Community-Partnered Dominican Republic Tobacco Control

Tobacco Use Cessation Clinical Trial

Official title:

Community-Partnered Tobacco Control in Underserved Dominican Republic Communities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01228916
• Other study ID #: 1R01CA132950-01A2
• Status: Completed
• Phase: N/A
• First received: October 25, 2010
• Last updated: April 19, 2016
• Start date: June 2010
• Est. completion date: November 2013

Study information

• Verified date: April 2016
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardDominican Republic: Consejo Nacional de Bioetica en SaludDominican Republic: Comite Independiente de Etica de Investigacion del Cibao (CIEIC)
• Study type: Interventional

Clinical Trial Summary

Tobacco use and tobacco-caused illnesses and death are increasing in developing countries globally, so it is critical to study these countries in order to effectively address the tobacco epidemic. The proposed project will test the effectiveness of community-based interventions for secondhand smoke and quitting smoking in eight underserved communities in the Dominican Republic. The project will also partner with communities and national and international groups to determine whether the methods and interventions from this study in the Dominican Republic can also be used to help other countries in the region and underserved groups in the United States.

Description:

The globalization of the tobacco epidemic poses significant morbidity and mortality burdens, with the brunt of impact increasingly borne by low-middle income countries. Research partnerships between investigators from high-income countries with well developed tobacco control research programs and their counterparts in low-middle income countries are needed to effectively address this global public health crisis. The Dominican Republic (DR) is a key site that mirrors the trends in Latin America: it is a low-middle income tobacco growing country with significant tobacco use and high levels of secondhand smoke exposure, and it is at a very early stage of tobacco control. The proposed project will assess baseline knowledge, attitudes, exposures, and behaviors regarding tobacco use and secondhand smoke, provide a randomized controlled trial of community-partnered interventions around secondhand smoke and tobacco cessation, and develop and implement a dissemination plan for national and regional impact and translation of methods and results to other underserved groups as appropriate. A multimethod assessment approach will be used, to include qualitative community assessments (RAPs), a series of quantitative surveys (household surveillances, community and smoker cohort surveys, and health care provider surveys), and a biomarker assessment of secondhand smoke exposure. Eight economically disadvantaged communities will be randomized to intervention or control conditions in a lagged treatment design; interventions will be developed and implemented based on the evidence base from other countries and from a current DR trial, and on input from national and local DR workgroups using a community partnered approach. The intervention is hypothesized to decrease tobacco use rates, increase the number of smokefree homes, denormalize smoking, increase awareness of and change attitudes regarding tobacco use and secondhand smoke risks, decrease exposure to secondhand smoke, and increase health care provider intervention in intervention- relative to control communities, with differences by geographic and demographic characteristics to be examined. The project will also engage international, national, and local DR workgroups to maintain communication of findings to key partners, host a national DR tobacco control conference with regional representation, and develop other action steps for local and regional dissemination of findings and evidence based interventions, resources, and infrastructures. Finally, the project will coordinate with the University of Rochester Clinical and Translational Sciences Institute for translation of current evidence based approaches and methodologies for implementation in the DR, and to explore whether any methodologies or interventions from the proposed trial in the DR can be translated to underserved groups in the United States. Effectively engaging early stage low-middle income countries in tobacco control research will be critical to reducing tobacco use and the burden of tobacco-caused illnesses globally.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3273
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 99 Years

Eligibility

Inclusion Criteria: For main study: adults (age 18 and older), speak and understand Spanish. For biomarker sub-study (hair samples): children 10 years or younger.

Exclusion Criteria: Non-Spanish speaker, younger than 18 years (except for biomarker sub-study), anyone with questionable capacity or clear decisional impairment.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Second Hand Tobacco Smoke
• Tobacco Use Cessation

Intervention

Behavioral:
• Tobacco Cessation and Secondhand Smoke Reduction
Awareness raising and resources for cessation and secondhand smoke reduction

Locations

Country	Name	City	State
Dominican Republic	Centro de Atencion Primaria Juan XXIII	Santiago

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Cancer Institute (NCI)

Country where clinical trial is conducted

Dominican Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-Reported Tobacco Use	Self report of current use of any tobacco product	Yrs 5	No
Secondary	Self Reported Exposure to Secondhand Smoke	Home smoking policies, implementation of clean indoor air laws, frequency of being close enough to breathe someone else's smoke	Yrs 5	No
Secondary	Self-Reported Tobacco Use	Self-reported use of any tobacco products after one year intervention-control period and prior to replication of intervention in control communities.	Year 4	No