[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hiv-infections\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hiv-infections":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,144,0,25,[9,40,67,89,120,141,169,194,216,246,273,296,326,357,385,416,439,465,489,511,532,558,580,605,632],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100629369","implementation-study-of-lenacapavir-pre-exposure-prophylaxis-for-hiv-prevention-100629369",false,"NCT07473778","Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention","Pioneering Research to Optimize Pre-exposure Prophylaxis (PrEP) Expansion With Lenacapavir (LEN)","PROPEL","Key Inclusion Criteria:\n\n* Able to comprehend and provide a signed written informed consent, which must be obtained prior to initiation of screening study procedures;\n* Willing and able to comply with all study requirements;\n* Presents at a study site needing or wanting PrEP for HIV prevention as determined by local clinical practice guidelines and institutional protocols, including new PrEP users (PrEP naïve) and current or former users of oral (emtricitabine\u002Ftenofovir disoproxil fumarate (coformulated; Truvada®; F\u002FTDF) or emtricitabine\u002Ftenofovir alafenamide (coformulated; Descovy®; F\u002FTAF)) or injectable (LEN or cabotegravir (CAB)) PrEP who indicate interest in discussing PrEP methods that they are clinically eligible to receive;\n* Eligible for LEN PrEP per standard of care procedures, for example, being HIV-1 negative at screening using a Food and Drug Administration (FDA) approved\u002Fcleared test for diagnosis of acute or primary HIV-1 infection;\n* After PrEP counseling to learn about the advantages and disadvantages of various PrEP methods:\n\n  1. Selects LEN PrEP as their chosen PrEP method; OR,\n  2. Selects a different PrEP method or chooses not to start or continue PrEP.\n\nKey Exclusion Criteria:\n\n* Any other indication not already listed above that would make the participant ineligible for LEN PrEP at enrollment according to local guidelines, organizational protocols, US Prescribing Information (USPI) for the PrEP product, and\u002For Center for Disease and Control (CDC) guidance.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":21,"type":22},3000,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to generate real-life information on the use of lenacapavir (LEN, YEZTUGO®, (YTG)) for pre-exposure prophylaxis (PrEP) across diverse clinical settings in the United States. The study will characterize how PrEP is initiated, used, and discontinued in routine clinical practice when LEN is added as PrEP option and will evaluate persistence on LEN PrEP.\n\nThe primary objective of this study is to evaluate real-life persistence on LEN PrEP at Week 52 in diverse clinical settings in the United States.",[26],"HIV Infections","RECRUITING","2026-08-18",{"date":30,"type":31},"2026-08-19","ACTUAL",{"date":33,"type":31},"2026-03-17",{"date":35,"type":22},"2029-04",{"name":37,"class":38},"Gilead Sciences","INDUSTRY",34,{"id":41,"slug":42,"hasResults":12,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":18,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":66},"100545913","positive-peers-intervention-clinical-trial-100545913","NCT06388109","Positive Peers Intervention Clinical Trial","Randomized Control Trial of Positive Peers mHealth App as a Clinic-based Intervention to Optimize HIV Outcomes Among Young, Minority Persons Living With HIV","PoPIT","Inclusion Criteria:\n\n* HIV+\n* Identifies as either a racial, ethnic, sexual or gender minority or a cisgender female and\n\nOne of the following:\n\n* Newly diagnosed within last 12 months\n* Out of care (greater than 6 months between any two HIV provider visits in last 24 months)\n* Not virally suppressed (any viral load \\> 200 copies in last 24 months)\n* Has a working smartphone\n* Functional English ability\n\nExclusion Criteria:\n\n* prior use of Positive Peers mobile app","13 Years","34 Years",{"count":51,"type":22},250,"INTERVENTIONAL",[54],"NA","The goal of this clinical trial is to learn if the Positive Peers mobile app intervention increases rates of viral suppression in young (13-34 y\u002Fo) persons with HIV.\n\nDoes use of the Positive Peers app improve viral suppression among young minority persons with HIV? What user characteristics are associated with a) viral suppression, b) retention in care, and c) perceived HIV-related stigma?\n\nParticipants will:\n\n* download the mobile app onto their personal smartphone\n* Use the mobile app as they find useful\n* complete online surveys at enrollment, 3 mo, 6, mo, 9 mo and 12 months.",[26],"2026-08-15",{"date":28,"type":31},{"date":60,"type":31},"2024-06-03",{"date":62,"type":22},"2027-11",{"name":64,"class":65},"MetroHealth Medical Center","OTHER",7,{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":19,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":52,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},"100652364","online-cohort-of-sexual-and-gender-minorities-evaluating-digital-interventions-to-improve-hiv-pre-exposure-prophylaxis-and-antiretroviral-treatment-uptake-and-adherence-100652364","NCT07772791","Online Cohort of Sexual and Gender Minorities: Evaluating Digital Interventions to Improve HIV Pre-Exposure Prophylaxis and Antiretroviral Treatment Uptake and Adherence","Online Cohort of Sexual and Gender Minorities: Evaluating the Effect of Digital Interventions on the Uptake and Adherence to HIV Pre-Exposure Prophylaxis and Antiretroviral Treatment","Inclusion Criteria:\n\nmale sex assigned at birth and identifying as a man, travesti, transgender person, or non-binary person; age ≥18 years; residing in Brazil; access to the internet; and self-reporting sex with a man in the past 12 months.\n\nExclusion Criteria:\n\nincorrectly answering the attention-check questions; and incomplete responses, defined as not reaching the end of the screening questionnaire",true,"MALE",{"count":21,"type":22},[54],"This study will create and follow an online cohort of sexual and gender minorities in Brazil to better understand the use of HIV prevention and treatment strategies, particularly pre-exposure prophylaxis (PrEP) and antiretroviral treatment (ART). Participants will complete online questionnaires at the beginning of the study and every three months for one year to provide information about medication use and adherence, sexual behaviors, HIV prevention and testing, sexually transmitted infections, mental health, and experiences of discrimination in health services.\n\nParticipants who are using PrEP or ART and agree to take part in the intervention will be randomly assigned to receive either a digital intervention or no digital intervention. The digital intervention will consist of weekly WhatsApp messages for six months, including reminders and information intended to support adherence to PrEP or ART.\n\nThe main question of the study is whether weekly WhatsApp messages can improve adherence to PrEP or ART among sexual and gender minorities in Brazil. The study hypothesis is that participants who receive the digital intervention will have higher adherence to PrEP or ART than participants who do not receive the intervention.",[26],"2026-08-14",{"date":30,"type":31},{"date":83,"type":31},"2026-05-25",{"date":85,"type":22},"2028-12",{"name":87,"class":65},"Oswaldo Cruz Foundation",1,{"id":90,"slug":91,"hasResults":12,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":74,"sex":18,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":52,"phases":101,"briefSummary":102,"conditions":103,"keywords":104,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":119},"100648960","screen2prevent-s2p-100648960","NCT07728123","Screen2Prevent (S2P)","Screen2Prevent (S2P): Using Digital Health to Improve HIV Screening and Prevention for Adolescents in the Emergency Department","S2P","Inclusion Criteria:\n\n* Age 14-24 years, inclusive\n* Present to the participating ED, regardless of chief complaint during the study period\n\nExclusion Criteria:\n\n* None","14 Years","24 Years",{"count":100,"type":22},84000,[54],"Screen2Prevent is a study intended to improve HIV prevention and detection through implementation and evaluation of three different broad-scale HIV screening approaches a) targeted, b) universally offered opt-in, and c) universally offered opt-out in Emergency Departments (EDs) by leveraging digital health to identify and link adolescents seeking care in the ED to HIV Pre-Exposure Prophylaxis (PrEP)\u002FAntiretroviral treatment (ART).",[26],[105,106,107,108,109,110],"HIV","adolescents","emergency department","preventive care","mHealth","PrEP",{"date":112,"type":31},"2026-08-17",{"date":114,"type":31},"2026-06-16",{"date":116,"type":22},"2028-10-31",{"name":118,"class":65},"Westat",5,{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":52,"phases":129,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},"100646950","phase-3-study-of-lenacapavir-teropavimab-and-zinlirvimab-versus-cabotegravir-and-rilpivirine-in-virologically-suppressed-adults-with-hiv-1-on-oral-daily-antiretroviral-therapy-100646950","NCT07682961","Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy","A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Switching to Long-acting Antiretroviral Therapy of Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab in Combination With the Capsid Inhibitor Lenacapavir Twice-Yearly Versus Cabotegravir and Rilpivirine Every 8 Weeks in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy","Key Inclusion Criteria:\n\n* Human immunodeficiency virus type 1 (HIV-1) susceptibility results from screening meeting specific criteria:\n\n  1\\) Proviral phenotypic susceptibility to both TAB and ZAB by the investigational protocol-defined assay at screening.\n* At least 1 documented HIV-1 RNA level measured between 6 months and 12 months (+2 months) prior to screening. This and any other HIV-1 RNA measurements documented in this period must be \\\u003C 50 copies\u002FmL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies\u002FmL). A single virologic elevation of ≥ 50 copies\u002FmL and \\\u003C 400 copies\u002FmL (transient detectable viremia or \"blips\") prior to screening are acceptable if the subsequent plasma HIV-1 RNA level is \\\u003C 50 copies\u002FmL.\n* A plasma HIV-1 RNA test \\\u003C 50 copies\u002FmL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies\u002FmL) within the last 6 months prior to screening.\n\n  1\\) If \\> 1 plasma HIV-1 RNA measurements in the last 6 months prior to screening are available, all must be \\\u003C 50 copies\u002FmL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies\u002FmL).\n* On a stable oral ARV therapy (ART) for ≥ 6 months prior to screening.\n\n  1. A change in ART regimen ≥ 3 months prior to the screening visit for reasons other than virologic failure (VF) (eg, tolerability, simplification, drug-drug interaction profile) is allowed; individuals with a change in ART regimen ≥ 3 months prior to screening must have been on the regimen for ≥ 3 months prior to screening, and all HIV-1 RNA measurements in that period must be \\\u003C 50 copies\u002FmL. There are no permitted changes to ART regimens between screening and Day 1.\n\nKey Exclusion Criteria:\n\n* History of an opportunistic infection or illness indicative of Stage 3 HIV disease.\n* History of treatment failure.\n* Known or suspected resistance to either CAB or RPV.\n\n  1. Resistance to CAB defined as the following mutations: G118R, Q148K, Q148R, T66K+L74M, E92Q+N155H, E138A+Q148R, E138K+Q148K\u002FR, G140C+Q148R, G140S+Q148H\u002FK\u002FR, Y143H+N155H, and Q148R+N155H.\n  2. Resistance to RPV defined as the following mutations: K101E and P; E138A, G, K, R, and Q; V179L; Y181C, I, and V; Y188L; H221Y; F227C; M230I and L, and the combination of L100I\u002FK103N.\n* Individuals with a dermatologic condition or implanted prothesis overlying the gluteal injection site for CAB + RPV.\n* Known hypersensitivity to the study intervention, its metabolites, or formulation excipients.\n* Active, serious infections (other than HIV-1) requiring therapy \\\u003C 30 days prior to randomization.\n* Active tuberculosis infection.\n* Acute hepatitis of any cause \\\u003C 30 days before randomization.\n* History of, or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding) or severe hepatic impairment (Child-Pugh Class C).\n* Active malignancy requiring acute systemic therapy.\n* Have poor venous access that would limit phlebotomy or intravenous (IV) infusion of study drugs.\n* Prior use of, or exposure to, LEN or a broadly neutralizing antibody (bNAb) for HIV-1.\n* Prior use of, or exposure to, long-acting (LA) injectable CAB or LA injectable RPV.\n* Prior use of, or exposure to, ibalizumab, fostemsavir, or maraviroc.\n* Baseline regimen consisting of monotherapy with any single antiretroviral (ARV).\n* Treatment with immunosuppressant therapies (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) within 4 weeks of screening (with the exception of a single short course of corticosteroids lasting ≤ 7 days) or have a comorbid condition with an anticipated need ongoing immunosuppressive treatment during the study.\n* Hepatitis C virus (HCV) antibody positive and HCV RNA detectable.\n* Chronic hepatitis B virus (HBV) infection, as determined by either:\n\n  1. Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit.\n  2. Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the screening visit.\n* Severe renal impairment-estimated glomerular filtration rate \\\u003C 30 mL\u002Fmin according to the Cockcroft-Gault formula.\n* Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant, as determined by the investigator.\n* Any of the following laboratory values at screening:\n\n  1. Alanine aminotransferase \\> 5 x upper limit of normal (ULN).\n  2. Direct bilirubin \\> 1.5 x ULN.\n  3. Platelets \\\u003C 50,000\u002Fmm\\^3.\n  4. Hemoglobin \\\u003C 8.0 g\u002FdL.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":128,"type":22},590,[130],"PHASE3","The goal of this clinical study is to compare how effective a long-acting injectable treatment of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) versus (CAB) and rilpivirine (RPV) injections given every 8 weeks in adults with HIV-1 whose virus is well controlled on daily oral treatment, after 1 year (52 weeks) of the treatment.\n\nThe primary objective of this study are to evaluate the efficacy of switching to the regimen of LEN, TAB, and ZAB versus switching to CAB and RPV in virologically suppressed people with HIV-1 (PWH) as determined by the proportion of participants with HIV-1 RNA ≥ 50 copies\u002FmL at Week 52.",[26],"2026-08-13",{"date":80,"type":31},{"date":136,"type":31},"2026-07-14",{"date":138,"type":22},"2033-03",{"name":37,"class":38},19,{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":18,"minAge":148,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":52,"phases":151,"briefSummary":152,"conditions":153,"keywords":154,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":161,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":168},"100641883","phase-3-a-study-to-investigate-cabotegravir-ultra-long-acting-cab-ula-plus-rilpivirine-ultra-long-acting-rpv-ula-in-adults-and-adolescents-with-hiv-who-are-virologically-suppressed-100641883","NCT07650916","A Study to Investigate Cabotegravir Ultra Long-Acting (CAB ULA) Plus Rilpivirine Ultra Long-Acting (RPV ULA) in Adults and Adolescents With HIV Who Are Virologically Suppressed","A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Cabotegravir Ultra Long-acting Plus Rilpivirine Ultra Long-acting or Cabotegravir Long-acting Plus Rilpivirine Long-acting in Adults and Adolescents With HIV Who Are Virologically Suppressed on ART","Inclusion criteria:\n\nPatient Study Participant (PSP) Inclusion criteria:\n\n* Adults and adolescents with HIV-1 infection aged 12 years or older with a weight \\>35 kg.\n* Documented HIV-1 RNA measurements \\\u003C50 copies\u002FmL in the 12 months prior to Screening.\n* HIV-1 RNA \\\u003C50 copies\u002FmL at screening assessment.\n* Must be on current daily oral antiretroviral regimen for at least 6 months uninterrupted prior to Screening.\n* Any prior switch in therapy must have occurred due to tolerability\u002Fsafety, access to medications, or convenience\u002Fsimplification, and must NOT have been done for virologic treatment failure (HIV-1 RNA ≥200 copies\u002FmL).\n\nExclusion criteria:\n\nPatient Study Participant (PSP) Exclusion criteria:\n\n* Any evidence of primary resistance based on the presence of any major known INSTI (including CAB) or NNRTI (including RPV) resistance-associated mutation.\n* Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening.\n* Any history of receiving long-acting therapy for HIV.\n* Previous exposure to CAB and\u002For RPV for treatment or prevention of HIV-1 infection.\n* Significant uncontrolled or clinically relevant comorbidities (e.g., cardiovascular, hepatic, renal, neurological, psychiatric) that may impact safety or study participation.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","12 Years",{"count":150,"type":22},564,[130],"This study compares the efficacy, safety and tolerability of CAB ULA and RPV ULA administered with CAB long acting (LA) and RPV LA administered in adults and adolescents with HIV who are virologically suppressed on anti-retroviral therapy (ART).",[26],[155,156,105,157,158,159,160],"Cabotegravir","Rilpivirine","Non-inferiority","Efficacy","Safety","Tolerability",{"date":80,"type":31},{"date":163,"type":31},"2026-06-25",{"date":165,"type":22},"2029-09-04",{"name":167,"class":38},"ViiV Healthcare",88,{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":52,"phases":179,"briefSummary":180,"conditions":181,"keywords":182,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":193},"100623209","phase-3-a-continued-access-study-for-participants-transitioning-from-viiv-healthcare-sponsored-or-viiv-healthcare-collaborative-parent-studies-for-hiv-treatment-100623209","NCT07393659","A Continued Access Study for Participants Transitioning From ViiV Healthcare-sponsored or ViiV Healthcare-collaborative Parent Studies for HIV Treatment","A Phase 3b, Open-label, Multicenter, Continued Access Study for Participants Transitioning From ViiV Healthcare Sponsored or ViiV Healthcare Collaborative Parent Studies for HIV Treatment","PATH","Inclusion Criteria:\n\n* Investigator confirmation of the participant's continued clinical benefit from the parent study intervention and the participant's completion of the protocol-defined treatment period in the parent study. The Investigator should ensure that the participant is still eligible for the parent study (i.e., have not met parent study discontinuation\u002F withdrawal criteria).\n* Participants or legally authorized representative (LAR) who are willing and able to comply with all scheduled visits, treatment plan, and other study procedures as outlined in the applicable appendix and determined by the Investigator.\n* Participant or LAR is able and willing to provide signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and this protocol. Where applicable, participants must provide written assent.\n\nExclusion Criteria:\n\n• Any reason that, in the opinion of the Investigator or Sponsor, precludes the participant's inclusion in the study.",{"count":178,"type":22},181,[130],"The purpose of this study is to provide continued access to the study treatment for participants from previous ViiV Healthcare studies who are still benefiting from it and do not have local access after completing the parent study. This continued access will also allow further collection of safety data. Eligible participants are those who completed a ViiV Healthcare-sponsored or collaborative parent study and are currently experiencing clinical benefit. The Sponsor will periodically review the study to consider other treatment access options.",[26],[183,184,185],"Human Immunodeficiency Virus (HIV)","Open label","Continued access","2026-08-12",{"date":80,"type":31},{"date":189,"type":31},"2026-07-21",{"date":191,"type":22},"2032-09-14",{"name":167,"class":38},4,{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":202,"enrollmentInfo":203,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":88},"100477875","relationship-of-inflammation-and-pulmonary-function-to-fungal-translocation-in-hiv-100477875","NCT05502653","Relationship of Inflammation and Pulmonary Function to Fungal Translocation in HIV","Relationship of Fungal Translocation, Inflammation, and Pulmonary Function in HIV","RIFFT","Inclusion Criteria:\n\n* Age 18 to 80\n* HIV positive\n* Virally-suppressed on ART for at least 6 months\n* subjects enrolled in Dr. Morris's HLRC Studies STUDY20020151, STUDY19080258, STUDY19060243, STUDY19070181, STUDY19070181, STUDY19050326 OR subjects being seen at the HIV\u002FPACT clinics.\n\nExclusion Criteria:\n\n* Contraindication to pulmonary function testing (i.e., abdominal or cataract surgery within 3 months, recent myocardial infarction, etc.).\n* individuals with clinical or radiographic evidence of another significant pulmonary diagnosis (e.g. interstitial lung disease, active asthma)\n* inflammatory bowel disease\n* pregnancy\n* use of antibiotics in the prior 2 weeks\n* immunomodulators in the prior 6 months\n* unable to perform any study procedures.","80 Years",{"count":204,"type":22},100,"The investigator will study the origin of fungal translocation in HIV, its relationship to the mycobiome, and its relationship to lung function and inflammation. Supported by the preliminary data and published studies, this project is based on the premise that circulating BDG derived from microbial translocation stimulates inflammation and worsens lung function in PWH.\n\nChronic obstructive pulmonary disease (COPD) is a significant public health problem with few therapies that modify disease trajectory. COPD is a leading cause of mortality in the United States associated with increased morbidity and healthcare costs. Long-acting bronchodilators and inhaled corticosteroids are mainstays of therapy that control symptoms and reduce acute exacerbation frequency, but do not have a significant impact on mortality or lung function trajectory. The National Heart, Lung, and Blood Institute's COPD National Action Plan focuses on the critical need for research to characterize COPD risk factors and disease mechanisms in order to improve the understanding of causes and progression of disease. The ultimate goal is to provide precision therapy to appropriate patient subgroups to preserve health or arrest disease progression.\n\nMicrobial organisms in the gut may have a profound effect on lung disease. The role of the gut-lung axis, defined as the cross-talk between gut microbiota and the lungs, in the pathogenesis of chronic respiratory diseases is emerging as an area of interest. Perturbations of gut microbiota characterized by low microbial diversity and changes in microbiota abundance are linked to childhood asthma risk, airflow obstruction in adult asthma, and severe lung dysfunction in cystic fibrosis. Studies in animals show that both a high fiber diet that modulates gut microbiota and an abundance of beneficial bacterial strains attenuate inflammation, emphysema, and COPD development in response to cigarette smoke exposure in murine models. In humans, recent investigations show differences in the gut microbial communities between COPD patients and healthy individuals as well as shifts in the gut microbiome with acute exacerbations of COPD.",[26,207,208],"Inflammation","COPD",{"date":80,"type":31},{"date":211,"type":31},"2022-09-01",{"date":213,"type":22},"2027-11-01",{"name":215,"class":65},"University of Pittsburgh",{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":74,"sex":18,"minAge":19,"maxAge":223,"enrollmentInfo":224,"targetDuration":4,"studyType":52,"phases":226,"briefSummary":228,"conditions":229,"keywords":230,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":245},"100539954","first-time-in-human-study-of-long-acting-vh4524184-formulations-100539954","NCT06310551","First Time in Human Study of Long Acting VH4524184 Formulations","A Phase 1 Double-Blind (Sponsor-unblinded), Placebo-Controlled Randomized, Single Ascending Dose and Multiple Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Parenterally Administered VH4524184 in Healthy Adults","Inclusion Criteria:\n\nAge\n\n1. Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.\n\n   Type of Participant and Characteristics\n2. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.\n3. Participants who are negative for SARS-CoV-2, performed on admission\u002Freadmission to the Phase 1 unit, using an approved molecular test (PCR).\n4. Participants who are able to understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions.\n\n   Weight\n5. Body weight ≥50.0 kg (110 lbs) for men and ≥45.0 kg (99 lbs) for women and body mass index within the range 18.5 to 32.0 kg\u002Fm\\^2 (inclusive) for all cohorts except B19. For Cohort B19, body mass index within the range \\>32.0 to 37.0 kg\u002Fm\\^2 (inclusive).\n\n   Sex and Contraceptive\u002FBarrier Requirements\n6. Male or female\n\n   1. Male Participants: No restrictions for male participants\n   2. Participants of female sex assigned at birth:\n\n      * A participant of childbearing potential (POCBP) (female sex assigned at birth) is eligible to participate as long as the participant is not pregnant, breastfeeding and utilizes a highly effective method of contraception.\n      * A participant of non-childbearing potential (PONCBP) is eligible to participate if all other eligibility criteria are met.\n\n   Informed Consent\n7. Capable of providing signed informed consent.\n\nExclusion Criteria:\n\nMedical Conditions\n\n1. History or presence of clinical condition or disorder that could be capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drug, interfering with the interpretation of data or would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits.\n2. Clinically significant abnormal blood pressure as determined by the investigator.\n3. Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.\n4. Breast cancer within the past 10 years.\n5. Current or chronic history of liver disease or known hepatic or biliary abnormalities.\n6. Medical history of cardiac arrhythmias or cardiac disease or a family and personal history of long QT syndrome.\n7. Underlying skin disease or disorder that would interfere with the administration of study product and\u002For assessment of injection site reactions.\n8. Clinically significant history of drug hypersensitivity, delayed-type hypersensitivity or severe hypersensitivity reactions, as well as history of \u002Fsensitivity to any of the study interventions including hyaluronidases.\n9. Current or anticipated need for chronic anti-coagulation except for the use of low dose acetylsalicylic acid (≤325 mg) or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease.\n10. History of seizure.\n11. Any known or suspected pre-existing psychiatric condition, including depression, anxiety and insomnia\u002Fsleep disturbances, at the discretion of the investigator.\n12. Any positive (abnormal) response confirmed by the investigator or clinician (or qualified designee) administered C-SSRS at screening.\n13. Insufficient muscle mass (gluteus medius or thigh) to support IM dose administration in the opinion of the investigator.\n14. Presence of tattoos, implants or skin piercings that may interfere with the administration of study product and\u002For assessment of ISRs, if they occur.\n15. History of or on-going high-risk behaviors that may put the participant at increased risk for HIV acquisition in the opinion of the investigator. This includes participants in HIV discordant relationships, or men who report current or prior unprotected anal sex with other men and those reporting prior or current injecting drug use.\n\n    Prior\u002FConcomitant Therapy\n16. Past or intended use of over-the-counter or prescription medication within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to dosing and for the duration of the study.\n17. Receipt of any live vaccine(s) or vaccines against SARS-CoV-2 within 28 days prior to screening or 14 days before or after scheduled SC or IM dosing.\n\n    Prior\u002FConcurrent Clinical Study Experience\n18. Exposure to more than 4 new investigational products (including long-acting investigational products) within 12 months prior to the first dosing day.\n19. Current enrollment or past participation in another investigational study in which an investigational intervention was administered within the last 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product before signing of consent (OR screening) any other clinical study.\n20. Participation in the study would result in loss of blood in excess of 500 mL over a 56-day period.\n21. Current enrollment or past participation in this clinical study, with the exception of participants who previously completed the Oral Lead In (OLI) but for operational or logistic reasons did not progress to CRU admission and receipt of injectable suspension for injection (SFI) or powder for suspension for injection (PFS) study medication or placebo, or prior participation in study 218803.\n\n    Diagnostic Assessments\n22. eGFR \\\u003C60 mL\u002Fmin or serum creatinine \\>1.1 x ULN.\n23. Hemoglobin \\\u003C12.5 g\u002FdL for men and \\\u003C11 g\u002FdL for women\n24. ALT or AST \\> upper limit of normal (ULN).\n25. Total bilirubin \\>1.5xULN.\n26. Any significant arrhythmia or ECG finding.\n27. Exclusion criteria for Screening ECG - a single repeat is allowed for eligibility determination.\n28. Presence of HBsAg and\u002For anti-HBc at Screening or within 3 months prior to first dose of study intervention.\n29. Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.\n30. Positive pre-study drug\u002Falcohol screen.\n31. Positive HIV antibody test.\n\n    Other Exclusions\n32. Regular alcohol consumption within 6 months prior to the study defined as: An average weekly intake of \\>14 units for males or \\>7 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (\\~240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.\n33. Regular use of known drugs of abuse.\n34. Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening and at admission.\n35. Sensitivity to the study drug, or components thereof, or other drug or other allergy that, in the opinion of the investigator or Sponsor Medical Monitor, contraindicates participation in the study.","55 Years",{"count":225,"type":22},372,[227],"PHASE1","The purpose of this study is to identify 1 or more doses of parenterally administered VH4524184 that are safe, well tolerated and yield a PK drug exposure profile necessary to deliver a long-acting antiretroviral therapy for the treatment of HIV-1 infection.",[26],[159,160,231,232,233,234,235,236],"Parenteral","First Time in Human","Pharmacokinetics","Ascending Dose","Multiple Dose","Healthy Adults","2026-08-05",{"date":239,"type":31},"2026-08-10",{"date":241,"type":31},"2024-03-21",{"date":243,"type":22},"2028-01-21",{"name":167,"class":38},3,{"id":247,"slug":248,"hasResults":12,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":254,"enrollmentInfo":255,"targetDuration":4,"studyType":52,"phases":257,"briefSummary":259,"conditions":260,"keywords":261,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":88},"100638731","phase-1-a-study-to-evaluate-jl18008-in-subject-with-hiv-immunological-non-responders-100638731","NCT07579741","A Study to Evaluate JL18008 in Subject With HIV Immunological Non-Responders","Evaluation of Pharmacokinetics, Pharmacodynamics, and Safety of JL18008 Injection in Healthy Adult Subjects \u002F HIV Immunological Non-Responders: A Randomized, Double-Blind, Placebo-Controlled Phase I\u002FII Clinical Study","JL18008","Inclusion Criteria:\n\n1. Age 18 to 65 years (inclusive), male or female.\n2. Body mass index (BMI) 18.0 to 32.0 kg\u002Fm² (inclusive); body weight ≥50.0 kg for males and ≥45.0 kg for females.\n3. Receiving combination antiretroviral therapy (cART) for at least 48 months, with a stable antiretroviral regimen for at least 3 months prior to enrollment.\n\n   Maintained HIV-1 RNA below 50 copies\u002FmL for at least 36 months (the earliest test date more than 36 months before enrollment), including transient viral blips (single HIV-1 RNA measurement between 50 and 200 copies\u002FmL after excluding laboratory error). At least two HIV-1 RNA results \\\u003C50 copies\u002FmL must be available (one may be from screening).\n4. Immunological non-responder criteria: CD4⁺ T cell count ≤350 cells\u002FμL within 1 year before screening. At least three CD4⁺ T cell counts ≤350 cells\u002FμL within 4 years before enrollment, with intervals of ≥3 months between tests (the third may be from screening).\n5. Willing to use effective non-pharmacological contraception with partner from screening until 3 months after study completion, and no plan for sperm\u002Fegg donation during this period.\n6. Able to understand and provide written informed consent, and willing to comply with all protocol-specified visits and procedures.\n\nExclusion Criteria:\n\n1. Known allergy to the study drug or any of its excipients.\n2. Receipt of immunosuppressants, immunomodulators, or systemic cytotoxic therapy within 3 months before screening.\n3. Receipt of hormone therapy within 1 month before screening, except for daily doses ≤10 mg prednisone or equivalent.\n4. History of severe autoimmune disease requiring systemic treatment or hospitalization, or any active autoimmune disease requiring treatment (including multiple sclerosis).\n5. History of systemic infection (viral, bacterial, parasitic, or fungal) requiring systemic treatment and\u002For hospitalization, or other opportunistic infection, within 30 days before screening.\n6. Active tuberculosis lesion within 30 days before screening.\n7. Blood disorders associated with hypersplenism (e.g., thalassemia, hereditary spherocytosis, Gaucher's disease, autoimmune hemolytic anemia) or history of splenectomy.\n8. Chronic diarrhea.\n9. Severe cardiovascular disease within 6 months before screening, including myocardial infarction, unstable angina, congestive heart failure (NYHA class ≥II), or arrhythmia requiring medication.\n10. Uncontrolled hypertension, defined as resting systolic blood pressure \\>140 mmHg and\u002For diastolic blood pressure \\>90 mmHg on at least two repeated measurements on different days despite antihypertensive treatment.\n11. Positive hepatitis B surface antigen (HBsAg), or positive hepatitis C virus antibody (HCV-Ab) with detectable HCV-RNA, or active syphilis.\n12. Any of the following laboratory abnormalities at screening: hemoglobin \\\u003C90 g\u002FL; neutrophil count \\\u003C1.5×10⁹\u002FL; platelet count \\\u003C100×10⁹\u002FL; serum creatinine \\>1.5× upper limit of normal (ULN); alanine aminotransferase \\>2.5×ULN; aspartate aminotransferase \\>2.5×ULN; alkaline phosphatase \\>2.5×ULN; total bilirubin \\>1.5×ULN; international normalized ratio \\>1.5; activated partial thromboplastin time \\>1.5×ULN.\n13. Diagnosis of cancer within the screening period.\n14. Severe neurological or psychiatric disease, or history of seizures.\n15. History of drug abuse within 3 months before screening, or positive urine drug screen (including morphine, methamphetamine, ketamine, MDMA, THC, cocaine), or history of alcohol abuse.\n16. Participation in another clinical trial with receipt of investigational drug within 3 months before screening.\n17. Vaccination within 6 weeks before screening, or plan to receive any vaccination within 1 year after enrollment.\n18. Pregnancy, positive pregnancy test, or breastfeeding.\n19. Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this clinical study.","65 Years",{"count":256,"type":22},30,[227,258],"PHASE2","The Phase Ib clinical trial is an add-on study based on combination antiretroviral therapy (cART). It adopts a multicenter, randomized, double-blind, placebo-controlled, multiple-dose design to evaluate the safety and efficacy of multiple intramuscular injections of JL18008 added to cART in HIV immunological non-responders (INRs).\n\nBased on the Phase Ia clinical data, three dose groups are planned for the Phase Ib trial: 20, 40, and 70 μg\u002Fkg of JL18008. Each group is planned to enroll 10 subjects (8 receiving active drug and 2 receiving placebo). All subjects must maintain their original cART regimen unchanged. Subjects in the active treatment groups will receive JL18008 injection in addition to cART, while those in the control group will receive placebo (JL18008 injection buffer) in addition to cART. The dosing regimen is tentatively once weekly (QW) for 4 consecutive weeks, which constitutes one treatment cycle, followed by an observation\u002Ffollow-up period. The study drug will be administered by intramuscular injection.",[26],[26,262,263],"Ib","Immunological Non-Responders","2026-08-04",{"date":266,"type":31},"2026-08-06",{"date":268,"type":31},"2026-05-26",{"date":270,"type":22},"2027-09-28",{"name":272,"class":38},"Jecho Biopharmaceuticals Co., Ltd.",{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":52,"phases":281,"briefSummary":282,"conditions":283,"keywords":284,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":245},"100619274","phase-1-dasatinib-for-hiv-1-reservoir-reduction-100619274","NCT07342491","Dasatinib for HIV-1 Reservoir Reduction","Inclusion Criteria:\n\n* HIV-1 infection\n* Active antiretroviral therapy received continuously for 48 months (or longer)\n* CD4+ cell count \\>450 cells\u002Fmm3 obtained within 12 months prior to study entry\n* Plasma HIV-1 RNA level below the lower limit of quantification within 90 days prior to study entry\n* Plasma HIV-1 RNA levels below the lower limit of quantification for \\>36 months at time of study entry\n* The following laboratory values obtained within 90 days prior to entry:\n\n  * Absolute neutrophil count (ANC) above the lower limit of normal\n  * Hemoglobin above the lower limit of normal\n  * Platelet count above the lower limit of normal\n  * Aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), and alkaline phosphatase \\\u003C1.5 x ULN\n  * Total bilirubin \\\u003C1.5 x ULN\n  * Negative hepatitis B virus (HBV) surface antigen (HBsAg)\n  * Negative HBV core antibody with one exception: individuals with positive HBV core antibody and HBV surface antibody are eligible for enrollment\n  * Negative hepatitis C virus (HCV) antibody (anti-HCV) or, if the anti-HCV is positive, a negative HCV RNA PCR\n  * Estimated glomerular filtration rate (eGFR) \\>70 mL\u002Fmin\u002F1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) 2021 equation or serum creatinine \\\u003C1.2 x ULN\n* QTc interval \\\u003C450 milliseconds on EKG performed at screening visit\n* Women who are able to become pregnant must have a negative serum or urine pregnancy test at screening and within 48 hours prior to study entry\n* Individuals (male or female) who are having sex that could lead to pregnancy, must agree to use at least two effective means of contraception when engaging in sexual activities that can result in pregnancy, from the time of enrollment through 60 days following the last dose of dasatinib\n* Able to swallow pills without difficulty.\n* Ability and willingness of participant or legally authorized representative to provide informed consent\n* Ability and willingness of participant to continue same ART regimen throughout the study\n\nExclusion Criteria:\n\n* Pre-ART viral load known to be \\\u003C2000 copies\u002FmL (HIV controller)\n* Known to have initiated ART during acute HIV infection\n* Presence of a drug-resistant virus with no alternative ART regimens available in the event that current ART regimen becomes compromised as a result of this study\n* Current pregnancy or breastfeeding or pregnancy planning during study participation\n* Recent hospitalization or surgery within 90 days prior to entry\n* Recent infection requiring intravenous antibiotics within 90 days prior to entry\n* Any evidence of hepatic impairment\n* Any known prior (lasting \\>180 days) or current history of gastrointestinal-related diseases\n* Active malignancy including myelodysplastic syndrome or myeloproliferative disease.\n* Any known prior (lasting \\>180 days) or current history of hematologic illness\n* Any known prior (lasting \\>180 days) or current history of cardiac-related diseases\n* Untreated hypothyroidism\n* Treatment for TB within the past 90 days.\n* Current respiratory disease requiring supplemental oxygen\n* Exposure to any systemic immunomodulatory drug (including maraviroc) in the 16 weeks prior to study entry\n* Exposure to anticoagulant or anti-platelet medications in the 16 weeks prior to study entry\n* Active use of medications known to prolong the QT interval\n* Known family history of Long QT Syndrome in a first-degree relative (i.e., parent, offspring, or sibling)\n* Active use of medications known to moderately or strongly induce or inhibit CYP3A4, including ART regimens that contain protease inhibitors, efavirenz, etravirine, or cobicistat at the time of screening or study entry\n* Current substance use which is likely to interfere with the conduct of the study\n* Anticipated conflict or inability to attend and complete all protocol-scheduled study visits and assessments\n* Known allergy\u002Fsensitivity or any hypersensitivity to components of dasatinib or its formulation\n* Active use of azithromycin, Ondansetron, Pentamidine at study entry",{"count":280,"type":22},14,[227],"This study will test if the medicine dasatinib can lower the hidden amount of HIV in the body, called the HIV \"reservoir.\" It will also check if dasatinib is safe and easy to take for people living with HIV who have a suppressed viral load while on antiretroviral therapy (ART). Adults 18 years or older who have been on ART for at least 48 months and have had a suppressed HIV-1 viral load for at least 36 months may be able to join.\n\nPeople will be randomly assigned to take dasatinib 100 mg by mouth once a day or a look-alike substance with no drug, called a placebo, for 12 weeks. Neither participants nor researchers will know who gets which (double-blind). The study team will do regular health checks and blood tests to track safety, tolerability, the HIV reservoir, and changes in immune cells.\n\nThe study lasts 36 weeks total: 12 weeks of treatment and 24 weeks of follow-up, with clinic visits and possible phone calls. Fourteen people will take part; eight will get dasatinib and six will get placebo. Dasatinib may lower the HIV reservoir, but this is not guaranteed. All medicines can cause side effects, called adverse events (AE). The study team will watch closely and provide medical support. Joining is your choice, and you can leave at any time. If you leave, the team will talk with you about next steps for your care.",[26],[285,286,105],"Antiretroviral Therapy (ART)","Viral Persistence","2026-08-03",{"date":264,"type":31},{"date":290,"type":31},"2026-05-08",{"date":292,"type":22},"2027-05-12",{"name":294,"class":295},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":74,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":304,"targetDuration":306,"studyType":23,"phases":4,"briefSummary":307,"conditions":308,"keywords":311,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":325},"100649650","metabolic-liver-disease-in-newly-diagnosed-people-living-with-hiv-mashiv-tr-100649650","NCT07737340","Metabolic Liver Disease in Newly Diagnosed People Living With HIV (MASHIV-TR)","Metabolic Liver Disease in Newly Diagnosed People Living With HIV: MASHIV-TR Cohort (MASHIV-TR)","MASHIV-TR","Inclusion Criteria (For the Patient Group \u002F Newly Diagnosed HIV+):\n\n* Citizens of the Republic of Türkiye\n* Adults (≥ 18 years of age)\n* Confirmed Anti-HIV positive (Newly diagnosed)\n* Patients who are initiating Antiretroviral Therapy (ART)\n\nInclusion Criteria (For the Healthy Control Group \u002F HIV-):\n\n* Citizens of the Republic of Türkiye\n* Adults (≥ 18 years of age)\n* Confirmed Anti-HIV negative\n\nExclusion Criteria:\n\n* There are no specified exclusion criteria for this study.",{"count":305,"type":22},411,"60 Months","This study aims to identify the risk factors that lead to the development of metabolic liver disease in people who have been newly diagnosed with HIV. The research will take place across 9 centers in Türkiye and plans to include 250 newly diagnosed individuals with HIV, alongside 161 healthy individuals without HIV as a control group.\n\nParticipants will have their liver health checked when they first join the study (baseline) and then once a year for up to 5 years (at 12, 24, 36, 48, and 60 months). The main goal of these visits is to monitor their metabolic health and understand who is at risk of developing a fatty liver condition known as MASLD (Metabolic dysfunction-Associated Steatotic Liver Disease).\n\nDuring each visit, the research team will collect information about the participants' general health, including their height, weight, medical and family history, lifestyle habits, and sleep patterns. They will also record any medications being taken, including HIV treatments. To thoroughly check liver health, researchers will use routine blood tests (measuring things like cholesterol, blood sugar, and kidney function) and painless, non-invasive imaging tests, such as ultrasounds and FibroScans, to measure liver fat and stiffness.",[26,309,310],"Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) & Steatohepatitis (MASH)","Fatty Liver",[105,312,285,313,314,315],"Newly Diagnosed HIV Infection","Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD)","Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Metabolic Syndrome","2026-07-29",{"date":318,"type":31},"2026-07-30",{"date":320,"type":31},"2024-06-01",{"date":322,"type":22},"2029-05-31",{"name":324,"class":65},"Yaşar Bayındır, MD",11,{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":74,"sex":75,"minAge":19,"maxAge":334,"enrollmentInfo":335,"targetDuration":4,"studyType":52,"phases":337,"briefSummary":338,"conditions":339,"keywords":343,"overallStatus":348,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":88},"100650042","healthmpowerment-korea-pilot-testing-the-cultural-adaptation-of-a-digital-hiv-intervention-for-men-who-have-sex-with-men-in-south-korea-100650042","NCT07741123","HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea","Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea","HMP Korea","Inclusion Criteria:\n\n* Male sex assigned at birth and current male gender identity\n* Aged 18 to 35 years\n* Current residence in the Seoul Metropolitan area\n* Korean nationality\n* Self-identify as a sexual minority (e.g., gay, bisexual, queer, or other non-heterosexual identity)\n* HIV-negative or HIV-unaware serostatus\n* Report at least 1 episode of condomless anal intercourse with a male partner in the prior 6 months\n\nExclusion Criteria:\n\n* Assigned female at birth or do not currently identify as male\n* Younger than 18 or older than 35 years of age\n* Non-residence in the Seoul Metropolitan area\n* Do not hold Korean nationality\n* Do not identify as a sexual minority\n* Known HIV-positive status\n* No reported episodes of condomless anal intercourse with a male partner in the prior 6 months","35 Years",{"count":336,"type":22},50,[54],"This study tests a mobile application (app) designed to support sexual health and prevent human immunodeficiency virus (HIV) among young men in South Korea. Researchers are interested to learn if the app is acceptable, easy to use, and helpful for young men who have sex with men (MSM).\n\nParticipants will complete a 15-minute online survey at the start of the study and another 15-minute survey 3 months later. Participants will be randomly assigned to 1 of 2 study groups for 3 months:\n\n1. Intervention Group: Participants receive access to the full mobile app, called Bandi. The app includes health articles, quizzes, community discussion forums, a personal sexual health log, and a clinic finder.\n2. Control Group: Participants receive access to a basic version of the app that includes informational articles and the clinic finder only.\n\nResearchers will compare both groups over 3 months to see if using the full app leads to higher rates of HIV testing and lower sexual risk behaviors.",[26,340,341,342],"HIV Prevention and Care","Risk Reduction Behavior","Digital Health",[344,345,346,347],"south korea","msm","mobile app","social stigma","NOT_YET_RECRUITING","2026-07-28",{"date":287,"type":31},{"date":352,"type":22},"2026-09-01",{"date":354,"type":22},"2027-06-30",{"name":356,"class":65},"Seul Ki Choi",{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":364,"targetDuration":4,"studyType":52,"phases":366,"briefSummary":367,"conditions":368,"keywords":369,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":384},"100608514","phase-2-a-phase-2b-study-evaluating-oral-vh4524184-regimens-in-treatment-nave-persons-with-hiv-1-innovate-study-100608514","NCT07202546","A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study)","A Phase 2b Randomized, Open-Label Active Controlled Study Evaluating the Safety and Efficacy of Oral VH4524184 Coadministered With Emtricitabine and Tenofovir Alafenamide in Treatment Naive Viremic Persons With HIV-1 (INNOVATE Study)","Inclusion Criteria:\n\n1. Participant must be at least 18 years of age (or older, if required for adults by local regulations) at the time of signing the informed consent.\n2. Screening CD4+ T-cell count \\>200 cells\u002Fmicrolitre (µL).\n3. Documented HIV-1 infection and Screening plasma HIV-1 RNA of ≥1000 copies\u002Fmillilitre (mL). A single repeat of this test is allowed within a single Screening period to determine eligibility.\n4. Treatment-naive: Defined as no ARVs (in combination or monotherapy) received after the diagnosis of HIV-1 infection.\n5. Body weight \\>=50.0 kilogram (kg) \\[(110 pounds (lbs)\\] for participants assigned male at birth and \\>=45.0 kg (99 lbs) for participants assigned female at birth. BMI within the range 18.5-35.5 kg\u002Fm\\^2 (inclusive - applies to males and females).\n6. There are no contraceptive requirements for participants assigned male at birth.\n7. Participants assigned female at birth are eligible to participate if they are not pregnant or breastfeeding and one of the following conditions applies:\n\n   * Is a Participant of non-childbearing potential (PONCBP);OR Is a Participant of childbearing potential (POCBP) and using a contraceptive method with a failure rate of less than (\\\u003C) 1% prior to and during the study intervention period, and for at least 1 week after the last dose of VH4524184 plus FTC\u002FTAF FDC, or through the end of study (if in the control arm and never received VH4524184).\n   * A POCBP must have a negative pregnancy test at Screening (serum) and on Day 1 (urine) before the first dose of study intervention.\n   * If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. Participant with a positive serum test must be excluded.\n8. Capable of giving signed informed consent. Persons who are placed in an institution by order of a public authority or a court are excluded from participation in this study.\n\nExclusion Criteria:\n\n1. Participants who are breastfeeding or plan to breastfeed during the study.\n2. Participants with acute HIV infection, evidenced by acute retroviral syndrome (e.g., fever, malaise, fatigue, etc.) and\u002For evidence of recent (within 3 months) documented viremia without antibody production and\u002For evidence of recent (within 3 months) documented seroconversion.\n3. Any evidence of an active Centres for Disease Control and Prevention (CDC) Stage 3 disease \\[CDC 2014\\], except cutaneous Kaposi's sarcoma not requiring systemic therapy during the study. Historical CD4+ cell counts less than 200 cells\u002FµL are not exclusionary.\n4. Unstable liver disease known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).\n5. History of cirrhosis with or without viral hepatitis co-infection.\n6. Participants with HCV co-infection will be excluded from the study.\n7. Individuals who are co-infected with HIV and HBV will be excluded Participants diagnosed with syphilis at Screening (i.e., positive syphilis testing) should be treated as per local guidelines and will be eligible to enroll at any time regardless of the stage of disease.\n8. Uncontrolled malignancy is excluded, whereas participants who have controlled malignancies may be included in agreement between the investigator and the ViiV Healthcare medical monitor.\n9. Any pre-existing physical, or mental condition (including alcohol or drug abuse) which, in the opinion of the investigator (with or without psychiatric evaluation) or the ViiV Healthcare medical monitor, may interfere with the participant's ability to comply with the dosing schedule and\u002For protocol evaluations or which may compromise the safety of the participant.\n10. Any condition which, in the opinion of the investigator or the ViiV Healthcare medical monitor, that may interfere with the absorption, distribution, metabolism or excretion of the study interventions or render the participant unable to take oral medication and normal gastrointestinal anatomy or motility or hepatic and\u002For renal function\n11. Clinically significant CV disease, as defined by history\u002Fevidence of congestive heart failure, symptomatic arrhythmia, angina\u002Fischemia, coronary artery bypass grafting surgery or percutaneous transluminal coronary angioplasty or any clinically significant cardiac disease.\n12. Participants receiving any protocol-prohibited medication and who are unwilling or unable to switch to an alternate medication.\n13. History of sensitivity to any of the study medications, or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the investigator or ViiV Healthcare medical monitor, contraindicates their participation.\n14. Current or anticipated need for chronic anti-coagulation with the exception of the use of low dose acetylsalicylic acid (≤325 mg) or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease.\n15. Treatment with any of the following agents within 60 days of Screening: radiation therapy, cytotoxic chemotherapeutic agents, any systemic immune suppressant.\n16. Treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity (such as hydroxyurea or foscarnet) within 30 days of Day 1.\n17. Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.\n18. Exposure to an approved vaccine within 14 days prior to Day 1.\n19. Current enrollment or past participation within the last 30 days before signing of consent in any other clinical study involving an investigational study intervention or any other type of medical research\n20. Participants with known or suspected presence of virologic resistance mutations as defined by the Stanford HIV Drug Resistance Database to INSTIs or NRTIs. This determination will be based on local virologic resistance testing, either at Screening or within the 3 months prior to Screening. ViiV Healthcare clinical virologist and\u002For ViiV Healthcare medical monitor will verify eligibility to this criterion prior to Day 1.\n21. Creatinine clearance (eGFR) of \\\u003C60 mL\u002Fmin\u002F1.73 m2 via CKD-EPI race neutral method \\[Delgado, 2021\\].\n22. ALT \\>3 times the upper limit of normal (ULN). A single repeat of ALT is allowed within a single screening period to determine eligibility.\n23. Any Grade 4 laboratory abnormality at screening, except for a Grade 4 CPK and lipid abnormalities (e.g., total cholesterol, triglycerides, etc.) will exclude a participant from the study unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the ViiV Healthcare medical monitor. A single repeat of any lab abnormality is allowed within a single screening period to determine eligibility.\n24. Any acute laboratory abnormality at screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound.\n25. Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination and will be the screening ECG entered into the eCRF): QT interval corrected for heart rate according to Fridericia's formula (QTcF) \\>450 msec (males) or \\>470 msec (females); \\>480 msec for participants with bundle branch block.",{"count":365,"type":22},186,[258],"This clinical study is testing a new medication, VH4524184, to see if it can effectively treat HIV-1 in adults who have never received treatment for their infection. The study is comparing two different doses of VH4524184, each taken with the medications emtricitabine and tenofovir alafenamide (FTC\u002FTAF), to a standard HIV treatment called dolutegravir and lamivudine (DTG\u002F3TC). The purpose of the study is to provide data on the long-term antiviral activity of the VH4524184 and provide information regarding dosing formulation for further evaluations.",[26],[370,371,372,373,374,375],"Fixed dose combination","Antiretroviral","Antiviral","Naive viremics","Innovate","VH4524184","2026-07-22",{"date":378,"type":31},"2026-07-23",{"date":380,"type":31},"2026-02-11",{"date":382,"type":22},"2028-05-22",{"name":167,"class":38},123,{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":391,"eligibilityCriteria":392,"healthyVolunteers":74,"sex":393,"minAge":19,"maxAge":4,"enrollmentInfo":394,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":396,"conditions":397,"keywords":401,"overallStatus":348,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":88},"100632658","pharmacokinetic-study-of-long-acting-antiretrovirals-and-contraceptives-in-hiv-100632658","NCT07516548","Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptives in HIV","Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptive Options in HIV Prevention","PHARAOH","Parent Tshireletso Study Inclusion Criteria:\n\n1. Female 18 years of age or older and willing and able to provide an informed consent\n2. \\\u003C 14 days after delivery (calendar day of birth = day 0)\n3. Negative HIV screening test (conducted at the time of enrolment)\n4. Female \\\u003C30 years old or has had \\\u003C 3 prior pregnancies (Gravida 1, 2, or 3 including this pregnancy)\n5. Plan to stay and receive postpartum and pediatric care in the Gaborone or Molepolole region for 24 months\n\nParent Tshireletso Study Exclusion Criteria\n\n1. Receiving carbamazepine, phenobarbital, phenytoin, oxycarbazepine, rifampin, rifabutin, rifapentine, systemic dexamethasone (\\>1 dose oral\u002FIV), or St. John's wort\n2. Suspected to have, recently diagnosed with, or on treatment for TB (due to interaction with rifampicin)\n3. Previous hypersensitivity reaction to CAB or other INSTI\n4. Unstable medical or psychiatric condition making it unlikely they will be able to adhere to injections every 2 months\n5. Plan for pediatric and post-partum care outside the government system (private clinics)\n6. Inflammatory skin condition that compromises the safety of the intramuscular injection\n7. Weight \\\u003C35kg\n\nParent Doris Duke Study Inclusion Criteria Post-partum females included;\n\n1. if HIV-uninfected or unknown HIV status, willing to be tested for HIV\n2. if HIV-infected, documented to be on DTG as part of an antiretroviral treatment regimen\n3. maternal age \\>18 years,\n4. ability to speak English or Setswana\n5. intend to be available for follow up in Molepolole, Gaborone or Mochudi for 18 months post-delivery\n6. have access to a cell phone (including phone of friend or relative)\n\nParent Doris Duke Study Exclusion Criteria Post-partum females excluded if\n\n1. did not attend antenatal care or were not included in Tsepamo surveillance\n2. maternal age \\\u003C18,\n3. females who do not speak English or Setswana,\n4. unable or unwilling to give consent\n5. will not be able to attend follow up at a study site\n6. do not have access to any cell phone for follow up calls\n\nAdditional Inclusion Criteria for this PK Study\n\n1. For DMPA and ETG implant groups, intends to initiate or continue use of DMPA or ETG implant for at least another three or six months, respectively,\n2. For the CAB-LA groups, have received at least three consecutive CAB injections on time, including the one administered concurrently while starting a contraceptive method,\n3. Willing to undergo phlebotomy every 4 weeks for the duration of the sub-study period Additional Exclusion Criteria for this PK Study\n\n1\\) Use or anticipated use of nicotine-containing products (e.g., cigarettes or hookahs) known to interact with CAB-LA for the duration of the sub-study period 2) Use within the previous 90 days, current use, or planned future concomitant use of other hormonal contraceptives, including oral contraceptive methods 3) BMI≥35 4) Has any of the following laboratory abnormalities within the last year:\n\n1. Serum ALT\\>5x ULN at the time of screening,\n2. Serum creatinine \\>2.5x ULN at the time of screening. 5) Has any other condition that, in the opinion of the sub-study PI\u002Fdesignee, would preclude informed consent, make study participation unsafe, or complicate interpretation of study outcome 6) HIV infected females on the Doris Duke parent study","FEMALE",{"count":395,"type":22},105,"This study is being done to understand how long-acting injectable cabotegravir (CAB-LA) used for HIV pre-exposure prophylaxis (PrEP) and hormonal contraceptive methods affect each other when used at the same time. Women who are already using CAB-LA or not using PrEP will choose to join one of several groups based on whether they use injectable contraceptive (IM DMPA), an etonogestrel implant, or no hormonal contraceptive. Participants will have study visits every 4 to 12 weeks for up to 12 or 24 weeks after starting a contraceptive method to collect blood samples and measure levels of CAB-LA and hormone concentrations. The study will compare these levels to see if taking CAB-LA changes hormone concentrations or if using hormonal contraception changes CAB-LA drug levels. Safety, side effects, satisfaction, and continuation of CAB-LA PrEP and contraceptive methods will also be evaluated.",[26,398,399,110,400],"Contraception","Drug-drug Interaction","Long-acting Injectable Cabotegravir for PrEP",[402,403,404,405,406,110,407],"Adolescent girls and young women","Injectable cabotegravir","Botswana","Long-acting injectable cabotegravir","Pharmacokinetic study","HIV prevention","2026-07-19",{"date":189,"type":31},{"date":411,"type":22},"2026-08-01",{"date":413,"type":22},"2026-12-31",{"name":415,"class":65},"University of Alabama at Birmingham",{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":422,"eligibilityCriteria":423,"healthyVolunteers":74,"sex":75,"minAge":19,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":52,"phases":426,"briefSummary":427,"conditions":428,"keywords":4,"overallStatus":348,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":88},"100498535","developing-an-hiv-disclosure-intervention-for-men-in-uganda-100498535","NCT05771519","Developing an HIV Disclosure Intervention for Men in Uganda","Development and Assessment of an HIV Disclosure Intervention for Men in Uganda","DASH","For all 3 Aims, \"index participants\" inclusion criteria will include:\n\n* men living with HIV\n* with sexually transmitted infection symptoms (e.g., urethral discharge, genital lesions)\n* either not accessing antiretroviral therapy (per self-report109 and\u002For clinic documentation) or accessing antiretroviral therapy without HIV viral suppression\n* age ≥18 years,\n* with at least one sexual partner in the past three months\n\nAims 2 and 3 have the additional inclusion criteria:\n\n* men living with HIV without HIV disclosure to at least one partner.\n\nIn Aims 2 and 3, male participants will be encouraged to invite sexual partners for enrollment. These \"partner participants\" will have the following inclusion criteria:\n\n* age ≥18 years\n* partnered with an enrolled man who reports HIV disclosure or plans for HIV disclosure with study support\n* referred by the male participant.\n\nExclusion Criteria:\n\n* an inability to speak the local language (Runyankole) or English\n* an inability to provide informed consent",{"count":425,"type":22},70,[54],"The goal of this clinical trial is to test an HIV disclosure intervention that the investigators are developing focused on men living with HIV in Uganda. The main questions the investigators are trying to answer is whether the HIV disclosure intervention the investigators develop will help men who receive this intervention to disclose their HIV status to a greater extent than men who receive standard care.\n\nParticipants assigned to the intervention group will likely participate in the following:\n\n* Sexual health education\n* Cognitive behavioral therapy strategies\n* Problem-solving skills building\n* Motivational interviewing\n* Developing a personalized HIV disclosure plan\n* Communication skills building\n* Role-playing disclosure strategies",[26,429],"Sexually Transmitted Infections (Not HIV or Hepatitis)","2026-07-15",{"date":432,"type":31},"2026-07-16",{"date":434,"type":22},"2026-09",{"date":436,"type":22},"2027-12",{"name":438,"class":65},"Brigham and Women's Hospital",{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":74,"sex":18,"minAge":19,"maxAge":223,"enrollmentInfo":446,"targetDuration":4,"studyType":52,"phases":448,"briefSummary":449,"conditions":450,"keywords":451,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":88},"100633350","phase-1-a-study-to-investigate-the-safety-and-pk-of-vh4770359-in-healthy-participants-100633350","NCT07525544","A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants","A Multi-part, Phase 1, First-Time-in-Human Study to Investigate Safety, Tolerability, and PK of VH4770359 in Healthy Participants","Inclusion Criteria:\n\n1. 18 to 55 years old\n2. BMI 18.5-37.0 kg\u002Fm2\n3. Male participants must adhere to contraception requirements or abstinence, and female participants must not be pregnant\u002Fbreastfeeding and be of non-childbearing potential.\n\nExclusion Criteria:\n\n1. Participants with significant medical history that could alter drug pharmacokinetics, pose a risk, or interfere with conduct.\n2. Has exclusionary psychiatric, hepatic, cardiovascular, gastrointestinal, respiratory, endocrine, neurological, hematological, or renal condition, or exclusionary malignancy.\n3. A positive test(s) for Hepatitis B surface antigen (HBsAg) and\u002For anti-HBc, hepatitis C antibodies, or human immunodeficiency virus (HIV).\n4. A history of or ongoing high-risk behaviors for HIV acquisition.\n5. Use of prohibited medications.\n6. Exclusionary allergies or sensitivities.\n7. Regular use of alcohol, drugs of abuse, tobacco, or nicotine products.\n8. Exclusionary prior or concurrent clinical study participation.",{"count":447,"type":22},214,[227],"VH4770359 (also known as GSK4770359) is an antiretroviral compound. This first-in-human study aims to evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered VH4770359 in healthy participants. The findings from this study will support the design of future clinical studies of VH4770359 in people living with HIV.",[26],[452,159,160,233,453,454,455,456],"First-Time-in-Human","Healthy participants","Human immunodeficiency virus (HIV)","VH4770359 (GSK4770359)","Oral","2026-07-10",{"date":459,"type":31},"2026-07-13",{"date":461,"type":31},"2026-05-14",{"date":463,"type":22},"2027-05-05",{"name":167,"class":38},{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":471,"eligibilityCriteria":472,"healthyVolunteers":74,"sex":18,"minAge":473,"maxAge":474,"enrollmentInfo":475,"targetDuration":4,"studyType":52,"phases":477,"briefSummary":478,"conditions":479,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":88},"100535336","phase-3-long-acting-hiv-pre-exposure-prophylaxis-integrated-with-sexual-and-reproductive-health---crct-100535336","NCT06250504","Long-Acting HIV Pre-Exposure Prophylaxis Integrated With Sexual and Reproductive Health - cRCT","Long-acting HIV Pre-Exposure Prophylaxis Integrated With Community-based Sexual and Reproductive Health in South Africa (LAPIS): A Hybrid (1a) Cluster Randomised Controlled Phase 3B Trial of Effectiveness and Implementation","LAPIS","Inclusion Criteria:\n\nAll young men and women aged 15-30 who are residing in the 40 administrative clusters in the study district and attend any integrated SRH\u002FHIV service\n\nDocumented HIV negative test\n\nSuitable for PrEP and\u002For already on PrEP\n\nWeight \\> 35 kg\n\nUnderstand the required dosing schedule and HIV testing.\n\nAware that details can be shared with a peer navigator to support their follow-up\n\nIf pregnant or breast feeding and\u002For planning to become pregnant participant can be offered CAB LA, if risk of acquiring HIV out weighs unknown risk of CAB LA, but must understand that safety in pregnancy or breast feeding for CAB LA has not been established and oral daily PrEP is a safe alternative.\n\nExclusion Criteria:\n\nHistory or presence of allergy to the study drugs or their components\n\nInvestigator assessment find them not suitable\n\nAdditional exclusion criteria for specific products:\n\nCAB LA: Taking medication that is contraindicated (Carbamazepine, oxcarbazepine, phenobarbital, phenytoin, Rifampin, rifapentine) and Severe mental health disorder, Hep B surface antigen positive, living with hepatitis C and not yet treated, or abnormal liver function tests (ALT more than two times the upper limit of normal)\n\nDapiRing: Pregnancy.","15 Years","30 Years",{"count":476,"type":22},2052,[130],"The goal of this hybrid (1a) Cluster Randomised Controlled Trial phase 3B trial is to evaluate the effectiveness and implementation of offering a choice of HIV Pre-Exposure Products (PrEP) through community-based sexual and reproductive health services, on PrEP uptake and retention, and population prevalence of sexually transmissible HIV amongst adolescents and young adults living in rural South Africa.\n\nResearchers will compare adding the choice of long-acting PrEP, i.e. two monthly injectable cabotegravir (CAB LA) or dapiravine vaginal ring and HIV post exposure prophylaxis packs to daily oral PrEP integrated with community-based SRH in the 20 intervention clusters with standard of care (SoC), daily oral PrEP integrated with community-based SRH in the 20 control clusters, on uptake and retention on PrEP. We hypothesise that offering a choice of long-acting or oral PrEP and PEP within the community-based delivery of SRH services will overcome the challenges and barriers to effective use of oral daily PrEP and lead to a population-level effect on uptake and retention on PrEP and thus the prevalence of sexually transmissible HIV amongst 15-30 year olds living in rural KwaZulu-Natal, South Africa.",[26],"2026-07-07",{"date":482,"type":31},"2026-07-09",{"date":484,"type":31},"2024-02-27",{"date":486,"type":22},"2026-10",{"name":488,"class":65},"Africa Health Research Institute",{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":495,"eligibilityCriteria":496,"healthyVolunteers":74,"sex":75,"minAge":48,"maxAge":497,"enrollmentInfo":498,"targetDuration":4,"studyType":52,"phases":500,"briefSummary":501,"conditions":502,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":503,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":510},"100533788","sexual-health-advocacy-for-guys---a-text-messaging-based-hiv-prevention-program-for-guys-who-are-into-guys-100533788","NCT06230367","Sexual Health Advocacy for Guys - a Text Messaging-based HIV Prevention Program for Guys Who Are Into Guys","Harnessing the Power of Text Messaging to Reduce HIV Incidence in Adolescent Males Across the United States","SHAG","Inclusion Criteria:\n\n1. have been assigned male sex at birth and currently have a cisgender identity;\n2. be aged 13-22 years old;\n3. have had anal sex in the past 12 months;\n4. be English-speaking;\n5. exclusively own a cell phone with an unlimited text messaging plan and intend to have the same cell phone number for the next 6 months;\n6. have Internet access to complete online surveys;\n7. provide informed assent for those under 18, and consent for those 18 years of age and older, including a capacity to consent and a positive self-safety assessment;\n8. Willing to take an OraQuick home test to confirm HIV negativity for youth who are 19-20 years of age or 18 years old and graduated high school. If they agree to do the test but do not upload a photo of their result, they will be eligible if they self-report a negative sero-status. Youth 18 years old who have not graduated high school, and 13-17 years of age will be asked to take a home test. If they determine that they cannot do so safely, they will be allowed to self-report their sero-status; and\n9. not currently enrolled in another HIV prevention program; or\n10. know anyone already enrolled in the RCT.\n\nExclusion Criteria:\n\n* Being HIV positive","22 Years",{"count":499,"type":22},5000,[54],"SHAG is a text messaging-based HIV prevention program designed for cisgender sexual minority boys and men 13-20 years of age across the United States. Investigators will test it against a control group that receives messages about healthy lifestyle.",[26],{"date":482,"type":31},{"date":505,"type":31},"2024-01-15",{"date":507,"type":22},"2027-12-01",{"name":509,"class":65},"Center for Innovative Public Health Research",2,{"id":512,"slug":513,"hasResults":12,"nctId":514,"briefTitle":515,"officialTitle":516,"acronym":4,"eligibilityCriteria":517,"healthyVolunteers":74,"sex":18,"minAge":19,"maxAge":223,"enrollmentInfo":518,"targetDuration":4,"studyType":52,"phases":520,"briefSummary":521,"conditions":522,"keywords":523,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":88},"100643152","phase-1-mass-balance-and-absolute-oral-bioavailability-of-14cvh4524184-100643152","NCT07636928","Mass Balance and Absolute Oral Bioavailability of [14C]VH4524184","A Phase 1, Open-Label, Single Dose Study to Assess the Absolute Bioavailability, Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]VH4524184 in Healthy Participants","Inclusion Criteria:\n\n1. Willing and able to sign the Informed Consent Form (ICF).\n2. Sex at birth: male or female; female participants must be of non-childbearing potential, or postmenopausal.\n3. Age: 18 to 55 years, inclusive, at screening.\n4. BMI: 18.0 to 32.0 kg\u002Fm\\^2, inclusive, at screening.\n5. Female participants of non-childbearing potential must have unequivocal documentation that they are not of childbearing potential Postmenopausal female participants must have a serum follicle-stimulating hormone (FSH) concentration \\>33.4 milli-international units per milliliter (mIU\u002FmL) at screening to confirm menopause.\n6. Male participants, if not surgically sterilized and who have a female partner of childbearing potential, must agree to use a condom during any sexual intercourse until the completion of the follow-up visit.\n7. Male participants must agree not to donate sperm from admission on Day -1 until the completion of the follow-up visit.\n8. All prescribed medication must have been stopped at least 30 days and \\>5 half-lives prior to admission to the clinical site on Day -1.\n9. All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications must have been stopped at least 14 days prior to admission to the clinical site on Day -1. An exception is made for paracetamol that is allowed up to admission to the clinical site on Day -1.\n10. Ability and willingness to abstain from alcohol from 48 hours prior to screening and admission to the clinical site on Day -1 until the last PK sample.\n11. Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, black tea, green tea, white tea, cola, chocolate, energy drinks), and grapefruit (juice) from 48 hours prior to admission to the clinical site.\n12. Good physical and mental health based on medical history, physical examination, clinical laboratory, electrocardiogram (ECG), and vital signs, as judged by the Investigator.\n\nExclusion Criteria:\n\n1. Employee of ICON, the Sponsor, GSK or associated vendors.\n2. History of relevant drug and\u002For food allergies.\n3. History of drug hypersensitivity, delayed-type hypersensitivity, or severe hypersensitivity reactions, as well as history of sensitivity to the study drug.\n4. Using tobacco\u002Fnicotine products within 60 days prior to the first study drug administration.\n5. History of alcohol abuse or drug addiction within 5 years prior to screening.\n6. Positive drug and\u002For alcohol screen at screening or admission to the clinical site.\n7. Average intake of more than 24 units of alcohol per week.\n8. Positive screen for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) 1 and 2 antibodies at screening.\n9. Participation in a drug study with a small molecule drug within 30 days or 5 half-lives if known (whichever is longer) prior to the first study drug administration in the current study. Participation in a clinical study with a biological within 90 days or 5 half-lives if known (whichever is longer) prior to the first study drug administration in the current study. Participation in 4 or more other drug studies in the 12 months prior to the first study drug administration in the current study.\n10. Donation or loss of more than 450 mL of blood within 60 days prior to the first study drug administration. Donation or loss of more than 1.5 L of blood (for male participants)\u002Fmore than 1.0 L of blood (for female participants) in the 10 months prior to the first study drug administration in the current study.\n11. Significant and\u002For acute illness within 14 days prior to the first study drug administration that may impact safety assessments, in the opinion of the Investigator.\n12. Any significant current\u002Fongoing known or suspected pre-existing psychiatric condition, including depression, anxiety, and\u002For insomnia\u002Fsleep disturbances and\u002For suicidal ideation, in the opinion of the Investigator.\n13. Unsuitable veins for infusion or blood sampling.\n14. Participation in a study with a 14C dose of ≥0.1 megabecquerel (MBq) in the period of 1 year prior to screening.\n15. Irregular defecation pattern.\n16. Pre-existing clinically relevant, in the opinion of the Investigator in discussion with the Sponsor medical monitor, gastro-intestinal pathology or diagnosis, eg, irritable bowel syndrome, inflammatory bowel disease, and\u002For significant baseline signs and symptoms.\n17. History or presence of clinical condition or disorder that could be capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drugs, interfering with the interpretation of data or would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits, in the opinion of the Investigator. The Investigator may contact the Sponsor medical monitor to discuss the inclusion of participants who have a history of specific conditions that are not expected to interfere with their participation in the study.",{"count":519,"type":22},9,[227],"The purpose of the study is to assess the bioavailability, mass balance, pharmacokinetics, metabolism and excretion of radiolabeled (14C) VH4524184.",[26],[375,454],"2026-06-29",{"date":526,"type":31},"2026-07-02",{"date":528,"type":31},"2026-06-04",{"date":530,"type":22},"2026-08-20",{"name":167,"class":38},{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":4,"eligibilityCriteria":538,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":539,"targetDuration":4,"studyType":52,"phases":541,"briefSummary":542,"conditions":543,"keywords":544,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":550,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":510},"100522873","texting-to-reduce-human-immunodeficiency-virus-hiv-risk-100522873","NCT06088277","Texting to Reduce Human Immunodeficiency Virus (HIV) Risk","Texting in Community Health Center Dental Clinics to Reduce HIV Risk","Inclusion Criteria:\n\n* Give informed consent and document consent via a signed and dated informed consent form in REDCap\n* Willing to comply with all study procedures and be available for the duration of the study\n* Be able to read either in English or Spanish\n* Be a dental clinic patient of record at one of our participating community health centers\n* Has at least one risk factor for HIV defined as self-report of at least one of the following: Men who have sex with men; multiple sex partners, or intravenous drug use\n\nExclusion Criteria:\n\n* Self-report of having HIV infection\n* Participating in another HIV study or another text message study\n* A woman who reports having sex exclusively with women\n* Does not have a mobile phone or other device which can receive text messages from Agile Health\n* Does not have unlimited texting on their mobile plan\n* Has not used any type of text messaging at least once in the past month\n* Single item literacy screening score of 2 or below.",{"count":540,"type":22},266,[54],"This is a 3-year study to test the efficacy of a text message-based intervention program. Dental patients at 4 community health centers (n= 266) will be randomized to receive either text messages (TMs) regarding HIV prevention or TMs regarding overall wellness. Prior to enrolling the 266 participants, the investigators will conduct a feasibility pilot (n=20) to test the TM delivery as well as all study procedures. For both the pilot and the randomized clinical trial (RCT), recruitment will be conducted at 4 Community Health Center dental clinics (Codman Square, East Boston (both East Boston and South End locations), Geiger Gibson, and Upham's Community Health Centers). Recruitment materials (flyers and permission to contact forms) may also be made available at other clinics within the health centers.\n\nThe study will enroll English and Spanish-speaking patients who have at least one risk factor for HIV but are HIV-negative. Patients enrolled in the pilot will complete self-report surveys at baseline, 1 and 2 months. Participants enrolled in the RCT will complete self-report surveys baseline, 3, 6, and 12 months after baseline; receive and respond to TM assessments during the 6-month intervention.",[26],[545,546,547,548,549],"Dental patients","Community Health Center Dental Clinics","Text messaging","HIV negative","HIV testing",{"date":551,"type":31},"2026-07-01",{"date":553,"type":31},"2024-08-16",{"date":555,"type":22},"2027-04-14",{"name":557,"class":65},"Boston University",{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":562,"acronym":563,"eligibilityCriteria":564,"healthyVolunteers":74,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":565,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":567,"conditions":568,"keywords":569,"overallStatus":348,"whyStopped":4,"lastUpdateSubmitDate":573,"lastUpdatePostDateStruct":574,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":579,"locationsCount":88},"100638066","dynamic-decision-support-for-integrating-prep-in-clinics-for-young-people-in-alabama-and-botswana-100638066","NCT07597824","DYnamic decisioN Support for IntegrAting PrEP in Clinics for Young People in Alabama and Botswana","DYNAMIC PrEP","Group 1\n\n* Inclusion for Alabama site:\n\n  * 18 years of age or older\n  * Currently using or eligible for PrEP\n* Inclusion for Botswana site:\n\n  * 18 years of age or older\n  * Participated in the parent Tshireletso study in Botswana\n* Exclusion for both sites:\n\n  * Under the age of 18\n  * HIV positive\n\nGroup 2\n\n* Inclusion for both sites:\n\n  * 18 years of age or older\n  * Currently working as PrEP providers or clinic administrators at outpatient clinics\n* Exclusion for both sites:\n\n  * Under the age of 18\n\nGroup 3\n\n* Inclusion for both sites:\n\n  * 18 years of age or older\n  * Currently working as policy makers or program leaders at outpatient clinics\n* Exclusion for both sites:\n\n  * Under the age of 18",{"count":566,"type":22},1000,"This study evaluates strategies to improve access to HIV prevention through the integration of pre-exposure prophylaxis (PrEP) into existing healthcare settings, rather than limiting delivery to specialty clinics. The study addresses barriers to PrEP uptake, including limited awareness, stigma, and restricted access, and recognizes that availability alone may not ensure initiation or sustained use.\n\nThe study includes two components. First, a longitudinal cohort of current PrEP users will be followed to assess changes in access, preferences, and PrEP use over time in real-world settings. Second, a dynamic decision-support toolkit will be developed and evaluated to support patients and providers in PrEP-related decision-making. The toolkit will include patient- and provider-facing components to support clinical decision-making, improve risk understanding, and facilitate integration of PrEP into routine healthcare. The toolkit will be refined and beta-tested in selected healthcare facilities in Botswana and Alabama.",[26,398,110],[570,110,571,404,572],"HIV adherence","young adults","Alabama","2026-06-23",{"date":163,"type":31},{"date":576,"type":22},"2026-06",{"date":578,"type":22},"2031-12",{"name":415,"class":65},{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":586,"eligibilityCriteria":587,"healthyVolunteers":74,"sex":393,"minAge":19,"maxAge":4,"enrollmentInfo":588,"targetDuration":4,"studyType":52,"phases":590,"briefSummary":591,"conditions":592,"keywords":593,"overallStatus":348,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":601,"leadSponsor":603,"locationsCount":88},"100521337","an-mhealth-intervention-to-improve-hiv-prevention-service-engagement-among-people-who-use-drugs-100521337","NCT06068283","An mHealth Intervention to Improve HIV Prevention Service Engagement Among People Who Use Drugs","LOTUS: An mHealth Intervention to Improve HIV Prevention Service Engagement Among People Who Use Drugs","LOTUS","Inclusion Criteria:\n\n* 18 years of age or older\n* Report weekly or daily use of opioids and\u002For stimulants in the past 6 months\n* Meet current CDC eligibility criteria for PrEP\n* Report low levels of HIV prevention service engagement in the past 6 months\n* Not currently, or planning on becoming, pregnant during the study\n* Owns a smartphone with internet web-browsing capabilities\n\nExclusion Criteria:\n\n* 17 years of age or younger\n* Does not report weekly or daily use of opioids and\u002For stimulants in the past 6 months\n* Does not meet current CDC eligibility criteria for PrEP\n* Report high levels of HIV prevention service engagement in the past 6 months\n* Currently, or planning on becoming, pregnant during the study\n* Does not own a smartphone with internet web-browsing capabilities",{"count":589,"type":22},40,[54],"The goal of this single arm pre-post study is to assess the feasibility, acceptability, and preliminary impact of the LOTUS intervention to improve HIV prevention service engagement among people who use drugs. LOTUS is a technology-delivered intervention that provides HIV prevention informational content and tips, peer social support and social networking features, a resource locator, HIV prevention monitoring and reminders (e.g., reminders for HIV\u002FSTI testing and PrEP doses), and a virtual space to have questions answered by health care professionals.",[26],[594,595,109,596],"Women","Drug Use","HIV Prevention","2026-06-22",{"date":599,"type":31},"2026-06-26",{"date":551,"type":22},{"date":602,"type":22},"2027-07-30",{"name":604,"class":65},"University of California, San Diego",{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":610,"acronym":4,"eligibilityCriteria":611,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":612,"enrollmentInfo":613,"targetDuration":4,"studyType":52,"phases":614,"briefSummary":615,"conditions":616,"keywords":618,"overallStatus":348,"whyStopped":4,"lastUpdateSubmitDate":623,"lastUpdatePostDateStruct":624,"startDateStruct":625,"completionDateStruct":627,"leadSponsor":629,"locationsCount":4},"100644328","robotic-bronchoscopy-with-cbct-image-fusion-for-pulmonary-nodule-diagnosis-in-people-living-with-hiv-100644328","NCT07663656","Robotic Bronchoscopy With CBCT Image Fusion for Pulmonary Nodule Diagnosis in People Living With HIV","Clinical Application and Promotion of Full-Situational Awareness Bronchoscopic Robot Combined With CBCT-Based Multimodal Image Fusion for the Diagnosis and Management of Pulmonary Nodules in People Living With HIV: A Multicenter Open-Label Controlled Study","Inclusion Criteria:\n\n1. Confirmed diagnosis of HIV infection; on stable antiretroviral therapy (ART) for ≥6 months with plasma HIV viral load \\\u003C50 copies\u002FmL.\n2. Presence of at least one pulmonary nodule ≤3 cm in maximum diameter on thin-section CT; radiological features suggestive of malignancy (e.g., part-solid or solid nodule with spiculation, lobulation, or vessel convergence) with estimated pretest probability of malignancy ≥50%.\n3. Age 18-70 years.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n5. Life expectancy ≥6 months.\n6. Voluntary written informed consent obtained prior to any study procedure; willingness and ability to comply with scheduled visits, procedures, and follow-up requirements.\n\nExclusion Criteria:\n\n1. Active pulmonary tuberculosis or Pneumocystis jirovecii pneumonia requiring acute treatment at the time of screening.\n2. Coagulation disorder: International Normalized Ratio (INR) \\>1.5 or platelet count \\\u003C50 × 10\\^9\u002FL.\n3. Prior definitive treatment for the target pulmonary nodule (e.g., surgical resection, radiotherapy, ablation, or systemic anti-tumor therapy).\n4. Unstable ART status: not on continuous ART or HIV viral load ≥50 copies\u002FmL within 3 months prior to enrollment.\n5. Target lesion already diagnosed definitively by previous percutaneous biopsy or surgical pathology.\n6. Severe cardiopulmonary dysfunction:\n\n   * Forced Expiratory Volume in 1 second (FEV1) \\\u003C50% predicted; or\n   * New York Heart Association (NYHA) Class III-IV heart failure.\n7. Pregnancy or breastfeeding.\n8. Participation in another interventional clinical trial within the past 3 months.\n9. Inability to complete follow-up (e.g., no fixed residence, unstable contact information).\n10. Any other condition that, in the investigator's judgment, would make the participant unsuitable for enrollment or pose unacceptable risk (including significant airway abnormality preventing safe navigation).","70 Years",{"count":204,"type":22},[54],"This multicenter study evaluates a full-situational awareness robotic bronchoscopy system combined with CBCT-based multimodal image fusion for diagnosing lung nodules in people living with HIV (PLWH).\n\nLung nodules are small lesions that may be benign or cancerous. In PLWH, accurate diagnosis is especially important but challenging. In this study, participants will be assigned to one of two groups:\n\n* Experimental group: Robotic bronchoscopy with real-time full-situational awareness and CBCT image fusion;\n* Control group: Electromagnetic navigation-guided bronchoscopy combined with radial endobronchial ultrasound (EBUS).\n\nIn both groups, rapid on-site cytologic evaluation (ROSE) will be performed to confirm tissue adequacy. For participants confirmed to have lung cancer and meeting safety criteria, an exploratory transbronchial cryoablation will be performed during the same procedure.\n\nThe study aims to compare diagnostic accuracy and safety between the two approaches and to explore the feasibility of immediate cryoablation for early-stage lung cancer in PLWH.",[26,617],"Pulmonary Nodule",[619,620,105,617,621,622],"Full-Situational Awareness Robotic Bronchoscopy","Cone-Beam CT","Cryoablation","Diagnostic Yield","2026-06-17",{"date":573,"type":31},{"date":626,"type":22},"2026-07",{"date":628,"type":22},"2028-03",{"name":630,"class":631},"wu qingguo","OTHER_GOV",{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":638,"eligibilityCriteria":639,"healthyVolunteers":74,"sex":393,"minAge":19,"maxAge":4,"enrollmentInfo":640,"targetDuration":4,"studyType":52,"phases":642,"briefSummary":643,"conditions":644,"keywords":647,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":623,"lastUpdatePostDateStruct":651,"startDateStruct":652,"completionDateStruct":654,"leadSponsor":656,"locationsCount":88},"100581669","an-effectiveness-trial-of-the-prep-for-wings-study-100581669","NCT06853314","An Effectiveness Trial of the PrEP for WINGS Study","An Effectiveness Trial of WINGS+PrEP: a Syndemic mHealth Intervention to Increase PrEP Uptake Among Women Impacted by Heavy Alcohol Use and Partner Violence in the Criminal Legal System","PFW","Inclusion Criteria:\n\nIdentify as a cis-gender woman Aged 18 or older HIV-negative Previous engagement with the criminal legal system or child protective services.\n\nMeet criteria for hazardous alcohol use Previous experience of intimate partner veiolence Report not taking PrEP in the past 90 days Recent experiences of HIV risk due to HIV risk exposure\n\nExclusion Criteria:\n\nAbility to speak and understand English is not sufficient to participate in assessments or intervention sessions.\n\nInability to complete informed consent process due to a psychiatric or cognitive impairment (assessed by the Mini Folstein exam)",{"count":641,"type":22},307,[54],"(Effectiveness Aim 1) To test the comparative effectiveness of PreP for WINGS versus PrEP alone on primary outcomes of increasing PrEP initiation measured by self-report\u002Fmedical records, recent adherence and longer-term adherence by self-report\u002Fmedical records over the 6-month follow-up; and secondary outcomes of decreasing IPV, hazardous drinking, recidivism, and HIV risks.\n\n(Moderation Aim 2) To test if the effectiveness of WINGS+PrEP on study outcomes is moderated by key participant subgroups based on race\u002Fethnicity, sexual orientation, age, education, incarceration history, IPV severity, substance use disorders (SUDs), digital access and literacy, housing stability, and medical mistrust.",[26,645,646],"Alcohol Use Disorder","Violence, Gender-Based",[648,649,650,110],"Intimate partner violence","Hazardous alcohol use","HIV infection",{"date":597,"type":31},{"date":653,"type":31},"2026-04-09",{"date":655,"type":22},"2027-06-01",{"name":657,"class":65},"Columbia University"]