[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hiv-antiretroviral-therapy-art-adherence\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hiv-antiretroviral-therapy-art-adherence":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,47,84,112,132,160,186,211,234,269,305,330],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100585305","pilot-of-an-intervention-to-reduce-alcohol-use-and-improve-art-adherence-among-men-living-with-hiv-with-pregnant-partners-in-uganda-100585305",false,"NCT06900634","Pilot of an Intervention to Reduce Alcohol Use and Improve ART Adherence Among Men Living With HIV With Pregnant Partners in Uganda.","Utilizing Implementation Research Methodologies to Adapt an Intervention to Reduce Alcohol Use and Improve HIV Care Outcomes Among Men Living With HIV Who Have Serodiscordant Pregnant Partners","Kisoboka Amaka","Inclusion Criteria:\n\nFOR MEN\n\n1. living with HIV;\n2. AUDIT-C positive (≥4) indicating potential hazardous drinking;\n3. \\>6 months since initial antiretroviral treatment (ART) initiation;\n4. an indicator of potential suboptimal treatment as prevention (TasP) either: (i) last HIV viral load test (within 6 months) was detectable (\\>20) or (ii) last viral load test between 6 and 13 months ago was detectable (\\>20) and reports missing ≥2 ART doses in the past 2 weeks or (iii) a lack of viral load test results for the prior 13 months in clinic records and reports missing ≥2 ART doses in the past 2 weeks\n5. not planning to move from the area within the next 6 months;\n6. have their own mobile phone and can be reached via phone.\n\nFOR WOMEN\n\n1. 18+ years of age (or emancipated minor)\n2. Pregnant\n3. HIV negative\n\nFOR COUPLES (IF INDIVIDUAL ELIGIBILITY CRITERIA ABOVE ARE MET)\n\n1. married\u002Fliving together \\>6 months;\n2. planning to stay together \\>6 months\n3. lived in the area for \\>3 months and\n4. not planning to move within \\\u003C6 months.\n5. similar responses on Couple Verification Screening (CVS) form, an instrument to determine if couples are legitimate (e.g., asking each person what they ate the last time they shared a meal with their partner).\n\nExclusion Criteria:\n\nFOR MEN\n\n1. visibly intoxicated at enrollment (eligible to enroll when not intoxicated);\n2. does not speak Luganda or English;\n3. currently receiving a majority of work payments via mobile money\u002Fdigital payments;\n4. participated in the Kisoboka pilot RCT;\n5. unable to read basic Luganda or English\n\nFOR WOMEN For safety purposes, we will not enroll women who do not feel they can safely participate in the study.","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","Hazardous alcohol use, which is common among men in Uganda, is a primary driver of both HIV risk and intimate partner violence (IPV) in this setting. Among men living with HIV, alcohol use is associated with non-adherence to antiretroviral therapy (ART) and a detectable viral load, increasing the risk of onward HIV transmission to partners. This risk is further heightened when the partner is pregnant, due to the potential for vertical transmission. Therefore, addressing factors that interfere with optimal HIV care outcomes among men living with HIV is critical to HIV prevention in pregnant women.\n\nThe goal of this randomized controlled trial (RCT) is to pilot test an intervention that combines alcohol reduction and economic strengthening to improve ART adherence. The study will assess implementation outcomes and preliminary efficacy among men living with HIV who engage in hazardous alcohol use and their pregnant partners (n=30 couples). The main questions it aims to answer are:\n\n1. What are the implementation outcomes (acceptability, appropriateness, feasibility, fidelity, and safety) at the individual, implementer, and organizational levels, and what bridging factors may impede success (e.g., community-academic partnership)?\n2. Does the intervention reduce hazardous alcohol use and improve ART adherence among men living with HIV?\n\nResearchers will compare the intervention group (n=15 couples) to the standard of care group (n=15 couples) to determine if the intervention leads to behavior change in alcohol use and ART adherence among men living with HIV.\n\nParticipants will:\n\n1. Men in the intervention group will receive the Amaka intervention, designed to reduce alcohol use and improve ART adherence.\n2. Complete assessments on hazardous alcohol use, ART adherence, and implementation outcomes at multiple time points (baseline, 3 and 6 months).\n3. Engage with implementers to provide post-implementation feedback on feasibility and acceptability.",[27,28],"HIV Antiretroviral Therapy (ART) Adherence","Alcohol Consumption",[30,31,32,33],"hiv","motivational interviewing","behavioral economics","alcohol use disorder","NOT_YET_RECRUITING","2026-06-17",{"date":37,"type":38},"2026-06-22","ACTUAL",{"date":40,"type":21},"2027-02-01",{"date":42,"type":21},"2028-02-01",{"name":44,"class":45},"San Diego State University","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":66,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":46},"100637254","improving-the-hiv-care-continuum-with-mhealth-technology-100637254","NCT07631104","Improving the HIV Care Continuum With mHealth Technology","Improving the HIV Care Continuum for Youth in the Deep South Through Mobile Health Technology","Inclusion Criteria:\n\n* Between the ages of 16 and 25 years\n* Diagnosed with HIV\n* Resident of South Carolina\n* Proficient in English\n\nExclusion Criteria:\n\n* Under 16 years of age or over 25 years of age\n* Is not a person living with HIV\n* Is not a resident of South Carolina\n* Is not proficient in English","16 Years","25 Years",{"count":57,"type":21},40,[24],"Youth living with HIV (YLHIV) face barriers to engagement and retention in HIV care, show poor medication adherence, and often fail to achieve and maintain viral suppression. YLHIV in the southern United States have particularly poor care engagement outcomes. South Carolina is one of nine states identified as \"key drivers\" of the US HIV epidemic, and HIV rates for youth in South Carolina have risen in recent years. Tailored interventions are urgently needed to improve outcomes for this population. One promising approach is to reach YLHIV via mobile Health (mHealth) technology, yet few efforts have sought to tailor mHealth interventions to the needs of YLHIV in the southern US. Thus, the scientific objective of this study is to pilot test a new mHealth intervention, called MindBodyU, designed to increase engagement\u002Fretention in care and ART adherence among YLHIV in South Carolina. In this study, investigators will evaluate the feasibility, acceptability, and initial efficacy of the mHealth intervention with a six-month pilot trial with 40 YLHIV in South Carolina.",[61,27,62,63,64,65],"HIV - Human Immunodeficiency Virus","mHealth Application","mHealth Intervention","Continuum of Care","Youth With HIV",[67,68,69,70,71,72,73,74],"Youth living with HIV (YLHIV)","immunology","HIV","adolescents","emerging\u002Fyoung adults","eHealth\u002FmHealth\u002Fdigital health","adherence\u002Fself-management","psychosocial intervention","2026-06-02",{"date":77,"type":38},"2026-06-05",{"date":79,"type":21},"2026-06-01",{"date":81,"type":21},"2028-06-01",{"name":83,"class":45},"University of South Carolina",{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":92,"minAge":18,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":96,"conditions":97,"keywords":102,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":46},"100575404","reducing-hazardous-alcohol-use-and-optimizing-treatment-as-prevention-among-men-living-with-hiv-in-risk-environments-100575404","NCT06771843","Reducing Hazardous Alcohol Use and Optimizing Treatment as Prevention Among Men Living With HIV in Risk Environments","Kisoboka: Reducing Hazardous Alcohol Use and Optimizing Treatment as Prevention Among Men Living With HIV in Risk Environments","Kisoboka","Inclusion Criteria:\n\n1. living with HIV;\n2. residing in a fishing community (on most days\u002Fnights);\n3. AUDIT-C positive (≥4) indicating potential hazardous drinking;\n4. \\>6 months since initial antiretroviral treatment (ART) initiation;\n5. not planning to move from the area within the next 6 months;\n6. have their own mobile phone and can be reached via phone.\n7. an indicator of potential suboptimal treatment as prevention (TasP) either:\n\n(i) last HIV viral load test (within 6 months) was detectable (\\>20) or (ii) last viral load test between 6 and 13 months ago was detectable (\\>20) and reports missing ≥2 ART doses in the past 2 weeks or (iii) a lack of viral load test results for the prior 13 months in clinic records and reports missing ≥2 ART doses in the past 2 weeks;\n\nExclusion Criteria:\n\n1. visibly intoxicated at enrollment (eligible to enroll when not intoxicated);\n2. does not speak Luganda or English;\n3. currently receiving a majority of work payments via mobile money\u002Fdigital payments;\n4. participated in the Kisoboka pilot RCT;\n5. unable to read basic Luganda or English","MALE",{"count":94,"type":21},716,[24],"The investigators developed the Kisoboka (\"It is possible\") Intervention to address limitations of existing evidence-based interventions to optimize treatment as prevention among men living with HIV who drink alcohol at hazardous levels in \"risk environments\" such as fishing communities through reductions in hazardous alcohol use, improved adherence to HIV medications and achieving undetectable HIV viral loads.\n\nSocial and structural determinants unique to fishing communities interact to create a risk environment where hazardous drinking impedes adherence to HIV medications among men living with HIV, including prevalent social norms of drinking, drinking as a way of experiencing \"reward\" and connecting with others (e.g. in the context of transactional sex), stressful work conditions, a \"live for today\" outlook, and a cash-based economy with no traditional savings infrastructure leading to ease of daily expenditure on drinking and sex work. These social and environmental conditions result in high levels of alcohol misuse and HIV risk, poor HIV outcomes, and exacerbation of HIV-associated wellness comorbidities such as poor mental and subjective physical health and food insecurity.\n\nThe goal of this study is to learn if the intervention called Kisoboka works to help men in fishing communities reduce hazardous alcohol use, be better able to take the participants HIV medication as prescribed, and have undetectable HIV viral loads. The investigators will compare the Kisoboka intervention to a brief alcohol screening, adherence counseling, and referrals, and to components of the Kisoboka intervention.\n\nParticipants will attend intervention counseling sessions according to the study arm to which the participants are randomly assigned. The number of sessions ranges from 1 to 6 over 1 to 16 weeks and are individual only or both individual and group sessions.",[27,98,99,100,101],"Alcohol Abuse","HIV Infection","Alcohol Use Disorder","HIV Infections",[32,31],"RECRUITING","2026-05-11",{"date":106,"type":38},"2026-05-12",{"date":108,"type":38},"2025-06-16",{"date":110,"type":21},"2029-02",{"name":44,"class":45},{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":119,"minAge":18,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":46},"100573343","hybrid-type-1-effectiveness-implementation-trial-of-motivation-matters-100573343","NCT06745050","Hybrid Type-1 Effectiveness-Implementation Trial of Motivation Matters!","Hybrid Type-1 Effectiveness-Implementation Trial of Motivation Matters! A Theory-Based mHealth Intervention to Support Early Antiretroviral Adherence in HIV+ African Women Who Engage in Sex Work","Inclusion Criteria:\n\n* Age \\>18\n* Transactional sex in past 12 months\n* HIV-positive\n* Not currently on ART\n* Enrolled in one of the Sex Workers Outreach Program clinics\n* Has access to mobile phone\n* Willing to receive study text messages\n* Able to read or have someone else read\n\nExclusion Criteria:\n\n* Plans to move away in next 6 months\n* Undetectable viral load at baseline\n* Pregnant","FEMALE",{"count":121,"type":21},350,[24],"The goal of this clinical trial is to learn if an interactive mHealth intervention will be effective in helping HIV-positive women in high-burden settings who are initiating antiretroviral therapy (ART) take their ART regularly as prescribed, effectively reducing their viral load. The main question it aims to answer is:\n\n\\- Compared to standard of care, will Motivation Matters! (MM!) be significantly more effective at achieving undetectable viral load in women with HIV by month six.\n\nResearchers will compare the undetectable HIV viral load in women who receive individualized text messages (intervention group) in addition to standard care to those who receive standard care alone (control group).\n\nParticipants in the intervention group will receive three messages per week in month one, then two messages per week for the six-month intervention period. Participants will be asked to send a brief, standardized reply to each message, indicating that they are doing well or that they have a question or problem. Regardless of study arm, women will receive ART and counseling consistent with Kenyan guidelines.",[27],{"date":106,"type":38},{"date":127,"type":38},"2026-03-30",{"date":129,"type":21},"2029-12-31",{"name":131,"class":45},"University of Washington",{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":142,"conditions":143,"keywords":147,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":46},"100566756","prevention-of-mother-to-child-transmission-pmtct-among-women-experiencing-depression-in-malawi-100566756","NCT06659315","Prevention of Mother-to-child Transmission (PMTCT) Among Women Experiencing Depression in Malawi","Addressing Perinatal Depression and PMTCT Adherence in Malawi: A Couple-Based Approach","Inclusion Criteria:\n\n* In a marriage or cohabitating union for at least 6 months.\n* One member of the couple is a woman in the second or third trimester of pregnancy who is living with HIV and screens positive for depression (\\>10 on the PHQ9).\n* Have revealed their HIV status to their partner if living with HIV\\>\n\nExclusion Criteria:\n\n* Fear their safety would be at risk.\n* Report incidents of severe intimate partner violence (IPV) in the past three months using the WHO IPV measure.",{"count":140,"type":21},180,[24],"Prevention of mother-to-child transmission (PMTCT) of HIV virtually eliminates transmission of HIV from mothers to their infants. Adherence to PMTCT (i.e., to antiretroviral therapy, infant prophylaxis, and exclusive breastfeeding) during pregnancy and the postpartum period is challenging, with evidence from sub-Saharan Africa (SSA) showing suboptimal adherence and persistent viremia among perinatal women. Perinatal depression (PD) is a major driver of women's poor adherence to PMTCT. Interventions that involve male partners to provide social and food\u002Feconomic support could be a promising approach for addressing PD and PMTCT, yet few interventions have intervened with couples to improve systems of support, communication, and other dyadic processes. The investigators propose to develop and test a couple-based approach to intervene on the mother's perinatal depressive symptoms and to strengthen the relationship and support system for partners to work together around depression to improve PMTCT adherence. The study will take place in antenatal and HIV care settings in Zomba, Malawi. The specific aims are: (1) to develop a couple-based intervention to target perinatal depression (PD) based on an evidence-based approach using problem-solving therapy (PST), augmented with content on couple communication and problem-solving skills; and (2) to assess the feasibility and acceptability (F\\&A) of the intervention via a pilot randomized controlled trial (RCT). Our short-term goal is the produce a couple-focused PST intervention that can be added to the global health toolkit for treating depression in perinatal women. Our long-term goal is to produce a high-impact and sustainable intervention leveraging the couple relationship that can be scaled-up to address depression, PMTCT adherence, and family health.",[27,144,145,146],"Perinatal Mental Health","Depression During Pregnancy","PMTCT",[148,149,150,146,151],"Perinatal depression","Couples","Problem-solving","ART adherence","2026-03-26",{"date":127,"type":38},{"date":155,"type":38},"2025-11-11",{"date":157,"type":21},"2027-07-01",{"name":159,"class":45},"University of California, San Francisco",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":169,"phases":4,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":185},"100579830","transitional-housing-and-hiv-health-100579830","NCT06829394","Transitional Housing and HIV Health","A Type 1 Hybrid Effectiveness-Implementation Evaluation of a City-Level Transitional Housing Program's Effects on Health, Economic, and Psychologic Outcomes Among People With HIV","Inclusion Criteria: Inclusion criteria for the Lottery Population will be all PWH in priority groups 1 or 2 included in the initial lottery for access to the AAY program.\n\nInclusion criteria for the Survey population is (1) eligible for the HIV transitional housing program (2) priority group 1 or 2 with anticipated inclusion in the initial lottery (3) no plans to leave Philadelphia in the next year (4) regular access to a telephone to be able to complete phone surveys (5) able to provide informed consent.\n\n\\-\n\nExclusion Criteria: Does not meet the above inclusion criteria.\n\n\\-",{"count":168,"type":21},200,"OBSERVATIONAL","The goal of this pilot study is to evaluate the implementation and outcomes of the Arms Around You (AAY) program, a supportive housing initiative launched by the Philadelphia Department of Public Health (PDPH) in 2024. The program aims to address housing instability among people with HIV (PWH) using a Housing First model. The main questions it seeks to answer are:\n\n1. How does AAY affect HIV-related outcomes, particularly viral suppression and antiretroviral therapy (ART) adherence?\n2. What are the program's effects on economic, psychological, and secondary health outcomes?\n3. How feasible, acceptable, and scalable is the program for broader implementation? Participants will be assigned to immediate program access or a waitlist using a random lottery system, creating treatment and control groups, respectively. Surveys and health data will be collected at baseline and over 36 months to assess changes in outcomes such as viral suppression, housing security, mental health, and financial well-being. Qualitative interviews with participants and stakeholders will complement quantitative findings to explore mechanisms of change and guide program optimization.",[69,27,172],"Housing Instability",[69,174,175],"Housing","Structural Interventions","2026-03-18",{"date":178,"type":38},"2026-03-23",{"date":180,"type":38},"2025-02-25",{"date":182,"type":21},"2028-08",{"name":184,"class":45},"University of Pennsylvania",2,{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":119,"minAge":18,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":22,"phases":195,"briefSummary":196,"conditions":197,"keywords":200,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":210},"100610354","cash-transfers-to-pregnant-women-with-hiv-100610354","NCT07226492","Cash Transfers to Pregnant Women With HIV","A Pilot Trial of an Unconditional Cash Transfer for Pregnant Women With HIV in Botswana","Inclusion Criteria:\n\n* Age 18 years or greater\n* Botswana citizen\n* Seeking\u002Freceiving antenatal care at antenatal clinics managed by the District Health Management Teams in Gaborone and Mogoditsane-Thamaga District\n* Confirmed pregnancy by standard laboratory methods (generally urine testing)\n* \\\u003C20 weeks gestational age (by ultrasound dating)\n* HIV seropositive\n* Economically vulnerable (self-reported annual income below the Botswana poverty line of 14,000 BWP per year, equivalent to the international poverty line of $2.15 in 2017 purchasing power parity)\n\nExclusion Criteria:\n\n* Does not meet all of the inclusion criteria\n* Unable to provide consent\n* Cognitive impairment, per discretion of study staff\n* Cannot be in the same household as another enrolled study participant",{"count":194,"type":21},100,[24],"The goal of this study is to evaluate the effectiveness and implementation of an unconditional cash transfer intervention to improve mental bandwidth, ART adherence, and postpartum retention among pregnant women with HIV in Botswana.\n\nThe main questions it seeks to answer are:\n\n1. Do unconditional monthly cash transfers improve mental bandwidth relative to usual care among pregnant women with HIV?\n2. Do unconditional monthly cash transfers improve ART adherence (PDC) during pregnancy and the postpartum period?\n3. Is delivery of UCTs via mobile money feasible and acceptable in public ANC clinics in Botswana?\n4. What barriers and facilitators affect implementation, and how should the model be adapted for a larger trial or a policy pilot (e.g., a pregnancy support grant)?",[69,198,27,199],"Pregnancy","Post-partum",[201],"Cash-transfer","2026-03-11",{"date":204,"type":38},"2026-03-13",{"date":206,"type":38},"2026-03-09",{"date":208,"type":21},"2028-01-04",{"name":184,"class":45},3,{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":217,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":92,"minAge":18,"maxAge":219,"enrollmentInfo":220,"targetDuration":4,"studyType":22,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":4},"100601902","implementation-and-effects-of-nishauri-on-hiv-treatment-outcomes-among-men-100601902","NCT07116538","Implementation and Effects of Nishauri on HIV Treatment Outcomes Among Men","Assessing the Implementation and Effects of Nishauri m-Health Intervention on HIV Care and Treatment Outcomes Among Men Living With HIV in Homa Bay County, Kenya","Nishauri I","Inclusion Criteria:\n\n* Male, own a smart phone or tablet, aged 18-55, willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Any mental or serious chronic illness that may affect particiattion and credibility of data being collected for the study.","55 Years",{"count":221,"type":21},347,[24],"About 1.3 million people in Kenya are living with HIV, and Homa Bay County has the highest rate in the country. Even though HIV treatment has improved, many men still face challenges staying in care, taking their medicine, and achieving good health. This is often because of stigma, male gender norms, and lack of support designed specifically for men.\n\nNishauri is a mobile health (mHealth) app created to help people living with HIV by sending reminders, health tips, and other support through their phones. It has already reached over 300,000 users in Kenya. However, it is not yet clear how well it works for men in improving care and treatment.\n\nThis study, led by Maseno University in Kenya and the University of California San Francisco in the U.S., will test how the Nishauri app affects men's HIV care. We will work with 347 men aged 18 to 55 who own a smartphone or tablet and are already receiving HIV treatment at four clinics in Homa Bay. We will collect information through surveys before and after using the app, and also conduct focus group discussions to better understand what helps or makes it hard for men to use the app.\n\nWe believe that using Nishauri will help improve men's treatment outcomes-like staying in care, taking medicine regularly, and having lower viral load.",[27],"2025-08-07",{"date":227,"type":38},"2025-08-11",{"date":229,"type":21},"2025-08-20",{"date":231,"type":21},"2026-07-17",{"name":233,"class":45},"Maseno University",{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":119,"minAge":242,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":22,"phases":245,"briefSummary":246,"conditions":247,"keywords":251,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":185},"100562583","optimizing-prevention-and-care-for-pregnant-and-postpartum-adolescent-girls-and-young-women-with-hiv-in-tanzania-100562583","NCT06605053","Optimizing Prevention and Care for Pregnant and Postpartum Adolescent Girls and Young Women With HIV in Tanzania","ENding HIV Transmission to Infants by Generating Evidence to Optimize Prevention and Care for Pregnant and Postpartum Adolescent Girls and Young Women With HIV in Tanzania (ENGAGE)","ENGAGE","Sub-study 1 (registry-based cohort analysis):\n\nInclusion Criteria:\n\n* Pregnant\u002Fpostpartum adolescent girls and young women (AGYW) with HIV aged 15-24 years, who started PMTCT services between January 1, 2018, and December 31, 2020.\n* Infants born to the included AGYW during this period.\n\nExclusion Criteria:\n\n* AGYW whose ART (Antiretroviral Therapy) status was not recorded.\n* Women who had not started ART.\n\nSub-study 2 (qualitative):\n\nInclusion Criteria:\n\n* AGYW living with HIV who are currently pregnant, previously pregnant\u002Fpostpartum, and never pregnant).\n* HCPs (Health Care Providers) at clinics providing PMTCT services.\n* Spouses\u002Fpartners\u002Fparents of AGYW and community stakeholders within the study setting.\n\nExclusion criteria\n\n\\- Mentally or severely ill individuals unable to participate in the study activities.\n\nSub-study 3 (co-production)\n\nInclusion criteria:\n\n* AGYW, HCPs, spouses\u002Fpartners, parents, and community stakeholders who participated in the qualitative study II.\n* Research team members.\n\nExclusion criteria:\n\n\\- Mentally or severely ill individuals unable to participate in the study activities.\n\nSub-study 4 (cluster-randomized implementation trial)\n\nInclusion criteria:\n\n\\- Pregnant AGYW living with HIV (new, previously diagnosed, and transfers) receiving vertical HIV prevention services in routine healthcare between January 1, 2026, and June 30, 2026, and followed up for at least one year until June 30, 2027.\n\nExclusion criteria:\n\n* AGYW whose ART (Antiretroviral Therapy) status was not recorded.","15 Years",{"count":244,"type":21},222,[24],"The goal of this clinical trial is to find better ways to care for pregnant and postpartum adolescent girls and young women (AGYW) aged 15-24 years with HIV in Tanzania, and to prevent them from passing HIV to their babies. The main questions it aims to answer are:\n\n* How often do young pregnant women with HIV go to their health appointments and stay on their treatment up to two years after giving birth?\n* How many babies born to young women with HIV stay HIV-free for two years?\n* How soon do young women with HIV get pregnant again after giving birth, and what factors affect this?\n* What are the best ways to help young women with HIV stay in care and stay healthy during and after pregnancy?\n* What social and structural factors affect whether young pregnant women with HIV go to their health appointments and stay on their treatment?\n* How can we work with young women with HIV to create and test a package of interventions to improve their healthcare during and after pregnancy?\n* Can this package of interventions help young women with HIV stay in care and remain healthy during and after pregnancy?\n\nParticipants will:\n\n* Have their health data analyzed via health service records of all women who received HIV prevention services between 2018 and 2020, and were followed until 2023, across 559 health facilities in Tanzania.\n* Participate in qualitative interviews to share their experiences and challenges with staying in care.\n* Help to co-create a package of interventions to improve care.\n* Take part in a cluster-randomized trial to test these interventions. Researchers will compare the outcomes of the intervention package to see if they improve care engagement, retention, and health outcomes for AGYW with HIV during and after pregnancy.",[27,146,198,248,249,250],"Retention in Care","HIV Viremia","Early Infant HIV Diagnosis",[252,69,253,146,254,255,256,257,258,259],"Adolescent girls and young women","Vertical transmission","Co-production","Co-design","Intervention","Tanzania","Sub-Saharan Africa","Retention in care","2025-06-27",{"date":262,"type":38},"2025-06-29",{"date":264,"type":38},"2024-10-07",{"date":266,"type":21},"2027-12",{"name":268,"class":45},"Karolinska Institutet",{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":276,"targetDuration":4,"studyType":22,"phases":278,"briefSummary":279,"conditions":280,"keywords":289,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":46},"100591839","khanya-ekhaya-a-home-based-intervention-100591839","NCT06985641","Khanya Ekhaya: A Home-Based Intervention","Home-Based Community Health Worker Support for Mental Health Among People Living With HIV in South Africa: A Hybrid Effectiveness Implementation Trial","Inclusion Criteria:\n\nCHWs:\n\n* at least 18 years old\n* must conduct home visits for people with HIV newly initiating or re-initiating ART at the approved clinic site\n\nPATIENTS:\n\n* at least 18 years old\n* seen by a CHW after newly initiating or re-initiating ART in the past three months\n* screen positive for depressive symptoms or harmful alcohol use\n\nExclusion Criteria:\n\nCHWs:\n\n-Unable or unwilling to complete informed consent and study procedures in English, isiXhosa, or Afrikaans\n\nPATIENTS:\n\n-Unable or unwilling to complete informed consent and study procedures in English, isiXhosa, or Afrikaans",{"count":277,"type":21},119,[24],"Mental health conditions, such as depression, anxiety, and harmful alcohol use are prevalent among people with chronic diseases, including HIV, and contribute to poor engagement in care. There is a need to address untreated mental health problems. Community health workers (CHWs) are frontline workers who play a central role in supporting vulnerable individuals to stay in care, including seeking people living with HIV who are newly initiating antiretroviral therapy (ART) or re-initiating after a period of care disengagement. CHW-delivered interventions are promising for improving engagement and retention in care. Yet, these programs rarely address mental health -a significant barrier to chronic disease care engagement and treatment. An approach that moves beyond providing care in the clinic setting is needed. Community-delivered home-based mental health care has been shown to be feasible and acceptable and shows promise for integration into broader community health care services for people with chronic conditions, such as HIV.",[69,27,281,282,283,284,285,286,287,288],"Mental Health","Substance Use Disorders","Stigma","Community Health Workers","Training","Global Health","Mental Health Recovery","Substance Use Recovery",[284,290,286,288,287,69,291,292,293,294,295,282],"Health Personnel","Health Care Seeking Behavior","Treatment Adherence and Compliance","Attitude of Health Personnel","Substance Use Stigma","Mental health Stigma","2025-05-14",{"date":298,"type":38},"2025-05-22",{"date":300,"type":21},"2025-09-01",{"date":302,"type":21},"2026-06-15",{"name":304,"class":45},"University of Maryland, College Park",{"id":306,"slug":307,"hasResults":11,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":311,"eligibilityCriteria":312,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":313,"targetDuration":314,"studyType":169,"phases":4,"briefSummary":315,"conditions":316,"keywords":317,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":46},"100562778","selection-of-resistant-mutations-to-dolutegravir-in-plwh-treated-in-mozambique-100562778","NCT06607588","Selection of Resistant Mutations to Dolutegravir in PLWH Treated in Mozambique","Selection of Resistant Mutations to Dolutegravir and Associated Drugs in PLWH Treated in Clinical Practice in Chokwé, Mozambique","REDOCH","Inclusion Criteria:\n\n* Patients able to understand and sign the informed consent form.\n* Documented HIV-1 infection.\n* Under the first line TLD for at least 6 months.\n* At least 3 months follow-up with CV \\>200c\u002Fml.\n\nExclusion Criteria:\n\n* Patients \\<18 years of age.\n* Under the first line regime other than TLD.\n* Patients with active neoplastic processes.\n* Patients with active opportunistic diseases.\n* Patients unable to give informed consent.",{"count":168,"type":21},"1 Day","The HIV infection not fully controlled, despite being under antiretroviral treatment, could make virus resistance against the antiretroviral treatments, making hardest the well control of HIV infection. The purpose of this research study is to confirm or deny if a not fully good controlled HIV infection could develop virus resistance against antiretroviral drugs that can difficult the good control of the HIV infection.",[69,27],[69,318,319,320,321],"ARV","Resistance","DTG","Africa",{"date":323,"type":38},"2025-05-15",{"date":325,"type":38},"2024-10-25",{"date":327,"type":21},"2026-09",{"name":329,"class":45},"Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia",{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":336,"eligibilityCriteria":337,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":338,"targetDuration":340,"studyType":169,"phases":4,"briefSummary":341,"conditions":342,"keywords":343,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":357},"100585421","prospective-multicenter-study-of-the-relationship-between-virological-effectiveness-and-compliance-in-hiv-1-infected-patients-treated-with-bictegravir-100585421","NCT06902142","Prospective Multicenter Study of the Relationship Between Virological Effectiveness and Compliance in HIV-1-infected Patients Treated With Bictegravir","Étude Multicentrique Prospective de la Relation Entre Efficacité Virologique et Observance Chez Des Patients Infectés Par le VIH-1 Traités Par Bictegravir","BICTECAPS","Inclusion Criteria:\n\n* People living with HIV-1\n* Age greater than or equal to 18 years\n* Having been informed about the study (non-opposition)\n* Acceptance of the use of electronic antiretroviral monitoring caps (MEMS caps)\n* People treated or starting treatment with bictegravir\u002F\u002Femtricitabine\u002Ftenofovir (B\u002FF\u002FTAF; antiretroviral treatment naïve, changing treatment, virological failure)\n\nExclusion Criteria:\n\n* Pregnant women\n* People living with HIV (PLHIV) living in institutionalization, with guardianship or impaired judgment (to avoid bias due to unability to assume responsibility for treatment compliance)\n* PLHIV receiving assistance incompatible with the use of the electronic pillbox.",{"count":339,"type":21},120,"12 Months","Modern once-daily antiretroviral therapies have evolved considerably, improving patients' quality of life. However, sub-optimal adherence to antiretroviral therapy (ART) can lead to insufficient viral suppression and the emergence of resistant HIV strains. In particular, several populations encountered in HIV clinical practice face obstacles to optimal adherence.\n\nThe investigators propose the prospective multicenter cohort study BICTECAPS, evaluating the effectiveness of the combination therapy bictegravir\u002Femtricitabine\u002Ftenofovir alafenamide (B\u002FF\u002FTAF) in routine practice. The investigators hypothesize that the pharmacokinetic profile and genetic barrier provided by B\u002FF\u002FTAF will enable a high rate of virological suppression at low to moderate levels of adherence, probably 100% virological suppression above 70% adherence.\n\nThe study is planned to include 120 patients with HIV infection treated with B\u002FF\u002FTAF, over a planned 2-year period with usual follow-up.\n\nThe aim of this work is to evaluate virological suppression rates at 6 and 12 months according to adherence levels defined by electronic antiretroviral monitoring caps (MEMS caps) and by intra-cellular TAF assay on blotting paper (dried blood spot, DBS).\n\nThe investigators hope to generate real-life data on B\u002FF\u002FTAF use from population groups generally under-represented in clinical trials, including robust measurements of adherence patterns using MEMS caps and DBS.\n\n. Key words : HIV-1 ; B\u002FF\u002FTAF ; Adherence ; Forgiveness",[27],[344,345,346,347],"HIV-1","B\u002FF\u002FTAF","Adherence","Forgiveness","2025-03-31",{"date":350,"type":38},"2025-04-03",{"date":352,"type":38},"2025-02-11",{"date":354,"type":21},"2027-09-01",{"name":356,"class":45},"Association pour la promotion de la recherche en maladies infectieuses et tropicales dans le Loiret",8]