GUM Remote Testing v4.0

Not Applicable

Not yet recruiting

• Conditions: Syphilis Infection; Hepatitis B and Hepatitis C; HIV Infections
• Interventions: Diagnostic Test: HIV diagnostic testing

• Registration Number: NCT06244966
• Lead Sponsor: Royal Devon and Exeter NHS Foundation Trust

Brief 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.

Study Timeline

• Study First Submitted: 2024-01-16
• Study First Submitted QC: 2024-01-29
• Study First Posted: 2024-02-06
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10
• Study Start: 2024-05
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Any client attending clinic for venous blood sampling	HIV diagnostic testing	Any client attending clinic for venous blood sampling for sexually transmitted disease diagnostics will also collect capillary blood using a finger prick

Primary Outcome Measures

Name	Time	Method
Comparative capillary and venous samples screening testing	1 year	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

Secondary Outcome Measures

Name	Time	Method
Comparative capillary and venous samples confirmatory testing	1 year	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

Trial Locations

Locations (1)

Royal Devon University Hospital NHS Foundation Trust; 🇬🇧 Exeter, Devon, United Kingdom