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Tobacco Use CessationNCT01228916

Community-Partnered Dominican Republic Tobacco Control

A study testing Tobacco Cessation and Secondhand Smoke Reduction in people with Tobacco Use Cessation and Second Hand Tobacco Smoke, run by University of Rochester at 1 site in Dominican Republic.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 1 year to 99 yearsHealthy volunteers can take part
What is being tested?
Tobacco Cessation and Secondhand Smoke Reduction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,273 participants
Where
1 siteDominican Republic
Study dates
Jun 2010to Nov 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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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Trial locations and contacts

1 site in 1 country.

Dominican Republic1 site
  • Centro de Atencion Primaria Juan XXIII

    Santiago de los Caballeros, Dominican Republic

Other trials in Dominican Republic

About this study

Official title: Community-Partnered Tobacco Control in Underserved Dominican Republic Communities

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.

Read the 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.

Being tested
Tobacco Cessation and Secondhand Smoke Reduction
Keywords
tobacco, smoking, secondhand smoke
Medical subject headings
Tobacco Use Cessation, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tobacco Cessation and Secondhand Smoke ReductionBehavioural

    Also called tobacco cessation, secondhand smoke, smokefree homes

    Awareness raising and resources for cessation and secondhand smoke reduction

Study groups in NCT01228916
Study groupRoleWhat they receive
Tobacco Cessation and Secondhand Smoke ReductionExperimentalCommunity 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
Receives: Behavioral: Tobacco Cessation and Secondhand Smoke Reduction
Delayed Intervention ControlNo interventionAssessment 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self-Reported Tobacco Use

    Self report of current use of any tobacco product

    Measured: Yrs 5

Secondary outcomes (2)
  1. 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

    Measured: Yrs 5

  2. 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.

    Measured: Year 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionNov 2013
  4. Study completionNov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,273 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01228916
Sponsor's protocol ID
1R01CA132950-01A2
Status last verified
Apr 2016
First submitted
25 Oct 2010
Last updated
21 Apr 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Tobacco Cessation and Secondhand Smoke Reduction in people with Tobacco Use Cessation and Second Hand Tobacco Smoke, run by University of Rochester at 1 site in Dominican Republic.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-Reported Tobacco Use (time frame: Yrs 5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2016.

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