Sexually Transmitted Diseases
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTClick Sexual Health Test
The Click Diagnostics device is a single-use (disposable), fully integrated, rapid, compact, device containing a polymerase chain reaction (PCR)-based nucleic acid amplification test (NAAT) for accurate, qualitative detection and differentiation of deoxyribonucleic acid (DNA) for Neisseria gonorrhea (NG), Trichomonas vaginalis (TV), and Chlamydia trachomatis (CT) organisms.
Sponsors
Visby Medical
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
14 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Benefits of the Click Device for the detection of CT, NG, and TV in self-collected vaginal specimens as compared to standard of care | up to 1 month | — |
| Costs of the Click Device for the detection of CT, NG, and TV in self-collected vaginal specimens as compared to standard of care | up to 1 month | — |
| Cost-effectiveness of the Click Device for the detection of CT, NG, and TV in self-collected vaginal specimens as compared to standard of care | up to 1 month | — |
| Preferences of the Click Device for the detection of CT, NG, and TV in self-collected vaginal specimens as compared to standard of care | up to 1 month | — |
| Usability of the Click Device for the detection of CT, NG, and TV in self-collected vaginal specimens as compared to standard of care | up to 1 month | — |
| Accuracy of treatment/no treatment decisions in light of the outcomes of testing for CT, NG, and TV infections by Click device as compared to standard of care | up to 1 month | — |
| Usability and Satisfaction will be measured by 5-point Likert scale responses, yes/no questions, and open-text questions from study subjects, study operators, and healthcare providers. | up to 1 month | The scale measures responses to questions in the form of: (1) Strongly Disagree, (2) Disagree, (3) Neutral, (4) Agree, and (5) Strongly agree. |
Countries
United States
Outcome results
None listed