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

Sexually Transmitted Diseases, Bacterial Clinical Trial

— Colli-Pee  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02552914
• Other study ID #: 1027/15
• Status: Completed
• Start date: September 2015
• Est. completion date: June 2018

Study information

• Verified date: July 2018
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: June 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Sexually Transmitted Diseases
• Sexually Transmitted Diseases, Bacterial

Intervention

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.

Locations

Country	Name	City	State
Belgium	Institute of Tropical Medicine	Antwerp

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Tropical Medicine, Belgium	Novosanis NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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