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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

Tracking Information
First Submitted Date September 12, 2019
First Posted Date September 23, 2019
Last Update Posted Date May 19, 2020
Actual Study Start Date December 3, 2019
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 18, 2019)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Healthcare Economic Study of the Click Sexual Health Test
Official Title A Healthcare Economic Study of the Click Sexual Health Test
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Sexually Transmitted Diseases
Intervention 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 18, 2019)
240
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 14 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Paula Walker 669-237-3894 paula.walker@clickdx.com
Contact: Danielle Desjardins danielle.desjardins@clickdx.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04099199
Other Study ID Numbers TP-000274
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Visby Medical
Study Sponsor Visby Medical
Collaborators Not Provided
Investigators Not Provided
PRS Account Visby Medical
Verification Date September 2019