A Healthcare Economic Study of the Click Sexual Health Test

Sexually Transmitted Diseases Clinical Trial

— HERO  

Official title:

A Healthcare Economic Study of the Click Sexual Health Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04099199
• Other study ID #: TP-000274
• Status: Completed
• Start date: December 3, 2019
• Est. completion date: March 29, 2021

Study information

• Verified date: November 2021
• Source: Visby Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: March 29, 2021
• Est. primary completion date: March 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
United States	Premier Health	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Visby Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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.	The scale measures responses to questions in the form of: (1) Strongly Disagree, (2) Disagree, (3) Neutral, (4) Agree, and (5) Strongly agree.	up to 1 month