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

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00551720
First received: October 30, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00551720

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

No publications provided by National Institute on Drug Abuse (NIDA)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00551720     History of Changes
Other Study ID Numbers: R01 DA 12344
Study First Received: October 30, 2007
Last Updated: October 30, 2007
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
HIV Seropositivity
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014