GonoScreen: Efficacy of Screening STIs in MSM

Not Applicable

Completed

Brief Summary: A 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).

Detailed Description: This study is a multicentre, controlled, randomized trial of 3x3 Ng/Ct screening (comparator) vs. no screening (intervention). It will be performed in the PrEP cohorts situated at the Institute of Tropical Medicine (ITM), Hôpital Saint-Pierre (HSP), Liège University Hospital (CHU), University Hospital of Gent (UZG) and Erasmus Hospital (EH). 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. After signing informed consent participants will be randomized via a computer-generated schema to either 3x3 screening or no Ng/Ct screening. In both arms, participants will be followed up in an identical fashion including 3x3 screening. The only difference between the arms will be that in the screening arm, Ng/Ct results will be sent by the STI Laboratory to the study physicians and these participants will be treated and partner contact tracing will be done. The Sexually Transmitted Infection (STI) Laboratory will only process the samples/report the results from the non-screening arm at the end of the study. In both arms, all individuals with symptoms compatible with Ng or Ct will be tested and treated for these infections according to current best practice guidelines. At the end of the 12-month study period, participants whose most recent tests were positive for Ng or Ct will receive treatment for these.

Recruitment & Eligibility

Inclusion Criteria

Able and willing to provide informed consent
Men (born as males) and transwomen aged 18 or more
Has had sex** with another man in the last 12 months
Enrolled in Belgian PrEP program at ITM/HSP/EH/CHU/UZG with approval for TDF/FTC (Tenofovir disoproxil fumarate/Emtricitabine) reimbursement from a Belgian Medical Aid
Willing to comply with the study procedures and to attend the clinic for the 3-monthly visits

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
No screening	No Screening	In the no screening arm, the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.

Primary Outcome Measures

Name	Time	Method
Incidence Rate of Ng Plus Ct Detected at Any Site Whilst Individuals Are Screened vs. Not Screened	12 months	number of diagnoses of Ng plus Ct in 12 months in screening/non-screening arms divided by number of scheduled study visits with available results for the diagnosis of Ng/Ct. The denominator does not include unscheduled visits.

Secondary Outcome Measures

Name	Time	Method
Cumulative Antimicrobial Exposure (Ceftriaxone/Azithromycin/Doxycycline)	12 months	Number of standard doses per 1000 person-years for azithromycin, ceftriaxone and doxycycline
Incidence Rate of Symptomatic Ng Plus Ct	12 months	Number of diagnoses of symptomatic Ng and Ct infections over 12 months divided by number of visits
Incidence Rate of Syphilis	12 months	Number of diagnoses of syphilis over 12 months divided by number of visits

Locations (5): Institute of Tropical Medicine
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Antwerp, Belgium
Hôpital Erasme
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Brussels, Belgium
CHU Liège
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Liège, Belgium
UZGent
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Gent, Belgium
CHU Saint-Pierre
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Brussels, Belgium