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 |
| Protocol serial number | 060983 LSHTM ITCR BA59 |
| Sponsor | London School of Hygiene and Tropical Medicine (UK) |
| Funder | Wellcome Trust |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. Proportion of workers accepting VCT |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
- Zimbabwe
Study participating centre
London School of Hygiene and Tropical Medicine
London
WC1E 7HT
United Kingdom
WC1E 7HT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
