Smoking Treatment in HIV Clinical Care Settings
2 other identifiers
interventional
207
1 country
1
Brief Summary
The study is designed to evaluate and compare the efficacy and cost effectiveness of 3 smoking cessation treatments with HIV-positive cigarette smokers. The treatments include face-to-face individual counseling, a computer-Internet-based self-help treatment and a self-help manual treatment.
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 Jan 2006
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 24, 2006
CompletedFirst Posted
Study publicly available on registry
February 28, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedJune 27, 2012
June 1, 2012
5 years
February 24, 2006
June 25, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
7 day point prevalence biochemically verified abstinence rates
3, 6, 9, and 12 months following treatment initiation
Study Arms (3)
Internet
EXPERIMENTALIndividual counseling + nicotine replacement. 6 sessions across a 3 month period.
Counseling
EXPERIMENTALIndividual counseling plus nicotine replacement treatment.
Self-Help
ACTIVE COMPARATORSelf-help Manual plus nicotine replacment treatment.
Interventions
All participants have access to an Internet-based self-help intervention that includes social support through message boards. All participants have access to 10 weeks of nicotine replacement treatment.
Six individual counseling sessions are provided over a 12 week treatment period. Participants also have access to a 10-week nicotine replacement treatment.
Participants receive a self-help manual and have access to a 10 nicotine replacement treatment.
Eligibility Criteria
You may qualify if:
- HIV positive
- years or older
- smoking "most days" during the past month
- must be able to read English
You may not qualify if:
- any contraindications for over-the-counter nicotine replacement treatment
- active psychotic symptoms
- severe cognitive deficits/dementia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94143, United States
Related Publications (2)
Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.
PMID: 39868569DERIVEDMdege ND, Shah S, Dogar O, Pool ER, Weatherburn P, Siddiqi K, Zyambo C, Livingstone-Banks J. Interventions for tobacco use cessation in people living with HIV. Cochrane Database Syst Rev. 2024 Aug 5;8(8):CD011120. doi: 10.1002/14651858.CD011120.pub3.
PMID: 39101506DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gary Humfleet, Ph.D.
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 24, 2006
First Posted
February 28, 2006
Study Start
January 1, 2006
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
June 27, 2012
Record last verified: 2012-06