An mHealth (Mobile Health) Intervention for Smoking Cessation in People With Tuberculosis: A Cluster Randomized Clinical Trial.

IMPORTANCE: Smoking worsens outcomes in people with tuberculosis (TB), while quitting hastens recovery.

OBJECTIVE: To assess the effectiveness of a mobile health (mHealth) intervention for achieving self-reported continuous tobacco abstinence at 6 months, supported by biochemical verification at 6 months, compared with usual care in people with TB.

DESIGN, SETTING, AND PARTICIPANTS: Multicenter, cluster randomized clinical trial conducted between September 18, 2023, and January 2, 2025, randomizing (2:1) 27 TB clinics in Bangladesh and Pakistan to mHealth or usual care groups. The follow-up was 6 months. Participants were eligible if they were 15 years or older, had been diagnosed with drug-sensitive pulmonary TB in the past 4 weeks, smoked daily, were willing to quit, and had access to mobile phones.

INTERVENTION: The mHealth group (n = 720) received text messages throughout TB treatment, daily for 2 months then monthly for 4 months, encouraging tobacco cessation. The usual care group (n = 360) received written information on tobacco cessation.

MAIN OUTCOMES AND MEASURES: The primary outcome was self-reported continuous abstinence at 6 months, verified biochemically using carbon monoxide breath test at 6 months. Secondary outcomes included self-reported point abstinence at 9 weeks and 6 months, TB treatment adherence (days receiving TB treatment), TB treatment success (cured + completed treatment), TB treatment failure, TB treatment default (interruption of TB treatment for ≥2 months), and death.

RESULTS: Of 9232 patients assessed for eligibility, 1080 were randomized; most were male (mHealth, 96.9%; usual care, 95.8%), and 985 were retained throughout the trial (91%). For the primary outcome, 300 of 720 participants (41.7%) in the mHealth group demonstrated self-reported and biochemically verified continuous abstinence at 6 months, compared with 55 of 360 (15.3%) in the usual care group (risk ratio, 3.0 [95% CI, 2.0-4.9]). In the mHealth vs usual care groups, respectively, mean TB treatment adherence was 174.3 (SD, 21.5) days vs 178.0 (SD, 12.1) days (P = .23), and treatment success was 89.3% vs 85.6% (risk ratio, 1.2 [95% CI, 0.9-1.6]). TB treatment failure (0.1% vs 0.5%) and default (3.1% vs 1.9%) were uncommon. Mortality was lower with mHealth (3.5%) vs usual care (7.5%) (hazard ratio, 0.4 [95%CI, 0.2-0.9]).

CONCLUSIONS AND RELEVANCE: An mHealth intervention was effective in achieving continuous abstinence in people with TB who smoked. mHealth is a feasible and effective intervention to help patients with TB quit smoking.

TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN86971818.