Smoking Cessation Program for Lao People With HIV

Sponsor
University of Oklahoma
Study ID
NCT07014605
Status
Not Yet Recruiting

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Conditions

  • HIV
  • Smoking Cessation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Smoking Cessation Self Help Guide — BEHAVIORAL
    Our team has translated and validated the World Health Organization's "A guide for tobacco users to quit" into Lao language for use as the self-help guide in this 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.
  • Smartphone-delivered Automated Messaging — BEHAVIORAL
    The MAP includes text messages, images, and videos with content 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, while reducing nicotine withdrawal symptoms and stress. The MAP will begin immediately after enrollment and continue for a 26-week period. The MAP approach allows for several levels of personalization for each participant, including tailoring to participants' specific health conditions, individual cessation phases, and participants' self-efficacy level or smoking status in the past week.

Study Details

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 Dates

First listed
Jun 11, 2025
Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Jul 31, 2029

Study Design

Enrollment
1,200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: AA-SH (Ask-Advise-Connect paired with self-help material)
    Participants will receive advice to quit smoking and be provided with a self-help guide to support smoking cessation.
  • Experimental: AA-MAP (Ask-Advise-Connect paired with mHealth-based automated treatment program)
    Participants will receive advice to quit smoking and be connected to the mHealth-based automated treatment program (MAP). MAP is a fully automated smartphone-based treatment program that involves interactive and personalized proactive messages, images, or videos.

Primary Outcome Measure

Reach [ Time Frame: At the end of the AA-SH/AA-MAP implementation at each ART clinic (up to 30 months) ]

Central Contacts

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