[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647125":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":31,"locations":31,"responsibleParty":32,"collaborators":34,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":31,"eligibilityCriteria":47,"healthyVolunteers":44,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":31,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":31,"overallStatus":65,"whyStopped":31,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":31},{"fullName":5,"class":6},"Tulane University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","200 mg oral doxy PEP (N=346)",[13],"Drug: Doxycycline",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","ACTIVE_COMPARATOR","Standard of care (i.e. no doxy PEP, N=173)",[19],"Other: Standard of Care (SOC)",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Doxycycline","Enrolled participants will be randomized 2:1 to receive 200 mg of doxy PEP taken within 24 hours of condomless sex versus standard of care. Only one trial of the use of doxy PEP (dPEP Kenya) has been conducted among women, and unfortunately this study had a null result.",[9],[27],"Doxy PEP",{"type":6,"name":29,"description":24,"armGroupLabels":30,"otherNames":31},"Standard of Care (SOC)",[15],null,{"type":33,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[35,38,40],{"name":36,"class":37},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"name":39,"class":6},"University of Alabama at Birmingham",{"name":41,"class":6},"Louisiana State University Health Sciences Center in New Orleans","100647125","phase-4-a-randomized-controlled-trial-of-doxycycline-post-exposure-prophylaxis-to-prevent-incident-bacterial-stis-among-women-in-the-united-states-100647125",false,"NCT07704957","A Randomized Controlled Trial of Doxycycline Post Exposure Prophylaxis to Prevent Incident Bacterial STIs Among Women in the United States","Inclusion Criteria:\n\n* Female\n* Aged 18-35\n* Reporting condomless vaginal sex with men AND least one of the following:\n\n  1. diagnosis of CT, gonorrhea, syphilis, or trichomonas in the past year\n  2. reporting 2 or more sexual partners in the past 6 months\n* Plan to continue to be sexually active over the next year\n* Have smartphone and be willing to engage with an app\n* If HIV+: Viral load\\\u003C200 copies\u002Fml and CD4 count \\>200 cells\u002Fmm3\n\nExclusion Criteria:\n\n* Pregnant, nursing, or intending to become pregnant\n* Reported allergy to tetracyclines\n* Liver disease or end-stage renal disease\n* Non-English Speaking\n* Taking concomitant medications which may impact doxycycline metabolism (e.g., systemic retinoids, antacids, barbiturates, carbamazepine, phenytoin, iron, warfarin, rifampin)\n* Not willing to take doxy PEP or comply with study procedures\n* Unable to provide informed consent","FEMALE","18 Years","35 Years",{"count":52,"type":53},519,"ESTIMATED","INTERVENTIONAL",[56],"PHASE4","The bacterial sexually transmitted infections (STIs) chlamydia, gonorrhea, and syphilis cause multiple adverse outcomes in women, and prevention strategies are critically needed. This project will determine the efficacy of doxycycline post-exposure prophylaxis (doxy PEP) to prevent STIs among women through a phase IV, open-label, randomized controlled trial.",[59,60,61,62,63,64],"Chlamydia Females","Gonorrhea Female","Syphilis Female","Adherence","Prophylaxis","Prevention","NOT_YET_RECRUITING","2026-07-10",{"date":68,"type":69},"2026-07-15","ACTUAL",{"date":71,"type":53},"2027-01-01",{"date":73,"type":53},"2032-04-01",{"name":5,"class":6}]