NOWDx Test for the Diagnosis of Syphilis | NCT05063344 | Trialant

NOWDx Test for the Diagnosis of Syphilis | NCT05063344 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Diagnostic Test: NOWDx Syphilis Test	Device	For this observational trial, the Intervention of interest is the NOWDx Syphilis Test.	Expectant mothers Lay users

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Contacts/Locations Module

Condition Browse Module