WithdrawnNot Applicable

NOWDx Test for the Diagnosis of Herpes Simplex Virus Type 2

Stopped: Deprioritized by Sponsor

United States0Started 2023-03-01

Plain-language 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).

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Compare NOWDx HSV-2 Test result to comparator method lab result to assess sensitivity and specificity of investigational device.

Timeframe: through study completion, an average of 6 months

Trial details

NCT IDNCT04294030

SponsorNOWDiagnostics, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-10-31

View on ClinicalTrials.gov More HSV-2 Infection trials