[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586764":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":34,"studyPopulation":27,"armGroups":35,"interventions":46,"overallOfficials":27,"centralContacts":52,"locations":58,"responsibleParty":76,"collaborators":78,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":91,"sex":92,"minAge":27,"maxAge":27,"enrollmentInfo":93,"targetDuration":27,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":104,"overallStatus":61,"whyStopped":27,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Botswana Harvard AIDS Institute Partnership","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":27},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"PrEP initiation among pregnant women seeking antenatal care","PrEP initiation among pregnant women seeking antenatal care defined as accepting either daily oral PrEP pills or the DPV-VR when offered at enrolment and evidence of self-reported use at 1-month.","Enrolment to 1 month post enrolment",{"measure":14,"description":15,"timeFrame":16},"PrEP persistence","Evidence of PrEP persistence at 9 months postpartum among women who initiated PrEP.","Enrolment to 9 months postpartum",{"measure":18,"description":19,"timeFrame":16},"PrEP adherence","PrEP adherence defined as either TFV or DPV hair levels (depending on PrEP method) at 9 months postpartum.",[21,24],{"measure":22,"description":23,"timeFrame":16},"PrEP Choice","Secondary outcomes are PrEP choice (pills vs. DPV-VR)",{"measure":25,"description":26,"timeFrame":16},"STI rates","Prevalence of chlamydia, gonorrhoea and trichomonas at enrolment, third trimester and 9 months postpartum",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":27,"primaryPurpose":31,"observationalModel":27,"timePerspective":27,"maskingInfo":32},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":33,"maskingDescription":27,"whoMasked":27},"NONE","The investigators are conducting a 2-arm 1:1 randomized trial to compare PrEP delivery with co-offer of STI testing for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis (using Xpert CT\u002FNG and TV assays) vs. standard-of-care (SOC, syndromic management) among pregnant women without HIV (n=600) in Botswana. Antenatal care clients will be offered PrEP (self-select oral pills or DPV-VR).\n\nParticipants will be followed up to 9 months postpartum. Women will be able to switch PrEP methods and start, stop, or restart PrEP at any time.\n\nPrimary outcomes are the proportion of clients who initiate PrEP, persist with use at 9 months postpartum, and adhere (quantified by hair drug levels). Secondary outcomes are PrEP choice (pills vs. DPV-VR), STI rates, and birth outcomes by randomization arm. Exploratory outcomes are HIV incidence, quality of care, adherence cofactors, and antimicrobial resistance.",[36,42],{"label":37,"type":38,"description":39,"interventionNames":40},"Intervention arm","EXPERIMENTAL","Participants randomized to the intervention arm will be offered Xpert® CT\u002FNG and TV testing and treatment (in addition to syndromic STI assessment) at three time points (enrolment, at the 32 weeks' gestation visit and 9-month post-delivery visit) or two time points for participants enrolled in their third trimester. If a client accepts Xpert® testing, they will be instructed by the study clinician\u002Fresearch assistant on how to self-collect a vaginal swab.",[41],"Diagnostic Test: Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testing",{"label":43,"type":44,"description":45,"interventionNames":27},"Standard-of-care arm","NO_INTERVENTION","Participants in the standard-of-care arm will receive syndromic STI assessment per Botswana national guidelines. They will be offered Xpert® CT\u002FNG and TV testing at the 9-month post-delivery visit only.",[47],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":27},"DIAGNOSTIC_TEST","Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testing","Xpert® CT\u002FNG and TV testing",[37],[53],{"name":54,"role":55,"phone":56,"phoneExt":27,"email":57},"Chelsea Morroni, MBChB, DFSRH, MPH, PhD","CONTACT","‭+267 316 6657‬","chelseaamorroni@gmail.com",[59],{"facility":60,"status":61,"city":62,"state":27,"zip":27,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"DHMT Clinics","RECRUITING","Gaborone","Botswana","BW",{"type":66,"coordinates":67},"Point",[68,69],25.90859,-24.65451,{"lat":69,"lon":68},[72],{"name":73,"role":55,"phone":74,"phoneExt":27,"email":75},"District Health Management Team, Greater Gaborone","+2673905792","researchreview.ggdhmt@gmail.com",{"type":77,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[79,81],{"name":80,"class":6},"University of Washington",{"name":82,"class":6},"University of Botswana","100586764","phase-3-sti-testing-to-enhance-prep-use-in-pregnancy-100586764",false,"NCT06919614","STI Testing to Enhance PrEP Use in Pregnancy","Improving PrEP Outcomes Among Pregnant Women in Botswana With an Integrated STI Testing and PrEP Delivery Model","STEP-UP","Inclusion Criteria:\n\n* Pregnant and seeking antenatal care\n* Self-identifying as a cis-gender woman\n* Living without HIV\n* Not currently using PrEP\n* Planning to remain in the city\u002Ftown of enrolment until 9 months post-delivery.\n* Planning to receive antenatal and postnatal care in the city\u002Ftown of enrolment.\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Male gender\n* Not pregnant\n* Living with HIV\n* Currently using PrEP\n* Not planning to remain in the city\u002Ftown of enrolment until 9 months post-delivery\n* Not planning to receive antenatal and postnatal care in the city\u002Ftown to enrolment\n* Not able or willing to provide informed consent for participation",true,"FEMALE",{"count":94,"type":95},600,"ESTIMATED","INTERVENTIONAL",[98],"PHASE3","The investigators are conducting a study in Botswana to see if offering STI testing along with expanded HIV prevention options (PrEP) helps more pregnant women start and continue using PrEP during and after pregnancy. Pregnant women (n=600) seeking antenatal care in Botswana will be enrolled and randomly assigned to receive the standard of care (standard STI assessment with no STI testing) versus STI testing for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis during pregnancy and postpartum. The investigators' hypothesis is that providing STI testing alongside PrEP offer will encourage more women to start and continue using PrEP.",[101,102,103],"PrEP Adherence","Sexually Transmitted Infections (STIs)","Pregnancy",[105,106,107,108,109,110,111,112,113,114,115],"Pregancy","PrEP","HIV","STIs","Chlamydia","Gonorrhoea","Gonorrhea","Trichomonas","Dapivirine","Truvada","Oral PrEP","2026-06-09",{"date":118,"type":119},"2026-06-11","ACTUAL",{"date":121,"type":119},"2025-06-18",{"date":123,"type":95},"2029-08-31",{"name":5,"class":6},1]