- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02552914
Evaluation of the Use of the Colli-Pee Device to Collect First-void Urine for Molecular Detection of STIs (Colli-Pee)
Evaluation of the Use of the Colli-Pee Device to Collect First-void Urine for Molecular Detection of Several Sexual Transmitted Infections, Including Reproducibility of the Test Results and Acceptability by MSM Participating in a PrEP Study
Study objectives:
- To evaluate the usability of the Colli-PeeTM device to collect first-void urine for nucleic acid detection of Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis and Mycoplasma genitalium.
- To collect feedback on the easiness of use and the willingness of future use of the Colli-PeeTM device.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study population:
The Colli-Pee study is a sub-study of the Be-PrEP-ared study (EudraCT number: 2015-000054-37). All participants who participate in the Be-PrEP-ared study will be asked to participate in this sub-study.
Study design:
Participants who agree to be included in this study will be asked to collect first-void urine using the Colli-PeeTM device the day after the baseline, month 6, month 12 and month 18 visit. They will be asked to send the urine container back to ITM using regular mail. In addition they will also be asked to complete a small questionnaire concerning the easiness of use and the willingness of future use of the Colli-PeeTM device at the enrolment visit and final visit of the Be-PrEP-ared study.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Antwerp, Belgium, 2000
- Institute of Tropical Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Participating in the Be-PrEP-ared study
- Willing to collect first-void urine the next day and to send it back to ITM using regular mail.
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detection of several STIs (CT/NG/MG/TV) on urine collected with the Colli-Pee device
Time Frame: up to 18 months
|
To evaluate the use of the Colli-Pee device to collect first-void urine for nucleic acid detection of Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis and Mycoplasma genitalium.
|
up to 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Easiness of use of the Colli-Pee device
Time Frame: up to 18 months
|
Using a questionnaire the easiness of use of the Colli-Pee device will be assessed
|
up to 18 months
|
Willingness of future use of the Colli-Pee device
Time Frame: up to 18 months
|
Using a questionnaire the willingness of future use of the Colli-Pee device will be assessed.
|
up to 18 months
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1027/15
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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