[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hiv-infections\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hiv-infections":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,145,0,25,[9,52,74,100,129,151,179,205,231,259,285,313,334,364,385,403,426,462,482,504,531,550,570,592,611],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100053226","phase-1-a-study-to-investigate-the-safety-and-pk-of-vh4770359-in-healthy-participants-100053226",false,"NCT07525544","A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants","A Multi-part, Phase 1, First-Time-in-Human Study to Investigate Safety, Tolerability, and PK of VH4770359 in Healthy Participants","Inclusion Criteria:\n\n1. 18 to 55 years old\n2. BMI 18.5-37.0 kg\u002Fm2\n3. Male participants must adhere to contraception requirements or abstinence, and female participants must not be pregnant\u002Fbreastfeeding and be of non-childbearing potential.\n\nExclusion Criteria:\n\n1. Participants with significant medical history that could alter drug pharmacokinetics, pose a risk, or interfere with conduct.\n2. Has exclusionary psychiatric, hepatic, cardiovascular, gastrointestinal, respiratory, endocrine, neurological, hematological, or renal condition, or exclusionary malignancy.\n3. A positive test(s) for Hepatitis B surface antigen (HBsAg) and\u002For anti-HBc, hepatitis C antibodies, or human immunodeficiency virus (HIV).\n4. A history of or ongoing high-risk behaviors for HIV acquisition.\n5. Use of prohibited medications.\n6. Exclusionary allergies or sensitivities.\n7. Regular use of alcohol, drugs of abuse, tobacco, or nicotine products.\n8. Exclusionary prior or concurrent clinical study participation.",true,"ALL","18 Years","55 Years",{"count":22,"type":23},214,"ESTIMATED","INTERVENTIONAL",[26],"PHASE1","VH4770359 (also known as GSK4770359) is an antiretroviral compound. This first-in-human study aims to evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered VH4770359 in healthy participants. The findings from this study will support the design of future clinical studies of VH4770359 in people living with HIV.",[29],"HIV Infections",[31,32,33,34,35,36,37,38],"First-Time-in-Human","Safety","Tolerability","Pharmacokinetics","Healthy participants","Human immunodeficiency virus (HIV)","VH4770359 (GSK4770359)","Oral","RECRUITING","2026-07-10",{"date":42,"type":43},"2026-07-13","ACTUAL",{"date":45,"type":43},"2026-05-14",{"date":47,"type":23},"2027-05-05",{"name":49,"class":50},"ViiV Healthcare","INDUSTRY",1,{"id":53,"slug":54,"hasResults":12,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":59,"targetDuration":4,"studyType":24,"phases":61,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":51},"100643152","phase-1-mass-balance-and-absolute-oral-bioavailability-of-14cvh4524184-100643152","NCT07636928","Mass Balance and Absolute Oral Bioavailability of [14C]VH4524184","A Phase 1, Open-Label, Single Dose Study to Assess the Absolute Bioavailability, Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]VH4524184 in Healthy Participants","Inclusion Criteria:\n\n1. Willing and able to sign the Informed Consent Form (ICF).\n2. Sex at birth: male or female; female participants must be of non-childbearing potential, or postmenopausal.\n3. Age: 18 to 55 years, inclusive, at screening.\n4. BMI: 18.0 to 32.0 kg\u002Fm\\^2, inclusive, at screening.\n5. Female participants of non-childbearing potential must have unequivocal documentation that they are not of childbearing potential Postmenopausal female participants must have a serum follicle-stimulating hormone (FSH) concentration \\>33.4 milli-international units per milliliter (mIU\u002FmL) at screening to confirm menopause.\n6. Male participants, if not surgically sterilized and who have a female partner of childbearing potential, must agree to use a condom during any sexual intercourse until the completion of the follow-up visit.\n7. Male participants must agree not to donate sperm from admission on Day -1 until the completion of the follow-up visit.\n8. All prescribed medication must have been stopped at least 30 days and \\>5 half-lives prior to admission to the clinical site on Day -1.\n9. All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications must have been stopped at least 14 days prior to admission to the clinical site on Day -1. An exception is made for paracetamol that is allowed up to admission to the clinical site on Day -1.\n10. Ability and willingness to abstain from alcohol from 48 hours prior to screening and admission to the clinical site on Day -1 until the last PK sample.\n11. Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, black tea, green tea, white tea, cola, chocolate, energy drinks), and grapefruit (juice) from 48 hours prior to admission to the clinical site.\n12. Good physical and mental health based on medical history, physical examination, clinical laboratory, electrocardiogram (ECG), and vital signs, as judged by the Investigator.\n\nExclusion Criteria:\n\n1. Employee of ICON, the Sponsor, GSK or associated vendors.\n2. History of relevant drug and\u002For food allergies.\n3. History of drug hypersensitivity, delayed-type hypersensitivity, or severe hypersensitivity reactions, as well as history of sensitivity to the study drug.\n4. Using tobacco\u002Fnicotine products within 60 days prior to the first study drug administration.\n5. History of alcohol abuse or drug addiction within 5 years prior to screening.\n6. Positive drug and\u002For alcohol screen at screening or admission to the clinical site.\n7. Average intake of more than 24 units of alcohol per week.\n8. Positive screen for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) 1 and 2 antibodies at screening.\n9. Participation in a drug study with a small molecule drug within 30 days or 5 half-lives if known (whichever is longer) prior to the first study drug administration in the current study. Participation in a clinical study with a biological within 90 days or 5 half-lives if known (whichever is longer) prior to the first study drug administration in the current study. Participation in 4 or more other drug studies in the 12 months prior to the first study drug administration in the current study.\n10. Donation or loss of more than 450 mL of blood within 60 days prior to the first study drug administration. Donation or loss of more than 1.5 L of blood (for male participants)\u002Fmore than 1.0 L of blood (for female participants) in the 10 months prior to the first study drug administration in the current study.\n11. Significant and\u002For acute illness within 14 days prior to the first study drug administration that may impact safety assessments, in the opinion of the Investigator.\n12. Any significant current\u002Fongoing known or suspected pre-existing psychiatric condition, including depression, anxiety, and\u002For insomnia\u002Fsleep disturbances and\u002For suicidal ideation, in the opinion of the Investigator.\n13. Unsuitable veins for infusion or blood sampling.\n14. Participation in a study with a 14C dose of ≥0.1 megabecquerel (MBq) in the period of 1 year prior to screening.\n15. Irregular defecation pattern.\n16. Pre-existing clinically relevant, in the opinion of the Investigator in discussion with the Sponsor medical monitor, gastro-intestinal pathology or diagnosis, eg, irritable bowel syndrome, inflammatory bowel disease, and\u002For significant baseline signs and symptoms.\n17. History or presence of clinical condition or disorder that could be capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drugs, interfering with the interpretation of data or would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits, in the opinion of the Investigator. The Investigator may contact the Sponsor medical monitor to discuss the inclusion of participants who have a history of specific conditions that are not expected to interfere with their participation in the study.",{"count":60,"type":23},9,[26],"The purpose of the study is to assess the bioavailability, mass balance, pharmacokinetics, metabolism and excretion of radiolabeled (14C) VH4524184.",[29],[65,36],"VH4524184","2026-06-29",{"date":68,"type":43},"2026-07-02",{"date":70,"type":43},"2026-06-04",{"date":72,"type":23},"2026-08-20",{"name":49,"class":50},{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":81,"targetDuration":4,"studyType":24,"phases":83,"briefSummary":84,"conditions":85,"keywords":86,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100539954","phase-1-first-time-in-human-study-of-long-acting-vh4524184-formulations-100539954","NCT06310551","First Time in Human Study of Long Acting VH4524184 Formulations","A Phase 1 Double-Blind (Sponsor-unblinded), Placebo-Controlled Randomized, Single Ascending Dose and Multiple Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Parenterally Administered VH4524184 in Healthy Adults","Inclusion Criteria:\n\nAge\n\n1. Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.\n\n   Type of Participant and Characteristics\n2. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.\n3. Participants who are negative for SARS-CoV-2, performed on admission\u002Freadmission to the Phase 1 unit, using an approved molecular test (PCR).\n4. Participants who are able to understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions.\n\n   Weight\n5. Body weight ≥50.0 kg (110 lbs) for men and ≥45.0 kg (99 lbs) for women and body mass index within the range 18.5 to 32.0 kg\u002Fm\\^2 (inclusive) for all cohorts except B19. For Cohort B19, body mass index within the range \\>32.0 to 37.0 kg\u002Fm\\^2 (inclusive).\n\n   Sex and Contraceptive\u002FBarrier Requirements\n6. Male or female\n\n   1. Male Participants: No restrictions for male participants\n   2. Participants of female sex assigned at birth:\n\n      * A participant of childbearing potential (POCBP) (female sex assigned at birth) is eligible to participate as long as the participant is not pregnant, breastfeeding and utilizes a highly effective method of contraception.\n      * A participant of non-childbearing potential (PONCBP) is eligible to participate if all other eligibility criteria are met.\n\n   Informed Consent\n7. Capable of providing signed informed consent.\n\nExclusion Criteria:\n\nMedical Conditions\n\n1. History or presence of clinical condition or disorder that could be capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drug, interfering with the interpretation of data or would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits.\n2. Clinically significant abnormal blood pressure as determined by the investigator.\n3. Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.\n4. Breast cancer within the past 10 years.\n5. Current or chronic history of liver disease or known hepatic or biliary abnormalities.\n6. Medical history of cardiac arrhythmias or cardiac disease or a family and personal history of long QT syndrome.\n7. Underlying skin disease or disorder that would interfere with the administration of study product and\u002For assessment of injection site reactions.\n8. Clinically significant history of drug hypersensitivity, delayed-type hypersensitivity or severe hypersensitivity reactions, as well as history of \u002Fsensitivity to any of the study interventions including hyaluronidases.\n9. Current or anticipated need for chronic anti-coagulation except for the use of low dose acetylsalicylic acid (≤325 mg) or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease.\n10. History of seizure.\n11. Any known or suspected pre-existing psychiatric condition, including depression, anxiety and insomnia\u002Fsleep disturbances, at the discretion of the investigator.\n12. Any positive (abnormal) response confirmed by the investigator or clinician (or qualified designee) administered C-SSRS at screening.\n13. Insufficient muscle mass (gluteus medius or thigh) to support IM dose administration in the opinion of the investigator.\n14. Presence of tattoos, implants or skin piercings that may interfere with the administration of study product and\u002For assessment of ISRs, if they occur.\n15. History of or on-going high-risk behaviors that may put the participant at increased risk for HIV acquisition in the opinion of the investigator. This includes participants in HIV discordant relationships, or men who report current or prior unprotected anal sex with other men and those reporting prior or current injecting drug use.\n\n    Prior\u002FConcomitant Therapy\n16. Past or intended use of over-the-counter or prescription medication within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to dosing and for the duration of the study.\n17. Receipt of any live vaccine(s) or vaccines against SARS-CoV-2 within 28 days prior to screening or 14 days before or after scheduled SC or IM dosing.\n\n    Prior\u002FConcurrent Clinical Study Experience\n18. Exposure to more than 4 new investigational products (including long-acting investigational products) within 12 months prior to the first dosing day.\n19. Current enrollment or past participation in another investigational study in which an investigational intervention was administered within the last 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product before signing of consent (OR screening) any other clinical study.\n20. Participation in the study would result in loss of blood in excess of 500 mL over a 56-day period.\n21. Current enrollment or past participation in this clinical study, with the exception of participants who previously completed the Oral Lead In (OLI) but for operational or logistic reasons did not progress to CRU admission and receipt of injectable suspension for injection (SFI) or powder for suspension for injection (PFS) study medication or placebo, or prior participation in study 218803.\n\n    Diagnostic Assessments\n22. eGFR \\\u003C60 mL\u002Fmin or serum creatinine \\>1.1 x ULN.\n23. Hemoglobin \\\u003C12.5 g\u002FdL for men and \\\u003C11 g\u002FdL for women\n24. ALT or AST \\>1.5x upper limit of normal (ULN)\n25. Total bilirubin \\>1.5xULN.\n26. Any significant arrhythmia or ECG finding.\n27. Exclusion criteria for Screening ECG - a single repeat is allowed for eligibility determination.\n28. Presence of HBsAg and\u002For anti-HBc at Screening or within 3 months prior to first dose of study intervention.\n29. Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.\n30. Positive pre-study drug\u002Falcohol screen.\n31. Positive HIV antibody test.\n\n    Other Exclusions\n32. Regular alcohol consumption within 6 months prior to the study defined as: An average weekly intake of \\>14 units for males or \\>7 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (\\~240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.\n33. Regular use of known drugs of abuse.\n34. Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening and at admission.\n35. Sensitivity to the study drug, or components thereof, or other drug or other allergy that, in the opinion of the investigator or Sponsor Medical Monitor, contraindicates participation in the study.",{"count":82,"type":23},372,[26],"The purpose of this study is to identify 1 or more doses of parenterally administered VH4524184 that are safe, well tolerated and yield a PK drug exposure profile necessary to deliver a long-acting antiretroviral therapy for the treatment of HIV-1 infection.",[29],[32,33,87,88,34,89,90,91],"Parenteral","First Time in Human","Ascending Dose","Multiple Dose","Healthy Adults",{"date":93,"type":43},"2026-06-30",{"date":95,"type":43},"2024-03-21",{"date":97,"type":23},"2028-01-21",{"name":49,"class":50},3,{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":24,"phases":109,"briefSummary":111,"conditions":112,"keywords":113,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":128},"100522873","texting-to-reduce-human-immunodeficiency-virus-hiv-risk-100522873","NCT06088277","Texting to Reduce Human Immunodeficiency Virus (HIV) Risk","Texting in Community Health Center Dental Clinics to Reduce HIV Risk","Inclusion Criteria:\n\n* Give informed consent and document consent via a signed and dated informed consent form in REDCap\n* Willing to comply with all study procedures and be available for the duration of the study\n* Be able to read either in English or Spanish\n* Be a dental clinic patient of record at one of our participating community health centers\n* Has at least one risk factor for HIV defined as self-report of at least one of the following: Men who have sex with men; multiple sex partners, or intravenous drug use\n\nExclusion Criteria:\n\n* Self-report of having HIV infection\n* Participating in another HIV study or another text message study\n* A woman who reports having sex exclusively with women\n* Does not have a mobile phone or other device which can receive text messages from Agile Health\n* Does not have unlimited texting on their mobile plan\n* Has not used any type of text messaging at least once in the past month\n* Single item literacy screening score of 2 or below.",{"count":108,"type":23},266,[110],"NA","This is a 3-year study to test the efficacy of a text message-based intervention program. Dental patients at 4 community health centers (n= 266) will be randomized to receive either text messages (TMs) regarding HIV prevention or TMs regarding overall wellness. Prior to enrolling the 266 participants, the investigators will conduct a feasibility pilot (n=20) to test the TM delivery as well as all study procedures. For both the pilot and the randomized clinical trial (RCT), recruitment will be conducted at 4 Community Health Center dental clinics (Codman Square, East Boston (both East Boston and South End locations), Geiger Gibson, and Upham's Community Health Centers). Recruitment materials (flyers and permission to contact forms) may also be made available at other clinics within the health centers.\n\nThe study will enroll English and Spanish-speaking patients who have at least one risk factor for HIV but are HIV-negative. Patients enrolled in the pilot will complete self-report surveys at baseline, 1 and 2 months. Participants enrolled in the RCT will complete self-report surveys baseline, 3, 6, and 12 months after baseline; receive and respond to TM assessments during the 6-month intervention.",[29],[114,115,116,117,118],"Dental patients","Community Health Center Dental Clinics","Text messaging","HIV negative","HIV testing",{"date":120,"type":43},"2026-07-01",{"date":122,"type":43},"2024-08-16",{"date":124,"type":23},"2027-04-14",{"name":126,"class":127},"Boston University","OTHER",2,{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":139,"phases":4,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":150},"100629369","implementation-study-of-lenacapavir-pre-exposure-prophylaxis-for-hiv-prevention-100629369","NCT07473778","Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention","Pioneering Research to Optimize Pre-exposure Prophylaxis (PrEP) Expansion With Lenacapavir (LEN)","PROPEL","Key Inclusion Criteria:\n\n* Able to comprehend and provide a signed written informed consent, which must be obtained prior to initiation of screening study procedures;\n* Willing and able to comply with all study requirements;\n* Presents at a study site needing or wanting PrEP for HIV prevention as determined by local clinical practice guidelines and institutional protocols, including new PrEP users (PrEP naïve) and current or former users of oral (emtricitabine\u002Ftenofovir disoproxil fumarate (coformulated; Truvada®; F\u002FTDF) or emtricitabine\u002Ftenofovir alafenamide (coformulated; Descovy®; F\u002FTAF)) or injectable (LEN or cabotegravir (CAB)) PrEP who indicate interest in discussing PrEP methods that they are clinically eligible to receive;\n* Eligible for LEN PrEP per standard of care procedures, for example, being HIV-1 negative at screening using a Food and Drug Administration (FDA) approved\u002Fcleared test for diagnosis of acute or primary HIV-1 infection;\n* After PrEP counseling to learn about the advantages and disadvantages of various PrEP methods:\n\n  1. Selects LEN PrEP as their chosen PrEP method; OR,\n  2. Selects a different PrEP method or chooses not to start or continue PrEP.\n\nKey Exclusion Criteria:\n\n* Any other indication not already listed above that would make the participant ineligible for LEN PrEP at enrollment according to local guidelines, organizational protocols, US Prescribing Information (USPI) for the PrEP product, and\u002For Center for Disease and Control (CDC) guidance.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":138,"type":23},3000,"OBSERVATIONAL","The goal of this observational study is to generate real-life information on the use of lenacapavir (LEN, YEZTUGO®, (YTG)) for pre-exposure prophylaxis (PrEP) across diverse clinical settings in the United States. The study will characterize how PrEP is initiated, used, and discontinued in routine clinical practice when LEN is added as PrEP option and will evaluate persistence on LEN PrEP.\n\nThe primary objective of this study is to evaluate real-life persistence on LEN PrEP at Week 52 in diverse clinical settings in the United States.",[29],"2026-06-26",{"date":93,"type":43},{"date":145,"type":43},"2026-03-17",{"date":147,"type":23},"2029-04",{"name":149,"class":50},"Gilead Sciences",28,{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":139,"phases":4,"briefSummary":160,"conditions":161,"keywords":164,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":51},"100638066","dynamic-decision-support-for-integrating-prep-in-clinics-for-young-people-in-alabama-and-botswana-100638066","NCT07597824","DYnamic decisioN Support for IntegrAting PrEP in Clinics for Young People in Alabama and Botswana","DYNAMIC PrEP","Group 1\n\n* Inclusion for Alabama site:\n\n  * 18 years of age or older\n  * Currently using or eligible for PrEP\n* Inclusion for Botswana site:\n\n  * 18 years of age or older\n  * Participated in the parent Tshireletso study in Botswana\n* Exclusion for both sites:\n\n  * Under the age of 18\n  * HIV positive\n\nGroup 2\n\n* Inclusion for both sites:\n\n  * 18 years of age or older\n  * Currently working as PrEP providers or clinic administrators at outpatient clinics\n* Exclusion for both sites:\n\n  * Under the age of 18\n\nGroup 3\n\n* Inclusion for both sites:\n\n  * 18 years of age or older\n  * Currently working as policy makers or program leaders at outpatient clinics\n* Exclusion for both sites:\n\n  * Under the age of 18",{"count":159,"type":23},1000,"This study evaluates strategies to improve access to HIV prevention through the integration of pre-exposure prophylaxis (PrEP) into existing healthcare settings, rather than limiting delivery to specialty clinics. The study addresses barriers to PrEP uptake, including limited awareness, stigma, and restricted access, and recognizes that availability alone may not ensure initiation or sustained use.\n\nThe study includes two components. First, a longitudinal cohort of current PrEP users will be followed to assess changes in access, preferences, and PrEP use over time in real-world settings. Second, a dynamic decision-support toolkit will be developed and evaluated to support patients and providers in PrEP-related decision-making. The toolkit will include patient- and provider-facing components to support clinical decision-making, improve risk understanding, and facilitate integration of PrEP into routine healthcare. The toolkit will be refined and beta-tested in selected healthcare facilities in Botswana and Alabama.",[29,162,163],"Contraception","PrEP",[165,163,166,167,168],"HIV adherence","young adults","Botswana","Alabama","NOT_YET_RECRUITING","2026-06-23",{"date":172,"type":43},"2026-06-25",{"date":174,"type":23},"2026-06",{"date":176,"type":23},"2031-12",{"name":178,"class":127},"University of Alabama at Birmingham",{"id":180,"slug":181,"hasResults":12,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":17,"sex":187,"minAge":19,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":24,"phases":190,"briefSummary":191,"conditions":192,"keywords":193,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":201,"leadSponsor":203,"locationsCount":51},"100521337","an-mhealth-intervention-to-improve-hiv-prevention-service-engagement-among-people-who-use-drugs-100521337","NCT06068283","An mHealth Intervention to Improve HIV Prevention Service Engagement Among People Who Use Drugs","LOTUS: An mHealth Intervention to Improve HIV Prevention Service Engagement Among People Who Use Drugs","LOTUS","Inclusion Criteria:\n\n* 18 years of age or older\n* Report weekly or daily use of opioids and\u002For stimulants in the past 6 months\n* Meet current CDC eligibility criteria for PrEP\n* Report low levels of HIV prevention service engagement in the past 6 months\n* Not currently, or planning on becoming, pregnant during the study\n* Owns a smartphone with internet web-browsing capabilities\n\nExclusion Criteria:\n\n* 17 years of age or younger\n* Does not report weekly or daily use of opioids and\u002For stimulants in the past 6 months\n* Does not meet current CDC eligibility criteria for PrEP\n* Report high levels of HIV prevention service engagement in the past 6 months\n* Currently, or planning on becoming, pregnant during the study\n* Does not own a smartphone with internet web-browsing capabilities","FEMALE",{"count":189,"type":23},40,[110],"The goal of this single arm pre-post study is to assess the feasibility, acceptability, and preliminary impact of the LOTUS intervention to improve HIV prevention service engagement among people who use drugs. LOTUS is a technology-delivered intervention that provides HIV prevention informational content and tips, peer social support and social networking features, a resource locator, HIV prevention monitoring and reminders (e.g., reminders for HIV\u002FSTI testing and PrEP doses), and a virtual space to have questions answered by health care professionals.",[29],[194,195,196,197],"Women","Drug Use","mHealth","HIV Prevention","2026-06-22",{"date":142,"type":43},{"date":120,"type":23},{"date":202,"type":23},"2027-07-30",{"name":204,"class":127},"University of California, San Diego",{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":18,"minAge":212,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":24,"phases":215,"briefSummary":217,"conditions":218,"keywords":219,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":228,"leadSponsor":230,"locationsCount":4},"100641883","phase-3-a-study-to-investigate-cabotegravir-ultra-long-acting-cab-ula-plus-rilpivirine-ultra-long-acting-rpv-ula-in-adults-and-adolescents-with-hiv-who-are-virologically-suppressed-100641883","NCT07650916","A Study to Investigate Cabotegravir Ultra Long-Acting (CAB ULA) Plus Rilpivirine Ultra Long-Acting (RPV ULA) in Adults and Adolescents With HIV Who Are Virologically Suppressed","A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Cabotegravir Ultra Long-acting Plus Rilpivirine Ultra Long-acting or Cabotegravir Long-acting Plus Rilpivirine Long-acting in Adults and Adolescents With HIV Who Are Virologically Suppressed on ART","Inclusion criteria:\n\nPatient Study Participant (PSP) Inclusion criteria:\n\n* Adults and adolescents with HIV-1 infection aged 12 years or older with a weight \\>35 kg.\n* Documented HIV-1 RNA measurements \\\u003C50 copies\u002FmL in the 12 months prior to Screening.\n* HIV-1 RNA \\\u003C50 copies\u002FmL at screening assessment.\n* Must be on current daily oral antiretroviral regimen for at least 6 months uninterrupted prior to Screening.\n* Any prior switch in therapy must have occurred due to tolerability\u002Fsafety, access to medications, or convenience\u002Fsimplification, and must NOT have been done for virologic treatment failure (HIV-1 RNA ≥200 copies\u002FmL).\n\nExclusion criteria:\n\nPatient Study Participant (PSP) Exclusion criteria:\n\n* Any evidence of primary resistance based on the presence of any major known INSTI (including CAB) or NNRTI (including RPV) resistance-associated mutation.\n* Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening.\n* Any history of receiving long-acting therapy for HIV.\n* Previous exposure to CAB and\u002For RPV for treatment or prevention of HIV-1 infection.\n* Significant uncontrolled or clinically relevant comorbidities (e.g., cardiovascular, hepatic, renal, neurological, psychiatric) that may impact safety or study participation.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","12 Years",{"count":214,"type":23},564,[216],"PHASE3","This study compares the efficacy, safety and tolerability of CAB ULA and RPV ULA administered with CAB long acting (LA) and RPV LA administered in adults and adolescents with HIV who are virologically suppressed on anti-retroviral therapy (ART).",[29],[220,221,222,223,224,32,33],"Cabotegravir","Rilpivirine","HIV","Non-inferiority","Efficacy","2026-06-19",{"date":170,"type":43},{"date":66,"type":23},{"date":229,"type":23},"2029-09-04",{"name":49,"class":50},{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":238,"enrollmentInfo":239,"targetDuration":4,"studyType":24,"phases":241,"briefSummary":242,"conditions":243,"keywords":245,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":4},"100644328","robotic-bronchoscopy-with-cbct-image-fusion-for-pulmonary-nodule-diagnosis-in-people-living-with-hiv-100644328","NCT07663656","Robotic Bronchoscopy With CBCT Image Fusion for Pulmonary Nodule Diagnosis in People Living With HIV","Clinical Application and Promotion of Full-Situational Awareness Bronchoscopic Robot Combined With CBCT-Based Multimodal Image Fusion for the Diagnosis and Management of Pulmonary Nodules in People Living With HIV: A Multicenter Open-Label Controlled Study","Inclusion Criteria:\n\n1. Confirmed diagnosis of HIV infection; on stable antiretroviral therapy (ART) for ≥6 months with plasma HIV viral load \\\u003C50 copies\u002FmL.\n2. Presence of at least one pulmonary nodule ≤3 cm in maximum diameter on thin-section CT; radiological features suggestive of malignancy (e.g., part-solid or solid nodule with spiculation, lobulation, or vessel convergence) with estimated pretest probability of malignancy ≥50%.\n3. Age 18-70 years.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n5. Life expectancy ≥6 months.\n6. Voluntary written informed consent obtained prior to any study procedure; willingness and ability to comply with scheduled visits, procedures, and follow-up requirements.\n\nExclusion Criteria:\n\n1. Active pulmonary tuberculosis or Pneumocystis jirovecii pneumonia requiring acute treatment at the time of screening.\n2. Coagulation disorder: International Normalized Ratio (INR) \\>1.5 or platelet count \\\u003C50 × 10\\^9\u002FL.\n3. Prior definitive treatment for the target pulmonary nodule (e.g., surgical resection, radiotherapy, ablation, or systemic anti-tumor therapy).\n4. Unstable ART status: not on continuous ART or HIV viral load ≥50 copies\u002FmL within 3 months prior to enrollment.\n5. Target lesion already diagnosed definitively by previous percutaneous biopsy or surgical pathology.\n6. Severe cardiopulmonary dysfunction:\n\n   * Forced Expiratory Volume in 1 second (FEV1) \\\u003C50% predicted; or\n   * New York Heart Association (NYHA) Class III-IV heart failure.\n7. Pregnancy or breastfeeding.\n8. Participation in another interventional clinical trial within the past 3 months.\n9. Inability to complete follow-up (e.g., no fixed residence, unstable contact information).\n10. Any other condition that, in the investigator's judgment, would make the participant unsuitable for enrollment or pose unacceptable risk (including significant airway abnormality preventing safe navigation).","70 Years",{"count":240,"type":23},100,[110],"This multicenter study evaluates a full-situational awareness robotic bronchoscopy system combined with CBCT-based multimodal image fusion for diagnosing lung nodules in people living with HIV (PLWH).\n\nLung nodules are small lesions that may be benign or cancerous. In PLWH, accurate diagnosis is especially important but challenging. In this study, participants will be assigned to one of two groups:\n\n* Experimental group: Robotic bronchoscopy with real-time full-situational awareness and CBCT image fusion;\n* Control group: Electromagnetic navigation-guided bronchoscopy combined with radial endobronchial ultrasound (EBUS).\n\nIn both groups, rapid on-site cytologic evaluation (ROSE) will be performed to confirm tissue adequacy. For participants confirmed to have lung cancer and meeting safety criteria, an exploratory transbronchial cryoablation will be performed during the same procedure.\n\nThe study aims to compare diagnostic accuracy and safety between the two approaches and to explore the feasibility of immediate cryoablation for early-stage lung cancer in PLWH.",[29,244],"Pulmonary Nodule",[246,247,222,244,248,249],"Full-Situational Awareness Robotic Bronchoscopy","Cone-Beam CT","Cryoablation","Diagnostic Yield","2026-06-17",{"date":170,"type":43},{"date":253,"type":23},"2026-07",{"date":255,"type":23},"2028-03",{"name":257,"class":258},"wu qingguo","OTHER_GOV",{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":17,"sex":187,"minAge":19,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":24,"phases":269,"briefSummary":270,"conditions":271,"keywords":274,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":278,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":51},"100581669","an-effectiveness-trial-of-the-prep-for-wings-study-100581669","NCT06853314","An Effectiveness Trial of the PrEP for WINGS Study","An Effectiveness Trial of WINGS+PrEP: a Syndemic mHealth Intervention to Increase PrEP Uptake Among Women Impacted by Heavy Alcohol Use and Partner Violence in the Criminal Legal System","PFW","Inclusion Criteria:\n\nIdentify as a cis-gender woman Aged 18 or older HIV-negative Previous engagement with the criminal legal system or child protective services.\n\nMeet criteria for hazardous alcohol use Previous experience of intimate partner veiolence Report not taking PrEP in the past 90 days Recent experiences of HIV risk due to HIV risk exposure\n\nExclusion Criteria:\n\nAbility to speak and understand English is not sufficient to participate in assessments or intervention sessions.\n\nInability to complete informed consent process due to a psychiatric or cognitive impairment (assessed by the Mini Folstein exam)",{"count":268,"type":23},307,[110],"(Effectiveness Aim 1) To test the comparative effectiveness of PreP for WINGS versus PrEP alone on primary outcomes of increasing PrEP initiation measured by self-report\u002Fmedical records, recent adherence and longer-term adherence by self-report\u002Fmedical records over the 6-month follow-up; and secondary outcomes of decreasing IPV, hazardous drinking, recidivism, and HIV risks.\n\n(Moderation Aim 2) To test if the effectiveness of WINGS+PrEP on study outcomes is moderated by key participant subgroups based on race\u002Fethnicity, sexual orientation, age, education, incarceration history, IPV severity, substance use disorders (SUDs), digital access and literacy, housing stability, and medical mistrust.",[29,272,273],"Alcohol Use Disorder","Violence, Gender-Based",[275,276,277,163],"Intimate partner violence","Hazardous alcohol use","HIV infection",{"date":198,"type":43},{"date":280,"type":43},"2026-04-09",{"date":282,"type":23},"2027-06-01",{"name":284,"class":127},"Columbia University",{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":139,"phases":4,"briefSummary":294,"conditions":295,"keywords":298,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":51},"100520384","people-living-with-hiv-oral-and-oropharyngeal-cancer-and-health-equity-100520384","NCT06055868","People Living With HIV, Oral and Oropharyngeal Cancer, and Health Equity","People Living With HIV (PLWH), Oral and Oropharyngeal Cancer, and Health Equity: A Qualitative Study","Inclusion Criteria:\n\n* Participants must be 18-years old or older.\n* Participants must be individuals living with HIV\n* Ability to speak and understand English\n* Identify as one or more racial\u002Fethnic minority groups or sexual and gender minority groups\n* All genders and members of all races and ethnic groups are eligible for this study.\n\nExclusion Criteria:\n\n* Younger than 18-years old.\n* Not living with HIV.\n* Not able to speak and understand English.\n* Not classified as one or more racial\u002Fethnic minority groups or sexual and gender minority groups.",{"count":293,"type":23},144,"This is an exploratory qualitative study among People Living With HIV (PLWH) of diverse racial\u002Fethnic and sexual and gender minority (SGM) identities to explore individual, interpersonal, and structural oral health equity factors that serve as barriers or facilitators of accessing oral health care, knowledge and perceptions of human papillomavirus (HPV) vaccination and Oral squamous cell carcinoma (OSCC) \u002FOropharyngeal squamous cell carcinoma (OPSCC), and to collect recommendations on how to increase access to oral health care and engage PLWH in OSCC\u002FOPSCC prevention.",[29,296,297],"Oral Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma",[299,300,301,302,303],"Health Equity","Focus Group","Sexual and Gender Minority","People living with HIV","HPV, human papillomavirus","2026-06-16",{"date":306,"type":43},"2026-06-18",{"date":308,"type":43},"2025-02-13",{"date":310,"type":23},"2029-11-30",{"name":312,"class":127},"University of California, San Francisco",{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":319,"targetDuration":4,"studyType":24,"phases":321,"briefSummary":322,"conditions":323,"keywords":324,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":4},"100642247","optimizing-implementation-of-long-acting-injectable-prep-100642247","NCT07649551","Optimizing Implementation of Long Acting Injectable PrEP","Provider\u002Fstaff inclusion criteria:\n\n1. 18 years of age or older,\n2. affiliated with a participating clinic, and\n3. be involved in prescribing or supporting PrEP care delivery.\n\nProvider\u002Fstaff exclusion criteria:\n\n1. 17 years of age or younger,\n2. not affiliated with a participating clinic, and\n3. not involved in prescribing or supporting PrEP care delivery.\n\nDe-identified electronic medical record review inclusion criteria:\n\n1. 16 years of age or older, and\n2. had a clinical visit for any form of PrEP care during the study period at a participating clinic site.\n\nDe-identified electronic medical record review exclusion criteria:\n\n1. 15 years of age or younger, and\n2. no clinical visit for any form of PrEP care during the study period at a participating clinic site.",{"count":320,"type":23},20,[110],"Our goal is to optimize LAI-PrEP implementation within the context of other PrEP methods. Our strategy is flexible to allow pivot to include forthcoming PrEP dosing options should they become available",[29],[163,325],"Pre-Exposure Prophylaxis","2026-06-09",{"date":304,"type":43},{"date":329,"type":23},"2027-01-01",{"date":331,"type":23},"2030-12-31",{"name":333,"class":127},"University of Minnesota",{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":17,"sex":18,"minAge":340,"maxAge":341,"enrollmentInfo":342,"targetDuration":4,"studyType":24,"phases":344,"briefSummary":345,"conditions":346,"keywords":348,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":51},"100501963","development-and-evaluation-of-a-virtual-reality-tool-for-at-risk-trauma-exposed-young-people-100501963","NCT05816083","Development and Evaluation of a Virtual Reality Tool for At-Risk Trauma-Exposed Young People","Inclusion Criteria for YMSM are as follows:\n\n* Someone who identifies as a YMSM or identifies as someone with romantic or physical attraction to individuals who identify as men\n* Is aged 15-30 years\n* Have experienced at least one ITE in lifetime (i.e., sexual assault, physical assault, witnessed domestic or community violence)\n* Report being consensually sexually active or planning to become sexually active with a partner in the next 12 months\n* Live in the Charleston, SC\u002FTri-county area\n\nInclusion Criteria for adolescents with SUD are as follows:\n\n* Someone who reports using substances in the past year (for participants ages 15-17) or the past 6 months (for participants ages 18-30)\n* Is aged 15-30 years\n* Have experienced at least one ITE in lifetime (i.e., sexual assault, physical assault, witnessed domestic or community violence)\n* Report being consensually sexually active or planning to become sexually active with a partner in the next 12 months\n* Live in the Charleston, SC\u002FTri-county area\n\nInclusion Criteria for front line healthcare workers are as follows:\n\n* works directly with adolescents who have experienced ITE and\u002For\n* works directly with adolescents or young adults with SUD and\u002For\n* works directly with YMSM and\u002For\n* works directly with and\u002For adolescent or young adults who are HIV-positive\n\nExclusion Criteria for all participants are as follows:\n\n* exhibits psychotic symptoms;\n* exhibits significant cognitive disability;\n* reports a history of Pervasive Developmental Disorder;\n* has active suicidal or homicidal ideations\n* self-reports high levels of motion sickness","15 Years","30 Years",{"count":343,"type":23},50,[110],"This is a multi-phased study, funded through a National Institute on Drug Abuse (NIDA) K24 grant that aims to ultimately refine a virtual reality tool through qualitative and quantitative research targeting HIV and substance abuse risk behavior among at-risk young people who have experienced psychosocial trauma. Participants eligible for this study include young men who have sex with men (YMSM)\u002Findividuals who are romantically\u002Fphysically attracted to men and adolescents with substance use disorder (SUD) between the ages of 15 - 30 and have experienced at least one traumatic event in their lifetime. Frontline healthcare workers who work within these populations are eligible for the study as well.",[347,29],"Substance Use Disorders",[349,350,351,352,353,354],"substance use disorders","alcohol use","substance use","HIV infections","HIV risk","virtual reality","2026-06-08",{"date":357,"type":43},"2026-06-10",{"date":359,"type":43},"2025-02-06",{"date":361,"type":23},"2026-11-30",{"name":363,"class":127},"Medical University of South Carolina",{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":4,"eligibilityCriteria":370,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":371,"enrollmentInfo":372,"targetDuration":4,"studyType":24,"phases":373,"briefSummary":374,"conditions":375,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":60},"100567242","phase-1-clinical-trial-to-evaluate-the-safety-and-immunogenicity-of-hiltonol-poly-iclc-adjuvanted-cd40hivrienv-vripro-in-adult-participants-who-previously-participated-in-hvtn-706-100567242","NCT06665646","Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Adult Participants Who Previously Participated in HVTN 706","A Phase 1 Open-label, Non-randomized, Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Adult Participants Who Previously Participated in HVTN 706","Inclusion Criteria:\n\n1. Formerly participated in HVTN 706 study as active vaccine arm or placebo recipient (those enrolled in the active vaccine arm of HVTN 706 must have received all 4 vaccinations according to the HVTN 706 protocol).\n2. Demonstrates an understanding of the study and is able and willing to complete the informed consent process.\n3. 18 to ≤ 60 years old, on day of enrollment.\n4. Available for clinic follow-up through the last clinic visit, willing to undergo FNA, and willing to be contacted 12 months after the last study-product administration.\n5. Agrees not to enroll in another study of an investigational agent during participation in the trial. If a potential participant is already enrolled in another clinical trial, approvals from the other trial sponsor and the HVTN 318 (Protocol Safety Review Team) PSRT are required prior to enrollment into HVTN 318. Previous enrollment in HVTN 706 study is a requirement, per inclusion criteria 1.\n6. In good general health according to the clinical judgment of the site investigator.\n7. Physical examination and laboratory results without clinically significant findings that would interfere with assessment of safety or reactogenicity in the clinical judgement of the site investigator.\n8. Agrees to discuss the potential for HIV acquisition and agrees to prevention counseling.\n9. Hemoglobin (Hgb):\n\n   * ≥11.0 g\u002FdL for women\n   * ≥13.0 g\u002FdL for men\n   * If receiving exogenous hormones for more than 6 consecutive months with dosing equivalent to parenteral testosterone ≥1000 mg every 12 weeks or estradiol valerate ≥2 mg\u002Fweek, determine hemoglobin eligibility based on the exogenous hormone reported.\n10. White blood cell (WBC) count = 2,500 to 12,000\u002Fmm\\^3 (WBC over 12,000\u002Fmm\\^3 is not exclusionary if further evaluation shows general good health and if PSRT approval is granted).\n11. Platelets = 125,000 to 550,000\u002Fmm\\^3.\n12. Alanine aminotransferase (ALT) \\\u003C 2.5 x upper limit of institutional reference range.\n13. Serum creatinine ≤ 1.1 x upper limit of normal (ULN) based on the institutional normal range.\n14. Systolic blood pressure of 90 to \\\u003C 140 mmHg and diastolic blood pressure of 50 to \\\u003C 90 mmHg at screening visit. The average blood pressure between the screening visit and the enrollment visit must be below 140 mmHg systolic and 90 mmHg diastolic. A single measurement ≥ 160 systolic mmHg or 100 mmHg diastolic during the current study evaluation is exclusionary.\n15. Negative HIV test results by one of the following options:\n\n    * For participants who received study product under HVTN 706\n\n      * A negative result from a HVTN HIV Diagnostic Testing Laboratory within 14 days prior to enrollment (see HVTN 318 HIV testing SSP for additional details); or\n      * A negative result from a non-HVTN laboratory following the external guidance for non-HVTN laboratories within 14 days prior to enrollment (external laboratory guidance for non-HVTN laboratories can be found in the guidance document, HIV Infection and VISP\u002FR Status Diagnostic Testing at External (non-HVTN Laboratories).\n    * For participants at who received placebo under HVTN 706\n\n      * A negative US Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA); or a chemiluminescent microparticle immunoassay (CMIA); or\n      * A negative result on 2 different HIV rapid tests (one of these rapid tests must be FDA approved)\n16. Negative for anti-Hepatitis C virus (HCV) Abs (anti-HCV) or negative HCV nucleic acid test (NAT) if anti-HCV antibodies (Abs) are detected.\n17. Negative for Hepatitis B surface antigen (Ag).\n18. Women with pregnancy potential:\n\n    * Must have a negative β-HCG pregnancy test (urine or serum) on day of enrollment.\n    * Must agree to use effective means of contraception from at least 21 days prior to enrollment until 8 weeks after their last scheduled vaccination. See Appendix D.\n    * Women who have had a total hysterectomy, bilateral oophorectomy, or bilateral salpingectomy Consider including the cyan-highlighted parenthetical for product-specific reasons: (verified by medical records) or menopause (no menses for ≥1 year) are not required to undergo pregnancy testing.\n19. Female volunteers must agree to not seek pregnancy through alternative methods, such as oocyte retrieval, artificial insemination, or in vitro fertilization from at least 21 days prior to enrollment through 8 weeks after their last scheduled vaccination timepoint.\n\nExclusion Criteria:\n\n1. Body mass index (BMI) ≥ 40. Enrollment of individuals with BMI ≥ 40, whom the site investigator assesses are in good health, may be considered by PSRT approval.\n2. Diabetes mellitus (DM). Type 2 DM controlled with diet alone (and confirmed by HgbA1c ≤ 8% within the last 6 months) or a history of isolated gestational diabetes are not exclusionary. Enrollment of individuals with Type 2 DM that is well controlled on hypoglycemic agent(s) may be considered by the PSRT on a case-by-case basis, provided that the HgbA1c is ≤ 8% within the last 6 months (sites may draw these at screening).\n3. Previous or current recipient of an investigational HIV vaccine (not applicable to previous placebo\u002Fcontrol recipients), with the exception of the HVTN 706 vaccine regimen as per Inclusion Criteria #1.\n4. Receipt of non-HIV investigational vaccine(s) received within the last 1 year. Exceptions include vaccines that have subsequently undergone licensure or Emergency Use Authorization (EUA) by the FDA or World Health Organization (WHO) Emergency Use Listing (EUL), or if outside the US, by the national Regulatory Authority (RA) authorizing this clinical trial.\n5. Congenital or acquired immunodeficiency, including systemic medication use likely to impair immune response to vaccine in the opinion of the site investigator, such as glucocorticoid use, ≥ prednisone 10 mg\u002Fday within 3 months prior to enrollment.\n6. Blood products or immunoglobulin within 16 weeks prior to enrollment; receipt of immunoglobulin within 16 weeks prior to enrollment requires PSRT approval.\n7. Receipt of any vaccine within 4 weeks prior to enrollment\n8. Initiation of Ag-based immunotherapy for allergies within the previous year (stable immunotherapy is not exclusionary); inclusion of participants who initiated immunotherapy within the previous year requires PSRT approval.\n9. Receipt of investigational research agents with a half-life of 7 or fewer days within 4 weeks prior to enrollment. If a potential participant has received investigational agents with a half-life of more than 7 days (or unknown half-life) within the past year, PSRT approval is required for enrollment.\n10. Use of injectable long-acting Cabotegravir within 18 months prior to enrollment.\n11. Serious adverse reactions to any vaccine, including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and\u002For abdominal pain. (Not applicable to a participant who had a non-anaphylactic adverse reaction to pertussis vaccine as a child.)\n12. Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema.\n13. Idiopathic urticaria within the past year.\n14. Bleeding disorder diagnosed by a clinician that would make study procedures a contraindication.\n15. History of seizure(s) within the past 3 years. Also applies to volunteer using medications in order to prevent or treat seizure(s) at any time within the past 3 years.\n16. Asplenia or functional asplenia.\n17. Active duty and reserve US military personnel.\n18. Any other chronic or clinically significant condition that, in the clinical judgment of the investigator, would jeopardize the safety or rights of the study participant, including but not limited to: clinically significant forms of substance use or alcohol use disorder(s), serious psychiatric disorders, any suicide attempt within the past 1 year (if between 1 and 2 years, consult PSRT for approval), or cancer that, in the clinical judgement of the site investigator, has potential for recurrence (excluding basal cell carcinoma).\n19. Asthma patients will not be enrolled if the volunteer has ANY of the following:\n\n    * Required either oral or parenteral corticosteroids for an exacerbation 2 or more times within the past year; OR\n    * Needed emergency care, urgent care, hospitalization, or intubation for an acute asthma exacerbation within the past year (eg, would NOT exclude individuals with asthma who meet all other criteria but sought urgent\u002Femergent care solely for asthma medication refills or coexisting conditions unrelated to asthma); OR\n    * Uses a short-acting rescue inhaler more than 2 days per week for acute asthma symptoms (ie, not for preventive treatment prior to athletic activity); OR\n    * Uses medium- to high-dose inhaled corticosteroids (\\> 250 mcg fluticasone or therapeutic equivalent per day), whether in single-therapy or dual-therapy inhalers (ie, with a long-acting beta agonist \\[LABA\\]); OR\n    * Uses more than 1 medication for maintenance therapy daily. Inclusion of anyone on a stable dose of more than 1 medication for maintenance therapy daily for greater than 2 years requires PSRT approval.\n20. A participant with a history of a potential immune-mediated medical condition (PIMMC), either active or remote. Specific examples are listed in Appendix F (AESI Index). Not exclusionary: 1) Remote history of Bell's palsy (\\> 2 years ago) not associated with other neurologic symptoms and 2) mild psoriasis or other mild, uncomplicated, localized, or dermatologic condition that does not require ongoing systemic treatment.\n21. History of allergy to local anesthetic (Novocaine, Lidocaine).\n22. Volunteer who is breastfeeding or pregnant.\n23. Investigator concern for difficulty with venous access based on clinical history and physical examination. For example, persons with a history of intravenous drug use or substantial difficulty with previous blood draws.","60 Years",{"count":189,"type":23},[26],"The clinical schedule will consist of 3 injections of CD40.HIVRI.Env (VRIPRO) at weeks 0, 4, and 24.40 volunteers without HIV and in overall good health, aged 18 to 60 years, who previously participated in the HVTN 706 trial.",[29],{"date":377,"type":43},"2026-06-05",{"date":379,"type":43},"2025-09-14",{"date":381,"type":23},"2027-05-04",{"name":383,"class":384},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":17,"sex":18,"minAge":371,"maxAge":391,"enrollmentInfo":392,"targetDuration":4,"studyType":139,"phases":4,"briefSummary":394,"conditions":395,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":396,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":51},"100373409","skeletal-muscle-energetics-and-fatiguability-in-older-individuals-100373409","NCT04142047","Skeletal Muscle Energetics and Fatiguability in Older Individuals","Inclusion Criteria:\n\n* Participants who are \\>= 60 years of age\n* HIV serostatus positive participants on stable antiretroviral therapy (ART) (no regimen change in last month) with undetectable HIV viral load (\\\u003C100 copies).\n* HIV serostatus negative participants\n\nExclusion Criteria:\n\n* Unable to understand the risks, benefits, and alternatives of participation and give meaningful consent\n* Contraindications to MRI\n* Significant cardiovascular, pulmonary or musculoskeletal or orthopedic disease that significantly limits exercise capacity\n* Significant lower extremity peripheral vascular disease.\n* Weight greater than 350 lbs\n* Cognitive or speech impairments that would limit completion of questionnaires or fatigue reporting.","90 Years",{"count":393,"type":23},200,"The investigators are studying whether metabolic abnormalities in calf (leg) muscle in older people with and others without HIV are associated with decreased abilities to exercise.",[222,29],{"date":355,"type":43},{"date":398,"type":43},"2019-09-05",{"date":400,"type":23},"2027-07-01",{"name":402,"class":127},"Johns Hopkins University",{"id":404,"slug":405,"hasResults":12,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":409,"eligibilityCriteria":410,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":24,"phases":413,"briefSummary":415,"conditions":416,"keywords":4,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":421,"completionDateStruct":422,"leadSponsor":424,"locationsCount":51},"100581724","phase-4-notre-optimizing-long-acting-pre-exposure-prophylaxis-and-medications-for-opioid-use-disorder-interventions-in-carceral-settings-100581724","NCT06854029","NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings","Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings","NOTRE","Inclusion Criteria:\n\n1. Adults (age 18) at a participating carceral site;\n2. Eligible for release within 120 days (sentenced and\u002For pretrial). Individuals who might be sentenced to federal prison will be excluded;\n3. History of OUD (meeting DSM-5 criteria of moderate or severe opioid use disorder at the time of incarceration; individuals not meeting the opioid-disorder criterion will be eligible if they were treated in an opioid agonist treatment program during the year before incarceration or met OUD criteria in the year prior to incarceration);\n4. HIV negative (as confirmed by a HIV rapid test);\n5. Clinically indicated for PrEP based on CDC guidelines during incarceration and\u002For the year prior to incarceration;\n6. Willing to enroll in buprenorphine treatment and PrEP and be randomized to either study arm; and\n7. Report that, during community re-entry they will reside in the geographic locations of the study.\n\nExclusion Criteria:\n\n1. Liver function test levels greater than four times normal (if we are unable to obtain labs, a determination by our site partner physicians will be made to allow inclusion);\n2. Active medical illness that may make participation hazardous (e.g., unstable diabetes, heart disease; renal impairment, Hepatitis B);\n3. Conditions or medications that may predispose to QTc prolongation (personal or family history of long QT syndrome, hypokalemia, medications that prolong QTc interval, e.g., macrolide antibiotics, azole antifungal compounds, anti-arrhythmics, antipsychotics and antidepressants);\n4. Untreated psychiatric disorder that may make participation hazardous (e.g., untreated psychosis, treated psychiatric disorders will be allowed);\n5. Known allergic reaction to PrEP or buprenorphine; and\n6. Suicidal ideation.",{"count":412,"type":23},450,[414],"PHASE4","The investigators plan to conduct an R61\u002F33 hybrid type 2 implementation-effectiveness trial that includes 1) a one-year exploratory R61 phase that will enable the development of the intervention protocol needed for the R33 trial phase including concrete R61 phase milestones; 2) a four-year R33 phase that will include a concurrent implementation evaluation and a randomized control trial.",[29,417,418],"Opioid Use Disorder","Incarceration; Lens","2026-06-03",{"date":70,"type":43},{"date":120,"type":23},{"date":423,"type":23},"2030-06-01",{"name":425,"class":127},"Duke University",{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":432,"eligibilityCriteria":433,"healthyVolunteers":12,"sex":187,"minAge":434,"maxAge":4,"enrollmentInfo":435,"targetDuration":4,"studyType":24,"phases":437,"briefSummary":439,"conditions":440,"keywords":450,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":459,"leadSponsor":460,"locationsCount":128},"100634904","phase-2-adjuvant-5-fluorouracil-following-thermal-ablation-to-improve-hpv-treatment-outcomes-in-women-with-hiv-in-kenya-100634904","NCT07545746","Adjuvant 5-Fluorouracil Following Thermal Ablation to Improve HPV Treatment Outcomes in Women With HIV in Kenya","Adjuvant 5-Fluorouracil Following Thermal Ablation to Improve HPV Treatment Outcomes in Women With HIV in Kenya : The ASCEND Trial","ASCEND","Inclusion Criteria\n\n* Women aged 25 years or older\n* Known HIV-positive status\n* On antiretroviral therapy (ART) for at least 60 days prior to enrollment\n* Positive HPV screening test screening result\n* Able to provide informed consent in English, Swahili, or Dholuo\n* Agree to use dual contraception during dosing phase if of childbearing potential\n* Planning to remain in study locale for duration of study (48 weeks) Exclusion Criteria\n* Current pregnancy or breastfeeding\n* History of anogenital cancer (cervical, vulvar, or anal)\n* Current use of immunosuppressive medications\n* History of total hysterectomy\n* Known allergy to 5FU\n* Medical comorbidity that would interfere with study participation\n* Unwilling or unable to use contraception during study participation","25 Years",{"count":436,"type":23},140,[438],"PHASE2","This randomized, placebo-controlled trial will evaluate self-administered 5-fluorouracil (5FU) to improve human papillomavirus (HPV) clearance after thermal ablation (TA) in Women With Human Immunodeficiency Virus (HIV) (WWH) in Kenya. The trial will also assess the safety, adherence, and acceptability of 5FU. Starting four weeks after TA, participants will self-administer 5FU cream or matched placebo intravaginally once every other week for 12 applications, with clinic visits at weeks 2, 8, 16, 24, and 48 for evaluation. All participants will be followed up to 48 weeks.\n\nIt is hypothesized that, compared to placebo, 5FU will increase HPV clearance at 24 weeks and that the proposed dosing schedule will be safe, well-tolerated, and acceptable in this population. Together with data from other studies, this trial will provide evidence on the use of self-administered intravaginal 5FU to improve HPV treatment outcomes in WWH in low- and middle-income countries, where the burden of cervical cancer is highest.",[29,441,442,443,444,445,446,447,448,449],"HPV Infection","Cervix Cancer","CIN2","CIN3","CIN1","CIN","Cervical Intraepithelial Neoplasia Grade 3","Cervical Intraepithelial Neoplasia Grade 1","Cervical Intraepithelial Neoplasia Grade 2\u002F3",[451,452,453,454],"5-fluorouracil (5FU)","thermal ablation (TA)","placebo","intravaginal topical","2026-06-01",{"date":457,"type":43},"2026-06-02",{"date":253,"type":23},{"date":255,"type":23},{"name":461,"class":127},"UNC Lineberger Comprehensive Cancer Center",{"id":463,"slug":464,"hasResults":12,"nctId":465,"briefTitle":466,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":468,"targetDuration":4,"studyType":24,"phases":470,"briefSummary":471,"conditions":472,"keywords":473,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":476,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":99},"100619274","phase-1-dasatinib-for-hiv-1-reservoir-reduction-100619274","NCT07342491","Dasatinib for HIV-1 Reservoir Reduction","Inclusion Criteria:\n\n* HIV-1 infection\n* Active antiretroviral therapy received continuously for 48 months (or longer)\n* CD4+ cell count \\>450 cells\u002Fmm3 obtained within 12 months prior to study entry\n* Plasma HIV-1 RNA level below the lower limit of quantification within 90 days prior to study entry\n* Plasma HIV-1 RNA levels below the lower limit of quantification for \\>36 months at time of study entry\n* The following laboratory values obtained within 90 days prior to entry:\n\n  * Absolute neutrophil count (ANC) above the lower limit of normal\n  * Hemoglobin above the lower limit of normal\n  * Platelet count above the lower limit of normal\n  * Aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), and alkaline phosphatase \\\u003C1.5 x ULN\n  * Total bilirubin \\\u003C1.5 x ULN\n  * Negative hepatitis B virus (HBV) surface antigen (HBsAg)\n  * Negative HBV core antibody with one exception: individuals with positive HBV core antibody and HBV surface antibody are eligible for enrollment\n  * Negative hepatitis C virus (HCV) antibody (anti-HCV) or, if the anti-HCV is positive, a negative HCV RNA PCR\n  * Estimated glomerular filtration rate (eGFR) \\>70 mL\u002Fmin\u002F1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) 2021 equation or serum creatinine \\\u003C1.2 x ULN\n* QTc interval \\\u003C450 milliseconds on EKG performed at screening visit\n* Women who are able to become pregnant must have a negative serum or urine pregnancy test at screening and within 48 hours prior to study entry\n* Individuals (male or female) who are having sex that could lead to pregnancy, must agree to use at least two effective means of contraception when engaging in sexual activities that can result in pregnancy, from the time of enrollment through 60 days following the last dose of dasatinib\n* Able to swallow pills without difficulty.\n* Ability and willingness of participant or legally authorized representative to provide informed consent\n* Ability and willingness of participant to continue same ART regimen throughout the study\n\nExclusion Criteria:\n\n* Pre-ART viral load known to be \\\u003C2000 copies\u002FmL (HIV controller)\n* Known to have initiated ART during acute HIV infection\n* Presence of a drug-resistant virus with no alternative ART regimens available in the event that current ART regimen becomes compromised as a result of this study\n* Current pregnancy or breastfeeding or pregnancy planning during study participation\n* Recent hospitalization or surgery within 90 days prior to entry\n* Recent infection requiring intravenous antibiotics within 90 days prior to entry\n* Any evidence of hepatic impairment\n* Any known prior (lasting \\>180 days) or current history of gastrointestinal-related diseases\n* Active malignancy including myelodysplastic syndrome or myeloproliferative disease.\n* Any known prior (lasting \\>180 days) or current history of hematologic illness\n* Any known prior (lasting \\>180 days) or current history of cardiac-related diseases\n* Untreated hypothyroidism\n* Treatment for TB within the past 90 days.\n* Current respiratory disease requiring supplemental oxygen\n* Exposure to any systemic immunomodulatory drug (including maraviroc) in the 16 weeks prior to study entry\n* Exposure to anticoagulant or anti-platelet medications in the 16 weeks prior to study entry\n* Active use of medications known to prolong the QT interval\n* Known family history of Long QT Syndrome in a first-degree relative (i.e., parent, offspring, or sibling)\n* Active use of medications known to moderately or strongly induce or inhibit CYP3A4, including ART regimens that contain protease inhibitors, efavirenz, etravirine, or cobicistat at the time of screening or study entry\n* Current substance use which is likely to interfere with the conduct of the study\n* Anticipated conflict or inability to attend and complete all protocol-scheduled study visits and assessments\n* Known allergy\u002Fsensitivity or any hypersensitivity to components of dasatinib or its formulation\n* Active use of azithromycin, Ondansetron, Pentamidine at study entry",{"count":469,"type":23},14,[26],"This study will test if the medicine dasatinib can lower the hidden amount of HIV in the body, called the HIV \"reservoir.\" It will also check if dasatinib is safe and easy to take for people living with HIV who have a suppressed viral load while on antiretroviral therapy (ART). Adults 18 years or older who have been on ART for at least 48 months and have had a suppressed HIV-1 viral load for at least 36 months may be able to join.\n\nPeople will be randomly assigned to take dasatinib 100 mg by mouth once a day or a look-alike substance with no drug, called a placebo, for 12 weeks. Neither participants nor researchers will know who gets which (double-blind). The study team will do regular health checks and blood tests to track safety, tolerability, the HIV reservoir, and changes in immune cells.\n\nThe study lasts 36 weeks total: 12 weeks of treatment and 24 weeks of follow-up, with clinic visits and possible phone calls. Fourteen people will take part; eight will get dasatinib and six will get placebo. Dasatinib may lower the HIV reservoir, but this is not guaranteed. All medicines can cause side effects, called adverse events (AE). The study team will watch closely and provide medical support. Joining is your choice, and you can leave at any time. If you leave, the team will talk with you about next steps for your care.",[29],[474,475,222],"Antiretroviral Therapy (ART)","Viral Persistence",{"date":70,"type":43},{"date":478,"type":43},"2026-05-08",{"date":480,"type":23},"2027-05-12",{"name":383,"class":384},{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":187,"minAge":434,"maxAge":490,"enrollmentInfo":491,"targetDuration":4,"studyType":24,"phases":493,"briefSummary":494,"conditions":495,"keywords":496,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":501,"completionDateStruct":502,"leadSponsor":503,"locationsCount":51},"100638010","clinic-vs-cliniccommunity-outreach-hpv-self-collection-to-increase-cervical-screening-in-women-living-with-hiv-100638010","NCT07624123","Clinic vs Clinic+Community Outreach HPV Self-Collection to Increase Cervical Screening in Women Living With HIV","Comparison of Clinic-based Versus Clinic-plus Community Outreach-based Strategy Via HPV Self-Collection to Increase Uptake of Cervical Cancer Screening Among Women Living With HIV: a Cluster Randomized Trial (CASCADE-3001-B)","C-3001B-P-CS7","Clinic Inclusion Criteria\n\n* Clinics selected for inclusion will include those clinics that provide Human Immunodeficiency Virus (HIV) care and distribute antiretroviral therapy (ART) to Women living with Human Immunodeficiency Virus (WLWH.\n* These clinics should also have the ability to collect their own data.\n* Such clinics could be supported by national programs and bilateral donor-funded initiatives\n\nInclusion Criteria for Medical Record Abstraction\n\n* Are living with Human Immunodeficiency Virus (HIV)\n* Are 25-49 years of age, or as recommended by the Zimbabwe National Screening Guidelines\n* Live in the catchment areas of or attend a study-eligible clinic\n* Are eligible for Human Papillomavirus (HPV)-based cervicovaginal testing either because:\n* They have never undergone cervical cancer screening before, or\n* They have never undergone HPV-based testing before and are now due for Visual Inspection with Acetic Acid and Cervicography (VIAC), per national guidelines, or\n* They have previously undergone HPV-based testing, and are now due for follow-up HPV-based testing per national guidelines, and \u002For\n* They underwent ablative or excisional treatment for presumed or confirmed cervical dysplasia \\>1 year ago and have not had any follow-up cervical cancer screening since treatment.\n\nExclusion Criteria for Medical Record Abstraction\n\n* Have had their cervix removed\n* Are pregnant or \\\u003C6 weeks post-delivery\n* Were positive on their most recent cervical cancer screening test and referred for further evaluation or treatment, but did not complete their referral\n* Have previously been treated for invasive cervical cancer","49 Years",{"count":492,"type":23},17734,[110],"This Clinical Trials Network for Human Immunodeficiency Virus (HIV)-Associated Cervical Cancer Screening and Treatment Optimization (CASCADE)-3001-B trial aims to assess how the introduction of a community-health-worker-facilitated model, in addition to the existing static clinic-only model, influences the rates of cervical cancer screening uptake among women living with HIV (WLWH). This study involves offering human papillomavirus (HPV) self-collection for cervical cancer screening to eligible WLWH.\n\nThe 'CASCADE' Network is a clinical trials network aimed at improving cervical cancer screening, management, and pre-cancer treatment for WLWH, in various healthcare settings. The network will conduct implementation trials to improve the triage of HPV-positive WLWH, as well as algorithms to optimize access to and options for effective treatment. Trials will be conducted using a mixed-methods approach aimed at assessing implementation strategies and outcomes and their potential to integrate into existing health systems.\n\nFurther understanding of HPV-based community-based strategies to reach WLWH, and the acceptability, feasibility, appropriateness, and cost of these strategies will be valuable for cervical cancer screening programs serving WLWH. Inputs from various 'CASCADE' Clinical Sites (CS) regarding feasible screening outreach options available in their settings for WLWH have guided this study that focuses on evaluating a pragmatic HPV self-collection implementation model to improve access to screening.\n\nWhile it is clear that HPV self-collection is a highly acceptable and feasible screening option, creating opportunities to conduct self-collection in alternative venues outside the clinic premises, and with the guidance of and facilitation by trusted community healthcare workers (CHWs) is an important implementation strategy that needs to be evaluated and considered for its potential benefit. Studies have not yet evaluated a community-based approach for HPV self-collection kit distribution among WLWH - who may have different characteristics, preferences, and access to screening services than women not living with HIV. Providing WLWH with the option of receiving HPV self-collection kits in their own homes or other community-based settings ('community-based HPV self-collection') is a novel implementation strategy that could improve cervical cancer screening rates among eligible women. Therefore, this novel trial aims to evaluate the feasibility and effectiveness of implementing community-based HPV self-collection among WLWH.",[442,29,441],[497,498],"self-collection","screening","2026-05-28",{"date":419,"type":43},{"date":174,"type":23},{"date":255,"type":23},{"name":461,"class":127},{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":508,"acronym":4,"eligibilityCriteria":509,"healthyVolunteers":17,"sex":510,"minAge":19,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":24,"phases":513,"briefSummary":514,"conditions":515,"keywords":517,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":51},"100610341","testing-the-wecare-intervention-to-address-mental-health-and-medication-adherence-challenges-among-msm-in-south-africa-100610341","NCT07226323","Testing the WeCare Intervention to Address Mental Health and Medication Adherence Challenges Among MSM in South Africa","Inclusion Criteria:\n\n* Male\n* reports sexual intercourse with a man in the past 6 months\n* reside in the Johannesburg metropolitan area with no plans to relocate during the next 6 months\n* ability to communicate in English\n* current prescription for any ART regimen (HIV-positive participants) or daily oral PrEP (HIV-negative participants) at the POP INN clinic.\n* HIV positive participant only: unsuppressed HIV viral load (HIV-1 RNA viral load ≥200 copies\u002FmL) in the sample collected in the past six months\n* HIV negative participants only: Self-reported challenges adhering to daily oral PrEP (i.e miss 3 or more tablets per week)\n* Moderate symptoms of depression during past 2 weeks (score on the PHQ-9 ≥10 and \\\u003C20)\n* Ability to understand and provide informed consent.\n\nExclusion Criteria:\n\n* Presently engaged in mental health therapy.\n* Participated in qualitative phase of WeCare study (AUR2-18-419) or open-pilot (present study).\n* Refuses audio recording of the in-person or online individual counselling session","MALE",{"count":512,"type":23},60,[110],"The goal of this clinical trial is to learn if the WeCare intervention-an adapted Friendship Bench program that integrates problem-solving therapy, minority-stress-informed content, and explicit PrEP\u002FART adherence skills-improves mental health and HIV medication adherence among men who have sex with men (MSM). It will also assess the safety, acceptability, and feasibility of delivering WeCare through trained lay coaches in community clinics.\n\nMain questions the trial aims to answer:\n\n* Does WeCare reduce symptoms of depression and anxiety among MSM?\n* Does WeCare improve PrEP and ART adherence and increase rates of viral suppression among participants on ART?\n* Is WeCare acceptable, feasible, and safe when delivered by lay coaches in POP INN clinics compared with usual care?",[29,516],"Mental Health",[518,519,520,521],"Men having sex with Men","Medication adherence","PrEP Adherence","ART Adherence","2026-05-27",{"date":524,"type":43},"2026-05-29",{"date":526,"type":43},"2025-12-01",{"date":528,"type":23},"2027-07-31",{"name":530,"class":127},"Emory University",{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":18,"minAge":538,"maxAge":434,"enrollmentInfo":539,"targetDuration":4,"studyType":24,"phases":541,"briefSummary":542,"conditions":543,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":544,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":128},"100555181","phase-1-the-tatelo-plus-study-100555181","NCT06508749","The Tatelo Plus Study","Phase I\u002FII Trial to Evaluate the Impact of Three Broadly Neutralizing Antibodies or Analytic Treatment Interruption on Viral Reservoir, Immune Function, and Maintenance of HIV Suppression in Early Treated Children in Botswana","Inclusion Criteria, Step 1\n\n* Previously enrolled in the EIT\u002FTatelo, or Moso Cohort Study\n* Receiving prescribed ART for at least 24 weeks prior to study entry as determined by the site investigator based on participant\u002Fparent\u002Fguardian report and available medical records\n* 24 weeks to 12 years of age at enrollment, inclusive\n* If entering Step 1a: HIV-1 RNA \\\u003C40 copies\u002FmL for at least 24 weeks prior to entry, including documented suppression to \\\u003C40 copies\u002FmL within 30 days of Step 1 entry\n* If entering Step 1b: HIV-1 RNA \\\u003C200 copies\u002FmL for at least 24 weeks prior to entry, including documented suppression to \\\u003C40 copies\u002FmL within 30 days of Step 1 entry.\n* Normal temperature (\\\u003C37.4°C axillary, or \\\u003C38°C non-axillary) and no signs or symptoms of acute illness at entry as determined by the site investigator based on participant\u002Fparent\u002Fguardian report and available medical records\n* Normal, grade 1 or grade 2 results for all of the following laboratory tests at screening, based on testing of specimens collected within 30 days prior to entry and grading per protocol:\n\n  * Hemoglobin\n  * Absolute neutrophil count\n  * Platelet count\n  * Alanine aminotransferase\n  * Aspartate aminotransferase\n  * Creatinine\n* For female participants who are able to become pregnant (defined as having reached menarche and not having undergone surgical sterilization), not pregnant based on testing performed from a specimen collected within 5 days prior to enrollment). Note: Pregnancy is not expected in Step 1 given the age range of eligible participants.\n* Expected to be available for the duration of participation and expected to comply with the visit schedule and other requirements as determined by the site investigator based on participant\u002Fparent\u002Fguardian report at entry\n* Not currently participating in another study of an investigational agent and is not expected to participate in any such study for the duration of participation, as determined by the site investigator based on participant\u002Fparent\u002Fguardian report at entry. Prior or current participation in the EIT\u002FTatelo or Moso cohort studies is permitted.\n* Parental\u002Flegal guardian is willing and able to provide written permission for child's participation and, child is willing and able to provide written assent for participation if 7- 17 years of age\n\nInclusion Criteria, Step 2\n\n* At or beyond the Week 24 visit in Step 1\n* Susceptible to at least 2 of the 3 bNAbs under study at or prior to Step 1 entry OR Negative EIA and negative qualitative DNA result at last available evaluation in Step 1 in the absence of available susceptibility data\n* No confirmed HIV-1 RNA ≥40 copies\u002FmL throughout Step 1 and for at least 24 weeks prior to Step 1 entry\n\nInclusion Criteria, Step 3\n\n* If entering from Step 1:\n\n  1. At or beyond the Week 24 visit in Step 1, with no confirmed HIV-1 RNA ≥40 copies\u002FmL throughout Step 1\n  2. Not eligible for Step 2\n  3. No confirmed HIV-1 RNA ≥40 copies\u002FmL for at least 96 weeks prior to Step 3 entry (or since 24 weeks of age if 96-120 weeks of age)\n  4. Detection of ≥60% of intact proviruses in heterochromatin DNA regions (i.e. non-genic DNA, satellite DNA, ZNF genes) from any PBMC sample analyzed by MIP-seq, and no recorded viremia (\\>40 copies\u002FmL) after this evaluation OR Negative EIA and negative Qualitative HIV DNA result within 12 weeks prior to Step 3 entry\n  5. Approved for entry by Clinical Management Committee (CMC)\n  6. Willingness and ability to provide independent written informed consent for participation or parental\u002Flegal guardian is willing and able to provide written permission for child's participation and, child is willing and able to provide written assent for participation if 7-17 years of age\n* If entering from Step 2:\n\n  1. At or beyond the Week 24 visit of Step 2, with HIV-1 RNA \\\u003C40 copies\u002FmL throughout Steps 1 and 2\n  2. No confirmed HIV-1 RNA ≥40 copies\u002FmL for at least 96 weeks prior to Step 3 entry (or since 24 weeks of age if 96-120 weeks of age)\n  3. Negative EIA and negative qualitative DNA result within 12 weeks prior to Step 3 entry OR Detection of ≥60% of intact proviruses in heterochromatin DNA regions (i.e. non-genic DNA, satellite DNA, ZNF genes) from any PBMC sample analyzed by MIP-seq, and no recorded viremia (\\>40 copies\u002FmL) after this evaluation entry AND approved for entry by CMC\n  4. For Moso participants, not currently being breastfed\n  5. Willingness and ability to provide independent written informed consent for participation or parental\u002Flegal guardian is willing and able to provide written permission for child's participation and, child is willing and able to provide written assent for participation if 7-17 years of age\n* If entering Step 3 directly upon enrollment:\n\n  1. Previously enrolled in the EIT\u002FTatelo, Moso, or BHP Adolescent Cohort Study\n  2. 96 weeks to 25 years of age at enrollment, inclusive\n  3. \"Non-encoding\" virus: Detection of ≥60% of intact proviruses in heterochromatin DNA regions (i.e. non-genic DNA, satellite DNA, ZNF genes) from any PBMC sample analyzed by MIP-seq, and no recorded viremia (\\>40 copies\u002FmL) after this evaluation OR \"No intact virus\": adolescent (13-25 years) with no intact HIV detected in at least 20 million PBMCs sampled within the prior 4 years\n  4. For \"non-encoding\" virus: Receiving prescribed ART prior to Step 3 entry, with HIV-1 RNA \\\u003C40 copies\u002FmL for at least 96 weeks prior to entry (or since 24 weeks of age if 96-120 weeks of age), including documented suppression to \\\u003C40 copies\u002FmL within 30 days of Step 3 entry\n  5. For \"no intact virus\": Receiving prescribed ART prior to Step 3 entry, with HIV-1 RNA \\\u003C40 copies\u002FmL for at least 10 years prior to entry, including documented suppression to \\\u003C40 copies\u002FmL within 30 days of Step 3 entry\n  6. Approved for entry by CMC\n  7. For Moso participants, not currently being breastfed\n  8. For female participants who are able to become pregnant (defined as having experienced menarche and not having undergone surgical sterilization), not pregnant based on testing performed from a specimen collected within 5 days prior to enrollment)\n  9. For female participants who are able to become pregnant (defined as having reached menarche and not having undergone surgical sterilization) and report sexual activity that could lead to pregnancy, willing to use two methods of contraception while on study. One of the two methods must be highly effective; highly effective methods include the following:\n\n     * Contraceptive intrauterine device or intrauterine system\n     * Subdermal contraceptive implant\n     * Progestogen injections\n     * Combined estrogen and progestogen oral contraceptive pills\n     * Percutaneous contraceptive patch\n     * Contraceptive vaginal ring The highly effective method must be initiated prior to enrollment. The second method must be a barrier method for dual protection against pregnancy and to avoid transmission of HIV during the ATI and other sexually transmitted infections.\n  10. For female participants who are able to become pregnant, not currently breastfeeding an infant, and not intending to breastfeed an infant for the duration of the study, based on participant\u002Fparent\u002Fguardian report at entry\n  11. For participants who report sexual activity, willing to receive counseling and to use condoms to avoid transmission of HIV\n  12. Expected to be available for the duration of participation and expected to comply with the visit schedule and other requirements as determined by the site investigator based on participant\u002Fparent\u002Fguardian report at entry\n  13. Not currently participating in another study of an investigational agent and is not expected to participate in any such study for the duration of participation, as determined by the site investigator based on participant\u002Fparent\u002Fguardian report at entry. Prior or current participation in the EIT\u002FTatelo, Moso, or BHP Adolescent cohort studies is permitted.\n  14. Willingness and ability to provide independent written informed consent for participation or parental\u002Flegal guardian is willing and able to provide written permission for child's participation and, child is willing and able to provide written assent for participation if 7-17 years of age\n\nInclusion Criteria, Step 4\n\n* Previously entered the study in Step 1 or Step 3. All participants will enter Step 4 upon completing a prior study step. Participants ending Step 1a or Step 1b who, for any reason, do not proceed to Step 2 or to Step 3 will be eligible to proceed to Step 4. Participants ending Step 2 who, for any reason, do not proceed to Step 3 will be eligible to proceed to Step 4. Participants ending Step 3 for any reason will be eligible to proceed to Step 4.\n\nExclusion Criteria:\n\n* Active tuberculosis (either suspected or proven) or malignancy.\n* Hepatitis B surface antigen (HBsAg) positive\n* Received within 30 days prior to study entry, or is identified as requiring, any of the following:\n\n  * Any immunoglobulin-based treatment\n  * Chronic (more than 14 days) systemic steroid treatment\n* Has any other documented or suspected clinically significant medical condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.\n* For participants entering Step 1 and Step 2: \\\u003C5 kg or \\>115kg.\n* For participants entering Step 3 directly: Received NNRTI-based ART (including efavirenz, nevirapine, rilpivirine) within 14 days of Step 3 entry","24 Weeks",{"count":540,"type":23},41,[26,438],"The purpose of this study is to advance pediatric HIV treatment and cure research by evaluating the impact of a combination of three anti-HIV-1 broadly neutralizing antibodies (bNAbs) or analytic treatment interruption (ATI) on viral reservoir, immune function, and maintenance of HIV suppression in early-treated children.",[222,29],{"date":524,"type":43},{"date":546,"type":43},"2024-11-11",{"date":548,"type":23},"2028-02-18",{"name":383,"class":384},{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":556,"eligibilityCriteria":557,"healthyVolunteers":12,"sex":187,"minAge":434,"maxAge":490,"enrollmentInfo":558,"targetDuration":4,"studyType":24,"phases":560,"briefSummary":561,"conditions":562,"keywords":563,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":569,"locationsCount":51},"100625876","clinic-vs-cliniccommunity-outreach-hpv-self-collection-to-increase-cervical-screening-in-women-with-hiv-100625876","NCT07428330","Clinic vs Clinic+Community Outreach HPV Self-Collection to Increase Cervical Screening in Women With HIV","Comparison of Clinic-based Versus Clinic-plus Community Outreach-based Strategy Via HPV Self-Collection to Increase Uptake of Cervical Cancer Screening Among Women Living With HIV: a Cluster Randomized Trial","CASCADE3001A","Clinic Inclusion Criteria\n\n* Clinics selected for inclusion will include those clinics that provide Human Immunodeficiency Virus (HIV) care and distribute antiretroviral therapy (ART) to Women living with Human Immunodeficiency Virus (WLWH.\n* These clinics should also have the ability to collect their own data.\n* Such clinics could be supported by national programs and bilateral donor-funded initiatives\n\nInclusion Criteria for Medical Record Abstraction\n\n* Are living with Human Immunodeficiency Virus (HIV)\n* Are 25-49 years of age, or as recommended by Uganda's Ministry of Health Cervical Cancer Prevention and Control Guidelines\n* Live in the catchment areas of or attend a study-eligible clinic\n* Are eligible for Human Papillomavirus (HPV)-based cervicovaginal testing either because:\n* They have never undergone cervical cancer screening before, or\n* They have never undergone HPV-based testing before and are now due for Acetic Acid (VIA), per national guidelines, or\n* They have previously undergone HPV-based testing, and are now due for follow-up HPV-based testing per national guidelines, and \u002For\n* They underwent ablative or excisional treatment for presumed or confirmed cervical dysplasia \\>1 year ago and have not had any follow-up cervical cancer screening since treatment.\n\nExclusion Criteria for Medical Record Abstraction\n\n* Have had their cervix removed\n* Are pregnant or \\\u003C3 months post-delivery\n* Were positive on their most recent cervical cancer screening test and referred for further evaluation or treatment, but did not complete their referral\n* Have previously been treated for invasive cervical cancer\n\nClinic Inclusion Criteria\n\n* Clinics selected for inclusion will include those clinics that provide Human Immunodeficiency Virus (HIV) care and distribute antiretroviral therapy (ART) to Women living with Human Immunodeficiency Virus (WLWH).\n* These clinics should also have the ability to collect their own data.\n* Such clinics could be supported by national programs and bilateral donor-funded initiatives",{"count":559,"type":23},7597,[110],"This Clinical Trials Network for Human Immunodeficiency Virus (HIV)-Associated Cervical Cancer Screening and Treatment Optimization (CASCADE) C3001-A trial aims to assess how the introduction of a community-health-worker-facilitated model, in addition to the existing static clinic-only model, influences the rates of cervical cancer screening uptake among women living with HIV (WLWH). This study involves offering human papillomavirus (HPV) self-collection for cervical cancer screening to eligible WLWH.\n\nThe 'CASCADE' Network is a clinical trials network aimed at improving cervical cancer screening, management, and pre-cancer treatment for WLWH, in various healthcare settings. The network will conduct implementation trials to improve the triage of HPV-positive WLWH, as well as algorithms to optimize access to and options for effective treatment. Trials will be conducted using a mixed-methods approach aimed at assessing implementation strategies and outcomes and their potential to integrate into existing health systems.\n\nFurther understanding of HPV-based community-based strategies to reach WLWH, and the acceptability, feasibility, appropriateness, and cost of these strategies will be valuable for cervical cancer screening programs serving WLWH. Inputs from various 'CASCADE' Clinical Sites (CS) regarding feasible screening outreach options available in their settings for WLWH have guided this study that focuses on evaluating a pragmatic HPV self-collection implementation model to improve access to screening.\n\nWhile it is clear that HPV self-collection is a highly acceptable and feasible screening option, creating opportunities to conduct self-collection in alternative venues outside the clinic premises, and with the guidance of and facilitation by trusted community healthcare workers is an important implementation strategy that needs to be evaluated and considered for its potential benefit. Studies have not yet evaluated a community-based approach for HPV self-collection kit distribution among WLWH - who may have different characteristics, preferences, and access to screening services than women not living with HIV. Providing WLWH with the option of receiving HPV self-collection kits in their own homes or other community-based settings ('community-based HPV self-collection') is a novel implementation strategy that could improve cervical cancer screening rates among eligible women. Therefore, this novel trial aims to evaluate the feasibility and effectiveness of implementing community-based HPV self-collection among WLWH.",[442,29,441],[498,497],"2026-05-26",{"date":499,"type":43},{"date":567,"type":43},"2026-02-03",{"date":255,"type":23},{"name":461,"class":127},{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":4,"eligibilityCriteria":576,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":577,"targetDuration":4,"studyType":24,"phases":579,"briefSummary":580,"conditions":581,"keywords":582,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":587,"startDateStruct":588,"completionDateStruct":589,"leadSponsor":591,"locationsCount":51},"100582848","the-tail-prep-study-100582848","NCT06868641","The TAIL-PrEP Study","The TAIL-PrEP Study: Acceptability and Feasibility of a Tailored Adherence Intervention for Safe Discontinuation of Long-acting PrEP","Inclusion criteria:\n\n* At least 18 years of age\n* HIV-negative (self-report)\n* Able to speak and read in English\n* Have access to an internet-connected device capable of running the online video conferencing platform\n* Have a private location at which to take online conference calls\n\nParticipants considering discontinuing cab-LA or LEN have the following additional inclusion criteria:\n\n\\- Considering discontinuing cab-LA or LEN\n\nParticipants discontinuing cab-LA have the following additional inclusion criteria:\n\n* Have discontinued cab-LA injections within the last three months\n* Not currently on cab-LA injections\n* Able to receive and send monthly packages\n* The study period will end for patient participants once the monthly blood draw result indicates that cab-LA levels are not detectable (estimated average of 6 months across all patients) or after 6 months of the study, whichever comes first. If at 6 months of study participation, cab-LA levels are still detectable and participants adhered to at least 50% of study activities (self-collecting and mailing monthly blood samples, completing monthly surveys, attending monthly coaching sessions), participants will be invited to participate in the study for an additional 6 months, for a total of up to 12 study visits.",{"count":578,"type":23},30,[110],"The goal of the TAIL-PrEP study is to understand how to support the safe discontinuation of injectable long-acting cabotegravir (cab-LA) and lenacapavir (LEN) while maximizing the public health impact of biomedical HIV prevention interventions. In Aim 1, the study will pilot test and assess the acceptability and feasibility of the TAIL-PrEP intervention: for participants discontinuing cab-LA, this will consist of monthly cabotegravir drug level monitoring to provide personalized HIV prevention coaching, for participants considering discontinuing cab-LA or LEN, this will consist of a one-time personalized HIV prevention coaching session. In Aim 2, the study will refine the TAIL-PrEP intervention and implementation strategy based on findings from the pilot study.",[29],[197,163,220,583,584,585,586],"Long-Acting Injectable","Acceptability","Feasibility","Lenacapavir",{"date":499,"type":43},{"date":174,"type":23},{"date":590,"type":23},"2027-03",{"name":284,"class":127},{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":598,"eligibilityCriteria":599,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":600,"targetDuration":4,"studyType":24,"phases":602,"briefSummary":603,"conditions":604,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":606,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":610,"locationsCount":51},"100487896","an-adaptive-randomized-controlled-trial-100487896","NCT05633056","An Adaptive Randomized Controlled Trial","Adaptive Evaluation of mHealth and Conventional Adherence Support Interventions to Optimize Outcome With New Treatment Regimens for Drug-resistant Tuberculosis and HIV in South Africa","ADAP-TIV","Inclusion Criteria:\n\n1. Culture or molecular test positive for MTB\n2. Molecular test positive for HIV or a documented HIV positive history\n3. Drug-susceptibility testing by molecular (i.e. GeneXpert MTB\u002FRIF) or conventional testing consistent with at least rifampicin-resistant TB,\n4. Initiating treatment with a Bedaquiline -containing TB regimen within 4 weeks of enrollment and first-time being treated with BDQ\n5. On treatment with Antiretroviral Therapy (ART) regimen, including dolutegravir-containing combination Antiretroviral Therapy regimen (i.e. Tenofovir-Lamivudine-Dolutergravir), or starting within 4 weeks of enrollment,\n6. Capacity for informed consent in either isiZulu or English\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Prisoners\n3. Discretion of IOR or clinician",{"count":601,"type":23},360,[110],"This is a prospective, adaptive, randomized controlled trial comparing the effectiveness of 4 intervention arms on a combined endpoint in adults with confirmed MDR-TB HIV initiating Bedaquiline-containing MDR-TB treatment regimens and on ART (integrase strand transfer inhibitor (INSTI)-based fixed dose combination therapy) in KwaZulu-Natal, South Africa. Interventions arms include: enhanced standard of care; psychosocial support; mHealth using cellular-enabled electronic dose monitoring; combined mHealth psychosocial support. Level of support will be adjusted using a differentiated service delivery (DSD)- informed assessment of treatment support needs.",[605,29],"Multi Drug Resistant Tuberculosis",{"date":499,"type":43},{"date":608,"type":43},"2023-03-07",{"date":147,"type":23},{"name":284,"class":127},{"id":612,"slug":613,"hasResults":12,"nctId":614,"briefTitle":615,"officialTitle":616,"acronym":617,"eligibilityCriteria":618,"healthyVolunteers":12,"sex":18,"minAge":619,"maxAge":20,"enrollmentInfo":620,"targetDuration":4,"studyType":139,"phases":4,"briefSummary":622,"conditions":623,"keywords":624,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":627,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":632,"locationsCount":634},"100450594","protocol-rv-583-multinational-observational-cohort-of-hiv-and-other-infections-100450594","NCT05147519","Protocol RV 583 Multinational Observational Cohort of HIV and Other Infections","Multinational Observational Cohort of HIV and Other Infections (MOCHI)","MOCHI","Step 1 Inclusion Criteria: Female or male aged 14-55 years; Documented negative HIV test according to site-specific HIV testing procedures at entry\u002Fscreening; Able and willing to provide informed consent; Willing to provide biometric identification; Available for follow-up for the planned study duration; Understands English or the local language as approved by the IRB, including people who are illiterate; Willing to provide contact information for themselves and one personal contact who would know their whereabouts during the study period; Willing to provide information regarding HIV risk behaviors and to undergo testing for HIV and other STIs; Considered to be vulnerable to HIV and other STIs based on any one or more of the following test results and\u002For self-reported behaviors:\n\n1. Documented history of newly diagnosed syphilis, gonorrhea, chlamydia, Mycoplasma genitalium, herpes simplex virus, or acute hepatitis C virus infection in the 24 weeks prior to screening\n2. Self-reported vaginal, oral, or anal intercourse in exchange for money as a regular source of income in the 24 weeks prior to screening\n3. Self-reported condomless vaginal or anal intercourse with at least three different partners living with HIV or of unknown status in the 24 weeks prior to screening\n4. Self- reported injection drug use (IDU) in the 24 weeks prior to screening\n5. Self-reported insertive or receptive anal intercourse with one or more different male or transgender partners in the 24 weeks prior to screening Step 1 Exclusion Criteria: Any significant condition (medical, psychologic\u002Fpsychiatric or social) that, in the judgment of the study investigator, might interfere with the conduct of the study; Active drug or alcohol use or dependence that, in the judgement of the study investigator, would interfere with adherence to study requirements; Current or past participation in a preventive or therapeutic HIV vaccine study, unless known placebo recipient; Positive β-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) at screening for people of child-bearing potential and people who are amenorrheic for less than 12 consecutive months.\n\nStep 2 Inclusion Criteria: New diagnosis of HIV in the last 90 days during Step 1 as determined by site-specific HIV testing procedures; Able and willing to continue follow-up for the planned study duration Step 2 Exclusion Criteria: Any significant condition (medical, psychologic\u002Fpsychiatric or social) that, in the judgment of the study investigator, might interfere with the conduct of the study; Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements","14 Years",{"count":621,"type":23},2500,"Multinational Observational Cohort of HIV and other Infections (MOCHI). This observational study is to gain information regarding the number of new HIV infections among people who engage in behaviors that make them vulnerable to acquiring HIV across multiple international sites.",[29],[625,626],"STI","Observational",{"date":499,"type":43},{"date":629,"type":43},"2021-11-05",{"date":631,"type":23},"2032-06-30",{"name":633,"class":127},"Henry M. Jackson Foundation for the Advancement of Military Medicine",4]