[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641835":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":44,"centralContacts":55,"locations":65,"responsibleParty":144,"collaborators":146,"id":155,"slug":156,"hasResults":157,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":29,"eligibilityCriteria":161,"healthyVolunteers":162,"sex":163,"minAge":164,"maxAge":165,"enrollmentInfo":166,"targetDuration":29,"studyType":169,"phases":170,"briefSummary":172,"conditions":173,"keywords":176,"overallStatus":189,"whyStopped":29,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":199},{"fullName":5,"class":6},"HIV Prevention Trials Network","NETWORK",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"3P mHealth package","EXPERIMENTAL","HIV PrEP, doxy-PEP, 3P mHealth package (3P: MyPrEP + PrEPmate + PrEPsmart tools) to assist with PrEP uptake and adherence decision making, standard-of-care PrEP adherence counseling from qualified study staff, handout about the different PrEP options available at the site",[13,14,15,16,17],"Drug: HIV PrEP - choice of F\u002FTDF, F\u002FTAF, or CAB-LA","Drug: STI PEP - Doxycycline as Doxy-PEP","Behavioral: 3P mHealth package","Behavioral: Handout about HIV PrEP options available at the site","Behavioral: Standard-of-care HIV PrEP counseling from qualified study staff",{"label":19,"type":20,"description":21,"interventionNames":22},"Standard-of-care services","ACTIVE_COMPARATOR","HIV PrEP, doxy-PEP, standard-of-care PrEP adherence counseling from qualified study staff, handout about the different PrEP options available at the site",[13,14,16,17],[24,30,34,38,41],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","HIV PrEP - choice of F\u002FTDF, F\u002FTAF, or CAB-LA","Choice of F\u002FTDF, F\u002FTAF, or CAB-LA for HIV prevention",[9,19],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"STI PEP - Doxycycline as Doxy-PEP","Doxycycline as doxy-PEP for STI prevention",[9,19],{"type":35,"name":9,"description":36,"armGroupLabels":37,"otherNames":29},"BEHAVIORAL","Suite of mHealth tools (MyPrEP, PrEPmate, PrEPsmart) to assist with HIV PrEP uptake and adherence decision making",[9],{"type":35,"name":39,"description":39,"armGroupLabels":40,"otherNames":29},"Handout about HIV PrEP options available at the site",[9,19],{"type":35,"name":42,"description":42,"armGroupLabels":43,"otherNames":29},"Standard-of-care HIV PrEP counseling from qualified study staff",[9,19],[45,49,52],{"name":46,"affiliation":47,"role":48},"Susan Buchbinder, MD","San Francisco Department of Public Health and University of California San Francisco","STUDY_CHAIR",{"name":50,"affiliation":51,"role":48},"Jorge Gallardo-Cartagena, MD","Centro de Investigaciones Tecnológicas Biomédicas y Medioambientales",{"name":53,"affiliation":54,"role":48},"Thiago Torres, MD","Instituto Nacional de Infectología Evandro Chagas",[56,61],{"name":57,"role":58,"phone":59,"phoneExt":29,"email":60},"Kailazarid Gomez-Feliciano, MPM","CONTACT","919-321-3486","kgomez@fhi360.org",{"name":62,"role":58,"phone":63,"phoneExt":29,"email":64},"Michelle Robinson","919-321-3585","mrobinson@fhi360.org",[66,84,99,116,128],{"facility":67,"status":29,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"UCLA Vine Street Clinic","Los Angeles","California","90095","United States","US",{"type":74,"coordinates":75},"Point",[76,77],-118.24368,34.05223,{"lat":77,"lon":76},[80],{"name":81,"role":58,"phone":82,"phoneExt":29,"email":83},"Jesse Clark, MD","323-461-3106","jlclark@mednet.ucla.edu",{"facility":85,"status":29,"city":86,"state":87,"zip":88,"country":71,"countryCode":72,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Bronx Prevention Research Center CRS","The Bronx","New York","10451",{"type":74,"coordinates":90},[91,92],-73.86641,40.84985,{"lat":92,"lon":91},[95],{"name":96,"role":58,"phone":97,"phoneExt":29,"email":98},"Ellen Morrison","212-305-6328","eam6@cumc.columbia.edu",{"facility":100,"status":29,"city":101,"state":29,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Fundacion Huesped CRS","Buenos Aires","C1427CEA","Argentina","AR",{"type":74,"coordinates":106},[107,108],-58.37723,-34.61315,{"lat":108,"lon":107},[111],{"name":112,"role":58,"phone":113,"phoneExt":114,"email":115},"Maria Figueroa","54-11-49817777","1132","maria.figueroa@huesped.org.ar",{"facility":117,"status":29,"city":118,"state":119,"zip":120,"country":121,"countryCode":122,"cosmosGeoPoint":123,"geoPoint":127,"contacts":29},"Instituto de Pesquisa Clinicaq Evandro Chagas CRS","Manguinhos","Rio de Janeiro","221045-900","Brazil","BR",{"type":74,"coordinates":124},[125,126],-43.24859,-22.87533,{"lat":126,"lon":125},{"facility":129,"status":29,"city":130,"state":29,"zip":131,"country":132,"countryCode":133,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"San Miguel CRS","Lima","32-15088","Peru","PE",{"type":74,"coordinates":135},[136,137],-77.02824,-12.04318,{"lat":137,"lon":136},[140],{"name":141,"role":58,"phone":142,"phoneExt":29,"email":143},"Javier Valencia","51-1948081626","jvalencia@impactaperu.org",{"type":145,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[147,150,153],{"name":148,"class":149},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"name":151,"class":152},"Gilead Sciences","INDUSTRY",{"name":154,"class":152},"ViiV Healthcare","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":167,"type":168},400,"ESTIMATED","INTERVENTIONAL",[171],"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",[174,175],"HIV Infection","Sexually Transmitted Infection",[177,178,179,180,181,182,183,184,185,186,187,188],"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":192,"type":193},"2026-06-22","ACTUAL",{"date":195,"type":168},"2026-09-01",{"date":197,"type":168},"2029-09-01",{"name":5,"class":6},5]