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

Completed

• Conditions: Sexually Transmitted Diseases, Bacterial

• Registration Number: NCT02552914
• Lead Sponsor: Institute of Tropical Medicine, Belgium

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 Timeline

• Study First Submitted: 2015-08-28
• Study Start: 2015-09
• Study First Submitted QC: 2015-09-16
• Study First Posted: 2015-09-17
• Primary Completion: 2018-05
• Study Completion: 2018-06
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-24
• Last Update Posted: 2018-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 186

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of several STIs (CT/NG/MG/TV) on urine collected with the Colli-Pee device	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 Outcome Measures

Name	Time	Method
Willingness of future use of the Colli-Pee device	up to 18 months	Using a questionnaire the willingness of future use of the Colli-Pee device will be assessed.
Easiness of use of the Colli-Pee device	up to 18 months	Using a questionnaire the easiness of use of the Colli-Pee device will be assessed

Trial Locations

Locations (1)

Institute of Tropical Medicine; 🇧🇪 Antwerp, Belgium