Smoking Cessation Program for Lao People With HIV

NCT07014605 | Not Yet Recruiting

• 2 other identifiers: IRB 17386U01CA294811
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

smoking cessation; cancer control; implementation science; low- and middle-income countries; mobile health

Outcome Measures

Primary Outcomes (2)

• Reach

  Reach is the proportion of PWH who smoke and are willing to make a quit attempt that enroll in treatment.

  At the end of the AA-SH/AA-MAP implementation at each ART clinic (up to 30 months)

• Effectiveness

  Effectiveness is the proportion of enrolled participants who achieve biochemically confirmed point prevalence abstinence 6 months after enrollment. Abstinence will be defined as biochemically confirmed self-reported 7-day point prevalence abstinence with expired CO \<6 ppm.

  6 months post enrollment

Secondary Outcomes (1)

• Impact

  At the end of the individual and clinic data collection (up to 36 months after the start of the AA-SH/AA-MAP implementation)

Study Arms (2)

AA-SH (Ask-Advise-Connect paired with self-help material)

ACTIVE COMPARATOR

Participants will receive advice to quit smoking and be provided with a self-help guide to support smoking cessation.

Behavioral: Smoking Cessation Self Help Guide

AA-MAP (Ask-Advise-Connect paired with mHealth-based automated treatment program)

EXPERIMENTAL

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.

Behavioral: Smartphone-delivered Automated Messaging

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.

AA-SH (Ask-Advise-Connect paired with self-help material)

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.

AA-MAP (Ask-Advise-Connect paired with mHealth-based automated treatment program)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Oklahoma: lead
• National Cancer Institute (NCI): collaborator
• Department of Communicable Disease Control, Ministry of Health, Lao PDR: collaborator
• National Tobacco Control Committee, Lao PDR: collaborator
• National Center for HIV/AIDS and STIs, Ministry of Health, Lao PDR: collaborator
• H. Lee Moffitt Cancer Center and Research Institute: collaborator

Study Sites (2)

Champasak Hospital

Champasak, Laos

Location

Setthathirath Hospital

Vientiane, Laos

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Phonepadith Xangsayarath, MD, PhD

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

  STUDY DIRECTOR

• Cate Moriasi, PhD

  The University of Oklahoma Health Campus (OUHC)

  STUDY DIRECTOR

Central Study Contacts

Thanh C Bui, MD, DrPH

CONTACT

+1-405-271-8001; thanh-c-bui@ou.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (participant)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: June 11, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): July 31, 2029
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After data collection is complete.
• Access Criteria: After an institutionally approved data sharing agreement is established, deidentified IPD will be shared via a secure data transfer mechanism approved by OUHSC. Data sharing requests will be reviewed and approved by the PI and OUHSC.

Locations

LA (2)