Notification of Donors With Positive Microbiology Markers
Recruitment status was Not yet recruiting
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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.
Condition |
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Human Immunodeficiency Virus Hepatitis B Hepatitis C Human T-lymphotropic Virus I & II Creutzfeldt-Jakob Syndrome HIV Infections |
Study Type: | Observational |
Study Design: | Observational Model: Case-Only Time Perspective: Retrospective |
Official Title: | Assessment of the Impact of Notification of Blood Donors Testing Positive for Microbiology Markers: What is the Psychological Impact of Notification and Does the Method of Notification Influence the Outcome? |
- The primary outcome measure for the study is the reported level of satisfaction with the notification process, including the information provided and the donor's emotional response. [ Time Frame: June-July 2010 ] [ Designated as safety issue: No ]
Estimated Enrollment: | 600 |
Study Start Date: | February 2010 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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Positive Blood Donors
Blood donors testing positive for HIV, HBV, HCV or HTLV in 2008 and 2009. Donors and patients notified of increased risk of vCJD in 2005.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
All donors testing positive for microbiology markers in 2008 and 2009, and those identified as at risk of vCJD in 2008.
Inclusion Criteria:
- deferred blood donor status, and
- deferral due to a positive result of a routine blood test for HIV, or hepatitis B, or hepatitis C, or HTLV, or having been identified as at risk of vCJD; and
- deferral occured in 2008 or 2009 (2007 for the pilot; 2005 for those at risk of vCJD and the control group); and
- donor registered at one of the NHSBT centres (English Blood Service in England and Wales);
Exclusion Criteria:
- not a blood donor; or
- no record of notification having taken place; or
- a member of Armed Forces or other profession where contact at the address provided could lead to a breach of confidentiality; or
- deferred before 2008 (if not in the pilot or notified of increased risk of vCJD);
- deferred as a result of a non-routine test or syphilis infection only; or
- donor registered with and notified by the Welsh, Scottish or Northern Irish Blood Services;
Contact: Cameron F Paige, MSc | +44 (0)208 271 6329 | cameron.paige@nhsbt.nhs.uk |
Contact: Patricia E Hewitt, FRCP FRCPath | +44 (0)20 8271 6331 | patricia.hewitt@nhsbt.nhs.uk |
United Kingdom | |
NHS Blood and Transplant, Transfusion Microbiology | Not yet recruiting |
Colindale, London, United Kingdom, NW9 5BG | |
Contact: Cameron F Paige, MSc +44 (0)208 271 6329 cameron.paige@nhsbt.nhs.uk | |
Contact: Patricia E Hewitt, FRCP FRCPath 020 8271 6331 patricia.hewitt@nhsbt.nhs.uk | |
Principal Investigator: Patricia E Hewitt, FRCP FRCPath |
Principal Investigator: | Patricia E Hewitt, FRCP FRCPath | NHS Blood and Transplant |
Study Director: | Theresa M Marteau, PhD FMedSci | Kings College, London |
Study Director: | Cameron F Paige, MSc | NHS Blood and Transplant |
Additional Information:
Publications:
Responsible Party: | Dr Patricia E Hewitt (Principal Investigator) - Consultant Specialist in Transfusion Microbiology, NHS Blood and Transplant |
ClinicalTrials.gov Identifier: | NCT01050881 History of Changes |
Other Study ID Numbers: | 001/DNS |
Study First Received: | January 14, 2010 |
Last Updated: | February 12, 2010 |
Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by NHS Blood and Transplant:
blood donor notification emotional response variant Creutzfeldt-Jacob Disease |
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome HIV Infections Hepatitis Hepatitis A Hepatitis B Hepatitis C Immunologic Deficiency Syndromes Creutzfeldt-Jakob Syndrome Virus Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases |
Immune System Diseases Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Hepadnaviridae Infections DNA Virus Infections Flaviviridae Infections Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Prion Diseases Central Nervous System Infections |
ClinicalTrials.gov processed this record on February 28, 2013