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

Primary Purpose

Smoking, HIV Infections, AIDS

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Positively Smoke Free
Standard care
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking focused on measuring HIV, AIDS, Smoking, Tobacco, Cessation, Tobacco use in persons living with HIV/AIDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • breastfeeding

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intensive behavioral intervention

Standard care

Arm Description

Eight session, behavioral intervention targeting HIV-infected smokers

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

Outcomes

Primary Outcome Measures

Three month point-prevalence abstinence from cigarettes

Secondary Outcome Measures

Three month continuous abstinence from cigarettes

Full Information

First Posted
April 19, 2010
Last Updated
April 25, 2018
Sponsor
Montefiore Medical Center
Collaborators
Albert Einstein College of Medicine, Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT01106638
Brief Title
A Trial to Test the Efficacy of a Tailored Intensive Smoking Cessation Intervention in Persons With HIV (PWHs)
Official Title
A Trial to Test the Efficacy of a Tailored Intensive Smoking Cessation Intervention in Persons With HIV (PWHs)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
December 2009 (Actual)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center
Collaborators
Albert Einstein College of Medicine, Yale University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, HIV Infections, AIDS
Keywords
HIV, AIDS, Smoking, Tobacco, Cessation, Tobacco use in persons living with HIV/AIDS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensive behavioral intervention
Arm Type
Experimental
Arm Description
Eight session, behavioral intervention targeting HIV-infected smokers
Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
Advice to quit, smoking cessation brochure, offer of nicotine patch
Intervention Type
Behavioral
Intervention Name(s)
Positively Smoke Free
Intervention Description
An eight session, group therapy intervention targeting smokers living with HIV/AIDS
Intervention Type
Behavioral
Intervention Name(s)
Standard care
Intervention Description
Advice to quit, smoking cessation brochure, and offer of nicotine patches
Primary Outcome Measure Information:
Title
Three month point-prevalence abstinence from cigarettes
Time Frame
3 months post-intervention
Secondary Outcome Measure Information:
Title
Three month continuous abstinence from cigarettes
Time Frame
Three months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV-infection current cigarette smoker high motivation to quit Exclusion Criteria: Pregnancy breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Shuter, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27215559
Citation
Shuter J, Pearlman BK, Stanton CA, Moadel AB, Kim RS, Weinberger AH. Gender Differences among Smokers Living with HIV. J Int Assoc Provid AIDS Care. 2016 Sep;15(5):412-7. doi: 10.1177/2325957416649439. Epub 2016 May 23.
Results Reference
derived
PubMed Identifier
22732470
Citation
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.
Results Reference
derived

Learn more about this trial

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

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