Trial record 11 of 41 for:    " January 13, 2010":" February 12, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Notification of Donors With Positive Microbiology Markers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by NHS Blood and Transplant.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Welsh Blood Service
Scottish National Blood Transfusion Service
Irish Blood Transfusion Service
Information provided by:
NHS Blood and Transplant
ClinicalTrials.gov Identifier:
NCT01050881
First received: January 14, 2010
Last updated: February 12, 2010
Last verified: January 2010
  Purpose

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
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?

Resource links provided by NLM:


Further study details as provided by NHS Blood and Transplant:

Primary Outcome Measures:
  • 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
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01050881

Contacts
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

Locations
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         
Sponsors and Collaborators
NHS Blood and Transplant
Welsh Blood Service
Scottish National Blood Transfusion Service
Irish Blood Transfusion Service
Investigators
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
  More Information

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 April 17, 2014