Clinical trial NCT06566677: Point of Care Rapid STI Test Optimization and Validation Extension
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chlamydia Trachomatis Genital Infection
Gonorrhea
Trichomoniasis
Lead sponsor: Wits RHI Research Centre Clinical Research Site
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2024-08-22
Enrollment: 364
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
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

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.

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

Primary outcomes:
measure: GeneXpert
timeFrame: 1 year
Secondary outcomes:
measure: Osom rapid testing kit
timeFrame: 1 year
Other outcomes:
measure: JD Biotech Trichomonas vaginalis antigen rapid test kit
timeFrame: 1 year
measure: JD Biotech C. Trachomatis/ N. Gonorrhoeae Ag combo rapid test
timeFrame: 1 year
measure: Cromatest Chlamydia one step rapid kit
timeFrame: 1 year
measure: NADAL Chlamydia Test
timeFrame: 1 year
measure: ACRO Biotech Gonorrhoea
timeFrame: 1 year
measure: Rapid Labs Gonorrhea
timeFrame: 1 year
Locations:
city: Hillbrow
country: South Africa
facility: Wits RHI Research Centre
state: Gauteng
Study officials:
References: