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

Study Overview
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Brief Summary
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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.

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

Conditions
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Tobacco Smoking

Intervention / Treatment
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* Behavioral: Tailored behavioral counseling
* Behavioral: Standard of Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>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. | Behavioral: Standard of Care<br>* 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.<br>|
| Experimental: Tailored Counseling<br>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. | Behavioral: Tailored behavioral counseling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Abstinence | 7-day point prevalence plus exhaled breath carbon monoxide < 7 parts per million (ppm) | 30 day follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cigarettes per day | Number of cigarettes smoked per day | 30 day follow-up | 
| Exhaled breath carbon monoxide | Exhaled breath carbon monoxide in parts per million (ppm) | 30 day follow-up | 
| Self-efficacy | Self-efficacy for smoking abstinence | 30 day follow-up |