HERO: A Healthcare Economic Study of the Click Sexual Health Test
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Documentation that the subject has provided informed consent prior to conducting study procedures
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Subject is symptomatic or asymptomatic for sexually transmitted infections
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Subject is female and 14 years of age or older at the time of enrollment
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Able and willing to follow study procedures
Exclusion Criteria:
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Subject has been previously enrolled in the study
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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
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Premier Health | Baton Rouge | Louisiana | United States | 70809 |
Sponsors and Collaborators
- Visby Medical
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TP-000274