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Motivation and Patch Treatment for HIV-positive Smokers (Positive PATHS)

This study has been completed.
Information provided by:
National Institute on Drug Abuse (NIDA) Identifier:
First received: October 30, 2007
Last updated: January 11, 2017
Last verified: October 2007
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 Intervention Phase
HIV Infections Smoking Cessation Behavioral: Standard Care Behavioral: Motivational Enhancement Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Motivation and Patch Treatment for HIV-positive Smokers

Resource links provided by NLM:

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • smoking cessation [ Time Frame: 6-months ]

Secondary Outcome Measures:
  • smoking cessation [ Time Frame: 2- and 4-months ]

Enrollment: 444
Study Start Date: January 1999
Study Completion Date: December 2004
Arms Assigned Interventions
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.

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.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00551720

United States, Massachusetts
Stanley Street Treatment and Resources, Inc.
Fall River, Massachusetts, United States, 02720
Greater New Bedford Community Center
New Bedford, Massachusetts, United States, 02740
United States, Rhode Island
Hope Center for HIV Care, Memorial Hospital
Pawtucket, Rhode Island, United States, 02906
Rhode Island Hospital HIV Clinic
Providence, Rhode Island, United States, 02903
The Miriam Hospital Immunology Clinic
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Principal Investigator: Raymond Niaura, PhD Brown University-Butler Hospital
Study Director: Elizabeth Lloyd-Richardson, PhD Brown University/The Miriam Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00551720     History of Changes
Other Study ID Numbers: R01DA012344 ( U.S. NIH Grant/Contract )
Study First Received: October 30, 2007
Last Updated: January 11, 2017

Keywords provided by National Institute on Drug Abuse (NIDA):
HIV positive
smoking cessation
smoking counseling

Additional relevant MeSH terms:
HIV Infections
HIV Seropositivity
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases processed this record on September 19, 2017