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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA036445-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Georgetown University | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this study is to determine whether Positively Smoke Free group therapy is more effective at promoting cessation than standard care.
There are 1.1 million persons living with HIV (PLWH) in the US, 60% of them smoke cigarettes, and 75% of these are interested in quitting. Almost none are currently accessing smoking cessation interventions designed to meet their specific needs and concerns.
Cigarette smoking is responsible for 24% of deaths among PLWH, and 30% of non-AIDS defining malignancies. It is driving the alarming rise in cardiac events and lung cancers in this highly vulnerable population. The lack of access to proven, effective, culturally appropriate tobacco cessation services represents a health disparity of the first order. The psychosocial profile of the PLWH-smoker community, characterized by high rates of psychiatric comorbidity, drug and alcohol use, and low levels of social support, suggests that achieving high cessation rates will be a great challenge.
Positively Smoke Free (PSF) is an intensive, multisession, group cessation program specifically developed for PLWH smokers. A pilot study of PSF yielded promising results. This proposal aims (1) to perform a definitive efficacy study of PSF by comparing 6-month biochemically confirmed abstinence rates in subjects randomized to PSF vs. standard care in a cohort of 450 PLWH smokers, (2) to determine the sociobehavioural moderators and mediators associated with successful cessation, and (3) to complete a careful cost analysis of PSF in order to estimate the incremental cost per quit associated program participation.
If PSF is proven to be effective it will establish a new treatment option for PLWH smokers. Determination of moderators and mediators of program success will provide insight into the mode of action of the intervention and will help guide the development of additional treatment strategies in the future. Finally, the cost analyses will provide critical information about the feasibility of program dissemination and implementation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positively Smoke Free group treatment | Experimental | Eight 90 minute group sessions (6-8 HIV-infected smokers per group) led by a pair of trained group leaders: a "professional" with psychology or social work training and a "peer" HIV-infected ex-smoker with tobacco treatment training. All subjects will be offered a 3 month supply of nicotine patches |
|
| Standard care | Active Comparator | Brief (<5 minutes) advice to quit Offer of nicotine patches Self-help brochure |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positively Smoke Free group treatment | Behavioral | See Arm Description |
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| Measure | Description | Time Frame |
|---|---|---|
| 6 month abstinence from cigarettes | Biochemically-confirmed 7-day point-prevalence abstinence from cigarettes at the 6-month timepoint | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cost per incremental quit | Estimated cost per incremental quit | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Shuter, MD | Montefiore Medical Center/Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States | ||
| Montefiore Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22732470 | Background | Moadel AB, Bernstein SL, Mermelstein RJ, Arnsten JH, Dolce EH, Shuter J. A randomized controlled trial of a tailored group smoking cessation intervention for HIV-infected smokers. J Acquir Immune Defic Syndr. 2012 Oct 1;61(2):208-15. doi: 10.1097/QAI.0b013e3182645679. | |
| 39101506 | Derived | Mdege ND, Shah S, Dogar O, Pool ER, Weatherburn P, Siddiqi K, Zyambo C, Livingstone-Banks J. Interventions for tobacco use cessation in people living with HIV. Cochrane Database Syst Rev. 2024 Aug 5;8(8):CD011120. doi: 10.1002/14651858.CD011120.pub3. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 3, 2017 | Sep 29, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard Care | Behavioral | See Arm Description |
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| The Bronx |
| New York |
| 10804 |
| United States |