[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576826":3},{"organization":4,"outcomesModule":7,"designInfo":20,"detailedDescription":29,"studyPopulation":19,"armGroups":30,"interventions":53,"overallOfficials":72,"centralContacts":76,"locations":85,"responsibleParty":102,"collaborators":104,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":19,"eligibilityCriteria":115,"healthyVolunteers":112,"sex":116,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":19,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":130,"overallStatus":133,"whyStopped":19,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"University of Chicago","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":19},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"7-day point prevalence abstinence (PPA)","Defined as self-reported no smoking in the past 7 days + Carbon Monoxide (CO)\\\u003C7 ppm","36 months",{"measure":14,"description":15,"timeFrame":12},"Dried blood spot phosphatidylethanol (PEth)","PEth level of less than 50ng\u002Fdl for cessation from heavy drinking linked (P30D)",{"measure":17,"description":18,"timeFrame":12},"Timeline Follow-Back (TLFB)","denial of self-reported heavy drinking days (denying any prior 7-day period with \\>7 drinks or any single day with 4 drinks) for the past 30 days",null,{"allocation":21,"interventionModel":22,"interventionModelDescription":19,"primaryPurpose":23,"observationalModel":19,"timePerspective":19,"maskingInfo":24},"RANDOMIZED","FACTORIAL","TREATMENT",{"masking":25,"maskingDescription":19,"whoMasked":26},"DOUBLE",[27,28],"INVESTIGATOR","OUTCOMES_ASSESSOR","This study was reviewed and approved for data analysis by the University of Chicago.\n\nThe research portion of this study was also submitted to and is pending approval from:\n\nBoard Name: AMREF ETHICAL AND SCIENTIFIC REVIEW COMMITTEE (ESRC) Board Affiliation: The AMREF ESRC is affiliated with AMREF Health Africa and accredited by National Commission for Science, Technology and Innovation (NACOSTI) since 200 Phone: +254 20 699 4000 Email: esrc.kenya@amref.org\n\nAddress:\n\nLangata Road PO Box 27691-00506 Nairobi, Kenya",[31,38,43,48],{"label":32,"type":33,"description":34,"interventionNames":35},"Experimental: Cystine (CYT) + Positively Smoke Free","EXPERIMENTAL","Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation and alcohol reduction\n\nCystine--used for smoking cessation and alcohol reduction",[36,37],"Drug: Cystine","Behavioral: Positively Smoke Free",{"label":39,"type":33,"description":40,"interventionNames":41},"Experimental: Cystine + Standard of Care","Cystine--used for smoking cessation and alcohol reduction\n\nStandard of Care--brief advice to quit provided in a standardized format bupropion--used for smoking cessation",[36,42],"Other: Standard of Care",{"label":44,"type":33,"description":45,"interventionNames":46},"Experimental: Placebo + Positively Smoke Free","Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation and alcohol reduction\n\nPlacebo--matched to bupropion",[37,47],"Other: Placebo",{"label":49,"type":50,"description":51,"interventionNames":52},"Placebo Comparator: Placebo + Standard of Care.","PLACEBO_COMPARATOR","Placebo--matched to bupropion\n\nStandard of Care--brief advice to quit provided in a standardized format",[47,42],[54,59,64,68],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":19},"DRUG","Cystine","Used for smoking cessation and alcohol reduction",[32,39],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":19},"BEHAVIORAL","Positively Smoke Free","An 8 session tailored behavioral treatment for smoking cessation and alcohol reduction",[32,44],{"type":6,"name":65,"description":66,"armGroupLabels":67,"otherNames":19},"Placebo","Matched to cystine",[44,49],{"type":6,"name":69,"description":70,"armGroupLabels":71,"otherNames":19},"Standard of Care","Standardized brief advice to quit smoking (standard of care)",[39,49],[73],{"name":74,"affiliation":5,"role":75},"Seth Himelhoch","PRINCIPAL_INVESTIGATOR",[77,82],{"name":78,"role":79,"phone":80,"phoneExt":19,"email":81},"Walter Mchembere","CONTACT","+254 20 3908219","wmchembere@cihebkenya.org",{"name":83,"role":79,"phone":80,"phoneExt":19,"email":84},"Emily Koech, MD","ekoech@cihebkenya.org",[86,97],{"facility":87,"status":19,"city":88,"state":19,"zip":19,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":19},"Mathari National Teaching and Referral Hospital","Nairobi","Kenya","KE",{"type":92,"coordinates":93},"Point",[94,95],36.81667,-1.28333,{"lat":95,"lon":94},{"facility":98,"status":19,"city":88,"state":19,"zip":19,"country":89,"countryCode":90,"cosmosGeoPoint":99,"geoPoint":101,"contacts":19},"Riruta Health Centre",{"type":92,"coordinates":100},[94,95],{"lat":95,"lon":94},{"type":103,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[105,108],{"name":106,"class":107},"National Cancer Institute (NCI)","NIH",{"name":109,"class":6},"University of Maryland","100576826","phase-3-optimizing-treatment-of-co-occurring-smoking-and-unhealthy-alcohol-use-among-pwh-in-nairobi-kenya-100576826",false,"NCT06790342","Optimizing Treatment of Co-occurring Smoking and Unhealthy Alcohol Use Among PWH in Nairobi, Kenya","Inclusion Criteria:\n\n1. Confirmed chart diagnosis of HIV\n2. At least 18 years or age\n3. Currently self-reports smoking (has smoked a cigarette within the past 7 days) and has expired air Carbon Monoxide (CO) 6ppm. Expired air CO provides an accurate indirect measure of carboxyhemoglobin (COHb) level and is a standard biochemical method for assessing a smoker's level of intake.\n4. Motivation to quit smoking within the next 6 months (score 6-8 on the Abrams and Biener Readiness to Quit Ladder)\n5. Meets criteria for heavy drinking: National Institute on Alcohol Abuse and Alcoholism (NIAAA) guidelines suggest gender-based criteria for heavy drinking but note that lower thresholds may be needed for people with a medical condition. PWH show increased physiologic injury and decreased survival at lower levels of alcohol consumption than those without HIV. Thus, we will use the lower limit for alcohol misuse\u002Fheavy drinking from the NIAAA guidelines for all study candidates, i.e. drinking 4+ drinks on a given day or \\>7 drinks\u002Fweek over the past 30 days\n6. Able to speak English (in Nairobi spoken English is near universal as English is an official language of Kenya)\n7. Willingness to accept behavioral and\u002For pharmacologic tobacco and alcohol treatment\n8. Willingness and ability to provide informed consent to participate.\n\nExclusion Criteria:\n\n1. Current receipt of any tobacco or alcohol use behavioral or pharmacologic treatment\n2. Previous allergic reaction or hypersensitivity to cytosine (CYT) (unlikely since CYT is not available in Kenya)\n3. History of severe alcohol withdrawal symptoms in the past 12 months, including seizure or hallucinations\n4. Pregnant, nursing, or becoming pregnant during the study\n5. Current use of any medication that would interfere with the protocol in the opinion of the Medically Accountable Physician\n6. Meets criteria for possible dementia by scoring below 10 on the Hopkins HIV Dementia Scale\n7. Unstable psychiatric illness\n8. Known plans to re-locate or travel away from the study site for more than two consecutive months during the study period\n9. Expected survival of less than 6 months.","ALL","18 Years","80 Years",{"count":120,"type":121},300,"ESTIMATED","INTERVENTIONAL",[124],"PHASE3","People with HIV (PWH) smoke tobacco cigarettes and drink alcohol at higher rates than the general population, both in the US and internationally, including low- and middle-income countries. Now that effective antiretroviral therapy is available throughout most of the world, PWH are surviving long enough to manifest the lethal consequences of both their smoking and drinking. In this project, the investigational team aims to advance the knowledge and understanding of treatment strategies (i.e. individual intensive counseling ± pharmacotherapy with cytisine) that target both tobacco and alcohol use among PWH in Kenya, a resource constrained environment, and to generate outcome data that may benefit co-users of tobacco and alcohol throughout the world.",[127,128,129],"HIV","Tobacco Use","Alcohol Use Disorder",[127,131,132],"Tobacco Cessation","Alcohol Reduction","NOT_YET_RECRUITING","2026-07-29",{"date":136,"type":137},"2026-07-30","ACTUAL",{"date":139,"type":121},"2026-07-31",{"date":141,"type":121},"2029-06-01",{"name":5,"class":6},2]