NCT04294030

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. 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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
3 years until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

8 months

First QC Date

March 1, 2020

Last Update Submit

February 28, 2024

Conditions

HSV-2 InfectionHerpes Simplex Virus Infection

Keywords

HSV-2Genital Herpes

Outcome Measures

Primary Outcomes (1)

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

    The results should be presented as sensitivity and specificity as compared to the comparator method and should have a point estimate of 95% with a lower bound of the two-sided 95% confidence interval of 90%.

    through study completion, an average of 6 months

Secondary Outcomes (1)

  • Compare results of NOWDx HSV-2 Tests conducted by lay users with expected results to evaluate test reproducibility by lay users.

    through study completion, an average of 6 months

Study Arms (4)

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

Device: Diagnostic Test: 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

Device: Diagnostic Test: 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

Device: Diagnostic Test: 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

Device: Diagnostic Test: NOWDx HSV-2 Test

Interventions

Diagnostic Test: NOWDx HSV-2 TestDEVICE

For this observational trial, the intervention of interest is the NOWDx HSV-2 Test.

Expectant mothersLay usersLow prevalence populationSexually active persons who self-select for HSV-2 testing

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Residents of the U.S. who elect to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Clinical Research Consortium

Tempe, Arizona, 85283, United States

Location

Clinical Research of South Florida

Coral Gables, Florida, 33134, United States

Location

Alliance for Multispecialty Research Lexington

Lexington, Kentucky, 40509, United States

Location

MeSH Terms

Conditions

Herpes SimplexHerpes Genitalis

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGenital Diseases, MaleMale Urogenital Diseases

Study Officials

  • Beth Cobb

    NOW Diagnostics, Inc.

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2020

First Posted

March 3, 2020

Study Start

March 1, 2023

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

February 29, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(3)