Notification of Donors With Positive Microbiology Markers

NCT01050881 | Completed DMC

• 1 other identifier: 001/DNS
• Study Type: observational
• Target: 217
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

blood donor notification; emotional response; variant Creutzfeldt-Jacob Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  July-August 2010

Study Arms (1)

Positive Blood Donors

Blood donors testing positive for HIV, HBV, HCV or HTLV in 2008 and 2009. Donors notified of increased risk of vCJD in 2005.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All donors testing positive for microbiology markers in 2008 and 2009, and those identified as at risk of vCJD in 2008.

You may qualify if:

• 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
• donor registered at one of the NHSBT centres (English Blood Service in England and Wales);

You may not qualify if:

• 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;

Sponsors & Collaborators

• NHS Blood and Transplant: lead
• Welsh Blood Service: collaborator
• Scottish National Blood Transfusion Service: collaborator
• Irish Blood Transfusion Service: collaborator

Study Sites (1)

NHS Blood and Transplant, Transfusion Microbiology

Colindale, London, NW9 5BG, United Kingdom

Location

Related Publications (5)

• Elam G, Oakley K, Connor N, Hewitt P, Ward HJ, Zaman SM, Chow Y, Marteau TM. Impact of being placed at risk of Creutzfeldt-Jakob disease: a qualitative study of blood donors to variant CJD cases and patients potentially surgically exposed to CJD. Neuroepidemiology. 2011;36(4):274-81. doi: 10.1159/000328646. Epub 2011 Jul 12.

  PMID: 21757956 BACKGROUND

• French DP, Maissi E, Marteau TM. Psychological costs of inadequate cervical smear test results. Br J Cancer. 2004 Nov 29;91(11):1887-92. doi: 10.1038/sj.bjc.6602224.

  PMID: 15534608 BACKGROUND

• Kleinman S, Wang B, Wu Y, Glynn SA, Williams A, Nass C, Ownby H, Busch MP; Retrovirus Epidemiology Donor Study. The donor notification process from the donor's perspective. Transfusion. 2004 May;44(5):658-66. doi: 10.1111/j.1537-2995.2004.03347.x.

  PMID: 15104645 BACKGROUND

• Tynell E, Norda R, Ekermo B, Sanner M, Andersson S, Bjorkman A. False-reactive microbiologic screening test results in Swedish blood donors-how big is the problem? A survey among blood centers and deferred donors. Transfusion. 2007 Jan;47(1):80-9. doi: 10.1111/j.1537-2995.2007.01067.x.

  PMID: 17207234 BACKGROUND

• Reynolds CA, Brailsford SR, Hewitt PE. Notifying blood donors of infection: results of a donor satisfaction survey. Transfus Med. 2015 Dec;25(6):358-65. doi: 10.1111/tme.12268. Epub 2015 Dec 28.

  PMID: 26707828 RESULT

Related Links

• WORLD HEALTH ORGANISATION, ca. 2009. Blood transfusion safety: Universal access to safe blood and blood products for transfusion.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Hepatitis B; Hepatitis C; Creutzfeldt-Jakob Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Flaviviridae Infections; Prion Diseases; Central Nervous System Infections; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Patricia E Hewitt, FRCP FRCPath

  NHS Blood and Transplant

  PRINCIPAL INVESTIGATOR

• Theresa M Marteau, PhD FMedSci

  King's College London

  STUDY DIRECTOR

• Cameron F Ousbey, MSc

  NHS Blood and Transplant

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2010
• First Posted: January 18, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2010
• Last Updated: May 10, 2022

Record last verified: 2022-05

Locations

GB (1)