Motivation and Patch Treatment for HIV-positive Smokers



Status:Completed
Conditions:Smoking Cessation, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 70
Updated:1/13/2017
Start Date:January 1999
End Date:December 2004

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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.

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.

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
We found this trial at
5
sites
Pawtucket, Rhode Island 02906
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from
Pawtucket, RI
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Fall River, Massachusetts 02720
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from
Fall River, MA
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New Bedford, Massachusetts 02740
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from
New Bedford, MA
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Providence, Rhode Island 02903
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from
Providence, RI
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Providence, Rhode Island 02906
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from
Providence, RI
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