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.
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
- Conditions the study is for
- Tobacco Use Cessation, Second Hand Tobacco Smoke
- What is being tested?
- Tobacco Cessation and Secondhand Smoke Reduction
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Tobacco Use Cessation, Second Hand Tobacco Smoke
- 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 group | Role | What they receive |
|---|---|---|
| Tobacco Cessation and Secondhand Smoke Reduction | Experimental | 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 Receives: Behavioral: Tobacco Cessation and Secondhand Smoke Reduction |
| Delayed Intervention Control | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Reported Tobacco Use
Self report of current use of any tobacco product
Measured: Yrs 5
Secondary outcomes (2)
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
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.
- First posted27 Oct 2010 (estimated)
- Study startJun 2010
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Deborah Ossip, University of Rochester
- Investigators
- Deborah J Ossip, PhD, Principal investigator, University of Rochester
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Partnered Tobacco Control in Underserved Dominican Republic Communities
- ClinicalTrials.gov ID
- NCT01228916
- Acronym / sponsor ID
- 1R01CA132950-01A2
- Conditions
- Tobacco Use Cessation, Second Hand Tobacco Smoke
- Keywords
- tobacco, smoking, secondhand smoke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,273 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 27 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tobacco Cessation and Secondhand Smoke Reduction | Experimental | Behavioral: Tobacco Cessation and Secondhand Smoke ReductionCommunity 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 |
| Delayed Intervention Control | No intervention | –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 |
Who may qualify
- Ages
- 1 year to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tobacco Cessation and Secondhand Smoke ReductionAlso: tobacco cessation, secondhand smoke, smokefree homesAwareness raising and resources for cessation and secondhand smoke reduction | Behavioural | Tobacco Cessation and Secondhand Smoke Reduction |
Primary outcome
Self-Reported Tobacco Use
Time frame: Yrs 5
Self report of current use of any tobacco product
2 secondary outcomes
Self Reported Exposure to Secondhand Smoke
Time frame: Yrs 5
Self-Reported Tobacco Use
Time frame: Year 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah J Ossip, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
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.