Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
145 participants
OBSERVATIONAL
1995-09-30
2015-12-31
Brief Summary
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Two clinical trials were conducted with patients from Harlem. Among those with active disease, a clinic-based surrogate family model was compared to traditional community-based directly observed therapy (DOT). Among those eligible for preventive therapy, a community-based intervention conducted by trained graduates of a TB DOT program (peer workers) was compared to traditional self-administered preventive treatment.
Detailed Description
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Control programs involve two major components. First, and of highest priority, is to detect persons with active tuberculosis and treat them with effective antituberculosis drugs, which prevents death from tuberculosis and stops the transmission of infection to other persons. Treatment of active tuberculosis involves taking multiple antituberculosis drugs daily or several times weekly for at least six months. Failure to take the medications for the full treatment period may mean that the disease is not cured and may recur. If sufficient medications are not prescribed early and taken regularly, the tuberculosis organism can become resistant to the drugs, and the drug resistant tuberculosis then may be transmitted to other persons. Drug resistant disease is difficult and expensive to treat, and in some cases, cannot be treated with available medications.
The second major goal of control efforts is the detection and treatment of persons who do not have active tuberculosis, but who have latent tuberculosis infection. These people may be at high risk of developing active tuberculosis. The only approved treatment modality for preventive therapy requires treatment daily or twice weekly for a minimum of six months, and many patients do not complete the full course of therapy. Public and patient programs are needed to increase the awareness of the problems associated with tuberculosis control.
The study is part of the NHLBI initiative "Behavioral Interventions for Control of Tuberculosis" . The concept for the initiative originated from the National Institutes of Health Working Group on Health and Behavior. The Request for Applications was released in October, 1994.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Community-based therapy (case)
Community-based directly observed therapy (DOT) - A community-based intervention conducted by trained graduates of a TB directly observed therapy (DOT) program (peer workers)
Community-based directly observed therapy (DOT)
A community-based intervention conducted by trained graduates of a TB directly observed therapy (DOT) program (peer workers)
Self-administered treatment (control)
Clinic directly observed therapy (DOT) - Traditional self-administered preventive treatment
Clinic directly observed therapy (DOT)
A traditional self-administered preventive treatment
Interventions
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Community-based directly observed therapy (DOT)
A community-based intervention conducted by trained graduates of a TB directly observed therapy (DOT) program (peer workers)
Clinic directly observed therapy (DOT)
A traditional self-administered preventive treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Columbia University
OTHER
Responsible Party
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Principal Investigators
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Wafaa El-Sadr, MD
Role: PRINCIPAL_INVESTIGATOR
University Professor; Director, ICAP, Department of Epidemiology
Locations
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Columbia University
New York, New York, United States
Countries
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Other Identifiers
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CUMC ID unknown (4948)
Identifier Type: -
Identifier Source: org_study_id