GonoScreen: Efficacy of Screening STIs in MSM

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1014 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-21

Study Completion Date

2022-08-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Neisseria Gonorrhoeae Infection Chlamydia Trachomatis Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

The study statistician will be blinded until the statistical analysis plan (SAP) is approved

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type OTHER

No Screening

Intervention Type OTHER

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

Interventions

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No Screening

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

Intervention Type OTHER

Eligibility Criteria

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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