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Completed

NCT Number: NCT04269434

GonoScreen: Efficacy of Screening STIs in MSM

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).

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Key information

Conditions

Neisseria Gonorrhoeae Infection Bacterial Infections Bacterial Infections and Mycoses Chlamydia Trachomatis Infection Communicable Diseases Genital Diseases Gonorrhea Gram-Negative Bacterial Infections Infections Neisseriaceae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Tropical Medicine, Antwerp, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Screening

Other

the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.

Primary outcomes

  1. Incidence Rate 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 outcomes

  1. Cumulative Antimicrobial Exposure (Ceftriaxone/Azithromycin/Doxycycline)

    Time frame: 12 months

    Number of standard doses per 1000 person-years for azithromycin, ceftriaxone and doxycycline

  2. Incidence Rate of Symptomatic Ng Plus Ct

    Time frame: 12 months

    Number of diagnoses of symptomatic Ng and Ct infections over 12 months divided by number of visits

  3. Incidence Rate of Syphilis

    Time frame: 12 months

    Number of diagnoses of syphilis over 12 months divided by number of visits

Sponsors and collaborators

Lead sponsor

Institute of Tropical Medicine, Belgium

Other

Registry information

Official study 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

Acronym: GonoScreen

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 13, 2020
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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