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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02072772
Enrollment
450
Registered
2014-02-27
Start date
2014-05-31
Completion date
2018-03-31
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use in Persons Living With HIV

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.

Interventions

BEHAVIORALPositively Smoke Free group treatment

See Arm Description

BEHAVIORALStandard Care

See Arm Description

Sponsors

Georgetown University
CollaboratorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Montefiore Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
6 month abstinence from cigarettes6 monthsBiochemically-confirmed 7-day point-prevalence abstinence from cigarettes at the 6-month timepoint

Secondary

MeasureTime frameDescription
Cost per incremental quit6 monthsEstimated cost per incremental quit

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026