CompletedNot Applicable

Point of Care Rapid STI Test Optimization and Validation Extension

South Africa364 participantsStarted 2023-01-26

Plain-language 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.

Who can participate

Age range18 Years – 25 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Participants must meet the following criteria to be eligible for inclusion in the study: * Cisgender adolescent girls and young women (18-25 years of age, inclusive), screened for or enrolled in the ARISE study. * Willing to provide written informed consent to participate in this sub-study. * Willing to provide additional samples including vaginal and endocervical swabs, urine and those collected through the use of tampons and disposable menstrual cups. Exclusion Criteria: * Cisgender male or transgender woman or transgender man * Age \<18 years * Unable or unwilling to provide written informed consent * Have any condition that in the opinion of the investigators will interfere with successful completion of sub-study procedures

What they're measuring

GeneXpert

Timeframe: 1 year

Trial details

NCT IDNCT06566677

SponsorWits RHI Research Centre Clinical Research Site

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-12-07

View on ClinicalTrials.gov More Chlamydia Trachomatis Genital Infection trials