Positive PATHS: Motivation and Patch Treatment for HIV-positive Smokers

Sponsor

National Institute on Drug Abuse (NIDA) (NIH)

Overall Status

Completed

CT.gov ID

NCT00551720

Collaborator

(none)

444

Enrollment

Locations

Arms

Duration (Months)

88.8

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Smoking Cessation	Behavioral: Standard Care Behavioral: Motivational Enhancement	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

444 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Motivation and Patch Treatment for HIV-positive Smokers

Study Start Date :

Jan 1, 1999

Actual Study Completion Date :

Dec 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Standard Care	Behavioral: Standard Care Brief advice and follow-up provided a smoking-cessation trained Health Educator PLUS nicotine patch
Experimental: Motivational Enhancement	Behavioral: Motivational Enhancement Brief advice and follow-up, nicotine patch, and the addition of a tailored motivational intervention and behavioral skills counseling for smoking cessation.

Arm

Intervention/Treatment

Experimental: Standard Care

Behavioral: Standard Care

Brief advice and follow-up provided a smoking-cessation trained Health Educator PLUS nicotine patch

Experimental: Motivational Enhancement

Behavioral: Motivational Enhancement

Brief advice and follow-up, nicotine patch, and the addition of a tailored motivational intervention and behavioral skills counseling for smoking cessation.

Outcome Measures

Primary Outcome Measures

smoking cessation [6-months]

Secondary Outcome Measures

smoking cessation [2- and 4-months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanley Street Treatment and Resources, Inc.	Fall River	Massachusetts	United States	02720
2	Greater New Bedford Community Center	New Bedford	Massachusetts	United States	02740
3	Hope Center for HIV Care, Memorial Hospital	Pawtucket	Rhode Island	United States	02906
4	Rhode Island Hospital HIV Clinic	Providence	Rhode Island	United States	02903
5	The Miriam Hospital Immunology Clinic	Providence	Rhode Island	United States	02906

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator: Raymond Niaura, PhD, Brown University-Butler Hospital
Study Director: Elizabeth Lloyd-Richardson, PhD, Brown University/The Miriam Hospital