Tuberculosis Clinical Trial
Official title:
A Cluster Randomized Trial of DOTS vs DOTS Plus Active Case Finding
Verified date | August 2017 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1000 |
Est. completion date | May 2011 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - All residents of the study communities will be eligible to be surveyed at their homes, regardless of gender, age, or ethnicity. |
Country | Name | City | State |
---|---|---|---|
Brazil | The Health Department of Rio de Janeiro, Brazil | Rio de Janeiro |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Universidade Federal do Rio de Janeiro |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | To compare case notification rates of TB in the 2 arms of the study during the ACF campaign. | During the intervention |
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