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NCT02190643 Clinical Trial

Improving Nicotine Patch Adherence Among Latino HIV-Positive Smokers

Smoking Clinical Trial

Official title:
Improving Nicotine Patch Adherence Among Latino HIV-Positive Smokers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02190643
Other study ID # R21DA035629
Secondary ID
Status Completed
Phase N/A
First received July 11, 2014
Last updated April 5, 2016
Start date April 2013
Est. completion date March 2016

Study information
Verified date April 2016
Source RAND
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date March 2016
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Cessation counseling with adherence focus

• Cessation counseling without adherence focus

Locations
Country Name City State
United States Bienestar Human Services Inc Los Angeles California

Sponsors (1)
Lead Sponsor Collaborator
RAND

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Continuous abstinence No smoking from the target quit date through the 3-month follow-up 3 months post-quit date No
Primary biochemically-verified 7-day point prevalence abstinence No smoking in the 7 prior days 3 months post-quit date No
Secondary Nicotine patch adherence 3 months post-quit date No
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