Condition category
Infections and Infestations
Date applied
14/10/2005
Date assigned
14/10/2005
Last edited
19/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr E Corbett

ORCID ID

Contact details

London School of Hygiene and Tropical Medicine
Department of Infectious and Tropical Diseases
Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)20 7927 2116
elizabeth.corbett@lshtm.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

074644; LSHTM ITCR BA79

Study information

Scientific title

A cluster randomised trial of two intensified tuberculosis case-finding strategies in an urban community severely affected by human immunodeficiency virus

Acronym

DETECTB

Study hypothesis

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 13/02/2007 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')

On 13/02/2007 the overall trial end date was changed to 01/12/2008.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Tuberculosis

Intervention

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.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

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)'.

Overall trial start date

01/02/2006

Overall trial end date

01/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120,000 - 110,000 as of 07/08/2006 (end of recruitment)

Participant exclusion criteria

Individual:
1. Declined consent to participate
2. Aged below 16 years

Recruitment start date

01/02/2006

Recruitment end date

07/08/2006

Locations

Countries of recruitment

Zimbabwe

Trial participating centre

London School of Hygiene and Tropical Medicine
London
WC1E 7HT
United Kingdom

Sponsor information

Organisation

London School of Hygiene and Tropical Medicine (UK)

Sponsor details

Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)20 7636 8636
Penny.Ireland@lshtm.ac.uk

Sponsor type

University/education

Website

http://www.lshtm.ac.uk/

Funders

Funder type

Charity

Funder name

Wellcome Trust (UK) (grant ref: 074644)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20923715

Publication citations

  1. Results

    Corbett EL, Bandason T, Duong T, Dauya E, Makamure B, Churchyard GJ, Williams BG, Munyati SS, Butterworth AE, Mason PR, Mungofa S, Hayes RJ, Comparison of two active case-finding strategies for community-based diagnosis of symptomatic smear-positive tuberculosis and control of infectious tuberculosis in Harare, Zimbabwe (DETECTB): a cluster-randomised trial., Lancet, 2010, 376, 9748, 1244-1253, doi: 10.1016/S0140-6736(10)61425-0.

Additional files

Editorial Notes