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

Tobacco Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04594109
• Other study ID #: 00022163
• Status: Completed
• Phase: N/A
• Start date: June 30, 2017
• Est. completion date: January 30, 2018

Study information

• Verified date: April 2023
• Source: Colorado State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 30, 2018
• Est. primary completion date: January 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections
• Tobacco Smoking

Intervention

Behavioral:
• Tailored behavioral counseling
Participants in the intervention arm were provided a one-time tailored cognitive-behavioral therapy in-person cessation counseling intervention lasting approximately one hour, a 30-day supply of nicotine replacement therapy (consisting of nicotine patches and nicotine gum; dosage according to current smoking intensity according to manufacturers instructions), and a tailored bi-directional text messaging program delivering two messages per day for four weeks. The TI session was adapted from the clinical practice guidelines to include behavioral elements rooted in the minority stress model. The intervention used addressed issues of stress related to HIV stigma, minority status and socioeconomic condition.
• Standard of Care
One-time standard of care in-person behavioral counseling lasting approximately one hour, plus a 30-day supply of nicotine replacement therapy consisting of nicotine patches and nicotine gum (dosage according to current smoking intensity according to manufacturers instructions). The standard of care behavioral counseling was adapted from the current U.S. clinical practice guidelines.

Locations

Country	Name	City	State
United States	Truth Initiative	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Colorado State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Abstinence	7-day point prevalence plus exhaled breath carbon monoxide < 7 parts per million (ppm)	30 day follow-up
Secondary	Cigarettes per day	Number of cigarettes smoked per day	30 day follow-up
Secondary	Exhaled breath carbon monoxide	Exhaled breath carbon monoxide in parts per million (ppm)	30 day follow-up
Secondary	Self-efficacy	Self-efficacy for smoking abstinence	30 day follow-up