Condition category
Infections and Infestations
Date applied
14/10/2005
Date assigned
14/10/2005
Last edited
06/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.lshtm.ac.uk/

Funders

Funder type

Charity

Funder name

Wellcome Trust

Alternative name(s)

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

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17199408

Publication citations

  1. 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.

Additional files

Editorial Notes