Status:
WITHDRAWN
NOWDx Test for the Diagnosis of Herpes Simplex Virus Type 2
Lead Sponsor:
NOWDiagnostics, Inc.
Conditions:
HSV-2 Infection
Herpes Simplex Virus Infection
Eligibility:
All Genders
18-64 years
Brief Summary
This study is designed to compare the performance of the NOWDx HSV-2 Test to a currently marketed device. The intent is to show the rapid test device is comparable to the currently marketed device. Th...
Detailed Description
The objective of this study is to establish the performance characteristics of the NOWDx HSV-2 Test based on comparison to the HerpeSelect 1 and 2 Immunoblot IgG and HerpeSelect 2 ELISA IgG assays. T...
Eligibility Criteria
Inclusion
- Sexually active persons who self-select for syphilis testing n=750 participants; \~250 per study site Inclusion criteria: sexually active persons 18-64 years old Exclusion criteria: persons \<18 years old; persons \>64 years old; persons with limited or no reading skills; persons who previously participated in a NOWDx study
- Expectant mothers n=90 participants; \~30 per study site Inclusion criteria: expectant mothers ≥18 years old Exclusion criteria: persons \<18 years old; persons with limited or no reading skills; persons who previously participated in a NOWDx study
- Low prevalence population n=201 participants; \~67 per study site Inclusion criteria: persons aged 18-64 years old claiming to lack sexual experience Exclusion criteria: persons \<18 years old; persons \>64 years old; persons with limited or no reading skills; persons who previously participated in a NOWDx study
- Lay users n=48 participants; \~16 per study site Inclusion criteria: persons 18-64 years old; ½ high risk sexual behavior; ½ low risk sexual behavior Exclusion criteria: persons \<18 years old; persons \>64 years old; persons with limited or no reading skills; persons who previously participated in a NOWDx study
Exclusion
Key Trial Info
Start Date :
March 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04294030
Start Date
March 1 2023
End Date
October 31 2023
Last Update
February 29 2024
Active Locations (3)
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1
Clinical Research Consortium
Tempe, Arizona, United States, 85283
2
Clinical Research of South Florida
Coral Gables, Florida, United States, 33134
3
Alliance for Multispecialty Research Lexington
Lexington, Kentucky, United States, 40509