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Behavioral Interventions for Control of TB

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

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 Intervention
Lung Diseases
Behavioral: Community-based directly observed therapy (DOT)
Behavioral: Clinic directly observed therapy (DOT)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Behavioral Interventions for Control of Tuberculosis

Resource links provided by NLM:

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • Treatment completion rate [ Time Frame: At end of study ] [ Designated as safety issue: No ]
    Prevalence of suspected and confirmed tuberculosis patients that completed treatment

Enrollment: 145
Study Start Date: September 1995
Study Completion Date: December 2015
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.


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

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT00005739

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)
Principal Investigator: Wafaa El-Sadr, MD University Professor; Director, ICAP, Department of Epidemiology
  More Information

Study Data/Documents: Abstract  This link exits the site

Responsible Party: Columbia University Identifier: NCT00005739     History of Changes
Other Study ID Numbers: CUMC ID unknown (4948)  R01HL055751 
Study First Received: May 25, 2000
Last Updated: December 21, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Respiratory Tract Diseases processed this record on October 21, 2016