KCE-181133: Wirksamkeit des STI-Screenings bei MSM - die GonoScreen-Studie

Zusammenfassung (Niederländisch oder Französisch oder Englisch)

Trial Description
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

Status

Open

 

Trial team

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

DOKUMENTE
Protocol  
Report

Q4/2022

Publication

 

REFERENZEN

Clinicaltrials.gov: NCT04269434

Webpage: 

FINANZIERUNGSSCHEMA

2018 Investigator led

Published on: 
2020/06/19