Community-Partnered Dominican Republic Tobacco Control
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| First Received Date ICMJE | October 25, 2010 | ||||||||
| Last Updated Date | July 10, 2012 | ||||||||
| Start Date ICMJE | June 2010 | ||||||||
| Estimated Primary Completion Date | July 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Self-Reported Tobacco Use [ Time Frame: Yrs 5 ] [ Designated as safety issue: No ] Self report of current use of any tobacco product |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01228916 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Community-Partnered Dominican Republic Tobacco Control | ||||||||
| Official Title ICMJE | Community-Partnered Tobacco Control in Underserved Dominican Republic Communities | ||||||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Tobacco Use | ||||||||
| Intervention ICMJE | Behavioral: Tobacco Cessation and Secondhand Smoke Reduction
Awareness raising and resources for cessation and secondhand smoke reduction
Other Names:
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 3656 | ||||||||
| Estimated Completion Date | July 2014 | ||||||||
| Estimated Primary Completion Date | July 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | 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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| Gender | Both | ||||||||
| Ages | 1 Year and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Dominican Republic | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01228916 | ||||||||
| Other Study ID Numbers ICMJE | 1R01CA132950-01A2 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Deborah Ossip, University of Rochester | ||||||||
| Study Sponsor ICMJE | University of Rochester | ||||||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Rochester | ||||||||
| Verification Date | July 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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