A randomized trial for combination nicotine replacement therapy for smoking cessation among people with HIV in a low-resourced setting.

Objective: The purpose of this study was to evaluate the efficacy of combination nicotine replacement therapy (c-NRT) for smoking cessation among people with HIV (PWH) in South Africa.

Design: We conducted an open label, individually randomized clinical trial.

Methods: Using a two-armed approach, PWH who smoke were randomized to receive either 1) intensive anti-smoking behavioral counseling (BC) or 2) intensive anti-smoking BC plus c-NRT (nicotine patches augmented by nicotine gum). Self-reported smoking abstinence was biochemically validated with exhaled breath carbon monoxide (CO) and urine cotinine at six months. Recruitment, provision of trial interventions, and follow-up of participants took place March 2014 through June 2016.

Results: We randomly assigned 280 participants to the BC arm and 281 participants to the BC + c-NRT arm. 438 (78%) participants were male and 123 (22%) were female. For our primary outcome of biochemically verified abstinence at six months, 41 (15%) were quit in the BC + c-NRT arm versus 28 (10%) in the BC arm, resulting in a 5% (95% CI -1%, 10%) absolute difference in relative risk and an adjusted odd ratio of 1.47 (95% CI: 0.86, 2.52) comparing the BC + c-NRT to the BC arm.

Conclusions: Although our results did not reach statistical significance, we found augmentation of BC with c-NRT to increase smoking abstinence at six months, which is consistent with performance in the general population. PWH in low-resource settings may benefit from the addition of c-NRT to existing tobacco cessation interventions.