Intensified primary health care at the workplace: investigating the impact on human immunodeficiency virus associated morbidity and tuberculosis epidemiology

ISRCTN ISRCTN44114250
DOI https://doi.org/10.1186/ISRCTN44114250
Secondary identifying numbers 060983 LSHTM ITCR BA59
Submission date
14/10/2005
Registration date
14/10/2005
Last edited
06/02/2015
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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific titleIntensified primary health care at the workplace: investigating the impact on human immunodeficiency virus associated morbidity and tuberculosis epidemiology
Study objectives1. 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedHuman immunodeficiency virus
InterventionCluster-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 typeOther
Primary outcome measure1. 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 measuresNo secondary outcome measures
Overall study start date01/09/2001
Completion date01/07/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants6440
Key inclusion criteriaSite:
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
Key exclusion criteriaIndividual:
1. Declined consent to participate
2. Sub-contracted or casual contract employee
Date of first enrolment01/09/2001
Date of final enrolment01/07/2004

Locations

Countries of recruitment

  • England
  • United Kingdom
  • Zimbabwe

Study participating centre

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

Sponsor information

London School of Hygiene and Tropical Medicine (UK)
University/education

Keppel Street
London
WC1E 7HT
England
United Kingdom

Phone +44 (0)20 7636 8636
Email Penny.Ireland@lshtm.ac.uk
Website http://www.lshtm.ac.uk/
ROR logo "ROR" https://ror.org/00a0jsq62

Funders

Funder type

Charity

Wellcome Trust
Private sector organisation / International organizations
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Abstract results 01/01/2007 No No