[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567451":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":36,"locations":42,"responsibleParty":60,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":9,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":25,"enrollmentInfo":75,"targetDuration":25,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":88,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"University of North Carolina, Chapel Hill","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Treat4All","EXPERIMENTAL","Treat4All will be based on Fleming's Project TrEAT, culturally adapted to the Malawi context, and enhanced to include content on HIV prevention and treatment activities (PrEP use for those at risk for HIV; ART adherence and viral suppression for PWH). The sessions will provide personalized feedback on alcohol use; a description of adverse effects of alcohol and its role in STI acquisition; a review of reasons to cut down or quit; risky situations, and how to handle them; and optional goal setting. Alcohol-related content of sessions will include reviewing drinking patterns, harmful effects of drinking, and alcohol use behavior change strategies. HIV prevention and treatment content of session will include strategies for increasing HIV care engagement, including ART initiation and adherence and PrEP use for those at risk for HIV. Each session will use cognitive problem solving, skills building, and goal setting to facilitate knowledge, motivation, and behavior to reduce heavy drinking",[13,14],"Behavioral: Treat4All","Behavioral: Standard of care (control arm)",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard of care (control arm)","ACTIVE_COMPARATOR","Participants in the control arm will receive usual care (UC). This includes sexual risk reduction counseling that integrates messaging on reducing alcohol use prior to sex and the recommendation to abstain from alcohol while on ART. Participants in this arm will continue to receive all STI or HIV-related services.",[14],[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","An alcohol reduction evidence-based intervention integrated with HIV status-neutral counseling",[9],null,{"type":22,"name":16,"description":27,"armGroupLabels":28,"otherNames":25},"Sexual risk reduction counseling",[16,9],[30,33],{"name":31,"affiliation":5,"role":32},"Angela Parcesepe, PhD, MPH, MSW","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":35,"role":32},"Kathryn Lancaster, PhD","Wake Forest",[37],{"name":38,"role":39,"phone":40,"phoneExt":25,"email":41},"Angela Parcesepe, PhD","CONTACT","919-843-9291","angela_parcesepe@unc.edu",[43],{"facility":44,"status":45,"city":46,"state":25,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Bwaila Hospital","RECRUITING","Lilongwe","Malawi","MW",{"type":50,"coordinates":51},"Point",[52,53],33.78725,-13.96692,{"lat":53,"lon":52},[56],{"name":57,"role":39,"phone":58,"phoneExt":25,"email":59},"Mitch Matoga","+2651755056","mmatoga@email.unc.edu",{"type":61,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[63],{"name":64,"class":65},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","NIH","100567451","enhancing-hiv-prevention-and-reducing-alcohol-use-among-people-receiving-sti-care-in-lilongwe-malawi-100567451",false,"NCT06668363","Enhancing HIV Prevention and Reducing Alcohol Use Among People Receiving STI Care in Lilongwe, Malawi","Enhancing HIV Prevention and Reducing Alcohol Use Among People Receiving STI Care in Lilongwe, Malawi: A Pilot Implementation Study","Inclusion Criteria:\n\n* Men and women age 18 years or older.\n* Receiving care at Bwaila STI clinic.\n* Report recent heavy drinking (greater than or equal to 4 drinks a day in the past 30 days for men and greater than or equal to 3 drinks a day in the past 30 days for women\n* Willing to receive an HIV test at study enrollment, if not previously diagnosed Report not taking ART, recent suboptimal adherence to ART, or recent history of unsuppressed HIV viral load \\[for PWH\\] or no recent oral PrEP use (self-reported taking no PrEP pills in past 7 days) \\[for those at risk of HIV\\]\n* Plan to reside in the Lilongwe area for at least 6 months.\n* Not participating in other HIV or alcohol programs\n* Ability and willingness of participant to provide informed consent.\n* Willingness to provide contact\u002Flocator information to be contacted for follow up study activities.\n\nExclusion Criteria:\n\n* Unable to participate in study activities due to psychological disturbance, cognitive impairment, or threatening behavior\n* Pregnant or breastfeeding\n* At risk of experiencing alcohol-related withdrawal symptoms\n* Acute physical or mental illness, including suicidal thoughts or behaviors\n* Participating in in other HIV or alcohol programs\n* Active drug dependence that would interfere with adherence to study requirements.\n* History of using injectible PrEP\n* Any other condition that in the opinion of the study investigator would compromise the safety of the study participant or study staff or would prevent proper conduct of the study.","ALL","18 Years",{"count":76,"type":77},160,"ESTIMATED","INTERVENTIONAL",[80],"NA","Purpose: To evaluate short-term efficacy and implementation of Treat4All, an alcohol reduction evidence-based intervention, for decreasing heavy drinking and optimizing HIV outcomes (viral suppression among People with HIV (PWH); Pre-exposure prophylaxis (PrEP) use among those at high risk of HIV)\n\nParticipants: Approximately 160 participants aged 18 years or older will be enrolled into this study.\n\nEligible participants will be recruited from two groups of individuals:\n\nPersons at risk of HIV: Individuals receiving (STI) care who report recent heavy drinking (n=80) and no recent use of PrEP. Persons with HIV: Individuals with HIV who report recent heavy drinking and either a history of unsuppressed viral load or recent suboptimal adherence to ART (n=80).\n\nProcedures (methods): Pilot two-arm randomized controlled trial (1:1; Treat4All Intervention vs Usual Care)",[83,84,85,86,87],"Alcohol Consumption","PrEP Uptake","Recent Heavy Drinking","HIV Prevention","HIV Treatment",[89,90,86,91,92],"PrEP","HIV","Alcohol reduction","Alcohol","2026-01-28",{"date":95,"type":96},"2026-01-30","ACTUAL",{"date":98,"type":96},"2024-12-12",{"date":100,"type":77},"2026-06",{"name":5,"class":6},1]