Point of Care Rapid STI Test Optimization and Validation Extension

NCT ID: NCT06566677

Last Updated: 2024-08-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 364 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-26
• Study Completion Date: 2023-12-07

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.

Conditions

Chlamydia Trachomatis Genital Infection; Gonorrhea; Trichomoniasis

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Washington

OTHER

Sponsor Role: collaborator

Wits RHI Research Centre Clinical Research Site

OTHER

Sponsor Role: lead

Responsible Party

Thesla Palanee-Phillips

Director of Clinical Trials

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Wits RHI Research Centre

Hillbrow, Gauteng, South Africa

Countries

South Africa

Other Identifiers

PROVE

Identifier Type: -

Identifier Source: org_study_id