Last reviewed · How we verify
NCT07061912
A Study to Evaluate the Performance of INSTI® HIV Self Test When Performed by Unobserved Intended Users in the US
NA trial testing NSTI® HIV Self-Test in Human Immunodeficiency Virus I Infection in 122 participants. Completed in 6 August 2025.
6 August 2025
Quick facts
| Lead sponsor | bioLytical Laboratories |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | screening |
| Enrollment | 122 |
| Start date | 24 July 2025 |
| Primary completion | 6 August 2025 |
| Estimated completion | 6 August 2025 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- NSTI® HIV Self-Test
Conditions studied
- Human Immunodeficiency Virus I Infection — all drugs for Human Immunodeficiency Virus I Infection →
- Human Immunodeficiency Virus II Infection — all drugs for Human Immunodeficiency Virus II Infection →
Sponsor
bioLytical Laboratories
Who can join
18 and older, any sex, with Human Immunodeficiency Virus I Infection or Human Immunodeficiency Virus II Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this study is to evaluate the performance of INSTI® HIV Self Test with unobserved intended user population. The purpose of this study is to document if a lay person, unassisted by a healthcare worker, is able to perform the INSTI® HIV Self Test correctly and without significant risk of incorrect results. The study aims to evaluate the clinical performance (i.e., diagnostic sensitivity and specificity) of the INSTI® HIV Self-Test in a lay user population.
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 NCT07061912
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Human Immunodeficiency Virus I Infection
Currently open trials in the same condition.
- NCT07530198 — HIV Therapeutic DNA Vaccine (ICVAX) Phase I Clinical Trial in Hong Kong · Phase 1 · recruiting
Other bioLytical Laboratories trials
Trials by the same sponsor.
- 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
- NCT06367621 — Retrospective Study of iStatis Syphilis Ab Test (POC) · 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 NCT07061912 (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: 20 August 2025
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/NCT07061912.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing