Zusammenfassung (Niederländisch oder Französisch oder Englisch)
| Title |
Does screening for gonorrhea and chlamydia reduce the incidence of these infections in men who have sex with men taking HIV pre exposure prophylaxis (PrEP): a randomized, multicentre controlled trial |
|
Participants (P) |
PrEP cohorts situated at the Institute of Tropical Medicine (ITM), Hôpital Saint-Pierre (HSP), University Hospital of Gent (UZG), Erasmus Hospital (EH) and Liège University Hospital (CHU). All men in follow up at these five centres who report having had sex with another man in the previous year and are enrolled for PrEP follow up will be eligible to participate in the study. |
|
Intervention (I) |
Participants in the intervention arm will not be screened for Ng/Ct for a period of 12 months, in reference to the routine practice of screening (and treating screening-positive) participants every 3 months. More specifically, participants in the intervention arm will have 3 site (urethra, pharynx and rectum) sampling performed every 3 months but these testing results will only be reported at the end of the 12 month period. |
|
Control (C) |
For a period of 12 months, all participants will be screened for Ng/Ct at three sites (urethra, pharynx and rectum) every three months according to current Belgian guidelines. If they test positive, they will be recalled for treatment for Ng/Ct and contact tracing. |
|
Outcome (O) |
Incidence rate of Ng plus Ct detected at any site whilst individuals are screened vs. not screened. |
|
Trial Design |
Multicentre, controlled, randomized trial of 3 site (urethra, pharynx and rectum) sampling performed every 3 months (3x3) for Neisseria gonorrhoea (Ng)/Chlamydia trachomatis (Ct) screening (comparator) vs. no screening (intervention) |
|
Sample Size |
1014 participants |
|
Trial duration |
26 months |
|
Budget |
€1 620 000 |
|
Sponsor |
Institute for Tropical Medicine |
|
Chief Investigator |
Chris Kenyon |
|
Participating Investigators |
Chris Kenyon, ITM, Antwerp Sophie Henrard, Hôpital Erasme, Bxl Agnes Libois , CHU St Pierre, Bxl Diana Huis in ’t Veld, UZ Gent Anne-Sophie Sauvage, CHU Liège |
| Protocol | Download protocol |
| Results | View publication The Lancet HIV |
For timelines and recruitment, see dashboard
Clinicaltrials.gov: NCT04269434
Webpage:
2018 Investigator led
