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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02552914

Acronym

Colli-Pee

Enrollment

186

Registered

2015-09-17

Start date

2015-09-30

Completion date

2018-06-30

Last updated

2018-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sexually Transmitted Diseases, Bacterial

Keywords

Colli-Pee, STI, first-void urine

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.

Interventions

DEVICEColli-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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026