Efficacy of a Gender-Relevant Smoking Cessation Intervention Among Women in Brazil: Findings from a Group Randomized Controlled Trial.

There is scarcity of smoking cessation programs that take gender into account during its development, implementation, and evaluation. We evaluated the efficacy of a theory-based, culturally, and gender-relevant smoking cessation intervention delivered by Community Health Workers (CHWs) among Brazilian women that augments the smoking cessation program offered through the public health system (PHS). A total of 328 women current smokers (100% cigarette smokers) were recruited across 8 towns in a tobacco producing state in Brazil between 2014 and 2017. Four towns were randomly assigned to the intervention (12 home visits by a CHW and a scheduled appointment to attend the smoking cessation program at the PHS) and four towns to the control condition (scheduled appointment to attend the cessation program at the PHS). The primary outcome was self-reported 7-day smoked tobacco abstinence at 7-month follow-up with biochemical verification. Retention at 7-month follow-up was 80.7% (intervention) and 85.1% (control). Using intention-to-treat analysis, abstinence at 7-month-follow-up was 20% in the intervention arm versus 11% in the control arm. Multivariable modeling showed that participants in the intervention arm had 1.88 times the odds of self-reported smoking cessation than control participants after adjustment for depressive symptomatology, self-efficacy, and having someone in the house who smokes. Besides the intervention, only self-efficacy remained significant in the full model as a predictor of cessation. Replication of these analyses using the objective measure of carbon monoxide at a cutoff score of 8 ppm yielded similar results. A theory-based, culturally, and gender-relevant intervention, delivered by CHWs, can successfully promote smoking cessation among women. Clinical Trial Registration No. NCT03845413.