[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hivaids\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hivaids":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,29,0,25,[9,46,75,100,121,141,169,192,212,239,264,290,316,341,364,388,412,438,464,488,517,538,567,589,613],{"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":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100573080","mypeeps-mobile-plus-a-multi-level-hiv-prevention-intervention-for-young-msm-100573080",false,"NCT06741618","MyPEEPS Mobile Plus: A Multi-Level HIV Prevention Intervention for Young MSM","MyPEEPS Mobile Plus","Inclusion Criteria:\n\n* 16-25 years of age\n* identify as male or non-binary\n* male sex assigned at birth\n* understand and read English\n* own a smartphone\n* report condomless anal sex with a male in the past year\n* HIV-negative (OraQuick verified)\n\nExclusion Criteria:\n\n* HIV Positive\n* If study staff determine participant unable to consent due to obvious and severe cognitive impairment or under the influence of drugs or alcohol\n* currently report consistent use of PrEP\n* currently enrolled in another HIV prevention study",true,"MALE","16 Years","25 Years",{"count":22,"type":23},500,"ESTIMATED","INTERVENTIONAL",[26],"NA","MyPEEPS Mobile Plus, a multi-level intervention for improving HIV prevention outcomes in YMSM, is a novel and evidence-driven approach using mobile technology to deliver HIV prevention information specifically developed for YMSM. Building on strong preliminary work, the proposed research is the next logical step in a body of work designed to assess whether refinement of this mobile intervention used in combination with virtual PrEP Peer Navigation will result in improvements in PrEP uptake and a reduction in HIV-related behavior. This is key to advancing HIV prevention among HIV-negative US persons at extremely high-risk for HIV seroconversion.",[29],"HIV\u002FAIDS",[31,32],"PrEP","care navigation","RECRUITING","2026-06-25",{"date":36,"type":37},"2026-06-26","ACTUAL",{"date":39,"type":37},"2026-04-20",{"date":41,"type":23},"2029-06-30",{"name":43,"class":44},"Columbia University","OTHER",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":52,"minAge":4,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":45},"100464686","screening-and-follow-up-in-patients-with-hiv-infection-combined-with-metabolic-associated-fatty-liver-disease-100464686","NCT05330923","Screening and Follow-up in Patients With HIV Infection Combined With Metabolic Associated Fatty Liver Disease","Inclusion Criteria:\n\n* Newly treated or treated AIDS patients;\n* Regular follow-up visits to the hospital, medication compliance is good;\n* Patients or their family members were willing to participate in the study by understanding the study plan and providing written informed consent.\n\nExclusion Criteria:\n\n* Unable to complete the position requirements of ultrasonic examination (lying flat) due to mobility difficulties;\n* Patients have poor compliance and cannot follow up regularly or take medicine on time;\n* Patients or family members cannot understand the conditions and objectives of the study;\n* Other conditions considered unsuitable for inclusion by the investigator.","ALL",{"count":54,"type":23},2000,"OBSERVATIONAL","Acquired immunodeficiency syndrome (AIDS) remains a severe global infectious disease, with over 38 million people living with HIV and around 35 million cumulative deaths worldwide by 2023; approximately 1.24 million HIV-positive individuals and 100,000 new infections are reported annually in China. Widespread use of HAART has prolonged HIV patients' survival and reduced AIDS-related mortality, yet non-AIDS comorbidities dominated by chronic liver disorders, particularly metabolic dysfunction-associated fatty liver disease (MAFLD), have become a major challenge in long-term HIV management. Triggered by elevated blood lipids from lifestyle, antiretroviral agents and inherited metabolic factors, MAFLD initiates with hepatic steatosis and may progress to NASH, liver fibrosis, cirrhosis and even hepatocellular carcinoma (HCC) without timely intervention. HIV-positive patients develop more severe MAFLD progression than HIV-negative counterparts; existing biopsy data shows 91% of ART-treated HIV patients have NAFLD, among whom 65% suffer from NASH complicated with liver fibrosis.\n\nFatty liver prevalence keeps rising with younger onset age in China, which highlights the necessity of early screening. Liver biopsy, the historical diagnostic gold standard for liver injury grading, is restricted by invasiveness, bleeding risks and poor reproducibility. Transient elastography (TE), a novel non-invasive ultrasonic technique, quantifies hepatic steatosis via the ultrasound attenuation parameter (UAP) and liver fibrosis via liver stiffness measurement (LSM), and has been validated and guideline-endorsed for multiple chronic liver diseases globally. Published foreign data report 35%, 42% and 22% prevalence of NAFLD, NASH and fibrosis in PLWH, while domestic evidence on HIV-associated MAFLD is limited, especially liver-related discrepancies among varied ART regimens. With the implementation of China's new medical insurance policy, numerous patients are shifting from non-INI regimens to once-daily single-tablet INSTI STR regimens, whose hepatic and lipid impacts remain unclear. This study targets early detection of HIV patients with concomitant fatty liver to optimize management strategies and improve clinical outcomes.\n\nOur preliminary cohort at Peking Union Medical College Hospital included 188 virologically suppressed HIV patients on ART, 56.9% (107\u002F188) of whom developed fatty liver (mild:27.1%, moderate:19.7%, severe:10.1%). Liver fibrosis (LSM≥7.3 kPa) was found in 12.8% (24\u002F188) subjects, with 1.1% having advanced cirrhosis, and no significant inter-group difference in fatty liver incidence was noted between INSTI and NNRTI recipients. These findings lay a foundation for early diagnosis and follow-up intervention of metabolic liver disease among HIV-infected populations.",[58,59,60,29],"Nonalcoholic Fatty Liver Disease","Nonalcoholic Steatohepatitis","Fibrosis",[62,63,64,65],"integrase inhibitors","non-nucleoside reverse transcriptase inhibitors","transient elastography","iLivTouch","2026-06-02",{"date":68,"type":37},"2026-06-04",{"date":70,"type":37},"2022-01-01",{"date":72,"type":23},"2029-06-01",{"name":74,"class":44},"Peking Union Medical College Hospital",{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":17,"sex":52,"minAge":82,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":24,"phases":85,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":45},"100391550","appalachian-partnership-to-reduce-disparities-aim-2-100391550","NCT04378439","Appalachian Partnership to Reduce Disparities (Aim 2)","Harnessing the Power of Peer Navigation and mHealth to Reduce Health Disparities in Appalachia","Inclusion Criteria:\n\n* reside in one of the rural Appalachian catchment countiesreside in one of the rural Appalachian catchment counties\n* be ≥18 years of age\n* report being assigned male sex at birth and having had sex with at least 1 man in past 12 months\n* provide informed consent","18 Years",{"count":84,"type":23},141,[26],"By combining two strategies (i.e., peer navigation and mHealth) into a complete, culturally compatible, bilingual intervention to increase the use of needed HIV, STI, and HCV prevention and care services among racially\u002Fethnically diverse GBMSM and transgender women in rural Appalachia.\n\nStudy Investigators anticipate that participants in the intervention group, relative to counterparts in the delayed-intervention group, will demonstrate increased HIV, STI, and HCV testing.",[29,88,89],"STI","HCV",[31],"2026-05-22",{"date":93,"type":37},"2026-05-26",{"date":95,"type":37},"2022-04-01",{"date":97,"type":23},"2027-05",{"name":99,"class":44},"Wake Forest University Health Sciences",{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":52,"minAge":82,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":24,"phases":109,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":45},"100551647","enhancing-the-organizational-social-context-to-improve-viral-suppression-and-retention-in-hiv-care-100551647","NCT06462807","Enhancing the Organizational Social Context to Improve Viral Suppression and Retention in HIV Care","Enhancing the Organizational Social Context to Improve Viral Suppression and Retention in HIV Care: A Randomized Controlled Trial","Inclusion Criteria:\n\nAim 1:\n\n* PLWH: in care in one of 12 clinics in Philadelphia\n\n  1. HIV diagnosis date at least one year prior to the administration of the clinic OSC measures\n  2. Philadelphia address at the time of HIV diagnosis\n  3. successfully linked to care at any point during the study period, defined as having documentation of 1 or more CD4 or Viral Load test results after the date of diagnosis\n* Clinic workers: clinic leaders, administrators, frontline staff, and providers across participating clinics\n\nAim 2:\n\n* PLWH: having an established diagnosis of HIV and receiving care at one of the 4 clinics at least 6 months before the pre-implementation period\n* Clinic workers: the entire pool of workers employed in the 2 clinics assigned to the intervention arm will be invited to participate in ARC\n\nAim 3:\n\n\\- Clinic staff and PLWH at clinics receiving ARC\n\nExclusion Criteria:\n\nAim 1:\n\n* PLWH: Persons in a correctional facility will be excluded from this analysis\n* Clinic workers: Participants who are not employed in one of the roles that were designated\n\nAim 2:\n\n* PLWH: Patients who get discharged from a clinic because they moved (or for other reasons) or who died will not be eligible to enter the pre-implementation cohort.\n* Clinic workers: Clinics assigned to SOC will not receive ARC but will be asked to complete surveys using the same schedule as the clinics assigned to receive ARC.",{"count":108,"type":23},1500,[26],"Despite the widespread use of effective antiretroviral therapy (ART), the HIV epidemic continues to impact racial and ethnic minority populations disproportionately. Although Black\u002FAfrican American persons account for 13% of the U.S. population, they account for 41% of new HIV diagnoses and experience the lowest rates of retention in HIV care and viral suppression (VS) compared to other racial\u002Fethnic groups. Structural racism and discrimination (SRD) likely contribute to racial disparities in HIV outcomes.\n\nAlthough the outpatient setting is a vitally important aspect of care provision for people living with HIV (PLWH), there are limited data on the impact of intra-organizational SRD on HIV outcomes. Longitudinal engagement in HIV care is needed for sustained VS and decreased community transmission of HIV. The organizational social context (OSC) includes organizational culture (organizational norms and values that drive quality of care), organizational climate (perception of the culture and how it impacts personal well-being), and workers' attitudes. Using a randomized controlled trial (RCT), we will implement ARC (Accessibility, Responsiveness, Continuity) to improve organizational behavior and reduce racial disparities in HIV outcomes for PLWH. ARC is an evidence-based intervention that uses three strategies (ARC principles, ARC component tools, and ARC mental models) to create OSCs that support the implementation of interventions to improve patient outcomes.\n\nClinics will be randomized to ARC (n = 2) or standard of care (SOC; n= 2). Those assigned to ARC will address SRD occurring at the organizational level affecting care, including referral and treatment patterns for PLWH. A pre-implementation period will be followed by ARC and ARC-associated implementation strategies for 36 months and then a 12-month post-implementation period where we will continue to measure HIV outcomes in both arms. We will compare HIV outcomes, namely VS and retention in care, and intermediate outcomes, such as linkage to mental health treatment and staff turn-over in clinics assigned to ARC and SOC.\n\nWe will also evaluate whether individual (self-efficacy, perceived discrimination) and organizational factors (OSC and cohesion of OSC measures) mediate the relationship between ARC, intermediate, and HIV outcomes. In preparation to the RCT, we will evaluate baseline OSC measures across 12 HIV clinics in Philadelphia and determine aspects of the OSC associated with VS and retention in care in a multi-level model adjusting for neighborhood SRD, patient-level factors, and clustering of patients nested in clinics and neighborhoods. We will then test the effectiveness of ARC in improving a primary outcome of VS and secondary outcome of retention in care at the end of the implementation period. We will examine the acceptability, sustainability, and cost of implementing ARC in outpatient HIV care. This research will advance understanding of the impact of SRD on HIV treatment outcomes and health services research and the implementation of a disseminable evidence-based practice aimed at reducing SRD.",[29],"2026-05-14",{"date":114,"type":37},"2026-05-19",{"date":116,"type":37},"2025-09-05",{"date":118,"type":23},"2027-12-01",{"name":120,"class":44},"University of Pennsylvania",{"id":122,"slug":123,"hasResults":12,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":17,"sex":52,"minAge":82,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":24,"phases":129,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":45},"100544320","an-economic-and-relationship-strengthening-intervention-to-reduce-alcohol-use-in-malawi-100544320","NCT06367348","An Economic and Relationship-strengthening Intervention to Reduce Alcohol Use in Malawi","Mlambe: A Randomized Controlled Trial of an Economic and Relationship-Strengthening Intervention to Reduce Alcohol Use in Malawi","Inclusion Criteria:\n\n1. In a married or cohabitating union\n2. Have at least one partner with a positive AUDIT-C screen in prior 3 months\n3. Must also currently be on ART for at least 6 months\n4. Must have disclosed their HIV status to their partner\n\nExclusion Criteria:\n\n1\\) Severe intimate partner violence reported in previous 3 months and\u002For fear that safety would be at risk by participation in the study (reported at screening). Couples who participated in Mlambe's pilot study will also be excluded.",{"count":22,"type":23},[26],"With a full-scale randomized control trial, the investigators will evaluate the efficacy and cost effectiveness of Mlambe, an economic and relationship-strengthening intervention that provides incentivized saving accounts, financial literacy training, and relationship skills education to break the cycle of poverty around drinking, strengthen couple support and communication, and reduce heavy drinking among HIV-affected married couples with a partner who drinks alcohol in Malawi.",[29,132],"Alcohol Abuse","2026-05-11",{"date":112,"type":37},{"date":136,"type":37},"2025-02-14",{"date":138,"type":23},"2028-05",{"name":140,"class":44},"University of California, San Francisco",{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":17,"sex":52,"minAge":82,"maxAge":148,"enrollmentInfo":149,"targetDuration":151,"studyType":55,"phases":4,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":168},"100416278","pre--and-post-treatment-lung-microbiota-metabolome-and-immune-signatures-at-the-site-of-disease-in-patients-with-active-pulmonary-tuberculosis-100416278","NCT04700579","Pre- and Post-treatment Lung Microbiota, Metabolome and Immune Signatures at the Site of Disease in Patients With Active Pulmonary Tuberculosis","TB-LUNG","Inclusion Criteria:\n\n* 18-60 years old.\n* Agree to undergo CXR and\u002For CT scan.\n* Has unilateral TB disease defined as one lung with extensive evidence of TB disease (non-applicable to healthy controls; sick controls will require an alternative diagnosis).\n* No evidence of prior TB treatment and\u002For CXR\u002FCT does not have obvious evidence of prior TB.\n* Willing to undergo a research bronchoscopy at baseline, 6 months and 18 months and likely to remain in the area for the study period.\n* If HIV-positive, must be stable on antiretroviral therapy (ART) for ≥1 year.\n* Able and willing to return for follow-up visits, with no plans to move in the near future.\n* Willing to comply with study requirements i.e. provision of contact details and written, informed consent prior to enrolment.\n\nExclusion Criteria:\n\n* Less than 18 years or older than 60 years of age.\n* Has already initiated TB treatment.\n* Rifampicin resistant.\n* Has a previous history of TB.\n* Bilateral TB disease defined as both lungs with extensive TB disease\n* Has received probiotics, antibiotics or inhaled steroids within three months prior to enrolment (not applicable to sick controls)\n* Has diabetes mellitus, which affects TB disease, treatment response, and the microbiome\n* Has a contraindication for bronchoscopy (e.g., FEV1 \\\u003C70%), as determined by bronchoscopists according to best practice guidelines\n* Has a daily alcohol intake of more than 6 beers or 4 mixed drinks\n* Is pregnant (a commercial human chorionic gonadotropin determination assay will be performed in accordance with manufacturer's guidance on urine) or pregnancy planned for follow-up period\n* Recent hospitalization for any reason","60 Years",{"count":150,"type":23},150,"18 Months","The diverse microbial communities in different parts of the human body (microbiome) are important for health but understudied in pulmonary tuberculosis (TB), which is the single biggest infectious cause of death in the world. The investigators will study the site-of-disease microbiome (in the lung bronchoalveolar space) in TB cases to investigate how, before TB treatment, metabolic compounds made by microbes affect host biomarkers important for TB control. The investigators will ask this question again at the end-of-treatment and one year later. Specifically, the investigators will sample the lung at the active TB hotspot identified by imaging and compare this to a non-involved lung segment usually in the opposite lung. The investigators will compare the lung microbiome to other sites in the body (i.e. oral cavity, nasopharynx, supraglottis, and gut). A small amount of blood (\\~15 ml) will be collected to assess peripheral immunological correlates of the host microbiome. Protected specimen brushings of the lung will be used to explore transcriptomic signatures and how these relate to the lung microbiome. The investigators will also apply these questions to the same number of controls (healthy patients and patients with an alternative diagnoses). This will lay the foundation for clinical trials to evaluate if specific bacteria have diagnostic (e.g., PCR) or therapeutic potential (e.g., antibiotics, prebiotics, probiotics, vaccines) where targeting the microbiome could improve clinical outcomes.",[154,29],"TB - Tuberculosis",[156,157,158],"Microbiome","Short Chain Fatty Acids","Immunological Biomarkers","2026-04-29",{"date":161,"type":37},"2026-05-06",{"date":163,"type":37},"2021-03-04",{"date":165,"type":23},"2027-12-31",{"name":167,"class":44},"University of Stellenbosch",3,{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":17,"sex":175,"minAge":19,"maxAge":176,"enrollmentInfo":177,"targetDuration":4,"studyType":24,"phases":178,"briefSummary":179,"conditions":180,"keywords":181,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":45},"100559615","prep-my-way-a-hybrid-type-1-clinical-effectiveness-implementation-trial-to-promote-prep-persistence-among-young-kenyan-women-100559615","NCT06566430","PrEP My Way: A Hybrid Type 1 Clinical Effectiveness-implementation Trial to Promote PrEP Persistence Among Young Kenyan Women","Inclusion Criteria:\n\n* young women (age 16-24 years)\n* initiating PrEP at the recruitment site (this criterion subsumes all necessary safety assessments for starting PrEP, including HIV-negative status and for those taking FTC\u002FTDF normal renal function and lack of Hepatitis B infection)\n* resident in Kisumu County\n* phone ownership\n* ability to understand KiSwahili, DhoLuo, and\u002For English\n\nExclusion Criteria:\n\n* inability to provide informed consent (e.g., intoxication)","FEMALE","24 Years",{"count":22,"type":23},[26],"PrEP My Way is a novel PrEP delivery system consisting of clinic-based PrEP initiation, followed by peer-delivered kits for HIV self-testing, PrEP refills, vaginal swabs for gonorrhea and chlamydia self-sampling, pregnancy tests, and contraception refills, if desired. Based on Social Cognitive Theory, the overall hypothesis is that PrEP My Way will overcome critical stigma and structural barriers that currently limit PrEP use and thus empower young women to promote their sexual health.\n\nPreliminary testing of PrEP My Way in Kisumu, Kenya found it to be highly feasible and acceptable, but PrEP use as an oral medication was lower than expected. Now that newer PrEP formulations are becoming available, the team is adding choice of PrEP formulation (i.e., oral tenofovir\u002Femtricitabine, injectable cabotegravir-long acting \\[CAB-LA\\], or dapivirine ring) as well as choice of adherence support from peers (e.g., SMS \\[short message service\\], routine check-ins and\u002For WhatsApp groups) to the intervention. The study team will then test the effectiveness of the augmented PrEP My Way intervention (with and without testing for gonorrhea and chlamydia due to cost concerns) on PrEP persistence in women with ongoing HIV prevention needs (i.e., self-reported desire for PrEP, self-reported HIV risk, condomless sex, and\u002For multiple sexual partners). The team will also track implementation, service, and client metrics per Proctor's framework and determine cost-effectiveness of the intervention",[29],[182],"prevention","2026-04-17",{"date":185,"type":37},"2026-04-22",{"date":187,"type":37},"2025-03-03",{"date":189,"type":23},"2028-12-01",{"name":191,"class":44},"Massachusetts General Hospital",{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":198,"enrollmentInfo":199,"targetDuration":4,"studyType":24,"phases":201,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":210,"locationsCount":211},"100573081","mypeeps-lite-trial-100573081","NCT06741631","MyPEEPS LITE Trial","Inclusion Criteria:\n\n* Be between 16-29 years of age;\n* Sex assigned at birth is male and identify gender as male or non-binary;\n* Understand and read English;\n* Live within US and its territories;\n* Own or have access to a smartphone;\n* Self-report anal sex with someone who has a penis in the last 12 months; and\n* Be HIV-negative or status unknown\n\nExclusion Criteria:\n\n* Individuals who identify as transgender","29 Years",{"count":200,"type":23},3200,[26],"This study will use community-informed advertisements and messages through electronic methods to recruit and retain a large (N=3,200), diverse national sample of high-risk young men who have sex with men (YMSM) and non-binary individuals that are assigned male sex at birth, 16-29 years of age to determine the efficacy of the MyPEEPS Mobile intervention on reduced incident HIV infections in comparison to a standard of care condition and to examine the degree to which reduced incident HIV infections occurs in the context of potential multilevel moderators and conceptual mediators. This is key to advancing HIV prevention among HIV-negative US persons at extremely high-risk for HIV seroconversion.",[29],"2026-02-24",{"date":206,"type":37},"2026-02-27",{"date":208,"type":37},"2025-01-10",{"date":189,"type":23},{"name":43,"class":44},2,{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":52,"minAge":82,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":24,"phases":222,"briefSummary":224,"conditions":225,"keywords":228,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":45},"100553014","phase-2-an-integrated-intervention-using-a-pill-ingestible-sensor-system-100553014","NCT06480578","An Integrated Intervention Using a Pill Ingestible Sensor System","An Integrated Intervention Using a Pill Ingestible Sensor System to Trigger Actions on Multifaceted Social and Behavioral Determinants of Health Among PLWH","Sensor-SBDOH","Inclusion Criteria:\n\n1. HIV-infected individuals in HIV care\n2. Greater than 17 years of age\n3. Demonstrated ability to take co-encapsulated ARVs at the time of screening\n4. Able to provide informed consent\n5. Receiving ART with sub-optimal adherence estimated by patient (self-reports \\\u003C 90% adherence over last 28 days) or treating clinician \\[e.g., based on gaps in treatment (e.g. missed appointments) or viral load elevations within 6 months\\], or at high risk for sub-optimal adherence, or with known challenges with SBDOH (e.g. unstable housing, substance use disorder, and poverty\n6. Currently receiving antiretroviral treatment that includes one of the following:\n\n   * TDF\u002FFTC (Truvada)\n   * TAF\u002FFTC (Descovy)\n   * EFV\u002FFTC\u002FTDF (Atripla)\n   * ABC\u002F3TC (Epzicom)\n   * DTG\u002FABC\u002F3TC (Triumeq)\n   * RPV\u002FTAF\u002FFTC (Odefsey)\n   * EVG\u002Fc\u002FFTC\u002FTAF (Genvoya)\n   * BIC\u002FFTC\u002FTAF (Biktarvy)\n7. For participants of reproductive potential, negative serum or urine pregnancy test with a sensitivity of ≤25 mIU\u002FmL at screening. This will be repeated again at study entry.\n\nNOTE: Participants are considered to be NOT of reproductive potential if:\n\n1. participants have had amenorrhea for at least 12 consecutive months prior to study entry (i.e., who have had no menses within 12 months prior to study entry), and have a documented FSH \\>40 IU\u002FmL; OR\n2. an FSH level is not available, but participants have had 24 consecutive months of amenorrhea (in the absence of medications known to induce amenorrhea); OR\n3. participants report having undergone surgical sterilization (e.g., hysterectomy, or bilateral oophorectomy, or bilateral tubal ligation\u002Fhysteroscopic tubal occlusion).\n\nExclusion Criteria:\n\n1. Inability to follow the study procedures manifested during the intake, as evidenced by mental confusion, disorganization, intoxication, withdrawal, risky or threatening behavior\n2. Pregnancy (Evaluated during the screening visit through a pregnancy test.)",{"count":221,"type":23},110,[223],"PHASE2","This study integrates technology-based adherence measures with alerts for social and behavioral determinants of health (SBDOH) to improve HIV treatment outcomes. It involves 110 adult patients from a Los Angeles County HIV clinic, focusing on those at risk for poor adherence. Participants will be randomized into intervention or usual care groups, with endpoints including intervention acceptability, SBDOH interventions, adherence to ART, viral load, and high-risk sexual activity. The study aims to assess the effectiveness of the integrated intervention in improving adherence, virologic outcomes, and reducing high-risk behavior among PLWH.",[29,226,227],"Medication Adherence","Social Determinants of Health (SDOH)",[29,226,229],"SDOH","2026-02-11",{"date":232,"type":37},"2026-02-13",{"date":234,"type":37},"2024-12-19",{"date":236,"type":23},"2027-07-01",{"name":238,"class":44},"University of California, Los Angeles",{"id":240,"slug":241,"hasResults":12,"nctId":242,"briefTitle":243,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":17,"sex":175,"minAge":245,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":24,"phases":248,"briefSummary":249,"conditions":250,"keywords":251,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":45},"100615913","peer-led-dynamic-choice-hiv-prevention-for-women-the-peer-led-dcp-pilot-study-100615913","NCT07298785","Peer-led Dynamic Choice HIV Prevention for Women: The Peer-led DCP Pilot Study","Inclusion Criteria:\n\n1. Age \\>=18 years or mature or mature minor \\>=15 years;\n2. Female sex at birth;\n3. HIV negative by country-standard testing algorithm\n4. Elevated risk of HIV exposure, defined as at least 1 of the following: a) eligible for PrEP based on Uganda Ministry of Health Guidelines; b) exchange of sex for goods or money in last 6 months; or c) work in bar or guesthouse\n\nExclusion Criteria:\n\n* Contraindication to country-recommended PrEP regimen per national guidelines\n* Participation in another HIV prevention study","15 Years",{"count":247,"type":23},60,[26],"This study will refine and pilot test the Peer-led Dynamic Choice HIV Prevention (DCP) intervention in a single-arm pilot trial. The study will test the hypothesis that the Peer-led Dynamic Choice HIV Prevention intervention will be feasible and increase biomedical HIV prevention coverage in the 6 months after receipt of the Peer-led DCP intervention compared to the standard of care in the 6 months prior to intervention implementation.",[29],[252,253,254,255],"Biomedical HIV Prevention","Peer Mentor Intervention","Uganda","Dynamic Choice HIV Prevention","2026-02-03",{"date":258,"type":37},"2026-02-05",{"date":260,"type":37},"2026-01-27",{"date":262,"type":23},"2027-06-30",{"name":140,"class":44},{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":270,"eligibilityCriteria":271,"healthyVolunteers":12,"sex":52,"minAge":82,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":24,"phases":274,"briefSummary":275,"conditions":276,"keywords":277,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":45},"100390076","scope-analytic-treatment-interruption-protocol-100390076","NCT04359186","SCOPE Analytic Treatment Interruption Protocol","Analytic Treatment Interruption in HIV Infection","SCOPE-ATI","Inclusion Criteria:\n\n* Willing and able to provide written informed consent\n* Age \\>= 18\n* Documented HIV infection\n* Antiretroviral therapy for at least 12 months\n* Screening plasma HIV RNA levels below level of detection (\\\u003C 40-75 copies\u002FmL), and all available determinations in past 12 months also below level of detection (blips allowed)\n* Screening CD4+ T-cell count \\>350 cells\u002FuL\n* If of childbearing potential, willing to use two methods of contraception\n* Willing to receive counseling regarding HIV transmission risk mitigation\n\nExclusion Criteria:\n\n* Pregnant or plans to become pregnant during the course of the study\n* Active hepatitis B, defined as (1) positive sAg or (2) positive cAb with negative sAb and positive HBV DNA\n* Active hepatitis C, defined as positive Hep C Ab with positive HCV RNA\n* Use of a non-nucleoside reverse transcriptase inhibitor and unable to switch regimen\n* Significant cardiovascular or cerebrovascular disease\n* Recent or prior (within past 5 years) malignancy\n* Severe kidney disease (CrCl \\\u003C 50 mL\u002Fmin via Cockroft-Gault method)\n* Severe hepatic impairment (Child-Pugh Class C) or unstable liver disease\n* Concurrent treatment with immunomodulatory drugs\n* Unable or unwilling to use barrier protection or pre-exposure prophylaxis (PrEP) to prevent HIV transmission with sexual partners not known to be HIV-infected",{"count":273,"type":23},40,[26],"The goal of this study is to understand the interaction between HIV and the host at the earliest stages when HIV medications are paused. Volunteers with HIV will interrupt antiretroviral therapy (ART) and then have intensive studies preformed two to three times per week. Most will resume therapy within three weeks, even if the virus does not rebound during this time.",[29],[278,29,279,280,281],"HIV","Antiretroviral therapy","HIV reservoir","Biomarkers","2026-01-21",{"date":284,"type":37},"2026-01-23",{"date":286,"type":37},"2020-10-15",{"date":288,"type":23},"2028-06",{"name":140,"class":44},{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":175,"minAge":82,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":24,"phases":299,"briefSummary":300,"conditions":301,"keywords":302,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":45},"100342422","an-mhealth-intervention-to-improve-outcomes-for-women-with-hivaids-100342422","NCT03738410","An mHealth Intervention to Improve Outcomes for Women With HIV\u002FAIDS","A Multi-Lingual, Culturally-Competent Mobile Health Intervention to Reduce Medical Mistrust, Stigma, and Improve Treatment Adherence Among Women Living With HIV\u002FAIDS (WLWH)","Inclusion Criteria:\n\n* Confirmed HIV diagnosis as per the clinic standard\n* Female \\>= 18 years old at enrollment\n* Currently active or recently returned into care or newly enrolled\n* With two or more previously scheduled visits (12 months prior to study enrollment\n* in the 12 months prior to enrollment:\n* missed one or more visits or\n* viral load detectable (\\>20 mL) or\n* not taking prescribed HIV anti-retroviral medications\n\nExclusion Criteria:\n\n* men\n* women who are cognitively impaired or are not able to consent for themselves\n* non-working cell phone\n* adolescents \\\u003C 18 years old at enrollment",{"count":298,"type":23},80,[26],"The purpose of this study is:\n\n1. To develop a new mobile health (mHealth) system that will send text messages to remind both pregnant and non-pregnant women with HIV to adhere to their treatment plan (like keeping appointments, fillings prescriptions, and taking their medication) and address individual barriers to HIV care (like stigma, medical mistrust and resilience).\n2. The intervention will also include patient navigation and motivational interviewing\n\n2\\) Investigators also want to see if the mHealth system is feasible, easily accepted and if it will impact patient health in a positive way.",[29],[303,304,305,306,307],"mHealth","mobile applications","culturally-competent","HIV stigma","Resilience","2026-01-20",{"date":282,"type":37},{"date":311,"type":37},"2022-05-02",{"date":313,"type":23},"2026-07-31",{"name":315,"class":44},"University of Miami",{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":12,"sex":52,"minAge":82,"maxAge":4,"enrollmentInfo":323,"targetDuration":4,"studyType":24,"phases":325,"briefSummary":326,"conditions":327,"keywords":328,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":211},"100537192","adelante-a-randomized-controlled-trial-to-improve-engagement-in-care-for-latinos-with-hiv-100537192","NCT06274632","ADELANTE: A Randomized Controlled Trial to Improve Engagement in Care for Latinos With HIV","ADELANTE: A Randomized Controlled Trial of an Intervention to Improve Engagement in Care for Latinos With HIV","Inclusion Criteria:\n\n* Self-identify as Latino\u002FLatina\u002FLatinx\u002FHispanic; adults 18 years and over; with HIV infection confirmed by standard laboratory results available in the medical record; 3 or more months from initial entry into care with a medical provider who can prescribe HIV antiretroviral treatment; receiving HIV primary care at Jackson Memorial Hospital or Thomas Street at Quentin Mease Health Center\u002FHarris Health System; and medical record evidence with last viral load (VL) indicating viral non-suppression (HIV RNA ≥200 cpm) within 12 months prior to assessment of eligibility, as it is typical for providers to obtain laboratories prior to a clinic visit in preparation for counseling.\n\nExclusion Criteria:\n\n* Lacks capacity to consent (measured by a validated screener), plans to move out of the county in the next 6 months, or currently participating in an HIV intervention study with ongoing follow-up.",{"count":324,"type":23},250,[26],"The goal of this study is to test the effectiveness of ADELANTE on viral suppression among Latinos with HIV and viral non-suppression. Participants will receive ADELANTE (5-session, community health worker-delivered, problem-solving intervention) or enhanced care condition (ECC, 5 reminder phone calls). We will evaluate the overall effectiveness of ADELANTE compared with ECC on rates of viral suppression and emergency room visits and hospitalizations. Our hypothesis is that ADELANTE participants will achieve higher rates of viral suppression and will have lower rates of emergency room visits and hospitalizations compared with ECC at 12 months post-randomization.",[29],[329,330,29,331,332],"Latino","Hispanic","health outcomes","community health worker","2026-01-07",{"date":335,"type":37},"2026-01-09",{"date":337,"type":37},"2024-05-22",{"date":339,"type":23},"2027-02-28",{"name":191,"class":44},{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":175,"minAge":82,"maxAge":4,"enrollmentInfo":347,"targetDuration":4,"studyType":24,"phases":349,"briefSummary":350,"conditions":351,"keywords":352,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":45},"100478437","women-shine-addressing-syndemics-and-hiv-among-women-through-tech-based-peer-engagement-100478437","NCT05509959","Women SHINE: Addressing Syndemics and HIV Among Women Through Tech-Based Peer Engagement","Inclusion Criteria:\n\n* Cisgender female\n* Diagnosis of HIV by a physician, healthcare provider, or community health worker\n* Aged 18 years or older\n* Speaking and reading English or Spanish\n* Adulthood experiences of interpersonal violence\n* Currently prescribed ART\n* Self-report of \\\u003C90% past-month ART adherence\n* Not currently participating in another adherence intervention\n* Access to an internet browser\n\nExclusion Criteria:\n\n* Unwillingness to participate in the intervention\n* Transgender female\n* No diagnosis of HIV by a physician, healthcare provider, or community health worker\n* Aged less than 18 years\n* Not speaking and reading English or Spanish\n* Not currently prescribed ART\n* Self-report of \\>= 90% past-month ART adherence\n* Currently participating in another adherence intervention\n* No access to an internet browser\n* Cognitive impairment limiting the ability to provide informed consent\n* Experiencing only childhood experiences of interpersonal violence\n* Inability to safely participate in the study based on secondary screener",{"count":348,"type":23},360,[26],"A two-arm RCT will be conducted to test the efficacy of Women SHINE, a web-based trauma-informed peer navigation-social support intervention (Figure 2). A total of 360 women living with HIV\u002FAIDS (WLHA) with a history of adulthood interpersonal violence who have been prescribed ART but are non-adherent (\\\u003C 90% ART adherent in the last 4 weeks) will be enrolled in the study. WLHA will be randomized (1:1) into one of the following conditions: 1) Women SHINE intervention arm (n=180) or 2) Control arm (n=180). The Women SHINE intervention arm will receive a four-month intervention including peer navigator (PN) one-on-one sessions, phone\u002Ftext-based check-ins, 7 psychoeducation weekly support group sessions (120 mins.) co-facilitated by a licensed therapist and PN, and access to a static website with resources for HIV care, interpersonal violence, trauma, mental health, and substance use. The control arm will receive one group session (60 mins.) on self-care and well-being and access to the aforementioned website with resources. Women will complete a video-based survey and mailed hair sample self-collection at baseline, 4-, 8-, and 12-months post-randomization, to evaluate improvements in ART adherence (Aim 1), emotion regulation, and PTSD symptoms (Aim 2). Investigators will examine the mediating effect of individual (retention in HIV care, coping self-efficacy, social support, ancillary support services use) and socio-structural (stigma, medical mistrust) mechanisms of change on the efficacy of Women SHINE (Aim 3).",[29],[353,354],"HIV Care Continuum","Psychoeducation","2025-10-15",{"date":357,"type":37},"2025-10-20",{"date":359,"type":37},"2022-11-15",{"date":361,"type":23},"2026-09-01",{"name":363,"class":44},"University of California, San Diego",{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":17,"sex":175,"minAge":370,"maxAge":82,"enrollmentInfo":371,"targetDuration":4,"studyType":24,"phases":373,"briefSummary":374,"conditions":375,"keywords":376,"overallStatus":378,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":45},"100440344","the-dreamer-girls-project-adaptation-of-sistasihle-for-hivaids-and-substance-abuse-prevention-among-black-adolescent-girls-100440344","NCT05014074","The Dreamer Girls Project: Adaptation of SISTA\u002FSIHLE for HIV\u002FAIDS and Substance Abuse Prevention Among Black Adolescent Girls","Inclusion Criteria\n\n1. Identify as a Black\u002FAfrican American female\n2. Be between the ages of 13-18 years old;\n3. Consent to being a part of the study (Parent consent and youth assent if under 18 years old);\n4. Live in Paterson, New Jersey at the time of the study;\n5. English as their first language.\n\nExclusion Criteria\n\n1. not identify as Black\u002FAfrican American only\n2. be under the age of 13 or over the age of 18\n3. no parental consent provided\n4. no youth assent provided\n5. does not live in Paterson\n6. does not read, speak or write in English\n7. is currently pregnant","13 Years",{"count":372,"type":23},10,[26],"The study will use focus group methodology in the formative evaluation phase. Focus group methodology provides a rich source of data and understanding of phenomena by allowing the researcher to examine the interaction among participants",[29],[377],"Black adolescent girls","NOT_YET_RECRUITING","2025-10-06",{"date":381,"type":37},"2025-10-09",{"date":383,"type":23},"2026-01",{"date":385,"type":23},"2026-05",{"name":387,"class":44},"Yale University",{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":4,"eligibilityCriteria":394,"healthyVolunteers":12,"sex":52,"minAge":82,"maxAge":395,"enrollmentInfo":396,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":398,"conditions":399,"keywords":400,"overallStatus":378,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":45},"100608569","comparison-of-the-body-roundness-index-and-a-body-shape-index-with-body-fat-and-visceral-fat-in-people-living-with-hiv-100608569","NCT07203261","Comparison of the Body Roundness Index and A Body Shape Index With Body Fat and Visceral Fat in People Living With HIV.","Comparison of the Body Roundness Index and A Body Shape Index With Body Fat and Visceral Fat in People Living With HIV: A Pilot Study","Inclusion Criteria:\n\n* Diagnosed with HIV\n* Receiving the same anti-retroviral therapy for \\>= 6 months.\n\nExclusion Criteria:\n\n* Pregnancy\n* Having an implantable cardioverters or pacemakers","75 Years",{"count":397,"type":23},65,"The study compares the Body Roundness Index (BRI) and the A Body Shape Index (ABSI) with with body fat and visceral fat in people living with HIV.",[29],[401,402],"human immunodeficiency virus","Body composition","2025-09-24",{"date":405,"type":37},"2025-10-02",{"date":407,"type":23},"2025-09-25",{"date":409,"type":23},"2026-12-31",{"name":411,"class":44},"Queens College, The City University of New York",{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":418,"eligibilityCriteria":419,"healthyVolunteers":12,"sex":52,"minAge":82,"maxAge":4,"enrollmentInfo":420,"targetDuration":4,"studyType":24,"phases":422,"briefSummary":423,"conditions":424,"keywords":426,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":45},"100589081","incentives-and-reminders-to-improve-long-term-medication-adherence-inmind-100589081","NCT06949774","INcentives and ReMINDers to Improve Long-term Medication Adherence (INMIND)","INcentives and ReMINDers to Improve Long-term Medication Adherence","INMIND","Inclusion Criteria:\n\n* Male and female clients age 18 and older.\n* Started ART at Mildmay or another clinic within the preceding 2 months\n* Able to speak and understand either English or Luganda.\n* Have their own cell phone or have consistent access to someone else's phone.\n* Willing to receive daily text messages for the 6 months of intervention duration.\n* Willing and able to use the WisePill device distributed for adherence verification for the duration of the study.\n\nExclusion Criteria:\n\n* Not mentally fit to consent.\n* Language other than Luganda or English.\n* Not willing to consistently use the Wisepill device for adherence measurement.",{"count":421,"type":23},550,[26],"Low medication adherence when initiating antiretroviral treatment (ART) is a key barrier to HIV virologic suppression, resulting in avoidable cases of drug resistance, death, and viral transmission. Routinized pill-taking can lead to successful long-term ART adherence, and short-term behavioral economics-based supports are a novel way to overcome the limited success of existing routinization interventions. This study proposes to test this combined approach for promoting long-term ART adherence using a Stage III Sequential, Multiple Assignment, Randomized Trial (SMART) design in one of the largest HIV clinics in Uganda to identify the most cost-effective adaptive intervention that if found effective is generalizable to other settings and other chronic diseases.",[29,226,425],"Habits",[427,428],"Behavioral: Daily Text Messages","Behavioral: Incentivization based on","2025-09-04",{"date":431,"type":37},"2025-09-11",{"date":433,"type":37},"2025-04-02",{"date":435,"type":23},"2029-10-31",{"name":437,"class":44},"RAND",{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":444,"eligibilityCriteria":445,"healthyVolunteers":17,"sex":52,"minAge":82,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":24,"phases":448,"briefSummary":449,"conditions":450,"keywords":451,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":211},"100518876","the-outreach-and-prevention-at-alcohol-venues-in-east-africa-study-opal-east-africa--aim-2-opal-aim-2-100518876","NCT06036238","The Outreach and Prevention at ALcohol Venues in East Africa Study (OPAL-East Africa- Aim 2) (OPAL-Aim 2)","Innovative Strategies to Promote Biomedical HIV Prevention Uptake and Retention Among High-risk Adults at Drinking Venues in Kenya and Uganda","OPAL-Aim 2","Inclusion Criteria:\n\n* Adult (≥18 years)\n* HIV-uninfected (by rapid HIV antibody test)\n* AUDIT-C score of \\>=4 for men and \\>=3 for women\n* Attending a clinical visit for initiation of biomedical HIV prevention with oral or injectable PrEP or oral PEP (or the dapivirine vaginal ring, if available)\n* Has access to a mobile phone\n\nExclusion Criteria:\n\n* Ineligible for PrEP based on MoH guidelines\n* Intention to move away from the study community in the coming year\n* Gross inebriation or inability to provide informed consent",{"count":447,"type":23},400,[26],"This study will evaluate the effect of a brief alcohol counseling intervention on PrEP and PEP adherence among adults with heavy alcohol use at high risk for HIV, while gaining insights into the facilitators, barriers, and cost-effectiveness of this approach.",[29],[452,453,254,454,455],"Alcohol use","Biomedical HIV prevention","Kenya","Counseling intervention","2025-09-02",{"date":458,"type":37},"2025-09-10",{"date":460,"type":37},"2024-05-17",{"date":462,"type":23},"2027-06",{"name":140,"class":44},{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":470,"eligibilityCriteria":471,"healthyVolunteers":17,"sex":175,"minAge":4,"maxAge":4,"enrollmentInfo":472,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":474,"conditions":475,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":486,"locationsCount":45},"100393642","measuring-adverse-pregnancy-and-newborn-congenital-outcomes-100393642","NCT04405700","Measuring Adverse Pregnancy and Newborn Congenital Outcomes","Measuring Adverse Pregnancy and Newborn Congenital Outcomes: An IeDEA Collaboration Study","MANGO","C1. Prospective recruitment of HIV+ and HIV- pregnant women enrolling in ANC at the site:\n\nInclusion criteria for women\n\n1. Pregnant and enrolled in ANC at the study site;\n2. Understands English or Swahili.\n\nExclusion criteria for women a. Any physical or mental disability that prevents the woman from providing informed consent\n\nInclusion criteria for infants\n\na. All infants at any gestational age who are born to enrolled women will be included Exclusion criteria for infants (none)\n\nC2. Data collection for all deliveries at the site:\n\nInclusion criteria for women a. Woman delivers at the site and the delivery is registered at the site\n\nExclusion criteria for women (none)\n\nInclusion criteria for live\u002Fstillborn infants\n\na. Infant is delivered at the site and results in the infant\u002Fstillbirth being registered at the site\n\nExclusion criteria for infants (none)\n\nC3. Photos\u002Fvideos of infants with CAs:\n\nInclusion criteria for infants\n\n1. The infant is live or stillborn at ≥ 24 weeks estimated gestational age\n2. The infant has a suspected CA on surface exam\n\nExclusion criteria for infants (none)",{"count":473,"type":23},2800,"The purpose of this study is to develop a pharmacovigilance (PV) surveillance program to monitor adverse pregnancy and infant outcomes, including the presence of congenital abnormalities, among HIV-positive and HIV-negative women and their infants at clinical sites affiliated with the International Epidemiology Databases to Evaluate consortium (IeDEA).",[29,476,477,478],"Pregnancy Related","Congenital Disorders","Newborn Morbidity","2025-08-15",{"date":481,"type":37},"2025-08-19",{"date":483,"type":37},"2020-09-29",{"date":485,"type":23},"2026-05-31",{"name":487,"class":44},"Indiana University",{"id":489,"slug":490,"hasResults":12,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":4,"eligibilityCriteria":494,"healthyVolunteers":17,"sex":52,"minAge":82,"maxAge":4,"enrollmentInfo":495,"targetDuration":4,"studyType":24,"phases":497,"briefSummary":498,"conditions":499,"keywords":503,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":516,"locationsCount":45},"100296200","project-i-test-implementing-hiv-testing-in-opioid-treatment-programs-100296200","NCT03135886","Project I Test: Implementing HIV Testing in Opioid Treatment Programs","A Cluster RCT to Increase HIV Testing in Substance Use Treatment Programs","Inclusion Criteria:\n\n* Eligible sites must:\n\n  1. See at least 150 unduplicated patients\u002Fyear\u002Fsite\n  2. Be capable and willing to prospectively collect data on the number of patients who a) are offered any HIV and\u002For HCV tests; b) completed these tests; c) are referred to care\u002Fevaluation (and type of referral) if positive; and d) are linked to care\u002Fevaluation within 30 days of diagnosis\n  3. Be capable and willing to provide patient demographics, testing data within demographic categories of gender and race\u002Fethnicity (in aggregate) and data on HIV\u002FHCV test reimbursement processes and outcomes\n  4. Have key staff willing to consent to participate in study surveys, qualitative interviews and intervention coaching throughout the study\n\nExclusion Criteria:\n\n* Sites will be excluded if:\n\n  1. Over 50% of patients served in the prior 6 months were HIV or HCV tested\n  2. They are terminated via PI decision\u002Fdiscretion",{"count":496,"type":23},418,[26],"This study will test two active evidence-based \"practice coaching\" (PC) interventions to improve opioid treatment programs' (OTPs') provision and sustained implementation of on-site 1) HIV testing and linkage to care and 2) HIV\u002FHepatitis C virus (HCV) testing and linkage to care among patients seeking\u002Freceiving substance use disorder treatment.\n\nAims are:\n\nAim 1: To evaluate the effectiveness of the PC interventions on improving patient uptake of HIV testing in OTPs including the incremental impact of the HIV\u002FHCV intervention on HIV testing.\n\nAim 2: To examine, using mixed-methods, the impact of the PC interventions on the initiation and sustained provision of HIV testing and timely linkage to care.\n\nAim 3: To evaluate the health outcomes, health care utilization, and cost-effectiveness of the PC interventions compared incrementally to one another and to the control condition.\n\nPrimary Hypothesis:\n\n1. The two PC interventions will result in significantly higher proportions of patients tested for HIV than the information control condition during the \"initial impact\" period (7-12 months post-randomization or T3), controlling for the proportion of patients tested during the baseline period, T1 (Primary) and during the \"sustained impact\" period, 13-18 months post-randomization or T4 (Secondary).\n2. The HIV\u002FHCV PC intervention will result in significantly higher proportions of patients tested for HIV than the HIV PC intervention during the initial impact period (7-12 months post-randomization or T3), controlling for the proportion of patients tested during the baseline period, T1 (Secondary) and during the \"sustained impact\" period, 13-18 months post-randomization or T4 (Secondary).",[29,500,501,502],"Hepatitis C","Substance Use Disorders","Opioid-use Disorder",[278,504,505,506,507,508,509],"HIV Testing","Hepatitis C Virus Testing","Opioid Use Disorder Treatment","Substance Use Disorders Treatment","Hepatitis C Virus","Practice Coaching","2025-07-25",{"date":512,"type":37},"2025-07-29",{"date":514,"type":37},"2017-06-12",{"date":313,"type":23},{"name":43,"class":44},{"id":518,"slug":519,"hasResults":12,"nctId":520,"briefTitle":521,"officialTitle":521,"acronym":522,"eligibilityCriteria":523,"healthyVolunteers":12,"sex":52,"minAge":82,"maxAge":4,"enrollmentInfo":524,"targetDuration":4,"studyType":24,"phases":526,"briefSummary":527,"conditions":528,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":537},"100552370","community-health-workers-and-mhealth-to-improve-viral-suppression-plus-champs-100552370","NCT06472206","Community Health Workers And MHealth to ImProve Viral Suppression Plus (CHAMPS+)","CHAMPS+","Inclusion Criteria:\n\n* Be able to speak, read, and write in English;\n* Be above 18 years of age;\n* Be willing to participate in any assigned arm of the intervention;\n* Have an HIV-1 RNA level \\>200 copies\u002FmL;\n* Own a smartphone;\n* Be able and willing to provide informed consent for study participation and consent for access to medical records.\n* Live, work and or receive care in AL, LA, or MS\n\nExclusion Criteria:\n\n* Reside in a nursing home, prison, and\u002For receiving in-patient psychiatric care at time of enrollment;\n* Terminal illness with life expectancy \\\u003C6 months; and\n* Planning to move out of the area in the next 12 months.",{"count":525,"type":23},420,[26],"Although global efforts have been made to end the HIV epidemic, there are still some gaps in HIV testing, antiretroviral therapy (ART) adherence, and viral suppression (VS) among people with HIV (PWH). These gaps are particularly prominent in the Deep South of the United States (US), where PWH face challenges in accessing healthcare services. In response, a team of experienced researchers has developed and tested the Community Health Workers And MHealth to ImProve Viral Suppression (CHAMPS) intervention. This intervention uses mobile health (mHealth) technology and a team of community health workers (CHW) to design an intervention to improve ART adherence and VS. The CHAMPS+ intervention adds a CHW delivered supportive risk reduction counseling during periods of non-suppression to prevent HIV transmission. The study will engage the participants by developing culturally relevant materials and retention strategies, evaluating the clinical effectiveness and sustainability of the intervention in Deep South settings, and assessing regionalized implementation factors. Ultimately, the study will test the effectiveness of CHAMPS+ on ART adherence and viral load suppression for PWH in Alabama, Louisiana, and Mississippi.",[29],"2025-07-02",{"date":531,"type":37},"2025-07-04",{"date":533,"type":37},"2024-09-23",{"date":535,"type":23},"2027-12-22",{"name":43,"class":44},5,{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":544,"eligibilityCriteria":545,"healthyVolunteers":17,"sex":18,"minAge":82,"maxAge":4,"enrollmentInfo":546,"targetDuration":4,"studyType":24,"phases":548,"briefSummary":550,"conditions":551,"keywords":552,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":563,"locationsCount":566},"100501800","phase-3-efficacy-acceptability-and-safety-of-event-driven-hiv-prep-using-tafftc-in-msm-in-thailand-and-france-100501800","NCT05813964","Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF\u002FFTC in MSM in Thailand and France.","A Randomized Controlled Trial to Evaluate the Efficacy, Acceptability and Safety of Event-driven Pre-exposure Prophylaxis for HIV Using TAF\u002FFTC in Men Who Have Sex With Men in Thailand and France","SimpPrEP","Inclusion Criteria:\n\n* Male at birth age ≥ 18 years old\n* Reporting having sex with men\n* Negative 4th generation HIV-1 and HIV-2 test\n* Reporting condomless anal sex with men not more often than two days during the previous month and able to plan their sexual activity\n* Risk of HIV acquisition based on self-report of at least one of the following behaviors during the 6 months before enrollment: condomless anal sex with at least 2 different sexual partners, sexually transmitted infection (rectal chlamydia and\u002For rectal gonorrhea and\u002For syphilis), provided or received money goods or favor in exchange of sex, binge drinking or use of non-injectable recreational drugs.\n* Consenting to participate and agreeing to follow the clinical trial procedures, including adherence to study visits every 3 months\n* In France: Person affiliated with or benefiting from a social security system (article L1121-11of the public health code in France)\n\nNon-inclusion criteria:\n\n* Symptoms and\u002For clinical signs consistent with an acute HIV infection\n* Women and trans women\n* Taking feminizing hormone therapy\n* Positive HIV test result at screening or enrollment even if HIV infection is not confirmed\n* Positive hepatitis B surface antigen test\n* ALT or AST \\> 4 ULN\n* Estimated glomerular filtration rate \\\u003C 60mL\u002Fmin\u002F1.73m²\n* History of chronic kidney disease, osteoporosis, osteopenia or pathological fracture not related to trauma\n* Hypersensitivity to the study products F\u002FTDF or F\u002FTAF\n* Past or concurrent participation in a HIV vaccine trial or concurrent participation in another clinical trial without the agreement of the principal investigators of the two trials\n* Use of intravenous drugs within the last 12 months\n* Person under legal guardianship\n* Not likely to comply with the clinical trial procedures or with any condition incompatible with study participation, upon the investigator's judgement.\n* Ongoing Post-Exposure Prophylaxis (PEP) for HIV",{"count":547,"type":23},524,[549],"PHASE3","The purpose of this study is to evaluate the efficacy, acceptability, and safety of a simplified event-driven pre-exposure prophylaxis of HIV based on oral TAF\u002FFTC in HIV-uninfected cisgender men who have sex with men (MSM).\n\nPrimary objective: To assess the efficacy of emtricitabine 200 mg + tenofovir alafenamide 25 mg (F\u002FTAF), taken 2 to 24 hours before sexual intercourse followed by a second dose 24 hours after the first intake, in reducing the risk of HIV acquisition in MSM relative to the background HIV incidence rate.",[29],[553,554,555,556],"PrEP exposure prophylaxis (PrEP)","On-demand","Event-driven","TAF","2025-06-17",{"date":559,"type":37},"2025-06-20",{"date":561,"type":37},"2024-06-05",{"date":97,"type":23},{"name":564,"class":565},"ANRS, Emerging Infectious Diseases","OTHER_GOV",4,{"id":568,"slug":569,"hasResults":12,"nctId":570,"briefTitle":571,"officialTitle":572,"acronym":4,"eligibilityCriteria":573,"healthyVolunteers":17,"sex":52,"minAge":245,"maxAge":574,"enrollmentInfo":575,"targetDuration":4,"studyType":24,"phases":577,"briefSummary":578,"conditions":579,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":168},"100497858","a-mobile-gaming-app-to-improve-adherence-to-prep-100497858","NCT05762705","A Mobile Gaming App to Improve Adherence to PrEP","A Multisite Randomized Trial of Viral Combat: A Mobile Gaming App to Improve Adherence to PrEP","Inclusion Criteria:\n\n* 15-34 years old\n* English speaking\n* Initiated PrEP in the last 30 days or re-initiated PrEP after not taking PrEP for at least 1 month\n* HIV negative as per clinician and clinical record\n* Able to give consent\u002Fassent and not impaired by cognitive or medical limitations as per clinical assessment.\n\nExclusion Criteria:\n\n* None","34 Years",{"count":576,"type":23},200,[26],"In this study, the investigators will test the mobile game, Viral Combat, for efficacy and acceptability among diverse participants, ages 15-34 years, receiving PrEP care in clinical settings in New England and Mississippi. Formative evaluation interviews will be conducted with stakeholders (healthcare workers, clinic administrators, and patients taking PrEP) to inform intervention delivery. Data from the formative interviews will also be used to make necessary adaptations to the game and assess acceptability for diverse populations and clinics. Viral Combat will then be further tested with 200 participants ages 15-34 years, receiving PrEP care at clinical sites in the South (n=100 Jackson, MS) and New England (n=100, Providence, RI; Boston, MA) in a multisite Hybrid Type 1 effectiveness-implementation randomized controlled trial (RCT). This trial will test the efficacy of the intervention compared to a control condition (a non-PrEP related game) on biological and behavioral measures. At the end of the trial, a summative evaluation of the implementation context using the i-PARIHS framework will occur. These interviews with study participants and clinic staff will inform future implementation and dissemination of Viral Combat.",[226,29],"2025-05-08",{"date":582,"type":37},"2025-05-14",{"date":584,"type":37},"2024-06-21",{"date":586,"type":23},"2027-03-03",{"name":588,"class":44},"Rhode Island Hospital",{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":594,"acronym":595,"eligibilityCriteria":596,"healthyVolunteers":17,"sex":52,"minAge":597,"maxAge":598,"enrollmentInfo":599,"targetDuration":4,"studyType":24,"phases":601,"briefSummary":602,"conditions":603,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":606,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":611,"locationsCount":45},"100556708","tools-to-identify-people-at-risk-or-already-infected-with-hiv-and-hcv-100556708","NCT06528626","Tools to Identify People At Risk or Already Infected with HIV and HCV","Wedge-Shaped Clusterded Randomizad Trial to Evaluate Two Tools to Identify People At Risk or Already Infected with HIV and HCV","ATENEA","Inclusion Criteria:\n\n\\- 14-65 years in the health area or who are captured for inclusion by health personnel. They give their consent to participate.\n\nExclusion Criteria:\n\n* Having already been included in the study, not signing the consent.","14 Years","65 Years",{"count":600,"type":23},240000,[26],"Wedge-Shaped Clusterded Randomizad Trial to Evaluate Two Tools to identify People at Risk or already Infected with HIV and HCV",[29,604,89],"STD","2025-02-27",{"date":187,"type":37},{"date":608,"type":37},"2023-07-01",{"date":610,"type":23},"2025-12-01",{"name":612,"class":44},"Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal",{"id":614,"slug":615,"hasResults":12,"nctId":616,"briefTitle":617,"officialTitle":618,"acronym":619,"eligibilityCriteria":620,"healthyVolunteers":17,"sex":52,"minAge":621,"maxAge":4,"enrollmentInfo":622,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":624,"conditions":625,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":639,"locationsCount":45},"100348214","observational-pharmaco-epidemiology-research--analysis-100348214","NCT03813862","Observational Pharmaco-Epidemiology Research & Analysis","OPERA Longitudinal Observational Database in the Study of Chronic Diseases, Treatments and Outcomes","OPERA","Inclusion Criteria:\n\n* Patients who are treated in the practices who enroll and participate in the study\n* Patients whose treatment is documented in the practice's electronic health record system\n\nExclusion Criteria:\n\n* Patients who opt out of OPERA","0 Years",{"count":623,"type":23},2000000,"Greater advances are needed in two separate but related areas in healthcare: 1) the Clinical Decision Support Systems that complement the EHR use in support of routine patient care, population management and disease management; and 2) the use of the point-of-care observational data from the provider-patient encounter that support realworld medical research and healthcare quality measure assessment. Real-world evaluations of treatments of chronic diseases in the context of comorbid conditions and special populations (minorities, women, mentally ill, and those with addiction) are limited. The purpose of the OPERA database is to help address this unmet need in clinical research.",[626,29,627,628,629,630,631],"Chronic Disease","Liver Diseases","Inflammatory Bowel Diseases","Cardiovascular Diseases","Rheumatic Diseases","Neurodegenerative Diseases","2025-02-24",{"date":634,"type":37},"2025-02-25",{"date":636,"type":37},"2013-12-01",{"date":638,"type":23},"2035-11",{"name":640,"class":641},"Epividian","INDUSTRY"]