NCT05063344

Brief Summary

This study is designed to compare the performance of the NOWDx Syphilis Test to a currently marketed device. The intent is to show the rapid test device is comparable to the currently marketed device. The NOWDx Syphilis Test is intended for qualitatively detecting the presence or absence of human antibodies to syphilis in human whole blood to aid in the diagnosis of infection caused by Treponema pallidum.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,535

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
completed

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
1.6 years until next milestone

First Posted

Study publicly available on registry

October 1, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

October 4, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2023

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

March 1, 2020

Last Update Submit

February 28, 2024

Conditions

Syphilis InfectionTreponema Pallidum Infection

Keywords

SyphilisTreponema Pallidum

Outcome Measures

Primary Outcomes (2)

  • Compare serological status to comparator method

    The comparator method used in this study is an algorithm comprised of results from three different commercially available syphilis assays: an FDA-cleared treponemal immunoassay, an FDA-cleared non-treponemal assay (RPR assay) and a second treponemal assay (TP-PA).

    through study completion, an average of 6 months

  • Evaluate test reproducibility by lay users

    Test lay user reproducibility using prepared samples for % agreement with expected results.

    through study completion, an average of 6 months

Study Arms (3)

Sexually active persons who self-select for syphilis 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 Syphilis 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 Syphilis 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 and 1/2 low risk sexual behavior

Device: Diagnostic Test: NOWDx Syphilis Test

Interventions

Diagnostic Test: NOWDx Syphilis TestDEVICE

For this observational trial, the Intervention of interest is the NOWDx Syphilis Test.

Expectant mothersLay usersSexually active persons who self-select for syphilis 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

You may qualify if:

  • \- sexually active persons 18-64 years old

You may not qualify if:

  • 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=222 participants; \~74 per study site
  • \- expectant mothers ≥18 years old
  • persons \<18 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
  • persons 18-64 years old;
  • ½ high risk sexual behavior; ½ low risk sexual behavior
  • persons \<18 years old; persons \>64 years old;
  • persons with limited or no reading skills;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

AMR Tempe

Tempe, Arizona, 85281, United States

Location

Matrix Clinical Research

Los Angeles, California, 90057, United States

Location

Segal Trials

North Miami, Florida, 33161, United States

Location

AMR Las Vegas

Las Vegas, Nevada, 89119, United States

Location

People Care Institute

West Orange, New Jersey, 07052, United States

Location

Multicare Rockwood

Cheney, Washington, 99004, United States

Location

MeSH Terms

Conditions

SyphilisTreponemal Infections

Condition Hierarchy (Ancestors)

Spirochaetales InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesCommunicable DiseasesGenital DiseasesUrogenital Diseases

Study Officials

  • Sharon Rabine, MS

    NOW Diagnostics, Inc.

    STUDY DIRECTOR

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

October 1, 2021

Study Start

October 4, 2021

Primary Completion

October 17, 2023

Study Completion

December 11, 2023

Last Updated

February 29, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(6)