NOWDx Test for the Diagnosis of Herpes Simplex Virus Type 2
NCT ID: NCT04294030
Last Updated: 2024-02-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2023-03-01
2023-10-31
Brief Summary
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Detailed Description
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The external clinical study along with in-house analytical studies will demonstrate the efficacy of the NOWDx HSV-2 Test as an aid in the diagnosis of HSV-2 infection for at home testing and point of care testing sites. Participants will self test and be tested by Clinical Laboratory Improvement Amendments (CLIA) Waived operators with the NOWDx HSV-2 Test at independent sites in Florida, Kentucky, and Arizona.
Two sample types will be tested with the NOWDx HSV-2 Test for each participant: capillary whole blood and venous whole blood. Sera from each participant will be tested at an independent reference laboratory.
The NOWDx HSV-2 Test will be evaluated in diverse populations of sexually active persons who self-select for genital herpes testing, expectant mothers, and persons claiming to lack sexual experience.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Sexually active persons who self-select for HSV-2 testing
Participants must be a mixture of English and Spanish speaking, geographically diverse, gender diverse, ethnically and racially diverse, economically diverse, and with different levels of education; 18-64 years
Diagnostic Test: NOWDx HSV-2 Test
For this observational trial, the intervention of interest is the NOWDx HSV-2 Test.
Expectant mothers
Participants must be a mixture of English and Spanish speaking, geographically diverse, gender diverse, ethnically and racially diverse, economically diverse, and with different levels of education; 18-64 years
Diagnostic Test: NOWDx HSV-2 Test
For this observational trial, the intervention of interest is the NOWDx HSV-2 Test.
Low prevalence population
Participants must be a mixture of English and Spanish speaking, geographically diverse, gender diverse, ethnically and racially diverse, economically diverse, and with different levels of education; 18-64 years
Diagnostic Test: NOWDx HSV-2 Test
For this observational trial, the intervention of interest is the NOWDx HSV-2 Test.
Lay users
Participants must be a mixture of English and Spanish speaking, geographically diverse, gender diverse, ethnically and racially diverse, economically diverse, and with different levels of education; 18-64 years; 1/2 high risk sexual behavior; 1/2 low risk sexual behavior
Diagnostic Test: NOWDx HSV-2 Test
For this observational trial, the intervention of interest is the NOWDx HSV-2 Test.
Interventions
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Diagnostic Test: NOWDx HSV-2 Test
For this observational trial, the intervention of interest is the NOWDx HSV-2 Test.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
64 Years
ALL
No
Sponsors
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NOWDiagnostics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Beth Cobb
Role: PRINCIPAL_INVESTIGATOR
NOW Diagnostics, Inc.
Locations
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Clinical Research Consortium
Tempe, Arizona, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
Alliance for Multispecialty Research Lexington
Lexington, Kentucky, United States
Countries
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Other Identifiers
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NOWDx HSV-2 Study
Identifier Type: -
Identifier Source: org_study_id
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