Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection
Conditions
Keywords
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.
Interventions
OTHERNo Screening
the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.
Sponsors
Institute of Tropical Medicine, Belgium
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Masking description
The study statistician will be blinded until the statistical analysis plan (SAP) is approved
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of Ng Plus Ct Detected at Any Site Whilst Individuals Are Screened vs. Not Screened | 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
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Antimicrobial Exposure (Ceftriaxone/Azithromycin/Doxycycline) | 12 months | Number of standard doses per 1000 person-years for azithromycin, ceftriaxone and doxycycline |
| Incidence Rate of Symptomatic Ng Plus Ct | 12 months | Number of diagnoses of symptomatic Ng and Ct infections over 12 months divided by number of visits |
| Incidence Rate of Syphilis | 12 months | Number of diagnoses of syphilis over 12 months divided by number of visits |
Countries
Belgium
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 506 |
| 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. | 508 |
| Total | 1,014 |
Baseline characteristics
| Characteristic | Screening | Total | No Screening |
|---|---|---|---|
| Age, Continuous | 39 years | 39 years | 39 years |
| Antibiotics in the last 6 months Any | 192 Participants | 365 Participants | 173 Participants |
| Antibiotics in the last 6 months Cephalosporins | 67 Participants | 144 Participants | 77 Participants |
| Antibiotics in the last 6 months Macroloides | 81 Participants | 175 Participants | 94 Participants |
| Antibiotics in the last 6 months Other | 3 Participants | 6 Participants | 3 Participants |
| Antibiotics in the last 6 months Penicillins | 63 Participants | 110 Participants | 47 Participants |
| Antibiotics in the last 6 months Quinolones | 11 Participants | 16 Participants | 5 Participants |
| Antibiotics in the last 6 months Tetracyclines | 57 Participants | 111 Participants | 54 Participants |
| Number of sex partners (last 3 months) | 4 Number of sex partners | 4 Number of sex partners | 4 Number of sex partners |
| Number of sex partners (mean) | 6.28 Number of sex partners | 6.77 Number of sex partners | 7.26 Number of sex partners |
| Number of unprotected sex partners in the last 3 months | 2 Number of unprotected sex partners | 2 Number of unprotected sex partners | 2 Number of unprotected sex partners |
| Number of unprotected sex partners (mean) | 3.80 Number of unprotected sex partners | 4.04 Number of unprotected sex partners | 4.28 Number of unprotected sex partners |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex/Gender, Customized Sex Male | 506 Participants | 1011 Participants | 505 Participants |
| Sex/Gender, Customized Sex Transwoman | 0 Participants | 3 Participants | 3 Participants |
| STI symptoms Missing | 0 Participants | 1 Participants | 1 Participants |
| STI symptoms No | 504 Participants | 1007 Participants | 503 Participants |
| STI symptoms Yes | 2 Participants | 6 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 12 months
Population: Per protocol analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Screening | Incidence Rate of Ng Plus Ct Detected at Any Site Whilst Individuals Are Screened vs. Not Screened | 0.155 Ng or CT cases per study visit |
| No Screening | Incidence Rate of Ng Plus Ct Detected at Any Site Whilst Individuals Are Screened vs. Not Screened | 0.205 Ng or CT cases per study visit |
Comparison: Compared to screening group95% CI: [1.068, 1.627]
Secondary
Cumulative Antimicrobial Exposure (Ceftriaxone/Azithromycin/Doxycycline)
Number of standard doses per 1000 person-years for azithromycin, ceftriaxone and doxycycline
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Screening | Cumulative Antimicrobial Exposure (Ceftriaxone/Azithromycin/Doxycycline) | Azithromycin | 0.0059 doses per 1000 person-years |
| Screening | Cumulative Antimicrobial Exposure (Ceftriaxone/Azithromycin/Doxycycline) | Ceftriaxone | 0.0008 doses per 1000 person-years |
| Screening | Cumulative Antimicrobial Exposure (Ceftriaxone/Azithromycin/Doxycycline) | Doxycycline | 0.0081 doses per 1000 person-years |
| No Screening | Cumulative Antimicrobial Exposure (Ceftriaxone/Azithromycin/Doxycycline) | Doxycycline | 0.0044 doses per 1000 person-years |
| No Screening | Cumulative Antimicrobial Exposure (Ceftriaxone/Azithromycin/Doxycycline) | Azithromycin | 0.0046 doses per 1000 person-years |
| No Screening | Cumulative Antimicrobial Exposure (Ceftriaxone/Azithromycin/Doxycycline) | Ceftriaxone | 0.0004 doses per 1000 person-years |
Comparison: For Azithromycin. Compared to screening group95% CI: [0.719, 0.863]
Comparison: For Ceftriaxone. Compared to screening group95% CI: [0.426, 0.739]
Comparison: For Doxycycline. Compared to screening group95% CI: [0.515, 0.588]
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
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Screening | Incidence Rate of Symptomatic Ng Plus Ct | 0.034 Symptomatic infections per study visit |
| No Screening | Incidence Rate of Symptomatic Ng Plus Ct | 0.046 Symptomatic infections per study visit |
Comparison: Compared to screening group95% CI: [0.963, 1.956]
Secondary
Incidence Rate of Syphilis
Number of diagnoses of syphilis over 12 months divided by number of visits
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Screening | Incidence Rate of Syphilis | 0.018 Syphilis cases per study visit |
| No Screening | Incidence Rate of Syphilis | 0.026 Syphilis cases per study visit |
Comparison: Compared to screening group95% CI: [0.943, 2.299]