[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592937":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":46,"collaborators":50,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":19,"enrollmentInfo":65,"targetDuration":19,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":83,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Indiana University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Enhanced Mentor Mother Strategy","EXPERIMENTAL","Participants will receive support from a Mentor Mother (MM) who delivers a risk-based, differentiated package of PMTCT services tailored to the needs of pregnant and postpartum women living with HIV (WLHIV). At each clinic visit, the MM will assess maternal and infant risk using a structured tool. Based on the result, the MM provides tailored support, such as counseling, navigation, linkage to resources, or increased follow-up. WLHIV without identified risks receive a streamlined support package. The strategy is integrated into routine antenatal and postnatal care at the study site.",[13],"Behavioral: Enhanced Mentor Mother Strategy",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BEHAVIORAL","The enhanced Mentor Mother strategy introduces a structured approach to differentiated PMTCT support, led by trained peer counselors\u002FMentor Mothers (MM). Mentor Mothers will be trained on how to perform risk stratification, and they will use a standardized form to identify and document psychosocial and clinical risk factors. Based on these, MMs then deliver tailored interventions, including additional counseling, community outreach, and referrals. Fidelity assessments and a process of audit and feedback will be used to further refine the strategy, which builds on national differentiated service delivery guidelines and integrates into routine care without requiring added clinic staff.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"James G Carlucci, MD, MPH","CONTACT","+1 317 944 7260","jimcarlu@iu.edu",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Burnt Forest Sub-District Hospital","RECRUITING","Burnt Forest","Uasin Gishu County","30100","Kenya","KE",{"type":36,"coordinates":37},"Point",[38,39],35.4325,0.21684,{"lat":39,"lon":38},[42],{"name":43,"role":23,"phone":44,"phoneExt":19,"email":45},"Rosa Chemwey, MBChB, MMed","+254 721 382 663","rosachemwey@gmail.com",{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","James G. Carlucci","Assistant Professor of Pediatrics",[51],{"name":52,"class":53},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100592937","enhanced-mentor-mother-strategy-for-pregnant-and-postpartum-women-living-with-hiv-100592937",false,"NCT06999928","Enhanced Mentor Mother Strategy for Pregnant and Postpartum Women Living With HIV","Pilot Implementation-Effectiveness Study of an Enhanced Mentor Mother Strategy","PIE-eMMs","Inclusion Criteria:\n\n* Pregnant and postpartum women living with HIV (and their infants born during the study)\n* ≥18 years of age\n* Enrolled in PMTCT services at BFSDH\n* Able to understand and provide informed consent in English or Kiswahili\n\nExclusion Criteria:\n\n* Women who are not pregnant or postpartum\n* \\\u003C18 years of age\n* Not enrolled in PMTCT services at BFSDH\n* Unable to understand and provide informed consent in English or Kiswahili\n* Cognitive impairment that would interfere with ability to participate in the study",true,"FEMALE","18 Years",{"count":66,"type":67},200,"ESTIMATED","INTERVENTIONAL",[70],"NA","Mentor Mothers (MMs) are peer supporters who help pregnant and postpartum women living with HIV (WLHIV) as they receive prevention of mother-to-child transmission of HIV (PMTCT) services in resource-limited settings like Kenya. Differentiated service delivery (DSD) is a care model that tailors services based on clients' needs, helping to improve both the quality and efficiency of care.\n\nThis hybrid implementation-effectiveness study will test whether an enhanced MM strategy that uses DSD can be successfully carried out and improve health outcomes for mothers and infants. The study will take place at Burnt Forest Sub-District Hospital (BFSDH) in Kenya.\n\nResearchers will ask:\n\n* Can the enhanced MM strategy be delivered as planned and accepted by patients and staff?\n* Does the strategy improve clinical outcomes like keeping mothers in PMTCT care, achieving HIV viral suppression, completing infant HIV testing, and preventing HIV transmission to infants? Researchers will compare health outcomes before and after the strategy is introduced at BFSDH, and also compare outcomes at other similar clinics that continue with standard MM services.\n\nWomen who choose to participate will meet with a MM during their routine antenatal and postnatal clinic visits. They will be offered the enhanced MM support, but can choose to receive standard care if they prefer.",[73,74,75,76,77,78,79,80,81,82],"Hiv","Transmission Vertical","Viremia","Adherence, Treatment","Stigmatization","Socioeconomic Adversity","Health Care Utilization","Health Care Acceptability","Peer Group","Mothers",[84,85,86,87,88,89,33],"prevention of mother-to-child transmission","retention","implementation","mentor mothers","differentiated service delivery","maternal-child health","2025-07-14",{"date":92,"type":93},"2025-07-15","ACTUAL",{"date":95,"type":93},"2025-07-10",{"date":97,"type":67},"2026-10-12",{"name":5,"class":6},1]