Neisseria Gonorrhoeae InfectionGonoScreenNCT04269434
GonoScreen: Efficacy of Screening STIs in MSM
A study testing No Screening in people with Neisseria Gonorrhoeae Infection and Chlamydia Trachomatis Infection, run by Institute of Tropical Medicine, Belgium at 5 sites in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection
- What is being tested?
- No Screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,014 participants
- Where
- 5 sitesBelgium
- Study dates
- 21 Sep 2020to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Enrolment in another interventional trial
- Tests HIV-positive at screening
- Symptoms of proctitis or urethritis
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Belgium5 sites
Institute of Tropical Medicine
Antwerp, 2000
CHU Saint-Pierre
Brussels, 1000
Hôpital Erasme
Brussels
UZGent
Ghent, 4000
CHU Liège
Liège
About this study
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
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).
Read the 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.
- Being tested
- No Screening
- Keywords
- screening
- Medical subject headings
- Gonorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No ScreeningOther
the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.
| Study group | Role | What they receive |
|---|---|---|
| Screening | No intervention | 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 | 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. Receives: Other: No Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Rate 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.
Measured: 12 months
Secondary outcomes (3)
Cumulative Antimicrobial Exposure (Ceftriaxone/Azithromycin/Doxycycline)
Number of standard doses per 1000 person-years for azithromycin, ceftriaxone and doxycycline
Measured: 12 months
Incidence Rate of Symptomatic Ng Plus Ct
Number of diagnoses of symptomatic Ng and Ct infections over 12 months divided by number of visits
Measured: 12 months
Incidence Rate of Syphilis
Number of diagnoses of syphilis over 12 months divided by number of visits
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start21 Sep 2020
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neisseria Gonorrhoeae InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,014 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chris Kenyon, MD, Principal investigator, Institute of Tropical Medicine Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269434
- Sponsor's protocol ID
- ITM202002
- Acronym
- GonoScreen
- Status last verified
- Oct 2024
- First submitted
- 11 Feb 2020
- Last updated
- 16 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vanbaelen T, Tsoumanis A, Florence E, Van Dijck C, Huis In 't Veld D, Sauvage AS, Herssens N, De Baetselier I, Rotsaert A, Verhoeven V, Henrard S, Van Herrewege Y, Van den Bossche D, Goffard JC, Padalko E, Reyniers T, Vuylsteke B, Hayette MP, Libois A, Kenyon C. Effect of screening for Neisseria gonorrhoeae and Chlamydia trachomatis on incidence of these infections in men who have sex with men and transgender women taking HIV pre-exposure prophylaxis (the Gonoscreen study): results from a randomised, multicentre, controlled trial. Lancet HIV. 2024 Apr;11(4):e233-e244. doi: 10.1016/S2352-3018(23)00299-0. Epub 2024 Feb 26.
PubMed 38423024
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04269434
- Acronym / sponsor ID
- GonoScreen / ITM202002
- Keywords
- screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,014 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 13 Feb 2020 (actual)
- Results
- Posted 16 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screening | No intervention | –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 | Other: No ScreeningIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Enrolment in another interventional trial
- Tests HIV-positive at screening
- Symptoms of proctitis or urethritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Screeningthe STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study. | Other | No screening |
Primary outcome
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.
3 secondary outcomes
Cumulative Antimicrobial Exposure (Ceftriaxone/Azithromycin/Doxycycline)
Time frame: 12 months
Incidence Rate of Symptomatic Ng Plus Ct
Time frame: 12 months
Incidence Rate of Syphilis
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38423024Vanbaelen T, Tsoumanis A, Florence E, Van Dijck C, Huis In 't Veld D, Sauvage AS, Herssens N, De Baetselier I, Rotsaert A, Verhoeven V, Henrard S, Van Herrewege Y, Van den Bossche D, Goffard JC, Padalko E, Reyniers T, Vuylsteke B, Hayette MP, Libois A, Kenyon C. Effect of screening for Neisseria gonorrhoeae and Chlamydia trachomatis on incidence of these infections in men who have sex with men and transgender women taking HIV pre-exposure prophylaxis (the Gonoscreen study): results from a randomised, multicentre, controlled trial. Lancet HIV. 2024 Apr;11(4):e233-e244. doi: 10.1016/S2352-3018(23)00299-0. Epub 2024 Feb 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Kenyon, MD principal investigator
Institute of Tropical Medicine Antwerp
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Screening in people with Neisseria Gonorrhoeae Infection and Chlamydia Trachomatis Infection, run by Institute of Tropical Medicine, Belgium at 5 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence Rate of Ng Plus Ct Detected at Any Site Whilst Individuals Are Screened vs. Not Screened (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04269434, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.