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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 6 months

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Group III: Lay usersExperimental Treatment1 Intervention

Group IV: Expectant mothersExperimental Treatment1 Intervention

0 / 1Eligibility criteria met