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

July 24, 2018 updated by: Institute of Tropical Medicine, Belgium

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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

186

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2000
        • Institute of Tropical Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Tropical Medicine, Belgium

Collaborators

Novosanis NV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

August 28, 2015

First Submitted That Met QC Criteria

September 16, 2015

First Posted (Estimate)

September 17, 2015

Study Record Updates

Last Update Posted (Actual)

July 26, 2018

Last Update Submitted That Met QC Criteria

July 24, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1027/15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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