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OpenTrials
Completed

NCT Number: NCT04099199

A Healthcare Economic Study of the Click Sexual Health Test

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.

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Key information

Conditions

Sexually Transmitted Diseases Communicable Diseases Disease Attributes Genital Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases

Age range

14 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Premier Health

Baton Rouge, Louisiana, 70809, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Click Sexual Health Test

Diagnostic 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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Visby Medical

Industry

Registry information

Acronym: HERO

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 23, 2019
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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