[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hiv\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hiv":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,298,0,25,[9,42,77,103,128,153,181,192,222,248,275,300,326,348,358,377,404,427,447,475,493,519,537,555,574],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100053444","big-chicago-a-trial-of-basic-income-guarantee-for-young-people-living-with-hiv-100053444",false,"NCT07502365","BIG Chicago: A Trial of Basic Income Guarantee for Young People Living With HIV","Inclusion Criteria:\n\n* Living with HIV for 24 months or longer;\n* Ages 18-35;\n* English-speaking;\n* One or both of the following:\n\n  1. Experienced a gap in HIV provider care of 6 or greater months during the prior 12-month period;\n  2. Had an unsuppressed viral load at any point within the prior 12-month period (unsuppressed meaning a viral load of 200 copies\u002FmL or higher);\n* Household income at or below 250% of the Federal Poverty Level; and\n* Experiencing financial distress, as based on a financial well-being score of 1-4 (high financial distress).\n\nExclusion Criteria:\n\n* Unwilling\u002Funable to provide informed consent\n* Unable to confirm HIV status\n* Unable to conduct the study in English","ALL","18 Years","35 Years",{"count":20,"type":21},304,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to compare two interventions - Basic Income Guarantee (BIG) + Treatment as Usual and Treatment as Usual among individuals living with HIV who have experienced financial hardships.\n\nThe main question it aims to answer is:\n\nCompared with the Treatment as Usual group, will participants in the BIG + Treatment as Usual group be more likely to improve care engagement and viral suppression?\n\nParticipants on the study will be:\n\n* Randomly assigned (like the flip of a coin) to participate in either BIG + Treatment as Usual or Treatment as Usual. Participants will have an equal chance of being placed in either group.\n* Complete 9 surveys over a 36 month period.\n* Complete a release of information so electronic medical record data can be accessed for the 18 months prior to treatment engagement and for 36 months from program enrollment.\n* Participants in the Treatment as Usual group will not receive any intervention.\n* HIV viral load testing will be confirmed at 3 timepoints (baseline, 12 months, and 18 months).\n* Participants in the BIG + Treatment as Usual group will receive $500 monthly income for 18 months.\n* Participants in the BIG + Treatment as Usual group will complete 3 social network surveys to assess how receiving BIG impacts their social networks.\n* A subset of participants in the BIG + Treatment as Usual group (30 participants) will complete 5 individual interviews over the course of receiving BIG and the 18 months after.",[27,28],"HIV","Financial Stress",[27,28],"NOT_YET_RECRUITING","2026-07-10",{"date":33,"type":34},"2026-07-13","ACTUAL",{"date":36,"type":21},"2026-07",{"date":38,"type":21},"2030-07",{"name":40,"class":41},"University of Chicago","OTHER",{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100054059","phase-2-combatting-hiv-or-other-stis-early-choose-100054059","NCT07510048","Combatting HIV Or Other STIs Early (CHOOSE)","Combatting HIV Or Other STIs Early (CHOOSE): An Integrated Strategy of Pre-Exposure Prophylaxis (PrEP) Mobile Health (mHealth) Support and Doxycycline Post-Exposure Prophylaxis (DoxyPEP)","CHOOSE","Inclusion Criteria\n\n* Age 13-24 years, inclusive;\n* Self-reports being at increased likelihood for HIV acquisition, defined as having anal sex with a male in their lifetime;\n* Owns an iOS or Android Smartphone and able to access all elements of the PrEP Choice package;\n* Not currently on PrEP and interested in learning more about PrEP;\n* Is not living with HIV;\n* Weighs at least 35 kg;\n* Willing to receive PrEP care from a provider at a participating ATN SC;\n* Able to understand, read, and speak English;\n* Able to participate at the study site; and\n* Willing and able to provide written informed consent.\n* If of legal age or otherwise able to provide independent informed consent as determined by local law and consistent with IRB policies: Willing and able to provide written informed consent for study participation.\n* If not of legal age or otherwise not able to provide independent informed consent as determined by local law and consistent with IRB policies: Parent or legal guardian is willing and able to provide written informed consent for study participation and potential participant is willing and able to provide written assent for study participation.\n\nExclusion Criteria:\n\n* Female;\n* In a mutually monogamous sexual relationship with a partner not living with HIV for the past 12 months;\n* Currently participating in an interventional trial of PrEP agents, or prior enrollment in HPTN 083, HPTN 083-01, or any other study of long-acting PrEP (including PURPOSE- 2 lenacapavir study);\n* Plan to move within 18 months to an area inaccessible to a participating ATN SC;\n* An employee of the participating SC; or\n* Any concurrent participation in other clinical trials or behavioral intervention studies without prior approval from the protocol team.\n* Any other medical, behavioral, or other conditions that in the opinion of the SC Project Lead could interfere with adherence to study procedures or the individual's ability to remain in the study for an 18-month period or compromise interpretation of study results.",true,"MALE","13 Years","24 Years",{"count":55,"type":21},200,[57],"PHASE2","The overarching goal of this project is to optimize the PrEP Choice integrated mHealth package and assess the efficacy and cost of PrEP Choice on PrEP initiation and adherence among young people. It is hypothesized that PrEP Choice will improve HIV PrEP uptake and adherence among young people and will be cost-effective to deliver to young people in the United States (U.S.). This study will also assess the uptake, adherence, and acceptability of DoxyPEP among young people.",[27,60,61,62],"STIs","STIs Prevention","HIV Prevention",[27,60,64,65,66,67,68],"sexually transmitted infection","PrEP","DoxyPEP","mobile health","mHealth",{"date":33,"type":34},{"date":71,"type":21},"2026-07-20",{"date":73,"type":21},"2029-03-30",{"name":75,"class":41},"Westat",6,{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":102},"100053999","olfactory-function-and-model-based-behavior-in-people-living-with-hiv-and-sud-100053999","NCT07637669","Olfactory Function and Model-Based Behavior in People Living With HIV and SUD","Olfactory Function and Model-based Behavior in People Living With HIV and SUD","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\nFor all participants:\n\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Aged 18-65 years old. Justification: prevalence of olfactory impairments increases with age; after age 53, the prevalence is 24.5 percent, increasing to 62.5 percent in people ages 80-97.\n* Agreement to adhere to Lifestyle Considerations throughout study duration.\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n\nFor participants in the HIV+ and SUD+ and HIV+ and SUD- groups:\n\n-HIV positive.\n\nFor participants in the HIV+ and SUD+ and HIV- \\& SUD+ groups:\n\n-Substance Use Disorder (SUD) other than Alcohol Use Disorder (AUD) or Tobacco Use Disorder (TUD).\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\nFor all participants:\n\n* History of neurological illnesses or neurosurgery including but not limited to cerebrovascular accident, Parkinson disease, Alzheimer disease, Huntington disease, central nervous system (CNS) tumor, significant head trauma with sequelae, multiple sclerosis or other demyelinating diseases, epilepsy, movement disorders. The MAI will also retain discretion to exclude based on a history of a neurological illness or trauma that may compromise data integrity.\n* History of current (past 12 months) uncontrolled major DSM-5 psychiatric disorder including major affective disorder, obsessive-compulsive disorder, schizophrenia, or posttraumatic stress disorder, excluding SUD.\n* Candidates who recently (12 hours prior to a study visit) used medications and\u002For substances that are psychoactive or otherwise affect alertness will have to pass a clinical assessment for intoxication on the day of the study visit. Based on participant preferences and MAI\u002FPI judgment, participants who fail the clinical assessment for intoxication will either be withdrawn or rescheduled.\n* History of clinically significant anaphylaxis, e.g., due to severe asthma or food and nonfood allergies (e.g., latex, detergents, soap, etc.). The MAI will retain discretion to exclude a participant based on this criterion.\n* Uncorrected impairments in visual acuity.\n* Non-English speaking. Justification: The data integrity of some of the behavioral tasks used in this study would be compromised as they have only been validated in English.\n* Pregnancy.\n* Any other condition that in the judgment of the investigators is incompatible with participation.\n\nFor participants in the HIV+ and SUD- and HIV- and SUD- groups:\n\n* History of current (past 12 months) SUD, excluding tobacco use disorder.\n* Pattern of alcohol and drug use in the past 12 months that is indicative of harmful use, loss of control over use, or physical dependence.\n* Daily alcohol or drug use (excluding caffeine and nicotine) for at least 4 continuous weeks in the past 12 months.\n\nFor participants in the HIV- and SU+ and HIV- and SUD- groups:\n\n-HIV positive.\n\nFor the Optional MRI Segment:\n\n-Unable to undergo MRI scanning due to certain metallic or magnetic devices or implants in the body, or claustrophobia.","65 Years",{"count":86,"type":21},120,"OBSERVATIONAL","Background:\n\nHuman immunodeficiency virus (HIV) infection can affect areas of the brain that control thinking ability. These same areas of the brain also control the sense of smell. HIV infection is common in people with substance use disorder (SUD). SUD also affects thinking ability. Researchers want to learn more about the connection between the sense of smell and decision-making ability in people with HIV, SUD, or both.\n\nObjective:\n\nTo test the sense of smell in people with HIV and\u002For SUD and how they make choices based on odors.\n\nEligibility:\n\nPeople aged 18 to 65 years with any of these: (1) HIV, (2) SUD, (3) both HIV and SUD, or (4) neither SUD nor HIV.\n\nDesign:\n\nParticipants will have 2 visits. Each visit will last 3 to 5 hours.\n\nIn visit 1, participants will have a blood draw and a saliva swab. They will answer questions about their health, sleep habits, food intake, and substance use. They will have smell tests:\n\nThey will smell scented sticks and answer questions about them. They will be blindfolded for some tests.\n\nThey will perform tasks on a computer. They will look at pictures and smell pleasant food odors, such as chocolate cake or pizza. Smells will be delivered using a nasal mask. Their sniffing and breathing will be measured. They may also be exposed to odor-free air. They will eat food that corresponds to one of the food odors they smelled.\n\nIn visit 2, participants will do a saliva swab and a different computer task that involves odors. They will also have tests of their attention and memory. Participants may opt to have an imaging scan of the brain.",[27,90],"Substance Use Disorder",[27,90,92,93],"Olfaction","Decision Making",{"date":33,"type":34},{"date":96,"type":21},"2026-07-16",{"date":98,"type":21},"2031-06-27",{"name":100,"class":101},"National Institute on Drug Abuse (NIDA)","NIH",1,{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":50,"sex":16,"minAge":111,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":102},"100053936","phase-1-cabotegravir-hormone-pkpd-interactions-for-hiv-prevention-100053936","NCT07672717","Cabotegravir-Hormone PK\u002FPD Interactions for HIV Prevention","CHIPP-PrEP: Cabotegravir-Hormone Interrogation of Pharmacokinetics\u002FPharmacodynamics (PK\u002FPD) for HIV Prevention","CHIPP-PrEP","Inclusion Criteria:\n\n* 19 years of age or older\n* For persons using exogenous hormones, must be on a stable regimen for ≥6 months and remain on that regimen throughout study conduct, and exogenous hormone regimens must be prescribed and managed under the care of a healthcare professional\n* For females, must be on a non-hormonal contraceptive agent, and must persist in contraceptive use for the duration of the study\n* Body weight greater than 35 kg (77.2 lbs)\n* HIV-1 uninfected at screening and enrollment as documented by an instrumented Ag\u002FAb assay and HIV-1 RNA testing\n* Understand and agree to local STI reporting requirements\n* Willing to abstain from additional antiretroviral agents (including PrEP agents, F\u002FTAF and F\u002FTDF) during the duration of the study\n* Willing to abstain from insertion of anything (drug, enema, penis, or sex toy) in the rectum or vagina for 72 hours before and 72 hours after each flexible sigmoidoscopy\n* Willing to refrain from aspirin and NSAID use for one week before and after each study biopsy visit\n* Willing and able to use condoms for all receptive anal intercourse and receptive vaginal intercourse for the duration of study participation\n* Able and willing to communicate in English\n* Able and willing to provide written informed consent to take part in the study\n* Able and willing to provide adequate information for locator purposes\n* Availability to return for all study visits, barring unforeseen circumstances\n* Agree not to participate in other research studies involving drugs and\u002For medical devices for the duration of the study\n\nExclusion Criteria:\n\n* History of previous long-acting antiretroviral use, including CAB-LA and long-acting lenacapavir\n* History of oral PrEP (F\u002FTDF, F\u002FTAF) use within the prior eight weeks\n* For females, if a participant is pregnant or plans to become pregnant during study duration\n* For females, if the participant is actively breastfeeding\n* For females, if the participant is post-menopausal or accessing exogenous hormone replacement therapy\n* For females, has irregular menstrual cycles\n* Has a tattoo or other dermatological condition which may interfere with product administration or interpretation of injection site reactions\n* Surgically-placed or injected buttock implants or filler, per self-report\n* One or more reactive or positive HIV test results at screening or enrollment, even if HIV infection is not confirmed\n* Current known HIV-infected partner(s)\n* Symptoms suggestive of acute HIV seroconversion at screening and enrollment\n* Known or suspected allergy to CAB-LA\n* Any ≥ Grade 2 laboratory abnormality at baseline as defined by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 - July 2017, and Addendum 3 (Rectal Grading Tables for Use in Microbicide Studies)\n* Significant rectal symptom(s) as determined by medical history or by participant self-report (including but not limited to presence of any unresolved injury, infectious or inflammatory condition of the local mucosa, history of inflammatory bowel disease, presence of symptomatic hemorrhoids, and presence of any painful anorectal conditions that would be tender to manipulation)\n* At screening or within the past 2 months: participant-reported symptoms and\u002For clinical or laboratory diagnosis of active rectal or genital infection requiring treatment per current CDC guidelines or symptomatic urinary tract infection (UTI). Infections requiring treatment include chlamydia (CT), gonorrhea (GC), syphilis, active HSV lesions, chancroid, genital sores or ulcers, and, if clinically indicated, genital warts. HSV seropositivity with no active genital lesions is not an exclusion criterion. (Note: if an STI apart from HIV is detected, the participant will be referred for treatment and can be retested in 30 days and re-screened once.)\n* History of significant gastrointestinal bleeding\n* Clinically significant cardiovascular disease, as defined by history of symptomatic arrhythmia, ischemia, or other significant cardiac disease\n* Current use of warfarin or heparin or other anticoagulant medications associated with increased risk for bleeding following mucosal biopsy (e.g., daily high dose aspirin \\[\\>81 mg\\], NSAIDs, or Pradaxa®)\n* Use of systemic or anorectal immunomodulatory medications within 4 weeks of enrollment or planned use at any time during study participation\n* Per participant report, use of any rectally or vaginally administered products containing N-9 (including condoms) or investigational products within 4 weeks of enrollment, or planned use of either at any time during study participation\n* Any other condition or prior therapy that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, make the individual unsuitable for the study or unable to comply with the study requirements.\n* Individuals with neocervix will be excluded from giving cervical biopsies, if eligible for study participation.","19 Years",{"count":113,"type":21},32,[115],"PHASE1","This is a research study to better understand how long-acting cabotegravir (CAB-LA) works to prevent HIV in people. This study will also evaluate the impact of endogenous and therapeutic hormones on CAB-LA pharmacology. The investigators will also evaluate if participants experience any medical problems when taking CAB-LA.",[27,118,119],"Prophylaxis","Injectable","RECRUITING",{"date":33,"type":34},{"date":123,"type":34},"2026-07-07",{"date":125,"type":21},"2031-12",{"name":127,"class":41},"Johns Hopkins University",{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":50,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},"100053662","linking-youth-to-pre-exposure-prophylaxis-prep-services-100053662","NCT07438041","Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services","Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services (LYPS): An Innovative Mobile Delivery and Mobile Health (mHealth) Intervention to Optimize PrEP Adherence and Persistence","LYPS","Inclusion Criteria:\n\n* Age 13-24 years, inclusive;\n* Reports anal or vaginal sex in the past year;\n* Is not living with HIV;\n* Weighs at least 35 kilograms (77 pounds);\n* Willing to receive PrEP care from a provider at a participating SC either in the clinic or at one of the designated places in the community being offered by the SC SC;\n* Has an Android-based smartphone or iPhone;\n* Has fluency in English (able to read, speak, and understand English); and\n* Willing to provide informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Has counter-indications for PrEP according to guidelines and approved local label;\n* Has any clinically significant systemic disease (including but not limited to significant or uncontrolled liver disease, gastrointestinal disease, kidney disease, thyroid disease, osteoporosis, or bone disease) or diabetes;\n* Any other medical, behavioral, or other conditions that, in the opinion of the SC project lead or designee, could interfere with adherence to study procedures or compromise interpretation of study results;\n* Concurrent participation in ATN 166, ATN 170, or any other clinical trial providing HIV medications (PrEP, vaccine, etc.) or currently receiving any PrEP-adherence or persistence behavioral intervention; or\n* Is currently incarcerated or pending incarceration.",{"count":137,"type":21},272,[24],"The LYPS intervention is a multi-level intervention that combines: a) structural-level delivery of PrEP and PrEP services by a community health professional (CHP) at a designated place in the community being offered by the SC where PrEP is not yet provided (e.g., participant's home, community partner location, or traveling mobile van), with b) an individual-level mobile application (app) to support PrEP adherence and persistence between CHP visits.",[27,65,141],"PrEP Adherence",[65,143,144,145],"Adherence","Oral PrEP","Injectable cabotegravir",{"date":33,"type":34},{"date":148,"type":21},"2026-07-27",{"date":150,"type":21},"2028-12-15",{"name":75,"class":41},4,{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":160,"minAge":17,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":22,"phases":163,"briefSummary":165,"conditions":166,"keywords":172,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":174,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":102},"100053892","early-phase-1-digital-intervention-delivered-via-street-medicine-to-increase-hiv-and-substance-use-care-among-survivors-of-sex-trafficking-100053892","NCT07699484","Digital Intervention Delivered Via Street Medicine to Increase HIV and Substance Use Care Among Survivors of Sex Trafficking","Digital Intervention Delivered Via Street Medicine to Increase HIV and Substance Use Care Among Survivors of Sexual Trafficking","1. Age 18 years and above at enrollment\n2. Woman\n3. Screen positive for lifetime sexual trafficking","FEMALE",{"count":162,"type":21},60,[164],"EARLY_PHASE1","The goal of this clinical trial is to learn if the CONNECT program helps women with a history of sex trafficking get connected to substance use, HIV\u002FSTI, and mental health services. It will also learn whether the program is practical to deliver and acceptable to participants. The main questions it aims to answer are:\n\nDoes CONNECT increase participants' engagement in substance use treatment (such as starting medication for opioid use disorder or therapy for alcohol use), HIV and STI prevention and treatment services (such as starting PrEP or getting tested for STIs), and mental health treatment (such as treatment for PTSD)? Is CONNECT feasible and acceptable for women with a history of sex trafficking?\n\nResearchers will compare CONNECT to usual care to see if CONNECT increases engagement in these health services. The program will be delivered in partnership with a Street Medicine team that provides care directly to unhoused women, with support from a trained care navigator.\n\nParticipants will:\n\nComplete the CONNECT program or receive usual care Work 1:1 with a care navigator who helps with referrals to substance use, HIV\u002FSTI, and mental health services (CONNECT group) Complete assessments at the start of the study and at a 2-month follow-up Answer questions about their substance use, health behaviors, mental health, and use of health services",[167,27,168,169,170,171],"Sex Trafficking","Substance Use (Drugs, Alcohol)","Mental Health","Sexual Violence","Treatment Engagement",[167,27,173,169,170,171],"Substance Use",{"date":33,"type":34},{"date":176,"type":21},"2026-10-05",{"date":178,"type":21},"2028-06-30",{"name":180,"class":41},"Lifespan",{"id":182,"slug":4,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":84,"enrollmentInfo":183,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":88,"conditions":184,"keywords":185,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":190,"leadSponsor":191,"locationsCount":102},"100641768",{"count":86,"type":21},[27,90],[27,90,92,93],"2026-07-01",{"date":188,"type":34},"2026-07-02",{"date":123,"type":21},{"date":98,"type":21},{"name":100,"class":101},{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":50,"sex":160,"minAge":200,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":204,"conditions":205,"keywords":207,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":214,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":221},"100590067","mentor-moms-study-100590067","NCT06962592","Mentor Moms+ Study","A Community-based Adaptation of a Peer-led Intervention to Address Alcohol Use and HIV Risk in Pregnant Women in South Africa (Mentor Moms+)","(MM+)","Inclusion Criteria:\n\n* • ≥ 16 years;\n\n  * Pregnancy confirmed;\n  * reported alcohol use during pregnancy (in last 2 months);\n  * lives within 20 kilometers of the study facility;\n  * able and willing to consent to study participation.\n\nExclusion Criteria:\n\n* Individuals not meeting the above criteria will be excluded.","16 Years",{"count":202,"type":21},100,[24],"The goal of this study is to adapt an existing evidence based intervention for use in pregnant and lactating people (PLP) who use alcohol. Through the pilot RCT, we aim to understand if tailored intervention, Mentor Mothers+, is effective in reducing alcohol use (primary outcome) and improving antiretroviral (PrEP or ART) adherence (secondary outcomes) among pregnant and breastfeeding women living with and without HIV in a community heavily burdened by this syndemic.\n\nThe investigators will conduct an pilot randomized control trial in 100 pregnant women, recruited during antenatal care (ANC) visits within the Saldanha Bay Municipality clinic in Cape Town, South Africa. The RCT will involve the delivery of brief, individual motivational interviewing sessions provided by trained mentor mothers from the community who are on either PrEP (living without HIV) or ART (living with HIV) and who stopped or reduced alcohol use during pregnancy. The enrolled participants will be followed for a 6-month period spanning both pregnancy and postpartum stages.",[27,206],"Alcohol Consumption",[208,209,210,211,212,213],"pregnant","postpartum","HIV prevention","HIV treatment","Alcohol use","breastfeeding",{"date":188,"type":34},{"date":216,"type":34},"2025-09-01",{"date":218,"type":21},"2027-08-31",{"name":220,"class":41},"University of California, Los Angeles",2,{"id":223,"slug":224,"hasResults":12,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":50,"sex":16,"minAge":229,"maxAge":230,"enrollmentInfo":231,"targetDuration":4,"studyType":22,"phases":233,"briefSummary":234,"conditions":235,"keywords":237,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":241,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":102},"100475404","phase-1-trial-of-allogeneic-reduced-intensity-hla-haploidentical-allogeneic-hematopoietic-cell-bone-marrow-transplantation-followed-by-graft-versus-host-disease-gvhd-prophylaxis-with-cyclophosphamide-bortezomib-and-maraviroc-for-hematologic-malignancies--100475404","NCT05470491","Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Bone Marrow Transplantation Followed by Graft-versus-Host-Disease (GVHD) Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies ...","A Phase I\u002FII Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Transplantation Followed by GVHD Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies in People Living With HIV (PLWH)","* INCLUSION CRITERIA - RECIPIENT:\n* Participants must have a histologically or cytologically confirmed hematologic malignancy with standard indication for allogeneic hematopoietic cell transplantation including, but not limited to, one of the following:\n\n  * Acute myeloid leukemia in morphologic complete remission (\\\u003C5% blasts in the bone marrow, no detectable abnormal peripheral blasts, and no extramedullary disease)\n  * Any secondary and\u002For treatment related myeloid neoplasm with antecedent history of myeloid neoplasm or previous chemotherapy\u002Fradiation\n  * B-cell acute lymphoblastic leukemia in first or subsequent complete remission\n  * T-cell acute lymphoblastic leukemia in first or subsequent complete remission\n  * Myelodysplastic syndrome of intermediate or higher score by the Revised International Prognostic Scoring System (IPSS-R)\n  * Primary myelofibrosis of intermediate-2 or higher risk by the Dynamic IPSS-Plus (DIPSS-Plus) or high to very high risk score (5 or higher) calculated with MIPSS70+ Calculator; DIPSS-Plus For Myeloproliferative Neoplasms on the Mutation Enhanced International Prognostic Score System (MIPSS70\u002FMIPSS70+)\n  * Chronic myelomonocytic leukemia\n  * Chronic myelogenous leukemia resistant to or intolerant of \\>=3 tyrosine kinase inhibitors or with history of accelerated phase or blast crisis\n  * B-cell lymphoma including Hodgkin lymphoma that has relapsed\u002Fprogressed within 1 year of completion of primary treatment, after autologous transplantation or has progressed through at least 2 lines of therapy\n  * Burkitt or lymphoblastic lymphoma: high-risk disease in first remission, progression\u002Frelapse after \\>=1 previous regimen\n  * Chronic lymphocytic leukemia with 17p deletion and\u002For unmutated IgHv or refractory or intolerant of both BTK and PI3K inhibitors\n  * Mature T or NK neoplasms as defined in the WHO guidelines of sufficient type and severity for allogeneic HCT based on published clinical practice guidelines\n  * T-Prolymphocytic leukemia progressing\u002Frelapsing after alemtuzumab and at least one other regimen\n  * B-Prolymphocytic leukemia progressing\u002Frelapsing after fludarabine and at least one other salvage regimen\n  * Hematologic malignancy of dendritic cell or histiocytic cell type\n  * Multiple myeloma that relapses after therapy with both a proteasome inhibitor and an immunomodulatory drug (IMiD), relapses after autologous transplantation, or manifests as plasma cell leukemia\n\nIn addition to standard indications for HCT: Participant with a hematologic malignancy eligible for consolidation of first remission with autologous transplantation, if autologous transplantation is not accessible to the participant.\n\n* HIV seropositive, with ART regimen that, when stable for \\>4 weeks, is associated with an HIV viral load \\\u003C400 copies\u002FmL at screening evaluations. Subsequent changes to avoid\u002Foptimize drug interactions with study drugs or essential supportive care drugs may be made to the ART regimen at any time during the eligibility assessment period, as long as the eligibility criteria were met and the regimen change is expected, by the study team and involved consultants\u002Fpharmacy, to be similarly effective for HIV control. These changes to the ART regimen are not part of the study. If changes to the ART regimen are made during the eligibility period, HIV viral load will be rechecked at least 1 week after the change but prior to protocol treatment consent.\n\n  * Dose level 1: ART regimen must include maraviroc\n  * Dose level 2 and 3: ART regimen must not include maraviroc and there must be no history of maraviroc intolerance or resistance\n* Age \\>= 18 years\n* At least one potentially suitable HLA-haploidentical first degree or collateral related donor. Recipients with donor-specific anti-HLA antibodies (DSAs) to all potential donors must have at least one potential donor option where the DSA strength has a mean fluorescence intensity of \\\u003C 5000 and antibodies are not complement-fixing.\n* Karnofsky performance score \\>=50 percent.\n* Adequate organ function defined as possessing all of the following:\n\n  * Cardiac ejection fraction by 2D ECHO of \\>=40 percent\n  * Forced expiratory volume-1 (FEV-1), forced vital capacity (FVC), and diffusing capacity of the lung for carbon monoxide (DLco, adjusted for hemoglobin) all of \\>=40 percent predicted. If unable to perform pulmonary function tests, there should be no evidence of dyspnea at rest, no requirement for supplemental oxygen, and oxygen saturation \\>92 percent on room air.\n  * Total bilirubin \\\u003C=3.0 mg\u002FdL (unless due to Gilbert's or hemolysis), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) \\\u003C= 5x the upper limit of normal, gamma glutamyl transferase (GGT) \\\u003C= 5x the upper limit of normal\n* Estimated serum creatinine clearance of \\>=50 mL\u002Fmin\u002F1.73m2 calculated using eGFR in the clinical lab\n* Ability of participant to understand and the willingness to sign a written informed consent document.\n* Individuals of childbearing potential and those that can father children must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for at least one-year post-allo HCT.\n\nEXCLUSION CRITERIA - RECIPIENT:\n\n* Participants who are receiving any other investigational agents that cannot be discontinued\u002Fcompleted at least 2 weeks prior to the date of beginning conditioning.\n* Poorly controlled malignant indication for transplantation, defined as:\n\n  * Leukemia not having achieved morphologic remission (i.e. bone marrow blasts \\>5 percent or active extramedullary disease)\n  * Lymphoma not having demonstrated some degree of treatment sensitivity (chemosensitivity, radiosensitivity) by clinical and\u002For radiologic assessment\n  * Multiple myeloma not in complete remission, as determined by negative immunofixation in serum and urine and disappearance of any soft tissue plasmacytomas and \\\u003C= 5 percent plasma cells in the bone marrow.\n* Uncontrolled intercurrent illness that in the opinion of the PI would make it unsafe to proceed with transplantation.\n* Study team is unable to identify an adequate antiretroviral regimen to adequately suppress the HIV viral load \\\u003C400 copies\u002FmL that is compatible with study drugs\n* Pregnancy\n* For lactating potential participants: unwilling to discontinue lactation prior to the start of study treatment on day -14.\n* Prohibitive allergy to a study drug or to compounds of similar chemical or biologic composition of the agents (eATG, steroids, cyclophosphamide, busulfan, pentostatin, maraviroc, bortezomib, plerixafor (dose level 3 only)) used in the study.\n* Lack of central access potential sufficient for transplant\n* Active psychiatric disorder which is deemed by the PI to have significant risk of compromising compliance with the transplant protocol and\u002For antiretroviral therapy\n* Grade 3-4 motor or sensory neuropathy per CTCAE version 5.0\n\nINCLUSION CRITERIA - RELATED DONOR:\n\n* Related donor (age \\>=12) deemed suitable and eligible, and willing to donate, per clinical evaluations, who are additionally willing to donate blood and\u002For PBSC graft aliquotfor research. Related donors will be evaluated in accordance with existing institutional Standard Policies and Procedures for determination of eligibility and suitability for clinical donation.\n* Ability of participant or parent\u002Flegal guardian to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA - RELATED DONOR:\n\n-Failure to qualify per institutional Standard Policies","12 Years","120 Years",{"count":232,"type":21},265,[115,57],"Background:\n\nPeople living with HIV(PLWH) are at a higher risk for cancers that may be curable with a bone marrow transplant. HIV infection itself is no longer a reason to not get a transplant, for patients who otherwise have a standard reason to need transplant.\n\nObjective:\n\nThis study is being done to see if a new combination of drugs (cyclophosphamide, maraviroc, and bortezomib) is both safe and effective at protecting against graft-versus-host disease after bone marrow transplant. The study will also test the transplant s impact on your survival and control of your cancer.\n\nEligibility:\n\nPeople aged 18 years and older living with HIV and a blood cancer that is eligible for a transplant. Healthy family members aged 12 or older who are half matched to transplant recipients are also needed to donate bone marrow.\n\nDesign:\n\nThe study will be done in 2 phases. The first phase will be to see if we can safely use a new combination of drugs to prevent GVHD. If the combination is safe in the first phase, the study will proceed to the second phase. In the second phase, we will see if this new combination can better protect against GVHD after transplant.\n\nParticipants will be screened. Their diagnoses, organ function and eligibility will be confirmed.\n\nParticipants will have a catheter inserted into a vein in their chest or neck. Medications and transfusions will be given through the catheter; blood will be drawn from it.\n\nParticipants will be in the hospital for 6 weeks or longer.\n\nThey will receive various drugs for 2 weeks to prep their body for the transplant.\n\nThe transplant cells will be administered through the catheter.\n\nParticipants will continue to receive drug treatments after the transplant.\n\nBlood transfusions may also be needed.\n\nParticipants will return 1-2 times per week for follow-up visits for 3 months after discharge.\n\nParticipants will have visits 6, 12, 18, 24 months after transplant, then once a year for 5 years.",[27,236],"Hematologic Malignancies",[238,239,240],"Hematopoietic Cell Transplant","HCT","Human Immunodeficiency Virus",{"date":188,"type":34},{"date":243,"type":34},"2023-01-26",{"date":245,"type":21},"2027-07-30",{"name":247,"class":101},"National Cancer Institute (NCI)",{"id":249,"slug":250,"hasResults":12,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":12,"sex":16,"minAge":256,"maxAge":84,"enrollmentInfo":257,"targetDuration":4,"studyType":22,"phases":259,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":102},"100577620","home-based-self-sampling-for-cervical-cancer-prevention-education-intervention-in-ghana-100577620","NCT06800664","Home-based Self-sampling for Cervical Cancer Prevention Education Intervention in Ghana","The Impact of an Evidence-Based, Behavioral Cervical Cancer Screening Intervention Among Women Living With HIV in Ghana (HOPE-inG): A Type 2 Hybrid Effectiveness Implementation Trial","HOPE-inG","Inclusion Criteria:\n\nGeneral criteria\n\n* ability to give consent per Institutional Review Board stipulations\n* residing in the Central Region\n* having no medical characteristics that would interfere with the ability to participate fully\n* the willingness to participate in this study.\n\n  (a) Healthcare provider eligibility: Inclusion criteria include an individual (no gender restrictions) who\n* possesses healthcare qualifications (i.e., patient navigators, physicians, nurses, health facility management),\n* works at the HIV health facility at study sites,\n* is ≥18 years old. (b) Eligibility for women living with HIV (Patients)\n* identified female at birth) who\n* are living with HIV between 25 and 65 years old (age consistent with WHO CC screening guidelines)\n* have never had CC screening (Pap or HPV test),\n* have not had a screening for the past 5 years\n\nExclusion Criteria:\n\n* Women will be excluded if they are pregnant or have had a hysterectomy.\n* WLWH who have a cervix are the main target population to develop the HOPE toolkit.\n* Women who are below 25 and those who are above 65 years will be excluded.","25 Years",{"count":258,"type":21},1500,[24],"The investigators propose to develop and\u002For adapt implementation strategies and a structured implementation plan to translate the HOPE intervention into existing healthcare practice in Ghana.\n\nThese \"implementation support strategies (ISS)\" are implementation strategies relevant to implementation support, which is concerned with moving (implementation) research into (implementation) practice.\n\nThe ultimate goal is to facilitate health system adoption and sustainment.",[262,27,263,264,265,266],"Cervical Cancer Screening","Self-sampling","Implementation Science","Intervention (Training) Condition","Implementation Strategies","2026-06-30",{"date":186,"type":34},{"date":270,"type":34},"2025-11-11",{"date":272,"type":21},"2029-05",{"name":274,"class":41},"Baylor University",{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":279,"acronym":280,"eligibilityCriteria":281,"healthyVolunteers":50,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":22,"phases":284,"briefSummary":285,"conditions":286,"keywords":287,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":152},"100599850","hiv-testing-in-community-health-center-dental-clinics-100599850","NCT07089849","HIV Testing in Community Health Center Dental Clinics","TEETH","Inclusion Criteria:\n\nCommunity health center:\n\n* Must be located in Suffolk County in Massachusetts.\n* Must provide dental care services.\n* Must possess the infrastructure necessary for laboratory-based HIV testing and counseling or have an affiliation with a laboratory that provides these service.\n\nProvider:\n\n* Dental care provider working at a participating community health center during the study period.\n\nPatient:\n\n* Be 18 years of age or older.\n* Receive dental care at a participating community health center during the study period.\n\nExclusion Criteria:\n\nPatient:\n\n* Self-report to be HIV positive at the time of the RHT\u002F referral.\n* Had an HIV test within 12 months (self-report or documented in EHR).",{"count":283,"type":21},6715,[24],"This is a cluster randomized trial among dental clinics (n=4) to evaluate whether rapid HIV testing (RHT) during dental visits improves HIV testing rates compared to referral for laboratory HIV testing. Clinics will be randomized to either RHT or referral for HIV testing for a nine-month period - HIV testing will be offered to n\\~6700 patients by \\~ 15 dental providers (dentists and dental hygienists). Outcomes will be assessed using electronic health record reports (EHR), which will include the completion rates of HIV testing among dental patients (84 days after dental visit) and the frequency at which dental providers offer HIV testing (Upon completion of the 9-month testing period).\n\nThe objectives of this study are to:\n\n* Compare the effectiveness of on-site rapid HIV testing versus referral to a CHC lab in increasing HIV test completion within 84 days of a dental clinic visit, using EHR data.\n* Assess the sustainability of the HIV testing protocol by evaluating changes in dental clinic HIV testing rates over time.",[27],[288,289,290,291],"Rapid HIV test","Referral for HIV test","Community Health Center Dental Clinics","Behavioral Model for Vulnerable Populations","2026-06-29",{"date":186,"type":34},{"date":295,"type":21},"2026-09",{"date":297,"type":21},"2028-03",{"name":299,"class":41},"Boston University",{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":307,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":309,"conditions":310,"keywords":315,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":323,"completionDateStruct":4,"leadSponsor":325,"locationsCount":102},"100058758","specimen-collections-from-participants-with-hiv-infection-kshv-infection-viral-related-pre-malignant-lesions-and-cancer-100058758","NCT00006518","Specimen Collections From Participants With HIV Infection, KSHV Infection, Viral-Related Pre-malignant Lesions and Cancer","Collection of Blood, Bone Marrow, Tumor, or Tissue Samples From Patients With HIV Infection, KSHV Infection, Viral-Related Pre-Malignant Lesions, and\u002For Cancer","* INCLUSION CRITERIA:\n* Age 18 years or older.\n* ECOG performance status less than or equal to 3\n\nAt least one of the following:\n\n* Exposure risk to HIV, KSHV, or HPV\n* HIV seropositive\n* KSHV seropositive\n* EBV seropositive\n* HTLV-1 seropositive\n\nNOTE: infection with HIV, KSHV, EBV, and HTLV-1 are life-long, so if participants have previously been seropositive or have had a disease associated with KSHV (KS, primary effusion lymphoma \\[PEL\\], or KSHV-multicentric Castleman s disease \\[MCD\\]), this is sufficient to meet this criterion for eligibility.\n\n* Malignancy, MCD, or skin lesions with appearance of KS\n* Cervical or anal intraepithelial lesion\n* Ability of participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nNone",{"count":308,"type":21},1029,"BACKGROUND:\n\n* A number of important scientific advances can be made through the study of blood, bone marrow, tumor, or other tissue samples from patients with HIV infection, infection with Kaposi s sarcoma associated herpesvirus (KSHV), infection with other oncogenic viruses, or cancer.\n* This protocol provides a mechanism to affect a variety of such studies.\n\nOBJECTIVES:\n\n-Acquisition of serum, circulating cells, bone marrow, and tumor or normal tissue samples from participants with HIV infection, KSHV infection, or with cancer.\n\nELIGIBILITY:\n\n-Eligibility criteria include age 18 years or older and at least one of the following: Exposure risk to HIV, KSHV, or HPV; HIV seropositive; KSHV seropositive; EBV seropositive; HTLV-1 seropositive; malignancy, Castleman s disease, or skin lesions with appearance of Kaposi s sarcoma; or cervical or anal intraepithelial lesion.\n\nDESIGN:\n\n* Up to 999 subjects will be enrolled in this study.\n* Blood samples may be collected at the initial visit, and at follow-up visits.\n* Other fluids\u002Fexcretions may be collected (such as urine, saliva, semen, and stool).\n* Tumor samples may be obtained by fine needle aspirate, by removal of pleural or peritoneal fluid, by skin punch biopsy, or by excisional biopsy, providing the tumor is accessible with minimal risk to the participants.\n* Specific risks will be described in a separate consent to be obtained at the time of the biopsy.\n* Samples will be studied in the HIV and AIDS Malignancy Branch, CCR, NCI; laboratories in NCI-Frederick; or those of collaborating investigators.",[27,311,312,313,314],"Kaposi's Sarcoma","Lymphomas","Multicentric Castleman's Disease","Primary Effusion Lymphoma",[316,317,27,318,319,320],"Tumor","Viruses","KSHV","AIDS","Natural History","2026-06-27",{"date":267,"type":34},{"date":324,"type":34},"2000-12-06",{"name":247,"class":101},{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":50,"sex":16,"minAge":17,"maxAge":333,"enrollmentInfo":334,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":336,"conditions":337,"keywords":338,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":343,"startDateStruct":344,"completionDateStruct":4,"leadSponsor":346,"locationsCount":102},"100054370","viral-load-in-blood-and-lymph-tissues-in-people-living-with-hiv-100054370","NCT00001316","Viral Load in Blood and Lymph Tissues in People Living With HIV","A Study of Viral Burden in Peripheral Blood Versus Lymphoid and Bone Marrow Tissue in People Living With HIV","* INCLUSION CRITERIA:\n\n  1. HIV status must be documented by a licensed ELISA and confirmed either by Western blot, or plasma viremia.\n  2. Aged 18 years or older.\n  3. Ability to give informed, written consent.\n  4. The following laboratory values:\n\n     1. Absolute neutrophil count of greater than 1000\u002Fmm\\^3\n     2. PT, PTT, within normal limits, (unless PTT is elevated in presence of positive lupus anticoagulant in a participant with no prior history of abnormal bleeding).\n     3. Adequate blood counts (PLWH: hemoglobin \\>= 9.0 g\u002FdL, HCT \\>= 28%, platelets \\>= 75,000; participants without HIV: hemoglobin \\>=11.2 g\u002FdL, HCT \\>=34.1%, platelets \\>=150,000)\n     4. Blood pressure \\\u003C=180\u002F100; pulse rate 50-100, unless a lower pulse rate is considered normal for the participant\n  5. Participants who do not have HIV will qualify as control participants.\n  6. Participants must have a clinically palpable lymph node in an easily accessible location.\n  7. Willingness to allow blood samples to be used for future studies of HIV infection\u002Fpathogenesis, undergo genetic testing including HLA testing, and undergo hepatitis screening\n\nEXCLUSION CRITERIA:\n\n1. Women who are pregnant and\u002For breast-feeding\n2. Currently abusing alcohol or other drugs including narcotics or cocaine\n3. Participants with AIDS dementia or with an AIDS related malignancy other than minimal Kaposi's sarcoma.\n4. No Aspirin or Non-Steroidal Anti-inflammatory medications (NSIADs) 7 days prior to procedure. Acetaminophen (Tylenol) is permitted at any time.\n5. Any medical condition for which the PI feels LN BX might be contraindicated\n6. Participants in which sedation is planned. Use of narcotics (other than as prescribed by a physician) or cocaine less than 1 week prior to the date of biopsy will be excluded.","100 Years",{"count":335,"type":21},400,"This is a study to determine the effect of the human immunodeficiency virus (HIV) on lymphoid tissues (e.g., lymph nodes) as compared to peripheral white blood cells. We have shown in previous studies that the lymph node is a major site of accumulation of HIV in the body, as well as being a site where much of the viral replication occurs which leads to the destruction of the body's immune system. To better understand the role of the lymph node in HIV infection and destruction of one s immunity, we wish to examine both the virus itself as well as the effects it is having on various types of white cells (called lymphocytes) obtained simultaneously from both peripheral blood and lymph nodes of people living with HIV (PLWH). We also need to look at cells derived from blood and lymph nodes from people who do not have HIV to serve as a control for experiments. We may also use your lymph node tissue and blood cells to attempt to make new T-cells, or rebuild the immune cells, in the laboratory by adding various factors or other substances released by different cells in the body. If you are living with HIV, you may be asked to undergo a second biopsy six weeks to 12 months after the first biopsy. Because of the ability of aspirin to interfere with blood clotting, you must have refrained from the use of aspirin for one week (7 days) prior to the biopsy date. You also cannot use non-aspirin containing, non-steroidal, anti-inflammatory medications (e.g., ibuprofen, naproxen, and similar drugs) one week (7 days) prior to the biopsy. In addition, pregnancy testing will be performed on all females at the time of admission and a positive test will exclude you from participation. No participant will undergo more than six biopsies while participating in this study unless a particular research requires it....",[27],[339,340,341,319,342,320],"Lymph Node","Polymerase Chain Reaction (PCR)","In Situ Hybridization","Excisional Biopsy",{"date":267,"type":34},{"date":345,"type":34},"1992-08-26",{"name":347,"class":101},"National Institute of Allergy and Infectious Diseases (NIAID)",{"id":349,"slug":4,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":50,"sex":16,"minAge":111,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":22,"phases":351,"briefSummary":116,"conditions":352,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":355,"completionDateStruct":356,"leadSponsor":357,"locationsCount":102},"100644787",{"count":113,"type":21},[115],[27,118,119],"2026-06-26",{"date":267,"type":34},{"date":36,"type":21},{"date":125,"type":21},{"name":127,"class":41},{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":365,"enrollmentInfo":366,"targetDuration":4,"studyType":22,"phases":368,"briefSummary":369,"conditions":370,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":371,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":375,"locationsCount":376},"100636695","phase-1-a-trial-to-evaluate-the-safety-and-tolerability-of-dv700p-rna-and-dv701b11-rna-immunization-in-combination-with-antiretroviral-analytical-treatment-interruption-ati-in-people-living-with-hiv-for-elicitation-of-v3-glycan-antibodies-100636695","NCT07569029","A Trial to Evaluate the Safety and Tolerability of DV700P-RNA and DV701B1.1-RNA Immunization in Combination With Antiretroviral Analytical Treatment Interruption (ATI) in People Living With HIV for Elicitation of V3-glycan Antibodies","A Nonrandomized Phase 1 Clinical Trial to Evaluate the Safety and Tolerability of DV700P-RNA and DV701B1.1-RNA Immunization in Combination With Antiretroviral Analytical Treatment Interruption (ATI) in People Living With HIV for Elicitation of V3-glycan Antibodies","Inclusion Criteria:\n\n* Able and willing to provide informed consent.\n* Age 18 to 60 years.\n* Documented HIV infection.\n* Lowest (nadir) CD4+ count between 250 and 450 cells\u002Fmm³.\n* On stable combination antiretroviral therapy (ART) for at least 48 weeks prior to screening.\n* Plasma HIV RNA \\\u003C50 copies\u002FmL for at least 48 weeks prior to enrollment, allowing limited transient increases.\n* CD4+ count \\>450 cells\u002Fmm³ and CD4+ percentage ≥15%.\n* Willing and able to comply with study visits and procedures.\n* Agrees not to participate in another investigational study during participation unless approved.\n* In general good health, with no clinically significant findings on physical exam or laboratory testing.\n* Hemoglobin ≥11.0 g\u002FdL (women) or ≥13.0 g\u002FdL (men).\n* Absolute neutrophil count ≥750\u002Fmm³.\n* Platelet count ≥100,000\u002Fmm³.\n* ALT \\\u003C2.5 × upper limit of normal.\n* Estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin\u002F1.73 m².\n* Serum creatinine ≤1.1 × upper limit of normal.\n* Serum calcium \\>8.5 mg\u002FdL.\n* Blood pressure within acceptable limits.\n* Agrees to use condoms during the specified period when ART is interrupted until HIV RNA is undetectable.\n* No evidence of active hepatitis C infection.\n* No evidence of active hepatitis B infection.\n* For individuals of pregnancy potential: negative pregnancy test prior to enrollment and agreement to use effective contraception during the required study period.\n* Agreement not to seek pregnancy during the required study period.\n\nExclusion Criteria:\n\n* Current use of ART that includes non-nucleoside reverse transcriptase inhibitors (NNRTIs).\n* Use of long-acting ART within 3 months prior to enrollment.\n* Known resistance to any component of the current ART regimen (excluding M184V\u002FI mutation).\n* Resistance to one or more drugs in two or more ART classes (excluding M184V\u002FI mutation).\n* Initiation of ART during acute HIV infection (within 1 year of HIV acquisition, if known).\n* History of advanced HIV-related illness (CDC Category C), except recurrent pneumonia, within 10 years prior to screening, or history of CD4 count \\\u003C200 cells\u002Fmm³ within the past 10 years.\n* History of severe HIV-related conditions, including opportunistic infections, HIV-associated cancers, lymphoma, neurocognitive disease, or progressive multifocal leukoencephalopathy.\n* Active or recent non-HIV-related cancer requiring systemic treatment within 36 months or expected need for treatment within 12 months (excluding minor skin cancers).\n* Active hepatitis B or hepatitis C infection.\n* Significant liver disease, including cirrhosis or advanced fatty liver disease.\n* Untreated or incompletely treated active or latent tuberculosis.\n* Pregnancy or breastfeeding.\n* Body mass index (BMI) ≥40 kg\u002Fm², unless approved.\n* Diabetes mellitus, except well-controlled type 2 diabetes as allowed.\n* History of or current atherosclerotic cardiovascular disease, including heart attack, angina, stroke, or peripheral arterial disease.\n* Previous receipt of an investigational HIV vaccine (prior placebo recipients allowed).\n* Receipt of a non-HIV investigational vaccine within 1 year, unless approved or licensed.\n* Conditions causing impaired immune function or use of immunosuppressive medications within the specified timeframe.\n* Prior receipt of anti-HIV monoclonal antibody therapy.\n* Receipt of certain vaccines within restricted timeframes prior to enrollment (including live or mRNA vaccines within 4 weeks).\n* Receipt of other vaccines within 14 days prior to enrollment.\n* History of myocarditis or pericarditis.\n* Recent initiation of allergy immunotherapy within 1 year (unless stable or approved).\n* Recent use of investigational agents within restricted timeframes prior to enrollment.\n* History of severe allergic reaction to mRNA vaccines or polyethylene glycol-containing products.\n* History of angioedema.\n* Idiopathic urticaria within the past year.\n* Chronic urticaria or urticaria within the past year.\n* History of urticaria associated with vaccination.\n* Bleeding disorders or use of systemic anticoagulants.\n* Conditions associated with increased risk of clotting or bleeding.\n* History of seizures within the past 3 years or use of anti-seizure medications within that period.\n* Absence of spleen or impaired splenic function.\n* Active duty or reserve military personnel (U.S.).\n* Any clinically significant medical, psychiatric, or substance use condition that may affect safety or study participation.\n* Uncontrolled or severe asthma.\n* History of immune-mediated medical conditions, except limited stable or resolved conditions as allowed.\n* Allergy to local anesthetics (e.g., lidocaine).\n* Difficulty with venous access that would interfere with study procedures.","60 Years",{"count":367,"type":21},42,[115],"This phase 1 study will evaluate the safety, tolerability, and immune responses of two experimental mRNA HIV vaccines in adults living with HIV who are in overall good health. The study will enroll about 42 participants at multiple study sites. Researchers will assess whether these vaccines can start or strengthen antibody responses against HIV. The study will also evaluate how a closely monitored planned pause in antiretroviral therapy affects these immune responses.",[27],{"date":292,"type":34},{"date":373,"type":21},"2026-06-02",{"date":218,"type":21},{"name":347,"class":101},11,{"id":378,"slug":379,"hasResults":12,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":22,"phases":385,"briefSummary":386,"conditions":387,"keywords":389,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":399,"completionDateStruct":400,"leadSponsor":402,"locationsCount":102},"100642967","kulindana-community-friendly-delivery-and-monitoring-of-tpt-to-improve-uptake-and-reduce-tb-transmission-100642967","NCT07628140","Kulindana: Community-friendly Delivery and Monitoring of TPT to Improve Uptake and Reduce TB Transmission","Kulindana: Expanding Access and Impact of Tuberculosis Preventative Therapy: Community-friendly Delivery and Monitoring of TPT to Improve Uptake and Reduce TB Transmission","Inclusion Criteria:\n\n* Household contacts (HHC) are eligible for enrolment if the participant shares a residential dwelling with an index TB patient and can provide informed consent (or parental consent, with assent if appropriate).\n* People living with HIV (PWH) are eligible for enrolment if the participant is an adult aged 15 and over, is eligible for TPT according to Kenyan National Guidelines, and can provide informed consent.\n\nExclusion Criteria:\n\n* HHC will be excluded if the participant plans on permanently relocating from the area within the next three months, is not willing to receive TPT screening and initiation at home, or is enrolled in any other investigational\u002Finterventional HIV or TB study.\n* PWH will be excluded if the participant plans on permanently relocating from the area within the next three months, has contraindications for TPT according to the Kenyan National Guidelines, or is enrolled in any other investigational\u002Finterventional HIV or TB study.",{"count":258,"type":21},[24],"The goal of this clinical trial is to learn if differentiated service delivery (DSD) of TB preventive therapy (TPT) improves uptake and completion of TPT in two populations: household contacts (HHC) of index TB patients and people living with HIV (PWH). The main questions it aims to answer are:\n\n* Is community-based and multi-month dispensing of short-course TPT with minimal clinic and laboratory monitoring associated with higher rates of initiation and completion of TPT, compared to standard of care, in both HHC and PWH?\n* Does community-based and DSD TPT reduce household and community TB transmission?\n\nResearchers will compare DSD TPT delivery to standard of care (SoC) to see if DSD TPT delivery has an effect on TPT uptake and completion.\n\nParticipants will:\n\n* Be assessed for TPT eligibility through either DSD TPT service delivery of SoC including differentiated TB screening procedures.\n* If eligible, receive DSD TPT service delivery or SoC TPT service delivery.\n* Over 12 weeks receive either DSD or SoC TPT adherence assessment and follow-up.\n* Have TPT completion assessed at 12 weeks following enrolment.\n* A subset of participants will be assess for TB incidence at 9 months following enrolment.",[388,27],"Tuberculosis Prevention",[390,391,392,393,27,394,395,396],"tuberculosis","household contact","TB preventive therapy","3HP","contact investigation","multi-month dispensing","differentiated service delivery","2026-06-25",{"date":267,"type":34},{"date":36,"type":21},{"date":401,"type":21},"2031-07",{"name":403,"class":41},"University of Washington",{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":410,"eligibilityCriteria":411,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":412,"targetDuration":4,"studyType":22,"phases":414,"briefSummary":415,"conditions":416,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":426},"100496608","ending-tobacco-use-through-interactive-tailored-messaging-for-cambodian-people-living-with-hivaids-100496608","NCT05746442","Ending Tobacco Use Through Interactive Tailored Messaging for Cambodian People Living With HIV\u002FAIDS","Ending Tobacco Use Through Interactive Tailored Messaging for Cambodian People Living With HIV\u002FAIDS (Project END-IT)","ProjectENDIT","Inclusion Criteria:\n\n* 1\\) being aged ≥18 years\n* 2\\) being HIV-positive\n* 3\\) self-reporting as a current combustible cigarette smoker (smoked ≥100 cigarettes in lifetime and currently smoke ≥1 cigarettes\u002Fday)\n* 4\\) willing to set a date for a quit attempt within 2 weeks of study enrollment\n* 5\\) being able to provide written informed consent to participate\n* 6\\) being able to read Khmer (score ≥4 points on the Rapid Estimate of Adult Literacy in Medicine-Short Form\n\nExclusion Criteria:\n\n* 1\\) history of a medical condition that precludes use of nicotine replacement therapy\n* 2\\) physician\u002Fclinician deemed ineligible to participate based on medical or psychiatric condition\n* 3\\) enrolled in another cessation program or use of other cessation medications.",{"count":413,"type":21},800,[24],"The goal of this research study is to test how well an automated text messaging smoking treatment program helps smokers with HIV quit smoking.",[417,27],"Smoking Cessation","2026-06-24",{"date":353,"type":34},{"date":421,"type":34},"2023-01-11",{"date":423,"type":21},"2027-09-30",{"name":425,"class":41},"H. Lee Moffitt Cancer Center and Research Institute",3,{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":431,"acronym":4,"eligibilityCriteria":432,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":433,"enrollmentInfo":434,"targetDuration":4,"studyType":22,"phases":436,"briefSummary":437,"conditions":438,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":441,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":445,"locationsCount":102},"100474101","the-neural-underpinnings-of-depression-and-cannabis-use-in-young-people-living-with-hiv-100474101","NCT05453513","The Neural Underpinnings of Depression and Cannabis Use in Young People Living With HIV","Inclusion Criteria:\n\n* HIV seropositivity confirmed with lab report, medical records, or HIV testing.\n* Between the ages of 18-39 years\n* Fluency in English or Spanish\n* Ability to provide informed consent and perform study procedures, including estimated full-scale intelligence quotient (IQ) \\>75 to ensure that participants are able to understand the study.\n* Cannabis users: To capture a wide range of cannabis use frequency, meeting Diagnostic and Statistical Manual 5 (DSM-5) criteria for Cannabis use Disorder (CUD) will not be required. However, in order to ensure sufficient exposure, cannabis use will be significant (self-reported use on ≥20 of the prior 30 days and positive THC urine toxicology).\n* Depressed: In order to capture a wide range of depression illness severity, we will allow participants with subthreshold depression, defined as a raw severity score of ≥12 on the Montgomery Asberg Depression Rating Scale (MADRS).\n\nExclusion Criteria:\n\n* Perinatally acquired HIV infection, as early neurodevelopmental alterations and HIV legacy effects may exist in this group\n* Pregnancy or lactation\n* Current Substance Use Disorder other than cannabis or nicotine\n* Certified for or self-reported medical cannabis use, or intent to become certified\n* Current cocaine use by self-report or urine toxicology\n* central nervous system (CNS) disease or injury, or neuro-degenerative disease\n* Unique pain syndromes (e.g. multiple sclerosis, rheumatoid arthritis);\n* Severe medical illness such as end-stage renal disease, heart failure, cirrhosis, or cancer\n* MRI contraindication such as claustrophobia, metallic ink tattoos, or pacemaker.\n\nDepressed cannabis non-users:\n\n* At baseline, all participants will be psychotropic-medication-free for ≥1 month prior to study enrollment (or ≥3 months for medications with longer half-lives). Benzodiazepines and sleeping aids taken on an as-needed basis will be allowed, however we will require a 4-day abstinence period before the scan.\n* Exclusionary are participants with a DSM-5 diagnoses of bipolar disorder, psychotic disorders, autism spectrum disorders, and all non-cannabis substance-related disorders will be exclusionary. disorder (PTSD) are not uncommon among depressed individuals and will be\n* Anxiety disorders, obsessive-compulsive disorder (OCD), and post-traumatic stress are allowed as long as depressive symptoms are primary.\n\natypical of depression. • Suicidal ideations (SI) without a specific plan (defined as passive SI) are common in depression and will be allowed. However, if SI constitutes an imminent risk to self or others (defined as active SI), the participant will be withdrawn from the study and emergency procedures will be initiated immediately, including ER admission.\n\nDepressed cannabis users:\n\n• Exclusion criteria will be the same as depressed cannabis non-users except for cannabis use.\n\nNon-depressed cannabis users:\n\n• Will have no major psychiatric conditions other than cannabis use\u002Fdisorder.\n\nNon-depressed cannabis non-users:\n\n• Exclusion criteria will be the same as for non-depressed cannabis users; in addition participants will not report cannabis use in the prior 90 days and have a urine toxicology test negative for cannabis.","59 Years",{"count":435,"type":21},280,[24],"To elucidate mechanisms of substance use disorders (SUD) and comorbid mental illnesses in people living with HIV (PLWH), the study team seeks to investigate reward and pain circuitry in cannabis use and depression comorbidity, two highly prevalent conditions in PLWH. The study team proposes a tightly integrative study to test the overall hypothesis that cannabis use and depression in young PLWH have an additive effect, inducing both reward deficits and pain hypersensitivity, and that this pattern will predict worse outcomes at 1 year follow-up.",[439,440,27],"Depression","Cannabis Use Disorder",{"date":292,"type":34},{"date":443,"type":34},"2022-04-01",{"date":245,"type":21},{"name":446,"class":41},"University of Miami",{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":453,"eligibilityCriteria":454,"healthyVolunteers":50,"sex":160,"minAge":200,"maxAge":53,"enrollmentInfo":455,"targetDuration":4,"studyType":22,"phases":457,"briefSummary":458,"conditions":459,"keywords":460,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":470,"completionDateStruct":471,"leadSponsor":473,"locationsCount":221},"100644248","the-comprehensive-adherence-resource-and-empowerment-support-cares-study-100644248","NCT07666139","The 'Comprehensive Adherence Resource and Empowerment Support' (CARES) Study","Adapting the 'Comprehensive Adherence Resource and Empowerment Support' Intervention for Multiple PrEP Methods Among Adolescent Girls and Young Women in South Africa and Zimbabwe","CARES","Aim 2:\n\nInclusion (AGYW):\n\n* age 16-24 years (in Zimbabwe, participants aged 16 to 17 years must meet the legal criteria for emancipation to be eligible)\n* has initiated PrEP during the study, or no more than 6 months before the study initiation date (for LEN PrEP), or no more than 3 months before the study initiation date (for oral, ring, or CAB PrEP), and\n* willing and able to provide written informed consent for access to medical records, or assent and parental consent if applicable\n* fluent in one of the study languages (English, isiXhosa, Shona, Ndebele)\n* target date for PrEP resupply (i.e., to ensure continued coverage) falls within the month.",{"count":456,"type":21},2100,[24],"The primary aim of this study is to adapt the Comprehensive Adherence Resource and Empowerment Support (CARES) intervention to support adolescent girls and young women (AGYW) aged 16-24 in Zimbabwe and South Africa in effectively using various forms of pre-exposure prophylaxis (PrEP), specifically oral, ring, and injectable PrEP. Originally developed for a clinical trial setting, CARES has shown promising results in enhancing effective PrEP use through a structured mix of counseling, SMS\u002Fphone calls, and peer support for daily oral PrEP and the PrEP ring. However, its resource-intensive design requires adaptation for routine public health settings to ensure feasibility, fidelity, acceptability, and effectiveness. This adapted intervention will be tailored with input from AGYW, PrEP providers, and local stakeholders to support sustainable PrEP use and address HIV prevention needs among AGYW. Additionally, it will incorporate injectable PrEP and be modified to suit routine public health contexts. Once the components are finalized, the adapted CARES intervention will be evaluated for effectiveness, feasibility, fidelity, and acceptability.",[27],[65,461,462,463,464,465,466,467],"AGYW","South Africa","Zimbabwe","Effectiveness","Feasibility","Acceptability","Fidelity","2026-06-23",{"date":353,"type":34},{"date":186,"type":21},{"date":472,"type":21},"2028-10-31",{"name":474,"class":41},"RTI International",{"id":476,"slug":477,"hasResults":12,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":4,"eligibilityCriteria":481,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":482,"targetDuration":4,"studyType":22,"phases":484,"briefSummary":485,"conditions":486,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":487,"startDateStruct":488,"completionDateStruct":489,"leadSponsor":491,"locationsCount":492},"100644095","liver-transplantation-from-donors-with-hiv-impact-on-opportunistic-infections-cancer-and-long-term-outcomes-expanding-hope-liver-100644095","NCT07665372","Liver Transplantation From Donors With HIV: Impact on Opportunistic Infections, Cancer, and Long-Term Outcomes (Expanding HOPE Liver)","HOPE in Action Liver Transplantation From Donors With HIV: Impact on Opportunistic Infections, Cancer, and Long-Term Outcomes","Inclusion Criteria:\n\n* Participant meets local criteria for liver or simultaneous liver kidney (SLK) transplant.\n* Participant or legally authorized representative (in accordance with Johns Hopkins Medicine Institutional Review Board (IRB) and local IRB policy) is able to understand and provide informed consent.\n* Participant has documented HIV infection by any licensed assay or documented history of detectable HIV-1 RNA.\n* Participant is ≥ 18 years old.\n* Most recent HIV-1 RNA \\\u003C 50 copies RNA\u002FmL. Viral blips between 50-400 copies will be allowed as long as there are not consecutive measurements \\> 200 copies\u002FmL. Organ recipients who are unable to tolerate Antiretroviral Therapy (ART) due to organ failure or recently started ART may be eligible despite a detectable viral load if safe and effective ART to be used by the recipient after transplantation is described.\n\nExclusion Criteria:\n\n* Participant has prior progressive multifocal leukoencephalopathy (PML), cryptosporidiosis of \\> 1 month duration, or prior primary Central Nervous System (CNS) lymphoma.\n* Participant is pregnant or breastfeeding.\n* Past or current medical problems or findings from medical history, physical examination, or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.",{"count":483,"type":21},80,[24],"This research is being done to better understand opportunistic infections and cancer in transplant recipients with HIV who receive livers from a donor with HIV compared to livers from donors without HIV.",[27],{"date":353,"type":34},{"date":295,"type":21},{"date":490,"type":21},"2031-08",{"name":127,"class":41},19,{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":4,"eligibilityCriteria":499,"healthyVolunteers":12,"sex":51,"minAge":500,"maxAge":501,"enrollmentInfo":502,"targetDuration":4,"studyType":22,"phases":504,"briefSummary":505,"conditions":506,"keywords":508,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":512,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":516,"locationsCount":102},"100581033","a-study-to-improve-skeletal-muscle-in-veterans-with-hiv-100581033","NCT06845046","A Study to Improve Skeletal Muscle in Veterans With HIV","A Randomized Trial to Optimize Skeletal Muscle While Reducing Adiposity in Veterans With HIV","Inclusion Criteria:\n\n* Veteran\n* HIV+\n* antiretroviral therapy = integrase strand transfer inhibitor for at least 3 months\n* HIV-1 RNA \\\u003C50 copies\u002Fml\n* age = 20 yrs\n* BMI 28-50 kg\u002Fm2\n\nExclusion Criteria:\n\n* unstable body weight (gain or loss \\> 5% over past 3 months)\n* diagnosed mitochondrial disorder\n* diagnosed type 1 or type 2 diabetes\n* use of metformin or other anti-diabetic agents for pre-diabetes\n* hemoglobin A1c of \\>6.5% at screening visit\n* inflammatory conditions or chronic corticosteroid use\n* stage 3 or greater kidney disease\n* dietary or herbal supplements known to affect body weight, muscle mass, or immune function\n* MRI incompatibility\n* inability to perform physical function tests due to anatomical limitations\n* contradictions to CPET such as exercise-induced ischemia or supplemental oxygen","20 Years","80 Years",{"count":503,"type":21},70,[24],"The Department of Veterans Affairs is the largest single provider of medical care to people with HIV in the United States. The condition of excess lipid within and around muscle, termed myosteatosis, predisposes Veterans to physical function decline, frailty, disability, and cardiometabolic diseases such as diabetes and cardiovascular disease. In the investigators current Merit supported cohort, the investigators found that 36% of Veterans with treated HIV and obesity have \"myosteatotic type obesity\". Based on the investigators findings, the investigators have designed a multipronged integrated intervention that combines: 1) dietary replacement of saturated with unsaturated fats; 2) administration of L-carnitine and omega-3 fatty acid supplementation; and 3) targeted resistance exercise training.",[27,507],"Obesity",[27,509,510,511],"obesity","skeletal muscle","dietary supplement",{"date":353,"type":34},{"date":514,"type":34},"2025-07-15",{"date":73,"type":21},{"name":517,"class":518},"VA Office of Research and Development","FED",{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":523,"acronym":4,"eligibilityCriteria":524,"healthyVolunteers":12,"sex":160,"minAge":17,"maxAge":4,"enrollmentInfo":525,"targetDuration":4,"studyType":22,"phases":526,"briefSummary":527,"conditions":528,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":531,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":535,"locationsCount":426},"100530089","identifying-and-addressing-barriers-to-retention-in-the-cervical-cancer-treatment-cascade-among-women-with-hiv-in-south-africa-part-2-100530089","NCT06182241","Identifying and Addressing Barriers to Retention in the Cervical Cancer Treatment Cascade Among Women With HIV in South Africa: Part 2","Inclusion Criteria:\n\n* Having a cervix\n* Aged 18+\n* Living with HIV\n* Recent high-risk abnormal Pap results within the last month (if needed, we may increase the range by up to 6 months to ensure that we meet our targets).\n\nExclusion Criteria:\n\n* Younger than 18 years old\n* HIV-negative\n* No cervix\u002Fhistory of hysterectomy\n* Recent normal or low-risk abnormal Pap results\n* Unable to provide informed consent or assent in English or isiZulu and\u002For have a significant psychiatric illness (e.g., active psychotic disorder or untreated bipolar disorder) that could interfere with participation will be excluded. Potential participants will also be asked if they have any health conditions that make it difficult for them to travel to the clinic.",{"count":483,"type":21},[24],"The investigators will conduct the formative work that is necessary to develop a novel, multi-level intervention (inclusive of patient- and provider-level components), which will increase awareness of and modify the complex, intersecting factors that contribute to cervical cancer development among cisgender women with HIV (WWH). In Aim 1a, the investigators will explore the multi-level barriers and facilitators to follow-up appointment attendance among WWH who have had a recent high-risk abnormal Pap smear in the past six months, via qualitative interviews with WWH who have either attended at least one follow-up visit (n\\\u003C10) or have not yet attended a follow-up visit (n\\\u003C10). In Aim 1b, the investigators will explore provider awareness of the HIV-cervical cancer relationship and perspectives on barriers to retention in care via qualitative interviews (n\\\u003C8). For Aim 2, The study team will leverage the Aim 1 data, develop a patient-level intervention (1-2 sessions) and a provider toolkit, with the goal of increasing retention in care among WWH who are at heightened risk for cervical cancer. The study team will seek feedback on the manual and the toolkit from providers and from a community advisory board. In Aim 3a, the investigators will test the feasibility and acceptability of the intervention in a pilot randomized control trial (RCT) (n\\\u003C60). The study team will also assess (1) changes in self-efficacy to attend cervical cancer-related healthcare appointments pre-post intervention, (2) the proportion of women who attend a follow-up appointment, and, of those participants, (3) the proportion of women who complete the next phase of treatment. In Aim 3b, the investigators will explore the feasibility of intervention implementation in the clinic and acceptability of the provider-level intervention components in qualitative interviews with providers, clinic staff, the interventionalists, and other key stakeholders (n\\\u003C10).",[529,530],"Cervical Cancer","Hiv",{"date":397,"type":34},{"date":533,"type":34},"2025-11-17",{"date":267,"type":21},{"name":536,"class":41},"Boston University Charles River Campus",{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":4,"eligibilityCriteria":543,"healthyVolunteers":50,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":544,"targetDuration":4,"studyType":22,"phases":546,"briefSummary":547,"conditions":548,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":550,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":554,"locationsCount":426},"100457852","practice-facilitation-as-a-strategy-to-improve-alcohol-treatment-adoption-and-implementation-in-hiv-care-100457852","NCT05241990","Practice Facilitation as a Strategy to Improve Alcohol Treatment Adoption and Implementation in HIV Care","A Hybrid Type III Implementation Trial Testing Practice Facilitation as a Strategy to Improve Alcohol Treatment Adoption and Implementation in HIV Care","Inclusion Criteria: Clinic Staff\n\n* Age \\> 18 years old\n* Confirmed to be clinic staff (clinical or administrative roles).\n* English speaking\n* Cognitively able to complete required survey or interview activities.\n\nExclusion Criteria Clinic Staff\n\n* Unable to speak English\n\nInclusion Criteria, Patients\n\n* Confirmed to be a person with HIV (PWH) receiving HIV care and participating in CNICS at one of the three clinic sites\n* Scoring AUDIT-C ≥3 for women or ≥4 for men, transgender women or men indicating unhealthy alcohol use.\n* Age ≥ 18 years old.\n* English speaking.\n* Cognitively able to participate in stepped care for unhealthy alcohol use.\n\nExclusion Criteria, Patients\n\n* Scoring AUDIT-C \\\u003C3 for women or \\\u003C4 for men or \\\u003C4 for transgender women or men\n* Age \\\u003C 18 years old\n* Participants cognitively unable to participate in the stepped care for unhealthy alcohol use.",{"count":545,"type":21},300,[24],"Despite availability of evidence-based alcohol reduction interventions (EBI), unhealthy alcohol use remains a barrier to HIV medication adherence, viral suppression and retention in HIV care and consequently HIV treatment as prevention (TASP). Guided by complementary implementation and evaluation frameworks-the Consolidated Framework for Implementation Research (CFIR) and RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance), The investigators will conduct a Hybrid Type 3 effectiveness-implementation evaluating implementation trial testing whether practice facilitation, an evidence-based multifaceted implementation strategy increases reach, adoption, implementation, and maintenance of stepped care for unhealthy alcohol use in three Center for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS) HIV clinics located in Boston, San Diego, and Chapel Hill. The investigators will secondarily test whether practice facilitation is associated with decreased unhealthy alcohol use, and improved Antiretroviral Therapy (ART) adherence and viral suppression at the patient level. In practice facilitation, a practice coach will offer tools, resources, hands-on guidance, and content expertise to assist sites in offering a stepped care model of alcohol treatment to patients with unhealthy alcohol use. Stepped care will include brief intervention, cognitive behavioral therapy, and alcohol pharmacotherapy. The practice facilitation intervention will be rolled out sequentially across sites. There will be three phases at each site: pre-implementation planning, implementation with formative evaluation, and post-implementation summative evaluation. Using mixed methods, The investigators specifically propose to meet the following specific aims: (Aim 1) Tailor the practice facilitation intervention to each site using mixed methods (pre-implementation); (Aim 2a) Determine the effects of practice facilitation on implementation of stepped care (primary) and alcohol use and HIV-related outcomes (secondary) using interrupted time series analysis with synthetic controls (summative evaluation); (Aim 2b) Determine the effect of practice facilitation on reach, adoption, and maintenance of evidence-based alcohol treatment using mixed methods (formative evaluation); and (Aim 3) Describe barriers and facilitators to implementation of alcohol-related interventions at each site to describe maintenance and inform widespread sustainable implementation.",[530,549],"Alcohol Use, Unspecified",{"date":353,"type":34},{"date":552,"type":34},"2023-02-15",{"date":423,"type":21},{"name":127,"class":41},{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":4,"eligibilityCriteria":561,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":333,"enrollmentInfo":562,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":563,"conditions":564,"keywords":565,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":570,"startDateStruct":571,"completionDateStruct":4,"leadSponsor":573,"locationsCount":102},"100060283","leukapheresis-to-obtain-plasma-or-lymphocytes-for-studies-of-hiv-infected-patients-including-long-term-non-progressors-100060283","NCT00029445","Leukapheresis to Obtain Plasma or Lymphocytes for Studies of HIV-infected Patients, Including Long-term Non-progressors","Evaluation of Viral Factors and Immune Parameters to Study HIV-Specific Immunity","* INCLUSION CRITERIA:\n\n  1. Adult (18 years-old or older)\n  2. Eligibility to undergo apheresis procedures; or, for participants who are unable to undergo apheresis, willingness to undergo blood draw for research purposes that remain within safety guidelines established by NIH policy.\n  3. Willingness to give informed consent for the storage of blood or tissue samples and HLA testing\n\nAND at least one of the following:\n\n* An HIV-seropositive participant categorized as an LTNP as defined by clinical and laboratory criteria, regardless of HLA class I type.\n* HIV-seropositive progressors\n* Persons who are seronegative for HIV but are family members of seropositive participants exhibiting immunologic control of HIV\n\nEXCLUSION CRITERIA:\n\n1. Pregnant\n2. Cardiovascular instability, severe anemia, inadequate venous access, severe coagulation disorder, or any other condition that the Principal Investigator or Apheresis Unit staff considers a contraindication to the apheresis procedure or research blood draw.\n3. Any condition that, in the opinion of the investigator, contraindicates participation in this study.",{"count":335,"type":21},"This study will collect white blood cells and plasma for research on how the immune system controls HIV infection. The immune system of a very small group of people with HIV, called non-progressors, has been able to control HIV for long periods without antiretroviral therapy. Some immune system-related genes important for this control have been identified in these patients.\n\nPeople living with HIV who are 18 years of age and older, documented or suspected long-term nonprogressors in generally good health may be eligible to screen for the study.\n\nParticipants will undergo apheresis (a method for collecting larger quantities of certain blood components than can safely be collected through a simple blood draw) if venous access is adequate once yearly. Some may be asked to return every six months.\n\n* Automated apheresis - Blood is drawn through a needle placed in an arm vein and spun in a machine, separating the blood components. The white cells are extracted and the red cells, with or without plasma (liquid part of the blood), are re-infused into the donor through a needle in the other arm. An anticoagulant (medication to prevent blood from clotting) is usually added to the blood while in the machine to prevent it from clotting during processing.\n* Blood draw - a needle placed in an arm vein for large volume (approx 75ml) blood draw if veins considered inadequate for apheresis procedure.\n\nSome of the blood collected through apheresis may be stored for future studies of HIV disease and immune function and for HLA testing, a genetic test of markers of the immune system.",[27],[320,566,567,568,569],"Long-term nonprogressors","HLA B*5701","Apheresis","HIV Infection",{"date":418,"type":34},{"date":572,"type":34},"2001-08-09",{"name":347,"class":101},{"id":575,"slug":576,"hasResults":12,"nctId":577,"briefTitle":578,"officialTitle":579,"acronym":4,"eligibilityCriteria":580,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":581,"targetDuration":4,"studyType":22,"phases":583,"briefSummary":584,"conditions":585,"keywords":586,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":592,"lastUpdatePostDateStruct":593,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":4},"100608290","integrating-uu-into-hiv-counseling-in-south-africa-intuit-20-100608290","NCT07199634","Integrating U=U Into HIV Counseling in South Africa (INTUIT-2.0)","Integrating U=U Into HIV Counseling in South Africa (INTUIT-2.0): a Cluster-Randomized Trial","Inclusion Criteria-\n\nClinic inclusion criteria:\n\n* Public sector facility\n* Primary care, outpatient clinic\n* Follows national guidelines for HIV counseling\n* Has dedicated HIV counselors\n* At least 10 patients receiving HIV counseling per week (based on pre-study data)\n* Follows national guidelines for lab monitoring (CD4 at diagnosis; VLs at 3 and 10 months on ART)\n* Is interested in participating, as indicated by \"sign-off\" from the head nurse \u002F facility director\n\nIndividual participant inclusion criteria:\n\n* Adult (at least 18 years)\n* Received HIV post-test counselling or adherence counseling\n* Able to consent\n* Provides informed consent\n* Speaks one of the primary study languages: English, Zulu, Sotho, Tsonga\n* Receives care at the facility as evidence by having a clinical record there\n\nIndividual participant exclusion Criteria:\n\n* Require acute medical care that would be hindered by participation in the study\n* Determined by clinical staff not to be physically or emotionally able to initiate ART\n* Children (under 18 years).\n* Prisoners or other institutionalized persons.\n* Do not speak one of the primary study languages: English, Zulu, Sotho\n* Are not able to consent (e.g. intoxicated or of limited mental capacity)\n* Do not consent to participate in the study, including linkage to clinical records for follow-up",{"count":582,"type":21},880,[24],"Undetectable = Untransmittable (U=U) is the scientific consensus that people with human immunodeficiency virus (HIV) who achieve viral suppression through antiretroviral treatment (ART) cannot transmit the virus sexually. While global studies confirm this, awareness of U=U remains very limited in sub-Saharan Africa, including South Africa, where only two-thirds of people living with HIV (PLHIV) are virally suppressed despite having the largest treatment program globally. Many PLHIV delay or avoid ART because they feel healthy and perceive little benefit, while also fearing stigma, disclosure, and social costs. U=U offers powerful motivation for ART uptake and adherence by reframing treatment as both a personal health and prevention tool, reducing internalised stigma, strengthening self-image, and supporting HIV prevention altruism. Yet, dissemination in Africa has lagged. To address this, the investigators developed an HIV treatment literacy App called \"Undetectable \\& You\", which delivers accurate U=U information alongside real-life video testimonials of PLHIV and their partners. This research will assess the impact of the \"Undetectable \\& You\" App in a cluster-randomized trial in South Africa. The study will establish whether disseminating U=U information via a video-based app at the time of HIV counselling improves retention in care and viral suppression among PLHIV in South Africa.\n\nAim 1. Refine the \"Undetectable \\& You\" App to help PLHIV navigate U=U within relationships.\n\nAim 2. Establish the real-world impact of \"Undetectable \\& You\" on retention on ART and viral suppression in a cluster-randomized trial.",[27],[587,588,589,590,591],"HIV Counseling South Africa","Antiretroviral treatment (ART)","Person living with HIV (PLWH)","Undetectable=Untransmittable (U=U)","Viral load","2026-06-22",{"date":397,"type":34},{"date":595,"type":21},"2026-08",{"date":597,"type":21},"2029-01",{"name":299,"class":41}]