Implementing Sustainable Mobile Health Technology to Optimize a Smoking Cessation Program for Lao People With HIV (Project I-STOP): Protocol for a Hybrid Type-2 Pragmatic Effectiveness-Implementation Study.

Background: Tobacco use remains the leading modifiable risk factor for causing cancer worldwide, particularly among people with HIV. In Laos, 61%-80% of male people with HIV and 3%-10% of female people with HIV smoke cigarettes. They currently have no theoretically and empirically based smoking cessation support. Our team developed a scalable and affordable mHealth (mobile health)-based automated treatment program to support Lao and Cambodian smokers to quit smoking. We also pioneered the Ask-Advise-Connect approach to identify patients who smoke and to connect them to treatment. Objective: This hybrid type-2 pragmatic effectiveness-implementation study aims to compare 2 smoking cessation implementation strategies in 8 antiretroviral therapy (ART) clinics in the 6 most populous regions across Laos, using a parallel cluster randomized trial design. Methods: We will compare an Ask-Advice-Connect approach paired with an mHealth-based automated treatment program (AA-MAP) with an Ask-Advice-Connect approach paired with less resource-intensive printed self-help material (AA-SH). To guide assessment of implementation determinants and outcomes, we use the Practical, Robust Implementation and Sustainability Model framework. Aim 1 is to evaluate the reach and effectiveness of AA-MAP vs AA-SH. Reach is the proportion of people with HIV who smoke and are willing to make a quit attempt that enroll in treatment. Effectiveness is the proportion of enrolled participants (n=up to 1200) who achieve biochemically confirmed point prevalence abstinence 6 months after enrollment. We hypothesize that compared with AA-SH, AA-MAP will have a lower reach but will be more effective. We will also estimate the real-world impact (impact = reach × effectiveness) of each intervention. Aim 2 is to evaluate other implementation outcomes (eg, adoption, implementation fidelity, and sustainability) and identify implementation determinants of AA-MAP and AA-SH in the ART clinic setting using mixed methods. Aim 3 is to conduct a comprehensive assessment of the resource use and costs of implementing AA-MAP and AA-SH and calculate the absolute and relative cost-effectiveness of the 2 intervention strategies. Results: The study has been funded since August 2024. This study was approved by the ethical review boards of the Lao Ministry of Health-National Ethics Committee for Health Research and the University of Oklahoma Health Campus. The Multiple Principal Investigators met with the selected ART clinics. As of September 2026, we have launched the implementation of AA-SH and AA-MAP at 4 ART clinics. We plan to expand the implementation at the other ART clinics by December 2026. Conclusions: This project will contribute important actionable inputs that will inform the influential Lao National Tobacco Control Committee and Ministry of Health to implement the strategies in diverse hospital settings in future large-scale hybrid type II/III trials. Ultimately, our course of research can transform health care delivery and contribute to reducing tobacco-related morbidities and mortalities in Laos.