[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650704":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":23,"studyPopulation":16,"armGroups":24,"interventions":37,"overallOfficials":47,"centralContacts":52,"locations":57,"responsibleParty":71,"collaborators":73,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":40,"eligibilityCriteria":82,"healthyVolunteers":79,"sex":83,"minAge":84,"maxAge":16,"enrollmentInfo":85,"targetDuration":16,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":60,"whyStopped":16,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Johns Hopkins Bloomberg School of Public Health","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":16},[9,13],{"measure":10,"description":11,"timeFrame":12},"HIV care engagement as assessed by the Number of participants who re-engage in HIV care","Number of participants who re-engage in HIV care, defined as attending at least one HIV clinical care visit within 6 months after study enrollment, as documented in the Medical Information System (MIS).","6 months",{"measure":14,"description":15,"timeFrame":12},"Antiretroviral therapy (ART) adherence as assessed by the percentage of days covered by dispensed antiretroviral medication","ART adherence, measured as the percentage of days covered by dispensed antiretroviral medication during the 6 months after study enrollment, based on Medical Information System pharmacy records.",null,{"allocation":18,"interventionModel":19,"interventionModelDescription":16,"primaryPurpose":20,"observationalModel":16,"timePerspective":16,"maskingInfo":21},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":22,"maskingDescription":16,"whoMasked":16},"NONE","This study will evaluate the feasibility, acceptability, and preliminary efficacy of a behavioral intervention designed to reduce intersectional HIV- and drug use-related stigma and improve HIV care engagement among women living with HIV who use drugs in Ukraine. A total of 100 eligible women will be randomized to either the intervention or a control condition. Participants in both groups will receive standard HIV care and a one-time consultation with a social worker, complete baseline, 3-month, and 6-month assessments, and have HIV care outcomes assessed. Participants assigned to the intervention will additionally attend five small-group sessions focused on stigma coping, cognitive-behavioral skills, communication, social support, and HIV care engagement, with an optional individual session involving a support person. The study will examine effects on HIV care engagement, antiretroviral therapy adherence, and stigma-related psychosocial outcomes to inform a future fully powered randomized controlled trial.",[25,31],{"label":26,"type":27,"description":28,"interventionNames":29},"Standard of Care (Control)","ACTIVE_COMPARATOR","Standard of Care (Control Arm): Participants randomized to the control arm will continue to receive standard HIV and substance use care available through the participant's usual healthcare providers. In addition, participants will receive a one-time consultation with a social worker (in person or remotely) and complete study assessments at baseline, 3 months, and 6 months. No stigma-reduction intervention sessions will be provided.",[30],"Behavioral: standard of care",{"label":32,"type":33,"description":34,"interventionNames":35},"Intervention Arm","EXPERIMENTAL","Experimental Intervention Arm: Participants randomized to the intervention arm will continue to receive standard HIV and substance use care, a one-time consultation with a social worker, and complete study assessments at baseline, 3 months, and 6 months. In addition, they will participate in five in-person, small-group sessions delivered over approximately 2-3 weeks that focus on reducing HIV- and drug use-related stigma through cognitive-behavioral coping skills, communication and social support strategies, and HIV care engagement. Participants may also complete an optional individual session with a psychologist facilitator and a support person.",[36],"Behavioral: Light Inside",[38,43],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":16},"BEHAVIORAL","Light Inside","Adapted intersectional stigma reduction intervention consisting of five facilitator-led, small-group sessions delivered over approximately 2-3 weeks. The intervention uses cognitive-behavioral strategies to reduce HIV- and drug use-related stigma by strengthening adaptive coping, cognitive restructuring, communication skills, social support, and HIV care self-efficacy to improve HIV care engagement and antiretroviral therapy adherence. Participants may also complete an optional individual session with a psychologist facilitator and a support person.",[32],{"type":39,"name":44,"description":45,"armGroupLabels":46,"otherNames":16},"standard of care","Standard of Care: Participants will continue to receive standard HIV and substance use care available through their usual healthcare providers. In addition, they will receive a one-time consultation with a social worker, delivered either in person or remotely, to provide support and linkage to available services.",[26],[48],{"name":49,"affiliation":50,"role":51},"Jill Owczarzak, PhD","Johns Hopkins University","PRINCIPAL_INVESTIGATOR",[53],{"name":49,"role":54,"phone":55,"phoneExt":16,"email":56},"CONTACT","667-306-8360","jillowczarzak@jhu.edu",[58],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":16,"geoPoint":16,"contacts":66},"Ukrainian Institute on Public Health Policy","RECRUITING","Kyiv","Kyiv Oblast","01054","Ukraine","UA",[67],{"name":68,"role":54,"phone":69,"phoneExt":16,"email":70},"Tetiana Kiriazova, PhD","+380 44 209-21-41","kiriazova@uiphp.org.ua",{"type":72,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR",[74],{"name":75,"class":76},"Fogarty International Center of the National Institute of Health","NIH","100650704","adaptation-and-evaluation-of-an-intersectional-stigma-reduction-intervention-to-increase-hiv-care-engagement-among-women-who-use-drugs-100650704",false,"NCT07751978","Adaptation and Evaluation of an Intersectional Stigma Reduction Intervention to Increase HIV Care Engagement Among Women Who Use Drugs","Inclusion Criteria:\n\n* Female; Age 18 years or older;\n* Registered in the national Medical Information System (MIS) as having received an HIV-positive diagnosis;\n* Registered in the MIS with injection drug use (IDU) as the probable mode of HIV transmission or with a documented history of injection drug use at any clinical visit.\n\nExclusion Criteria:\n\n* Does not meet the inclusion criteria;\n* Unable to provide informed consent;\n* Unable to provide informed consent due to intoxication, the effects of drug use, or severe psychiatric impairment at the time of consent.","FEMALE","18 Years",{"count":86,"type":87},100,"ESTIMATED","INTERVENTIONAL",[90],"NA","The goal of this study is to test whether a program reduce stigma will help women living HIV remain in HIV care.",[93],"HIV",[95],"HIV, women who use drugs, HIV care engagement, cognitive behavioral interventions","2026-10-07",{"date":98,"type":99},"2026-10-08","ACTUAL",{"date":101,"type":99},"2026-09-18",{"date":103,"type":87},"2028-09",{"name":5,"class":6},1]