Point of Care Rapid STI Test Optimization and Validation Extension

NCT06566677 | Completed

• 1 other identifier: PROVE
• Study Type: observational
• Target: 364
• Locations: 1 country
• Sites: 1

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.

Conditions

Chlamydia Trachomatis Genital Infection; Gonorrhea; Trichomoniasis

Outcome Measures

Primary Outcomes (1)

• GeneXpert

  A PCR instrument was used to assess the presence of chlamydia trichomatis and gonorrhea from samples taken using endocervical swabs.

  1 year

Secondary Outcomes (1)

• Osom rapid testing kit

  1 year

Other Outcomes (6)

• JD Biotech Trichomonas vaginalis antigen rapid test kit

  1 year

• JD Biotech C. Trachomatis/ N. Gonorrhoeae Ag combo rapid test

  1 year

• Cromatest Chlamydia one step rapid kit

  1 year

Eligibility Criteria

• Age: 18 Years - 25 Years
• Gender Eligibility Details: Cisgender females.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wits RHI Research Centre Clinical Research Site: lead
• University of Washington: collaborator

Study Sites (1)

Wits RHI Research Centre

Hillbrow, Gauteng, 2038, South Africa

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biological specimens such as blood and vaginal fluid will be used to validate commercially available point of care diagnostic STI tests for Neisseria gonorrhoea (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV) as well as other STIs where applicable.

MeSH Terms

Conditions

Gonorrhea; Trichomonas Infections

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Protozoan Infections; Parasitic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Trials

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 22, 2024
• Study Start: January 26, 2023
• Primary Completion: December 7, 2023
• Study Completion: December 7, 2023
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)