Self-testing for HCV Re-infection in MSM

NCT04004299 | Unknown

• 3 other identifiers: NL67745.078.18MEC-2018-1637IN-NL-987-4653
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 7

Brief Summary

HIV+MSM (men who have sex with men) that have been cured of a hepatitis C viral infection (HCV) are at risk for HCV re-infection (5-10% per year). One intervention to reduce HCV incidence in this population may be to decrease the time to diagnosis of HCV re-infections in order to decrease the duration that these re-infected patients may transmit their HCV to sex partners. Diagnosis of HCV re-infection is followed by counseling on transmission risk in combination with prompt initiation of HCV therapy, which will prevent new HCV infections on the population level. In this study the investigators evaluate the effect and feasibility of more frequent and home-based testing for HCV on the time to diagnosis and treatment of HCV re-infections.

Conditions

Hepatitis C Recurrent; HIV-1-infection

Keywords

Hepatitis C re-infection

Outcome Measures

Primary Outcomes (1)

• Change in time to HCV re-infection diagnosis with the intervention in MITT population

  Comparison of the time to HCV re-infection diagnosis in patients using the HCV RNA self-test (intervention) with the time to HCV re-infection diagnosis with the standard diagnostic approach (virtual control) in the modified intention to treat (MITT) population.

  Last negative HCV test to first positive HCV test (from start study to first positive HCV test in up to 2 years)

Secondary Outcomes (4)

• Change in time to HCV re-infection diagnosis with the intervention in PP

  Last negative HCV test to first positive HCV test (from start study to first positive HCV test in up to 2 years)

• Acceptability of intervention in target population: percentage that accepted to participate and eventually self-collected and sent in at least one plasma sample

  Through study process, from start screening to study completion, at least 3 years

• HCV re-infection incidence in study population

  During follow-up period of 2 years

• HCV infections found at screening

  At screening visit (T=0)

Study Arms (1)

HCV self-test intervention

OTHER

Diagnostic intervention: participant performs capillary blood sampling at home in between outpatient clinic visits (3 months after) and sends the sample to the investigator's laboratory by regular post mail for HCV RNA analysis. This is on top of standard of care ALT measurement at every 6-monthly outpatient clinic visit, followed by HCV RNA testing if ALT is elevated. Follow-up period is 2 years, in which participants will perform and send in 4 self-tests, in combination with filling out 4 questionnaires into sexual risk behavior.

Diagnostic Test: HCV RNA self-test

Interventions

HCV RNA self-test DIAGNOSTIC_TEST

Self-test set including instruction manual (video available as well), finger prick device, tube and envelope to safely transport biological material. Patient takes capillary blood sample, collects it in the tube and sends the sample to the lab by regular post mail.

HCV self-test intervention

Eligibility Criteria

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

You may qualify if:

• Cured of HCV defined as an SVR (=documented negative HCV RNA test) at least 12 weeks after the end of DAA therapy and no new documented positive HCV RNA test after the date of the SVR
• Spontaneous clearance of HCV infection defined as two consecutive negative HCV RNA tests at least 3 months apart after a positive HCV RNA test.
• In care for an HIV infection in an HIV clinic in a study center or HIV negative and receiving PrEP at a PrEP clinic
• Able and willing to perform the self-test at home after viewing the instruction video
• Willing to fill out a questionnaire on risk behavior at the time of HCV self-testing
• At risk of HCV re-infection according to a short questionnaire, in other words, patients should have one of the following risk factors:
• Receptive unprotected (condomless) anal intercourse in the last 6 months
• Fisting or being fisted without gloves in the last 6 months
• Sharing toys in the last 6 months
• Syphilis or LGV in the last 12 months,
• Slamming (injecting drug use) in the last 12 months
• Sharing sniffing straws or other objects to sniff drugs in the last 12 months

You may not qualify if:

• Age \< 18
• Patients that are tested by HCV RNA as a standard of care test (e.g. in the context of PREP use) \> 1x/year
• Patients that are expected to be tested by ALT at their HIV or PREP clinic \<1x/year

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (7)

Ziekenhuis Rijnstate

Arnhem, Gelderland, Netherlands

NOT YET RECRUITING

Catharina Ziekenhuis Eindhoven

Eindhoven, North Brabant, 5602 ZA, Netherlands

NOT YET RECRUITING

Medisch Spectrum Twente

Enschede, Overijssel, 7500 KA, Netherlands

NOT YET RECRUITING

Spaarne Gasthuis

Haarlem, South Holland, 2000 AK, Netherlands

NOT YET RECRUITING

Erasmus Medical Center (EMC)

Rotterdam, South Holland, 3000 CA, Netherlands

RECRUITING

Maasstad Ziekenhuis

Rotterdam, South Holland, 3007 AC, Netherlands

NOT YET RECRUITING

Utrecht Medical University Center (UMCU)

Utrecht, Netherlands

NOT YET RECRUITING

Related Publications (3)

• Boerekamps A, van den Berk GE, Lauw FN, Leyten EM, van Kasteren ME, van Eeden A, Posthouwer D, Claassen MA, Dofferhoff AS, Verhagen DWM, Bierman WF, Lettinga KD, Kroon FP, Delsing CE, Groeneveld PH, Soetekouw R, Peters EJ, Hullegie SJ, Popping S, van de Vijver DAMC, Boucher CA, Arends JE, Rijnders BJ. Declining Hepatitis C Virus (HCV) Incidence in Dutch Human Immunodeficiency Virus-Positive Men Who Have Sex With Men After Unrestricted Access to HCV Therapy. Clin Infect Dis. 2018 Apr 17;66(9):1360-1365. doi: 10.1093/cid/cix1007.

  PMID: 29186320 BACKGROUND

• Ingiliz P, Martin TC, Rodger A, Stellbrink HJ, Mauss S, Boesecke C, Mandorfer M, Bottero J, Baumgarten A, Bhagani S, Lacombe K, Nelson M, Rockstroh JK; NEAT study group. HCV reinfection incidence and spontaneous clearance rates in HIV-positive men who have sex with men in Western Europe. J Hepatol. 2017 Feb;66(2):282-287. doi: 10.1016/j.jhep.2016.09.004. Epub 2016 Sep 17.

  PMID: 27650285 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

Study Officials

• Bart Rijnders, MD PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bart Rijnders, MD PhD

CONTACT

31107033510; b.rijnders@erasmusmc.nl

Rosanne Verwijs, MD

CONTACT

31612725005; n.verwijs@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single arm open label multicenter study with diagnostic intervention using capillary blood sampling

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: July 2, 2019
• Study Start: July 18, 2019
• Primary Completion: February 28, 2023
• Study Completion: June 30, 2023
• Last Updated: August 12, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (7)