NCT02190643

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

Enrollment Period

2.6 years

First QC Date

July 11, 2014

Last Update Submit

April 5, 2016

Conditions

Smoking

Keywords

SmokingHIVLatinoCessationNicotine patch

Outcome Measures

Primary Outcomes (2)

  • Continuous abstinence

    No smoking from the target quit date through the 3-month follow-up

    3 months post-quit date

  • biochemically-verified 7-day point prevalence abstinence

    No smoking in the 7 prior days

    3 months post-quit date

Secondary Outcomes (1)

  • Nicotine patch adherence

    3 months post-quit date

Study Arms (2)

Adherence condition

EXPERIMENTAL

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.

Behavioral: Cessation counseling with adherence focus

Standard condition

ACTIVE COMPARATOR

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.

Behavioral: Cessation counseling without adherence focus

Interventions

Cessation counseling with adherence focusBEHAVIORAL
Adherence condition
Cessation counseling without adherence focusBEHAVIORAL
Standard condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Latino
  • HIV positive
  • current, daily smoker
  • ready to set quit date in next 30 days
  • willing to try the nicotine patch

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bienestar Human Services Inc

Los Angeles, California, 90022, United States

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2014

First Posted

July 15, 2014

Study Start

April 1, 2013

Primary Completion

November 1, 2015

Study Completion

March 1, 2016

Last Updated

April 6, 2016

Record last verified: 2016-04

Locations

US(1)