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
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) | Other |
| Study type | Treatment |
| Scientific title | Intensified primary health care at the workplace: investigating the impact on human immunodeficiency virus associated morbidity and tuberculosis epidemiology |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/09/2001 |
| Completion date | 01/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 6440 |
| Key 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 |
| Key exclusion criteria | Individual: 1. Declined consent to participate 2. Sub-contracted or casual contract employee |
| Date of first enrolment | 01/09/2001 |
| Date of final enrolment | 01/07/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
- Zimbabwe
Study participating centre
London School of Hygiene and Tropical Medicine
London
WC1E 7HT
United Kingdom
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
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? |
|---|---|---|---|---|---|
| Abstract results | 01/01/2007 | No | No |
