GonoScreen: Efficacy of Screening STIs in MSM

Institute of Tropical Medicine, Belgium

Status: Completed

Conditions: Neisseria Gonorrhoeae Infection; Chlamydia Trachomatis Infection

Treatments: Other: No Screening

Study type: Interventional

Funder types: Other

Identifiers

NCT04269434

ITM202002

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,014 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,014 participants in 2 patient groups

Screening

No Intervention group

Description:

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.

No screening

Other group

Description:

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.

Treatment:

Other: No Screening