~0 spots leftby Apr 2026

Rapid Diagnostics for HIV and Hepatitis

Recruiting in Palo Alto (17 mi)
+3 other locations
Overseen byEugene Schiff, MD
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: MedMira Laboratories Inc.
No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the efficacy of two rapid diagnostic tests in plasma, venipuncture whole blood, and fingerstick whole blood. The clinical performance of Multiplo HBc/HIV/HCV will be determined by comparing the results with patient infected status for HIV-1/2 (human immunodeficiency viruses 1 and 2), HBV (hepatitis B virus) and HCV (hepatitis C virus). The clinical performance of Reveal HBsAg will be determined by comparing the results with patient infected status for HBV. Subject participation in the study will consist of a single one-hour visit, at which time blood samples will be drawn for testing with the investigational devices and with approved comparator assays. The test results, which are the outcome of the study, will be obtained only once, at the time of this visit.

Eligibility Criteria

Inclusion Criteria

13 years of age or older
able to sign consent form (or parent/guardian sign consent plus subject sign assent for ages 13-18)
willing to complete the risk assessment questionnaire,
See 7 more

Treatment Details

Interventions

  • Multiplo HBc/HIV/HCV (Diagnostic Test)
  • Reveal HBsAg (Diagnostic Test)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Diagnostic: Multiplo HBc/HIV/HCV + Reveal HBsAgExperimental Treatment1 Intervention
Subjects tested with investigational devices and approved comparator assay algorithms for HIV and hepatitis B and C.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Keck School of Medicine - LAUSCLos Angeles, CA
NYC Dept Health & Mental HygieneNew York, NY
SCFLD Hepatology Diagnostic Research LaboratoryMiami, FL
Minneapolis Medical Research FoundationMinneapolis, MN
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Who Is Running the Clinical Trial?

MedMira Laboratories Inc.Lead Sponsor

References