[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585305":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":27,"locations":33,"responsibleParty":50,"collaborators":52,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":9,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":11,"enrollmentInfo":67,"targetDuration":11,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":82,"whyStopped":11,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"San Diego State University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Kisoboka Amaka","EXPERIMENTAL",null,[13],"Behavioral: Kisoboka Amaka",{"label":15,"type":16,"description":11,"interventionNames":17},"Screening and Referral","ACTIVE_COMPARATOR",[18],"Behavioral: Screening and Referral",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"BEHAVIORAL","KISOBOKA AMAKA intervention adapts and combines a behavioral intervention with a structural component. The behavioral intervention component includes, alcohol screening, financial literacy training, and counseling and goal setting related to savings, alcohol use, and HIV care engagement. The structural intervention component focuses on depositing earnings into mobile savings programs. Kisoboka Amaka content will be \"finalized\" in aims 1 and 2. However, we expect core intervention components to remain unchanged including: 4 counseling sessions (2 individual, 2 group), 2x weekly text message reminders of goals and mobile money set up. Potential additional components include: 1 family focused couples session, self monitoring of alcohol use (via mobile breathalyzer) and PEth (an objective biomarker measure of alcohol use) boosted alcohol counseling.",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"Alcohol screening and referral and emphasizing the importance of HIV care engagement and ART adherence",[15],[28],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},"Amanda P Miller, PhD, MS","CONTACT","610-203-1134","apmiller@sdsu.edu",[34],{"facility":35,"status":11,"city":36,"state":11,"zip":11,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Makerere University Walter Reed Program","Kampala","Uganda","UG",{"type":40,"coordinates":41},"Point",[42,43],32.58219,0.31628,{"lat":43,"lon":42},[46],{"name":47,"role":30,"phone":48,"phoneExt":11,"email":49},"Fred Magala, Program Director","+256312330400","muwrp@muwrp.org",{"type":51,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[53,56],{"name":54,"class":55},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","NIH",{"name":57,"class":6},"Makerere University","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","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":68,"type":69},60,"ESTIMATED","INTERVENTIONAL",[72],"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.",[75,76],"HIV Antiretroviral Therapy (ART) Adherence","Alcohol Consumption",[78,79,80,81],"hiv","motivational interviewing","behavioral economics","alcohol use disorder","NOT_YET_RECRUITING","2026-06-17",{"date":85,"type":86},"2026-06-22","ACTUAL",{"date":88,"type":69},"2027-02-01",{"date":90,"type":69},"2028-02-01",{"name":5,"class":6},1]