Tobacco Smoking
Conditions
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.
Interventions
BEHAVIORALTailored 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.
BEHAVIORALStandard 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.
Sponsors
Colorado State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Abstinence | 30 day follow-up | 7-day point prevalence plus exhaled breath carbon monoxide \< 7 parts per million (ppm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cigarettes per day | 30 day follow-up | Number of cigarettes smoked per day |
| Exhaled breath carbon monoxide | 30 day follow-up | Exhaled breath carbon monoxide in parts per million (ppm) |
| Self-efficacy | 30 day follow-up | Self-efficacy for smoking abstinence |
Countries
United States
Outcome results
None listed