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Behavioral Interventions for Control of TB

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT00005739
First received: May 25, 2000
Last updated: December 21, 2015
Last verified: December 2015

May 25, 2000
December 21, 2015
September 1995
December 2004   (final data collection date for primary outcome measure)
Visit adherence rate [ Time Frame: At the end of study ] [ Designated as safety issue: No ]
Prevalence of suspected and confirmed tuberculosis patients that continued treatment
Not Provided
Complete list of historical versions of study NCT00005739 on ClinicalTrials.gov Archive Site
Treatment completion rate [ Time Frame: At end of study ] [ Designated as safety issue: No ]
Prevalence of suspected and confirmed tuberculosis patients that completed treatment
Not Provided
Not Provided
Not Provided
 
Behavioral Interventions for Control of TB
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients with suspected and confirmed TB
  • Lung Diseases
  • Tuberculosis
  • 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
  • Behavioral: Clinic directly observed therapy (DOT)
    A traditional self-administered preventive treatment
    Other Name: Clinic DOT
  • 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)
    Intervention: Behavioral: Community-based directly observed therapy (DOT)
  • Self-administered treatment (control)
    Clinic directly observed therapy (DOT) - Traditional self-administered preventive treatment
    Intervention: Behavioral: Clinic directly observed therapy (DOT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
145
December 2015
December 2004   (final data collection date for primary outcome measure)

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

Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005739
CUMC ID unknown (4948), R01HL055751
No
Not Provided
Not Provided
Columbia University
Columbia University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Wafaa El-Sadr, MD University Professor; Director, ICAP, Department of Epidemiology
Columbia University
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP