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Community-Partnered Tobacco Control in Underserved Dominican Republic Communities


N/A
1 Year
N/A
Open (Enrolling)
Both
Tobacco Use

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Trial Information

Community-Partnered Tobacco Control in Underserved Dominican Republic Communities


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.


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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Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Self-Reported Tobacco Use

Outcome Description:

Self report of current use of any tobacco product

Outcome Time Frame:

Yrs 5

Safety Issue:

No

Principal Investigator

Deborah J Ossip, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Rochester

Authority:

United States: Institutional Review Board

Study ID:

1R01CA132950-01A2

NCT ID:

NCT01228916

Start Date:

June 2010

Completion Date:

July 2014

Related Keywords:

  • Tobacco Use
  • tobacco
  • smoking
  • secondhand smoke

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