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

NCT ID: NCT02072772

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2018-03-31

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.

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.

Conditions

Tobacco Use in Persons Living With HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Positively Smoke Free group treatment

Intervention Type: BEHAVIORAL

See Arm Description

Standard care

Brief (\<5 minutes) advice to quit Offer of nicotine patches Self-help brochure

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: BEHAVIORAL

See Arm Description

Interventions

Positively Smoke Free group treatment

See Arm Description

Intervention Type: BEHAVIORAL

Standard Care

See Arm Description

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Georgetown University

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Shuter, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center/Albert Einstein College of Medicine

Locations

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22732470 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39101506 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R01DA036445-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2013-260

Identifier Type: -

Identifier Source: org_study_id