Motivation and Patch Treatment for HIV-positive Smokers (Positive PATHS)
Primary Purpose
HIV Infections, Smoking Cessation
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Standard Care
Motivational Enhancement
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV, HIV positive, AIDS, smoking cessation, smoking, smoking counseling
Eligibility 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
Sites / Locations
- Stanley Street Treatment and Resources, Inc.
- Greater New Bedford Community Center
- Hope Center for HIV Care, Memorial Hospital
- Rhode Island Hospital HIV Clinic
- The Miriam Hospital Immunology Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Standard Care
Motivational Enhancement
Arm Description
Outcomes
Primary Outcome Measures
smoking cessation
Secondary Outcome Measures
smoking cessation
Full Information
NCT ID
NCT00551720
First Posted
October 30, 2007
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00551720
Brief Title
Motivation and Patch Treatment for HIV-positive Smokers
Acronym
Positive PATHS
Official Title
Motivation and Patch Treatment for HIV-positive Smokers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Smoking Cessation
Keywords
HIV, HIV positive, AIDS, smoking cessation, smoking, smoking counseling
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
444 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Care
Arm Type
Experimental
Arm Title
Motivational Enhancement
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
Brief advice and follow-up provided a smoking-cessation trained Health Educator PLUS nicotine patch
Intervention Type
Behavioral
Intervention Name(s)
Motivational Enhancement
Intervention Description
Brief advice and follow-up, nicotine patch, and the addition of a tailored motivational intervention and behavioral skills counseling for smoking cessation.
Primary Outcome Measure Information:
Title
smoking cessation
Time Frame
6-months
Secondary Outcome Measure Information:
Title
smoking cessation
Time Frame
2- and 4-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Niaura, PhD
Organizational Affiliation
Brown University-Butler Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elizabeth Lloyd-Richardson, PhD
Organizational Affiliation
Brown University/The Miriam Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Stanley Street Treatment and Resources, Inc.
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Greater New Bedford Community Center
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Facility Name
Hope Center for HIV Care, Memorial Hospital
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Rhode Island Hospital HIV Clinic
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
The Miriam Hospital Immunology Clinic
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19719796
Citation
Lloyd-Richardson EE, Stanton CA, Papandonatos GD, Shadel WG, Stein M, Tashima K, Flanigan T, Morrow K, Neighbors C, Niaura R. Motivation and patch treatment for HIV+ smokers: a randomized controlled trial. Addiction. 2009 Nov;104(11):1891-900. doi: 10.1111/j.1360-0443.2009.02623.x. Epub 2009 Aug 28.
Results Reference
derived
Learn more about this trial
Motivation and Patch Treatment for HIV-positive Smokers
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