Clinical trial NCT04099199: A Healthcare Economic Study of the Click Sexual Health Test
Official title: A Healthcare Economic Study of the Click Sexual Health Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sexually Transmitted Diseases
Lead sponsor: Visby Medical
Sponsor class: INDUSTRY
First posted: 2019-09-23
Enrollment: 59
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Benefits of the Click Device for the detection of CT, NG, and TV in self-collected vaginal specimens as compared to standard of care
timeFrame: up to 1 month
measure: Costs of the Click Device for the detection of CT, NG, and TV in self-collected vaginal specimens as compared to standard of care
timeFrame: up to 1 month
measure: 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
timeFrame: up to 1 month
measure: Preferences of the Click Device for the detection of CT, NG, and TV in self-collected vaginal specimens as compared to standard of care
timeFrame: up to 1 month
measure: Usability of the Click Device for the detection of CT, NG, and TV in self-collected vaginal specimens as compared to standard of care
timeFrame: up to 1 month
measure: 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
timeFrame: up to 1 month
measure: 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.
timeFrame: up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Premier Health
state: Louisiana
Study officials:
References:
citation: 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.