Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
4000 participants
INTERVENTIONAL
2019-10-01
2023-06-30
Brief Summary
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Detailed Description
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This observation may be the result of the fact that PrEP users are, by definition, at risk for sexually transmitted infections because PrEP is only prescribed to those at risk for HIV. However, another explanation may be that in the new context of HIV "treatment as prevention" and the availability of PREP as a way to protect oneself against HIV, the incidence of HCV in HIV uninfected MSM is changing. Furthermore, if PrEP use would lead to an increase in sexual risk-taking, this may eventually lead to an increase in the incidence of HCV among HIV negative MSM on PrEP. If these HCV infections among HIV negative MSM remain unnoticed, they are a continuous source of HCV infections in HIV+MSM as well for the larger HIV-MSM community. Furthermore, PrEP as well as the very well-documented efficacy of HIV treatment as prevention can be expected to increase sexual mixing of HIV- and HIV+MSM.
Based on the observations described above, we hypothesize that undiagnosed HCV infections in HIV negative MSM are (or may become) an important source of HCV (re)infections in HIV+MSM as well as the larger HIV-MSM population.
Primary objectives:
1. Measure the prevalence of HCV in a large group of HIV-negative MSM attending sexual health clinics in the Netherlands.
2. Assess Risk Factors for HCV in order to validate the HCV-MOSAIC risk score in HIV-MSM, which may allow for a more cost-effective (=targeted) HCV testing of HIV-MSM in the future
Secondary objectives:
1. Measure the acceptability of HCV testing in HIV-MSM at public health clinics.
2. Evaluate the HCV outcome in terms of the proportion of HCV infections that cleared spontaneously (= HCV IgG positive but HCV RNA negative) versus the total number of HCV IgG positive clients.
The HCV-immunoglobulin G (IgG) test is offered on top of the regular sexually transmitted infection (STI) tests. A positive HCV-IgG test will be followed by an HCV-RNA test. Clients known to be HCV IgG positive as a result of a previous HCV infection will be tested for HCV using an HCV-RNA test.
Before HCV testing, participants will be asked to fill out a detailed study questionnaire about possible risk factors for HCV acquisition (PREP use, receptive unprotected anal intercourse, use of non-IV or injection drugs during sex, fisting, recent diagnosis of ulcerative rectal STI, etc.).
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Testing for HCV
HCV IgG test and questionnaire; both at visit to the sexual health clinic
HCV IgG test
An HCV IgG test (performed on blood already collected for regular STI tests), combined with a questionnaire on sexual risk behavior. If client is HCV IgG positive, a HCV RNA test will be performed.
Interventions
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HCV IgG test
An HCV IgG test (performed on blood already collected for regular STI tests), combined with a questionnaire on sexual risk behavior. If client is HCV IgG positive, a HCV RNA test will be performed.
Eligibility Criteria
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Inclusion Criteria
* Willing to undergo HCV testing
Exclusion Criteria
MALE
No
Sponsors
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Public Health Service of Rotterdam-Rijnmond
UNKNOWN
Erasmus Medical Center
OTHER
Responsible Party
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Bart Rijnders
Principal Investigator
Principal Investigators
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Bart J.A. Rijnders, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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GGD Rotterdam Rijnmond
Rotterdam, , Netherlands
Countries
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Central Contacts
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References
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Hoornenborg E, Achterbergh RCA, Schim van der Loeff MF, Davidovich U, Hogewoning A, de Vries HJC, Schinkel J, Prins M, van de Laar TJW; Amsterdam PrEP Project team in the HIV Transmission Elimination AMsterdam Initiative, MOSAIC study group. MSM starting preexposure prophylaxis are at risk of hepatitis C virus infection. AIDS. 2017 Jul 17;31(11):1603-1610. doi: 10.1097/QAD.0000000000001522.
Vanhommerig JW, Lambers FA, Schinkel J, Geskus RB, Arends JE, van de Laar TJ, Lauw FN, Brinkman K, Gras L, Rijnders BJ, van der Meer JT, Prins M; MOSAIC (MSM Observational Study of Acute Infection With Hepatitis C) Study Group; van der Meer JT, Molenkamp R, Mutschelknauss M, Nobel HE, Reesink HW, Schinkel J, van der Valk M, van den Berk GE, Brinkman K, Kwa D, van der Meche N, Toonen A, Vos D, van Broekhuizen M, Lauw FN, Mulder JW, Arends JE, van Kessel A, de Kroon I, Boonstra A, van der Ende ME, Hullegie S, Rijnders BJ, van de Laar TJ, Gras L, Smit C, Lambers FA, Prins M, Vanhommerig JW, van der Veldt W. Risk Factors for Sexual Transmission of Hepatitis C Virus Among Human Immunodeficiency Virus-Infected Men Who Have Sex With Men: A Case-Control Study. Open Forum Infect Dis. 2015 Aug 6;2(3):ofv115. doi: 10.1093/ofid/ofv115. eCollection 2015 Sep.
Newsum AM, Stolte IG, van der Meer JT, Schinkel J, van der Valk M, Vanhommerig JW, Buve A, Danta M, Hogewoning A, Prins M; MOSAIC collaborators. Development and validation of the HCV-MOSAIC risk score to assist testing for acute hepatitis C virus (HCV) infection in HIV-infected men who have sex with men (MSM). Euro Surveill. 2017 May 25;22(21):30540. doi: 10.2807/1560-7917.ES.2017.22.21.30540.
Other Identifiers
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IN-NL-987-4652
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
MEC-2019-0105
Identifier Type: -
Identifier Source: org_study_id
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