Behavioral Interventions for Control of TB

NCT00005739 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 145

Last updated 2015-12-23

No results posted yet for this study

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.

Conditions

Interventions

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)

BEHAVIORAL

Clinic directly observed therapy (DOT)

A traditional self-administered preventive treatment

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH
  • Columbia University

    lead OTHER

Principal Investigators

  • Wafaa El-Sadr, MD · University Professor; Director, ICAP, Department of Epidemiology

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-09-30
Primary Completion
2004-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00005739 on ClinicalTrials.gov