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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 186
- Locations
- 1
- Primary Endpoint
- Detection of several STIs (CT/NG/MG/TV) on urine collected with the Colli-Pee device
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
- Not provided
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Willingness of future use of the Colli-Pee device(up to 18 months)
- Easiness of use of the Colli-Pee device(up to 18 months)