Smoking Cessation Program for Lao People With HIV

Summary

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.

Conditions

• Smoking Cessation
• HIV

Interventions

BEHAVIORAL

Smoking Cessation Self Help Guide

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.

BEHAVIORAL

Smartphone-delivered Automated Messaging

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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Department of Communicable Disease Control, Ministry of Health, Lao PDR

  collaborator UNKNOWN

• National Tobacco Control Committee, Lao PDR

  collaborator OTHER

• National Center for HIV/AIDS and STIs, Ministry of Health, Lao PDR

  collaborator UNKNOWN

• H. Lee Moffitt Cancer Center and Research Institute

  collaborator OTHER

• University of Oklahoma

  lead OTHER

Principal Investigators

• Phonepadith Xangsayarath, MD, PhD · Department of Communicable Disease Control, Ministry of Health, Lao PDR

• Cate Moriasi, PhD · The University of Oklahoma Health Campus (OUHC)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-01

Primary Completion

2028-12-31

Completion

2029-07-31

Countries

• Laos

Study Locations