[{"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:":115},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,84],{"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":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100650928","characterization-of-doxycycline-pharmacokinetics-and-adherence-100650928",false,"NCT07755618","Characterization of Doxycycline Pharmacokinetics and Adherence","Characterization of Doxycycline Pharmacokinetics and Adherence Post-Single and Repeat Dosing Schemas","Inclusion Criteria:\n\n1. Aged 18 to 65 years of age at the time of screening\n2. Able and willing to follow study participation requirements and provide informed consent to take part in the study\n3. Has a non-reactive\u002Fnegative HIV test results at screening per applicable algorithm\n4. Has and is able to maintain a caput (head) of hair, that has not been chemically treated (defined as hair that has been bleached, permed, relaxed or dyed\u002Fcolored) and is greater than one centimeter in length for the duration of the study\n5. For females of reproductive potential: Has a negative urine pregnancy test at screening\n6. For females of reproductive potential: Using at least two effective methods of contraception for at least 30 days (inclusive) prior to enrollment and intending to use two effective methods of contraception for the duration of study participation. It is strongly recommended that at least one barrier method (e.g. condoms) in addition to a hormonal contraception method be used. Examples of acceptable and effective methods include:\n\n   1. Hormonal methods (oral pills, vaginal ring, depo, transdermal or implant)\n   2. Intrauterine device (IUD) inserted at least 30 days prior to enrollment\n   3. Surgical sterilization (of participant or partner(s)) including bilateral tubal ligation or vasectomized male partners\n   4. Barrier methods (condom with\u002Fwithout spermicide, sponge, cervical cap, diaphragm)\n   5. Self-identifies as having same sex partners\n   6. Self-reported sexually abstinent as defined by abstaining from penile-vaginal intercourse for 90 days prior to enrollment and intending to remain sexually abstinent for the duration of study participation\n7. Has access to a smartphone and\u002For laptop and is able and willing to participate in video-based communications with study staff for directly observed dosing requirements\n8. In good general health, in the opinion of the investigator of record (IoR) or designee and has no medical condition that would adversely impact the conduct of the study (inclusive of self-reported conditions and\u002For those found upon medical history and examination or in available medical records). This includes, but is not limited to, having an intact, healthy gastrointestinal tract (without damage or functional disruption) and the ability to swallow pills\n\nExclusion Criteria:\n\n1. Per participant report, planned or active use of any anticonvulsants at screening and an unwillingness to restrict use of certain medications (iron, antacids, etc.) for the duration of the study\n2. For females of reproductive potential: Pregnant or currently breastfeeding, or intends to become pregnant and\u002For breastfeed during the study\n3. Has any of the following laboratory abnormalities:\n\n   1. An estimated calculated creatinine clearance (CrCl) less than 60 mL\u002Fmin by the Cockcroft-Gault formula at screening\n   2. Positive for hepatitis B surface antigen (HBsAg) at screening\n   3. Has a Grade 2 or higher clinically significant laboratory abnormality as defined by The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 - July 2017 (exception: a CrCl ≥ 60 mL\u002Fmin at enrollment is permissible for enrollment)\n4. Per participant reported symptoms or clinical and\u002For laboratory diagnosis of an active pharyngeal, anorectal, or reproductive tract infection (RTI) requiring treatment at screening and enrollment per current US Centers for Disease Control and Prevention (CDC) guidelines (https:\u002F\u002Fwww.cdc.gov\u002Fstd\u002Ftreatment-guidelines\u002Fdefault.htm). Infections requiring treatment include Neisseria gonorrhoeae (GC), Chlamydia trachomatis (CT), syphilis, active herpes simplex virus (HSV) lesions, or symptomatic genital warts, chancroid, pelvic inflammatory disease (PID), bacterial vaginosis (BV), symptomatic vaginal candidiasis, and trichomoniasis\n5. Participation in research studies involving drugs, products, or vaccines within 30 days of the enrollment and for the duration of the study\n6. Has donated blood within 8 weeks of enrollment of approximately 1 pint (550 mL)\n7. Has a known allergy (adverse reaction) to any of the components of the study product, including known hypersensitivity to tetracycline-class antibiotics\n8. Prior use of doxycycline or any other tetracycline-class antibiotic within 30 days prior to enrollment\n9. Has an active infection that may be responsive to treatment with doxycycline or another tetracycline antibiotic\n10. Has evidence or history of any other condition (e.g., gastrectomy, seizure disorder), that, in the opinion of the IoR or designee, would make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives",true,"ALL","18 Years","65 Years",{"count":21,"type":22},16,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The purpose of this study is to evaluate the effect of body changes on doxycycline concentrations for different dosing schedules. This study will involve a single dose phase and a multiple dose phase. Healthy individuals who do not have a sexually transmitted infection (STI), including acute (e.g., gonorrhea or chlamydia) or chronic (e.g., HIV or HSV-2) infections will be enrolled in this study. Study participants will be randomized to a dosing schedule in each phase and come to the research clinic throughout their time on study for sample collection. Study participants that choose to enroll in this study will be enrolled for about 37 days.",[28],"Sexually Transmitted Infection",[30,31,32],"Doxycycline","Pharmacokinetics","PK Sampling","NOT_YET_RECRUITING","2026-08-05",{"date":36,"type":37},"2026-08-10","ACTUAL",{"date":39,"type":22},"2026-08-01",{"date":41,"type":22},"2027-07-01",{"name":43,"class":44},"HIV Prevention Trials Network","NETWORK",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":16,"sex":53,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},"100641835","phase-3-duo-a-phase-iiib-individual-level-randomized-controlled-trial-of-an-integrated-strategy-100641835","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","MALE","29 Years",{"count":56,"type":22},400,[58],"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",[61,28],"HIV Infection",[63,64,65,66,67,68,69,70,71,72,73,74],"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)","2026-06-15",{"date":77,"type":37},"2026-06-22",{"date":79,"type":22},"2026-09-01",{"date":81,"type":22},"2029-09-01",{"name":43,"class":44},5,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":16,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":4,"studyType":23,"phases":96,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":5},"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":95,"type":22},300,[97],"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.",[100,101],"Pregnancy","HIV Infections",[103,104,105,106],"Pre-exposure Prophylaxis (PrEP)","Contraception","Dual Prevention Pill (DPP)","Pregnancy Prevention","2026-02-17",{"date":109,"type":37},"2026-02-19",{"date":111,"type":22},"2026-05-15",{"date":113,"type":22},"2028-05-15",{"name":43,"class":44},""]