[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570090":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":41,"responsibleParty":88,"collaborators":90,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":25,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":25,"enrollmentInfo":103,"targetDuration":25,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":25,"overallStatus":61,"whyStopped":25,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"University of North Carolina, Chapel Hill","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Enhanced Friendship Bench","EXPERIMENTAL","Friendship Bench problem-solving therapy, social support sessions and home visits during the 3rd trimester as well as postpartum.",[13],"Behavioral: Enhanced Friendship Bench",{"label":15,"type":16,"description":17,"interventionNames":18},"Enhanced usual care","ACTIVE_COMPARATOR","Continue with usual outpatient care, enhanced to provide a mental health evaluation; brief supportive counseling; information, education, and support on common mental disorders; and (if indicated) facilitation of referral for further follow-up at a mental health clinic or psychiatric unit.",[19],"Behavioral: Enhanced usual care",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Friendship Bench problem-solving therapy involving 4 prenatal and 2 postnatal counseling sessions, enhanced for HIV care engagement with 2 social support building sessions and monthly home visits for ART delivery and counseling during the 3rd trimester and the first 3 months postpartum.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Usual care for mental health in public facilities in Malawi includes options for basic supportive counseling by a primary provider or nurse, medication management by the primary provider (amitriptyline is the one antidepressant typically available at primary health centers and is rarely prescribed for depression), referral to the clinic psychiatric nurse or mental health clinic, or in more severe cases referral to the psychiatric units at tertiary care hospitals. For the proposed study, usual care will be enhanced to provide a mental health evaluation; brief supportive counseling; information, education, and support on common mental disorders; and (if indicated) facilitation of referral for further follow-up at a mental health clinic or psychiatric unit.",[15],[30],{"name":31,"affiliation":5,"role":32},"Brian Pence, PhD, MPH","PRINCIPAL_INVESTIGATOR",[34,38],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},"CONTACT","1-919-966-7446","bpence@unc.edu",{"name":39,"role":35,"phone":25,"phoneExt":25,"email":40},"Angela Bengtson, PhD, MA","angelabengtson@emory.edu",[42,59,67,74,81],{"facility":43,"status":44,"city":45,"state":25,"zip":25,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Area 18 Health Center","NOT_YET_RECRUITING","Lilongwe","Malawi","MW",{"type":49,"coordinates":50},"Point",[51,52],33.78725,-13.96692,{"lat":52,"lon":51},[55],{"name":56,"role":35,"phone":57,"phoneExt":25,"email":58},"Steve Mphonda","265-1755056","smphonda@unclilongwe.org",{"facility":60,"status":61,"city":45,"state":25,"zip":25,"country":46,"countryCode":47,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},"Area 25 Health Center","RECRUITING",{"type":49,"coordinates":63},[51,52],{"lat":52,"lon":51},[66],{"name":56,"role":35,"phone":57,"phoneExt":25,"email":58},{"facility":68,"status":61,"city":45,"state":25,"zip":25,"country":46,"countryCode":47,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},"Bwaila Hospital",{"type":49,"coordinates":70},[51,52],{"lat":52,"lon":51},[73],{"name":56,"role":35,"phone":57,"phoneExt":25,"email":58},{"facility":75,"status":61,"city":45,"state":25,"zip":25,"country":46,"countryCode":47,"cosmosGeoPoint":76,"geoPoint":78,"contacts":79},"Kawale Health Center",{"type":49,"coordinates":77},[51,52],{"lat":52,"lon":51},[80],{"name":56,"role":35,"phone":57,"phoneExt":25,"email":58},{"facility":82,"status":61,"city":45,"state":25,"zip":25,"country":46,"countryCode":47,"cosmosGeoPoint":83,"geoPoint":85,"contacts":86},"Likuni Mission Hosptial",{"type":49,"coordinates":84},[51,52],{"lat":52,"lon":51},[87],{"name":56,"role":35,"phone":57,"phoneExt":25,"email":58},{"type":89,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[91],{"name":92,"class":93},"National Institute of Mental Health (NIMH)","NIH","100570090","enhanced-problem-solving-therapy-and-hiv-engagement-support-to-improve-perinatal-mental-health--hiv-outcomes-in-malawi-100570090",false,"NCT06702722","Enhanced Problem-solving Therapy and HIV Engagement Support to Improve Perinatal Mental Health & HIV Outcomes in Malawi","Enhanced Problem-solving Therapy and HIV Engagement Support to Improve Perinatal Mental Health and HIV Outcomes in Malawi: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Presenting for antenatal care at one of our 5 recruitment sites\n* ≥ 18 years of age\n* ≤ 34 weeks gestation\n* HIV-positive, based on medical records\n* Initiating, re-initiating, or on established ART during index pregnancy\n* Elevated depressive symptoms as indicated by a EPDS score ≥10. The EPDS is widely used to assess perinatal mood disorders that has been validated in perinatal populations in Malawi with this cut point to identify probable perinatal depression\n\nExclusion Criteria:\n\n* Suicidal ideation evaluated as acute risk.\n* Other health concerns requiring emergent response.","FEMALE","18 Years",{"count":104,"type":105},400,"ESTIMATED","INTERVENTIONAL",[108],"NA","The main objective of the proposed study is to evaluate the effectiveness of the Enhanced Friendship Bench intervention to improve perinatal depression, HIV care engagement, and infant health outcomes among pregnant women with HIV and depression in Malawi.",[111,112,113],"HIV","Depression","Depression, Postpartum","2026-04-28",{"date":116,"type":117},"2026-04-29","ACTUAL",{"date":119,"type":117},"2025-02-26",{"date":121,"type":105},"2028-06",{"name":5,"class":6},5]