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

April 25, 2018 updated by: Jonathan Shuter, Montefiore Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

147

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HIV-infection
  • current cigarette smoker
  • high motivation to quit

Exclusion Criteria:

  • Pregnancy
  • breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Three month point-prevalence abstinence from cigarettes
Time Frame: 3 months post-intervention
3 months post-intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Three month continuous abstinence from cigarettes
Time Frame: Three months post-intervention
Three months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Collaborators

Albert Einstein College of Medicine
Yale University

Investigators

  • Principal Investigator: Jonathan Shuter, MD, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

April 19, 2010

First Submitted That Met QC Criteria

April 19, 2010

First Posted (Estimate)

April 20, 2010

Study Record Updates

Last Update Posted (Actual)

April 27, 2018

Last Update Submitted That Met QC Criteria

April 25, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21DA023362 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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