GonoScreen: Efficacy of Screening STIs in MSM

Overview

A Multicentre, controlled, randomized trial of 3 site (urethra, pharynx and rectum) sampling performed every 3 months (3×3) for Neisseria gonorrhoea (Ng)/Chlamydia trachomatis (Ct) screening (comparator) vs. no screening (intervention).

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2022

Detailed Description

This study is a multicentre, controlled, randomized trial of 3×3 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 3×3 screening or no Ng/Ct screening. In both arms, participants will be followed up in an identical fashion including 3×3 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.

Interventions

  • Other: No Screening
    • the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.

Arms, Groups and Cohorts

  • No Intervention: Screening
    • 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
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of Ng plus Ct detected at any site whilst individuals are screened vs. not screened
    • Time Frame: 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 Measures

  • Cumulative antimicrobial exposure (ceftriaxone/azithromycin/doxycycline)
    • Time Frame: 12 months
    • number of standard doses per 1000 person-years
  • Incidence of symptomatic Ng plus Ct
    • Time Frame: 12 months
  • Incidence of syphilis
    • Time Frame: 12 months
  • Incidence of HIV
    • Time Frame: 12 months
  • Economic impact of cessation of 3×3 screening in MSM in Belgium
    • Time Frame: 12 months
    • 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).
  • Questionnaire to assess the variations in PrEP users’ perceptions towards STI screening
    • Time Frame: 12 months
    • questions to enhance discussion on sexual health, STI prevention and the role of screening for STIs.

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Institute of Tropical Medicine, Belgium
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Chris Kenyon, MD, Principal Investigator, Institute of Tropical Medicine Antwerp
  • Overall Contact(s)
    • Annelies De Hondt, MSc, 003232470716, adehondt@itg.be

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