[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657216":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":37,"studyPopulation":19,"armGroups":38,"interventions":49,"overallOfficials":64,"centralContacts":68,"locations":77,"responsibleParty":152,"collaborators":154,"id":158,"slug":159,"hasResults":160,"nctId":161,"briefTitle":162,"officialTitle":162,"acronym":19,"eligibilityCriteria":163,"healthyVolunteers":160,"sex":164,"minAge":165,"maxAge":19,"enrollmentInfo":166,"targetDuration":19,"studyType":169,"phases":170,"briefSummary":172,"conditions":173,"keywords":176,"overallStatus":180,"whyStopped":19,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":190},{"fullName":5,"class":6},"Yale University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":19},[9],{"measure":10,"description":11,"timeFrame":12},"7-day point-prevalence abstinence confirmed by exhaled carbon monoxide (eCO)","Self-reported tobacco abstinence over the past 7 days, confirmed by eCO of \\\u003C6ppm","12 weeks",[14,17,21,25,26,28],{"measure":10,"description":15,"timeFrame":16},"Self-reported tobacco abstinence over the past 7 days, confirmed by eCO \\\u003C6ppm","24 weeks",{"measure":18,"description":19,"timeFrame":20},"Self-reported 7 day point prevalence smoking abstinence",null,"Week 18",{"measure":22,"description":23,"timeFrame":24},"Cigarettes per day","Self-reported reduction in mean number of cigarettes per day","Week 12",{"measure":22,"description":23,"timeFrame":20},{"measure":22,"description":23,"timeFrame":27},"Week 24",{"measure":29,"description":30,"timeFrame":27},"HIV viral load, detectable","HIV viral load greater than 50 copies per milliliter of blood and detectable on standard lab test",{"allocation":32,"interventionModel":33,"interventionModelDescription":19,"primaryPurpose":34,"observationalModel":19,"timePerspective":19,"maskingInfo":35},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":36,"maskingDescription":19,"whoMasked":19},"NONE","Cigarette smoking is a major threat to health among persons with HIV (PWH). Via direct effects and link with TUD-related conditions (behaviors and medical conditions that drive poor outcomes), smoking causes more lost life years than treated HIV. Cardiovascular disease, lung disease, and cancer are indeed leading causes of death among PWH. Guidelines recommend medications for TUD (MTUD) and behavioral interventions to promote smoking cessation. Data also support use of contingency management (CM) to target smoking cessation and treatment adherence. Yet, adoption of these approaches in HIV clinics has been suboptimal. Past projects have found that clinical pharmacist-prescribed TUD treatment involving MTUD with CM integrated in HIV clinics offers a feasible, acceptable, and practical solution to overcome multi-level challenges to adoption of such TUD treatments. Past projects have identified opportunities for enhanced patient-centeredness with: 1) creation of teamlets (little teams) to collaborate with clinical pharmacists to address challenges with MTUD access and implement CM; 2) use of multi-target CM to reward progress in addressing TUD-related care, HIV, and TUD-related conditions plus smoking abstinence; 3) promotion of patient choice in MTUD selection and flexibility for remote versus in-person services; and 4) focus on reducing health disparities. Grounded in the socioecological model and implementation science principles, this project will include a randomized trial to compare the effectiveness of teamlet-delivered CM as an adjunct to clinical pharmacist prescribed MTUD with teamlet telephone booster over 12 weeks among 794 PWH receiving care in one of six sites. This study will develop procedures directly informed by perspectives of PWH. The primary outcome is exhaled carbon monoxide-confirmed 7-day smoking abstinence at week 12 (Aim 1). This study will explore whether the effectiveness of the interventions differ based on access to basic needs (Aim 2). Consistent with a hybrid type 2 effectiveness-implementation approach, this study will include an implementation-focused evaluation incorporating perspectives of PWH, clinical pharmacists, and other teamlet members using qualitative and quantitative data; measures of intervention delivery; and economic viability via micro-costing and cost-effectiveness analyses (Aim 3). The research team brings together expertise in HIV, pharmacy, addiction medicine, smoking cessation, CM, clinical trials, health disparities, implementation science, and health economics. Innovative features of the proposal are: 1) clinical pharmacist delivered TUD treatment with teamlets integrated in HIV clinics; and 2) collaboratively created multi-target CM program to address smoking, HIV, and TUD-related conditions. The study has potential for high impact by generating data on and associated costs of a reproducible, scalable, sustainable strategy suitable for transforming TUD treatment in HIV clinics nationally.",[39,45],{"label":40,"type":41,"description":19,"interventionNames":42},"Clinical pharmacist-prescribed MTUD with teamlet booster","EXPERIMENTAL",[43,44],"Drug: nicotine patch, nicotine gum, nicotine lozenge, varenicline, bupropion","Behavioral: Teamlet booster",{"label":46,"type":41,"description":19,"interventionNames":47},"Clinical pharmacist-prescribed MTUD + teamlet delivered CM and booster",[43,48,44],"Behavioral: Multi-target Contingency Management",[50,55,60],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":19},"DRUG","nicotine patch, nicotine gum, nicotine lozenge, varenicline, bupropion","Clinical pharmacist prescribed MTUD, based on participant choice: nicotine patch, nicotine gum, nicotine lozenge, varenicline, bupropion. Participants on nicotine replacement may choose both a long acting (patch) and short acting (gum, lozenge) option to use at the same time.",[46,40],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":19},"BEHAVIORAL","Multi-target Contingency Management","Participants will earn prizes for progress towards tobacco abstinence, achieving tobacco abstinence, and progress in improving HIV and other related health conditions.",[46],{"type":56,"name":61,"description":62,"armGroupLabels":63,"otherNames":19},"Teamlet booster","Participants will receive a booster call by a teamlet member after MTUD is prescribed to address any MTUD access issues and answer MTUD related questions.",[46,40],[65],{"name":66,"affiliation":5,"role":67},"E. Jennifer Edelman, MD, MHS","PRINCIPAL_INVESTIGATOR",[69,73],{"name":66,"role":70,"phone":71,"phoneExt":19,"email":72},"CONTACT","203-737-7115","ejennifer.edelman@yale.edu",{"name":74,"role":70,"phone":75,"phoneExt":19,"email":76},"June-Marie Weiss, MA, MEd","203-737-3347","junemarie.weiss@yale.edu",[78,96,110,125,137],{"facility":79,"status":19,"city":80,"state":81,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"Bridgeport Hospital Primary Care Center Infectious Disease Clinic","Bridgeport","Connecticut","06610","United States","US",{"type":86,"coordinates":87},"Point",[88,89],-73.18945,41.17923,{"lat":89,"lon":88},[92],{"name":93,"role":70,"phone":94,"phoneExt":19,"email":95},"Manisha Gupta, MD","(203) 384-3079","Manisha.Gupta@bpthosp.org",{"facility":97,"status":19,"city":98,"state":81,"zip":99,"country":83,"countryCode":84,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Yale Center for Infectious Diseases","New Haven","06511",{"type":86,"coordinates":101},[102,103],-72.92816,41.30815,{"lat":103,"lon":102},[106],{"name":107,"role":70,"phone":108,"phoneExt":19,"email":109},"Erika Payne, PharmD","(203) 200-6899","erika.payne@ynhh.org",{"facility":111,"status":19,"city":112,"state":113,"zip":114,"country":83,"countryCode":84,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Center for Comprehensive Care at Jersey City Medical Center","Jersey City","New Jersey","07305",{"type":86,"coordinates":116},[117,118],-74.07764,40.72816,{"lat":118,"lon":117},[121],{"name":122,"role":70,"phone":123,"phoneExt":19,"email":124},"Nina Cooperman, PhD","(201) 395-7600","cooperna@rwjms.rutgers.edu",{"facility":126,"status":19,"city":127,"state":113,"zip":128,"country":83,"countryCode":84,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Center for Comprehensive Care at St. Joseph's Health","Paterson","07503",{"type":86,"coordinates":130},[131,132],-74.17181,40.91677,{"lat":132,"lon":131},[135],{"name":122,"role":70,"phone":136,"phoneExt":19,"email":124},"(973) 754-4701",{"facility":138,"status":19,"city":139,"state":140,"zip":141,"country":83,"countryCode":84,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Special Treatment And Research (STAR) at SUNY Downstate","Brooklyn","New York","11203",{"type":86,"coordinates":143},[144,145],-73.94958,40.6501,{"lat":145,"lon":144},[148],{"name":149,"role":70,"phone":150,"phoneExt":19,"email":151},"Jessica Yager, MD","(718) 270-3745","jessica.yager@downstate.edu",{"type":153,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[155],{"name":156,"class":157},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","NIH","100657216","phase-4-smoking-cessation-medication-and-rewards-using-a-teamlet-to-treat-tobacco-use-disorder-smarttt-20-among-persons-with-hiv-a-multi-site-hybrid-type-2-effectiveness-implementation-trial-100657216",false,"NCT07835555","Smoking Cessation Medication And Rewards Using a Teamlet to Treat Tobacco Use Disorder (SMARTTT 2.0) Among Persons With HIV: A Multi-site Hybrid Type 2 Effectiveness-implementation Trial","Inclusion Criteria:\n\n* Have been diagnosed with HIV;\n* Receive care at one of the participating sites;\n* Are \\>18 years old;\n* Have smoked \\>100 cigarettes lifetime;\n* Smoke everyday or some days;\n* Smoke, on average, \\>5 cigarettes per day; and\n* Provide written informed consent.\n\nExclusion Criteria:\n\n* Exclusive use of non-cigarette tobacco or nicotine products, including e-cigarettes;\n* Self-report or urine testing confirming pregnancy, nursing, or trying to conceive;\n* Life-threatening or unstable medical, surgical, or psychiatric condition;\n* Anticipate being unable to return for follow-up for any reason, such as travel, planned procedure;\n* Inability to provide \\>1 form of contact information;\n* Inability to read or understand English or Spanish.","ALL","18 Years",{"count":167,"type":168},794,"ESTIMATED","INTERVENTIONAL",[171],"PHASE4","Cigarette smoking is an important cause of illness and death among persons with HIV (PWH). This project will study the impact of adding contingency management (use of financial rewards) to receiving medications and counseling on promoting smoking abstinence and other health outcomes among PWH. As treatments will be provided by clinical pharmacists and other team members in HIV clinics, factors relevant for implementing this model to inform real-world practice will also be evaluated.",[174,175],"Tobacco Use Disorder\u002FCigarette Smoking","HIV",[177,178,179,175],"tobacco use disorder","cigarette smoking","contingency management","NOT_YET_RECRUITING","2026-09-16",{"date":183,"type":184},"2026-09-23","ACTUAL",{"date":186,"type":168},"2027-09-30",{"date":188,"type":168},"2031-09-30",{"name":5,"class":6},5]