Mobile Health Technology for Personalized Tobacco Cessation Support in Laos (Project Support Laos): Protocol for a Randomized Controlled Trial.

Background: Tobacco use remains the leading cause of preventable morbidity and mortality in Lao People's Democratic Republic (Lao PDR). Despite the prevalence of cigarette smoking in Lao PDR (51% in men and 7% in women), no national tobacco treatment programs are available. Therefore, the development and evaluation of sustainable tobacco cessation interventions suitable for widespread adoption in Lao PDR are pressing public health needs. Objective: This project aims to adapt our theoretically and empirically based mobile health (mHealth) technology to help people quit smoking cigarettes in Lao PDR. Methods: Our mHealth approach includes a fully automated, interactive, personalized, smartphone-delivered intervention for behavioral treatment. This project includes 2 main phases. In the first phase, we use formative research methods to adapt our intervention content to the sociocultural context, language, and communication styles of Laotians. In the second phase, we conduct a randomized controlled trial to evaluate the efficacy of our mHealth intervention. In the trial, adult smokers are recruited through 2 national hospitals: Setthathirath Hospital in Vientiane and Champasak Hospital in Champasak Province. Participants (n=500) are randomized to either the standard care (SC; n=250) or automated treatment (AT; n=250) group. SC consists of brief advice to quit smoking delivered by research staff, self-help written materials, and a 2-week supply of nicotine replacement therapy (transdermal patches). AT consists of all SC components plus a fully automated smartphone-based treatment program that involves interactive and personalized proactive messages, images, or videos. The primary health outcome of the trial is biochemically confirmed self-reported 7-day point prevalence abstinence 12 months post study enrollment. Secondary outcomes include abstinence at 3 and 6 months post enrollment. Results: This study was approved by the ethical review boards of the respective domestic and international institutions. Data collection for the formative phase occurred from January 2022 to May 2023, and data analyses are ongoing. Data collection for the trial phase is ongoing and is expected to be completed by the end of 2026. Conclusions: If the proposed project is successful, it has the potential to transform health care services for tobacco treatment throughout Lao PDR and, ultimately, to significantly reduce tobacco-induced morbidity and mortality in the country. The AT's potential for widespread adoption and sustainability is enhanced by the direct involvement of Lao governmental stakeholders at multiple national institutes. Furthermore, the US-Lao collaborative work and capacity-building activities in this project will contribute to creating a knowledge base for mHealth research applications and advancing mHealth research capacity in Lao PDR.