[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516498":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":32,"locations":42,"responsibleParty":70,"collaborators":74,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":12,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":102,"overallStatus":44,"whyStopped":12,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"University of Louisville","OTHER",[8,13,19],{"label":9,"type":10,"description":11,"interventionNames":12},"AUDIT \u003C8","NO_INTERVENTION","Participants whose audit score is less than eight are assigned to this arm. AUDIT is a 10-item screening tool developed by the World Health Organization (WHO) to assess alcohol consumption, dependence, and experience of alcohol-related harm. AUDIT \\\u003C8 is non-hazardous.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"AUDIT >8 + SBIRT","EXPERIMENTAL","This is an experimental arm, and AUDIT \\>8 is hazardous. The goal is to make connections on the impact of the SBIRT intervention on PrEP engagement and alcohol use among the participants to create a full picture of the impact of the intervention on groups exhibiting different types of alcohol use.",[18],"Behavioral: Screening, Brief Intervention, Referral to Treatment (SBIRT)",{"label":20,"type":10,"description":21,"interventionNames":12},"AUDIT > 8 NO SBIRT","This is NOT an experimental arm, despite an AUDIT score \\> 8.",[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":12},"BEHAVIORAL","Screening, Brief Intervention, Referral to Treatment (SBIRT)","SBIRT has been defined by SAMHSA as a comprehensive, integrated, public health approach to the delivery of early intervention for individuals with risky alcohol and drug use and the timely referral to more intensive substance abuse treatment for those who have substance abuse disorders. There is consensus that a comprehensive SBIRT model includes screening, brief intervention\u002Fbrief treatment, and referral to treatment. In addition there are following characteristics:\n\n* It is brief (e.g., typically about 5-10 minutes for brief interventions; about 5 to 12 sessions for brief treatments)\n* The screening is universal.\n* One or more specific behaviors related to risky alcohol and drug use are targeted.\n* The services occur in a public health non-substance abuse treatment setting.\n* It is comprehensive (comprised of screening, brief intervention\u002Ftreatment, and referral to treatment).\n* Strong research or experiential evidence supports the model's effectiveness.",[14],[29],{"name":30,"affiliation":5,"role":31},"Shirish Barve, PhD","PRINCIPAL_INVESTIGATOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":12,"email":37},"Andrea Reyes Vega, MD, MSc","CONTACT","502852884","a0reye02@louisville.edu",{"name":39,"role":35,"phone":40,"phoneExt":12,"email":41},"Vania Remenik, MD","5028528884","vania.remenik@louisville.edu",[43],{"facility":5,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Louisville","Kentucky","40202","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-85.75941,38.25424,{"lat":54,"lon":53},[57,60,61,62,65,67,69],{"name":58,"role":35,"phone":59,"phoneExt":12,"email":37},"Andrea M Reyes Vega, MD,MSc","502-852-8884",{"name":39,"role":35,"phone":12,"phoneExt":12,"email":41},{"name":30,"role":31,"phone":12,"phoneExt":12,"email":12},{"name":63,"role":64,"phone":12,"phoneExt":12,"email":12},"Smita Ghare, PhD","SUB_INVESTIGATOR",{"name":66,"role":64,"phone":12,"phoneExt":12,"email":12},"Jelani Kerr, PhD",{"name":68,"role":64,"phone":12,"phoneExt":12,"email":12},"Lesley Harris, PhD",{"name":34,"role":64,"phone":12,"phoneExt":12,"email":12},{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"SPONSOR_INVESTIGATOR","Shirish S Barve","Professor",[75],{"name":76,"class":77},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","NIH","100516498","alcohol-misuse-gut-microbial-dysbiosis-and-prep-care-continuum-application-and-efficacy-of-sbirt-intervention-100516498",false,"NCT06005298","Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum: Application and Efficacy of SBIRT Intervention","Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum: Application and Efficacy of SBIRT Intervention (SEAL)","SEAL","Inclusion Criteria:\n\n* Age: 18-85 years\n* Confirmation of seronegative HIV, Hep B, and Hep C status\n* PrEP users\n* English-speaking or Spanish speaking\n* Cognitively competent to provide consent\n* Attend a participating healthcare facility\n\nExclusion Criteria:\n\n* Inability to consent\n* Existing diagnosis of major psychiatric illness\n* Unstable medical conditions (e.g., cancer)\n* Taking immunosuppressants or Chemotherapy\n* Taking daily antibiotics or probiotics\n* Severe gastrointestinal\u002Fliver disease\n* Autoimmune disease",true,"ALL","18 Years","85 Years",{"count":91,"type":92},120,"ESTIMATED","INTERVENTIONAL",[95],"NA","This randomized control trial study among Pre-exposure prophylactic users (PrEP) aims to learn and determine the efficacy of Screening, brief intervention, and referral to treatment (SBRIT) in reducing the risk of alcohol use. The main questions it aims to answer are:\n\n1. How alcohol use impacts the PrEP continuum and to understand how early intervention and treatment approach affects alcohol use and PrEP adherence.\n2. Investigate the effectiveness of the SBIRT intervention in preventing hazardous alcohol use and its impact on gut dysbiosis in PrEP users.\n3. To determine alterations in the gut microbiome (dysbiosis), intestinal homeostasis, systemic inflammation, and markers of liver disease associated with hazardous alcohol use among PrEP users.",[98,99,100,101],"Alcohol Use Disorder","Risk Behavior, Health","Dysbiosis","HIV Infections",[103,104,105],"PrEP","Alcohol","SBIRT","2024-07-17",{"date":108,"type":109},"2024-07-22","ACTUAL",{"date":111,"type":109},"2023-08-01",{"date":113,"type":92},"2027-10-24",{"name":72,"class":6},1]