A Trial of Positively Smoke Free Group Therapy for HIV-infected Smokers
2 other identifiers
interventional
450
1 country
2
Brief Summary
The purpose of this study is to determine whether Positively Smoke Free group therapy is more effective at promoting cessation than standard care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2014
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2014
CompletedFirst Posted
Study publicly available on registry
February 27, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedOctober 6, 2025
September 1, 2025
3.8 years
February 25, 2014
September 30, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
6 month abstinence from cigarettes
Biochemically-confirmed 7-day point-prevalence abstinence from cigarettes at the 6-month timepoint
6 months
Secondary Outcomes (1)
Cost per incremental quit
6 months
Study Arms (2)
Positively Smoke Free group treatment
EXPERIMENTALEight 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 COMPARATORBrief (\<5 minutes) advice to quit Offer of nicotine patches Self-help brochure
Interventions
See Arm Description
Eligibility Criteria
You may qualify if:
- HIV-infection
- Receives care at Montefiore Medical Center or Georgetown University
- Motivated to quit
- Willing to attend eight 90 minute group sessions
You may not qualify if:
- Pregnancy or breastfeeding
- Contraindication to nicotine patch use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Montefiore Medical Centerlead
- Georgetown Universitycollaborator
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (2)
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Montefiore Medical Center
The Bronx, New York, 10804, United States
Related Publications (2)
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.
PMID: 22732470BACKGROUNDMdege 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.
PMID: 39101506DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Shuter, MD
Montefiore Medical Center/Albert Einstein College of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2014
First Posted
February 27, 2014
Study Start
May 1, 2014
Primary Completion
March 1, 2018
Study Completion
March 1, 2018
Last Updated
October 6, 2025
Record last verified: 2025-09