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 range

18 Years – 25 Years

Sex

FEMALE

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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