Dried blood spot testing in UK prisons
| ISRCTN | ISRCTN05628482 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05628482 |
| Secondary identifying numbers | Version 1 |
- Submission date
- 11/03/2011
- Registration date
- 18/05/2011
- Last edited
- 28/07/2014
- 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 Noel Craine
Scientific
Scientific
Micobiology dept
Ysbyty gwynedd
Gwynedd
Bangor
LL57 2PW
United Kingdom
Study information
| Study design | Stepped wedge cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Diagnostic |
| Scientific title | Cluster randomised controlled trial of dried blood spot testing in UK prisons |
| Study objectives | An intervention using dried blood spot testing for blood borne viruses will increase the blood borne viral diagnostic testing rate in prisons. This is defined as the proportion of the monthly prison throughput who take up the offer of a diagnostic test for blood borne viral infection (either venepuncture pre-intervention or DBS post intervention). |
| Ethics approval(s) | 10/MRE09/23 Research ethics commitee for Wales It was noted that as this research will not be taking place within the NHS and is not a clinical trial of a medicinal product for human use, it falls outside the remit of Research Ethics Committees as set out in the Governance Arrangements for NHS Research Ethics Committees (GAfREC). The members present agreed that has this study fallen within their remit it would have been given a favourable opinion.The National Offender Management system (NOMS) and Ministry of Justice were also contacted; both bodies were satisfied that the study did not need further consideration by themselves. |
| Health condition(s) or problem(s) studied | Blood borne virus infection [Hepatitis C, Hepatitis B, Human immunodeficiency virus (HIV)] |
| Intervention | 1. Dried blood spot testing (DBS) for blood borne viral infection 2. Comparing DBS against standard venepuncture based testing 3. The planned intervention is the opt-in offer of DBS testing for blood borne viruses (BBV) infection to all inmates at reception 4. The test will be offered by clinically trained prison health staff (either prison doctors or senior nursing staff) in a confidential manner 5. Results will likewise be fed back to inmates requesting diagnostic testing in a manner that ensures both confidentiality and prevents deductive disclosure. Intervention thus the training of prison healthcare staff in BBV diagnostic testing and the dried blood spot test |
| Intervention type | Other |
| Primary outcome measure | Change in blood borne viral diagnostic testing rate in prisons with introduction of DBS |
| Secondary outcome measures | Epidemiological data on prison disease prevalence for ongoing mathematical modelling research |
| Overall study start date | 07/04/2011 |
| Completion date | 07/04/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Prison throughput within study time period for each of five prisons recruited to the study |
| Key inclusion criteria | Five UK prisons - all inmates offered intervention |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 07/04/2011 |
| Date of final enrolment | 07/04/2012 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Micobiology dept
Bangor
LL57 2PW
United Kingdom
LL57 2PW
United Kingdom
Sponsor information
Public Health Wales (UK)
Government
Government
Health Protection
Temple of Peace and Health
Cathays Park
Cardiff
CF10 3NW
United Kingdom
| Website | http://www.wales.nhs.uk/sitesplus/888/ |
|---|---|
"ROR" |
https://ror.org/00265c946 |
Funders
Funder type
Government
Public Health Wales (UK)
No information available
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? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2015 | Yes | No |
