Prevalence of HCV in HIV-negative MSM

NCT04005248 | Unknown

• 2 other identifiers: MEC-2019-0105IN-NL-987-4652
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief 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 attending sexual health clinics in the Netherlands is needed.

Conditions

Hepatitis C Virus Infection

Outcome Measures

Primary Outcomes (2)

• HCV antibody prevalence

  Percentage of HCV IgG antibody positive clients per 1000 HIV-negative MSM tested

  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

  From start study to end of study, at least 2 years

Secondary Outcomes (2)

• HCV infection prevalence

  From start study to end of study, at least 2 years

• Proportion participating in study

  From start inclusion to end of inclusion period, at least 1 year

Study Arms (1)

Testing for HCV

OTHER

HCV IgG test and questionnaire; both at visit to the sexual health clinic

Diagnostic Test: HCV IgG test

Interventions

HCV IgG test DIAGNOSTIC_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.

Testing for HCV

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-identifying as a man-who-has-sex-with-men (MSM)
• Willing to undergo HCV testing

You may not qualify if:

• Clients known to be HIV positive

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Public Health Service of Rotterdam-Rijnmond: collaborator

Study Sites (1)

GGD Rotterdam Rijnmond

Rotterdam, Netherlands

RECRUITING

Related Publications (3)

• 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.

  PMID: 28657964 BACKGROUND

• 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.

  PMID: 26634219 BACKGROUND

• 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.

  PMID: 28597832 BACKGROUND

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Bart J.A. Rijnders, MD PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bart J.A. Rijnders, MD PhD

CONTACT

003110-7033510; b.rijnders@erasmusmc.nl

Rosanne Verwijs, MD

CONTACT

00316-12725005; n.verwijs@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Cross-sectional study

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: July 2, 2019
• Study Start: October 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: January 28, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)