[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"human-immunodeficiency-virus-hiv-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:human-immunodeficiency-virus-hiv-infection":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,75,107],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100609081","secondary-cervical-cancer-prevention-of-vulnerable-women-with-hpv-and-hiv-co-infection-in-india-100609081",false,"NCT07209917","Secondary Cervical Cancer Prevention of Vulnerable Women With HPV and HIV Co-infection in India","Secondary Cervical Cancer Prevention of Vulnerable Women With Human Papillomavirus (HPV) and Human Immunodeficiency Virus (HIV) Co-infection in India","SAKHI","Inclusion Criteria:\n\n1. WLH, 25 - 50 years of age; based on HIV-based guidelines;\n2. Receiving ART for \\> 12 months to ensure medication stabilization, and ensure any impact on the cervical cancer outcomes will not be attributed solely to recent ART initiation, as validated by an ART card given to all ART patients;\n3. Screened as HPV positive by RT-PCR (Reverse Transcription Polymerase Chain Reaction) for oncogenic genes; and assessed to be VIA negative;\n4. Have not participated in Phase I Formative Study.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women due to hormonal and dietary guideline differences;\n2. Women older than age 50. These women will be immediately referred to a gynecology specialist.","FEMALE","25 Years","50 Years",{"count":21,"type":22},348,"ESTIMATED","INTERVENTIONAL",[25],"NA","Cervical cancer (CC) remains one of the most common malignancies among women in India, with nearly 100,000 women diagnosed annually and over 60,000 preventable deaths annually. With high-risk human papillomavirus (HR-HPV) as the causative agent for CC, one risk factor that places women at high risk for CC is human immunodeficiency virus (HIV), as impaired immune response against Human papillomavirus (HPV) may result in persistent HR-HPV infection, a critical risk factor for progression of HPV-related cervical oncogenesis. Progression of precancerous lesions among women living with HIV (WLH) is also associated with: 1) lack of HPV screening; 2) high levels of depressive symptoms and stigma; and 3) malnutrition, which negatively impacts the activation and proliferation of immune cells. Yet programs that offer WLH with comprehensive services focused on HPV screening and psychological and nutritional support are almost non-existent, and the gap is critical. Nutrition plays an integral role in relationship to HPV\u002FHIV co-infection, as demonstrated by an increased risk of HR-HPV associated with poor nutrition; nutritional deficiencies are likewise linked to cervical intra-epithelial neoplasia. The immunological effect of malnutrition may also be exacerbated among WLH due to elevated energy demands of chronic immune activation; worsened with HPV\u002FHIV co-infection. Further, depressive symptoms (aka depression for brevity) partially mediate the effect of food insecurity on HIV viral suppression. In our completed ASHA-Nutrition R01 study of antiretroviral (ART) adherence, the investigators trained lay community health workers, named Accredited Social Health Activist (ASHA), to improve the health of 600 rural WLH by providing emotional support, skill-building, nutrition education, and\u002For protein-enriched food supplements. In that study, our intervention, co-delivered by our trained ASHA, and guided by nurses, led to increased CD4+ T cell recovery and improved anthropometric and psychosocial outcomes. The investigators found that ASHA support plus protein supplements and nutritional education were significantly associated with improved CD4 counts and increased lean mass at 18 months (P \\\u003C 0.001), as well as significant improvements in depression, ART adherence, social support and internalized stigma. In our sub study, CC screening of 598 of these WLH revealed that 13% were found to have abnormal cervical lesions and 4 (1%) had squamous CC. Preliminary evidence also revealed that nutritional supplements may be associated with a 40% reduction in the risk of abnormal cervical lesions (adjusted odds ratio \\[aOR\\] = 0.60), with an association between serum albumin and reduced risk of abnormal lesions (aOR= 0.39).\n\nWith a focus on secondary prevention of CC, the investigators hope to mitigate the link between HR-HPV persistence and risk of CC as well as improve the health of women co-infected with HPV\u002FHIV (W-Co-V). Our stellar team plans to build upon our prior ASHA-Nutrition intervention, using formative research to refine a nurse-led, ASHA co-delivered, nutrition-enhanced SAKHI HPV intervention, adapted for W-Co-V. This will be followed by a randomized controlled trial (RCT), assessing the efficacy of our refined comprehensive, multifaceted SAKHI HPV intervention, as compared with an enhanced Standard of Care (SOC+) (usual care + 3 sessions \\[wellness, basic nutrition and HPV\u002FHIV health promotion\\]) among 348 high-risk co-infected women to prevent CC while remaining engaged in the HIV treatment cascade, and managing nutritional health. Recruited participants will be individually randomized in a 1:1 ratio into the two study arms. Our Primary outcome is HR-HPV persistence (2 positive tests for the same HR-HPV type, separated by 12-18 months). The two aims incorporating RCT interventions are as follows:\n\nAim 2. To evaluate the efficacy of SAKHI HPV intervention among 348 W-Co-V on the primary outcome (HR-HPV persistence) as compared to the Enhanced Standard of Care (SOC+) program. H2: Compared to the SOC+ participants, SAKHI participants will have lower rates of HR-HPV persistence.\n\nAim 3. Assess the impact of the SAKHI program secondarily on: 1) HIV indices (HIV viral load; CD4 count); 2) Nutritional index (serum albumin) at 6-, 12-, and 18-months.",[28,29,30],"Cervical Cancer","Human Papillomavirus (HPV) Infection","Human Immunodeficiency Virus (HIV) Infection",[32,33,34],"Cervical Cancer Prevention","HPV-HIV Co-Infection","ASHA-Nutrition","RECRUITING","2026-06-23",{"date":38,"type":39},"2026-06-26","ACTUAL",{"date":41,"type":39},"2026-02-01",{"date":43,"type":22},"2029-04-30",{"name":45,"class":46},"University of California, Irvine","OTHER",3,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100391347","phase-2-doravirine-dor-in-human-immunodeficiency-virus-hiv-infected-children-aged-4-weeks-to-12-years-and-45-kg-mk-1439-066-100391347","NCT04375800","Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to \u003C12 Years and \u003C45 kg (MK-1439-066)","A Phase 2 Clinical Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Doravirine and Doravirine\u002FLamivudine\u002FTenofovir Disoproxil Fumarate in Participants With HIV-1, Who Are 4 Weeks to Less Than 12 Years of Age and Weigh Less Than 45 kg","Inclusion Criteria:\n\n* Has human immunodeficiency virus type 1 (HIV-1) infection confirmed at screening\n* Has appropriate treatment history defined as treatment-naïve (TN) or with documented virologic suppression (HIV-1 ribonucleic acid \\[RNA\\] \\\u003C50 copies\u002FmL) on stable combination antiretroviral therapy (cART) for ≥3 months\n* Body weight is \\>3 kg to \\\u003C45 kg\n* If female, is not pregnant or breastfeeding, and one of the following applies:\n* Is not a woman of childbearing potential (WOCBP)\n* Is a WOCBP using an acceptable form of contraception, or is abstinent\n* If a WOCBP must have a negative pregnancy test (urine or serum) within 24 hours of the first dose of study intervention\n\nStudy Extension Inclusion Criteria:\n\n* Has completed the Week 96 visit\n* Is considered, in the opinion of the investigator, to have derived benefit from treatment with doravirine (DOR) plus the 2 nucleoside\u002Fnucleotide analog reverse transcriptase inhibitor (NRTIs) selected by the investigator, or doravirine\u002Flamivudine\u002Ftenofovir disoproxil fumarate (DOR\u002F3TC\u002FTDF), by Week 96 of the study\n* Is considered, in the opinion of the investigator, to be a clinically appropriate candidate for additional treatment with DOR regimens (DOR plus 2 NRTIs selected by the investigator or DOR\u002F3TC\u002FTDF)\n* Understands the procedures in the study extension and has provided (or have the participant's legally acceptable representative, if applicable, provide) documented informed consent\u002Fassent to enter the study extension and continue treatment with DOR regimens (DOR plus 2 NRTIs selected by the investigator or DOR\u002F3TC\u002FTDF) until it is available locally in countries participating in the study or for up to an additional 224 weeks (whichever comes first)\n\nExclusion Criteria:\n\n* Has evidence of renal disease\n* Demonstrates evidence of liver disease\n* Has clinical or laboratory evidence of pancreatitis\n* Has any history of malignancy\n* Has presence of any active acquired immunodeficiency syndrome (AIDS)-defining opportunistic Infection\n* Has an active diagnosis of hepatitis, including hepatitis B co-infection\n* Has current active tuberculosis and\u002For is being treated with a rifampicin-containing regimen\n* Has a medical condition that precludes absorption or intake of oral pellets\u002Fgranules\n* Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound results of the study or interfere with participating for the entire duration of the study\n* Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or other prohibited therapy\n* Is currently participating in or has participated in an interventional clinical study with an investigational compound or device from 45 days prior to Day 1 through the treatment period\n* Has a documented or known virologic resistance to DOR\n* Has any history of viremia (HIV RNA \\>1000 copies\u002FmL) after at least 3 months on a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen","ALL","4 Weeks","11 Years",{"count":59,"type":22},84,[61],"PHASE2","This is a single-group, open-label, multi-site study in pediatric participants with human immunodeficiency virus type 1 (HIV-1) infection, aged 4 weeks to \\\u003C12 years and weighing \\\u003C45 kg, who are treatment-naive (TN) or have been virologically suppressed (VS) on stable combination antiretroviral therapy (cART) for ≥3 months with no history of treatment failure. The primary objectives are:\n\n* To evaluate the steady state pharmacokinetics (PK) of doravirine (DOR) \\[MK-1439\\] when given in combination with 2 nucleoside\u002Fnucleotide analog reverse transcriptase inhibitors (NRTIs) or as part of the fixed-dose combination (FDC) of DOR\u002Flamivudine (3TC)\u002Ftenofovir disproxil fumarate (TDF) in participants ≥6 to \\\u003C12 years and weighing ≥14 to \\\u003C45 kg.\n* To evaluate the safety and tolerability of DOR when given with 2 NRTIs or as part of the FDC of DOR\u002F3TC\u002FTDF, in participants ≥6 to 12 years and weighing ≥14 to \\\u003C45 kg, through Week 24.",[30],"2026-04-24",{"date":66,"type":39},"2026-04-28",{"date":68,"type":39},"2021-02-03",{"date":70,"type":22},"2034-04-11",{"name":72,"class":73},"Merck Sharp & Dohme LLC","INDUSTRY",24,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":55,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100584256","strategies-to-achieve-viral-suppression-for-youth-with-hiv-100584256","NCT06886971","Strategies to AchieVe Viral Suppression for Youth With HIV","Strategies to AchieVe Viral Suppression for Youth With HIV (The SAVVY Study)","SAVVY","Inclusion Criteria:\n\n* prescribed ART,\n* willing to sign informed consent (including communication with one's primary HIV provider)\n\nExclusion Criteria:\n\n* Relevant drug resistance mutations (per medical record) that compromises activity of Cabotegravir (CBG) + rilpivirine (RPV)\n* disallowed medications,\n* pregnancy.\n* Mental health, cognitive, or behavioral dysfunction that in the opinion of the site PI would impair participation;\n* severe illness\u002Fhospitalization at the time of enrollment,\n* plan to move away in the next 12 months.","12 Years","30 Years",{"count":86,"type":22},288,[25],"Although there have been advances in antiretroviral treatment (ART) for HIV, adolescents and young adults living with HIV (AHIV) continue to have disparate HIV outcomes particularly viral suppression (VS), when compared to other populations likely related to multi-layered challenges (social determinants, cognitive development), system, and biomedical challenges including the reliance on oral ART as the only choice for HIV treatment. Given that approximately 1\u002F3 of AHIV despite being in care fail to attain or sustain VS with resultant individual and public health risk, there is a need to develop real-world implementable interventions that can improve the participants virologic outcomes. The Strategies to AchieVe Viral Suppression for Youth with HIV (SAVVY) Study aims to 1) optimize personal ART choice by using the HIV-ASSIST clinical program to inform CHOICE counseling regarding an AHIV's preferred approach, including the possibility of long-acting injectable ART (LAI-ART); 2) facilitate access to the participants preferred choice through deploying a focused team to navigate barriers to attaining LAI-ART; and 3) decipher and address the patient, provider, and systemic barriers to the uptake and routinization of LAI-ART among AHIV by applying an implementation science framework and assessing cost-effectiveness providing critical data to support comprehensive approaches to optimizing ART and VS for AHIV, a key population identified in the Ending the HIV Epidemic in the United States Initiative.",[30],[91,92,93,94,95,96],"adolescents","long-acting antiretroviral treatment","youth","young adu;ts","viral suppression","effectiveness","2026-02-02",{"date":99,"type":39},"2026-02-04",{"date":101,"type":39},"2024-11-10",{"date":103,"type":22},"2028-07-31",{"name":105,"class":46},"Johns Hopkins University",1,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":115,"sex":55,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":23,"phases":120,"briefSummary":121,"conditions":122,"keywords":129,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":106},"100595994","empowering-knowledge-self-testing--resilience-through-innovative-methods-for-hiv-100595994","NCT07039682","Empowering Knowledge, Self-Testing & Resilience Through Innovative Methods for HIV","Developing a Digital-Based Education and Self-Screening Model to Improve Knowledge, Self-Awareness, and HIV Testing Coverage Among Adolescents","EKSTRIM","Inclusion Criteria:\n\n* Adolescents aged 15-17 years\n* Reside or attend school in the Yogyakarta area\n* Currently enrolled in one of the participating high schools\n* Able to read and understand Bahasa Indonesia\n* Own or have regular access to a smartphone or digital device with internet connectivity\n* Provide informed assent to participate in the study\n* Have obtained written parental or guardian consent\n\nExclusion Criteria:\n\n* Adolescents outside the 15-17 age range\n* Unable to access digital devices or internet independently\n* Previously diagnosed with HIV (as this study targets prevention and self-screening among untested adolescents)\n* Unwilling or unable to provide informed assent or whose parents\u002Fguardians do not provide consent\n* Currently participating in another HIV-related intervention study",true,"15 Years","17 Years",{"count":119,"type":22},400,[25],"The goal of this study is to learn whether a digital tool can help improve HIV knowledge, self-awareness, and testing among adolescents in Yogyakarta, Indonesia. The tool includes online HIV education, a self-assessment for HIV risk, and access to trained peer educators for support. The study will also explore how comfortable and willing adolescents are to use this kind of digital health service.\n\nThe main questions the study aims to answer are:\n\n* Can this digital tool help adolescents better understand HIV and their personal risk?\n* Will more adolescents be willing to get tested for HIV after using the tool?\n* What factors affect whether adolescents accept and use digital HIV services?\n\nResearchers will compare two groups of high school students:\n\n* One group will use the digital tool for 6 weeks\n* The other group will receive standard HIV education (not through the tool)\n\nParticipants will:\n\n* Answer surveys before and after the 6-week period\n* Learn about HIV through videos and interactive content\n* Use the tool to assess their personal HIV risk\n* Receive support from trained peer educators (online)\n\nThe researchers hope this study will lead to new ways of using technology to improve HIV prevention and testing for young people.",[30,123,124,125,126,127,128],"HIV Prevention","Adolescent Health","Digital Education Interventions","Digital Health Intervention","Health Education","HIV Stigma",[130,131,132,133],"hiv prevention","adolescent health","health education","digital intervention","NOT_YET_RECRUITING","2025-06-18",{"date":137,"type":39},"2025-06-26",{"date":139,"type":22},"2025-07-31",{"date":141,"type":22},"2025-12-31",{"name":143,"class":46},"Universitas Sebelas Maret"]