[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hiv-prevention\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hiv-prevention":33},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,48,0,25,[9,53,78,108,141,174,198,226,248,270,293,325,338,361,386,415,439,462,488,514,535,554,587,605,627],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":21,"enrollmentInfo":22,"targetDuration":4,"studyType":25,"phases":26,"briefSummary":28,"conditions":29,"keywords":34,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100054059","phase-2-combatting-hiv-or-other-stis-early-choose-100054059",false,"NCT07510048","Combatting HIV Or Other STIs Early (CHOOSE)","Combatting HIV Or Other STIs Early (CHOOSE): An Integrated Strategy of Pre-Exposure Prophylaxis (PrEP) Mobile Health (mHealth) Support and Doxycycline Post-Exposure Prophylaxis (DoxyPEP)","CHOOSE","Inclusion Criteria\n\n* Age 13-24 years, inclusive;\n* Self-reports being at increased likelihood for HIV acquisition, defined as having anal sex with a male in their lifetime;\n* Owns an iOS or Android Smartphone and able to access all elements of the PrEP Choice package;\n* Not currently on PrEP and interested in learning more about PrEP;\n* Is not living with HIV;\n* Weighs at least 35 kg;\n* Willing to receive PrEP care from a provider at a participating ATN SC;\n* Able to understand, read, and speak English;\n* Able to participate at the study site; and\n* Willing and able to provide written informed consent.\n* If of legal age or otherwise able to provide independent informed consent as determined by local law and consistent with IRB policies: Willing and able to provide written informed consent for study participation.\n* If not of legal age or otherwise not able to provide independent informed consent as determined by local law and consistent with IRB policies: Parent or legal guardian is willing and able to provide written informed consent for study participation and potential participant is willing and able to provide written assent for study participation.\n\nExclusion Criteria:\n\n* Female;\n* In a mutually monogamous sexual relationship with a partner not living with HIV for the past 12 months;\n* Currently participating in an interventional trial of PrEP agents, or prior enrollment in HPTN 083, HPTN 083-01, or any other study of long-acting PrEP (including PURPOSE- 2 lenacapavir study);\n* Plan to move within 18 months to an area inaccessible to a participating ATN SC;\n* An employee of the participating SC; or\n* Any concurrent participation in other clinical trials or behavioral intervention studies without prior approval from the protocol team.\n* Any other medical, behavioral, or other conditions that in the opinion of the SC Project Lead could interfere with adherence to study procedures or the individual's ability to remain in the study for an 18-month period or compromise interpretation of study results.",true,"MALE","13 Years","24 Years",{"count":23,"type":24},200,"ESTIMATED","INTERVENTIONAL",[27],"PHASE2","The overarching goal of this project is to optimize the PrEP Choice integrated mHealth package and assess the efficacy and cost of PrEP Choice on PrEP initiation and adherence among young people. It is hypothesized that PrEP Choice will improve HIV PrEP uptake and adherence among young people and will be cost-effective to deliver to young people in the United States (U.S.). This study will also assess the uptake, adherence, and acceptability of DoxyPEP among young people.",[30,31,32,33],"HIV","STIs","STIs Prevention","HIV Prevention",[30,31,35,36,37,38,39],"sexually transmitted infection","PrEP","DoxyPEP","mobile health","mHealth","NOT_YET_RECRUITING","2026-07-10",{"date":43,"type":44},"2026-07-13","ACTUAL",{"date":46,"type":24},"2026-07-20",{"date":48,"type":24},"2029-03-30",{"name":50,"class":51},"Westat","OTHER",6,{"id":54,"slug":55,"hasResults":12,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":18,"sex":19,"minAge":60,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":25,"phases":63,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100513690","leveraging-chatbot-to-improve-prep-in-the-southern-united-states-100513690","NCT05968755","Leveraging Chatbot to Improve PrEP in the Southern United States","Leveraging Chatbot Technology to Improve PrEP Awareness and Uptake Among Black MSM in the Southern United States","Inclusion Criteria:\n\n* Being cisgender Black male\n* Being aged ≥ 18 years\n* Having Internet access\n* Speaking English\n* Self-reporting condomless sex with another man in the past 6 months\n* HIV negative or untested.\n\nExclusion Criteria:\n\n* Having lived in the US South less than 3 months\n* Having received antiretroviral therapy (ART) treatment.","18 Years",{"count":62,"type":24},145,[64],"NA","The purpose of this study is to develop a chatbot intervention to promote PrEP awareness and uptake among Black men who have sex with men (MSM) in the Southern United States.",[33,67,68],"PrEP Awareness","PrEP Uptake","2026-07-01",{"date":71,"type":44},"2026-07-02",{"date":46,"type":24},{"date":74,"type":24},"2027-07-01",{"name":76,"class":51},"Yale University",4,{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":18,"sex":85,"minAge":60,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":25,"phases":89,"briefSummary":90,"conditions":91,"keywords":92,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":107},"100645020","phase-2-evaluating-the-safety-and-immunogenicity-of-polyvalent-dna-and-recombinant-gp120-protein-hiv-vaccine-pdphv-in-healthy-hiv-uninfected-adults-100645020","NCT07675629","Evaluating the Safety and Immunogenicity of Polyvalent DNA and Recombinant gp120 Protein HIV Vaccine (PDPHV) in Healthy, HIV-uninfected Adults","Phase 2a Clinical Trial to Evaluate the Safety and Immunogenicity of Polyvalent Env (A, B, C, A\u002FE) \u002F Gag (C) DNA and gp120 (A, B, C, A\u002FE) Protein HIV-1 Vaccines (PDPHV) With Either Alhydrogel or GLA-SE in Healthy Adults Living Without HIV","Inclusion Criteria:\n\n1. Age of 18 to 55 years\n2. Access to a trial site and willingness to be followed for the planned duration of the study.\n3. Ability and willingness to provide informed consent\n4. Demonstrates an understanding of the study\n5. Agrees not to enroll in another study of an investigational research agent\n6. Good general health as shown by medical history, physical exam, and screening laboratory tests\n7. Willingness to receive HIV test results\n8. Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling.\n9. Assessed by the clinic staff as being at \"low risk\" for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit.\n10. Hemoglobin ≥ 11.0 g\u002FdL for volunteers who were born female, ≥ 12.0 g\u002FdL for volunteers who were born male\n11. White blood cell count = 3,000 to 12,000 cells\u002Fmm3\n12. Total lymphocyte count \\> 800 cells\u002Fmm3\n13. Remaining differential either within institutional normal range or with site physician approval\n14. Platelets = 125,000 to 450,000\u002Fmm3\n15. Chemistry panel: ALT\\\u003C 1.25 times the institutional upper limit of normal; creatinine \\\u003C 1.1 times institutional upper limit of normal.\n16. Negative HIV-1 and -2 blood test\n17. Negative Hepatitis B surface antigen (HBsAg)\n18. Negative anti-Hepatitis C virus antibodies (anti-HCV)\n19. Urinalysis\n\n    * Negative or trace urine glucose, and\n    * Negative or trace urine protein, and\n    * Negative, trace, or 1+ urine hemoglobin (if 1+ hemoglobin is present on dipstick in the absence of menstruation, a microscopic urinalysis with red blood cells morphology within institutional normal range)\n20. Volunteers who were born female: negative serum or urine beta human chorionic gonadotropin (β HCG) pregnancy test performed prior to vaccination on the day of initial vaccination.\n21. Reproductive status: A volunteer who was born female must:\n\n    * Agree to consistently use effective contraception for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment until at least 3 months after last vaccination.;\n    * Or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation (verified by medical records where available, or based on the judgement of the local investigator);\n    * Or have no male sexual partner.\n22. Volunteers who were born female must also agree not to seek pregnancy through alternative methods, such as artificial insemination, or in vitro fertilization until at least 3 months after last vaccination.\n\nExclusion Criteria:\n\n1. Blood products received within 120 days before first vaccination.\n2. Investigational research agents received within 30 days before first vaccination.\n3. Body mass index (BMI) ≥ 40.\n4. Intent to participate in another study of an investigational research agent or any other study that requires HIV antibody testing.\n5. Pregnant or breastfeeding.\n6. Active duty and reserve US military personnel.\n7. HIV vaccine(s) received in a prior HIV vaccine trial.\n8. Non-HIV experimental vaccine(s) received within the last 1 year in a prior vaccine trial unless the vaccine subsequently received regulatory approval or emergency authorization.\n9. Live attenuated vaccines, other than the influenza vaccine, received within 30 days before first vaccination or scheduled within 14 days after injection.\n10. Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination.\n11. Allergy treatment with antigen injections within 30 days before the first vaccination or those that are scheduled within 14 days after the first vaccination\n12. Immunosuppressive medications received within 168 days before the first vaccination.\n13. Serious adverse reactions to vaccines or to vaccine components, including a history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and\u002For abdominal pain.\n14. Immunoglobulin received within 60 days before the first vaccination.\n15. Autoimmune disease, connective tissue disease, or history of vasculitis. A volunteer with a history of a potential immune-mediated medical condition (PIMMC), either active or remote. Not exclusionary: (1) remote history of Bell's palsy (\\>2 years ago) not associated with other neurologic symptoms; (2) mild psoriasis or other mild, uncomplicated, localized or dermatologic condition that does not require ongoing systemic treatment; (3) remote history (\\>10 years ago) of Kawasaki disease without sequelae; and (4) celiac disease well controlled for 6 months with diet only.\n16. Immunodeficiency.\n17. Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health as per the investigator's judgement.\n18. Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a volunteer's ability to give informed consent.\n19. Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.\n20. Current anti-tuberculosis (TB) prophylaxis or therapy.\n21. Asthma other than mild, well-controlled asthma\n22. Diabetes mellitus type 1 or type 2, including cases controlled with diet alone. (Not excluded: history of isolated gestational diabetes.)\n23. Uncontrolled thyroid disease, recent thyroidectomy, or new onset hypothyroidism or hyperthyroidism, defined as new or changing doses of thyroid medication within the last 12 months.\n24. Hypertension\n\n    * If a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled (defined as ≥ 90 mmHg diastolic or ≥ 140 mmHg systolic after 10 minutes' rest).\n    * If a person has NOT been found to have elevated blood pressure or hypertension during screening or previously, exclude for systolic blood pressure ≥ 140 mm Hg at enrollment or diastolic blood pressure ≥ 90 mm Hg at enrollment. One repeat attempt at measurement on a different date is allowed.\n25. Bleeding disorder diagnosed by a doctor.\n26. Malignancy.\n27. Seizure disorder: History of seizure(s) within past three years.\n28. Asplenia: any condition resulting in the absence of a functional spleen.\n29. History of hereditary angioedema, acquired angioedema, or idiopathic angioedema.","ALL","55 Years",{"count":88,"type":24},126,[27],"The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of polyvalent env (A,B,C,A\u002FE)\u002Fgag (C) DNA prime and gp120 (A,B,C,A\u002FE) protein HIV-1 vaccines boost (PDPHV) with either Alhydrogel or GLA-SE in healthy, HIV-uninfected adults.\n\nVolunteers will receive either the PDPHV or the placebo (normal saline) by intramuscular injections. Some volunteers will receive Alhydrogel and others will receive GLA-SE as part of the protein boost.",[33],[93,94,95,96],"HIV-1","vaccine","antibody","human study","2026-06-25",{"date":99,"type":44},"2026-06-30",{"date":101,"type":24},"2026-09-01",{"date":103,"type":24},"2029-08",{"name":105,"class":106},"Worcester HIV Vaccine","INDUSTRY",2,{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":18,"sex":85,"minAge":60,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":25,"phases":119,"briefSummary":120,"conditions":121,"keywords":124,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100636430","examining-migration-social-bonds-transnationalism-and-hiv-prevention-pathways-among-african-immigrants-100636430","NCT07565584","Examining Migration, Social Bonds, Transnationalism, and HIV Prevention Pathways Among African Immigrants.","Migration, Social Bonds, Transnationalism, and HIV Prevention Pathways Among African Immigrants (MiST-Pathways)","MiST-Pathways","Inclusion Criteria: Individuals must meet ALL of the following criteria:\n\n* Age 18 to 50 years at the time of enrollment\n* Self-identify as a first-generation African immigrant (born in an African country and currently residing in the United States)\n* Currently reside in New York or Massachusetts\n* Able to communicate in English at approximately a 3rd-grade reading level\n* Have access to a smartphone or computer with internet capability sufficient to participate in Zoom and\u002For WhatsApp-based study activities\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Are under 18 years of age\n* Do not self-identify as a first-generation African immigrant\n* Do not reside in New York or Massachusetts\n* Are unable to provide informed consent\n* Do not have access to the technology required for virtual participation (Zoom and\u002For WhatsApp)","50 Years",{"count":118,"type":24},144,[64],"The goal of this mixed-methods pilot study is to learn whether migration experiences, social bonds, and transnational ties shape HIV prevention decision-making, including HIV testing, HIV self-testing (HIVST), and pre-exposure prophylaxis (PrEP) uptake, among first-generation African immigrants aged 18 to 50 residing in New York and Massachusetts. The main questions it aims to answer are:\n\n* What relationship typologies and migration-related relational mechanisms influence HIV testing, HIVST, and PrEP decision-making among African immigrants?\n* Can a relationship-tailored HIV prevention intervention component, co-developed with the community, demonstrate feasibility and acceptability among African immigrants?\n* Does exposure to the prioritized intervention component show directional increases in HIV testing intention, willingness to use HIVST, interest in PrEP, and readiness for relationship-based prevention communication? There is no comparison group. All Aim 3 participants receive the same co-developed intervention component.\n\nParticipants will:\n\n* Complete a qualitative interview (60-90 minutes) and\u002For a structured electronic survey (15-20 minutes) about their relationship experiences, migration history, and HIV prevention behaviors.\n* Take part in a 3-4 hour structured group deliberation session called a Palava Hut Conversation to co-develop and prioritize HIV prevention intervention ideas.\n* Complete a baseline survey, receive the prioritized intervention component in a structured Zoom session, and complete a follow-up survey with an optional 60-90 minute cognitive interview for a subset of participants.",[33,122,123],"HIV Testing","Sexual and Reproductive Health",[125,126,127,128,129,33,130],"HIV selt-testing (HIVST)","Pre-exposure prophylaxis (PrEP)","African immigrants","Transnationalism","Relationship Typologies","Palava Hut Conversations","2026-06-24",{"date":133,"type":44},"2026-06-29",{"date":135,"type":24},"2026-08-04",{"date":137,"type":24},"2027-09",{"name":139,"class":51},"State University of New York at Buffalo",1,{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":18,"sex":147,"minAge":60,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":25,"phases":150,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":164,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":77},"100615436","evaluating-an-interactive-digital-toolkit-for-womens-prep-implementation-100615436","NCT07292584","Evaluating an Interactive Digital Toolkit for Women's PrEP Implementation","Inclusion Criteria:\n\n* HIV-negative\n* Cisgender women\n* 18 years or older\n* English-speaking\n* Report sexual activity in the last six months or anticipate sexual activity in the next six months.\n\nExclusion Criteria:\n\n* Younger than 18 years of age\n* Do not identify as female and\u002For were not biologically assigned female at birth\n* Living with HIV\n* Report no sexual activity in the past six months and no anticipated sexual activity in the next six months\n* Unable or unwilling to provide informed consent","FEMALE",{"count":149,"type":24},125,[64],"The goal of this study is to test if a Digital PrEP Toolkit helps cisgender women learn about and access PrEP in Alabama and Mississippi. PrEP is a medication that prevents HIV infection. The main questions it aims to answer are: Can participants complete the Digital PrEP Toolkit in under 10 minutes? Do participants find the Digital PrEP Toolkit useful and easy to use? Does the Digital PrEP Toolkit increase the number of women who start taking PrEP?\n\nInvestigators will work with up to 125 women at 3 HIV and STI clinics in Alabama and Mississippi.\n\nParticipants will use the Digital PrEP Toolkit on a tablet at the clinic. They will answer questions about their HIV knowledge before and after using the Toolkit. Participants will then discuss PrEP options with a healthcare staff member and decide if they want to start PrEP. Participants will answer follow-up questions at 3 months. Investigators will also review participants' medical records at 6 months to see if they started PrEP and are still taking it.",[33,153,123],"HIV Risk",[36,155,156,157,158,159,160,161,162,163],"HIV prevention","cisgender women","Digital Health","Digital Intervention","Health Education","Decision Support Tool","Alabama","Mississippi","Southeast United States","RECRUITING","2026-06-18",{"date":167,"type":44},"2026-06-23",{"date":169,"type":44},"2026-04-20",{"date":171,"type":24},"2027-12",{"name":173,"class":51},"University of Alabama at Birmingham",{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":85,"minAge":60,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":25,"phases":184,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":164,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":107},"100603426","restore-study-r61-phase-recovery-and-engagement-for-stimulant-users-on-re-entry-100603426","NCT07136363","RESTORE Study R61 Phase: Recovery and Engagement for Stimulant Users on Re-entry","RESTORE Study R61 Pilot Phase: Recovery and Engagement for Stimulant Users on Re-entry","RESTORE","Inclusion Criteria:\n\n* Be 18 years of age or older\n* Have a DSM-5 diagnosis of stimulant use disorder (methamphetamine and\u002For cocaine)\n* Be at risk for or living with HIV\n* Be transitioning to the community from a closed justice setting, such as:\n\nJail Prison Justice-mandated residential substance use program\n\n* Be able to provide informed consent\n* Be willing and able to use a smartphone app (DynamiCare)\n\nExclusion Criteria:\n\n* Severe medical or psychiatric disability making participation unsafe\n* Unable to provide consent or engage with the intervention",{"count":183,"type":24},40,[64],"Justice-involved individuals face disproportionately high rates of stimulant use disorder and HIV, along with disrupted access to HIV treatment and prevention services like ART and PrEP. Contingency management (CM) is the most effective intervention for stimulant use, but its use in justice-involved populations has been limited by logistical and structural barriers. DynamiCare is an FDA-approved mobile app that delivers behavioral CM and has shown promise in reducing stimulant use, but its impact on HIV-related outcomes remains unknown. The RESTORE study (Recovery and Engagement for Stimulant Users on Re-entry) will evaluate whether combining DynamiCare with patient navigation (DynamiCare-plus) improves PrEP\u002FART initiation and reduces stimulant use among individuals recently released from justice settings. The R61 phase will assess feasibility, acceptability, and preliminary effectiveness among 40 participants. If milestones are met, the R33 phase will scale to a randomized controlled trial with 252 participants to assess effectiveness, implementation, and cost. This scalable, mobile approach has the potential to address a critical gap in care for a highly vulnerable population.",[30,187,188,33],"Stimulant Use Disorder","Justice Involved Populations","2026-06-12",{"date":191,"type":44},"2026-06-15",{"date":193,"type":44},"2026-06-01",{"date":195,"type":24},"2027-07-31",{"name":197,"class":51},"University of Texas Southwestern Medical Center",{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":85,"minAge":205,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":25,"phases":208,"briefSummary":210,"conditions":211,"keywords":212,"overallStatus":164,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":225},"100553366","phase-4-post-injectable-cabotegravir-antiretroviral-salvage-strategy-options-trial-100553366","NCT06485154","Post-Injectable Cabotegravir Antiretroviral Salvage Strategy Options Trial","PICASSO","Inclusion Criteria:\n\n1. Male or female.\n2. Age ≥ 15 years, inclusive, at the time of signing the informed consent.\n3. Body weight ≥ 35 kg.\n4. Confirmed HIV-1 infection.\n5. Exposure to at least one dose of CAB-LA PrEP in the past 12 months.\n6. Consent to initiation of ART.\n7. Estimated glomerular filtration rate (eGFR) \\> 50 min\u002FmL\n\nExclusion Criteria:\n\n1. Any previous exposure to DTG.\n2. Concurrent or recent (within the preceding 3 months) participation in another interventional clinical trial with a compound likely to interfere with any of the investigational medicinal products.\n3. Known hypersensitivity or specific contraindications to the use of any of the active drugs in the treatment arms or similar compounds.\n4. Is receiving or has received the following agents within 28 days prior to screening, and cannot discontinue their use for the duration of the study:\n\n   1. tuberculosis therapy (i.e., rifampicin, rifapentine, rifabutin), with the exception of isoniazid (INH) prevention therapy;\n   2. anti-convulsants (e.g., carbamazepine, oxcarbazepine, phenobarbital, phenytoin);\n   3. herbal products (e.g., St John's Wort).\n5. Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the volunteer or the objectives of the study or impair their ability to comply with the dosing schedule and\u002For protocol evaluations. The Investigator should make this determination in consideration of the volunteer's medical history.\n6. Participant is judged by the Investigator to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results. This including inability or an unwillingness to be followed up for the study period.","15 Years",{"count":207,"type":24},100,[209],"PHASE4","This is a single-arm, open-label, effectiveness study designed to evaluate the use of Tenofovir, Lamivudine, and Dolutegravir in people with newly diagnosed HIV-1 infection initiating first-line Antiretroviral Therapy with Cabotegravir-Long-acting Pre-Exposure Prophylaxis exposure in the preceding 12 months. Participants will be followed up for a period of 12 months from enrolment.",[33],[213,214,215],"Pre-Exposure Prophylaxis (PrEP)","Antiretroviral therapy","Tenofovir Disoproxil Fumarate\u002FLamivudine\u002FDolutegravir","2026-06-04",{"date":218,"type":44},"2026-06-09",{"date":220,"type":44},"2024-06-01",{"date":222,"type":24},"2026-08-31",{"name":224,"class":51},"University of Witwatersrand, South Africa",3,{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":85,"minAge":60,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":25,"phases":234,"briefSummary":235,"conditions":236,"keywords":238,"overallStatus":164,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":140},"100637702","feasibility-of-internet-based-hiv-prevention-research-100637702","NCT07625917","Feasibility of Internet-based HIV Prevention Research","Inclusion Criteria:\n\n* 18 years or older\n* US residency\n* English or Spanish fluency\n* injection drug use (self-report, past 30 days)\n* basic reading comprehension\n\nExclusion Criteria:\n\n* HIV status known to be positive",{"count":233,"type":24},500,[64],"The study will use social media to recruit a diverse sample of people who self-report injecting drugs, assessing the feasibility of online assessments and participants' ability to perform at-home self-administered HIV testing. Participants will complete online questionnaires at baseline and will be mailed HIV testing kits that they will self-administer and mail to a central laboratory. Investigators will track completion of questionnaires and whether at-home self-administered HIV tests were completed and sent to the laboratory.",[33,237],"Injection Drug Use",[239],"HIV testing","2026-05-29",{"date":216,"type":44},{"date":243,"type":44},"2025-08-01",{"date":245,"type":24},"2028-05-29",{"name":247,"class":51},"Montefiore Medical Center",{"id":249,"slug":250,"hasResults":12,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":18,"sex":147,"minAge":60,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":25,"phases":258,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":225},"100600902","initiative-for-chinese-sex-workers-to-promote-wellbeing-and-improve-hiv-prevention-by-reducing-intersectional-stigma-100600902","NCT07103525","Initiative for Chinese Sex Workers to Promote Wellbeing and Improve HIV Prevention by Reducing intersEctional Stigma","INSPIRE: Initiative for Chinese Sex Workers to Promote Wellbeing and Improve HIV Prevention by Reducing intersEctional Stigma","INSPIRE","Inclusion Criteria:\n\n* Female Sex Workers: A person who identifies as a woman, Chinese, a massage parlor (MP) worker in Queens, who is at least 18 years old, and has provided sexual services in the past 12 months, will be eligible.\n* Community advisory board (CAB) members: self identifies as a community member providing services to immigrant Chinese women and is at least 18 years old.\n* Peer Advocates: self identifies as current or previous sex worker, is a Chinese adult woman, and speaks both Mandarin and English.\n* Medical Providers: self identifies as a current medical provider who works with Chinese immigrant adults and speaks English.\n\nExclusion Criteria:\n\n* Female Sex Workers: Because completion of HIV testing is our primary study outcome, women who received an HIV test in the previous 3 months or who know they are HIV-positive will be excluded from the study.\n* Community advisory board (CAB) members: Does not speak English or is under the age of 18.\n* Peer Advocates: Does not speak English\u002FMandarin or is under the age of 18.\n* Medical Providers: Does not speak English or does not provide care to Chinese immigrant adults (e.g., pediatricians).",{"count":257,"type":24},70,[64],"During the development phase (Aim 1), investigators will use a community-driven process to further refine a preliminary intervention design that was developed based on previous research.\n\nFor the intervention phase (Aim 2), investigators will conduct a pilot randomized controlled trial of the multi-level intervention. For the individual-level component of the intervention, investigators will recruit 70 Chinese immigrant FSWs who work in MPs in Queens, NYC (n=35 intervention participants and n=35 control participants).\n\nTo assess the feasibility and acceptability of intervention implementation (Aim 3), investigators will conduct in-depth qualitative interviews with 12 FSW study participants and the 2 peer advocates and focus groups with 4-5 staff from each of the 3 organizations (3 focus groups total and 12-15 focus group participants in total).",[33,261],"Wellbeing","2026-05-28",{"date":240,"type":44},{"date":265,"type":24},"2026-06",{"date":267,"type":24},"2028-01",{"name":269,"class":51},"NYU Langone Health",{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":18,"sex":147,"minAge":60,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":25,"phases":280,"briefSummary":281,"conditions":282,"keywords":283,"overallStatus":164,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":286,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":140},"100565185","using-prep-doing-it-for-ourselves-100565185","NCT06638892","Using PrEP, Doing It for Ourselves","Cluster Randomized Controlled Trial of Using PrEP, Doing it for Ourselves [UPDOs] Protective Styles: A Multi-level Intervention to Improve HIV Testing and PrEP Uptake Among At-risk Populations Living in the Southeastern Region of the United States","UPDOs","Inclusion Criteria:\n\n* Black\n* cisgender female\n* Ages 18+\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Does not identify as Black\n* Not a cisgender female",{"count":279,"type":24},1000,[64],"The goal of this clinical trial is to test a new online program called UPDOs Protective Styles to help people in the southeastern United States learn about and start using PrEP (pre-exposure prophylaxis), a medicine that helps prevent HIV. The study focuses on people who may be at higher risk for HIV and have not had equal access to PrEP.\n\nThe main questions it aims to answer are:\n\nDoes UPDOs help more people trust and understand PrEP? Does UPDOs increase the number of people who start and continue using PrEP?\n\nResearchers will compare two groups:\n\nOne group will use UPDOs, which includes six weekly videos, blog discussions, and access to telehealth services through Q Care Plus. The other group will receive standard HIV prevention materials from the CDC.\n\nParticipants will:\n\nBe recruited from 32 beauty salons in areas with high HIV rates. Complete surveys at the start of the study and again at 6, 12, 24, 32, and 52 weeks.\n\nHave access to HIV testing and PrEP prescriptions through Q Care Plus.\n\nThis study will also look at how well the program works in different communities and how easy it is to use and share.",[33,36],[284,285],"Black Women","Community-based Research",{"date":193,"type":44},{"date":288,"type":44},"2026-02-13",{"date":290,"type":24},"2030-01",{"name":292,"class":51},"Duke University",{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":18,"sex":19,"minAge":60,"maxAge":301,"enrollmentInfo":302,"targetDuration":4,"studyType":25,"phases":303,"briefSummary":304,"conditions":305,"keywords":308,"overallStatus":164,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":323,"locationsCount":107},"100603210","safe-spaces-4-sexual-health-100603210","NCT07133555","Safe Spaces 4 Sexual Health","Expanding Safe Spaces 4 Sexual Health, a Mobile Van HIV\u002FSTI Testing and Care Linkage Strategy, for MSM in Online Spaces","SS4SH","Inclusion Criteria:\n\n* Male\n* 18-49 years of age\n* Ability to read and speak English\n* Baltimore area resident\n* Report sex with a male in the past 12 months\n\nExclusion Criteria:\n\n* not male-self identified individual","49 Years",{"count":207,"type":24},[64],"In an earlier study, the study team carried out an HIV\u002FSexually transmitted infection (STI) testing approach which found men who have sex with men (MSM) at-risk of getting or spreading HIV in online spaces and linked them to testing services on a mobile van. The goal of this present study is to add on to this approach by connecting participants (MSM aged 18-49 residing in the Baltimore area) with a peer health navigator to support them with getting pre-exposure prophylaxis (PrEP) or HIV care services after testing. Researchers will compare using a peer health navigator approach to using a referrals-only approach to get PrEP or HIV care services. Participants will be assigned to either Arm A (group that receives peer health navigator help) or Arm B (group that gets referred) to get PrEP or HIV care.",[306,307,33],"HIV Counseling and Testing","HIV Risk Behavior",[309,310,311,312,313,314,315,316],"geosocial networking application","peer health coach","peer health navigator","hiv mobile testing","black msm","online spaces","linkage to HIV treatment","linkage to HIV prevention","2026-05-21",{"date":319,"type":44},"2026-05-22",{"date":321,"type":44},"2025-08-10",{"date":99,"type":24},{"name":324,"class":51},"Johns Hopkins University",{"id":326,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":21,"enrollmentInfo":327,"targetDuration":4,"studyType":25,"phases":328,"briefSummary":28,"conditions":329,"keywords":330,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":52},"100632158",{"count":23,"type":24},[27],[30,31,32,33],[30,31,35,36,37,38,39],"2026-05-19",{"date":319,"type":44},{"date":334,"type":24},"2026-04",{"date":336,"type":24},"2029-09",{"name":50,"class":51},{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":344,"eligibilityCriteria":345,"healthyVolunteers":18,"sex":85,"minAge":60,"maxAge":346,"enrollmentInfo":347,"targetDuration":4,"studyType":25,"phases":349,"briefSummary":350,"conditions":351,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":357,"leadSponsor":359,"locationsCount":140},"100637993","mhealth-service-linkage-for-young-adults-impacted-by-the-criminal-legal-system-100637993","NCT07599722","mHealth Service Linkage for Young Adults Impacted by the Criminal Legal System","Technology Enhanced Substance Use and HIV Service Navigation for Justice-Involved Young Adults","LYNX","Inclusion Criteria:\n\n* Self-report recent criminal legal involvement (past year);\n* Self-identify as HIV-negative\n* Endorse behaviors in the past 6 months indicating consideration of PrEP per the Center for Disease Control and Prevention's (CDC) risk indices\n* Meet the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) Tools' criteria for identifying the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) substance use disorder\n* Are conversant in English.\n\nExclusion Criteria:\n\n* Being on PrEP\n* Cognitive delays that would interfere with consent or participation\n* Inability to provide contact information for \\>2 locator individuals","29 Years",{"count":348,"type":24},50,[64],"This study is designed to test Project LYNX, a program designed to help young adults (ages 18-29) with recent criminal legal system involvement can find and get connected to substance use and HIV-prevention services in the community. The program combines support from a trained peer navigator with easy-to-use digital tools.\n\nThe study will:\n\n* Adapt an existing navigator program by adding new digital (eHealth) tools that were co-developed with young adults. These tools will help navigators refer participants to the right health services.\n* Refine and test the updated program to make sure it works well and is easy to use.\n* Evaluate whether the program is feasible, acceptable, and helpful in linking young adults to substance use treatment and HIV-prevention services.\n\nThe overall goal is to create a practical, user-friendly system that supports young adults find and get connected to services for substance use and HIV prevention that they need.",[33,352],"Substance Use","2026-05-13",{"date":355,"type":44},"2026-05-20",{"date":69,"type":24},{"date":358,"type":24},"2027-02-01",{"name":360,"class":51},"University of Pittsburgh",{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":367,"eligibilityCriteria":368,"healthyVolunteers":18,"sex":19,"minAge":60,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":25,"phases":370,"briefSummary":371,"conditions":372,"keywords":373,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":107},"100566912","pre-exposure-prophylaxis-prep-adherence-for-black-msm-100566912","NCT06661343","Pre-exposure Prophylaxis (PrEP) Adherence for Black MSM","A Multi-Level Integrated Strategy to Optimize PrEP Adherence for Black MSM and Accelerate Implementation at Scale","C4+3MV","Inclusion Criteria:\n\n* Self-identify as male.\n* Self-Identify as Black people.\n* Aged 18 or older.\n* Self Report having sex with men in the past 6 months.\n* Eligible for PrEP or currently prescribed PrEP.\n* Willing to participate in behavioral intervention sessions.\n\nExclusion Criteria:\n\n* Currently diagnosed with HIV.\n* Unable to provide informed consent.\n* Unable to fully engage with the intervention due to health issues.\n* Participating in another clinical trial with conflicting outcomes.",{"count":233,"type":24},[64],"The goal of this clinical trial is to learn if two interventions-C4 and C4+3MV-can improve PrEP adherence (taking medication to prevent HIV) among Black men who have sex with men (MSM). The study will also explore the most effective ways to support participants in continuing their PrEP use over time.\n\nThe main questions it aims to answer are:\n\n* Does the C4 program help participants take PrEP more regularly?\n* Does adding the 3MV intervention to C4 provide additional support for adherence?\n\nResearchers will compare two intervention strategies to see if they result in better PrEP adherence:\n\n* C4 Intervention: A program focused on individualized care coordination and addressing structural needs.\n* C4 + 3MV Intervention: A combination of care coordination with additional behavioral change sessions.\n\nParticipants will:\n\n* Participate in PrEP education and counseling sessions.\n* Have their PrEP use monitored through dried blood spot (DBS) tests.\n* Complete questionnaires about their experiences and challenges with PrEP. Receive support sessions tailored to address individual barriers to PrEP adherence.",[33],[30,36,374,375,376,377,378],"Black MSM","Stigma Reduction","Client Centered Care Coordination","Many Men Many Voices","Evidence-based Intervention",{"date":380,"type":44},"2026-05-18",{"date":382,"type":24},"2026-08-01",{"date":384,"type":24},"2029-06-30",{"name":76,"class":51},{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":392,"eligibilityCriteria":393,"healthyVolunteers":18,"sex":147,"minAge":205,"maxAge":86,"enrollmentInfo":394,"targetDuration":4,"studyType":25,"phases":396,"briefSummary":397,"conditions":398,"keywords":401,"overallStatus":164,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":413,"locationsCount":140},"100528235","phase-4-uncpm-22314---pregnancy-infant-and-maternal-health-outcomes-study-100528235","NCT06158126","UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study","UNCPM 22314 - Evaluating the Safety of Pregnancy, Infant and Maternal Health Outcomes Among PrEP Users in Malawi","PrIMO","Inclusion Criteria:\n\nMaternal participants:\n\n* Confirmed pregnancy by urine pregnancy test or ultrasound.\n* Aged 15 years or older\n* PrEP-eligible by Malawi local guidelines\n* Confirmed HIV-negative based on the local HIV testing algorithm\n* Hepatitis B surface antigen (HBsAg) negative\n* Weight \\>35 kg\n* Provided informed consent and expressed willingness to participate in study activities with their infants.\n\nInfant participants: Infant participants will enter the study with their mother as unborn infants. There are no specific eligibility criteria for infant participation otherwise.\n\nExclusion Criteria:\n\nMaternal participants will not be eligible to enter the prospective cohort study if any of the following conditions are identified during the screening process:\n\n* Known to be living with HIV\n* Known allergies to CAB-LA, TDF\u002F3TC or FTC\u002FTDF\n* Other current significant disease process (active or chronic), substance use, or social circumstances that, in the judgment of the site investigator would make participation in the study unsafe.\n* Intention to leave the study site's catchment area of Bwaila before scheduled study exit.",{"count":395,"type":24},621,[209],"The primary purpose of this study is to assess the safety of long-acting injectable cabotegravir (CAB-LA) and oral pre-expose prophylaxis (PrEP) (FTC\u002FTDF or 3TC\u002FTDF) for the prevention of HIV during pregnancy and breastfeeding among pregnant women and their infants in Malawi. The main question the study aims to answer is:\n\n\\- Do composite adverse pregnancy events, maternal health outcomes, and\u002For infant health outcomes differ between individuals taking oral PrEP and those taking CAB-LA?\n\nWomen who are already using PrEP at the time of pregnancy diagnosis or those who initiate PrEP during pregnancy will enroll into a Safety Cohort where they will be closely followed up during pregnancy while optimizing their antenatal care (ANC) per the Malawi ANC package. Women will have access to either CAB-LA or oral PrEP and will be given an opportunity to choose one option. Women and their infants will attend a series of follow-up visits through pregnancy, birth, and the postnatal period.\n\nIn addition, the study will contribute to the development of a national PrEP Pregnancy Registry which will be initially rolled out in Lilongwe and Blantyre -the two most populous cities in Malawi-before a nationwide roll out begins under the guidance of the Malawi Ministry of Health.",[399,33,400],"Pre-exposure Prophylaxis","Pregnancy Related",[36,402,403,404,155,405,406],"Pregnancy","Breastfeeding","Infant health","Maternal health","Eliminating mother-to-child transmission (EMTCT)","2026-05-01",{"date":409,"type":44},"2026-05-05",{"date":411,"type":44},"2024-04-17",{"date":171,"type":24},{"name":414,"class":51},"University of North Carolina, Chapel Hill",{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":421,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":85,"minAge":60,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":424,"phases":4,"briefSummary":425,"conditions":426,"keywords":427,"overallStatus":164,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":435,"leadSponsor":437,"locationsCount":140},"100628851","mobile-vehicle-based-delivery-of-lenacapavir-pre-exposure-prophylaxis-in-los-angeles-county-100628851","NCT07467018","Mobile Vehicle-Based Delivery of Lenacapavir Pre-Exposure Prophylaxis in Los Angeles County","Mobile Vehicle-Based Delivery of Lenacapavir Pre-Exposure Prophylaxis in Los Angeles County (MOVE-LA)","MOVE-LA","Inclusion Criteria:\n\n* Being reached for mobile health services by a UCLA HHC mobile van\n* ≥18 years of age\n* Able to provide informed consent\n* English or Spanish-speaking\n* Willing and able to comply with study procedures\n* HIV unknown or negative status and HIV negative based on rapid 4th generation Ag\u002FAb test on the day of enrollment\n* At-risk for HIV, based on clinician assessment (based on CDC guidelines; includes any individual requesting PrEP, regardless of reported risk factors for HIV)\n* Pregnant and breastfeeding women\u002Fpeople can be offered LEN with counseling about benefits and risks.\n\nExclusion Criteria:\n\n* Any clinical or psychosocial condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to take LEN PrEP\n* Known hypersensitivity to the study drug, the metabolites, or formulation excipient\n* BMI \\\u003C35 kg\u002Fm2 (77 pounds)\n* On oral or other long-acting PrEP and unwilling to discontinue\n* Already taking LEN for HIV prevention\n* Known HIV diagnosis or positive 4th generation HIV Ab\u002FAg test (on day of enrollment) or subsequent lab-based confirmatory testing.",{"count":207,"type":24},"OBSERVATIONAL","This project evaluates the implementation strategy of the delivery of lenacapavir pre-exposure prophylaxis (LEN PrEP) - a newly available long-acting, injectable medication for human immunodeficiency virus (HIV) prevention - via a mobile health van model for people who are unstably housed in Los Angeles County (LAC). People who are unhoused or are facing housing instability experience significant barriers to accessing HIV prevention care in traditional clinic settings. In 2022, approximately 13% of newly diagnosed HIV cases in LAC were experiencing homelessness, a 36% increase over the prior period. The study will work with the University of California, Los Angeles (UCLA) Health's Homeless Healthcare Collaborative (HHC), which operates mobile health vans staffed by clinicians, social workers, and community health workers, to bring LEN PrEP directly to community settings, such as shelters, encampments, community centers, and transitional housing facilities.\n\nThis study has three primary aims:\n\n1. Characterize uptake of LEN PrEP among unstably housed people in LAC receiving health services via HHC's mobile program.\n2. Evaluate how many study participants stay on LEN PrEP through 52 weeks.\n3. Understand costs, acceptability, and sustainability of the mobile LEN PrEP delivery model.",[33],[428,429,155,430],"lenacapavir","community-based health delivery","homelessness","2026-04-21",{"date":433,"type":44},"2026-04-23",{"date":431,"type":44},{"date":436,"type":24},"2027-12-31",{"name":438,"class":51},"University of California, Los Angeles",{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":18,"sex":147,"minAge":205,"maxAge":21,"enrollmentInfo":447,"targetDuration":4,"studyType":25,"phases":449,"briefSummary":450,"conditions":451,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":458,"leadSponsor":460,"locationsCount":225},"100634950","peer-led-service-delivery-model-for-pregnant-and-lactating-adolescent-girls-and-young-women-in-zimbabwe-100634950","NCT07546344","Peer-led Service Delivery Model for Pregnant and Lactating Adolescent Girls and Young Women in Zimbabwe","Peer-led Service Delivery Model to Increase HIV Prevention and Contraception in Pregnant and Lactating Adolescent Girls and Young Women in Zimbabwe: a Pilot Study","Ontanga","Inclusion Criteria:\n\n* either pregnant or have at least one child who is less than 18 months of age at the time of initial engagement\n* Aged 15 - 24 years old",{"count":448,"type":24},600,[64],"This is a pilot cluster-randomized control trial co-led by Dr. Valentina Cambiano, Associate Professor of Epidemiology at University College London, UK and Professor Euphemia Sibanda, Research Director at the Centre for Sexual Health and HIV Research (CeSHHAR Zimbabwe). The goal of the proposed study is to evaluate the appropriateness, feasibility, acceptability, uptake, costs and cost-effectiveness of a community-based, HIV-status neutral peer-led service delivery model in which young mentor mothers (YMM) work with pregnant and lactating adolescent girls and young women (PL-AGYW, aged 15-24), up to two-years post-birth, in Zimbabwe to promote uptake of contraception and HIV prevention.\n\nYMM living with HIV have been found to be effective in supporting their peers for prevention of mother-to-child transmission of HIV and adherence to treatment through the \"Zvandiri\" programme. The investigators propose adapting the \"Zvandiri\" YMM to include those without HIV to promote behaviour to prevent HIV and unintended pregnancies. This proposed intervention is building on the formative work that had the overall aim of co-developing with AGYW (aged 15-24) a Pre-Exposure Prophylaxis (PrEP) implementation intervention for AGYW who need it, that attracts them to PrEP, and supports pregnant and lactating adolescent girls and young women while taking it.",[33,452,453],"Contraceptive Usage","Adherence, Medication","2026-04-16",{"date":456,"type":44},"2026-04-22",{"date":334,"type":24},{"date":459,"type":24},"2027-06",{"name":461,"class":51},"University College, London",{"id":463,"slug":464,"hasResults":12,"nctId":465,"briefTitle":466,"officialTitle":467,"acronym":468,"eligibilityCriteria":469,"healthyVolunteers":18,"sex":85,"minAge":60,"maxAge":4,"enrollmentInfo":470,"targetDuration":4,"studyType":25,"phases":471,"briefSummary":472,"conditions":473,"keywords":474,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":484,"leadSponsor":486,"locationsCount":140},"100579161","private-sector-access-to-testing-for-health-sustainability-100579161","NCT06820697","Private-sector Access to Testing for Health Sustainability","Expanding Access to HIV Self-test Kits: Sustaining Private Sector Channels That Enable Access to Preventive Health Services","PATHS","Inclusion Criteria:\n\n* Owners\u002Fstaff of retail drug shops and pharmacies located in the study regions\n* Age 18 and older\n\nExclusion Criteria:\n\n* Refusal to install and track sales and distribution of HIVST kits using the Maisha Meds data system provided.",{"count":23,"type":24},[64],"New and innovative strategies are urgently needed to increase the uptake of HIV prevention and sexual and reproductive health services among adolescent girls and young women (AGYW) in sub-Saharan Africa. To ensure the real-world sustainability of free distribution of HIV self-test kits to AGYW by private drug shops and pharmacies, investigators will rigorously test supply-side subsidy structures for shopkeepers' provision of HIV-self test kits to AGYW combined with prosocial motivational supports. The combination of non-monetary and monetary support structures aims to emulate real-world health financing models for public-private partnerships and ultimately aims to improve equity in access to critical prevention services for AGYW at scale.",[33],[30,475,476,477,478,479],"Tanzania","Pharmacies","AGYW","HIV self-test kits","adolescent girls and young women","2026-04-14",{"date":482,"type":44},"2026-04-17",{"date":69,"type":24},{"date":485,"type":24},"2029-04-30",{"name":487,"class":51},"University of California, San Francisco",{"id":489,"slug":490,"hasResults":12,"nctId":491,"briefTitle":492,"officialTitle":492,"acronym":493,"eligibilityCriteria":494,"healthyVolunteers":12,"sex":85,"minAge":60,"maxAge":4,"enrollmentInfo":495,"targetDuration":4,"studyType":25,"phases":497,"briefSummary":498,"conditions":499,"keywords":503,"overallStatus":164,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":140},"100632143","integrating-sexual-pleasure-into-harm-reduction-services-for-men-who-have-sex-with-men-and-transgender-persons-who-engage-in-chemsex-or-substance-use-in-thailand-100632143","NCT07509853","Integrating Sexual Pleasure Into Harm Reduction Services for Men Who Have Sex With Men and Transgender Persons Who Engage in Chemsex or Substance Use in Thailand","PLEASURE","Inclusion Criteria:\n\n* MSM, transgender women, transgender men, or non-binary persons\n* Age ≥18 years\n* Engaged in chemsex or substance use within past 12 months\n* Able to provide informed consent\n\nExclusion Criteria:\n\n• Unable to communicate in Thai sufficiently to complete study procedures",{"count":496,"type":24},300,[64],"The study evaluates the integration of a sexual pleasure-based approach into harm reduction services for MSM and transgender persons engaging in chemsex or substance use in Thailand, using the \"Pleasuremeter\" tool to improve sexual health and related outcomes.",[33,352,500,501,502],"Mental Health","Sexually Transmitted Infections (STIs)","Chemsex",[504],"PrEP, Harm reduction, Chemsex, Transgender, Sexual pleasure","2026-04-02",{"date":507,"type":44},"2026-04-08",{"date":509,"type":44},"2025-05-01",{"date":511,"type":24},"2028-05-01",{"name":513,"class":51},"Institute of HIV Research and Innovation Foundation, Thailand",{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":518,"acronym":4,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":85,"minAge":60,"maxAge":4,"enrollmentInfo":520,"targetDuration":4,"studyType":25,"phases":522,"briefSummary":523,"conditions":524,"keywords":526,"overallStatus":164,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":528,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":140},"100632374","the-implementation-of-a-trans-tailored-harm-reduction-service-for-transgender-persons-in-relation-to-chemsex-and-substance-use-it-rex-100632374","NCT07512856","The Implementation of a Trans-tailored Harm Reduction Service for Transgender Persons in Relation to chemsEX and Substance Use (iT-REX)","Inclusion Criteria:\n\n* Self-identified transgender women, transgender men, or non-binary persons\n* Age ≥18 years\n* HIV-negative\n* Engaged in chemsex or substance use within past 12 months\n* Able to provide informed consent\n\nExclusion Criteria:\n\n• Inability to communicate in Thai sufficiently to complete study procedures",{"count":521,"type":24},140,[64],"This study evaluates a comprehensive transgender-tailored harm reduction service for transgender women, transgender men, and non-binary individuals engaging in chemsex or substance use in Thailand, focusing on PrEP uptake, HIV\u002FSTI outcomes, mental health, and socio-legal impacts.",[33,352,525,501,502],"Mental Health Disorders",[527],"PrEP, Harm reduction, Chemsex, Transgender",{"date":529,"type":44},"2026-04-06",{"date":531,"type":44},"2024-02-01",{"date":533,"type":24},"2028-02-01",{"name":513,"class":51},{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":539,"acronym":540,"eligibilityCriteria":541,"healthyVolunteers":18,"sex":19,"minAge":60,"maxAge":4,"enrollmentInfo":542,"targetDuration":4,"studyType":424,"phases":4,"briefSummary":544,"conditions":545,"keywords":546,"overallStatus":164,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":548,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":553,"locationsCount":140},"100632375","host-led-harm-reduction-approach-among-men-who-have-sex-with-men-who-engaged-in-chemsex-in-bangkok-thailand-a-pre-implementation-study-100632375","NCT07512869","Host Led Harm Reduction Approach Among Men Who Have Sex With Men Who Engaged in Chemsex in Bangkok, Thailand: A Pre-Implementation Study","HAMMOCK","Inclusion Criteria:\n\n* MSM aged ≥18 years\n* Able to communicate in Thai\n* Specific by group:\n\n  * Chemsex hosts: hosted ≥2 times in past 6 months\n  * Chemsex guests: attended ≥2 times in past 6 months\n  * CSO \u002F hospital \u002F police staff: working ≥3 months in related roles\n* Provide informed consent\n\nExclusion Criteria:\n\n• Unable to provide informed consent (e.g., under substance influence at consent)",{"count":543,"type":24},76,"This study evaluates the pre-implementation phase of a host-led harm reduction model for men who have sex with men (MSM) engaging in chemsex in Bangkok, Thailand, focusing on understanding harms, contexts, and needs to develop a tailored intervention.",[33,352,500,501],[547],"Chemsex, Harm reduction",{"date":529,"type":44},{"date":550,"type":44},"2025-02-17",{"date":552,"type":24},"2028-12-30",{"name":513,"class":51},{"id":555,"slug":556,"hasResults":12,"nctId":557,"briefTitle":558,"officialTitle":559,"acronym":4,"eligibilityCriteria":560,"healthyVolunteers":18,"sex":19,"minAge":60,"maxAge":561,"enrollmentInfo":562,"targetDuration":4,"studyType":25,"phases":564,"briefSummary":565,"conditions":566,"keywords":572,"overallStatus":164,"whyStopped":4,"lastUpdateSubmitDate":579,"lastUpdatePostDateStruct":580,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":586,"locationsCount":225},"100626311","california-meps-hub-100626311","NCT07433985","California MEPS Hub","California Hub for HIV\u002FSTI\u002FSUD Prevention Research With Reentry Populations","Inclusion Criteria:\n\nRCT Participants\n\n* Assigned male at birth\n* Ages 18 - 59\n* Was released from incarceration in the previous 12 months (incarceration is defined as a stay in jail, prison, or detention centers for over 24 hours)\n* Reports an SUD diagnosis or seeking SUD services at any time in the 24 months prior to enrollment\n* During the 24 months prior to enrollment, either:\n\n  1. Reports intercourse with a person assigned male at birth\n  2. Reports injection drug use\n* Has not received an HIV diagnosis (based on self-report)\n* Possesses a smartphone or plans to obtain one\n* Plans to reside within designated jurisdictions (counties) for the 9 months following enrollment\n\nCBO and agency staff participating in implementation surveys or interviews\n\n* \\>=18 years of age\n* Employed at a study site or otherwise involved with intervention implementation and\u002For maintenance OR works at an agency in the counties where the study is taking place (Los Angeles, Riverside, San Bernardino, and Alameda counties, California).\n* Willing to provide informed consent for participation.\n\nExclusion Criteria:\n\nRCT Participants:\n\n* Does not have a smart phone and is not willing to obtain one\n* Is not able to speak and understand English\n* Has insufficient reading skills to operate a mobile application on a cell phone\n\nCBO participating in implementation interviews\n\n\\- n\u002Fa","59 Years",{"count":563,"type":24},318,[64],"The California Hub for HIV\u002FSUD Prevention Research with Reentry Populations addresses the question: \"Can the evidence-based MEPS intervention be adapted and implemented at a range of organizations to effectively serve a wider range of clients?\"\n\nThe Mobile Enhanced Prevention Support (MEPS) intervention was originally implemented in Los Angeles County and was proven successful in promoting biomedical HIV prevention (PrEP) uptake and preventative screenings in people who used drugs who recently left incarceration. MEPS is an evidence-based intervention for people with substance use disorders (SUD) that incorporates a client-centered planning session, including trained peer mentors, service utilization incentives, and a mobile application (GeoPass).\n\nThe study includes a randomized controlled trial (RCT) across three community partners located in Riverside and Alameda Counties. At least 300 people will be enrolled in these three counties; the first 200 will be randomized to either receive the intervention or usual care, with the final 100 all receiving the intervention. The primary implementation outcome for the study involves using an implementation science framework and assessment tools to examine MEPS's implementation. Key outcomes include how well the implementation strategies used support intervention enrollment and retention, integration with existing services in each partnering community agency, and perceived intervention acceptability, feasibility, appropriateness, and maintenance at 6- and 12-months. The primary effectiveness outcome for the study is an increase in HIV testing, PrEP uptake and adherence, and SUD service utilization at 6 months and 12 months in the MEPS compared to the usual care group. Secondary effectiveness outcomes include frequency of service use for SUDs, hepatitis C virus testing, and linkage to care for those who test positive for HIV or hepatitis C.",[33,567,568,569,570,571],"Sexually Transmitted Infections (STI)","Preexposure Prophylaxis (PrEP)","Incarceration","Hepatitis C Virus (HCV)","Substance Use Disorder (SUD)",[573,574,575,576,577,578],"implementation science","contingency management","mobile health technology (mHealth)","community based participatory research","type 3 hybrid implementation effectiveness trial","randomized controlled trial","2026-04-01",{"date":581,"type":44},"2026-04-03",{"date":583,"type":44},"2025-12-01",{"date":585,"type":24},"2029-07-31",{"name":438,"class":51},{"id":588,"slug":589,"hasResults":12,"nctId":590,"briefTitle":591,"officialTitle":591,"acronym":592,"eligibilityCriteria":593,"healthyVolunteers":18,"sex":85,"minAge":60,"maxAge":4,"enrollmentInfo":594,"targetDuration":4,"studyType":424,"phases":4,"briefSummary":595,"conditions":596,"keywords":597,"overallStatus":164,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":140},"100631837","pre-implementation-study-to-develop-trans-tailored-services-for-transgender-persons-in-relation-to-chemsex-100631837","NCT07505875","Pre-implementation Study to Develop Trans-tailored Services for Transgender Persons in Relation to chemsEX","T-REX","Inclusion Criteria:\n\n* Age ≥18 years\n* Able to communicate in Thai\n* Provide informed consent\n\nExclusion Criteria:\n\n• Unable to participate in in-depth interview (IDI) (online or onsite)",{"count":348,"type":24},"The study is a pre-implementation cross-sectional study exploring chemsex behaviors among transgender persons and gathering perspectives from multiple stakeholders to inform the development of transgender-tailored harm reduction services.",[352,33,501],[547],"2026-03-31",{"date":529,"type":44},{"date":601,"type":44},"2024-05-01",{"date":603,"type":24},"2027-05-01",{"name":513,"class":51},{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":609,"acronym":4,"eligibilityCriteria":610,"healthyVolunteers":12,"sex":19,"minAge":60,"maxAge":346,"enrollmentInfo":611,"targetDuration":4,"studyType":25,"phases":613,"briefSummary":614,"conditions":615,"keywords":618,"overallStatus":164,"whyStopped":4,"lastUpdateSubmitDate":620,"lastUpdatePostDateStruct":621,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":225},"100632141","evaluation-of-mhealth-intervention-to-promote-hiv-prevention-and-overcome-stigma-among-transgender-women-empowher-100632141","NCT07509827","Evaluation of mHealth Intervention to Promote HIV Prevention and Overcome Stigma Among Transgender Women (EMPOW.HER)","Inclusion Criteria:\n\n* Age 18-29 years\n* Male sex at birth\n* Self-identify as transgender woman\u002Ffemale spectrum\n* HIV-negative (laboratory confirmed)\n* Recent condomless sex\n* Able to understand Thai\n* Not on PrEP or poorly adherent (≤3 pills\u002Fweek)\n\nExclusion Criteria:\n\n* Serious cognitive or psychiatric condition affecting consent\n* Active suicidal ideation or major mental illness\n* Medical contraindications to PrEP\n* Enrolled in another HIV intervention study",{"count":612,"type":24},108,[64],"This study aims to develop and evaluate a multi-component mHealth intervention (mHC and FRESH) to reduce HIV-related and intersectional stigma and improve PrEP use among HIV-negative young transgender women (TGW) in Thailand.",[33,616,617],"HIV Related Stigma","PrEP Adherence",[39,36,619],"HIV stigma","2026-03-29",{"date":581,"type":44},{"date":623,"type":44},"2024-08-01",{"date":625,"type":24},"2028-07-31",{"name":513,"class":51},{"id":628,"slug":629,"hasResults":12,"nctId":630,"briefTitle":631,"officialTitle":632,"acronym":4,"eligibilityCriteria":633,"healthyVolunteers":18,"sex":85,"minAge":60,"maxAge":4,"enrollmentInfo":634,"targetDuration":4,"studyType":25,"phases":636,"briefSummary":637,"conditions":638,"keywords":643,"overallStatus":164,"whyStopped":4,"lastUpdateSubmitDate":645,"lastUpdatePostDateStruct":646,"startDateStruct":648,"completionDateStruct":649,"leadSponsor":651,"locationsCount":140},"100607926","hiv-self-testing-for-partners-of-hiv-uninfected-postpartum-women-100607926","NCT07194902","HIV Self-testing for Partners of HIV-uninfected Postpartum Women","HIV Self-testing for Partners of HIV-uninfected Postpartum Women to Facilitate PrEP and Antiretroviral Therapy Uptake to Promote HIV Treatment and Prevention","Female Inclusion Criteria:\n\n* woman\n* Age ≥18\n* ≥30 weeks pregnant per medical record due date\n* non-reactive third trimester HIV test (verified from their antenatal care chart)\n* reporting at least one unknown-serostatus partner\n* fluent in English or isiZulu\n* willing to give researchers permission to contact them for repeated assessments\n* able to provide informed consent\n\nMale Inclusion Criteria: partners meeting the inclusion criteria as described above, and who complete verification questions to confirm their identity and status as the partners of the enrolled female participants. Additional inclusion criteria for men include:\n\n* man\n* Age ≥18\n* partner of enrolled women, confirmed via couples verification tool\n* fluent in English or isiZulu\n* willing to give researchers permission to contact them\n* able to provide informed consent.\n\nExclusion Criteria: Individuals with significant psychiatric illness that could interfere with participation or the ability to provide informed consent will be excluded at the discretion of the study team.",{"count":635,"type":24},120,[64],"The purpose of this study is to test the feasibility and acceptability of a combination intervention to promote HIV self-testing (HIVST) for Partners and PrEP uptake for HIV-uninfected Postpartum Women (\"H4P\"). H4P includes evidence-based cognitive behavioral therapy (CBT) strategies, such as communication skills training, motivational interviewing, and problem-solving. The investigators will conduct a randomized pilot trial of the H4P intervention to evaluate the feasibility, acceptability, and preliminary effectiveness of a multi-step PrEP uptake and HIV self-test kit intervention for postpartum HIV-uninfected women (N = 60 and their male partners) who report a partner of unknown serostatus, and their partners, in the province of KwaZulu-Natal, South Africa.",[639,640,68,641,642,33],"HIV Self-testing","Male Partners of HIV-negative Postpartum Women","Feasibility","Acceptability",[33,36,644],"HIV Self-Testing","2026-03-19",{"date":647,"type":44},"2026-03-23",{"date":645,"type":44},{"date":650,"type":24},"2026-08-28",{"name":652,"class":51},"Massachusetts General Hospital"]