A Smart Approach to Treating Tobacco Use Disorder in Persons Living With HIV

  • STATUS
    Recruiting
  • participants needed
    632
  • sponsor
    Yale University
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Updated on 19 February 2024
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smoking cessation therapy
tobacco use disorder

Summary

Many people living with HIV (PLWH) smoke. Smoking in these individuals is often undertreated. This study plans to assess the ability of various clinical pathways involving tobacco treatment medications and contingency management (paying smokers for not smoking) to improve smoking cessation in a group of PLWH.

Description

Using a Sequential Multiple Assignment Randomized Trial (SMART) design, this project is a two-arm, two-stage randomized trial of 632 adult PWH who smoke cigarettes and receive care in one of three health systems. At inception, participants will be randomized to either combination nicotine replacement therapy (NRT, patch + short-acting NRT) or combination NRT+contingency management (CM). At 12 weeks, responders (non-smoking participants confirmed by exhaled carbon monoxide [eCO]) in both arms will receive 12 more weeks of the same treatment. Non-responders (participants with continued smoking by self-report and/or eCO) in both the NRT and NRT+CM arms will be re-randomized to 12 weeks of treatment, either with medication switch to varenicline (VAR) or intensified level of CM (start CM if no CM during first 12 weeks, or CM with higher reward schedule ["CM plus"] if NRT+CM group initially). The intervention will be delivered by trained clinical pharmacists. The primary outcome will be eCO-confirmed abstinence at 24 weeks post-enrollment. The specific aims of the proposed study are to: (1) identify the optimal adaptive approach to promote eCO-confirmed smoking abstinence (2) study the effectiveness of various adaptive strategies on CD4 count, HIV viral suppression, and VACS index (validated measure of morbidity and mortality risk); and (3) grounded in implementation science and using a Hybrid Effectiveness-Implementation Type I design, identify barriers and facilitators to delivering our intervention to inform future implementation.

Details
Condition Tobacco Use Cessation
Age 18years - 100years
Treatment Varenicline, Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler, Contingency Management
Clinical Study IdentifierNCT04490057
SponsorYale University
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

HIV positive
Receiving HIV care at Yale-New Haven Hospital, Mount Sinai Hospital, or SUNY Downstate STAR clinic
Have smoked >100 cigarettes in lifetime
Currently smokes some days or every day
Smokes, on average, > 5 cigarettes per day
Able to provide written informed consent

Exclusion Criteria

Using only non-cigarette nicotine products (i.e., e-cigs, Juul, etc.)
Currently using NRT, VAR (defined as use in the prior 7 days)
Self-report or urine testing confirming pregnancy, nursing, or trying to conceive
Life-threatening or unstable medical, surgical, or psychiatric condition
Inability to provide at least one collateral contact (family member or friend)
Living out of state
Unable to read or understand English
Clear my responses
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