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

Colorado State University (CSU)

Status: Completed

Conditions: Tobacco Smoking

Treatments: Behavioral: Tailored behavioral counseling; Behavioral: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT04594109

00022163

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard of Care

Tailored Counseling

Experimental group

Description:

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.

Treatment:

Behavioral: Tailored behavioral counseling