Sexually Transmitted Diseases, Bacterial Clinical Trial
Official title:
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 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.
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