Status:
COMPLETED
Point of Care Rapid STI Test Optimization and Validation Extension
Lead Sponsor:
Wits RHI Research Centre Clinical Research Site
Collaborating Sponsors:
University of Washington
Conditions:
Chlamydia Trachomatis Genital Infection
Gonorrhea
Eligibility:
FEMALE
18-25 years
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 kits/devices for po...
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), ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 26 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 7 2023
Estimated Enrollment :
364 Patients enrolled
Trial Details
Trial ID
NCT06566677
Start Date
January 26 2023
End Date
December 7 2023
Last Update
August 26 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Wits RHI Research Centre
Hillbrow, Gauteng, South Africa, 2038