[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518876":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":43,"responsibleParty":77,"collaborators":79,"id":91,"slug":26,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":98,"sex":99,"minAge":100,"maxAge":26,"enrollmentInfo":101,"targetDuration":26,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"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",[44,61],{"facility":45,"status":46,"city":47,"state":26,"zip":26,"country":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Kenya Medical Research Institute (KEMRI)","RECRUITING","Mbita","Kenya",{"type":50,"coordinates":51},"Point",[52,53],34.20736,-0.42492,{"lat":53,"lon":52},[56,59],{"name":57,"role":38,"phone":26,"phoneExt":26,"email":58},"Jaqui Mwango","jabermwango@gmail.com",{"name":60,"role":34,"phone":26,"phoneExt":26,"email":26},"James Ayieko, MBChB, MPH, PhD",{"facility":62,"status":46,"city":63,"state":26,"zip":26,"country":64,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Infectious Diseases Research Collaboration (IDRC)","Mbarara","Uganda",{"type":50,"coordinates":66},[67,68],30.64851,-0.60467,{"lat":68,"lon":67},[71,75],{"name":72,"role":38,"phone":73,"phoneExt":26,"email":74},"Brian Beesiga, MBChB","+256 (0) 312 281 479","bbeesiga@idrc-uganda.org",{"name":76,"role":34,"phone":26,"phoneExt":26,"email":26},"Moses R Kamya, MBChB, MMed, PhD",{"type":78,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[80,82,84,86,88],{"name":81,"class":6},"University of California, Berkeley",{"name":83,"class":6},"Makerere University",{"name":85,"class":6},"Infectious Diseases Research Collaboration, Uganda",{"name":87,"class":6},"Kenya Medical Research Institute",{"name":89,"class":90},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","NIH","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":102,"type":103},400,"ESTIMATED","INTERVENTIONAL",[106],"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.",[109],"HIV\u002FAIDS",[111,112,64,48,113],"Alcohol use","Biomedical HIV prevention","Counseling intervention","2025-09-02",{"date":116,"type":117},"2025-09-10","ACTUAL",{"date":119,"type":117},"2024-05-17",{"date":121,"type":103},"2027-06",{"name":5,"class":6},2]