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This study is a multi-center study with a minimum of three CLIA-waived intended operator sites in the United States in which prospectively self-collected vaginal specimens obtained from subjects who are symptomatic or asymptomatic for CT, NG, or TV will be evaluated with the Click Sexual Health Test in a Clinical Laboratory Improvement Amendments (CLIA) waived setting. Subjects interested in participating in this study will be assessed for eligibility and asked to give informed consent and assent, if applicable, by the Investigational Review Board (IRB). Only those subjects who meet the inclusion and exclusion criteria may be enrolled in the study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Click Sexual Health Test | Diagnostic Test | The Click 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The percent sensitivity and specificity of the Click Device for detection of CT in self-collected vaginal specimens as compared to Patient Infected Status (PIS) using vaginal specimens collected by a qualified Health Care Provider (HCP) | up to 6 months | |
| The percent sensitivity and specificity of the Click Device for detection of NG in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP | up to 6 months | |
| The percent sensitivity and specificity of the Click Device for detection of TV in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Usability will be measured by 5-point Likert scale responses, yes/no questions, and open text questions from study operators. | Questions are around three domains of interest: i) instructions, ii) operations, and iii) visual interpretation for the Click device for detection of CT, NG, and TV with patient self-collected specimens. The 5-point Likert scale will measure responses to questions in the form of: (1) Strongly Disagree, (2) Disagree, (3) Neutral, (4) Agree, and (5) Strongly Agree |
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Inclusion Criteria:
Exclusion Criteria:
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The study population comprises female subjects greater than or equal to 14 years of age visiting any of the participating clinics for any reason, who may be symptomatic or asymptomatic for STIs at locations including but not limited to: OB/GYN and primary care offices, as well as sexually transmitted disease, teen, public health, and family planning clinics. Any subject who meets the inclusion/exclusion criteria is eligible to participate in this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Therafirst Medical Center | Fort Lauderdale | Florida | 33308 | United States | ||
| Planned Parenthood North Central States |
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| up to 6 months |
| Saint Paul |
| Minnesota |
| 55114 |
| United States |
| Planned Parenthood of the St. Louis Region and Southwest Missouri | St Louis | Missouri | 63108 | United States |
| Lawrence OB/GYN Clinical Research, LLC | Lawrenceville | New Jersey | 08648 | United States |
| Planned Parenthood Gulf Coast | Houston | Texas | 77023 | United States |
| ID | Term |
|---|---|
| D002690 | Chlamydia Infections |
| D006069 | Gonorrhea |
| D014245 | Trichomonas Infections |
| ID | Term |
|---|---|
| D002694 | Chlamydiaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D016870 | Neisseriaceae Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
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