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

What Was Tested

The trial (phase 4) is built around Therapeutic nicotine (patch, non-peptide).

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.

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as behavioral and drug.

More on the Plan

Cigarette smoking is a major threat to health among persons with HIV (PWH).

Via direct effects and link with TUD-related conditions (behaviors and medical conditions that drive poor outcomes), smoking causes more lost life years than treated HIV.

Guidelines recommend medications for TUD (MTUD) and behavioral interventions to promote smoking cessation.

Data also support use of contingency management (CM) to target smoking cessation and treatment adherence.

Who Took Part

794 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Have been diagnosed with HIV;. Receive care at one of the participating sites;. Are \>18 years old;. Have smoked \>100 cigarettes lifetime;. Smoke everyday or some days;.

The full record lists 7 inclusion and 6 exclusion criteria; among the exclusions: 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;.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Therapeutic nicotine (patch, non-peptide) study did not mask who received what.

It started in 2027-09-30 with completion listed for 2030-09-30.

It ran at 5 sites in United States (5).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 7-day point-prevalence abstinence confirmed by exhaled carbon monoxide (eCO) (time frame: 12 weeks).

It also tracked 6 secondary outcomes, for example 7-day point-prevalence abstinence confirmed by exhaled carbon monoxide (eCO), Self-reported 7 day point prevalence smoking abstinence, Cigarettes per day, Cigarettes per day, Cigarettes per day and HIV viral load, detectable.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 794 people.

With 794 participants it is a large trial for this field.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.