Point of Care Rapid STI Test Optimization and Validation Extension (PROVE)

Validation of Selected Point of Care Rapid STI Diagnostic Tests for Laboratory Based and Self- Test Use - A Sub-Study of Acceptability Research on Integrated Point of Care Sexually Transmitted Infection (STI) Testing and Expanded Partner Therapy (EPT) (ARISE)

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.

Study Overview

• Status: Completed
• Conditions: Gonorrhea; Chlamydia Trachomatis Genital Infection; Trichomoniasis

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 Type: Observational
• Enrollment (Actual): 364

Contacts and Locations

Study Locations

• South Africa
  • Gauteng
    • Hillbrow, Gauteng, South Africa, 2038
      • WITS RHI Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Participants screened and/or enrolled into ARISE (HREC Ref No. 210614): Sexually active non-pregnant, HIV-negative, cis-gender AGYW aged 18-25

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
JD Biotech Trichomonas vaginalis antigen rapid test kit	Trichomonas vaginalis antigen rapid test kit	1 year
JD Biotech C. Trachomatis/ N. Gonorrhoeae Ag combo rapid test	Urine or vaginal cavity swab or vaginal glans sample to diagnose chlamydia trichomati and gonorroea	1 year
Cromatest Chlamydia one step rapid kit	Female cervical swab and male urethral swab specimens to diagnose chlamydia	1 year
NADAL Chlamydia Test	Female or male urethral swab/male Urine used to diagnose chlamydia	1 year
ACRO Biotech Gonorrhoea	Female cervical swab/ male urethral swab to diagnose gonorrhoea	1 year
Rapid Labs Gonorrhea	Sterile Female cervical swab/ male urethral swab to diagnose gonorrhea	1 year

Collaborators and Investigators

• Sponsor: Wits RHI Research Centre Clinical Research Site
• Collaborators: University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2023
• Primary Completion (Actual): December 7, 2023
• Study Completion (Actual): December 7, 2023

Study Registration Dates

• First Submitted: August 16, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 22, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Communicable Diseases; Sexually Transmitted Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Parasitic Diseases; Protozoan Infections; Neisseriaceae Infections; Sexually Transmitted Diseases, Bacterial; Urogenital Diseases; Genital Diseases; Infections; Gonorrhea; Trichomonas Infections
• Other Study ID Numbers: PROVE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Results of the validations will be shared with study staff, study participants, CAB members and other key stakeholders. Results will additionally be disseminated to the local and research community and the public at large through conference presentations and publication in peer-reviewed journals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No