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Trial record 6 of 182 for:    chlamydia infection | "Sexually Transmitted Diseases"

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

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ClinicalTrials.gov Identifier: NCT02552914
Recruitment Status : Completed
First Posted : September 17, 2015
Last Update Posted : July 25, 2018
Sponsor:
Collaborator:
Novosanis NV
Information provided by (Responsible Party):
Institute of Tropical Medicine, Belgium

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.

Condition or disease Intervention/treatment
Sexually Transmitted Diseases, Bacterial Device: Colli-Pee

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
Actual Enrollment : 186 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : September 2015
Actual Primary Completion Date : May 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
First-void urine


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02552914


Locations
Belgium
Institute of Tropical Medicine
Antwerp, Belgium, 2000
Sponsors and Collaborators
Institute of Tropical Medicine, Belgium
Novosanis NV

Responsible Party: Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier: NCT02552914     History of Changes
Other Study ID Numbers: 1027/15
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018

Keywords provided by Institute of Tropical Medicine, Belgium:
Colli-Pee
STI
first-void urine

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Bacterial
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female
Bacterial Infections