NCT06244966

GUM Remote Testing v4.0

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Royal Devon and Exeter NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Capillary blood sample results are compared to venous blood results

Detailed 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.

Conditions

• HIV Infections
• Syphilis Infection
• Hepatitis B and Hepatitis C

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	HIV diagnostic testing	Finger-prick capillary blood will be tested alongside venous blood

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2024-02-06
• Last updated: 2024-04-10

Locations

1 site across 1 country: United Kingdom