This study's long-term goal is to improve clinical outcomes among smokers living with HIV (SLWH) by providing smoking cessation interventions in HIV clinical care that will increase the chances of quitting smoking, limits costs and burden on staff and reach many smokers living with HIV.
This study will utilize Multiphase Optimization Strategy (MOST) to optimize a smoking cessation treatment for HIV clinical care by directly targeting patient barriers to quitting and clinical care barriers to reaching and effectively treating a broad heterogeneous population of smokers living with HIV. The four intervention components will be aimed at barriers to quitting among smokers living with HIV and include Motivational Interviewing; Peer Mentoring; Text-messaging; Combination Nicotine Replacement Therapy. These components have shown promise in research but are under-utilized to help smokers living with HIV quit and have not been tested in an optimization trial. This study will also incorporate data to evaluate the fidelity, acceptability and feasibility of the interventions in the HIV clinical care context in order to identify the most cost-effective, sustainable and scalable tobacco treatment package for the care environment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Six sessions of phone counseling over 10-12 weeks with MI counselor trained in motivational interviewing and tobacco use treatment.
Eight sessions of informal counseling with an experienced peer former smoker living with HIV to model healthy behavior and provide practical advice and tips for quitting based on their lived experience.
NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.
New York University School of Global Public Health
New York, New York, United States
RECRUITINGBiochemically-validated 7-day point prevalence smoking abstinence among SLWH in HIV clinical care
Self-reported 7-day cigarette PPA (point prevalence abstinence), with biochemical verification of CO (carbon monoxide) ≤6 ppm and negative salivary cotinine
Time frame: 32 weeks
Self-reported 30-day PPA
Self-reported 30-day cigarette PPA (point prevalence abstinence)
Time frame: 32 weeks
Self-reported 7-day PPA
Self-reported 7-day cigarette PPA (point prevalence abstinence) with carbon monoxide verification (\<=6 ppm)
Time frame: 8 and 16 weeks
Self-reported 30-day PPA
Self-reported 30-day cigarette PPA (point prevalence abstinence)
Time frame: 8 and 16 weeks
Quit attempts
Number of quit attempts (of at least 24 hours) in last 7 days and since last assessment
Time frame: 8, 16, and 32 weeks
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If they smoke 10 or more cigarettes per day (CPD), participants will receive 2 weeks of 21 mg patches, 2 weeks of 14 mg patches and 2 weeks of 7 mg patches; if they smoke less than 10 CPD, participants will receive 4 weeks of 14 mg patches and 2 weeks of 7 mg patches. Participants will receive either 2 or 4 mg of nicotine lozenges for a total of up to 20 lozenges per day.