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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099199
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Visby Medical

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
Sexually Transmitted Diseases Diagnostic Test: Click Sexual Health Test

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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Healthcare Economic Study of the Click Sexual Health Test
Actual Study Start Date : December 3, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Click 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.


Primary Outcome Measures :
  1. Benefits of the Click Device for the detection of CT, NG, and TV in self-collected vaginal specimens as compared to standard of care [ Time Frame: up to 1 month ]
  2. Costs of the Click Device for the detection of CT, NG, and TV in self-collected vaginal specimens as compared to standard of care [ Time Frame: up to 1 month ]
  3. 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 [ Time Frame: up to 1 month ]
  4. Preferences of the Click Device for the detection of CT, NG, and TV in self-collected vaginal specimens as compared to standard of care [ Time Frame: up to 1 month ]
  5. Usability of the Click Device for the detection of CT, NG, and TV in self-collected vaginal specimens as compared to standard of care [ Time Frame: up to 1 month ]
  6. 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 [ Time Frame: up to 1 month ]
  7. 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. [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study population comprises female subjects greater than or equal to 14 years of age who may be symptomatic or asymptomatic for sexually transmitted infections at locations including, but not limited to: physician offices, OB/GYN, emergency department, and urgent care. Any subject who meets the eligibility will be enrolled in the study.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099199


Contacts
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Contact: Paula Walker 669-237-3894 paula.walker@clickdx.com
Contact: Danielle Desjardins danielle.desjardins@clickdx.com

Locations
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United States, Louisiana
Premier Health Recruiting
Baton Rouge, Louisiana, United States, 70809
Sponsors and Collaborators
Visby Medical
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Responsible Party: Visby Medical
ClinicalTrials.gov Identifier: NCT04099199    
Other Study ID Numbers: TP-000274
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female