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This is a multi-center study in which the performance of the Visby Medical Men's Sexual Health Test is evaluated when run by male subjects of 14 years of age and older on self-collected first catch urine samples using the audio-visual instructions provided by the Visby App and/or written instructions provided by the printed User Instructions.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visby Medical Men's STI PCR Test Kit | Diagnostic Test | The Visby Medical Men's STI PCR Test is a single use (disposable), automated PCR (Polymerase Chain Reaction) in vitro diagnostic self-test for the rapid detection and differentiation of DNA from Chlamydia trachomatis and Neisseria gonorrhoeae in male urine specimens. This test is intended to be sold over the counter (OTC) for use by males suspected of sexually transmitted infection with Chlamydia trachomatis and Neisseria gonorrhoeae. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Objective | Evaluate the performance of the Visby test when run by male subjects ≥ 14 years of age, on self-collected first catch urine sample using the audio-visual instructions provided by the Visby App and/or written instructions provided by the printed User Instructions. | up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of subjects with a penis ≥14 years of age who are symptomatic or asymptomatic for sexual transmitted infections (STIs). Subjects will be classified as symptomatic if they report unusual urethral discharge, painful urination, testicular or scrotal pain/swelling, increased urinary frequency, pain or bleeding during sex/intercourse within 7 days prior to enrollment.
To better represent the end users of this product, subjects not actively seeking health care will be recruited into the study with the goal that ~30% of subjects would fall in this category.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington, Virology Research Clinic | Recruiting | Seattle | Washington | 98104 | United States |
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| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |