Condition category
Infections and Infestations
Date applied
11/03/2011
Date assigned
18/05/2011
Last edited
28/07/2014
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 Noel Craine

ORCID ID

Contact details

Micobiology dept
Ysbyty gwynedd
Gwynedd
Bangor
LL57 2PW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 1

Study information

Scientific title

Cluster randomised controlled trial of dried blood spot testing in UK prisons

Acronym

Study hypothesis

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

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.

Study design

Stepped wedge cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Diagnostic

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

07/04/2011

Overall trial end date

07/04/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Five UK prisons - all inmates offered intervention

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Prison throughput within study time period for each of five prisons recruited to the study

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

07/04/2011

Recruitment end date

07/04/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Micobiology dept
Bangor
LL57 2PW
United Kingdom

Sponsor information

Organisation

Public Health Wales (UK)

Sponsor details

Health Protection
Temple of Peace and Health
Cathays Park
Cardiff
CF10 3NW
United Kingdom

Sponsor type

Government

Website

http://www.wales.nhs.uk/sitesplus/888/

Funders

Funder type

Government

Funder name

Public Health Wales (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25061233

Publication citations

  1. Results

    Craine N, Whitaker R, Perrett S, Zou L, Hickman M, Lyons M, A stepped wedge cluster randomized control trial of dried blood spot testing to improve the uptake of hepatitis C antibody testing within UK prisons., Eur J Public Health, 2014, doi: 10.1093/eurpub/cku096.

Additional files

Editorial Notes