NCT06566677

Point of Care Rapid STI Test Optimization and Validation Extension

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
• Phase: —
• Study type: Observational
• Enrollment: 364 (actual)
• Sponsor: Wits RHI Research Centre Clinical Research Site · Academic / Other
• Sex: Female
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

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 kits/devices 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 one's home.

Conditions

• Chlamydia Trachomatis Genital Infection
• Gonorrhea
• Trichomoniasis

Timeline

• Start date: 2023-01-26
• Primary completion: 2023-12-07
• Completion: 2023-12-07
• First posted: 2024-08-22
• Last updated: 2024-08-26

Locations

1 site across 1 country: South Africa