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
060983 LSHTM ITCR BA59
Study information
Scientific title
Intensified primary health care at the workplace: investigating the impact on human immunodeficiency virus associated morbidity and tuberculosis epidemiology
Acronym
Study hypothesis
1. To compare the acceptability of two Voluntary Counselling and Testing (VCT) strategies at the workplace
2. To test whether on-site availability of VCT linked to intensified primary health care at the workplace reduces HUman Immunodeficiency Virus (HIV)-associated morbidity, and if so, to an extent that is cost effective for businesses in high HIV prevalence areas
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
Other
Trial type
Treatment
Patient information sheet
Condition
Human immunodeficiency virus
Intervention
Cluster-randomised trial of Small and Medium size Enterprises (SMEs) in Zimbabwe.
Randomisation unit: each participating business site
Number of sites: 22
The randomisation was to provide Voluntary Counselling and Testing (VCT) through either:
1. On-site rapid HIV testing at occupational clinics
2. Use of free vouchers to an off-site testing centre
Open cohort, with active recruitment of all eligible new employees until the end of follow-up
Stratified randomisation according to pre-intervention absenteeism rates (low/medium/high).
The trial will provide the framework for an observational study of Tuberculosis (TB) epidemiology (impact of HIV on incidence, prevalence and duration of TB disease before diagnosis).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Proportion of workers accepting VCT
2. Incidence rates of severe morbidity (composite: death, medical retirement, hospitalisation, TB, illness requiring five days or more off work) according to the VCT strategy allocated
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/09/2001
Overall trial end date
01/07/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Site:
1. Has HIV prevention policy in place
2. Willing to supply access to workforce and to absenteeism data
3. Agreement of Workers Committee
Individuals within sites:
1. Based at the study site (not alternative workplace)
2. On a contract of six months or longer
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
6440
Participant exclusion criteria
Individual:
1. Declined consent to participate
2. Sub-contracted or casual contract employee
Recruitment start date
01/09/2001
Recruitment end date
01/07/2004
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
Funders
Funder type
Charity
Funder name
Wellcome Trust
Alternative name(s)
Wellcome
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
Publication citations
-
Corbett EL, Bandason T, Cheung YB, Munyati S, Godfrey-Faussett P, Hayes R, Churchyard G, Butterworth A, Mason P, Epidemiology of tuberculosis in a high HIV prevalence population provided with enhanced diagnosis of symptomatic disease., PLoS Med., 2007, 4, 1, e22, doi: 10.1371/journal.pmed.0040022.