Clinical trial NCT02552914: Evaluation of the Use of the Colli-Pee Device to Collect First-void Urine for Molecular Detection of STIs
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sexually Transmitted Diseases, Bacterial
Keywords: Colli-Pee
STI
first-void urine
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
Collaborators: name: Novosanis NV
First posted: 2015-09-17
Enrollment: 186
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Detection of several STIs (CT/NG/MG/TV) on urine collected with the Colli-Pee device
timeFrame: up to 18 months
Secondary outcomes:
measure: Easiness of use of the Colli-Pee device
timeFrame: up to 18 months
measure: Willingness of future use of the Colli-Pee device
timeFrame: up to 18 months
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Institute of Tropical Medicine
Study officials:
References:
citation: 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.