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Behavioral Interventions for Control of TB

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ClinicalTrials.gov Identifier: NCT00005739
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : December 23, 2015
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Columbia University

Brief Summary:

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.


Condition or disease Intervention/treatment
Lung Diseases Tuberculosis Behavioral: Community-based directly observed therapy (DOT) Behavioral: Clinic directly observed therapy (DOT)

Detailed Description:

Tuberculosis was on the decline from the mid 1950s until the mid 1980s; however, the United States is now experiencing a resurgence of tuberculosis. In 1992, approximately 27,000 new cases were reported, an increase of about 20 percent from 1985 to 1992. Not only are tuberculosis cases on the increase, but a serious aspect of the problem is the recent occurence of outbreaks of multidrug resistant (MDR) tuberculosis, which poses an urgent public health problem and requires rapid intervention.

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.


Study Type : Observational
Actual Enrollment : 145 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Behavioral Interventions for Control of Tuberculosis
Study Start Date : September 1995
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Group/Cohort Intervention/treatment
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)
Behavioral: Community-based directly observed therapy (DOT)
A community-based intervention conducted by trained graduates of a TB directly observed therapy (DOT) program (peer workers)
Other Name: Community-based DOT

Self-administered treatment (control)
Clinic directly observed therapy (DOT) - Traditional self-administered preventive treatment
Behavioral: Clinic directly observed therapy (DOT)
A traditional self-administered preventive treatment
Other Name: Clinic DOT




Primary Outcome Measures :
  1. Visit adherence rate [ Time Frame: At the end of study ]
    Prevalence of suspected and confirmed tuberculosis patients that continued treatment


Secondary Outcome Measures :
  1. Treatment completion rate [ Time Frame: At end of study ]
    Prevalence of suspected and confirmed tuberculosis patients that completed treatment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with suspected and confirmed TB
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005739


Locations
United States, New York
Columbia University
New York, New York, United States, 10023
Sponsors and Collaborators
Columbia University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Wafaa El-Sadr, MD University Professor; Director, ICAP, Department of Epidemiology

Study Data/Documents: Abstract  This link exits the ClinicalTrials.gov site

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00005739     History of Changes
Other Study ID Numbers: CUMC ID unknown (4948)
R01HL055751 ( U.S. NIH Grant/Contract )
First Posted: May 26, 2000    Key Record Dates
Last Update Posted: December 23, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Tuberculosis
Lung Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Respiratory Tract Diseases