Tuberculosis Clinical Trial
Official title:
Behavioral Interventions for Control of Tuberculosis
To compare alternative methods to ensure completion of treatment and preventive therapy for
tuberculosis (TB) in inner cities, and to identify the most cost-effective methods to
accomplish that. The basis for comparison included adherence rates and cost savings as
primary outcomes, and other parameters such as patient satisfaction, development of social
networks, and participation in support programs as secondary outcomes.
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.
Status | Completed |
Enrollment | 145 |
Est. completion date | December 2015 |
Est. primary completion date | December 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: -Patients with suspected and confirmed TB Exclusion Criteria: -Patients that are not a part of the therapy program established at Harlem Hospital, New York City |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Columbia University | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visit adherence rate | Prevalence of suspected and confirmed tuberculosis patients that continued treatment | At the end of study | No |
Secondary | Treatment completion rate | Prevalence of suspected and confirmed tuberculosis patients that completed treatment | At end of study | No |
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