Smoking Cessation Program for Lao People With HIV

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 have no reliable smoking cessation support. Thus, implementing sustainable and evidence-based smoking cessation interventions for PWH in Laos is needed. The investigators developed a scalable and affordable mHealth-based automated treatment program (MAP) to support Lao and Cambodian smokers to quit smoking. 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 connect them to treatment. Our team pioneered the Ask-Advise-Connect (AAC, asking patients about smoking at every visit, briefly advising those who smoke to quit, and connecting them to treatment) approach, which showed great impact in our previous US studies. The purpose of this study is to compare 2 smoking cessation implementation strategies in 8 antiretroviral therapy (ART) clinics in the 6 most populous regions in Laos, using a hybrid type-2 pragmatic effectiveness-implementation study and a parallel cluster randomized trial design. Specifically, the investigators 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). The investigators will use the Practical, Robust Implementation and Sustainability Model (PRISM), which expands the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework to include more 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 who achieve biochemically confirmed point prevalence abstinence 6 months after enrollment. The investigators will also estimate the real-world impact (impact = reach × effectiveness) of each intervention. Aim 2 is to determine other implementation outcomes of AA-MAP and AA-SH. Aim 3 is to assess the resource use and costs of implementing AA-MAP and AA-SH. The project has the potential to transform HIV care and to reduce tobacco-related cancers and other morbidities.

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 inform trial.show_full_description

Inclusion Criteria: 1. aged ≥18 years 2. reachable within 30 days of the target assessment date by different methods (up to 4 phone calls on different days and times, 3 text messages for each platform \[e.g., SMS, Telegram, or WhatsApp\], 3 emails if applicable, and via direct contact at a prescheduled clinic appointment if applicable) 3. consenting to be contacted after 6 months of enrollment and able to provide written informed consent to participate. Exclusion Criteria: * None.