[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100499691":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":38,"centralContacts":42,"locations":51,"responsibleParty":93,"collaborators":95,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":34,"eligibilityCriteria":105,"healthyVolunteers":101,"sex":106,"minAge":107,"maxAge":34,"enrollmentInfo":108,"targetDuration":34,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":119,"overallStatus":54,"whyStopped":34,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Varenicline + Positively Smoke Free - Mobile","EXPERIMENTAL","Offer of varenicline per package dosing with dose escalation over week 1: 0.5 mg once daily on days 1 - 3, 0.5 mg twice daily on days 4 -7, followed by 1.0 mg twice daily on days 8 to 84.\n\nOffer of Positively Smoke Free Mobile delivered by mobile phone including 42 days of content, tailored to individual quit date.",[13,14],"Drug: Varenicline","Behavioral: Positively Smoke Free Mobile (PSF-M)",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard Care","ACTIVE_COMPARATOR","Brief advice to quit tobacco Offer of referral to the national tobacco quitline",[20],"Behavioral: Standard Care",[22,29,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Varenicline","Per package dosing, tablet taken orally",[9],[28],"Champix, apovarenicline, Nocrav",{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"BEHAVIORAL","Positively Smoke Free Mobile (PSF-M)","Behavioral tobacco cessation intervention for people living with HIV, delivered via mobile phone",[9],null,{"type":30,"name":16,"description":36,"armGroupLabels":37,"otherNames":34},"Brief cessation advice plus referral to local tobacco quitline",[16],[39],{"name":40,"affiliation":5,"role":41},"Gina Kruse, MD","PRINCIPAL_INVESTIGATOR",[43,47],{"name":40,"role":44,"phone":45,"phoneExt":34,"email":46},"CONTACT","303-724-4811","gina.kruse@cuanschutz.edu",{"name":48,"role":44,"phone":49,"phoneExt":34,"email":50},"Yamila L Sierra, MPH","(303) 724-4549","yamila.sierra@cuanschutz.edu",[52,72],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"University of Colorado","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-104.83192,39.72943,{"lat":64,"lon":63},[67,69,71],{"name":40,"role":44,"phone":45,"phoneExt":34,"email":68},"Gina.Kruse@cuanschutz.edu",{"name":48,"role":44,"phone":70,"phoneExt":34,"email":50},"303-724-4549",{"name":40,"role":41,"phone":34,"phoneExt":34,"email":34},{"facility":73,"status":54,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"VHS Infectious Disease Medical Centre, CART Clinical Research Site","Chennai","Tamil Nadu","600113","India","IN",{"type":61,"coordinates":80},[81,82],80.27847,13.08784,{"lat":82,"lon":81},[85,89],{"name":86,"role":44,"phone":87,"phoneExt":34,"email":88},"N Kumarasammy","09176912007","kumarasamy@cartcrs.org",{"name":90,"role":44,"phone":91,"phoneExt":34,"email":92},"Poongulali Selvamuthu","09940560019","poongulali@cartcrs.org",{"type":94,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[96],{"name":97,"class":98},"National Cancer Institute (NCI)","NIH","100499691","phase-3-vpsf-m-for-tobacco-cessation-in-hiv-care-in-india-100499691",false,"NCT05786547","V+PSF-M for Tobacco Cessation in HIV Care in India","Varenicline and Mobile Behavioral Assistance for Tobacco Cessation in HIV Care in India","Inclusion Criteria:\n\n* Adults (≥18 years)\n* Confirmed HIV diagnosis\n* Self-reported current smoking or dual tobacco use verified either by exhaled carbon monoxide ≥7 ppm, or by positive qualitative cotinine point-of-care test\n* Able to read at 6th grade level or greater and speak Tamil, Telugu or English\n* Able to use varenicline safely based on evaluation by primary provider at VHS\n* Women of childbearing potential who consent to use a medically approved method of contraception or abstain from intercourse while taking study medication and for one month after.\n* Ready to quit or interested in quitting\n\nExclusion Criteria:\n\n* Pregnant or planning to become pregnant in the next 6 months\n* Breastfeeding\n* Myocardial infarction in past 30 days or unstable angina\n* History of liver or kidney failure\n* Alanine aminotransferase and Aspartate aminotransferase \\> 2 times upper limit of normal or creatinine clearance \\\u003C50 in past 6 months\n* History of suicide attempt\n* Current suicidal ideation\n* Untreated or unstable major depressive disorder\n* History of psychosis or on anti-psychotic medications\n* Cognitive impairment limiting ability to consent\n* Allergy to varenicline","ALL","18 Years",{"count":109,"type":110},400,"ESTIMATED","INTERVENTIONAL",[113],"PHASE3","The goal of this research study is to test an intervention to help quit tobacco use in participants with Human Immunodeficiency Virus (HIV).\n\nThe study interventions used in this research study are:\n\n* Positively Smoke Free - Mobile (PSF-M) (mobile behavioral program)\n* Varenicline (or Chantix, apovarenicline, Champix or Nocrav)",[116,117,118],"Human Immunodeficiency Virus","Smoking Cessation","Smoking, Tobacco",[116,117,118],"2025-06-13",{"date":122,"type":123},"2025-06-15","ACTUAL",{"date":125,"type":123},"2024-01-02",{"date":127,"type":110},"2026-07-22",{"name":5,"class":6},2]