Implementing Sustainable mobile health Technology to Optimize smoking cessation Program for Lao people with HIV (I-STOP) - PROJECT SUMMARY: Tobacco use remains the leading modifiable risk factor for preventing cancer globally, particularly among people with HIV (PWH). In Lao People's Democratic Republic (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 critically needed. There is substantial evidence that mobile health (mHealth)- based smoking cessation interventions are effective, cost-effective, and affordable. We developed a scalable and affordable mHealth-based automated treatment program (MAP) to support Lao and Cambodian smokers to quit smoking. The MAP involves interactive, tailored, personalized content (text messages, photos, and videos) delivered via a smartphone app. Along with effective cessation treatments, it is imperative to implement procedures to identify patients who smoke and to facilitate connections to treatment. One such approach pioneered by our team is Ask-Advise-Connect (AAC, asking patients about smoking at every visit, briefly advising those who smoke to quit, and connecting them to treatment), which showed great impact in our US studies. The purpose of this application is to compare 2 smoking cessation implementation strategies in 8 antiretroviral therapy (ART) clinics in the 5 most populous provinces/regions across Laos, using a hybrid type-2 pragmatic effectiveness-implementation study and a parallel cluster randomized trial design. Specifically, we will compare an AAC approach paired with our previously developed MAP (AA-MAP) to an AAC approach paired with less resource intensive printed self-help material (AA-SH). To guide our implementation work, we use the Practical, Robust Implementation and Sustainability Model (PRISM), which expands the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework to include more key, multilevel contextual factors relevant to program implementation. 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=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 multi-level implementation outcomes (e.g., adoption, implementation fidelity, and sustainability) 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. The project has the potential to transform HIV care delivery throughout the country and to reduce tobacco-related cancers and other morbidities.
