A tailored telehealth group tobacco cessation treatment program for people with HIV: Study protocol for a randomized controlled trial

Background: Smoking-related illnesses are the leading cause of death among people with HIV (PWH). Yet, there are few effective evidence-based interventions that help PWH quit smoking. The group-based program Positively Smoke Free is a biobehavioral cessation intervention for PWH with a growing evidence base. This study builds on prior work of Positively Smoke Free and addresses numerous weaknesses of prior trials for this population. We describe the Positively Quit Trial, a randomized controlled trial comparing a videoconferencing delivered Positively Smoke Free intervention to an attention-matched condition, assessing cessation over a 1-year period. Methods: This attention-matched, randomized (1:1) controlled trial compares Positively Smoke Free Video-Groups to an updated version of Healthy Relationship Video-Groups. Participants are PWH, aged 18 years and older, who smoke at least one cigarette per day. All are offered nicotine replacement therapy patches and given brief advice to quit. Participants are enrolled in 12 group sessions focusing on either smoking cessation for PWH or broader topics regarding living healthy with HIV; in both conditions, Social Cognitive Theory is the guiding theoretical framework. Participants complete assessments at baseline, days 42, 90, 180, and 360; self-reported abstinence is verified with a video-observed cheek swab sent to a lab and tested for cotinine. Primary outcomes: Biochemically confirmed 7-day point prevalence smoking abstinence at day 360 is the primary outcome. Cost per quit, sustained abstinence at various timepoints, and biochemical confirmed abstinence at three and six months are secondary outcomes. Effects of smoking cessation on CD4 and virologic suppression are also explored.