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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Antimicrobial Exposure (Ceftriaxone/Azithromycin/Doxycycline) | Number of standard doses per 1000 person-years for azithromycin, ceftriaxone and doxycycline | 12 months |
| Incidence Rate of Symptomatic Ng Plus Ct |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris Kenyon, MD | Institute of Tropical Medicine Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Tropical Medicine | Antwerp | 2000 | Belgium | |||
| CHU Saint-Pierre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38423024 | Derived | 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. |
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Recruitment started on 21st September 2020 and was completed on 4th June 2021. Participants were recruited at 5 sites (Institute of Tropical Medicine Antwerp, University Hospital Ghent, University Hospital Erasme Brussels, University Hospital Saint-Pierre Brussels and University Hospital Liège.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. No Screening: the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | No Screening |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Per protocol analysis | Posted | Number | 95% Confidence Interval | Ng or CT cases per study visit | 12 months |
|
No adverse event data collected in this study.
Serious and other [non-serious] adverse events were not collected or assessed as part of the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chris Kenyon | Instituut van Tropische Geneeskunde Antwerpen | +3232470786 | ckenyon@itg.be |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 28, 2021 | Mar 2, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 1, 2021 | Mar 2, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006069 | Gonorrhea |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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The study statistician will be blinded until the statistical analysis plan (SAP) is approved
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Number of diagnoses of symptomatic Ng and Ct infections over 12 months divided by number of visits
| 12 months |
| Incidence Rate of Syphilis | Number of diagnoses of syphilis over 12 months divided by number of visits | 12 months |
| Brussels |
| 1000 |
| Belgium |
| Hôpital Erasme | Brussels | Belgium |
| UZGent | Ghent | 4000 | Belgium |
| CHU Liège | Liège | Belgium |
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.
No Screening: the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Number of sex partners (last 3 months) | Median | Inter-Quartile Range | Number of sex partners |
|
| Number of sex partners (mean) | Mean | Full Range | Number of sex partners |
|
| Number of unprotected sex partners in the last 3 months | Median | Inter-Quartile Range | Number of unprotected sex partners |
|
| Number of unprotected sex partners (mean) | Mean | Full Range | Number of unprotected sex partners |
|
| STI symptoms | Count of Participants | Participants |
|
| Antibiotics in the last 6 months | Count of Participants | Participants |
|
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.
No Screening: the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.
|
|
|
| Secondary | Cumulative Antimicrobial Exposure (Ceftriaxone/Azithromycin/Doxycycline) | Number of standard doses per 1000 person-years for azithromycin, ceftriaxone and doxycycline | Posted | Number | 95% Confidence Interval | doses per 1000 person-years | 12 months |
|
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|
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| Secondary | Incidence Rate of Symptomatic Ng Plus Ct | Number of diagnoses of symptomatic Ng and Ct infections over 12 months divided by number of visits | Posted | Number | 95% Confidence Interval | Symptomatic infections per study visit | 12 months |
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| Secondary | Incidence Rate of Syphilis | Number of diagnoses of syphilis over 12 months divided by number of visits | Posted | Number | 95% Confidence Interval | Syphilis cases per study visit | 12 months |
|
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|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. No Screening: the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| Yes |
|
| Doxycycline |
|
| Incidence rate ratio |
| 0.561 |
| 2-Sided |
| 95 |
| 0.426 |
| 0.739 |
| Non-Inferiority |
No prespecified margin |
| For Doxycycline. Compared to screening group | Incidence rate ratio | 0.55 | 2-Sided | 95 | 0.515 | 0.588 | Non-Inferiority | No prespecified margin |