GonoScreen: Efficacy of Screening STIs in MSM

Study Overview
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Brief Summary
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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
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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.

Official Title
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Does Screening for Gonorrhea and Chlamydia Affect the Incidence of These Infections in Men Who Have Sex With Men Taking HIV Pre Exposure Prophylaxis (PrEP): a Randomized, Multicentre Controlled Trial

Conditions
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Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection

Intervention / Treatment
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* Other: No Screening


Participation Criteria
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Eligibility Criteria
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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: Enrolment in another interventional trial Tests HIV-positive at screening Symptoms of proctitis or urethritis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Screening<br>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. | |
| Other: No screening<br>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. | Other: No Screening<br>* the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Ng plus Ct detected at any site whilst individuals are screened vs. not screened | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative antimicrobial exposure (ceftriaxone/azithromycin/doxycycline) | number of standard doses per 1000 person-years | 12 months | 
| Incidence of symptomatic Ng plus Ct |  | 12 months | 
| Incidence of syphilis |  | 12 months | 
| Incidence of HIV |  | 12 months | 
| Economic impact of cessation of 3x3 screening in MSM in Belgium | amount of costs relating to laboratory testing, price of antimicrobial therapy and administration and costs of consultations from standard sources such as Rijksinstituut voor ziekte- en invaliditeitsverzekering/Institut national d'assurance maladie-invalidité (RIZIV/INAMI) reimbursement schema and Belgisch Centrum voor Farmacotherapeutische Informatie (BCFI). | 12 months | 
| Questionnaire to assess the variations in PrEP users' perceptions towards STI screening | questions to enhance discussion on sexual health, STI prevention and the role of screening for STIs. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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screening