NCT02552914

Evaluation of the Use of the Colli-Pee Device to Collect First-void Urine for Molecular Detection of STIs

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 186 (actual)
• Sponsor: Institute of Tropical Medicine, Belgium · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Sexually Transmitted Diseases, Bacterial

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-05-01
• Completion: 2018-06-01
• First posted: 2015-09-17
• Last updated: 2018-07-26

Locations

1 site across 1 country: Belgium