A Trial to Test the Efficacy of a Tailored Intensive Smoking Cessation Intervention in Persons With HIV (PWHs)

Sponsor

Montefiore Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01106638

Collaborator

Albert Einstein College of Medicine (Other), Yale University (Other)

147

Enrollment

Location

Arms

Actual Duration (Months)

9.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether an intensive, eight session behavioral intervention is superior to standard care in achieving abstinence from cigarettes in smokers living with HIV/AIDS.

Condition or Disease	Intervention/Treatment	Phase
Smoking HIV Infections AIDS	Behavioral: Positively Smoke Free Behavioral: Standard care	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

147 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Trial to Test the Efficacy of a Tailored Intensive Smoking Cessation Intervention in Persons With HIV (PWHs)

Actual Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

Apr 1, 2011

Actual Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intensive behavioral intervention Eight session, behavioral intervention targeting HIV-infected smokers	Behavioral: Positively Smoke Free An eight session, group therapy intervention targeting smokers living with HIV/AIDS
Active Comparator: Standard care Advice to quit, smoking cessation brochure, offer of nicotine patch	Behavioral: Standard care Advice to quit, smoking cessation brochure, and offer of nicotine patches

Arm

Intervention/Treatment

Experimental: Intensive behavioral intervention

Eight session, behavioral intervention targeting HIV-infected smokers

Behavioral: Positively Smoke Free

An eight session, group therapy intervention targeting smokers living with HIV/AIDS

Active Comparator: Standard care

Advice to quit, smoking cessation brochure, offer of nicotine patch

Behavioral: Standard care

Advice to quit, smoking cessation brochure, and offer of nicotine patches

Outcome Measures

Primary Outcome Measures

Three month point-prevalence abstinence from cigarettes [3 months post-intervention]

Secondary Outcome Measures

Three month continuous abstinence from cigarettes [Three months post-intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

HIV-infection
current cigarette smoker
high motivation to quit

Exclusion Criteria:

Pregnancy
breastfeeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montefiore Medical Center	Bronx	New York	United States	10467

Sponsors and Collaborators

Montefiore Medical Center
Albert Einstein College of Medicine
Yale University

Investigators

Principal Investigator: Jonathan Shuter, MD, Montefiore Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jonathan Shuter, principal investigator, Montefiore Medical Center

ClinicalTrials.gov Identifier:

NCT01106638

Other Study ID Numbers:

R21DA023362

First Posted:

Apr 20, 2010

Last Update Posted:

Apr 27, 2018

Last Verified:

Apr 1, 2018

Keywords provided by Jonathan Shuter, principal investigator, Montefiore Medical Center

Tobacco use in persons living with HIV/AIDS

Additional relevant MeSH terms:

HIV Infections

Study Results

No Results Posted as of Apr 27, 2018