Cigarette smoking remains one of the most serious health challenges facing people living with HIV. Smoking cessation in HIV clinics has long been difficult to achieve, yet a newly published randomised clinical trial in JAMA Network Open (February 2026) offers real guidance. Researchers found that clinical pharmacist-led treatment combining nicotine replacement therapy and contingency management significantly improved tobacco use outcomes. The findings change how we should think about tobacco use disorder treatment in HIV settings.

The Study at a Glance

The SMARTTT trial enrolled 323 participants across HIV clinics at Yale New Haven Hospital Health System, SUNY Downstate, and Mount Sinai Health System. Most participants (72.6%) identified as Black or African American. Their mean age was 55 years. They smoked an average of 12.8 cigarettes per day at baseline.

Researchers used a sequential multiple-assignment randomised trial (SMART) design. This allowed them to randomise participants twice, not just once. The design lets clinicians adapt treatment based on whether a patient responds to the first stage. It suits complex, real-world clinical populations where one fixed approach rarely works for everyone.

Two Stages of Treatment, Tailored to Response

In stage one, all participants received nicotine replacement therapy (NRT). Half also received contingency management (CM), a structured programme where clinicians reward verified smoking abstinence with tangible incentives such as gift cards or reloadable debit cards. Participants could earn up to $350 during stage one.

At 12 weeks, those who confirmed abstinence continued their existing treatment. Those who did not respond entered stage two. Researchers rerandomised them to either switch to oral medications (varenicline or bupropion) or intensify the CM component, with potential rewards rising to $850.

Researchers measured cigarettes smoked per day (CPD) as the primary outcome. Confirmed 7-day abstinence was the secondary measure.

What the Results Show About Smoking Cessation in HIV Clinics

At 12 weeks, both groups cut their daily cigarette consumption substantially. The NRT alone group averaged 5.2 CPD. The NRT plus CM group averaged 4.9 CPD. That difference was not statistically significant. Abstinence rates, however, told a very different story.

In the NRT plus CM group, 22.5% of participants confirmed abstinence at 12 weeks. In the NRT-only group, only 9.8% did. The adjusted odds ratio was 2.70. That is a clinically meaningful gap.

Among those who did not respond in stage one, what happened next depended on their initial treatment. Participants who started with NRT alone and then added CM in stage two averaged just 3.0 CPD at week 24. Those who switched to oral medications averaged 6.8 CPD. Adding CM made a clear difference. For participants who already received CM from the start, intensifying it further did not produce additional reductions in CPD.

The highest abstinence rates at week 24 came from the group that started with NRT plus CM and then had their CM intensified. That group reached an estimated 30.0% abstinence by the end of the trial.

The Role of Clinical Pharmacists in Smoking Cessation in HIV Clinics

Who delivered the treatment matters just as much as what the treatment was. Residency-trained clinical pharmacists embedded within HIV clinics ran every part of the programme. They prescribed medications, gave brief advice, tracked progress, and ran the contingency management sessions.

This model addresses a real and well-documented gap. HIV clinicians regularly report barriers to tackling tobacco use with their patients. Time pressure, competing clinical priorities, and low confidence around prescribing smoking cessation medications all get in the way. Clinical pharmacists step into that space effectively. They already operate in HIV care settings, routinely handle medication for tobacco use disorder, and can deliver the consistent, structured follow-up that these programmes require.

Each participant completed 10 pharmacist visits across 24 weeks. That level of sustained contact is hard to deliver without dedicated staff. The study showed it is achievable in real HIV clinic environments.

Why Contingency Management Strengthens Tobacco Use Disorder Treatment in HIV

Contingency management draws on well-established behavioural principles. When a person receives a reliable reward for a verifiable behaviour, that behaviour becomes more likely to continue. In this context, participants earned rewards each time they confirmed smoking abstinence through a breath carbon monoxide test.

The rewards were not large. During stage one, participants receiving CM averaged just $34.90 in total earnings. Yet abstinence rates more than doubled compared to those receiving NRT alone. The size of the reward mattered less than the consistency and immediacy of the reinforcement.

The US Centers for Medicare and Medicaid Services recently endorsed CM for tobacco use disorder and other substance use conditions. Several states have issued Medicaid demonstration waivers to fund CM programmes. This is a sign that policymakers now recognise what the research has shown for years: CM works, and it can be delivered at scale.

Choosing the Right Strategy for the Right Goal

The SMARTTT trial makes one thing very clear. The best adaptive treatment strategy depends on the goal. Those aiming primarily to reduce daily cigarette consumption should start with NRT alone. If they do not respond, adding CM in stage two produces the greatest reduction in CPD. Those aiming for full abstinence should start with NRT plus CM from day one. If they do not respond, intensifying CM gives the best chance of reaching that goal.

This matters practically. Not every person who smokes sets out wanting to quit entirely. Reducing daily consumption is a meaningful clinical target in its own right, and this trial shows it is reachable through pharmacist-led smoking cessation in HIV clinics.

Limitations Worth Noting

The COVID-19 pandemic delayed enrolment by nearly a year. The trial team reduced the sample size and shifted the primary outcome from abstinence to CPD as a result. That change meant the study lacked full statistical power to detect abstinence differences in stage two.

Oral medication prescribing was lower than expected. The varenicline recall during the study period disrupted access and likely heightened caution among both prescribers and patients. The study also ran in urban, northeastern US clinics, which may limit how far the findings generalise. The research team did not follow up with participants beyond the 24-week treatment window, so durability of effects remains unknown.

A Model Worth Building On

Clinical pharmacist-led tobacco use disorder treatment in HIV clinics works. This trial produced clinically meaningful reductions in smoking across a predominantly Black and African American population that smoking cessation programmes have historically underserved. The combination of structured medications, consistent pharmacist contact, and contingency management built around verified abstinence delivered real results.

The approach adapts to the person. It concentrates the most intensive support on those who need it after the first stage. It gives clinicians a clear, evidence-based decision tree rather than a one-size-fits-all protocol. And it positions clinical pharmacists as central to delivering smoking cessation in HIV clinics at a meaningful scale.

The evidence points in one direction. How healthcare systems choose to invest in and implement this model will determine whether people living with HIV can access it.

Source: jamanetwork