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| Name | Class |
|---|---|
| Novosanis NV | INDUSTRY |
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Study objectives:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colli-Pee | Device | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Only participants participating in the Be-PrEP-ared study (EudraCT number: 2015-000054-37) can be enrolled. These are men having sex with men who are at high risk acquiring HIV.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Tropical Medicine | Antwerp | 2000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30948618 | Derived | De Baetselier I, Smet H, Abdellati S, De Deken B, Cuylaerts V, Reyniers T, Vuylsteke B, Crucitti T. Evaluation of the 'Colli-Pee', a first-void urine collection device for self-sampling at home for the detection of sexually transmitted infections, versus a routine clinic-based urine collection in a one-to-one comparison study design: efficacy and acceptability among MSM in Belgium. BMJ Open. 2019 Apr 3;9(4):e028145. doi: 10.1136/bmjopen-2018-028145. |
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| ID | Term |
|---|---|
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003141 | Communicable Diseases |
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First-void urine
| up to 18 months |
| D000091662 |
| Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |