NCT05233228 Mobile Health Technology for Personalized Tobacco Cessation Support in Laos
| NCT ID | NCT05233228 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Oklahoma |
| Condition | Cigarette Smoking |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2022-04-27 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 500 participants in total. It began in 2022-04-27 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: (pilot RCT in the R21 Phase and main RCT in the R33 Phase): 1. aged ≥18 years 2. self-reported current combustible cigarette smokers (smoked at least 100 cigarettes in lifetime and currently smoke ≥1 cigarette/day) 3. willing to set a quit date within 2 weeks of study enrollment 4. able to provide written informed consent to participate 5. able to read Lao (score ≥4 points on the Rapid Estimate of Adult Literacy in Medicine-Short Form). Exclusion Criteria: (pilot RCT in the R21 Phase and main RCT in the R33 Phase) 1. history of a medical condition that precludes use of NRT 2. ineligibility to participate based on medical or psychiatric conditions diagnosed by a physician/clinician 3. enrollment in another cessation program or current use of other cessation medications.
Contact & Investigator
Shweta Kulkarni, MS
STUDY DIRECTOR
Stephenson Cancer Center, TSET Health Promotion Research Center of OUHSC
Frequently Asked Questions
Who can join the NCT05233228 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Cigarette Smoking. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05233228 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05233228 currently recruiting?
Yes, NCT05233228 is actively recruiting participants. Contact the research team at thanh-c-bui@ouhsc.edu for enrollment information.
Where is the NCT05233228 trial being conducted?
This trial is being conducted at Champasak, Laos, Vientiane, Laos.
Who is sponsoring the NCT05233228 clinical trial?
NCT05233228 is sponsored by University of Oklahoma. The principal investigator is Shweta Kulkarni, MS at Stephenson Cancer Center, TSET Health Promotion Research Center of OUHSC. The trial plans to enroll 500 participants.