Innovative Approaches to Tuberculosis Control

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Johns Hopkins University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Universidade Federal do Rio de Janeiro
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00472316
First received: May 10, 2007
Last updated: August 7, 2009
Last verified: August 2009
  Purpose

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472316

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

No publications provided

Responsible Party: Dr. Jonathan Golub, PhD., Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00472316     History of Changes
Other Study ID Numbers: 2 U19 AI045432-06
Study First Received: May 10, 2007
Last Updated: August 7, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 16, 2014