Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT05233228

Mobile Health Technology for Personalized Tobacco Cessation Support in Laos

Led by University of Oklahoma · Updated on 2025-08-15

500

Participants Needed

2

Research Sites

226 weeks

Total Duration

On this page

Sponsors

U

University of Oklahoma

Lead Sponsor

S

Setthathirath Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

In Lao People's Democratic Republic (Lao PDR), 51% of adult men and 7% of adult women smoke tobacco. The development and evaluation of sustainable tobacco cessation interventions suitable for widespread adoption in nations such as Lao PDR are pressing public health needs. To address this need, the investigators propose a project that adapts a theoretically and empirically based mobile health (mHealth) technology to help people quit smoking cigarettes in Lao PDR. This mHealth approach includes a fully automated, interactive, personalized, smartphone-delivered intervention for behavioral treatment, delivered through our Insight™ platform. This proposed project for Lao PDR includes 2 main phases. In the R21 Phase, the investigators will use formative research methods to adapt our intervention content to the sociocultural context, language, and communication styles of Laotians. In the subsequent R33 Phase, the investigators will conduct a randomized controlled trial (RCT) to evaluate the efficacy of our mHealth intervention and technology. Adult smokers of both sexes will be recruited through 2 large hospitals: Setthathirath Hospital in Vientiane and Champasak Hospital in Champasak Province. Participants (n=500) will be randomized to 1 of 2 treatment groups: Standard Care (SC; n=250) or Automated Treatment (AT; n=250). SC consists of brief advice to quit smoking delivered by research staff, self-help written materials, and a 2-week supply of NRT (transdermal patches). AT consists of all SC components plus a fully automated smartphone-based treatment program that involves interactive and personalized proactive messages, images, or videos. The primary health outcome of the trial is biochemically confirmed self-reported 7-day point prevalence abstinence 12 months post study enrollment. The project also aims to advance mHealth research capacity in Lao PDR and sustain the US-Lao PDR research network. The project has the potential to transform healthcare services for tobacco cessation treatment throughout the country and, ultimately, to reduce tobacco-induced morbidity and mortality significantly.

CONDITIONS

Official Title

Mobile Health Technology for Personalized Tobacco Cessation Support in Laos

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older
  • Currently smoking combustible cigarettes (smoked at least 100 cigarettes in lifetime and smoke at least 1 cigarette per day)
  • Willing to set a quit date within 2 weeks of study enrollment
  • Able to provide written informed consent to participate
  • Able to read Lao language with adequate literacy (score 4 or higher on Rapid Estimate of Adult Literacy in Medicine-Short Form)
Not Eligible

You will not qualify if you...

  • History of a medical condition that prevents use of nicotine replacement therapy (NRT)
  • Ineligible due to medical or psychiatric conditions diagnosed by a physician or clinician
  • Currently enrolled in another smoking cessation program or using other cessation medications

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Champasak Hospital

Champasak, Laos

Actively Recruiting

2

Setthathirath Hospital

Vientiane, Laos

Actively Recruiting

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Research Team

T

Thanh C Bui, MD, DrPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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