Innovative Approaches to Tuberculosis Control

NCT00472316 | Completed DMC

• 1 other identifier: 2U19AI045432-06
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed as a cluster-randomized trial. The cluster unit is at the community level. Communities will be randomized to 1 of 2 study arms: DOTS+ACF or DOTS. Communities in the DOTS+ACF arm will receive door-to-door symptom screening of the entire population by health care workers between 2 and 4 times over a 9-month period. Those communities in the DOTS-arm will receive the current standard of care in those communities (PCF). All study communities will be receiving between 4 and 6 visits by community health workers annually as part of a program to assess and follow-up illnesses in each household. Households with ill residents will be visited more often. The intervention for this study is simply adding 3 to 5 simple questions to the current protocol. For subjects responding positively to these questions, results will be returned to the subject at their home and routine, standard of care follow-up diagnostic and treatment algorithms will be followed.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• To compare TB incidence in communities randomized to DOTS+ACF and DOTS alone over the 18-month period following ACF campaign.

  18 months following invetervention

Secondary Outcomes (1)

• To compare case notification rates of TB in the 2 arms of the study during the ACF campaign.

  During the intervention

Interventions

Active Case Finding for Tuberculosis BEHAVIORAL

Active case finding of TB in the community using community health workers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Residents of AP3.1 and AP 5.3 in Rio de Janeiro Brazil

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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Universidade Federal do Rio de Janeiro: collaborator

Study Sites (1)

The Health Department of Rio de Janeiro, Brazil

Rio de Janeiro, 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 Officials

• Jonathan Golub, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2007
• First Posted: May 11, 2007
• Study Start: May 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: May 1, 2011
• Last Updated: August 18, 2017

Record last verified: 2017-08

Locations

BR (1)