GUM Remote Testing v4.0

NHS Foundation Trust

Status: Not yet enrolling

Conditions: Syphilis Infection; HIV Infections; Hepatitis B and Hepatitis C

Treatments: Diagnostic Test: HIV diagnostic testing

Study type: Interventional

Funder types: Other

Identifiers

NCT06244966

2312510

Details and patient eligibility

About

Capillary blood sample results are compared to venous blood results

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults
• Able and willing to provide informed consent.
• Already having a venous blood sample for clinical care

Exclusion criteria

• Failure to consent

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Any client attending clinic for venous blood sampling

Experimental group

Description:

Any client attending clinic for venous blood sampling for sexually transmitted disease diagnostics will also collect capillary blood using a finger prick

Treatment:

Diagnostic Test: HIV diagnostic testing