N/A
N=1,014
GonoScreen: Efficacy of Screening STIs in MSM
Neisseria Gonorrhoeae Infection · Chlamydia Trachomatis Infection
Bottom Line
View on ClinicalTrials.gov: NCT04269434 ↗Enrolled (actual)
1,014
Serious AEs
—
Results posted
Oct 2024
Primary outcome: Primary: Incidence Rate of Ng Plus Ct Detected at Any Site Whilst Individuals Are Screened vs. Not Screened — 0.155; 0.205 Ng or CT cases per study visit
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- No Screening (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Institute of Tropical Medicine, Belgium
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate of Ng Plus Ct Detected at Any Site Whilst Individuals Are Screened vs. Not Screened |
0.155; 0.205 | — |
| SECONDARY Cumulative Antimicrobial Exposure (Ceftriaxone/Azithromycin/Doxycycline) |
0.0059; 0.0046; 0.0008; 0.0004; 0.0081; 0.0044 | — |
| SECONDARY Incidence Rate of Symptomatic Ng Plus Ct |
0.034; 0.046 | — |
| SECONDARY Incidence Rate of Syphilis |
0.018; 0.026 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT04269434). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.