Mobile Health Technology for Personalized Tobacco Cessation Support in Laos

R21 Phase: Adaption of the AT intervention content

In stage 1, formative research, including literature searches, quantitative results, and qualitative methods (e.g., key informant interviews) are often conducted to determine how well an original intervention will fit the needs and preferences of the target population. The investigators will conduct in-depth interviews with 30 healthcare providers at participating hospitals to learn more about how they typically motivate patients to quit smoking and stay abstinent. Inclusion criteria for all healthcare providers in the R21 Phase include 1) age ≥18 years; and 2) the ability to provide written informed consent to participate. They can develop intervention messages if they wish or pinpoint the sources of treatment content that they use. The investigators will use purposive sampling to select 15 providers from each hospital, 15 of each sex, and ensure the sample is diverse with regard to age and specialty. Also, the investigators will conduct 8 focus group discussions with 40-60 patients who smoke (5-8 persons/group, 4 groups/hospital) to identify additional factors that motivate patients to quit smoking and stay abstinent, barriers to quitting, and strategies to overcome these barriers. Inclusion criteria for all patients in the R21 Phase include 1) age ≥18 years; 2) self-reported current combustible cigarette smoking (smoked ≥100 cigarettes in lifetime and currently smoke ≥1 cigarette/day); 3) planning to quit in the next 6 months or having actually made a quit attempt; and 4) the ability to provide written informed consent to participate. The investigators will use purposive sampling to select a diverse sample with regard to age, residence (urban vs. rural), disease type, and cessation phase, per the Phase-Based Model (PBM; see Conceptual Framework). The investigators will conduct separate group discussions for men and women (2 groups for each sex at each hospital). For all qualitative components in the R21 Phase, the investigators will use open-ended questions in all interviews/discussions. All interviews/discussions will be recorded using a digital voice-recording app on an encrypted smartphone and will be transcribed verbatim. Qualitative data will be analyzed using thematic content analysis with the aid of the R-based Qualitative Data Analysis software package. Themes will be based on the purpose of each component and on theoretical constructs of the PBM.

In stage 2, the investigators will integrate information gathered in the first stage to modify the original intervention. Also at this stage, the investigators will translate all English intervention materials and assessments that will be used in the R33 Phase to Lao, mirroring the WHO's recommended methodology. First, a health scientist, whose native language is Lao, will lead the forward translation process, focusing on conceptual (vs. literal) meaning and comprehensible language for the broadest audience. Second, a more senior bilingual health expert will review the translation, discuss disagreements with the forward translator, edit, and finalize the forward translation. Third, 2 other bilingual health professionals will independently rate the quality of the translation on 5 dimensions: conceptual equivalence, clarity in meaning, comprehensibility, use of common simple language, and cultural appropriateness. Any discrepancies will be discussed to reach consensus on translation or editing. Fourth, the investigators will conduct 6 panel discussions (1 with female smokers, 1 with male smokers, and 1 with mixed-sex healthcare professionals at each participating hospital; 5-7 panelists per group). This step aims to evaluate material comprehensibility as well as linguistic and cultural appropriateness for the target populations, particularly to identify linguistic differences by regions (north vs. south) in Lao PDR and to find and use common words. Fifth, 2 other bilingual health professionals will independently backward translate the materials into English. Finally, the PI and site-PI will independently review and rate the backward-translations for conceptual equivalence with the original English versions.

In stage 3, the investigators will load the intervention content onto the Insight™ platform and assessments into REDCap and will preliminarily test them (on smartphones/ tablets) with 20 patients who smoke (10 male, 10 female). Additionally, the investigators will systematically document continuous feedback from local investigators and staff members who implement stages 2 and 3 for adaption refinement. In stage 4, the investigators will refine the intervention based on the results and feedback from stage 3. Critical changes at this stage (e.g., major deviations from the original intervention) will only be made in consultation with the leadership team.

Stage 5 will be a 3-month pilot efficacy trial with 50 patients. Activities at this stage will mirror the full efficacy trial in the R33 Phase, except that only 50 patients will be recruited and treatment will last 3 months. In addition to the efficacy outcomes, the investigators will collect data for further adaption and refinement.