- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00472316
Innovative Approaches to Tuberculosis Control
August 15, 2017 updated by: Johns Hopkins University
A Cluster Randomized Trial of DOTS vs DOTS Plus Active Case Finding
This study is designed as a cluster-randomized trial.
The cluster unit is at the community level.
Communities will be randomized to 1 of 2 study arms: DOTS+ACF or DOTS.
Communities in the DOTS+ACF arm will receive door-to-door symptom screening of the entire population by health care workers between 2 and 4 times over a 9-month period.
Those communities in the DOTS-arm will receive the current standard of care in those communities (PCF).
All study communities will be receiving between 4 and 6 visits by community health workers annually as part of a program to assess and follow-up illnesses in each household.
Households with ill residents will be visited more often.
The intervention for this study is simply adding 3 to 5 simple questions to the current protocol.
For subjects responding positively to these questions, results will be returned to the subject at their home and routine, standard of care follow-up diagnostic and treatment algorithms will be followed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Despite free ARV drugs and free TB treatment, and an expanding DOTS program, TB rates have not diminished in this city overall (29), suggesting that DOTS alone will not be sufficient to turn the tide.
Nevertheless, an elemental ACF strategy did appear to work well in this city.
A prior International Collaborations in Infectious Disease Research (ICIDR), in one area of Rio de Janeiro, evaluated the use of the WHO's directly observed therapy, short course (DOTS) strategy versus an enhanced DOTS strategy (DOTS-A), which included household contact investigation as a means of identifying cases.
A statistically significant reduction in incidence rates between DOTS versus DOTS-A communities was seen from 2000 to 2002 (Figure 2), suggesting that ACF strategies can be instrumental in reducing incidence rates if subjects are detected and treated.
Treatment completion rates among new TB cases were not significantly different statistically in the 2 study arms, however treatment completion rates overall increased from 68% to 77% over the course of the study.
Overall, the DOTS communities exhibited little change (+7%) in TB incidence over the 5-year period, while DOTS-A communities showed a combined decrease (-14%) (P<0.05).
The difference suggests that a large scale ACF campaign at a more intensive level (ie, door-to-door case finding) could have a significant impact on long-term TB incidence in a community.
Study Type
Observational
Enrollment (Actual)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Rio de Janeiro, Brazil
- The Health Department of Rio de Janeiro, Brazil
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Residents of AP3.1 and AP 5.3 in Rio de Janeiro Brazil
Description
Inclusion Criteria:
- All residents of the study communities will be eligible to be surveyed at their homes, regardless of gender, age, or ethnicity.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To compare TB incidence in communities randomized to DOTS+ACF and DOTS alone over the 18-month period following ACF campaign.
Time Frame: 18 months following invetervention
|
18 months following invetervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To compare case notification rates of TB in the 2 arms of the study during the ACF campaign.
Time Frame: During the intervention
|
During the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jonathan Golub, PhD, Johns Hopkins University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
May 10, 2007
First Submitted That Met QC Criteria
May 10, 2007
First Posted (Estimate)
May 11, 2007
Study Record Updates
Last Update Posted (Actual)
August 18, 2017
Last Update Submitted That Met QC Criteria
August 15, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2U19AI045432-06 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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