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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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 Acceptabil

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 Summary:

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.


Sponsor: Institute of Tropical Medicine, Belgium

Current Primary Outcome: 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.


Original Primary Outcome: Detection of several STIs (CT/NG/MG/TV) on urine collected with the Colli-Pee device [ Time Frame: up to 30 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.


Current Secondary Outcome:

  • Easiness of use of the Colli-Pee device [ Time Frame: up to 18 months ]
    Using a questionnaire the easiness of use of the Colli-Pee device will be assessed
  • Willingness of future use of the Colli-Pee device [ Time Frame: up to 18 months ]
    Using a questionnaire the willingness of future use of the Colli-Pee device will be assessed.


Original Secondary Outcome:

  • Easiness of use of the Colli-Pee device [ Time Frame: up to 30 months ]
    Using a questionnaire the easiness of use of the Colli-Pee device will be assessed
  • Willingness of future use of the Colli-Pee device [ Time Frame: up to 30 months ]
    Using a questionnaire the willingness of future use of the Colli-Pee device will be assessed.


Information By: Institute of Tropical Medicine, Belgium

Dates:
Date Received: August 28, 2015
Date Started: September 2015
Date Completion: March 2018
Last Updated: March 1, 2017
Last Verified: March 2017