[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615098":3},{"organization":4,"outcomesModule":7,"designInfo":126,"detailedDescription":133,"studyPopulation":125,"armGroups":134,"interventions":147,"overallOfficials":161,"centralContacts":169,"locations":179,"responsibleParty":226,"collaborators":228,"id":232,"slug":233,"hasResults":234,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":125,"eligibilityCriteria":238,"healthyVolunteers":239,"sex":240,"minAge":241,"maxAge":242,"enrollmentInfo":243,"targetDuration":125,"studyType":246,"phases":247,"briefSummary":249,"conditions":250,"keywords":252,"overallStatus":257,"whyStopped":125,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":267},{"fullName":5,"class":6},"HIV Prevention Trials Network","NETWORK",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":125},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"PrEP adherence to DPP during randomized crossover period 1","Intraerythrocytic Tenofovir Diphosphate (TFV-DP) concentrations in dried blood spot (DBS)","Week 12",{"measure":14,"description":15,"timeFrame":12},"PrEP adherence to 2PR during randomized crossover period 1","Intraerythrocytic TFV-DP concentrations in DBS",{"measure":17,"description":15,"timeFrame":18},"PrEP adherence to DPP during randomized crossover period 2","Week 24",{"measure":20,"description":15,"timeFrame":18},"PrEP adherence to 2PR during randomized crossover period 2",[22,26,28,30,31,34,36,38,41,45,47,50,52,55,57,60,62,64,66,68,70,73,76,78,80,82,84,87,91,93,95,97,99,102,104,106,108,110,112,115,117,119,121,123],{"measure":23,"description":24,"timeFrame":25},"PrEP adherence to DPP during Choice period","TFV-DP concentrations in DBS","Week 48",{"measure":27,"description":24,"timeFrame":25},"PrEP adherence to 2PR during Choice period",{"measure":23,"description":29,"timeFrame":25},"Self-reported adherence",{"measure":27,"description":29,"timeFrame":25},{"measure":32,"description":33,"timeFrame":18},"Acceptability of DPP during crossover period","Answers to acceptability questionnaire based on overall acceptability measure as well as a range of acceptability dimensions (e.g., product size, color, dosing, etc.)",{"measure":35,"description":33,"timeFrame":18},"Acceptability of 2PR during crossover period",{"measure":37,"description":33,"timeFrame":25},"Acceptability of DPP during Choice period",{"measure":39,"description":40,"timeFrame":25},"Acceptability of 2PR during Choice period","Acceptability of 2PR based on answers to acceptability questionnaire based on overall acceptability measure as well as a range of acceptability dimensions (e.g., product size, color, dosing, etc.)",{"measure":42,"description":43,"timeFrame":44},"Preference for DPP","Preference of DPP at enrollment","Day 0",{"measure":42,"description":46,"timeFrame":18},"Preference of DPP at completion of the crossover phase of the study",{"measure":48,"description":49,"timeFrame":44},"Preference for 2PR","Preference of 2PR at enrollment",{"measure":48,"description":51,"timeFrame":18},"Preference of 2PR at completion of the crossover phase of the study",{"measure":53,"description":54,"timeFrame":25},"PrEP persistence on DPP during the Choice period","Proportion of participants still using their chosen regimen at end of the Choice period",{"measure":56,"description":54,"timeFrame":25},"PrEP persistence on 2PR during the Choice period",{"measure":58,"description":59,"timeFrame":25},"Overall tolerability of DPP","Tolerability",{"measure":61,"description":59,"timeFrame":25},"Overall tolerability of 2PR",{"measure":63,"description":59,"timeFrame":18},"Tolerability of DPP during the crossover period",{"measure":65,"description":59,"timeFrame":18},"Tolerability of 2PR during the crossover period",{"measure":67,"description":59,"timeFrame":25},"Tolerability of DPP during the Choice period",{"measure":69,"description":59,"timeFrame":25},"Tolerability of 2PR during the Choice period",{"measure":71,"description":72,"timeFrame":25},"Overall side effects of DPP","Grade 2+ Adverse Events (AE)",{"measure":74,"description":75,"timeFrame":25},"Overall side effects of 2PR","Grade 2+ AE",{"measure":77,"description":75,"timeFrame":18},"Side effects of DPP during the crossover period",{"measure":79,"description":75,"timeFrame":18},"Side effects of 2PR during the crossover period",{"measure":81,"description":75,"timeFrame":25},"Side effects of DPP during the Choice period",{"measure":83,"description":75,"timeFrame":25},"Side effects of 2PR during the Choice period",{"measure":85,"description":86,"timeFrame":25},"Overall unintended IPV of DPP","Intimate Partner Violence (IPV)",{"measure":88,"description":89,"timeFrame":90},"Overall unintended IPV of 2PR","IPV","Week48",{"measure":92,"description":89,"timeFrame":18},"Unintended IPV of DPP during the crossover period",{"measure":94,"description":89,"timeFrame":18},"Unintended IPV of 2PR during the crossover period",{"measure":96,"description":89,"timeFrame":25},"Unintended IPV of DPP during the Choice period",{"measure":98,"description":89,"timeFrame":25},"Unintended IPV of 2PR during the Choice period",{"measure":100,"description":101,"timeFrame":25},"Overall unintended pregnancy of DPP","Pregnancy",{"measure":103,"description":101,"timeFrame":25},"Overall unintended pregnancy of 2PR",{"measure":105,"description":101,"timeFrame":18},"Unintended pregnancy of DPP during the crossover period",{"measure":107,"description":101,"timeFrame":18},"Unintended pregnancy of 2PR during the crossover period",{"measure":109,"description":101,"timeFrame":25},"Compare unintended pregnancy of DPP during the Choice period",{"measure":111,"description":101,"timeFrame":25},"Compare unintended pregnancy of 2PR during the Choice period",{"measure":113,"description":114,"timeFrame":25},"Overall unintended HIV incidence of DPP","HIV incidence",{"measure":116,"description":114,"timeFrame":25},"Overall unintended HIV incidence of 2PR",{"measure":118,"description":114,"timeFrame":18},"Unintended HIV incidence of DPP during the crossover period",{"measure":120,"description":114,"timeFrame":18},"Unintended HIV incidence of 2PR during the crossover period",{"measure":122,"description":114,"timeFrame":25},"Unintended HIV incidence of DPP during the Choice period",{"measure":124,"description":114,"timeFrame":25},"Unintended HIV incidence of 2PR during the Choice period",null,{"allocation":127,"interventionModel":128,"interventionModelDescription":129,"primaryPurpose":130,"observationalModel":125,"timePerspective":125,"maskingInfo":131},"RANDOMIZED","CROSSOVER","Phase 2b, open label, multisite, randomized crossover study of DPP versus 2PR","PREVENTION",{"masking":132,"maskingDescription":125,"whoMasked":125},"NONE","To evaluate adherence to a single DPP consisting of co-formulated Tenofovir Disoproxil Fumarate and Emtricitabine (FTC\u002FTDF) plus combined ethinyl estradiol\u002Flevonorgestrel oral contraceptive (COC), compared with a two-pill regimen (2PR) consisting of daily oral FTC\u002FTDF pill and combined COC pill, for pre-exposure prophylaxis PrEP and pregnancy prevention in women without HIV.",[135,143],{"label":136,"type":137,"description":138,"interventionNames":139},"DPP\u002F2PR\u002FChoice","EXPERIMENTAL","Daily DPP for 12 weeks followed by daily 2PR for 12 weeks followed by 24 weeks of Choice",[140,141,142],"Drug: DPP","Drug: 2PR","Drug: Free Choice",{"label":144,"type":137,"description":145,"interventionNames":146},"2PR\u002FDPP\u002FChoice","Daily 2PR for 12 weeks followed by daily DPP for 12 weeks followed by 24 weeks of Choice",[140,141,142],[148,153,157],{"type":149,"name":150,"description":151,"armGroupLabels":152,"otherNames":125},"DRUG","DPP","Daily, single, co-formulated, FTC\u002FTDF + combined ethinyl estradiol\u002Flevonorgestrel oral contraceptive pill",[144,136],{"type":149,"name":154,"description":155,"armGroupLabels":156,"otherNames":125},"2PR","Daily, two-pill regimen of oral FTC\u002FTDF and ethinyl estradiol\u002Flevonorgestrel oral contraceptive pill",[144,136],{"type":149,"name":158,"description":159,"armGroupLabels":160,"otherNames":125},"Free Choice","Choice of either DPP or 2PR",[144,136],[162,166],{"name":163,"affiliation":164,"role":165},"Lisa Haddad, MD","Population Council","STUDY_CHAIR",{"name":167,"affiliation":168,"role":165},"Harriet Nuwagaba-Biribonwoha, MD","ICAP at Columbia University",[170,175],{"name":171,"role":172,"phone":173,"phoneExt":125,"email":174},"Scott Rose","CONTACT","919-321-3530","srose@fhi360.org",{"name":176,"role":172,"phone":177,"phoneExt":125,"email":178},"Michelle Robinson","919-321-3585","mrobinson@fhi360.org",[180,196,211],{"facility":181,"status":125,"city":182,"state":125,"zip":125,"country":183,"countryCode":184,"cosmosGeoPoint":185,"geoPoint":190,"contacts":191},"Eswatini Prevention Center CRS","Mbabane","Eswatini","SZ",{"type":186,"coordinates":187},"Point",[188,189],31.13333,-26.31667,{"lat":189,"lon":188},[192],{"name":193,"role":172,"phone":194,"phoneExt":125,"email":195},"Harriet Nuwagaba-Biribonwoha, MD, PhD","268-76024678","hn2158@cumc.columbia.edu",{"facility":197,"status":125,"city":198,"state":125,"zip":125,"country":199,"countryCode":200,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"MU-JHU Research Collaboration (MUJHU CARE LTD) CRS","Kampala","Uganda","UG",{"type":186,"coordinates":202},[203,204],32.58219,0.31628,{"lat":204,"lon":203},[207],{"name":208,"role":172,"phone":209,"phoneExt":125,"email":210},"Clemensia Nakabiito, MD","256-41-541044","cnakabiito@mujhu.org",{"facility":212,"status":125,"city":213,"state":125,"zip":125,"country":214,"countryCode":215,"cosmosGeoPoint":216,"geoPoint":220,"contacts":221},"Spilhaus CRS","Harare","Zimbabwe","ZW",{"type":186,"coordinates":217},[218,219],31.05337,-17.82772,{"lat":219,"lon":218},[222],{"name":223,"role":172,"phone":224,"phoneExt":125,"email":225},"Felix Mhlanga, MBChB, MMED","263-772-335232","fmhlanga@uz-ucsf.co.zw",{"type":227,"investigatorFullName":125,"investigatorTitle":125,"investigatorAffiliation":125,"oldNameTitle":125,"oldOrganization":125},"SPONSOR",[229],{"name":230,"class":231},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH","100615098","phase-2-phase-2b-open-label-multisite-randomized-crossover-study-of-dpp-versus-2pr-100615098",false,"NCT07288190","Phase 2b, Open Label, Multisite, Randomized Crossover Study of DPP Versus 2PR","A Multisite, Open-label, Randomized Crossover Study Comparing Adherence to a Single Daily Dual Prevention Pill (DPP) Versus FTC\u002FTDF and Combined Oral Contraception Separate Pill Dosing (2PR), Given for Pre-exposure Prophylaxis and Pregnancy Prevention in Women","Inclusion Criteria:\n\n* Age 16 through 39 years old (inclusive) at Screening.\n* Adults must be able and willing to provide informed consent. Adolescents (16- and 17-year-olds) will be consented according to applicable local guidelines, by obtaining participant assent and where applicable parental or guardian permission.\n* Able and willing to provide adequate locator information.\n* Able and willing to comply with all study procedures.\n* Must be post-menarche and pre-menopausal and could potentially become pregnant.\n* Sexually active, defined as having had penile-vaginal sex within the 3 months before Screening (per self-report)\n* Negative pregnancy test at Screening and Enrollment.\n* Does not intend to become pregnant within the next 12 months.\n* Willing to use COCs for at least 48 weeks as their method of contraception.\n* HIV negative at Screening and Enrollment.\n* Willing to use oral PrEP for at least 48 weeks.\n* Hepatitis B (HBV) surface antigen (HbsAg) negative per blood test at Screening.\n* Hepatitis C (HCV) negative at Screening.\n* Normal estimated creatinine clearance (eCrCl) ≥ 60 ml\u002Fmin per blood test at Screening.\n\nExclusion Criteria:\n\n* Intolerance, adverse reaction, or laboratory abnormality associated with PrEP use in the past.\n* Unable to become pregnant e.g., had a tubal ligation or hysterectomy or otherwise lacks a uterus, or is currently using another form of contraception.\n* Medically ineligible for combined hormonal contraception and specifically COCs per World Health Organization (WHO) medical eligibility criteria for contraceptive use or similar local medical eligibility guidelines (e.g., Centers for Disease Control and Prevention eligibility criteria).\n* Medically ineligible for PrEP based on WHO and\u002For local guidelines.\n* Using or planning to use another pregnancy prevention product other than oral contraception (condoms are permitted) during the next 48 weeks.\n* Using or planning to use another HIV prevention product other than condoms during the next 48 weeks.\n* Any other condition the clinician feels would jeopardize the health and wellbeing of the participant",true,"FEMALE","16 Years","39 Years",{"count":244,"type":245},300,"ESTIMATED","INTERVENTIONAL",[248],"PHASE2","To evaluate adherence to a single dual-prevention pill (DPP) compared with a two-pill regimen (2PR) for pre-exposure prophylaxis (PrEP) and pregnancy prevention in women without HIV.",[101,251],"HIV Infections",[253,254,255,256],"Pre-exposure Prophylaxis (PrEP)","Contraception","Dual Prevention Pill (DPP)","Pregnancy Prevention","NOT_YET_RECRUITING","2026-02-17",{"date":260,"type":261},"2026-02-19","ACTUAL",{"date":263,"type":245},"2026-05-15",{"date":265,"type":245},"2028-05-15",{"name":5,"class":6},3]