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

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.

Study Overview

• Status: Completed
• Conditions: Sexually Transmitted Diseases
• Intervention / Treatment: Diagnostic test: Click Sexual Health Test

• Study Type: Observational
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Premier Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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

Collaborators and Investigators

• Sponsor: Visby Medical

Publications and helpful links

General Publications

• Dawkins M, Bishop L, Walker P, Otmaskin D, Ying J, Schmidt R, Harnett G, Abraham T, Gaydos CA, Schoolnik G, DiBenedetto K. Clinical Integration of a Highly Accurate Polymerase Chain Reaction Point-of-Care Test Can Inform Immediate Treatment Decisions for Chlamydia, Gonorrhea, and Trichomonas. Sex Transm Dis. 2022 Apr 1;49(4):262-267. doi: 10.1097/OLQ.0000000000001586.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 3, 2019
• Primary Completion (ACTUAL): March 29, 2021
• Study Completion (ACTUAL): March 29, 2021

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: September 18, 2019
• First Posted (ACTUAL): September 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 30, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Sexually Transmitted Diseases
• Other Study ID Numbers: TP-000274

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED