A Healthcare Economic Study of the Click Sexual Health Test

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-03

Study Completion Date

2021-03-29

Brief Summary

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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

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Conditions

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Sexually Transmitted Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

14 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Locations

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Premier Health

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED

PMID: 34813579 (View on PubMed)

Other Identifiers

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TP-000274

Identifier Type: -

Identifier Source: org_study_id