Sexually Transmitted DiseasesHERONCT04099199
A Healthcare Economic Study of the Click Sexual Health Test
An observational study of Sexually Transmitted Diseases, run by Visby Medical at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Diseases
- What is being tested?
- Click Sexual Health Test
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2019to 29 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Click Sexual Health Test
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Click Sexual Health TestDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Benefits of the Click Device for the detection of CT, NG, and TV in self-collected vaginal specimens as compared to standard of care
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start3 Dec 2019
- Primary completion29 Mar 2021
- Study completion29 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Visby Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099199
- Sponsor's protocol ID
- TP-000274
- Acronym
- HERO
- Status last verified
- Nov 2021
- First submitted
- 12 Sep 2019
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 34813579
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Healthcare Economic Study of the Click Sexual Health Test
- ClinicalTrials.gov ID
- NCT04099199
- Acronym / sponsor ID
- HERO / TP-000274
- Conditions
- Sexually Transmitted Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Visby MedicalIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 29 Mar 2021 (actual)
- Study completion
- 29 Mar 2021 (actual)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Click Sexual Health TestThe 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. | Diagnostic test | – |
Primary outcome
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
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
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
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
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Derived from this study: PubMed 34813579Dawkins 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexually Transmitted Diseases, run by Visby Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: up to 1 month). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04099199, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.