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Diagnostic Test

Sexually active persons who self-select for HSV-2 testing for Genital Herpes

N/A
Waitlist Available
Led By Beth Cobb
Research Sponsored by NOWDiagnostics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 6 months
Awards & highlights

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. The NOWDx HSV-2 Test is intended for qualitatively detecting the presence or absence of human Immunoglobulin G (IgG) class antibodies to HSV-2 in human whole blood to aid in the diagnosis of infection caused by herpes simplex virus type 2 (HSV-2).

Eligible Conditions
  • Genital Herpes
  • Herpes

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Compare NOWDx HSV-2 Test result to comparator method lab result to assess sensitivity and specificity of investigational device.
Secondary study objectives
Compare results of NOWDx HSV-2 Tests conducted by lay users with expected results to evaluate test reproducibility by lay users.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Sexually active persons who self-select for HSV-2 testingExperimental Treatment1 Intervention
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
Group II: Low prevalence populationExperimental Treatment1 Intervention
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
Group III: Lay usersExperimental Treatment1 Intervention
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
Group IV: Expectant mothersExperimental Treatment1 Intervention
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

Find a Location

Who is running the clinical trial?

NOWDiagnostics, Inc.Lead Sponsor
3 Previous Clinical Trials
1,714 Total Patients Enrolled
Beth CobbPrincipal InvestigatorNOW Diagnostics, Inc.
2 Previous Clinical Trials
1,585 Total Patients Enrolled
~0 spots leftby Sep 2025
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