A Trial of Positively Smoke Free Group Therapy for HIV-infected Smokers

The purpose of this study is to determine whether Positively Smoke Free group therapy is more effective at promoting cessation than standard care.

Study Overview

• Status: Completed
• Conditions: Tobacco Use in Persons Living With HIV
• Intervention / Treatment: Behavioral: Positively Smoke Free group treatment; Behavioral: Standard Care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 450
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • Georgetown University Medical Center
  • New York
    • The Bronx, New York, United States, 10804
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• HIV-infection
• Receives care at Montefiore Medical Center or Georgetown University
• Motivated to quit
• Willing to attend eight 90 minute group sessions

Exclusion Criteria:

• Pregnancy or breastfeeding
• Contraindication to nicotine patch use

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Positively Smoke Free group treatment; 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	Behavioral: Positively Smoke Free group treatment; See Arm Description
Active Comparator: Standard care; Brief (<5 minutes) advice to quit Offer of nicotine patches Self-help brochure	Behavioral: Standard Care; See Arm Description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost per incremental quit	Estimated cost per incremental quit	6 months

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: National Institute on Drug Abuse (NIDA); Georgetown University
• Investigators: Principal Investigator: Jonathan Shuter, MD, Montefiore Medical Center/Albert Einstein College of Medicine

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: February 25, 2014
• First Submitted That Met QC Criteria: February 26, 2014
• First Posted (Estimated): February 27, 2014

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 2013-260; R01DA036445-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No