HIV InfectionsNCT06244966
GUM Remote Testing v4.0
A study testing HIV diagnostic testing in people with HIV Infections and Syphilis Infection, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Capillary blood sample results are compared to venous blood results Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Syphilis Infection, Hepatitis B and Hepatitis C
- What is being tested?
- HIV diagnostic testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2024to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults
- Able and willing to provide informed consent.
- Already having a venous blood sample for clinical care
Who cannot join
- Failure to consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Devon University Hospital NHS Foundation Trust
Exeter, Devon, EX2 5AD
Alison Kerridge, 01392403055, rduh.research-eastern@nhs.net
Cressida Auckland, 01392406459, cressida.auckland@nhs.net
About this study
Official title: Verifying Remote Low Volume Blood Tests for Genito-urinary Infections Including Syphilis and Bloodborne Viruses
Capillary blood sample results are compared to venous blood results
Read the 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.
- Being tested
- HIV diagnostic testing
- Medical subject headings
- HIV Infections, Hepatitis B, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV diagnostic testingDiagnostic test
Also called Syphilis diagnostic testing, Hepatitis diagnostic testing
Finger-prick capillary blood will be tested alongside venous blood
| Study group | Role | What they receive |
|---|---|---|
| Any client attending clinic for venous blood sampling | Experimental | Any client attending clinic for venous blood sampling for sexually transmitted disease diagnostics will also collect capillary blood using a finger prick Receives: Diagnostic Test: HIV diagnostic testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (1)
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study startMay 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Comparative study of two collection methods for blood samples
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244966
- Sponsor's protocol ID
- 2312510
- Status last verified
- Apr 2024
- First submitted
- 16 Jan 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verifying Remote Low Volume Blood Tests for Genito-urinary Infections Including Syphilis and Bloodborne Viruses
- ClinicalTrials.gov ID
- NCT06244966
- Acronym / sponsor ID
- 2312510
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 6 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Comparative study of two collection methods for blood samples
| Arm | Type | Receives |
|---|---|---|
| Any client attending clinic for venous blood sampling | Experimental | Diagnostic Test: HIV diagnostic testingAny client attending clinic for venous blood sampling for sexually transmitted disease diagnostics will also collect capillary blood using a finger prick |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults
- Able and willing to provide informed consent.
- Already having a venous blood sample for clinical care
Key exclusion criteria (1 listed)
- Failure to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIV diagnostic testingAlso: Syphilis diagnostic testing, Hepatitis diagnostic testingFinger-prick capillary blood will be tested alongside venous blood | Diagnostic test | Any client attending clinic for venous blood sampling |
Primary outcome
Comparative capillary and venous samples screening testing
Time frame: 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
1 secondary outcome
Comparative capillary and venous samples confirmatory testing
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: No. No data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV diagnostic testing in people with HIV Infections and Syphilis Infection, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cressida Auckland (01392 406459, cressida.auckland@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparative capillary and venous samples screening testing (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024; AzTrials last refreshed its copy on 28 Oct 2026.