Clinical trial NCT04269434: GonoScreen: Efficacy of Screening STIs in MSM
Official title: 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: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neisseria Gonorrhoeae Infection
Chlamydia Trachomatis Infection
Keywords: screening
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 1014
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence Rate of Ng Plus Ct Detected at Any Site Whilst Individuals Are Screened vs. Not Screened
timeFrame: 12 months
Secondary outcomes:
measure: Cumulative Antimicrobial Exposure (Ceftriaxone/Azithromycin/Doxycycline)
timeFrame: 12 months
measure: Incidence Rate of Symptomatic Ng Plus Ct
timeFrame: 12 months
measure: Incidence Rate of Syphilis
timeFrame: 12 months
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Institute of Tropical Medicine
city: Brussels
country: Belgium
facility: CHU Saint-Pierre
city: Brussels
country: Belgium
facility: Hôpital Erasme
city: Gent
country: Belgium
facility: UZGent
city: Liège
country: Belgium
facility: CHU Liège
Study officials:
affiliation: Institute of Tropical Medicine Antwerp
name: Chris Kenyon, MD
role: PRINCIPAL_INVESTIGATOR
References: