Community-Partnered Dominican Republic Tobacco Control

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Rochester
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Deborah Ossip, University of Rochester
ClinicalTrials.gov Identifier:
NCT01228916
First received: October 25, 2010
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Tobacco Use Cessation
Second Hand Tobacco Smoke
Behavioral: Tobacco Cessation and Secondhand Smoke Reduction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Community-Partnered Tobacco Control in Underserved Dominican Republic Communities

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Self-Reported Tobacco Use [ Time Frame: Yrs 5 ] [ Designated as safety issue: No ]
    Self report of current use of any tobacco product


Secondary Outcome Measures:
  • Self Reported Exposure to Secondhand Smoke [ Time Frame: Yrs 5 ] [ Designated as safety issue: No ]
    Home smoking policies, implementation of clean indoor air laws, frequency of being close enough to breathe someone else's smoke

  • Self-Reported Tobacco Use [ Time Frame: Year 4 ] [ Designated as safety issue: No ]
    Self-reported use of any tobacco products after one year intervention-control period and prior to replication of intervention in control communities.


Estimated Enrollment: 3656
Study Start Date: June 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tobacco Cessation and Secondhand Smoke Reduction
Community based interventions to raise awareness regarding secondhand smoke exposure, clean indoor air laws, smokefree homes, risks of tobacco use and benefits of cessation; include talks, healthcare provider training, radio public service announcements and talk shows, tleevision interviews, cessation classes and individual sessions, health fairs, community marches for smokefree spaces, materials and resources for assisting in tobacco use cessation, estsablishing smokefree homes, adhering to smokefree laws
Behavioral: Tobacco Cessation and Secondhand Smoke Reduction
Awareness raising and resources for cessation and secondhand smoke reduction
Other Names:
  • tobacco cessation
  • secondhand smoke
  • smokefree homes
No Intervention: Delayed Intervention Control
Assessment only during comparison period (no interventions will be provided over and above any secular trends in communities); delayed intervention will be provided at end of 1 year comparison period

Detailed 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.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01228916

Contacts
Contact: Deborah J. Ossip, Ph.D. 585-275-0528 deborah_ossip@urmc.rochester.edu
Contact: Zahira Quinones, MD 809) 580-1962 ext x 4416 z_quinonespdt@yahoo.com

Locations
Dominican Republic
Centro de Atencion Primaria Juan XXIII Recruiting
Santiago, Dominican Republic
Contact: Sergio Diaz, MD       s_diazpdt@yahoo.com   
Contact: Deborah J Ossip, PhD    585-275-0528    deborah_ossip@urmc.rochester.edu   
Principal Investigator: Sergio Diaz, MD         
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Deborah J Ossip, PhD University of Rochester
  More Information

No publications provided

Responsible Party: Deborah Ossip, Principal Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT01228916     History of Changes
Other Study ID Numbers: 1R01CA132950-01A2
Study First Received: October 25, 2010
Last Updated: October 31, 2013
Health Authority: United States: Institutional Review Board
Dominican Republic: Consejo Nacional de Bioetica en Salud
Dominican Republic: Comite Independiente de Etica de Investigacion del Cibao (CIEIC)

Keywords provided by University of Rochester:
tobacco
smoking
secondhand smoke

ClinicalTrials.gov processed this record on September 29, 2014