Motivation and Patch Treatment for HIV-positive Smokers

HIV Infections Clinical Trial

— Positive PATHS  

Official title:

Motivation and Patch Treatment for HIV-positive Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00551720
• Other study ID #: R01DA012344
• Status: Completed
• Phase: Phase 3
• First received: October 30, 2007
• Last updated: January 11, 2017
• Start date: January 1999
• Est. completion date: December 2004

Study information

• Verified date: October 2007
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 444
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• HIV Seropositivity
• Smoking Cessation

Intervention

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

Locations

Country	Name	City	State
United States	Stanley Street Treatment and Resources, Inc.	Fall River	Massachusetts
United States	Greater New Bedford Community Center	New Bedford	Massachusetts
United States	Hope Center for HIV Care, Memorial Hospital	Pawtucket	Rhode Island
United States	Rhode Island Hospital HIV Clinic	Providence	Rhode Island
United States	The Miriam Hospital Immunology Clinic	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	smoking cessation		6-months
Secondary	smoking cessation		2- and 4-months