GUM Remote Testing v4.0
Verifying Remote Low Volume Blood Tests for Genito-urinary Infections Including Syphilis and Bloodborne Viruses
1 other identifier
interventional
40
1 country
1
Brief Summary
Capillary blood sample results are compared to venous blood results
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv-infections
Started May 2024
Shorter than P25 for not_applicable hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2024
CompletedFirst Posted
Study publicly available on registry
February 6, 2024
CompletedStudy Start
First participant enrolled
May 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedApril 10, 2024
April 1, 2024
1 year
January 16, 2024
April 9, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Comparative capillary and venous samples confirmatory testing
1 year
Study Arms (1)
Any client attending clinic for venous blood sampling
EXPERIMENTALAny client attending clinic for venous blood sampling for sexually transmitted disease diagnostics will also collect capillary blood using a finger prick
Interventions
Finger-prick capillary blood will be tested alongside venous blood
Eligibility Criteria
You may qualify if:
- Adults
- Able and willing to provide informed consent.
- Already having a venous blood sample for clinical care
You may not qualify if:
- Failure to consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Devon University Hospital NHS Foundation Trust
Exeter, Devon, EX2 5AD, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2024
First Posted
February 6, 2024
Study Start
May 1, 2024
Primary Completion
May 1, 2025
Study Completion
May 1, 2025
Last Updated
April 10, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share
No data will be shared