[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"HIV Prevention Trials Network\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":88},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,56],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100641835","phase-3-duo-a-phase-iiib-individual-level-randomized-controlled-trial-of-an-integrated-strategy-100641835",false,"NCT07658976","Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy","Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy of HIV PrEP and STI PEP for Young Men","Inclusion Criteria:\n\n1. Men ages 18 - 29 years\n2. Men who are in communities most affected by the HIV epidemic\n3. Willing and able to provide informed consent\n4. Reports having anal sex with men in the last 6 months\n5. Have certain risk factors for HIV acquisition, defined as any of the following in the past 6 months:\n\n   1. Any condomless anal sex with a man; not including within a monogamous relationship with an HIV-negative partner or an HIV-positive partner who is virally suppressed\n   2. Reporting 2 or more male partners, regardless of condom use\n   3. Reporting gonorrhea, chlamydia, or syphilis diagnosis\n   4. Any stimulant use (e.g., cocaine, amphetamines)\n6. Not on PrEP within the past 3 months due to participant choice\n7. Interested in learning more about PrEP or starting PrEP\n8. No evidence of HIV infection at Screening and Enrollment, based on the HIV testing algorithm\n9. Owns an iOS or Android mobile phone and able to successfully download mobile apps and send and receive text messages\n10. Must not share the mobile phone used for their participation in the study\n11. Able to read and write\n\nExclusion Criteria:\n\n1. Participated in HPTN 113-01\n2. Currently participating in another interventional trial of PrEP agents, or prior enrollment in studies of long-acting PrEP, including HPTN 083\n3. Plans to move away from the study area within the next year\n4. Currently on doxycycline for STI PEP\n5. Has ever used CAB-LA or other long-acting PrEP agent\n6. Tetracycline allergy\n7. Prior diagnosis of HIV infection\n8. Reactive HIV rapid test at Screening or reactive HIV Ag\u002FAb rapid test at Enrollment, regardless of subsequent HIV test results\n9. Any other condition that, in the opinion of the Investigator of Record (IoR)\u002Fdesignee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives would make the patient unsuitable for the study or unable\u002Funwilling to comply with the study requirements",true,"MALE","18 Years","29 Years",{"count":21,"type":22},400,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Individual-Level Randomized Controlled Trial of an Integrated Strategy of HIV pre-exposure prophylaxis (PrEP) and sexually transmitted infection (STI) post-exposure prophylaxis (PEP) for Young Men",[28,29],"HIV Infection","Sexually Transmitted Infection",[31,32,33,34,35,36,37,38,39,40,41,42],"Human Immunodeficiency Virus (HIV)","Sexually Transmitted Infection (STI)","Pre-Exposure Prophylaxis (PrEP)","Post-Exposure Prophylaxis (PEP)","Integrated Strategy","Young Men","Doxycycline for STI Post-Exposure Prophylaxis (Doxy-PEP)","Chlamydia Trachomatis (CT)","Neisseria Gonorrhea (NG)","Hepatitis B (HBV)","Mobile Health Tools (mHealth)","MyPrEP + PrEPmate + PrEPsmart Tools (3P)","NOT_YET_RECRUITING","2026-06-15",{"date":46,"type":47},"2026-06-22","ACTUAL",{"date":49,"type":22},"2026-09-01",{"date":51,"type":22},"2029-09-01",{"name":53,"class":54},"HIV Prevention Trials Network","NETWORK",5,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":16,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":4,"studyType":23,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},"100615098","phase-2-phase-2b-open-label-multisite-randomized-crossover-study-of-dpp-versus-2pr-100615098","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","FEMALE","16 Years","39 Years",{"count":67,"type":22},300,[69],"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.",[72,73],"Pregnancy","HIV Infections",[75,76,77,78],"Pre-exposure Prophylaxis (PrEP)","Contraception","Dual Prevention Pill (DPP)","Pregnancy Prevention","2026-02-17",{"date":81,"type":47},"2026-02-19",{"date":83,"type":22},"2026-05-15",{"date":85,"type":22},"2028-05-15",{"name":53,"class":54},3,""]