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Clinical Trials/NCT04594109
NCT04594109
Completed
Not Applicable

Development of a Tailored Smoking Cessation Program for Individuals With HIV Infection in Washington, D.C.

Colorado State University1 site in 1 country25 target enrollmentJune 30, 2017
ConditionsTobacco Smoking

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tobacco Smoking
Sponsor
Colorado State University
Enrollment
25
Locations
1
Primary Endpoint
Smoking Abstinence
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Morbidity and mortality from smoking-related diseases among people living with HIV (PLWH) in the U.S. surpasses that due to HIV itself. Conventional smoking cessation treatments have not demonstrated strong efficacy among PLWH. The investigators conducted a pilot randomized controlled trial (RCT) to evaluate a tailored smoking cessation intervention based on the minority stress model, hypothesizing that behavioral counseling through this lens would enhance cessation. The investigators compared standard of care counseling (SOC) to a tailored intervention (TI) including one face-to-face counseling session incorporating cognitive behavioral therapy to build resilience, and 30 days of 2-way text messaging.

Registry
clinicaltrials.gov
Start Date
June 30, 2017
End Date
January 30, 2018
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jessica Elf

Assistant Professor

Colorado State University

Eligibility Criteria

Inclusion Criteria

  • ≥18 years of age
  • report being HIV-infected
  • be a resident of the Washington, D.C. area
  • current, daily smokers of tobacco
  • have a confirmed smoking status of 6 parts per million (ppm) or more by using an exhaled carbon monoxide breath monitor
  • agree to participate
  • be willing to set a quit date within 7 days of baseline assessment.

Exclusion Criteria

  • are currently using smokeless tobacco or electronic cigarettes at least every day
  • are currently using nicotine replacement therapy or other smoking cessation treatment
  • report being HIV-uninfected
  • report having heart disease or high blood pressure not controlled by medication
  • are currently in an alcohol treatment program
  • are pregnant (exclusion items 4-6 are contraindications of nicotine replacement therapy, which will be provided)
  • do not have a primary care provider or HIV care provider to refer to in the event of an adverse reaction to nicotine replacement therapy.

Outcomes

Primary Outcomes

Smoking Abstinence

Time Frame: 30 day follow-up

7-day point prevalence plus exhaled breath carbon monoxide \< 7 parts per million (ppm)

Secondary Outcomes

  • Exhaled breath carbon monoxide(30 day follow-up)
  • Cigarettes per day(30 day follow-up)
  • Self-efficacy(30 day follow-up)

Study Sites (1)

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