|
ISRCTN
|
ISRCTN44114250
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Intensified primary health care at the workplace: investigating the impact on human immunodeficiency virus associated morbidity and tuberculosis epidemiology
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
060983 LSHTM ITCR BA59
|
|
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
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
Zimbabwe
|
|
Disease/condition/study domain
|
Human immunodeficiency virus
|
|
Participants - 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
|
|
Participants - exclusion criteria
|
Individual:
1. Declined consent to participate
2. Sub-contracted or casual contract employee
|
|
Anticipated start date
|
01/09/2001
|
|
Anticipated end date
|
01/07/2005
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
6440 - recruitment ends on the 1st July 2004
|
|
Interventions
|
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).
|
|
Primary outcome measure(s)
|
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 measure(s)
|
No secondary outcome measures
|
|
Sources of funding
|
The Wellcome Trust (UK) (grant ref: 060983)
|
|
Trial website
|
|
|
Publications
|
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17199408
|
|
Contact name
|
Dr
E
Corbett
|
|
Address
|
London School of Hygiene and Tropical Medicine
Department of Infectious and Tropical Diseases
Keppel Street
|
|
City/town
|
London
|
|
Zip/Postcode
|
WC1E 7HT
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7927 2116
|
|
Fax
|
+44 (0)20 7637 4314
|
|
Email
|
elizabeth.corbett@lshtm.ac.uk
|
|
Sponsor
|
London School of Hygiene and Tropical Medicine (UK)
|
|
Address
|
Keppel Street
|
|
City/town
|
London
|
|
Zip/Postcode
|
WC1E 7HT
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7636 8636
|
|
Fax
|
+44 (0)20 7637 4314
|
|
Email
|
Penny.Ireland@lshtm.ac.uk
|
|
Sponsor website:
|
http://www.lshtm.ac.uk/
|
|
Date applied
|
14/10/2005
|
|
Last edited
|
13/12/2007
|
|
Date ISRCTN assigned
|
14/10/2005
|
