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

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.

We conducted an open-label, individually randomized clinical trial.

Using a two-armed approach, PWH who smoke were randomized to receive either intensive antismoking behavioral counselling or intensive antismoking behavioral counseling 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 6 months. Recruitment, provision of trial interventions, and follow-up of participants took place in March 2014 through June 2016.

We randomly assigned 280 participants to the behavioral counseling arm and 281 participants to the behavioral counseling + c-NRT arm. Four hundred and thirty-eight (78%) participants were men and 123 (22%) were women. For our primary outcome of biochemically verified abstinence at 6 months, 41 (15%) were quit in the behavioral counseling + c-NRT arm vs. 28 (10%) in the behavioral counseling arm, resulting in a 5% [95% confidence interval (CI) -1 to 10%] absolute difference in relative risk and an adjusted odd ratio of 1.47 (95% CI 0.86-2.52) comparing the behavioral counseling + c-NRT to the behavioral counseling arm.

Although our results did not reach statistical significance, we found augmentation of behavioral counseling with c-NRT to increase smoking abstinence at 6 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.