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Completed

NCT Number: NCT02552914

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

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.

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Key information

Conditions

Sexually Transmitted Diseases, Bacterial Bacterial Infections Bacterial Infections and Mycoses Communicable Diseases Disease Attributes Genital Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Institute of Tropical Medicine

Antwerp, 2000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colli-Pee

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Institute of Tropical Medicine, Belgium

Other

Collaborators

  • Novosanis NV

Registry information

Official study 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

Acronym: Colli-Pee

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 17, 2015
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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