[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518876":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":43,"responsibleParty":79,"collaborators":81,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":101,"sex":102,"minAge":103,"maxAge":26,"enrollmentInfo":104,"targetDuration":26,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care (Control)","ACTIVE_COMPARATOR","Standard of care; alcohol counseling per Ministry of Health (MoH) guidelines",[13],"Behavioral: Standard of Care",{"label":15,"type":16,"description":17,"interventionNames":18},"Healthy Living Intervention","EXPERIMENTAL","Healthy Living Intervention in-person alcohol counseling with booster phone calls",[19],"Behavioral: Healthy Living Intervention (HLI)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Healthy Living Intervention (HLI)","The Healthy Living Intervention (HLI) is a brief alcohol counseling intervention developed using the Information, Motivation, and Behavioral skills (IMB) model, a framework in which information, motivation, and behavioral skills are key determinants of health behavior. Participants initiating PrEP will be randomized to either HLI or standard of care alcohol counseling.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard of Care","Participants who are randomized to the control arm will receive basic alcohol counseling through the Ministry of Health if it is provided as standard of care.",[9],[32],{"name":33,"affiliation":5,"role":34},"Gabriel Chamie, MD, MPH","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Kara Marson, MPH","CONTACT","650-346-5774","kara.marson@ucsf.edu",{"name":33,"role":38,"phone":26,"phoneExt":26,"email":42},"gabriel.chamie@ucsf.edu",[44,62],{"facility":45,"status":46,"city":47,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Kenya Medical Research Institute (KEMRI)","RECRUITING","Mbita","Kenya","KE",{"type":51,"coordinates":52},"Point",[53,54],34.20736,-0.42492,{"lat":54,"lon":53},[57,60],{"name":58,"role":38,"phone":26,"phoneExt":26,"email":59},"Jaqui Mwango","jabermwango@gmail.com",{"name":61,"role":34,"phone":26,"phoneExt":26,"email":26},"James Ayieko, MBChB, MPH, PhD",{"facility":63,"status":46,"city":64,"state":26,"zip":26,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Infectious Diseases Research Collaboration (IDRC)","Mbarara","Uganda","UG",{"type":51,"coordinates":68},[69,70],30.64851,-0.60467,{"lat":70,"lon":69},[73,77],{"name":74,"role":38,"phone":75,"phoneExt":26,"email":76},"Brian Beesiga, MBChB","+256 (0) 312 281 479","bbeesiga@idrc-uganda.org",{"name":78,"role":34,"phone":26,"phoneExt":26,"email":26},"Moses R Kamya, MBChB, MMed, PhD",{"type":80,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[82,84,86,88,90],{"name":83,"class":6},"University of California, Berkeley",{"name":85,"class":6},"Makerere University",{"name":87,"class":6},"Infectious Diseases Research Collaboration, Uganda",{"name":89,"class":6},"Kenya Medical Research Institute",{"name":91,"class":92},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","NIH","100518876","the-outreach-and-prevention-at-alcohol-venues-in-east-africa-study-opal-east-africa--aim-2-opal-aim-2-100518876",false,"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",true,"ALL","18 Years",{"count":105,"type":106},400,"ESTIMATED","INTERVENTIONAL",[109],"NA","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.",[112],"HIV\u002FAIDS",[114,115,65,48,116],"Alcohol use","Biomedical HIV prevention","Counseling intervention","2025-09-02",{"date":119,"type":120},"2025-09-10","ACTUAL",{"date":122,"type":120},"2024-05-17",{"date":124,"type":106},"2027-06",{"name":5,"class":6},2]