Back to resultsImproving Nicotine Patch Adherence Among Latino HIV-Positive Smokers
Primary Purpose
Smoking
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cessation counseling with adherence focus
Cessation counseling without adherence focus
Sponsored by
About this trial
This is an interventional treatment trial for Smoking focused on measuring Smoking, HIV, Latino, Cessation, Nicotine patch
Eligibility Criteria
Inclusion Criteria:
- 18 years or older
- Latino
- HIV positive
- current, daily smoker
- ready to set quit date in next 30 days
- willing to try the nicotine patch
Exclusion Criteria:
- suffering from any medical condition which would prevent using the nicotine patch
- currently using other tobacco products or e-cigarettes
- currently receiving counseling or medication to quit or reduce smoking
Sites / Locations
- Bienestar Human Services Inc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Adherence condition
Standard condition
Arm Description
Brief smoking cessation counseling session (based on 5 A's approach) that includes a module focused on improving adherence to using the nicotine patch, plus 8-week supply of nicotine patches.
Brief smoking cessation counseling session (based on 5 A's approach) that does not include a module focused on improving nicotine patch adherence, plus 8-week supply of nicotine patches.
Outcomes
Primary Outcome Measures
Continuous abstinence
No smoking from the target quit date through the 3-month follow-up
biochemically-verified 7-day point prevalence abstinence
No smoking in the 7 prior days
Secondary Outcome Measures
Nicotine patch adherence
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02190643
Brief Title
Improving Nicotine Patch Adherence Among Latino HIV-Positive Smokers
Official Title
Improving Nicotine Patch Adherence Among Latino HIV-Positive Smokers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RAND
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this study is to evaluate a smoking cessation program for Latino HIV-positive smokers focused on improving adherence to using the nicotine skin patch.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking
Keywords
Smoking, HIV, Latino, Cessation, Nicotine patch
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adherence condition
Arm Type
Experimental
Arm Description
Brief smoking cessation counseling session (based on 5 A's approach) that includes a module focused on improving adherence to using the nicotine patch, plus 8-week supply of nicotine patches.
Arm Title
Standard condition
Arm Type
Active Comparator
Arm Description
Brief smoking cessation counseling session (based on 5 A's approach) that does not include a module focused on improving nicotine patch adherence, plus 8-week supply of nicotine patches.
Intervention Type
Behavioral
Intervention Name(s)
Cessation counseling with adherence focus
Intervention Type
Behavioral
Intervention Name(s)
Cessation counseling without adherence focus
Primary Outcome Measure Information:
Title
Continuous abstinence
Description
No smoking from the target quit date through the 3-month follow-up
Time Frame
3 months post-quit date
Title
biochemically-verified 7-day point prevalence abstinence
Description
No smoking in the 7 prior days
Time Frame
3 months post-quit date
Secondary Outcome Measure Information:
Title
Nicotine patch adherence
Time Frame
3 months post-quit date
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years or older
Latino
HIV positive
current, daily smoker
ready to set quit date in next 30 days
willing to try the nicotine patch
Exclusion Criteria:
suffering from any medical condition which would prevent using the nicotine patch
currently using other tobacco products or e-cigarettes
currently receiving counseling or medication to quit or reduce smoking
Facility Information:
Facility Name
Bienestar Human Services Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Improving Nicotine Patch Adherence Among Latino HIV-Positive Smokers
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