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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Sexually Transmitted Diseases, Bacterial

Intervention / Treatment
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* Device: Colli-Pee


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of several STIs (CT/NG/MG/TV) on urine collected with the Colli-Pee device | 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. | up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Easiness of use of the Colli-Pee device | Using a questionnaire the easiness of use of the Colli-Pee device will be assessed | up to 18 months | 
| Willingness of future use of the Colli-Pee device | Using a questionnaire the willingness of future use of the Colli-Pee device will be assessed. | up to 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colli-Pee, STI, first-void urine