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

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BACKGROUND Tobacco use remains the leading modifiable risk factor for preventing cancer globally, particularly among people with HIV (PWH). In Laos, 61%–80% of male PWH and 3%–10% of female PWH smoke cigarettes. PWH who smoke in Laos currently have no theoretically and empirically based smoking cessation support. Thus, implementing sustainable and evidence-based smoking cessation interventions for PWH in Laos is a pressing need. Our team developed a scalable and affordable mHealth-based automated treatment program (MAP) to support Lao and Cambodian smokers to quit smoking. We also pioneered the Ask-Advise-Connect (AAC) approach to identify patients who smoke and to connect them to treatment, which showed great impact in our previous US studies. OBJECTIVE The aim of this hybrid type-2 pragmatic effectiveness-implementation study is 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 (AAC) approach paired with an mHealth-based automated treatment program(AA-MAP) to an AAC 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 (PRISM) framework. Aim 1 is to evaluate the reach and effectiveness of AA-MAP versus AA-SH. Reach is the proportion of PWH who smoke and are willing to make a quit attempt that enroll in treatment. Effectiveness is the proportion of enrolled participants (n=up to 1,200) 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 (e.g., 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 This study was approved by the ethical review boards of the Lao Ministry of Health (MOH)–National Ethics Committee for Health Research and the University of Oklahoma Health Campus. The Multiple Principal Investigators met with the selected ART clinics, explained the study, and discussed an implementation plan and potential challenges. All the selected clinics expressed their commitment to implementing the proposed project. We plan to launch the implementation of AA-SH and AA-MAP in the first set of ART clinics in June 2026. CONCLUSIONS The successful completion of this project will contribute important actionable inputs that will inform the influential Lao NTCC and MOH to implement the strategies in diverse hospital settings in future large-scale hybrid type II/III trials. Ultimately, our course of research has the potential to transform healthcare delivery and to contribute to reducing tobacco-related morbidities and mortalities in Laos. CLINICALTRIAL ClinicalTrials.gov NCT07014605; Registered June 11, 2025, https://clinicaltrials.gov/study/NCT07014605

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