NCT04269434: GonoScreen

GonoScreen: Efficacy of Screening STIs in MSM

Completed NA Results posted Last updated 16 October 2024

What this trial tests

NA trial testing No Screening in Neisseria Gonorrhoeae Infection in 1,014 participants. Completed in 31 August 2022.

Timeline

21 September 2020

Primary endpoint
31 August 2022

31 August 2022

Quick facts

Lead sponsor	Institute of Tropical Medicine, Belgium
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	screening
Enrollment	1,014
Start date	21 September 2020
Primary completion	31 August 2022
Estimated completion	31 August 2022
Sites	5 locations across Belgium

Drugs / interventions tested

• No Screening

Conditions studied

• Neisseria Gonorrhoeae Infection — all drugs for Neisseria Gonorrhoeae Infection →
• Chlamydia Trachomatis Infection — all drugs for Chlamydia Trachomatis Infection →

Sponsor

Institute of Tropical Medicine, Belgium

Who can join

18 and older, male only, with Neisseria Gonorrhoeae Infection or Chlamydia Trachomatis Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Incidence Rate of Ng Plus Ct Detected at Any Site Whilst Individuals Are Screened vs. Not Screened Primary · 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.

Group	Value	95% CI
Screening	0.155	0.128 – 0.186
No Screening	0.205	0.171 – 0.246

Cumulative Antimicrobial Exposure (Ceftriaxone/Azithromycin/Doxycycline) Secondary · 12 months

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

Azithromycin

Group	Value	95% CI
Screening	0.0059	0.0055 – 0.0063
No Screening	0.0046	0.0043 – 0.0050

Ceftriaxone

Group	Value	95% CI
Screening	0.0008	0.0007 – 0.0009
No Screening	0.0004	0.0004 – 0.0006

Doxycycline

Group	Value	95% CI
Screening	0.0081	0.0075 – 0.0086
No Screening	0.0044	0.0041 – 0.0048

Incidence Rate of Symptomatic Ng Plus Ct Secondary · 12 months

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

Group	Value	95% CI
Screening	0.034	0.023 – 0.049
No Screening	0.046	0.032 – 0.067

Incidence Rate of Syphilis Secondary · 12 months

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

Group	Value	95% CI
Screening	0.018	0.011 – 0.029
No Screening	0.026	0.016 – 0.042

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Vanbaelen T, Tsoumanis A, Florence E, Van Dijck C, et al · · 2024 · cited 39× · PMID 38423024 · DOI 10.1016/s2352-3018(23)00299-0
2. Does screening for<i>Neisseria gonorrhoeae</i>and<i>Chlamydia trachomatis</i>affect the incidence of these infections in men who have sex with men taking HIV pre-exposure prophylaxis (PrEP)Results from a randomized, multicentre controlled trial (the Gonoscreen study)
   Vanbaelen T, Tsoumanis A, Florence E, Van Dijck C, et al · · 2023 · DOI 10.1101/2023.08.14.23294056