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 |
| Secondary identifying numbers | 074644; LSHTM ITCR BA79 |
- 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
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 |
|---|---|
| elizabeth.corbett@lshtm.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 01/02/2006 |
| Completion date | 01/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 120,000 - 110,000 as of 07/08/2006 (end of recruitment) |
| 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
- England
- United Kingdom
- Zimbabwe
Study participating centre
London School of Hygiene and Tropical Medicine
London
WC1E 7HT
United Kingdom
WC1E 7HT
United Kingdom
Sponsor information
London School of Hygiene and Tropical Medicine (UK)
University/education
University/education
Keppel Street
London
WC1E 7HT
England
United Kingdom
| Phone | +44 (0)20 7636 8636 |
|---|---|
| Penny.Ireland@lshtm.ac.uk | |
| Website | http://www.lshtm.ac.uk/ |
"ROR" |
https://ror.org/00a0jsq62 |
Funders
Funder type
Charity
Wellcome Trust (UK) (grant ref: 074644)
Private sector organisation / International organizations
Private sector organisation / International organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
