[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100528235":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":46,"centralContacts":51,"locations":58,"responsibleParty":71,"collaborators":73,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":91,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":56,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":106,"overallStatus":61,"whyStopped":56,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"University of North Carolina, Chapel Hill","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral PrEP (FTC\u002FTDF or TDF\u002F3TC) during pregnancy","ACTIVE_COMPARATOR","The arm will include pregnant women who have met eligibility criteria, consented, and chosen to initiate or remain on oral PrEP (FTC\u002FTDF or TDF\u002F3TC) during pregnancy. Within the arm, they will be grouped according to whether they started oral PrEP before or after pregnancy diagnosis. All participants will continue to be offered oral PrEP throughout the study and will be followed up for the duration of the study. All women will be registered into the PrEP Pregnancy Registry as part of routine care.",[13,14],"Drug: Initiating daily oral PrEP during pregnancy","Drug: Already using daily oral PrEP at the time of pregnancy diagnosis",{"label":16,"type":17,"description":18,"interventionNames":19},"Long-acting injectable cabotegravir (CAB-LA) during pregnancy","EXPERIMENTAL","The arm will include pregnant women who have met eligibility criteria, consented, and chosen to initiate or remain on injectable PrEP (CAB-LA) during pregnancy. Within the arm, they will be grouped according to whether they started CAB-LA before or after pregnancy diagnosis. All participants will continue to be offered CAB-LA throughout the study and will be followed up for the duration of the study. All women will be registered into the PrEP Pregnancy Registry as part of routine care.",[20,21],"Drug: Initiating injectable PrEP during pregnancy","Drug: Already using injectable PrEP (CAB-LA) at the time of pregnancy diagnosis",[23,30,35,41],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Initiating daily oral PrEP during pregnancy","Group 1a will include pregnant women who initiate oral PrEP when already pregnant, at enrollment into the study.",[9],[29],"Tenofovir disoproxil fumarate (TDF)\u002Femtricitabine (FTC) or lamivudine (3TC) (FTC\u002FTDF or TDF\u002F3TC)",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Already using daily oral PrEP at the time of pregnancy diagnosis","Group 1b will include women already using daily oral PrEP at the time of pregnancy diagnosis and enrollment in the study.",[9],[29],{"type":24,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Initiating injectable PrEP during pregnancy","Group 2a will include pregnant women who initiate injectable PrEP (CAB-LA) when already pregnant, at enrollment into the study.",[16],[40],"CAB-LA",{"type":24,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Already using injectable PrEP (CAB-LA) at the time of pregnancy diagnosis","Group 2b will include women using injectable PrEP (CAB-LA) at the time of pregnancy diagnosis and enrollment into the study.",[16],[40],[47],{"name":48,"affiliation":49,"role":50},"Friday Saidi, MBBS, MMED","UNC Project Malawi","PRINCIPAL_INVESTIGATOR",[52],{"name":53,"role":54,"phone":55,"phoneExt":56,"email":57},"Charity Nakanga, MBBS, MSc","CONTACT","265 88 556 5888",null,"cnakanga@unclilongwe.org",[59],{"facility":60,"status":61,"city":62,"state":56,"zip":56,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":56},"Bwaila Distict Hospital","RECRUITING","Lilongwe","Malawi","MW",{"type":66,"coordinates":67},"Point",[68,69],33.78725,-13.96692,{"lat":69,"lon":68},{"type":72,"investigatorFullName":56,"investigatorTitle":56,"investigatorAffiliation":56,"oldNameTitle":56,"oldOrganization":56},"SPONSOR",[74,77,80],{"name":75,"class":76},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH",{"name":78,"class":79},"United States President's Emergency Plan for AIDS Relief","FED",{"name":81,"class":82},"Ministry of Health, Malawi","OTHER_GOV","100528235","phase-4-uncpm-22314---pregnancy-infant-and-maternal-health-outcomes-study-100528235",false,"NCT06158126","UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study","UNCPM 22314 - Evaluating the Safety of Pregnancy, Infant and Maternal Health Outcomes Among PrEP Users in Malawi","PrIMO","Inclusion Criteria:\n\nMaternal participants:\n\n* Confirmed pregnancy by urine pregnancy test or ultrasound.\n* Aged 15 years or older\n* PrEP-eligible by Malawi local guidelines\n* Confirmed HIV-negative based on the local HIV testing algorithm\n* Hepatitis B surface antigen (HBsAg) negative\n* Weight \\>35 kg\n* Provided informed consent and expressed willingness to participate in study activities with their infants.\n\nInfant participants: Infant participants will enter the study with their mother as unborn infants. There are no specific eligibility criteria for infant participation otherwise.\n\nExclusion Criteria:\n\nMaternal participants will not be eligible to enter the prospective cohort study if any of the following conditions are identified during the screening process:\n\n* Known to be living with HIV\n* Known allergies to CAB-LA, TDF\u002F3TC or FTC\u002FTDF\n* Other current significant disease process (active or chronic), substance use, or social circumstances that, in the judgment of the site investigator would make participation in the study unsafe.\n* Intention to leave the study site's catchment area of Bwaila before scheduled study exit.",true,"FEMALE","15 Years","55 Years",{"count":96,"type":97},621,"ESTIMATED","INTERVENTIONAL",[100],"PHASE4","The primary purpose of this study is to assess the safety of long-acting injectable cabotegravir (CAB-LA) and oral pre-expose prophylaxis (PrEP) (FTC\u002FTDF or 3TC\u002FTDF) for the prevention of HIV during pregnancy and breastfeeding among pregnant women and their infants in Malawi. The main question the study aims to answer is:\n\n\\- Do composite adverse pregnancy events, maternal health outcomes, and\u002For infant health outcomes differ between individuals taking oral PrEP and those taking CAB-LA?\n\nWomen who are already using PrEP at the time of pregnancy diagnosis or those who initiate PrEP during pregnancy will enroll into a Safety Cohort where they will be closely followed up during pregnancy while optimizing their antenatal care (ANC) per the Malawi ANC package. Women will have access to either CAB-LA or oral PrEP and will be given an opportunity to choose one option. Women and their infants will attend a series of follow-up visits through pregnancy, birth, and the postnatal period.\n\nIn addition, the study will contribute to the development of a national PrEP Pregnancy Registry which will be initially rolled out in Lilongwe and Blantyre -the two most populous cities in Malawi-before a nationwide roll out begins under the guidance of the Malawi Ministry of Health.",[103,104,105],"Pre-exposure Prophylaxis","HIV Prevention","Pregnancy Related",[107,108,109,110,111,112,113],"PrEP","Pregnancy","Breastfeeding","Infant health","HIV prevention","Maternal health","Eliminating mother-to-child transmission (EMTCT)","2026-05-01",{"date":116,"type":117},"2026-05-05","ACTUAL",{"date":119,"type":117},"2024-04-17",{"date":121,"type":97},"2027-12",{"name":5,"class":6},1]