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Completed

NCT Number: NCT02072772

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgetown University Medical Center, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positively Smoke Free group treatment

Behavioral

See Arm Description

Standard Care

Behavioral

See Arm Description

Primary outcomes

  1. 6 month abstinence from cigarettes

    Time frame: 6 months

    Biochemically-confirmed 7-day point-prevalence abstinence from cigarettes at the 6-month timepoint

Secondary outcomes

  1. Cost per incremental quit

    Time frame: 6 months

    Estimated cost per incremental quit

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • Georgetown University
  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Feb 27, 2014
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.