Last reviewed · How we verify
NCT06357819
INSTI® HCV (Hepatitis C Virus) Antibody Self-Test Contrived Result Interpretation
trial testing INSTI HCV Self Test in Hepatitis C in 405 participants. Completed in 17 December 2023.
17 December 2023
Quick facts
| Lead sponsor | bioLytical Laboratories |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 405 |
| Start date | 12 October 2023 |
| Primary completion | 17 December 2023 |
| Estimated completion | 17 December 2023 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- INSTI HCV Self Test
Conditions studied
- Hepatitis C — all drugs for Hepatitis C →
Sponsor
bioLytical Laboratories
Who can join
18 and older, any sex, with Hepatitis C. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this Interpretation Assessment was to document if "lay" people, non-professional and inexperienced in self-testing, were able to successfully perform the steps to use a Hepatitis C Virus (HCV) Self-Test (HCVST) device, without product familiarization \[demonstration\].
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06357819
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of INSTI HCV Self Test
Trials testing the same drug.
- NCT06369116 — Trial of Hepatitis C Self-Testing in the Hands of Untrained Lay Users · NA · completed
Other recruiting trials for Hepatitis C
Currently open trials in the same condition.
- NCT06263829 — HCV Tappt Adherence Study · NA · recruiting
- NCT06179498 — Partner Navigation Intervention for Hepatitis C Treatment Among Young People Who Inject Drugs · NA · recruiting
- NCT06367465 — Feasibility and Acceptability of HCV Treatment in Pregnancy · recruiting
- NCT05668780 — Buprenorphine Integration Research and Community Health · NA · active not recruiting
- NCT05208697 — Tele-Harm Reduction · NA · active not recruiting
Other bioLytical Laboratories trials
Trials by the same sponsor.
- NCT07061912 — A Study to Evaluate the Performance of INSTI® HIV Self Test When Performed by Unobserved Intended Users in the US · NA · completed
- NCT06368453 — A Study to Evaluate the Performance, Usability, and Result Interpretation of INSTI® HIV Self-Test · NA · completed
- NCT06368466 — A Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Sites · NA · completed
- NCT06368479 — Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Site Settings · NA · completed
- NCT06365606 — Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis Syphilis Ab Test at the Point- Of-Care Sites · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06357819 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by bioLytical Laboratories
- Last refreshed: 10 April 2024
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/NCT06357819.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing