A Healthcare Economic Study of the Click Sexual Health Test

NCT04099199 | Completed

• 1 other identifier: TP-000274
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexually Transmitted Diseases

Outcome Measures

Primary Outcomes (7)

• 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

Interventions

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.

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Visby Medical: lead

Study Sites (1)

Premier Health

Baton Rouge, Louisiana, 70809, United States

Location

Related Publications (1)

• 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.

  PMID: 34813579 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 23, 2019
• Study Start: December 3, 2019
• Primary Completion: March 29, 2021
• Study Completion: March 29, 2021
• Last Updated: December 1, 2021

Record last verified: 2021-11

Locations

US (1)