Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06566677
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
Point of Care Rapid STI Test Optimization and Validation Extension
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Validation of Selected Point of Care Rapid STI Diagnostic Tests for Laboratory Based and Self- Test Use - A Sub-Study of Acceptability Research on Integrated Point of Care Sexually Transmitted Infection STI Testing and Expanded Partner Therapy EPT ARISE
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROVE
Brief Summary:
The purpose of this sub-study PROVE is to support and facilitate the validation of commercially available point of care POC sexually transmitted infection STI diagnostic test kitsdevices for potential on-site laboratory use as well as bedside use in parallel to gold standard established testing methodologies A further extension of bedside testing would include self-testing
Detailed Description:
Screening and Enrolment procedures for the ARISE study HREC Ref No 210614 involves adolescent girls and young women AGYW being screened for Neisseria gonorrhoea NG Chlamydia trachomatis CT and Trichomonas vaginalis TV as determined through testing of clinician-collected genital swabs followed by GeneXpert OSOM rapid TV testing or through wet mount visualisation of the micro-organisms of interest This will generate a pool of AGYW with known STI diagnoses who if positive will be treated on-site on the day of STI detection It will also create an ideal opportunity to leverage access to samples from willing participants prior to STI treatment if STI positive for validation of a range of alternate STI test kits Samples provided will enable same-day parallel testing on additional platforms for validation of the sensitivity and specificity of these alternate tests against the known validated platformsThis initiative will expand the menu of cost effective and user friendly STI test kits that may ultimately be used in other research studies in public clinic settings and as self-tests performed discretely in the convenience and privacy of ones home
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None