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Innovative Approaches to Tuberculosis Control

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by Johns Hopkins University.
Recruitment status was:  Active, not recruiting
Universidade Federal do Rio de Janeiro
Information provided by:
Johns Hopkins University Identifier:
First received: May 10, 2007
Last updated: August 7, 2009
Last verified: August 2009
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.

Condition Intervention Phase
Tuberculosis Behavioral: Active Case Finding for Tuberculosis Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Cluster Randomized Trial of DOTS vs DOTS Plus Active Case Finding

Resource links provided by NLM:

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • To compare TB incidence in communities randomized to DOTS+ACF and DOTS alone over the 18-month period following ACF campaign. [ Time Frame: 18 months following invetervention ]

Secondary Outcome Measures:
  • To compare case notification rates of TB in the 2 arms of the study during the ACF campaign. [ Time Frame: During the intervention ]

Estimated Enrollment: 1000
Study Start Date: May 2007
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Active Case Finding for Tuberculosis
    Active case finding of TB in the community using community health workers
Detailed Description:
Despite free ARV drugs and free TB treatment, and an expanding DOTS program, TB rates have not diminished in this city overall (29), suggesting that DOTS alone will not be sufficient to turn the tide. Nevertheless, an elemental ACF strategy did appear to work well in this city. A prior International Collaborations in Infectious Disease Research (ICIDR), in one area of Rio de Janeiro, evaluated the use of the WHO's directly observed therapy, short course (DOTS) strategy versus an enhanced DOTS strategy (DOTS-A), which included household contact investigation as a means of identifying cases. A statistically significant reduction in incidence rates between DOTS versus DOTS-A communities was seen from 2000 to 2002 (Figure 2), suggesting that ACF strategies can be instrumental in reducing incidence rates if subjects are detected and treated. Treatment completion rates among new TB cases were not significantly different statistically in the 2 study arms, however treatment completion rates overall increased from 68% to 77% over the course of the study. Overall, the DOTS communities exhibited little change (+7%) in TB incidence over the 5-year period, while DOTS-A communities showed a combined decrease (-14%) (P<0.05). The difference suggests that a large scale ACF campaign at a more intensive level (ie, door-to-door case finding) could have a significant impact on long-term TB incidence in a community.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Residents of AP3.1 and AP 5.3 in Rio de Janeiro Brazil

Inclusion Criteria:

  • All residents of the study communities will be eligible to be surveyed at their homes, regardless of gender, age, or ethnicity.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00472316

The Health Department of Rio de Janeiro, Brazil
Rio de Janeiro, Brazil
Sponsors and Collaborators
Johns Hopkins University
Universidade Federal do Rio de Janeiro
Principal Investigator: Jonathan Golub, PhD Johns Hopkins University
  More Information

Responsible Party: Dr. Jonathan Golub, PhD., Johns Hopkins University Identifier: NCT00472316     History of Changes
Other Study ID Numbers: 2U19AI045432-06 ( US NIH Grant/Contract Award Number )
Study First Received: May 10, 2007
Last Updated: August 7, 2009

Additional relevant MeSH terms:
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections processed this record on June 23, 2017