Point of Care Rapid STI Test Optimization and Validation Extension

Completed

• Conditions: Trichomoniasis; Chlamydia Trachomatis Genital Infection; Gonorrhea

• Registration Number: NCT06566677
• Lead Sponsor: Wits RHI Research Centre Clinical Research Site

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 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.

Study Timeline

• Study Start: 2023-01-26
• Primary Completion: 2023-12-07
• Study Completion: 2023-12-07
• Status Verified: 2024-08
• Study First Submitted: 2024-08-16
• Study First Submitted QC: 2024-08-20
• Study First Posted: 2024-08-22
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 364

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
GeneXpert	1 year	A PCR instrument was used to assess the presence of chlamydia trichomatis and gonorrhea from samples taken using endocervical swabs.

Secondary Outcome Measures

Name	Time	Method
Osom rapid testing kit	1 year	A rapid point-of-care test for the diagnosis of Trichomonas vaginalis in women using dacron swabs.

Trial Locations

Locations (1)

Wits RHI Research Centre; 🇿🇦 Hillbrow, Gauteng, South Africa