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

ISRCTN	ISRCTN84352452
DOI	https://doi.org/10.1186/ISRCTN84352452
Protocol serial number	074644; LSHTM ITCR BA79
Sponsor	London School of Hygiene and Tropical Medicine (UK)
Funder	Wellcome Trust (UK) (grant ref: 074644)

Submission date: 14/10/2005
Registration date: 14/10/2005
Last edited: 19/06/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr E Corbett
Scientific

London School of Hygiene and Tropical Medicine
Department of Infectious and Tropical Diseases
Keppel Street
London
WC1E 7HT
United Kingdom

Phone	+44 (0)20 7927 2116
Email	elizabeth.corbett@lshtm.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A cluster randomised trial of two intensified tuberculosis case-finding strategies in an urban community severely affected by human immunodeficiency virus
Study acronym	DETECTB
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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)'.
Completion date	01/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	120000
Key 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
Key exclusion criteria	Individual: 1. Declined consent to participate 2. Aged below 16 years
Date of first enrolment	01/02/2006
Date of final enrolment	07/08/2006

Locations

Countries of recruitment

United Kingdom
England
Zimbabwe

Study participating centre

London School of Hygiene and Tropical Medicine

London
WC1E 7HT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	09/10/2010		Yes	No