Smoking Cessation Program for Lao People With HIV

Experimental Design: The investigators chose cluster (vs. individual) randomized controlled trial (RCT) design as it is a robust, pragmatic design for service interventions (AA-SH/AA-MAP) at the cluster (ART clinics) level rather than the patient level. They considered a stepped-wedge design, which would have allowed all clinics to receive both interventions during the trial and within-cluster comparisons. However, that would have presented the risk of unequal chronological exposure to interventions, and the potential risk of internal contamination due to carry-over effects (i.e., during the 6-month treatment period, enrollees may be exposed to the other intervention if the clinic switched interventions). Thus, the investigators chose the parallel cluster RCT design but will allow all clinics the option to implement both AA-SH and AA-MAP after the trial period.

Study sites and participant recruitment: Participants will be recruited from 8 ART clinics in the 6 provinces/regions that are most populous or have an increasing HIV+ incidence. Besides currently registered patients, these clinics together gain approximately 1,500 new patients each year. These clinics provide comprehensive care for registered ART patients, including ART, ART adherence counseling, nutrition, risk-reduction counseling, and treatments for comorbidities other than tobacco use. Registered patients have periodic prescheduled appointments (about once per month for new patients and once per 4 months for patients with controlled viral load). To avoid potential skewness, the investigators will create 2 sets of 4 clinics with comparable patient populations and available resources and then randomly assign each set to an implementation strategy (AA-SH or AA-MAP).

Evaluation of reach and effectiveness of the AA-SH/AA-MAP approaches: In clinics assigned to AA-SH, staff will ask the patient if s/he smokes at every visit, advise smokers to quit, ask if they want to receive help with quitting, and provide them with a self-help guide. The AA-SH will be performed by counselors (counseling sessions occur at almost every visit and counselors have more time with patients) or nurses (when vital signs or blood samples are collected). It is optional for physicians to provide additional brief advice to quit (physicians have a more authoritative voice in Asian culture but less time with patients). The investigators will document which types of healthcare professionals provide advice to quit for additional analysis. The clinic staff will use a short form attached to patients' paper medical records to perform AA-SH, with a standardized question about smoking status (Did you [participant] smoke cigarettes in the past 7 days? [Yes/No]), a sample script to briefly advise smokers to quit, and 2 standardized questions about intent to quit (Are you [participant] willing to make a quit attempt in the next 2 weeks? [Yes/Remind me later], and if yes: Do you [participant] want to receive more information regarding how to quit? [Yes/No]). Those who answer yes to both questions will be provided with the self-help guide. The staff will also ask patients if they consent to be contacted at 6 months by research staff. The self-help guide is a 22-page booklet that the investigators developed in our R21/R33 study. Attached to the guide is an information sheet regarding NRT (e.g., patches and lozenges), where to buy them, and how to use them.

In the AA-MAP arm, clinic staff will do the ask-advise steps, and then will ask if smokers use a smartphone and proactively connect them to the MAP. Specifically, clinic staff will show a QR code (linked to a brief REDCap form) to smokers, and guide them through scanning the QR code, answering the few questions on the landing page (about their names and contact information), and submitting the form. Through our ongoing studies in Laos, NCLE/NTCC staff members have been proficient at managing the mHealth platform and app; these will serve in the MAP core team to provide technical assistance to all end users. Within 48 hours of receiving the REDCap form, MAP core staff will communicate with the enrollees to instruct them to download, sign up, and use the smoking cessation app. An instructional video of these steps will also be sent to the enrollees. For smokers who do not have a smartphone, the clinic staff will explain that the smoking cessation intervention will be available to them in the future. Our smoking cessation app is fully automated and interactive. Its content is adapted from the team's previous efforts and from the WHO/US NCI-suggested message banks. MAP is designed to tap the theoretical mechanisms described in the Phase-Based Model (PBM). That is, treatment content is designed to increase motivation, self-efficacy, use of coping skills and social support, and to reduce nicotine withdrawal symptoms and stress. The mHealth treatment will begin immediately after enrollment and will continue for 26 weeks. MAP allows for several levels of personalization and tailoring for each participant. First, at Day 1, participants will be asked some questions about their biological sex, past quit attempts, and the presence or fear of specific comorbidities. Messages tailored to these responses will be delivered automatically throughout the treatment period. Second, there will be different bins of messages for different cessation phases to ensure that the intervention content targets critical mechanisms of each phase. Phase identification follows the PBM's suggestion: preparation (enrollment to quit date), cessation (quit date to 4 weeks post-quit date), and maintenance (4-26 weeks post-quit date). Finally, the app will prompt participants to complete a brief (4-6 items) assessment every week (e.g., stress or self-efficacy levels); answers to these questions will drive the delivery of appropriate content to each participant.

Training ART clinic staff: All potential AAC implementers at each ART clinic will receive an initial 2-hour in-person group training on implementing AAC and collecting data using REDCap. The training also includes information on why PWH should quit smoking, the effectiveness of the AAC approach in high-income countries, healthcare provider roles, available NRTs in Laos, and time for questions and answers. The initial training will be held immediately prior to the launch of the AA-SH/AA-MAP implementation at the ART clinics and will emphasize the importance of fidelity to AA-SH/AA-MAP. The initial training will be video recorded for future review and for training of newly hired clinic staff. There will be 4 "booster" training sessions at months 1, 6, 12, and 18 to reinforce the information in the initial training, address emerging issues, and answer clinic staff's questions. These 30-minute booster sessions will coincide with required clinic-wide staff meetings. Both the initial and booster training sessions will involve didactic lectures and role-playing exercises.

Other strategies to ensure treatment and implementation fidelity: The investigators will also use other strategies as recommended by the NIH Behavior Change Consortium and Carroll's conceptual framework for implementation fidelity to maximize fidelity across multiple clinics. These include all clinics following a standardized protocol, building the standardized AAC component into the medical questionnaire, and monitoring AA-SH/AA-MAP enrollment in REDCap.

Assessment of reach and effectiveness. PWH who smoke and are willing to make a quit attempt within the next 2 weeks will be offered treatment (self-help guide or MAP). Reach is the proportion who enroll in treatment. The pool of participants for the assessment of effectiveness is AA-SH/AA-MAP enrollees. At 6 months post-enrollment, the research team will assess the smoking status of enrollees through a survey. Participants who self-report quitting will be seen in person at the clinic within 30 days post-survey for biochemical verification. The investigators will try to arrange this visit to coincide with participants' regular/prescheduled clinic visit for ART or other services. A local research staff member (not associated with ART clinics) will collect the data using the REDCap mobile app on a tablet. The research staff will assess up to 1,200 treatment enrollees at 6 months.

Other outcomes: The investigators will also estimate the impact of AA-SH and AA-MAP. Impact, the multiplicative effect of reach and effectiveness, is crucial in evaluating health intervention implementation. An intervention may have a broad reach but limited effectiveness, or have strong effectiveness but limited reach, and hence ultimately may have limited public health impact.

Evaluation of other multi-level implementation outcomes of AA-SH/AA-MAP: The investigators will use a mixed methods approach to assess other PRISM-based implementation outcomes (e.g., adoption, implementation fidelity, and sustainability) and to identify key determinants associated with these outcomes (e.g., intervention characteristics, patient characteristics, organization characteristics, or external factors). The investigators will use the convergent mixed methods design, in which quantitative and qualitative data are collected separately and then merged in analysis for interpretation.

Evaluation of the resource/cost associated with AA-SH/AA-MAP: To inform the decision-making of public sector stakeholders, the investigators will conduct an assessment of the resources needed to widely implement the interventions, and the potential gain from investing those resources from the perspective of the governmental service-providers.