Notification of Donors With Positive Microbiology Markers
|ClinicalTrials.gov Identifier: NCT01050881|
Recruitment Status : Unknown
Verified January 2010 by NHS Blood and Transplant.
Recruitment status was: Not yet recruiting
First Posted : January 18, 2010
Last Update Posted : February 15, 2010
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 or disease|
|Human Immunodeficiency Virus Hepatitis B Hepatitis C Human T-lymphotropic Virus I & II Creutzfeldt-Jakob Syndrome HIV Infections|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|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?|
|Study Start Date :||February 2010|
|Estimated Primary Completion Date :||June 2010|
|Estimated Study Completion Date :||October 2010|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01050881
|Contact: Cameron F Paige, MSc||+44 (0)208 271 firstname.lastname@example.org|
|Contact: Patricia E Hewitt, FRCP FRCPath||+44 (0)20 8271 email@example.com|
|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 firstname.lastname@example.org|
|Contact: Patricia E Hewitt, FRCP FRCPath 020 8271 6331 email@example.com|
|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||King's College London|
|Study Director:||Cameron F Paige, MSc||NHS Blood and Transplant|