Clinical Pharmacists, Medications, and Contingency Management for Targeting Smoking in HIV Clinics: A Randomized Clinical Trial.

Abstract

There is a lack of robust strategies to reduce cigarette smoking among people with HIV. To identify optimal adaptive treatment strategies involving clinical pharmacist-delivered medications for tobacco use disorder and contingency management (CM) for smoking reduction among people with HIV. From July 27, 2020, through March 28, 2024, using a sequential multiple-assignment randomized clinical trial, people with HIV who smoked cigarettes were recruited and randomized 1:1 to nicotine replacement therapy (NRT) with or without CM (stage 1). After 12 weeks of treatment (stage 2), individuals with confirmed abstinence continued stage 1 treatment; individuals without confirmed abstinence were rerandomized to switch to oral medications for tobacco use disorder or to intensified CM. Interventions were delivered by clinical pharmacists in HIV clinics across 24 weeks. Stage 1 included NRT with or without CM (rewards for confirmed abstinence). Stage 2 included either a switch to varenicline or bupropion or intensification to more rewards for abstinence. Each stage involved 5 clinical pharmacist visits. The primary outcome was cigarettes per day (CPD), and the secondary outcome was 7-day confirmed abstinence at 12 and 24 weeks with imputation. Analyses were conducted using intention-to-treat principles. In total, 323 participants (181 [56.0%] male at birth; 317 [72.5%] Black or African American; mean [SD] age, 55.1 [10.7] years) smoked a mean (SD) of 12.8 (7.2) CPD at baseline. At 12 weeks, participants in the NRT plus CM (least-squares mean [LSM], 4.9 [97.5% CI, 3.5-6.2] CPD) and NRT (LSM, 5.2 [97.5% CI, 3.9-6.5] CPD) groups smoked similar numbers of CPD (adjusted LSM difference, -0.3 [97.5% CI, -1.9 to 1.3]; P = .66). Abstinence was greater at 12 weeks in the NRT plus CM group (36 of 160 [22.5%]) compared with the NRT group (16 of 163 [9.8%]) (adjusted odds ratio [AOR], 2.70 [99.0% CI, 1.19-6.14]; P = .002). Among participants without week 12 abstinence, the effect of intensifying vs switching on week 24 CPD varied by stage 1 treatment. Intensifying was better among individuals starting with NRT alone (adjusted LSM difference, -3.8 [97.5% CI, -6.0 to -1.5] CPD; P < .001) but not among individuals initially receiving NRT plus CM (adjusted LSM difference, 0.3 [97.5% CI, -2.1 to 2.6] CPD; P = .80). Abstinence at 24 weeks was similar among individuals in intensified vs switched groups regardless of stage 1 treatment (AOR, 1.5 [99% CI, 0.4-4.2]; P = .37; P = .85 for interaction). Overall, 24-week CPD was lowest with the adaptive treatment strategy involving NRT followed by NRT plus CM (eg, LSM, 2.6 [99% CI, 1.1-4.1] CPD vs 4.2 [99% CI, 2.6-5.9] CPD for NRT plus CM followed by NRT plus CM intensified), and abstinence was highest for the NRT plus CM followed by the intensified strategy (eg, LSM, 30.0% [99% CI, 16.2%-48.7%] vs 12.8% [99% CI, 5.2%-28.3%] for NRT followed by NRT plus CM intensified). In this randomized clinical trial of people with HIV who smoked cigarettes, CM was an effective adjunct to clinical pharmacist-delivered NRT for improving tobacco-related outcomes. Optimal timing to add CM differed based on treatment goals. ClinicalTrials.gov Identifier: NCT04490057.