Innovative Approaches to Tuberculosis Control

NCT ID: NCT00472316

Last Updated: 2017-08-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2011-05-31

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.

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.

Conditions

Tuberculosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Active Case Finding for Tuberculosis

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• All residents of the study communities will be eligible to be surveyed at their homes, regardless of gender, age, or ethnicity.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Golub, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

The Health Department of Rio de Janeiro, Brazil

Rio de Janeiro, , Brazil

Countries

Brazil

Other Identifiers

2U19AI045432-06

Identifier Type: NIH

Identifier Source: org_study_id

View Link