[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533464":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":38,"locations":44,"responsibleParty":62,"collaborators":64,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":9,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":25,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":25,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TENDAI4PrEP","EXPERIMENTAL","TENDAI4PrEP problem-solving intervention will likely entail 4-5 sessions, inclusive of the dyadic session with a partner, with an optional postpartum booster session. The intervention will involve PrEP education and psychoeducation, Nzira Itsva (a culturally adapted Life Steps intervention), and problem-solving therapy.",[13],"Behavioral: TENDAI4PrEP",{"label":15,"type":16,"description":17,"interventionNames":18},"Enhanced Treatment as Usual (ETAU)","ACTIVE_COMPARATOR","Participants randomized to ETAU will receive care as usual, which is monthly visits to the ANC, plus a pamphlet of information that describes PrEP efficacy, safety during pregnancy\u002Fpostpartum, and PrEP availability at the ANC. Antenatal treatment as usual will also be enhanced at the clinic level through the provider-level training, which will be offered to all clinic staff in a nonrandomized design. ETAU participants will also be referred for psychological services at the hospital.",[19],"Other: Enhanced treatment as usual",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","An adapted problem-solving PrEP use intervention for HIV negative pregnant persons living with psychological distress, their partners, and antenatal care providers.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Enhanced treatment as usual","Includes monthly visits to the ANC plus a pamphlet of information that describes PrEP efficacy.\n\nsafety during pregnancy\u002Fpostpartum, and PrEP availability at the ANC.",[15],[31,35],{"name":32,"affiliation":33,"role":34},"Amelia M Stanton, PhD","Boston University","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":37,"role":34},"Walter Mangezi, MD","University of Zimbabwe",[39],{"name":40,"role":41,"phone":42,"phoneExt":25,"email":43},"Conall O'Cleirigh","CONTACT","617-643-0385","cocleirigh@mgh.harvard.edu",[45],{"facility":37,"status":46,"city":47,"state":25,"zip":25,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Harare","Zimbabwe","ZW",{"type":51,"coordinates":52},"Point",[53,54],31.05337,-17.82772,{"lat":54,"lon":53},[57,61],{"name":36,"role":41,"phone":58,"phoneExt":59,"email":60},"+263712606560","no ext","wmangezi@yahoo.co.uk",{"name":36,"role":34,"phone":25,"phoneExt":25,"email":25},{"type":34,"investigatorFullName":40,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Director of Behavioral Medicine \u002F Associate Professor",[65,66],{"name":37,"class":6},{"name":33,"class":6},"100533464","adaptation-of-an-intervention-addressing-barriers-to-prep-use-among-pregnant-women-in-zimbabwe-100533464",false,"NCT06226155","Adaptation of an Intervention Addressing Barriers to PrEP Use Among Pregnant Women in Zimbabwe","TENDAI4PrEP: Adaptation of a Problem-solving Intervention to Address Individual and Provider Level Barriers to PrEP Uptake and Adherence Among Pregnant Women in Zimbabwe","Inclusion Criteria:\n\nAcross all aims participants must be\n\n1. Pregnant\n2. Presenting at the Chitungwiza Central Hospital ANC\n3. Aged 15+\n4. Willing to provide informed consent or assent\n5. Have HIV negative status\n6. At risk for HIV acquisition (defined as having a male partner of unknown HIV status, suspicions of partner infidelity, reporting multiple partners, or history of STI and\u002For recent condomless sexual activity)\n7. Score \\>5 on the Shona Symptom Questionnaire\n\n   For the RCT, eligible participants must also be willing to\n8. Initiate PrEP prior to randomization\n9. Bring their pregnancy partner (if they are safe doing so).\n\nExclusion Criteria:\n\n1. Inability to provide informed consent\u002Fassent and\u002For complete procedures in Shona or English\n2. Current interfering untreated or unstable mental health condition that precludes functional involvement in the study (e.g., active psychosis, untreated bipolar disorder)","ALL","15 Years","55 Years",{"count":78,"type":79},132,"ESTIMATED","INTERVENTIONAL",[82],"NA","The purpose of this study is to develop a multi-level PrEP adherence and persistence intervention as an adaptation of the TENDAI ('grateful' in Shona) program, a problem-solving approach to reduce depression and increase HIV treatment adherence among people living with HIV in Zimbabwe. The new intervention, TENDAI4PrEP, will be designed to improve PrEP uptake and persistence among pregnant persons in Zimbabwe. If feasibility, acceptability, and preliminary efficacy are demonstrated, the intervention will be ready for large-scale effectiveness\u002Fimplementation testing. This program will has the potential to address a critical public health challenge impacting pregnant and postpartum persons in Zimbabwe: the prevention of HIV acquisition and transmission.",[85,86,87],"HIV Infections","Pregnancy Related","Depression, Anxiety","2026-03-30",{"date":90,"type":91},"2026-03-31","ACTUAL",{"date":93,"type":91},"2024-10-21",{"date":95,"type":79},"2027-03-31",{"name":5,"class":6},1]