Evaluation of the Use of the Colli-Pee Device to Collect First-void Urine for Molecular Detection of STIs
NCT ID: NCT02552914
Last Updated: 2018-07-26
Study Results
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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COMPLETED
186 participants
OBSERVATIONAL
2015-09-30
2018-06-30
Brief Summary
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* 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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Colli-Pee
Participants will be asked to use the colli-pee to collect first-void urine and to send it back to the Institute of Tropical Medicine by regular mail.
Eligibility Criteria
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Inclusion Criteria
* Willing to collect first-void urine the next day and to send it back to ITM using regular mail.
Exclusion Criteria
18 Years
MALE
Yes
Sponsors
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Novosanis NV
INDUSTRY
Institute of Tropical Medicine, Belgium
OTHER
Responsible Party
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Locations
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Institute of Tropical Medicine
Antwerp, , Belgium
Countries
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References
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De Baetselier I, Smet H, Abdellati S, De Deken B, Cuylaerts V, Reyniers T, Vuylsteke B, Crucitti T. Evaluation of the 'Colli-Pee', a first-void urine collection device for self-sampling at home for the detection of sexually transmitted infections, versus a routine clinic-based urine collection in a one-to-one comparison study design: efficacy and acceptability among MSM in Belgium. BMJ Open. 2019 Apr 3;9(4):e028145. doi: 10.1136/bmjopen-2018-028145.
Other Identifiers
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1027/15
Identifier Type: -
Identifier Source: org_study_id
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