Digital-Assisted Community Pharmacy Cessation for Dual-Tobacco Users in Jordan: A Hybrid Cluster Randomized Controlled Trial

Tobacco use remains a major public health challenge in Jordan, where cigarette smoking and waterpipe use are both common and dual use is increasingly prevalent. Community pharmacies are highly accessible healthcare settings, yet structured smoking-cessation services remain underutilized. This study evaluated the clinical effectiveness and implementation of Dual-Quit Digital, a pharmacist-delivered cessation counseling program tailored to the type of tobacco used, paired with a 6-month automated WhatsApp® (Menlo Park, CA, USA) follow-up system. We conducted a pragmatic, two-arm, parallel-group, Hybrid Type 2 cluster randomized controlled trial in 16 community pharmacies in Jordan, randomized 1:1 to intervention or usual care. A total of 320 adult tobacco users were enrolled (160 per arm). The intervention combined a structured in-pharmacy pharmacist consultation, tailored behavioral support, phenotype-stratified pharmacotherapy support, and 6 months of semi-automated WhatsApp® follow-up with telepharmacy escalation for predefined red-flag responses. The control arm received usual care, consisting of opportunistic brief advice and standard over-the-counter sales without proactive follow-up. The primary outcome was biochemically verified continuous abstinence at 6 months, defined as exhaled carbon monoxide (CO) < 10 ppm and analyzed using intention-to-treat principles. Secondary outcomes included 7-day point prevalence abstinence (PPA) at 3 and 6 months, 30-day PPA at 6 months, both-product abstinence among baseline dual users, pharmacotherapy uptake and adherence, and implementation-relevant outcomes, including service reach, feasibility of recruitment, and digital engagement metrics. All 16 pharmacies were retained, and all 320 randomized participants were included in the intention-to-treat analysis. At 6 months, CO-verified continuous abstinence was achieved by 26.3% of participants in the intervention arm compared with 11.3% in the control arm (adjusted odds ratio [aOR] 2.84, 95% CI 1.55–5.18; p < 0.001). The intervention also improved 7-day PPA at 3 months (33.1% vs. 15.6%; aOR 2.68, 95% CI 1.56–4.60; p < 0.001), 7-day PPA at 6 months (30.6% vs. 14.4%; aOR 2.62, 95% CI 1.48–4.62; p = 0.001), and 30-day PPA at 6 months (28.1% vs. 11.9%; aOR 2.89, 95% CI 1.59–5.24; p < 0.001). Among baseline dual users, both-product abstinence was higher in the intervention arm (21.9% vs. 7.8%; aOR 3.30, 95% CI 1.12–9.75; p = 0.026). Pharmacotherapy initiation was more frequent in the intervention arm (72.5% vs. 28.1%; p < 0.001), as was self-reported adherence for at least 8 weeks among initiators (56.0% vs. 26.7%; p = 0.002). In the intervention arm, active patient response rates to scheduled WhatsApp® messages remained substantial, with 88.1% responding at Week 1, 73.8% at Week 4, 67.5% at Month 3, and 61.3% at Month 6; 145 red-flag triggers were captured from 62 participants, and 84.1% of escalations resulted in successful pharmacist follow-up within 48 h. The Dual-Quit Digital model significantly improved smoking-cessation outcomes compared with usual care and proved operationally feasible. These findings support integrating phenotype-stratified pharmacist counselling, pharmacotherapy support, and low-burden digital follow-up as a pragmatic cessation model for Jordan and similar settings.