A Trial to Test the Efficacy of a Tailored Intensive Smoking Cessation Intervention in Persons With HIV (PWHs)
1 other identifier
interventional
147
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2009
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 19, 2010
CompletedFirst Posted
Study publicly available on registry
April 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedApril 27, 2018
April 1, 2018
1.3 years
April 19, 2010
April 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Three month point-prevalence abstinence from cigarettes
3 months post-intervention
Secondary Outcomes (1)
Three month continuous abstinence from cigarettes
Three months post-intervention
Study Arms (2)
Intensive behavioral intervention
EXPERIMENTALEight session, behavioral intervention targeting HIV-infected smokers
Standard care
ACTIVE COMPARATORAdvice to quit, smoking cessation brochure, offer of nicotine patch
Interventions
An eight session, group therapy intervention targeting smokers living with HIV/AIDS
Advice to quit, smoking cessation brochure, and offer of nicotine patches
Eligibility Criteria
You may qualify if:
- HIV-infection
- current cigarette smoker
- high motivation to quit
You may not qualify if:
- Pregnancy
- breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Montefiore Medical Centerlead
- Albert Einstein College of Medicinecollaborator
- Yale Universitycollaborator
Study Sites (1)
Montefiore Medical Center
The Bronx, New York, 10467, United States
Related Publications (2)
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.
PMID: 27215559DERIVEDMoadel 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.
PMID: 22732470DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Shuter, MD
Montefiore Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
April 19, 2010
First Posted
April 20, 2010
Study Start
December 1, 2009
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
April 27, 2018
Record last verified: 2018-04