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

  • End date
    Aug 31, 2025
  • participants needed
  • sponsor
    Yale University
Updated on 1 September 2021


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.


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 oral medication, varenicline or bupropion, 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 aHybrid Effectiveness-Implementation Type I design, identify barriers and facilitators to delivering our intervention to inform future implementation.

Condition Tobacco Use Cessation
Treatment Varenicline, Contingency Management, Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler, Varenicline or bupropion
Clinical Study IdentifierNCT04490057
SponsorYale University
Last Modified on1 September 2021


Yes No Not Sure

Inclusion Criteria

HIV positive
Receiving HIV care at Yale-New Haven Hospital, Mount Sinai Hospital, or SUNY Downstate STAR clinic
>= 18 years old
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, or bupropion (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 (except at Mount Sinai site)
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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