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

Not Applicable

Completed

• Conditions: Tobacco Smoking

• Registration Number: NCT04594109
• Lead Sponsor: Colorado State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-30
• Primary Completion: 2018-01-29
• Study Completion: 2018-01-30
• Study First Submitted: 2020-10-14
• Study First Submitted QC: 2020-10-14
• Study First Posted: 2020-10-20
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-17
• Last Update Posted: 2023-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Smoking Abstinence	30 day follow-up	7-day point prevalence plus exhaled breath carbon monoxide \< 7 parts per million (ppm)

Secondary Outcome Measures

Name	Time	Method
Cigarettes per day	30 day follow-up	Number of cigarettes smoked per day
Self-efficacy	30 day follow-up	Self-efficacy for smoking abstinence
Exhaled breath carbon monoxide	30 day follow-up	Exhaled breath carbon monoxide in parts per million (ppm)

Trial Locations

Locations (1)

Truth Initiative; 🇺🇸 Washington, District of Columbia, United States