Notification of Donors With Positive Microbiology Markers

Summary

Each year around 200 blood donors in the UK are found to be infected with blood-borne diseases (HIV, hepatitis B, hepatitis C, and HTLV), while several others have been identified as having an increased risk of variant Creutzfeldt-Jakob Disease (vCJD). Although the notification procedures for these infections vary, their effectiveness and appropriateness have never been evaluated in a systematic study.

The proposed research has been designed to assess the responses of blood donors to notification and their satisfaction with how they were informed about the infection. The study will be implemented using standard questionnaire-based measures (French et al, 2004; Marteau \& Bekker, 1992).

The study will involve approximately 600 blood donors who were informed of an infection or possible infection with blood-borne diseases in 2008 and 2009, and approximately 100 donors notified of possible risk of vCJD infection in 2005. A comparable group of 2005 donors will be included to control for the effects of time. As the majority of donors testing positive donated to NHS Blood and Transplant (NHSBT), the participants will be identified from the NHSBT database only, and their availability confirmed through their GP or specialist clinician. A standardized questionnaire will be then sent to all those identified as eligible.

The study will last 12 months, but direct participant involvement will be limited to the time required to complete the questionnaire, which should take under one hour. To safeguard confidentiality, no identifiable personal data will be used in the analysis. Where demographic or medical information already held by NHSBT is retrieved to minimise response burden, this will be pseudonymised before use.

The study is sponsored by the blood services for England, Wales, Scotland and Northern Ireland. The results will be used to inform notification procedures in the future.

Conditions

• Human Immunodeficiency Virus
• Hepatitis B
• Hepatitis C
• Human T-lymphotropic Virus I & II
• Creutzfeldt-Jakob Syndrome

Sponsors & Collaborators

• Welsh Blood Service

  collaborator OTHER

• Scottish National Blood Transfusion Service

  collaborator UNKNOWN

• Irish Blood Transfusion Service

  collaborator OTHER

• NHS Blood and Transplant

  lead OTHER_GOV

Principal Investigators

• Patricia E Hewitt, FRCP FRCPath · NHS Blood and Transplant

• Theresa M Marteau, PhD FMedSci · King's College London

• Cameron F Ousbey, MSc · NHS Blood and Transplant

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-03-31

Primary Completion

2010-10-31

Completion

2010-11-30

Countries

• United Kingdom

Study Locations