Innovative Approaches to Tuberculosis Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00472316
Recruitment Status : Completed
First Posted : May 11, 2007
Last Update Posted : August 18, 2017
Universidade Federal do Rio de Janeiro
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment
Tuberculosis Behavioral: Active Case Finding for Tuberculosis

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.

Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Cluster Randomized Trial of DOTS vs DOTS Plus Active Case Finding
Study Start Date : May 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis
U.S. FDA Resources

Intervention Details:
    Behavioral: Active Case Finding for Tuberculosis
    Active case finding of TB in the community using community health workers

Primary Outcome Measures :
  1. 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 :
  1. To compare case notification rates of TB in the 2 arms of the study during the ACF campaign. [ Time Frame: During the intervention ]

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Johns Hopkins University Identifier: NCT00472316     History of Changes
Other Study ID Numbers: 2U19AI045432-06 ( U.S. NIH Grant/Contract )
First Posted: May 11, 2007    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections