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ISRCTN
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ISRCTN84352452
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ClinicalTrials.gov identifier
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Public title
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A cluster randomised trial of two intensified tuberculosis case-finding strategies in an urban community severely affected by human immunodeficiency virus
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Scientific title
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Acronym
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DETECTB
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Serial number at source
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074644; LSHTM ITCR BA79
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Study hypothesis
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1. To compare the cumulative yield and residual burden of two potentially sustainable intensified TB case-finding methods applied for 3 years in a high HIV setting
2. To investigate HIV-specific point prevalence and incidence of active TB disease in an urban community before and after the intervention period (as of 13th February 2007 this hypothesis was changed to 'To investigate the change in point prevalence of culture-positive TB disease in an urban community before and after the intervention period')
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Zimbabwe
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Disease/condition/study domain
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Tuberculosis
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Participants - inclusion criteria
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Site:
1. Study neighbourhoods based on Census Evaluation Units (CEUs) in residential suburbs of South-West and Western Harare
2. Three to four CEUs combined to provide:
a. 2000-3000 adults registered for 2002 Census
b. No flats or Halls of Residence
c. At least 500 km distance between study neighbourhoods
All eligible neighbourhoods included
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Participants - exclusion criteria
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Individual:
1. Declined consent to participate
2. Aged below 16 years
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Anticipated start date
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01/02/2006
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Anticipated end date
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01/12/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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120,000 - 110,000 as of 07/08/2006 (end of recruitment). Follow up continuing.
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Interventions
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Cluster-randomised trial of high density neighbourhoods in Zimbabwe
Randomisation unit: each neighbourhood site
Number of sites: 46
Each neighbourhood is randomised to receive either mobile clinic or door-to-door enquiry.
Open cohort of all adults living in households within study neighbourhoods (~120,000 in total). Stratified randomisation according to pre-intervention TB case-notification rates.
As of 13/02/2007 the anticipated end date of this trial was shortened to the 1st December 2008. This trial is closed to recruitment: follow up continuing
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Primary outcome measure(s)
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Cumulative yield of TB cases detected through six rounds of periodic (six-monthly) case-finding intervention delivered through either:
1. House-to-house enquiry for chronic coughers
2. Mobile diagnostic clinic visits
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Secondary outcome measure(s)
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HIV-specific point prevalence and incidence of active TB disease before and immediately after the intervention (for whole study area with both arms combined) - as of 13/02/2007 this secondary outcome measure was changed to: 'Point prevalence of culture-positive TB disease before and immediately after the intervention (for whole study area with both arms combined)'.
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Sources of funding
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The Wellcome Trust (UK) (grant ref: 074644)
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Trial website
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Publications
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2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20923715
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Contact name
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Dr
E
Corbett
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Address
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London School of Hygiene and Tropical Medicine
Department of Infectious and Tropical Diseases
Keppel Street
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City/town
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London
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Zip/Postcode
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WC1E 7HT
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Country
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United Kingdom
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Tel
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+44 (0)20 7927 2116
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Fax
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+44 (0)20 7637 4314
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Email
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elizabeth.corbett@lshtm.ac.uk
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Sponsor
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London School of Hygiene and Tropical Medicine (UK)
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Address
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Keppel Street
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City/town
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London
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Zip/Postcode
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WC1E 7HT
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 8636
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Fax
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+44 (0)20 7637 4314
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Email
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Penny.Ireland@lshtm.ac.uk
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Sponsor website:
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http://www.lshtm.ac.uk/
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Date applied
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14/10/2005
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Last edited
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10/11/2010
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Date ISRCTN assigned
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14/10/2005
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