A Healthcare Economic Study of the Click Sexual Health Test (HERO)

Visby Medical

Status: Completed

Conditions: Sexually Transmitted Diseases

Treatments: Diagnostic Test: Click Sexual Health Test

Study type: Observational

Funder types: Industry

Identifiers

NCT04099199

TP-000274

Details and patient eligibility

About

This is a multicenter study with a minimum of three CLIA-Waived intended operator sites in which prospectively collected vaginal swab specimens will be evaluated with the Click Sexual Health Test as compared to standard of care. The specimen collection will occur over one study visit for each enrolled subject, but study staff will continue to follow the subject through standard of care until the subject receives treatment or she is lost to follow up.

Enrollment: 59 patients

Sex: Female

Ages: 14+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Documentation that the subject has provided informed consent prior to conducting study procedures
• Subject is symptomatic or asymptomatic for sexually transmitted infections
• Subject is female and 14 years of age or older at the time of enrollment
• Able and willing to follow study procedures

Exclusion criteria

• Subject has been previously enrolled in the study
• Subject has a contraindication, medical condition, serious intercurrent illness or other circumstance that in the investigator's judgement, could jeopordize the subject's safety or could interfere with the study procedures
• Use of antiperspirants and deodorants or the following vaginal products: douches, washes, lubricants, vaginal wipes, vaginal moisturizers, or feminine hygiene spray in the genital area, within 48 hours prior to enrollment.