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NCT06566677: PROVE

Point of Care Rapid STI Test Optimization and Validation Extension

Completed Last updated 26 August 2024
What this trial tests

trial in Chlamydia Trachomatis Genital Infection in 364 participants. Completed in 7 December 2023.

Timeline
26 January 2023
Primary endpoint
7 December 2023
7 December 2023

Quick facts

Lead sponsorWits RHI Research Centre Clinical Research Site
StatusCompleted
Study typeOBSERVATIONAL
Enrollment364
Start date26 January 2023
Primary completion7 December 2023
Estimated completion7 December 2023
Sites1 location across South Africa

Conditions studied

Sponsor

Wits RHI Research Centre Clinical Research Site

Who can join

Adults 18 to 25, female only, with Chlamydia Trachomatis Genital Infection or Gonorrhea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Validation of Rapid Point-of-Care Diagnostic Tests for Sexually Transmitted Infection Self-Testing Among Adolescent Girls and Young Women.
    Reddy K, Hao J, Sigcu N, Govindasami M, et al · · 2025 · cited 1× · PMID 40647603 · DOI 10.3390/diagnostics15131604

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06566677.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing