahlich C, Montesinos Guevara CM, Gillard S, Brett E, Allwright L, Iqbal N, Khan A, Perot C, Marks J, Mantovani N. Global Prevalence and Mental Health Outcomes of Intimate Partner Violence Among Women: A Systematic Review and Meta-Analysis. Trauma Violence Abuse. 2024 Jan;25(1):494-511. doi: 10.1177/15248380231155529. Epub 2023 Feb 24.
- Background: PubMed 40210704Stein C, Flor LS, Gil GF, Khalil M, Herbert M, Aravkin AY, Arrieta A, Baeza de Robba MJ, Bustreo F, Cagney J, Calderon-Anyosa RJC, Carr S, Chandan JK, Chandan JS, Coll CVN, de Andrade FMD, de Andrade GN, Debure AN, DeGraw E, Hammond B, Hay SI, Knaul FM, Lim RQH, McLaughlin SA, Metheny N, Minhas S, Mohr JK, Mullany EC, Murray CJL, O'Connell EM, Patwardhan V, Reinach S, Scott D, Spencer CN, Sorensen RJD, Stockl H, Twalibu A, Valikhanova A, Vasconcelos N, Zheng P, Gakidou E. The health effects associated with physical, sexual and psychological gender-based violence against men and women: a Burden of Proof study. Nat Hum Behav. 2025 Jun;9(6):1201-1216. doi: 10.1038/s41562-025-02144-2. Epub 2025 Apr 10.
- Background: PubMed 36463914Kuchukhidze S, Panagiotoglou D, Boily MC, Diabate S, Eaton JW, Mbofana F, Sardinha L, Schrubbe L, Stockl H, Wanyenze RK, Maheu-Giroux M. The effects of intimate partner violence on women's risk of HIV acquisition and engagement in the HIV treatment and care cascade: a pooled analysis of nationally representative surveys in sub-Saharan Africa. Lancet HIV. 2023 Feb;10(2):e107-e117. doi: 10.1016/S2352-3018(22)00305-8. Epub 2022 Dec 1.
- Background: PubMed 41957660Ahmed CV, Thornicroft M, Chileshe K, Ntebeka BM, Dovel K, Bogart LM, Chavez NR, Bwalya FT, Brooks MJ, Swendeman D. Church-based problem-solving therapy for adolescent girls and young women with a history of gender-based violence in Zambia: study protocol for a hybrid type 1 randomized controlled trial. Trials. 2026 Apr 10;27(1):370. doi: 10.1186/s13063-026-09625-3.
- Background: PubMed 32164692Means AR, Kemp CG, Gwayi-Chore MC, Gimbel S, Soi C, Sherr K, Wagenaar BH, Wasserheit JN, Weiner BJ. Evaluating and optimizing the consolidated framework for implementation research (CFIR) for use in low- and middle-income countries: a systematic review. Implement Sci. 2020 Mar 12;15(1):17. doi: 10.1186/s13012-020-0977-0.
- Background: PubMed 34631201Dworkin ER, Weaver TL. The impact of sociocultural contexts on mental health following sexual violence: A conceptual model. Psychol Violence. 2021 Sep;11(5):476-487. doi: 10.1037/vio0000350.
- Background: PubMed 24560342Li Y, Marshall CM, Rees HC, Nunez A, Ezeanolue EE, Ehiri JE. Intimate partner violence and HIV infection among women: a systematic review and meta-analysis. J Int AIDS Soc. 2014 Feb 13;17(1):18845. doi: 10.7448/IAS.17.1.18845. eCollection 2014.
- Background: PubMed 19664226Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
- Background: PubMed 22029430Chibanda D, Mesu P, Kajawu L, Cowan F, Araya R, Abas MA. Problem-solving therapy for depression and common mental disorders in Zimbabwe: piloting a task-shifting primary mental health care intervention in a population with a high prevalence of people living with HIV. BMC Public Health. 2011 Oct 26;11:828. doi: 10.1186/1471-2458-11-828.
- Background: PubMed 25435885Maddoux J, Symes L, McFarlane J, Koci A, Gilroy H, Fredland N. Problem-solving and mental health outcomes of women and children in the wake of intimate partner violence. J Environ Public Health. 2014;2014:708198. doi: 10.1155/2014/708198. Epub 2014 Nov 11.
- Background: PubMed 23671407Devries KM, Mak JY, Bacchus LJ, Child JC, Falder G, Petzold M, Astbury J, Watts CH. Intimate partner violence and incident depressive symptoms and suicide attempts: a systematic review of longitudinal studies. PLoS Med. 2013;10(5):e1001439. doi: 10.1371/journal.pmed.1001439. Epub 2013 May 7.
- Background: PubMed 34723926Conroy AA, Jain JP, Sheira L, Frongillo EA, Neilands TB, Cohen MH, Wilson TE, Chandran A, Adimora AA, Kassaye S, Sheth AN, Fischl MA, Adedimeji A, Turan JM, Tien PC, Weiser SD. Mental Health Mediates the Association Between Gender-Based Violence and HIV Treatment Engagement in US Women. J Acquir Immune Defic Syndr. 2022 Feb 1;89(2):151-158. doi: 10.1097/QAI.0000000000002848.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charisse V Ahmed, PhD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mpata Yathu ("Our Space") in people with HIV and Common Mental Health Problems, run by University of California, San Francisco at 2 sites in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07132905, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.