Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00472316
Status:
COMPLETED
Last Update Posted:
2017-08-18
First Post:
2007-05-10
Brief Title:
Innovative Approaches to Tuberculosis Control
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
A Cluster Randomized Trial of DOTS vs DOTS Plus Active Case Finding
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 DOTSACF or DOTS Communities in the DOTSACF 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 WHOs 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 P005 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None