Motivation and Patch Treatment for HIV-positive Smokers (Positive PATHS)
January 11, 2017 updated by: National Institute on Drug Abuse (NIDA)
The purpose of this study is to develop and evaluate a brief, clinic-based smoking cessation treatment for an HIV+ population.
We compared two treatments, a brief advice and follow-up plus nicotine patch treatment(Standard Care; SC) and brief advice and follow-up, nicotine patch, with the addition of a tailored motivational intervention and behavioral skills counseling for smoking cessation (Motivationally-Enhanced; ME), in a randomized controlled trial.
We hypothesized that those HIV+ participants receiving the ME will demonstrate greater biochemically verified smoking abstinence rates at 6-month follow-up than those receiving the SC control treatment.
All study participants were offered use of the nicotine patch.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Cigarette smoking is highly prevalent among HIV+ individuals, posing unique health risks, impacting HAART-therapy effectiveness, and possibly altering the course of the disease.
To our knowledge, Motivation and Patch Treatment for HIV-Positive Individuals (Positive PATHS) was the first NIH-funded smoking cessation intervention designed to motivate HIV+ smokers to quit.
Participants were referred by physicians at eight Immunology clinics in New England and randomized to receive either a brief, two-session intervention (Standard Care; SC) modeled on PHS guidelines, or a more intensive, four-session motivational counseling intervention (Motivational-Enhancement; ME).
All physicians participating in the trial were trained in study eligibility criteria, as well as basic smoking cessation counseling strategies (based on the PHS guidelines).
Interested individuals were then referred to the study, with a study researcher explaining the details of the study and obtaining informed consent.
Participants were then assisted in completing baseline assessments via laptop computer, and then randomized to receive either a brief intervention (2-sessions) designed to reflect the standard of care in outpatient hospital settings and modeled on PHS guidelines (standard care; SC) or a more intensive (4-session) motivational counseling intervention (motivational enhancement; ME), with both interventions providing 8-weeks of nicotine replacement (patches; NRT) to those participants willing to set a quit date.
Follow-up assessments, including biochemical verification of self-reported quitters (via carbon monoxide measurement) were conducted at 2, 4, and 6 months from baseline.
This study is among the first to examine the health effects of a delivered smoking cessation intervention to an HIV+ population, with the results having implications for treatments in clinical care settings.
Study Type
Interventional
Enrollment (Actual)
444
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
-
-
Massachusetts
-
Fall River, Massachusetts, United States, 02720
- Stanley Street Treatment and Resources, Inc.
-
New Bedford, Massachusetts, United States, 02740
- Greater New Bedford Community Center
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Rhode Island
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Pawtucket, Rhode Island, United States, 02906
- Hope Center for HIV Care, Memorial Hospital
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Providence, Rhode Island, United States, 02903
- Rhode Island Hospital HIV Clinic
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Providence, Rhode Island, United States, 02906
- The Miriam Hospital Immunology Clinic
-
-
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 to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Be receiving care for HIV at one of the participating immunology clinics
- Be 18 years old or older
- Be current (past 7 days) cigarette smoker
- Speak English or Spanish
Exclusion Criteria:
- Are pregnant or nursing
- Have uncontrolled hypertension
- Use other forms of tobacco like cigars or chewing tobacco or are using anything else to help with quitting smoking
- Are allergic to the nicotine patch or have a skin condition like eczema or psoriasis that makes them unable to use the patch
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: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Standard Care
|
Brief advice and follow-up provided a smoking-cessation trained Health Educator PLUS nicotine patch
|
|
Experimental: Motivational Enhancement
|
Brief advice and follow-up, nicotine patch, and the addition of a tailored motivational intervention and behavioral skills counseling for smoking cessation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
smoking cessation
Time Frame: 6-months
|
6-months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
smoking cessation
Time Frame: 2- and 4-months
|
2- and 4-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Raymond Niaura, PhD, Brown University-Butler Hospital
- Study Director: Elizabeth Lloyd-Richardson, PhD, Brown University/The Miriam Hospital
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.
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
January 1, 1999
Study Completion (Actual)
December 1, 2004
Study Registration Dates
First Submitted
October 30, 2007
First Submitted That Met QC Criteria
October 30, 2007
First Posted (Estimate)
October 31, 2007
Study Record Updates
Last Update Posted (Estimate)
January 12, 2017
Last Update Submitted That Met QC Criteria
January 11, 2017
Last Verified
October 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DA012344 (U.S. NIH Grant/Contract)
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