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CompletedNCT02564653Updated Jun 1, 2020

Implementing Tobacco Use Guidelines in Community Health Centers in Vietnam Public Health System

An interventional study of Technical Assistance, training and clinical reminders and TTC+Referral to Community Health Worker in Tobacco Use Cessation, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-06-01.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
4,733
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Vietnam has a smoking prevalence that is the second highest among South East Asian countries (SEACs). With a population of approximately 90 million, Vietnam also has the second largest total number of adult smokers (over 16 million) in SEA. According to the World Health Organization (WHO), most reductions in mortality from tobacco use in the near future will be achieved through helping current users quit. Tobacco use treatment, as defined by the U.S. Preventive Health Service Guideline (Guideline) on Treating Tobacco use and Dependence, is evidence-based and highly cost-effective. Yet, in the U.S. and globally, adoption of recommended care is suboptimal. The objective of this proposal is to fill the current research-to-practice gap by conducting a randomized controlled trial that compares the effectiveness and cost effectiveness of two practical and highly replicable strategies for implementing evidence-based guidelines for the treatment of tobacco use in public health clinics in Vietnam. The proposed implementation strategies draw on evidence-based approaches, and the WHO's recently released guidelines for implementing Article 14 of the Framework Convention on Tobacco Control (FCTC). The FCTC is an evidence-based treaty that was developed by the WHO in response to the globalization of the tobacco epidemic. Vietnam ratified the FCTC in 2004; however, they have not taken steps to implement Article 14 which specifies the need to integrate best practices for treating tobacco use and dependence into routine preventive care. The proposed implementation strategies also build on the growing literature that supports the effectiveness of integrating community health workers as members of the health care team to improve access to preventive services.

Read the detailed description

The long-term goal of the project is to develop a generalizable model for implementing evidence-based tobacco use treatment within existing health systems locally and globally. The objective of this proposal is to fill the current research-to-practice gap by conducting a randomized controlled trial that compares the effectiveness and cost of two practical and highly replicable strategies for implementing evidence-based guidelines for the treatment of tobacco use in public health clinics and community based settings in Vietnam. The proposed implementation strategies draw on evidence-based approaches and the WHO's recently released guidelines for implementing Article 14 of the Framework Convention on Tobacco Control (FCTC). The FCTC is an evidence-based treaty that was developed by the WHO in response to the globalization of the tobacco epidemic Article 14specifies the need to integrate clinical best practices for treating tobacco use and dependence into routine preventive care. The proposed implementation strategies also build on the growing literature that supports the effectiveness of integrating community health workers as members of the health care team to improve access to preventive services.

02

Conditions studied

  • Tobacco Use Cessation
03

In context

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Patient eligibility:
  • Current patients at community health center for routine visit
  • 18 years or older
  • Current or regular smoker (>1 cigarette in past 7 days)
  • Willingness to complete survey
  • 18 years or older
  • Willingness to complete survey or interview
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
4,733 participants (actual)

Study arms

  • Other
    Technical Assistance, training,clinical reminders

    provider adherence to tobacco use treatment guidelines

    Behavioral: Technical Assistance, training and clinical reminders

  • Other
    TTC + help of community health workers

    We will assess this secondary aim by comparing smoking cessation outcomes among smokers who receive brief provider counseling alone only vs. smokers who receive provider counseling + community health worker counseling. The purpose of this assessment is to specifically analyze the impact of the community health worker counseling component of the intervention using a quasiexperimental design that leverages the larger RCT.

    Behavioral: TTC+Referral to Community Health Worker

Interventions

  • BehavioralTechnical Assistance, training and clinical reminders

    Technical Assistance, training and clinical reminders (TTC)

  • BehavioralTTC+Referral to Community Health Worker

    TTC+ referral to a VHW for additional counseling and follow-up

06

What researchers measure

Primary outcomes

  1. Adherence to tobacco use treatment guidelines and costs

    patient exit interviews

    Time frame: Up to 12 months

Secondary outcomes

  1. Smoking abstinence

    Surveys will be conducted in person and smoking abstinence will be validated using carbon monoxide (CO) monitoring

    Time frame: Up to 12 months

Other outcomes

  1. Barriers and facilitators for tobacco use treatment

    practice environment checklist to inventory current policies, work flow, systems (e.g. chart systems) and staff roles and responsibilities in general and specifically related to tobacco use treatment

    Time frame: Up to 12 months

07

Study locations

1 site
  • NYU Langone Medical Center
    New York, New York 10016, United States
08

References and documents

Publications

  • VanDevanter N, Vu M, Nguyen A, Nguyen T, Van Minh H, Nguyen NT, Shelley DR. A qualitative assessment of factors influencing implementation and sustainability of evidence-based tobacco use treatment in Vietnam health centers. Implement Sci. 2020 Sep 9;15(1):73. doi: 10.1186/s13012-020-01035-6. PubMed 32907603 ↗
  • VanDevanter N, Kumar P, Nguyen N, Nguyen L, Nguyen T, Stillman F, Weiner B, Shelley D. Application of the Consolidated Framework for Implementation Research to assess factors that may influence implementation of tobacco use treatment guidelines in the Viet Nam public health care delivery system. Implement Sci. 2017 Feb 28;12(1):27. doi: 10.1186/s13012-017-0558-z. PubMed 28241770 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02564653
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Oct 1, 2015
Start date
Aug 2015
Primary completion
Aug 2019
Completion
Aug 2019
Last update
Jun 1, 2020

Study contacts

Donna Shelley, MD, MPH
principal investigator · NYU School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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