GonoScreen: Efficacy of Screening STIs in MSM (GonoScreen)

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

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).

Study Overview

• Status: Completed
• Conditions: Chlamydia Trachomatis Infection; Neisseria Gonorrhoeae Infection
• Intervention / Treatment: Other: No Screening

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.

• Study Type: Interventional
• Enrollment (Actual): 1014
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2000
    • Institute of Tropical Medicine
  • Brussels, Belgium
    • Hôpital Erasme
  • Brussels, Belgium, 1000
    • CHU Saint-Pierre
  • Gent, Belgium, 4000
    • UZGent
  • Liège, Belgium
    • CHU Liège

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institute of Tropical Medicine, Belgium

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 21, 2020
• Primary Completion (ACTUAL): August 31, 2022
• Study Completion (ACTUAL): August 31, 2022

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (ACTUAL): February 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 6, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: screening
• Additional Relevant MeSH Terms: Pathologic Processes; Sexually Transmitted Diseases; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Chlamydiaceae Infections; Sexually Transmitted Diseases, Bacterial; Infections; Communicable Diseases; Chlamydia Infections; Gonorrhea
• Other Study ID Numbers: ITM202002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No