Hepatitis C Virus InfectionNCT04005248
Prevalence of HCV in HIV-negative MSM
A study testing HCV IgG test in people with Hepatitis C Virus Infection, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
This study measures the prevalence of undiagnosed hepatitis C virus (HCV) infection in HIV-negative men-who-have-sex-with-men (MSM) visiting the sexual health clinics of public health services (in dutch: gemeentelijke gezondheidsdienst, GGD), in order to evaluate if systematic screening for HCV of HIV-negative MSM… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Hepatitis C Virus Infection
- What is being tested?
- HCV IgG test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2019to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Self-identifying as a man-who-has-sex-with-men (MSM)
- Willing to undergo HCV testing
Who cannot join
- Clients known to be HIV positive
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
GGD Rotterdam Rijnmond
Rotterdam
About this study
Official title: Prevalence of Undiagnosed HCV Infections in HIV-negative MSM Visiting a Sexual Health Clinic.
This study measures the prevalence of undiagnosed hepatitis C virus (HCV) infection in HIV-negative men-who-have-sex-with-men (MSM) visiting the sexual health clinics of public health services (in dutch: gemeentelijke gezondheidsdienst, GGD), in order to evaluate if systematic screening for HCV of HIV-negative MSM attending sexual health clinics in the Netherlands is needed.
Read the detailed description
Until recently, sexually acquired HCV infections were thought to be limited to HIV-positive MSM. Yet, emerging data show that the prevalence of HCV among HIV uninfected MSM that opt-in for HIV pre-exposure prophylaxis (PrEP) is much higher. It was 5% (n=18/375) in Amsterdam and 2% (n=4/200) in Antwerp (Be-PrEP-ared; EudraCT2015-000054-37) (23).
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:
- Measure the prevalence of HCV in a large group of HIV-negative MSM attending sexual health clinics in the Netherlands.
- 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:
- Measure the acceptability of HCV testing in HIV-MSM at public health clinics.
- 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
- Hepatitis C Virus Infection
- Being tested
- HCV IgG test
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCV IgG testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Testing for HCV | Other | HCV IgG test and questionnaire; both at visit to the sexual health clinic Receives: Diagnostic Test: HCV IgG test |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV antibody prevalence
Percentage of HCV IgG antibody positive clients per 1000 HIV-negative MSM tested
Measured: From start study to end of study, at least 2 years
Value of HCV-MOSAIC risk score in HIV-negative MSM
Assess risk factors for a positive HCV IgG test in the study population according to the HCV-MOSAIC risk score, using sexual behavior questionnaires. The HCV-MOSAIC risk score is validated to identify HIV+MSM at risk for an acute HCV infection (Newsum et al, 2017).
HCV-MOSAIC risk score:
- Condomless receptive anal intercourse in the last 6 months - 1.1
- Sharing of sex toys in the last 6 months - 1.2
- Unprotected fisting in the last 6 months - 0.9
- Injecting drug use in the last 12 months - 1.4
- Sharing of straws when using nasally administered drug in the last 12 months - 1.0
- Ulcerative STI in the last 12 months - 1.4
Cut-off sum ≥2.0 = at risk for acute HCV infection
Measured: From start study to end of study, at least 2 years
Secondary outcomes (2)
HCV infection prevalence
Prevalence of active HCV infection (RNA positive) among those with HCV IgG antibodies
Measured: From start study to end of study, at least 2 years
Proportion participating in study
Percentage of HIV-negative MSM that accepted to be tested for HCV
Measured: From start inclusion to end of inclusion period, at least 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start1 Oct 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C Virus InfectionStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cross-sectional study
- Masking
- None (open label)
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Service of Rotterdam-Rijnmond
- Responsible party
- Principal investigator, Bart Rijnders, Erasmus Medical Center
- Investigators
- Bart J.A. Rijnders, MD PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005248
- Sponsor's protocol ID
- MEC-2019-0105
- Other IDs
- IN-NL-987-4652
- Status last verified
- Jan 2020
- First submitted
- 25 Jun 2019
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28657964Vanhommerig 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.
PubMed 26634219Newsum 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.
PubMed 28597832
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Undiagnosed HCV Infections in HIV-negative MSM Visiting a Sexual Health Clinic.
- ClinicalTrials.gov ID
- NCT04005248
- Acronym / sponsor ID
- MEC-2019-0105
- Conditions
- Hepatitis C Virus Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Public Health Service of Rotterdam-Rijnmond
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study measures the prevalence of undiagnosed hepatitis C virus (HCV) infection in HIV-negative men-who-have-sex-with-men (MSM) visiting the sexual health clinics of public health services (in dutch: gemeentelijke gezondheidsdienst, GGD), in order to evaluate if systematic screening for HCV of HIV-negative MSM attending sexual health clinics in the Netherlands is needed.
Detailed description
Until recently, sexually acquired HCV infections were thought to be limited to HIV-positive MSM. Yet, emerging data show that the prevalence of HCV among HIV uninfected MSM that opt-in for HIV pre-exposure prophylaxis (PrEP) is much higher. It was 5% (n=18/375) in Amsterdam and 2% (n=4/200) in Antwerp (Be-PrEP-ared; EudraCT2015-000054-37) (23).
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:
- Measure the prevalence of HCV in a large group of HIV-negative MSM attending sexual health clinics in the Netherlands.
- 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:
- Measure the acceptability of HCV testing in HIV-MSM at public health clinics.
- 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.).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cross-sectional study
| Arm | Type | Receives |
|---|---|---|
| Testing for HCV | Other | Diagnostic Test: HCV IgG testHCV IgG test and questionnaire; both at visit to the sexual health clinic |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Self-identifying as a man-who-has-sex-with-men (MSM)
- Willing to undergo HCV testing
Key exclusion criteria (1 listed)
- Clients known to be HIV positive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HCV IgG testAn 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. | Diagnostic test | Testing for HCV |
Primary outcome
HCV antibody prevalence
Time frame: From start study to end of study, at least 2 years
Percentage of HCV IgG antibody positive clients per 1000 HIV-negative MSM tested
Value of HCV-MOSAIC risk score in HIV-negative MSM
Time frame: From start study to end of study, at least 2 years
Assess risk factors for a positive HCV IgG test in the study population according to the HCV-MOSAIC risk score, using sexual behavior questionnaires. The HCV-MOSAIC risk score is validated to identify HIV+MSM at risk for an acute HCV infection (Newsum et al, 2017). HCV-MOSAIC risk score: * Condomless receptive anal intercourse in the last 6 months - 1.1 * Sharing of sex toys in the last 6 months - 1.2 * Unprotected fisting in the last 6 months - 0.9 * Injecting drug use in the last 12 months - 1.4 * Sharing of straws when using nasally administered drug in the last 12 months - 1.0 * Ulcerative STI in the last 12 months - 1.4 Cut-off sum ≥2.0 = at risk for acute HCV infection
2 secondary outcomes
HCV infection prevalence
Time frame: From start study to end of study, at least 2 years
Proportion participating in study
Time frame: From start inclusion to end of inclusion period, at least 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Background: PubMed 28657964Hoornenborg 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.
- Background: PubMed 26634219Vanhommerig 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.
- Background: PubMed 28597832Newsum 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bart J.A. Rijnders, MD PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HCV IgG test in people with Hepatitis C Virus Infection, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bart J.A. Rijnders, MD PhD (003110-7033510, b.rijnders@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCV antibody prevalence (time frame: From start study to end of study, at least 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04005248, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.