Evaluation of the Use of the Colli-Pee Device to Collect First-void Urine for Molecular Detection of STIs (Colli-Pee)
|ClinicalTrials.gov Identifier: NCT02552914|
Recruitment Status : Active, not recruiting
First Posted : September 17, 2015
Last Update Posted : March 1, 2018
- 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.
|Condition or disease||Intervention/treatment|
|Sexually Transmitted Diseases, Bacterial||Device: Colli-Pee|
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.
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 Type :||Observational|
|Actual Enrollment :||186 participants|
|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|
|Actual Study Start Date :||September 2015|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||August 2018|
- 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.
- 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.
- 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.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02552914
|Institute of Tropical Medicine|
|Antwerp, Belgium, 2000|