Evaluation of the Use of the Colli-Pee Device to Collect First-void Urine for Molecular Detection of STIs
Colli-Pee
1 other identifier
observational
186
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedFirst Posted
Study publicly available on registry
September 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedJuly 26, 2018
July 1, 2018
2.7 years
August 28, 2015
July 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Detection of several STIs (CT/NG/MG/TV) on urine collected with the Colli-Pee device
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 Outcomes (2)
Easiness of use of the Colli-Pee device
up to 18 months
Willingness of future use of the Colli-Pee device
up to 18 months
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institute of Tropical Medicine, Belgiumlead
- Novosanis NVcollaborator
Study Sites (1)
Institute of Tropical Medicine
Antwerp, 2000, Belgium
Related Publications (1)
De Baetselier I, Smet H, Abdellati S, De Deken B, Cuylaerts V, Reyniers T, Vuylsteke B, Crucitti T. Evaluation of the 'Colli-Pee', a first-void urine collection device for self-sampling at home for the detection of sexually transmitted infections, versus a routine clinic-based urine collection in a one-to-one comparison study design: efficacy and acceptability among MSM in Belgium. BMJ Open. 2019 Apr 3;9(4):e028145. doi: 10.1136/bmjopen-2018-028145.
PMID: 30948618DERIVED
Biospecimen
First-void urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2015
First Posted
September 17, 2015
Study Start
September 1, 2015
Primary Completion
May 1, 2018
Study Completion
June 1, 2018
Last Updated
July 26, 2018
Record last verified: 2018-07