[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603160":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":27,"centralContacts":31,"locations":40,"responsibleParty":54,"collaborators":56,"id":59,"slug":36,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":36,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":82,"overallStatus":90,"whyStopped":36,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Behavioral: Mpata Yathu (\"Our Space\")",{"label":15,"type":10,"description":16,"interventionNames":17},"Waitlist Control - Delayed Mpata Yathu Intervention","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).",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"BEHAVIORAL","Mpata Yathu (\"Our Space\")","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.",[9,15],[25,26],"Church-Based Problem-Solving Therapy","Lay counselor-delivered Problem-Solving Therapy",[28],{"name":29,"affiliation":5,"role":30},"Charisse V Ahmed, PhD","PRINCIPAL_INVESTIGATOR",[32,38],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Moomba M Thornicroft, MPH","CONTACT","+260 97 4218181",null,"mcpals4life@gmail.com",{"name":29,"role":34,"phone":36,"phoneExt":36,"email":39},"charisse.ahmed@ucsf.edu",[41],{"facility":42,"status":36,"city":43,"state":36,"zip":36,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Not applicable (multi-site study)","Lusaka","Zambia","ZM",{"type":47,"coordinates":48},"Point",[49,50],28.28713,-15.40669,{"lat":50,"lon":49},[53],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},{"type":55,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[57],{"name":58,"class":6},"University of California, Los Angeles","100603160",false,"NCT07132905","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","MYT","Inclusion Criteria:\n\nTo be eligible for enrollment in the RCT, participants must meet the following criteria:\n\n1. aged 15 to 24 years;\n2. Speak Nyanja, Bemba, and\u002For English fluently;\n3. Reside in the Matero or Chawama constituency area during the time of recruitment;\n4. 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:\n\n   * Section 7 (Physical Violence by Intimate Partner): Reports of being slapped, pushed, hit with a fist, kicked, dragged, choked, or threatened\u002Fattacked with a weapon by a husband or partner.\n   * 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.\n   * Section 9 (Emotional Abuse by Intimate Partner): Reports of being insulted, belittled, intimidated, or threatened by a partner.\n   * Section 10 (Physical Violence by Non-Partner): Lifetime experiences of being beaten or physically mistreated by someone other than a partner since age 15.\n   * 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.\n5. 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\n6. 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.\n\nExclusion Criteria:\n\nWomen will be excluded if they:\n\n1. Require emergency treatment for any crisis (mental, physical, emotional) at the time of screening\n2. Report severe symptoms of depression (score \\> 14 on PHQ-9) or no to mild depression symptoms (PHQ-9 score \\\u003C10), and\u002For severe anxiety symptoms using the Generalized Anxiety Disorder 7-item scale or GAD-7 (score \\>14 on GAD-7)\n3. Have intellectual or cognitive disabilities that limit their ability to complete the screening tools, interact with a lay counselor and\u002For provide informed consent; and\u002For\n4. Are considered in immediate danger (e.g., reoccurring physical violence) during time of the study.\n5. Are currently receiving formal mental health counseling or psychotherapy (to avoid duplication of care and potential confounding effects).","FEMALE","15 Years","24 Years",{"count":70,"type":71},180,"ESTIMATED","INTERVENTIONAL",[74],"NA","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.\n\nMpata 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.\n\nThe study is a two-arm randomized controlled trial. Participants will be randomly assigned to either:\n\n1. Immediate Intervention Group - Receives the Mpata Yathu intervention between baseline and 3-month follow-up\n2. 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\n\nA 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.\n\nThe 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.\n\nData 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.\n\nThis 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.",[77,78,79,80,81],"HIV","Common Mental Health Problems","PTSD - Post Traumatic Stress Disorder","Depression Disorder","Anxiety",[83,84,85,44,86,87,88,89],"Gender-based violence","Problem-solving therapy","Adolescent girls and young women","Lay counselors","Mental health","HIV treatment engagement","HIV prevention","NOT_YET_RECRUITING","2025-08-13",{"date":93,"type":94},"2025-08-20","ACTUAL",{"date":96,"type":71},"2025-09-22",{"date":98,"type":71},"2026-06-30",{"name":5,"class":6},1]