[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pmtct\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pmtct":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100566756","prevention-of-mother-to-child-transmission-pmtct-among-women-experiencing-depression-in-malawi-100566756",false,"NCT06659315","Prevention of Mother-to-child Transmission (PMTCT) Among Women Experiencing Depression in Malawi","Addressing Perinatal Depression and PMTCT Adherence in Malawi: A Couple-Based Approach","Inclusion Criteria:\n\n* In a marriage or cohabitating union for at least 6 months.\n* One member of the couple is a woman in the second or third trimester of pregnancy who is living with HIV and screens positive for depression (\\>10 on the PHQ9).\n* Have revealed their HIV status to their partner if living with HIV\\>\n\nExclusion Criteria:\n\n* Fear their safety would be at risk.\n* Report incidents of severe intimate partner violence (IPV) in the past three months using the WHO IPV measure.","ALL","18 Years",{"count":19,"type":20},180,"ESTIMATED","INTERVENTIONAL",[23],"NA","Prevention of mother-to-child transmission (PMTCT) of HIV virtually eliminates transmission of HIV from mothers to their infants. Adherence to PMTCT (i.e., to antiretroviral therapy, infant prophylaxis, and exclusive breastfeeding) during pregnancy and the postpartum period is challenging, with evidence from sub-Saharan Africa (SSA) showing suboptimal adherence and persistent viremia among perinatal women. Perinatal depression (PD) is a major driver of women's poor adherence to PMTCT. Interventions that involve male partners to provide social and food\u002Feconomic support could be a promising approach for addressing PD and PMTCT, yet few interventions have intervened with couples to improve systems of support, communication, and other dyadic processes. The investigators propose to develop and test a couple-based approach to intervene on the mother's perinatal depressive symptoms and to strengthen the relationship and support system for partners to work together around depression to improve PMTCT adherence. The study will take place in antenatal and HIV care settings in Zomba, Malawi. The specific aims are: (1) to develop a couple-based intervention to target perinatal depression (PD) based on an evidence-based approach using problem-solving therapy (PST), augmented with content on couple communication and problem-solving skills; and (2) to assess the feasibility and acceptability (F\\&A) of the intervention via a pilot randomized controlled trial (RCT). Our short-term goal is the produce a couple-focused PST intervention that can be added to the global health toolkit for treating depression in perinatal women. Our long-term goal is to produce a high-impact and sustainable intervention leveraging the couple relationship that can be scaled-up to address depression, PMTCT adherence, and family health.",[26,27,28,29],"HIV Antiretroviral Therapy (ART) Adherence","Perinatal Mental Health","Depression During Pregnancy","PMTCT",[31,32,33,29,34],"Perinatal depression","Couples","Problem-solving","ART adherence","RECRUITING","2026-03-26",{"date":38,"type":39},"2026-03-30","ACTUAL",{"date":41,"type":39},"2025-11-11",{"date":43,"type":20},"2027-07-01",{"name":45,"class":46},"University of California, San Francisco","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":56,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":61,"conditions":62,"keywords":67,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":5},"100562583","optimizing-prevention-and-care-for-pregnant-and-postpartum-adolescent-girls-and-young-women-with-hiv-in-tanzania-100562583","NCT06605053","Optimizing Prevention and Care for Pregnant and Postpartum Adolescent Girls and Young Women With HIV in Tanzania","ENding HIV Transmission to Infants by Generating Evidence to Optimize Prevention and Care for Pregnant and Postpartum Adolescent Girls and Young Women With HIV in Tanzania (ENGAGE)","ENGAGE","Sub-study 1 (registry-based cohort analysis):\n\nInclusion Criteria:\n\n* Pregnant\u002Fpostpartum adolescent girls and young women (AGYW) with HIV aged 15-24 years, who started PMTCT services between January 1, 2018, and December 31, 2020.\n* Infants born to the included AGYW during this period.\n\nExclusion Criteria:\n\n* AGYW whose ART (Antiretroviral Therapy) status was not recorded.\n* Women who had not started ART.\n\nSub-study 2 (qualitative):\n\nInclusion Criteria:\n\n* AGYW living with HIV who are currently pregnant, previously pregnant\u002Fpostpartum, and never pregnant).\n* HCPs (Health Care Providers) at clinics providing PMTCT services.\n* Spouses\u002Fpartners\u002Fparents of AGYW and community stakeholders within the study setting.\n\nExclusion criteria\n\n\\- Mentally or severely ill individuals unable to participate in the study activities.\n\nSub-study 3 (co-production)\n\nInclusion criteria:\n\n* AGYW, HCPs, spouses\u002Fpartners, parents, and community stakeholders who participated in the qualitative study II.\n* Research team members.\n\nExclusion criteria:\n\n\\- Mentally or severely ill individuals unable to participate in the study activities.\n\nSub-study 4 (cluster-randomized implementation trial)\n\nInclusion criteria:\n\n\\- Pregnant AGYW living with HIV (new, previously diagnosed, and transfers) receiving vertical HIV prevention services in routine healthcare between January 1, 2026, and June 30, 2026, and followed up for at least one year until June 30, 2027.\n\nExclusion criteria:\n\n* AGYW whose ART (Antiretroviral Therapy) status was not recorded.","FEMALE","15 Years",{"count":59,"type":20},222,[23],"The goal of this clinical trial is to find better ways to care for pregnant and postpartum adolescent girls and young women (AGYW) aged 15-24 years with HIV in Tanzania, and to prevent them from passing HIV to their babies. The main questions it aims to answer are:\n\n* How often do young pregnant women with HIV go to their health appointments and stay on their treatment up to two years after giving birth?\n* How many babies born to young women with HIV stay HIV-free for two years?\n* How soon do young women with HIV get pregnant again after giving birth, and what factors affect this?\n* What are the best ways to help young women with HIV stay in care and stay healthy during and after pregnancy?\n* What social and structural factors affect whether young pregnant women with HIV go to their health appointments and stay on their treatment?\n* How can we work with young women with HIV to create and test a package of interventions to improve their healthcare during and after pregnancy?\n* Can this package of interventions help young women with HIV stay in care and remain healthy during and after pregnancy?\n\nParticipants will:\n\n* Have their health data analyzed via health service records of all women who received HIV prevention services between 2018 and 2020, and were followed until 2023, across 559 health facilities in Tanzania.\n* Participate in qualitative interviews to share their experiences and challenges with staying in care.\n* Help to co-create a package of interventions to improve care.\n* Take part in a cluster-randomized trial to test these interventions. Researchers will compare the outcomes of the intervention package to see if they improve care engagement, retention, and health outcomes for AGYW with HIV during and after pregnancy.",[26,29,63,64,65,66],"Pregnancy","Retention in Care","HIV Viremia","Early Infant HIV Diagnosis",[68,69,70,29,71,72,73,74,75,76],"Adolescent girls and young women","HIV","Vertical transmission","Co-production","Co-design","Intervention","Tanzania","Sub-Saharan Africa","Retention in care","2025-06-27",{"date":79,"type":39},"2025-06-29",{"date":81,"type":39},"2024-10-07",{"date":83,"type":20},"2027-12",{"name":85,"class":46},"Karolinska Institutet"]