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NCT06244966 Clinical Trial

GUM Remote Testing v4.0

HIV Infections Clinical Trial

Official title:
Verifying Remote Low Volume Blood Tests for Genito-urinary Infections Including Syphilis and Bloodborne Viruses

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06244966
Other study ID # 2312510
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2024
Est. completion date May 2025

Study information
Verified date April 2024
Source Royal Devon and Exeter NHS Foundation Trust
Contact Cressida Auckland
Phone 01392 406459
Email cressida.auckland@nhs.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Capillary blood sample results are compared to venous blood results

Description:

Capillary blood samples can be taken by patients from their own finger without requiring a healthcare professional to take a blood sample. Samples taken this way can be posted from home. This crucially avoids visits to the clinic or hospital to have blood samples taken. It would reduce the burden on healthcare professionals and is often preferred by patients. It is important to demonstrate that the results of an analysis performed on capillary blood samples are equivalent to the analysis of a standard venous sample. This study aims to collect, in parallel to a standard venous blood sample, a capillary blood sample taken by the participant which is then added to specially designed filter paper (dried plasma spot sample) or other collection devices. Parallel analysis of paired samples will then allow the investigators to assess if results measured in samples taken using the two methods are similar. The investigators will recruit 40 participants for each collection device to this study. It is important to obtain a range of positive and negative results from the study participants, and from stored samples and quality control material.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date May 2025
Est. primary completion date May 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults - Able and willing to provide informed consent. - Already having a venous blood sample for clinical care Exclusion Criteria: - Failure to consent

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• HIV diagnostic testing
Finger-prick capillary blood will be tested alongside venous blood

Locations
Country Name City State
United Kingdom Royal Devon University Hospital NHS Foundation Trust Exeter Devon

Sponsors (1)
Lead Sponsor Collaborator
Royal Devon and Exeter NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparative capillary and venous samples screening testing To have sufficient parallel samples (capillary and venous) collected to demonstrate equivalence of the results of HIV, HBV, HCV and syphilis testing using the Roche Cobas e601 platform 1 year
Secondary Comparative capillary and venous samples confirmatory testing To have sufficient parallel samples (capillary and venous) collected to demonstrate equivalence of the results of HIV, HBV, HCV and syphilis testing using other platforms and for viral load 1 year
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