NCT04269434

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,014

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

September 21, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

October 16, 2024

Completed
Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

1.9 years

First QC Date

February 11, 2020

Results QC Date

April 3, 2023

Last Update Submit

October 11, 2024

Conditions

Neisseria Gonorrhoeae InfectionChlamydia Trachomatis Infection

Keywords

screening

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Cumulative Antimicrobial Exposure (Ceftriaxone/Azithromycin/Doxycycline)

    12 months

  • Incidence Rate of Symptomatic Ng Plus Ct

    12 months

  • Incidence Rate of Syphilis

    12 months

Study Arms (2)

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.

Other: No Screening

Interventions

No ScreeningOTHER

the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.

No screening

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Enrolment in another interventional trial
  • Tests HIV-positive at screening
  • Symptoms of proctitis or urethritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Institute of Tropical Medicine

Antwerp, 2000, Belgium

Location

CHU Saint-Pierre

Brussels, 1000, Belgium

Location

Hôpital Erasme

Brussels, Belgium

Location

UZGent

Ghent, 4000, Belgium

Location

CHU Liège

Liège, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 38423024DERIVED

MeSH Terms

Conditions

Gonorrhea

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesCommunicable DiseasesGenital DiseasesUrogenital Diseases

Results Point of Contact

Title
Dr. Chris Kenyon
Organization
Instituut van Tropische Geneeskunde Antwerpen
ckenyon@itg.be
+3232470786

Study Officials

  • Chris Kenyon, MD

    Institute of Tropical Medicine Antwerp

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The study statistician will be blinded until the statistical analysis plan (SAP) is approved
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2020

First Posted

February 13, 2020

Study Start

September 21, 2020

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

October 16, 2024

Results First Posted

October 16, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

BE(5)