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Smoking Cessation Medication And Rewards Using a Teamlet to Treat Tobacco Use Disorder (SMARTTT 2.0) Among Persons With HIV: A Multi-site Hybrid Type 2 Effectiveness-implementation Trial

ConditionsTobacco Use Disorder/Cigarette SmokingHIV
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University

About this trial

Cigarette smoking is an important cause of illness and death among persons with HIV (PWH). This project will study the impact of adding contingency management (use of financial rewards) to receiving medications and counseling on promoting smoking abstinence and other health outcomes among PWH. As treatments will be provided by clinical pharmacists and other team members in HIV clinics, factors relevant for implementing this model to inform real-world practice will also be evaluated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have been diagnosed with HIV;

Receive care at one of the participating sites;

Are >18 years old;

Have smoked >100 cigarettes lifetime;

Disqualifiers

Exclusive use of non-cigarette tobacco or nicotine products, including e-cigarettes;

Self-report or urine testing confirming pregnancy, nursing, or trying to conceive;

Life-threatening or unstable medical, surgical, or psychiatric condition;

Anticipate being unable to return for follow-up for any reason, such as travel, planned procedure;

Trial design

Design model

Parallel

Treatments tested in this trial

  • nicotine patch, nicotine gum, nicotine lozenge, varenicline, bupropion

    Drug

    Clinical pharmacist prescribed MTUD, based on participant choice: nicotine patch, nicotine gum, nicotine lozenge, varenicline, bupropion. Participants on nicotine replacement may choose both a long acting (patch) and short acting (gum, lozenge) option to use at the same time.

  • Multi-target Contingency Management

    Behavioral

    Participants will earn prizes for progress towards tobacco abstinence, achieving tobacco abstinence, and progress in improving HIV and other related health conditions.

  • Teamlet booster

    Behavioral

    Participants will receive a booster call by a teamlet member after MTUD is prescribed to address any MTUD access issues and answer MTUD related questions.

Treatment groups

794 Participants
are divided into 2 treatment groups
Group A: Clinical pharmacist-prescribed MTUD with teamlet boosterExperimental treatment 2 interventions
Group B: Clinical pharmacist-prescribed MTUD + teamlet delivered CM and boosterExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

7-day point-prevalence abstinence confirmed by exhaled carbon monoxide (eCO)

Self-reported tobacco abstinence over the past 7 days, confirmed by eCO of \<6ppm

Time frame
12 weeks

Secondary outcomes

1

7-day point-prevalence abstinence confirmed by exhaled carbon monoxide (eCO)

Self-reported tobacco abstinence over the past 7 days, confirmed by eCO \<6ppm

Time frame
24 weeks
2

Self-reported 7 day point prevalence smoking abstinence

Time frame
Week 18
3

Cigarettes per day

Self-reported reduction in mean number of cigarettes per day

Time frame
Week 12
4

Cigarettes per day

Self-reported reduction in mean number of cigarettes per day

Time frame
Week 18

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: