Optimizing behavioral and pharmacological smoking cessation interventions among people with HIV: results of a factorial design randomized trial

Abstract

Background: People living with HIV/AIDS (PWH) smoke at nearly three times the rate of the general population. Interventions to promote sustained quitting among PWH are urgently needed. Methods: Our study used a randomized factorial design to evaluate the effects of varenicline, compared to placebo, and behavioral cessation therapy, Positively Smoke Free (PSF), compared to Standard of Care (SOC) among PWH who smoke. The study was designed with power to detect a small effect (Cohen's h of .28-.36) with 240 participants. The primary outcome was the 7-day point prevalence abstinence (PPA) confirmed by exhaled carbon monoxide<10ppm for both main effects at 36 weeks. The study was conducted from June 2016-November 2020. During the study's last year, recruitment was halted due to COVID-19. Results: The study randomized 184 participants with power to detect a medium effect (Cohen's h of .41). Participants were mostly African-American (89.7%), men (62.8%) who smoked mentholated cigarettes (96.7%). Nearly all received antiretroviral medication (96.2%). Quit rates for the entire sample were 7.5% at 36 weeks. Compared to those who received placebo, neither those who received varenicline (36 weeks (OR [95%CI], 1.31 [0.33–5.22]), p = 0.70) nor PSF (36 weeks (OR [95%CI], 0.26 [0.03–2.44]), p = 0.24) were more likely to quit smoking. Conclusions: Among an urban living, primarily African American sample of PWH who smoke neither varenicline nor PSF was found to be efficacious at 36 weeks. Our study was not powered to detect small effects sizes. Larger trials are needed to establish tobacco treatment standards for PWH who smoke.