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

Institute of Tropical Medicine, Belgium

Status

Completed

Conditions

Sexually Transmitted Diseases, Bacterial

Treatments

Device: Colli-Pee

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT02552914

1027/15

Details and patient eligibility

About

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.

Full 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.

Enrollment

186 patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria