Smoking Cessation Program for Lao People With HIV

Starting soon · Not applicable

Conditions studied: Smoking Cessation, HIV

In brief

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.

Key facts

Study ID

NCT07014605

Run by

University of Oklahoma

People needed

1200

Starts

2026-08-01

Expected to finish

2029-07-31

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• aged ≥18 years
• 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)
• consenting to be contacted after 6 months of enrollment and able to provide written informed consent to participate.

You may not qualify if…

• None.

Where it is running

• Champasak Hospital — Champasak, Laos
• Setthathirath Hospital — Vientiane, Laos

Full record on ClinicalTrials.gov

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