A Cluster-Randomized Trial of DOTS vs DOTS Plus Active Case Finding

NCT00414882 | Completed

• 1 other identifier: 06-0017
• Study Type: observational
• Target: 200,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to see if one plan for identifying and treating tuberculosis (TB) works better than another in reducing new cases of TB. The first plan is the DOTS program, which provides free TB treatment to people seeking it. The second plan provides free TB treatment to people seeking it and involves program staff going door-to-door in communities to identify new cases of TB, DOTS plus active case-finding program (ACF). Researchers believe that by detecting TB cases earlier and supervising treatment it will help to prevent spreading and decrease TB in these areas. The study population will be 200,000 people in 6 communities of Santa Cruz and 14 communities of Northeast Rio de Janeiro, Brazil, receiving DOTS or DOTS plus ACF. Individuals in the DOTS plus ACF part of the study will be interviewed 2-4 times during a 9 month period. Patients with symptoms will provide a sputum specimen. Patients identified as having TB will begin treatment and be observed for 6.

Conditions

Mycobacterium Tuberculosis

Keywords

TB, tuberculosis, Mycobacterium tuberculosis, Brazil

Eligibility Criteria

• Age: Up to 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All residents of the study communities will be eligible to be surveyed at their homes, regardless of gender, age, or ethnicity. In the DOTS+ACF communities, all households will be surveyed and symptomatic subjects will provide sputum specimens. The subjects will be males and females with no restriction on age, with and without active TB, and living in communities with a high prevalence of TB.
• Children will be included if they have TB per routine practice and will be surveyed in the DOTS+ACF arm for symptoms with their parent's verbal permission and presence.

You may not qualify if:

• All residents of the 20 selected communities will be eligible to participate in the study. Consent will not be requested for DOTS, because this is now the standard of care for the area. Verbal consent will be requested for use of household data to analyze the effectiveness of active case finding. However, even households that refuse to participate in the survey (which is extremely unlikely because this is part of the routine survey in which all households currently participate) will be included when calculating TB incidence for the community.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Municipal Health Department

Rio de Janeiro, 21945, Brazil

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: December 21, 2006
• First Posted: December 22, 2006
• Study Start: July 10, 2007
• Primary Completion: June 28, 2009
• Study Completion: June 1, 2012
• Last Updated: January 31, 2019

Record last verified: 2011-04

Locations

BR (1)