Hepatitis C RecurrentSELFIENCT04004299
Self-testing for HCV Re-infection in MSM
A study testing HCV RNA self-test in people with Hepatitis C Recurrent and HIV-1-infection, run by Erasmus Medical Center at 7 sites in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hepatitis C Recurrent, HIV-1-infection
- What is being tested?
- HCV RNA self-test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 7 sitesNetherlands
- Study dates
- 18 Jul 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- OR
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Netherlands7 sites, 7 recruiting
- Not yet recruiting
Ziekenhuis Rijnstate
Arnhem, Gelderland
Marc Claassen, PhD
- Not yet recruiting
Catharina Ziekenhuis Eindhoven
Eindhoven, North Brabant, 5602 ZA
Heidi Ammerlaan
- Not yet recruiting
Medisch Spectrum Twente
Enschede, Overijssel, 7500 KA
Corine Delsing
- Not yet recruiting
Spaarne Gasthuis
Haarlem, South Holland, 2000 AK
Robin Soetekouw
- Recruiting
Erasmus Medical Center (EMC)
Rotterdam, South Holland, 3000 CA
Bart J Rijnders, MD, PhD, 31107033510, b.rijnders@erasmusmc.nl
- Not yet recruiting
Maasstad Ziekenhuis
Rotterdam, South Holland, 3007 AC
Jan den Hollander, MD PhD
- Not yet recruiting
Utrecht Medical University Center (UMCU)
Utrecht
Joop Arends, MD PhD
About this study
Official title: Time to Diagnosis of HCV Re-infection With the Use of a Self-test: A Feasibility Study
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.
Read the detailed description
Elimination of HCV was recently formulated as a WHO target and was set for the year 2030. Globally, approximately 6.2% of HIV-infected patients are co-infected with HCV. Of the patients living with HIV, people who inject drugs (PWID) and men who have sex with men (MSM) are at particularly high risk of HCV co-infection. Until recently, the prevalence of chronic hepatitis C virus infection (HCV) in Dutch HIV+MSM was very high at 4,8% (compared with 0.2% in the Dutch population in general). After unrestricted availability of direct-acting antivirals since the end of 2015, the prevalence of chronic HCV in HIV+MSM decreased rapidly. A subsequent decrease in the incidence of HCV of 51% was observed in 2016, but no further decline was seen in 2017. Additionally, the incidence of HCV re-infections in HIV+MSM that were cured of a previous HCV infection continues to be high (5-10% per year).
The continuously high re-infection risk and the lack of a further decline in the HCV incidence after 2016 illustrates that universal DAA therapy for all patients diagnosed with a chronic HCV infection on its own will not result in HCV elimination. Other interventions are needed to reach the WHO goal of HCV elimination by 2030. One of these additional interventions may be decreasing 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.
Objective:
To assess the effectivity of HCV RNA self-testing in reducing the time to diagnosis of HCV re-infection in MSM previously cured of an HCV infection, compared to the current diagnostic standard of care.
To evaluate whether the uptake of self-testing is sufficient and warrants the use of HCV RNA self-testing in clinical practice.
Study design:
Prospective controlled intervention trial. MSM cured of an HCV infection who are at continued risk for an HCV re-infection (based on the results of a short questionnaire, APPENDIX B) are offered HCV RNA self-testing and asked to use the test every 6 months for 2 consecutive years.
Study population:
225 to 250 adult MSM cured of HCV from 10-15 HIV and PREP clinics in the Netherlands and Belgium.
Intervention:
Eligible patients are instructed on the use of a capillary blood self-collection kit. They receive 2 kits per year for 2 consecutive years to allow them to send plasma to the virology lab of the Erasmus MC every 6 months by regular post mail.
Primary endpoints:
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 (control) in the modified intention to treat population.
Secondary endpoints:
- 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 (control) in the subpopulation that has sent in all planned self-tests during their entire follow-up (per protocol analysis).
- Of the HIV+MSM that were offered to participate in the study, the percentage that accepted to participate and eventually self-collected and sent in at least one plasma sample in each 12-month period of study participation.
- Overall incidence of HCV re-infection in the entire study population regardless of the type HCV diagnostic test that was used.
- Number of screen failures as a result of a positive HCV-RNA test at the screening visit.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The burden associated with participation in the study consists of taking a finger prick blood sample for the self-test 4 times in 2 years and sending the sample to the laboratory by regular post mail. No costs will have to be made for mailing the sample. Capillary finger-prick blood sampling is used as a standard diagnostic test for many diseases (e.g. glucose monitoring in diabetes) and is associated with a negligible risk. The study may potentially be beneficial for those participants in which an HCV re-infection is diagnosed as they will be referred for counseling and HCV therapy which has the potential to prevent transmission to sex partners.
- Conditions
- Hepatitis C Recurrent, HIV-1-infection
- Being tested
- HCV RNA self-test
- Keywords
- Hepatitis C re-infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCV RNA self-testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: HCV RNA self-test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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 subpopulation that sent in all planned self-tests during their entire follow-up (Per Protocol analysis).
Measured: 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
Of the HIV+MSM that were offered to participate in the study, the percentage that accepted to participate and eventually self-collected and sent in at least one plasma sample in each 12-month period of study participation.
Measured: Through study process, from start screening to study completion, at least 3 years
HCV re-infection incidence in study population
Overall incidence of HCV re-infection in the entire study population regardless of the type of HCV diagnostic test that was used.
Measured: During follow-up period of 2 years
HCV infections found at screening
Number of newly diagnosed HCV infections at the time of the screening visit as a result of a positive HCV-RNA test at the screening visit.
Measured: At screening visit (T=0)
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 start18 Jul 2019
- Primary completion28 Feb 2023 (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 RecurrentStudies 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
- Single arm open label multicenter study with diagnostic intervention using capillary blood sampling
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bart Rijnders, Erasmus Medical Center
- Investigators
- Bart Rijnders, MD PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004299
- Sponsor's protocol ID
- NL67745.078.18
- Other IDs
- MEC-2018-1637, IN-NL-987-4653
- Acronym
- SELFIE
- Status last verified
- Aug 2019
- First submitted
- 20 Jun 2019
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29186320Ingiliz 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.
PubMed 27650285Vanhommerig 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 26634219
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time to Diagnosis of HCV Re-infection With the Use of a Self-test: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04004299
- Acronym / sponsor ID
- SELFIE / NL67745.078.18
- Conditions
- Hepatitis C Recurrent, HIV-1-infection
- Keywords
- Hepatitis C re-infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 18 Jul 2019 (actual)
- Primary completion
- 28 Feb 2023 (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.
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.
Detailed description
Elimination of HCV was recently formulated as a WHO target and was set for the year 2030. Globally, approximately 6.2% of HIV-infected patients are co-infected with HCV. Of the patients living with HIV, people who inject drugs (PWID) and men who have sex with men (MSM) are at particularly high risk of HCV co-infection. Until recently, the prevalence of chronic hepatitis C virus infection (HCV) in Dutch HIV+MSM was very high at 4,8% (compared with 0.2% in the Dutch population in general). After unrestricted availability of direct-acting antivirals since the end of 2015, the prevalence of chronic HCV in HIV+MSM decreased rapidly. A subsequent decrease in the incidence of HCV of 51% was observed in 2016, but no further decline was seen in 2017. Additionally, the incidence of HCV re-infections in HIV+MSM that were cured of a previous HCV infection continues to be high (5-10% per year).
The continuously high re-infection risk and the lack of a further decline in the HCV incidence after 2016 illustrates that universal DAA therapy for all patients diagnosed with a chronic HCV infection on its own will not result in HCV elimination. Other interventions are needed to reach the WHO goal of HCV elimination by 2030. One of these additional interventions may be decreasing 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.
Objective:
To assess the effectivity of HCV RNA self-testing in reducing the time to diagnosis of HCV re-infection in MSM previously cured of an HCV infection, compared to the current diagnostic standard of care.
To evaluate whether the uptake of self-testing is sufficient and warrants the use of HCV RNA self-testing in clinical practice.
Study design:
Prospective controlled intervention trial. MSM cured of an HCV infection who are at continued risk for an HCV re-infection (based on the results of a short questionnaire, APPENDIX B) are offered HCV RNA self-testing and asked to use the test every 6 months for 2 consecutive years.
Study population:
225 to 250 adult MSM cured of HCV from 10-15 HIV and PREP clinics in the Netherlands and Belgium.
Intervention:
Eligible patients are instructed on the use of a capillary blood self-collection kit. They receive 2 kits per year for 2 consecutive years to allow them to send plasma to the virology lab of the Erasmus MC every 6 months by regular post mail.
Primary endpoints:
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 (control) in the modified intention to treat population.
Secondary endpoints:
- 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 (control) in the subpopulation that has sent in all planned self-tests during their entire follow-up (per protocol analysis).
- Of the HIV+MSM that were offered to participate in the study, the percentage that accepted to participate and eventually self-collected and sent in at least one plasma sample in each 12-month period of study participation.
- Overall incidence of HCV re-infection in the entire study population regardless of the type HCV diagnostic test that was used.
- Number of screen failures as a result of a positive HCV-RNA test at the screening visit.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The burden associated with participation in the study consists of taking a finger prick blood sample for the self-test 4 times in 2 years and sending the sample to the laboratory by regular post mail. No costs will have to be made for mailing the sample. Capillary finger-prick blood sampling is used as a standard diagnostic test for many diseases (e.g. glucose monitoring in diabetes) and is associated with a negligible risk. The study may potentially be beneficial for those participants in which an HCV re-infection is diagnosed as they will be referred for counseling and HCV therapy which has the potential to prevent transmission to sex partners.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm open label multicenter study with diagnostic intervention using capillary blood sampling
| Arm | Type | Receives |
|---|---|---|
| HCV self-test intervention | Other | Diagnostic Test: HCV RNA self-testDiagnostic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- OR
- 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
Key exclusion criteria (3 listed)
- 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
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 RNA self-testSelf-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. | Diagnostic test | HCV self-test intervention |
Primary outcome
Change in time to HCV re-infection diagnosis with the intervention in MITT population
Time frame: Last negative HCV test to first positive HCV test (from start study to first positive HCV test in up to 2 years)
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.
4 secondary outcomes
Change in time to HCV re-infection diagnosis with the intervention in PP
Time frame: 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
Time frame: Through study process, from start screening to study completion, at least 3 years
HCV re-infection incidence in study population
Time frame: During follow-up period of 2 years
HCV infections found at screening
Time frame: At screening visit (T=0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Background: PubMed 29186320Boerekamps 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.
- Background: PubMed 27650285Ingiliz 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.
- 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.
- Individual participant dataSharing planned: No
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 Rijnders, MD PhD principal investigator
Erasmus Medical Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HCV RNA self-test in people with Hepatitis C Recurrent and HIV-1-infection, run by Erasmus Medical Center at 7 sites 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 13 inclusion and 3 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 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 Rijnders, MD PhD (31107033510, b.rijnders@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in time to HCV re-infection diagnosis with the intervention in MITT population (time frame: Last negative HCV test to first positive HCV test (from start study to first positive HCV test in up to 2 years)). 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 NCT04004299, 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 12 Aug 2019.