Hepatitis CNCT05146609
Acceptance of Hepatitis C Screening by Self-testing in High Risk and General Population
A study testing Screening HCV. HR-HOSPITAL, Screening HCV. HR-DDP and Screening HCV. GP-HOSPITAL in people with Hepatitis C, run by University of La Laguna at 1 site in Spain.
Trial summary
The main purpose of the study is to evaluate the acceptance and viability of self-testing using dried blood spot (DBS) testing assisted by center of origin or referral hospital, as a strategy for screening for hepatitis C virus (HCV) in high risk population (ex-users of drug dependence centers) compared to the general… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Screening HCV. HR-HOSPITAL, Screening HCV. HR-DDP and Screening HCV. GP-HOSPITAL
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,384 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2022to Jun 2024
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All subjects who have contacted a drug dependence center between 2013 and 2017, as well as patients from a group of a primary care center.
- Signed informed consent.
Who cannot join
- Patient's refusal to participate in the study.
- Negative HCV serology or viral load in the last year.
- Death.
- Belonging to another health area
- Not having the patient's address in the hospital's computer system.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Complejo Hospitalario Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
Manuel Hernandez-Guerra, MD, +34922678559, mhernand@ull.edu.es
About this study
The main purpose of the study is to evaluate the acceptance and viability of self-testing using dried blood spot (DBS) testing assisted by center of origin or referral hospital, as a strategy for screening for hepatitis C virus (HCV) in high risk population (ex-users of drug dependence centers) compared to the general population assisted by primary care centers.
Read the detailed description
This is a randomized clinical trial involving patients who between 2013 and 2017 have contacted the drug dependence center and patients from general population.
After selecting those who do not meet any exclusion criteria, a letter will be sent to them inviting them to participate in this study. This letter will contain the study information sheet and informed consent, and a self-testing kit with an explanatory leaflet so that each person can carry out the test in a simple and easy way.
The main purpose of the study is to evaluate the acceptance and viability of self-testing using dried blood spot (DBS) testing, to study whether support improves participation and to identify predictors of participation.
For the present study, assuming an increase of 18% participation (from 18% to 28% offering support by the patient's referral center, and based on a previous study in our environment of self-testing in the general population), taking into account a power of 80%, alpha error of 5%, and losses of 20%, will require 346 patients per group.
- Conditions
- Hepatitis C
- Being tested
- Screening HCV. HR-HOSPITAL, Screening HCV. HR-DDP, Screening HCV. GP-HOSPITAL, Screening HCV. GP-PCC
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening HCV. HR-HOSPITALBehavioural
Screening HCV in high risk population by themselves or at referral hospital.
Screening HCV. HR-DDPBehavioural
Screening HCV in high risk population by themselves or at drug dependence center.
Screening HCV. GP-HOSPITALBehavioural
Screening HCV in general population by themselves or at referral hospital.
Screening HCV. GP-PCCBehavioural
Screening HCV in general population by themselves or at primary care center.
| Study group | Role | What they receive |
|---|---|---|
| HR-HOSPITAL | Experimental | Patients assigned to the strategy HR-HOSPITAL, who are high risk population (HR), will receive an invitation letter for HCV screening with DBS to be performed by themselves or at the referral hospital. Receives: Behavioral: Screening HCV. HR-HOSPITAL |
| HR-DDP | Experimental | Patients assigned to the strategy HR-DDP, who are high risk population, will receive an invitation letter for HCV screening with DBS to be performed by themselves or at the drug dependence center (DDP) the participants used to attend. Receives: Behavioral: Screening HCV. HR-DDP |
| GP-HOSPITAL | Experimental | Patients assigned to the strategy GP-HOSPITAL, who are general population (GP), will receive an invitation letter for HCV screening with DBS to be performed by themselves or at the referral hospital. Receives: Behavioral: Screening HCV. GP-HOSPITAL |
| GP-PCC | Experimental | Patients assigned to the strategy GP-PCC, who are general population (GP), will receive an invitation letter for HCV screening with DBS to be performed by themselves or at the primary care center (PCC) to be performed by the general practitioner. Receives: Behavioral: Screening HCV. GP-PCC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance of the intervention
Overall screening rate
Measured: 12 months
Secondary outcomes (2)
Viability
The investigators will measure and report the amount of DBS received from the participants, taking into account the group to which the participants belong.
Measured: 12 months
Participation
Number of participants by sending their DBS and different possible factors associated to a higher rate of participation.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start1 Feb 2022
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of La Laguna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Hernandez-Guerra, MD, University of La Laguna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146609
- Sponsor's protocol ID
- TGSS_EXCAD_AP
- Status last verified
- Dec 2023
- First submitted
- 25 Oct 2021
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
European Association for Study of Liver. EASL Clinical Practice Guidelines: management of hepatitis C virus infection. J Hepatol. 2014 Feb;60(2):392-420. doi: 10.1016/j.jhep.2013.11.003. Epub 2013 Dec 9. No abstract available.
PubMed 24331294Baumert TF, Juhling F, Ono A, Hoshida Y. Hepatitis C-related hepatocellular carcinoma in the era of new generation antivirals. BMC Med. 2017 Mar 14;15(1):52. doi: 10.1186/s12916-017-0815-7.
PubMed 28288626Westbrook RH, Dusheiko G. Natural history of hepatitis C. J Hepatol. 2014 Nov;61(1 Suppl):S58-68. doi: 10.1016/j.jhep.2014.07.012. Epub 2014 Nov 3.
PubMed 25443346Sarin SK, Kumar M. Natural history of HCV infection. Hepatol Int. 2012 Oct;6(4):684-95. doi: 10.1007/s12072-012-9355-6. Epub 2012 Mar 9.
PubMed 26201520Buti M, Dominguez-Hernandez R, Casado MA, Sabater E, Esteban R. Healthcare value of implementing hepatitis C screening in the adult general population in Spain. PLoS One. 2018 Nov 28;13(11):e0208036. doi: 10.1371/journal.pone.0208036. eCollection 2018.
PubMed 30485377Juanbeltz R, Perez-Garcia A, Aguinaga A, Martinez-Baz I, Casado I, Burgui C, Goni-Esarte S, Reparaz J, Zozaya JM, San Miguel R, Ezpeleta C, Castilla J; EIPT-VHC Study Group. Progress in the elimination of hepatitis C virus infection: A population-based cohort study in Spain. PLoS One. 2018 Dec 4;13(12):e0208554. doi: 10.1371/journal.pone.0208554. eCollection 2018.
PubMed 30513107Morales-Arraez D, Hernandez-Guerra M. Electronic Alerts as a Simple Method for Amplifying the Yield of Hepatitis C Virus Infection Screening and Diagnosis. Am J Gastroenterol. 2020 Jan;115(1):9-12. doi: 10.14309/ajg.0000000000000487. No abstract available.
PubMed 31833860Fitz JG. Hepatology after Hepatitis C. Dig Dis. 2016;34(5):603-6. doi: 10.1159/000445276. Epub 2016 Jun 22.
PubMed 27332966Crespo J, Albillos A, Buti M, Calleja JL, Garcia-Samaniego J, Hernandez-Guerra M, Serrano T, Turnes J, Acin E, Berenguer J, Berenguer M, Colom J, Fernandez I, Fernandez Rodriguez C, Forns X, Garcia F, Rafael Granados, Lazarus JV, Molero JM, Molina E, Perez Escanilla F, Pineda JA, Rodriguez M, Romero M, Roncero C, Saiz de la Hoya P, Sanchez Antolin G. Elimination of hepatitis C. Positioning document of the Spanish Association for the Study of the Liver (AEEH). Gastroenterol Hepatol. 2019 Nov;42(9):579-592. doi: 10.1016/j.gastrohep.2019.09.002. Epub 2019 Oct 5. English, Spanish.
PubMed 31594683Morales-Arraez D, Hernandez-Bustabad A, Medina-Alonso MJ, Santiago-Gutierrez LG, Garcia-Gil S, Diaz-Flores F, Perez-Perez V, Nazco J, Fernandez de Rota Martin P, Gutierrez F, Hernandez-Guerra M. Telemedicine and decentralized hepatitis C treatment as a strategy to enhance retention in care among people attending drug treatment centres. Int J Drug Policy. 2021 Aug;94:103235. doi: 10.1016/j.drugpo.2021.103235. Epub 2021 Apr 7.
PubMed 33838399Bedford J, Enria D, Giesecke J, Heymann DL, Ihekweazu C, Kobinger G, Lane HC, Memish Z, Oh MD, Sall AA, Schuchat A, Ungchusak K, Wieler LH; WHO Strategic and Technical Advisory Group for Infectious Hazards. COVID-19: towards controlling of a pandemic. Lancet. 2020 Mar 28;395(10229):1015-1018. doi: 10.1016/S0140-6736(20)30673-5. Epub 2020 Mar 17. No abstract available.
PubMed 32197103Blach S, Kondili LA, Aghemo A, Cai Z, Dugan E, Estes C, Gamkrelidze I, Ma S, Pawlotsky JM, Razavi-Shearer D, Razavi H, Waked I, Zeuzem S, Craxi A. Impact of COVID-19 on global HCV elimination efforts. J Hepatol. 2021 Jan;74(1):31-36. doi: 10.1016/j.jhep.2020.07.042. Epub 2020 Aug 7.
PubMed 32777322
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance of Hepatitis C Screening by Self-testing in High Risk and General Population
- ClinicalTrials.gov ID
- NCT05146609
- Acronym / sponsor ID
- TGSS_EXCAD_AP
- Conditions
- Hepatitis C
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,384 participants (estimated)
- Lead sponsor
- University of La LagunaUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 7 Dec 2021 (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.
The main purpose of the study is to evaluate the acceptance and viability of self-testing using dried blood spot (DBS) testing assisted by center of origin or referral hospital, as a strategy for screening for hepatitis C virus (HCV) in high risk population (ex-users of drug dependence centers) compared to the general population assisted by primary care centers.
Detailed description
This is a randomized clinical trial involving patients who between 2013 and 2017 have contacted the drug dependence center and patients from general population.
After selecting those who do not meet any exclusion criteria, a letter will be sent to them inviting them to participate in this study. This letter will contain the study information sheet and informed consent, and a self-testing kit with an explanatory leaflet so that each person can carry out the test in a simple and easy way.
The main purpose of the study is to evaluate the acceptance and viability of self-testing using dried blood spot (DBS) testing, to study whether support improves participation and to identify predictors of participation.
For the present study, assuming an increase of 18% participation (from 18% to 28% offering support by the patient's referral center, and based on a previous study in our environment of self-testing in the general population), taking into account a power of 80%, alpha error of 5%, and losses of 20%, will require 346 patients per group.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HR-HOSPITAL | Experimental | Behavioral: Screening HCV. HR-HOSPITALPatients assigned to the strategy HR-HOSPITAL, who are high risk population (HR), will receive an invitation letter for HCV screening with DBS to be performed by themselves or at the referral hospital. |
| HR-DDP | Experimental | Behavioral: Screening HCV. HR-DDPPatients assigned to the strategy HR-DDP, who are high risk population, will receive an invitation letter for HCV screening with DBS to be performed by themselves or at the drug dependence center (DDP) the participants used to attend. |
| GP-HOSPITAL | Experimental | Behavioral: Screening HCV. GP-HOSPITALPatients assigned to the strategy GP-HOSPITAL, who are general population (GP), will receive an invitation letter for HCV screening with DBS to be performed by themselves or at the referral hospital. |
| GP-PCC | Experimental | Behavioral: Screening HCV. GP-PCCPatients assigned to the strategy GP-PCC, who are general population (GP), will receive an invitation letter for HCV screening with DBS to be performed by themselves or at the primary care center (PCC) to be performed by the general practitioner. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All subjects who have contacted a drug dependence center between 2013 and 2017, as well as patients from a group of a primary care center.
- Signed informed consent.
Key exclusion criteria (5 listed)
- Patient's refusal to participate in the study.
- Negative HCV serology or viral load in the last year.
- Death.
- Belonging to another health area
- Not having the patient's address in the hospital's computer system.
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 |
|---|---|---|
| Screening HCV. HR-HOSPITALScreening HCV in high risk population by themselves or at referral hospital. | Behavioural | HR-HOSPITAL |
| Screening HCV. HR-DDPScreening HCV in high risk population by themselves or at drug dependence center. | Behavioural | HR-DDP |
| Screening HCV. GP-HOSPITALScreening HCV in general population by themselves or at referral hospital. | Behavioural | GP-HOSPITAL |
| Screening HCV. GP-PCCScreening HCV in general population by themselves or at primary care center. | Behavioural | GP-PCC |
Primary outcome
Acceptance of the intervention
Time frame: 12 months
Overall screening rate
2 secondary outcomes
Viability
Time frame: 12 months
Participation
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Background: PubMed 24331294European Association for Study of Liver. EASL Clinical Practice Guidelines: management of hepatitis C virus infection. J Hepatol. 2014 Feb;60(2):392-420. doi: 10.1016/j.jhep.2013.11.003. Epub 2013 Dec 9. No abstract available.
- Background: PubMed 28288626Baumert TF, Juhling F, Ono A, Hoshida Y. Hepatitis C-related hepatocellular carcinoma in the era of new generation antivirals. BMC Med. 2017 Mar 14;15(1):52. doi: 10.1186/s12916-017-0815-7.
- Background: PubMed 25443346Westbrook RH, Dusheiko G. Natural history of hepatitis C. J Hepatol. 2014 Nov;61(1 Suppl):S58-68. doi: 10.1016/j.jhep.2014.07.012. Epub 2014 Nov 3.
- Background: PubMed 26201520Sarin SK, Kumar M. Natural history of HCV infection. Hepatol Int. 2012 Oct;6(4):684-95. doi: 10.1007/s12072-012-9355-6. Epub 2012 Mar 9.
- Background: PubMed 30485377Buti M, Dominguez-Hernandez R, Casado MA, Sabater E, Esteban R. Healthcare value of implementing hepatitis C screening in the adult general population in Spain. PLoS One. 2018 Nov 28;13(11):e0208036. doi: 10.1371/journal.pone.0208036. eCollection 2018.
- Background: PubMed 30513107Juanbeltz R, Perez-Garcia A, Aguinaga A, Martinez-Baz I, Casado I, Burgui C, Goni-Esarte S, Reparaz J, Zozaya JM, San Miguel R, Ezpeleta C, Castilla J; EIPT-VHC Study Group. Progress in the elimination of hepatitis C virus infection: A population-based cohort study in Spain. PLoS One. 2018 Dec 4;13(12):e0208554. doi: 10.1371/journal.pone.0208554. eCollection 2018.
- Background: PubMed 31833860Morales-Arraez D, Hernandez-Guerra M. Electronic Alerts as a Simple Method for Amplifying the Yield of Hepatitis C Virus Infection Screening and Diagnosis. Am J Gastroenterol. 2020 Jan;115(1):9-12. doi: 10.14309/ajg.0000000000000487. No abstract available.
- Background: PubMed 27332966Fitz JG. Hepatology after Hepatitis C. Dig Dis. 2016;34(5):603-6. doi: 10.1159/000445276. Epub 2016 Jun 22.
- Background: PubMed 31594683Crespo J, Albillos A, Buti M, Calleja JL, Garcia-Samaniego J, Hernandez-Guerra M, Serrano T, Turnes J, Acin E, Berenguer J, Berenguer M, Colom J, Fernandez I, Fernandez Rodriguez C, Forns X, Garcia F, Rafael Granados, Lazarus JV, Molero JM, Molina E, Perez Escanilla F, Pineda JA, Rodriguez M, Romero M, Roncero C, Saiz de la Hoya P, Sanchez Antolin G. Elimination of hepatitis C. Positioning document of the Spanish Association for the Study of the Liver (AEEH). Gastroenterol Hepatol. 2019 Nov;42(9):579-592. doi: 10.1016/j.gastrohep.2019.09.002. Epub 2019 Oct 5. English, Spanish.
- Background: PubMed 33838399Morales-Arraez D, Hernandez-Bustabad A, Medina-Alonso MJ, Santiago-Gutierrez LG, Garcia-Gil S, Diaz-Flores F, Perez-Perez V, Nazco J, Fernandez de Rota Martin P, Gutierrez F, Hernandez-Guerra M. Telemedicine and decentralized hepatitis C treatment as a strategy to enhance retention in care among people attending drug treatment centres. Int J Drug Policy. 2021 Aug;94:103235. doi: 10.1016/j.drugpo.2021.103235. Epub 2021 Apr 7.
- Background: PubMed 32197103Bedford J, Enria D, Giesecke J, Heymann DL, Ihekweazu C, Kobinger G, Lane HC, Memish Z, Oh MD, Sall AA, Schuchat A, Ungchusak K, Wieler LH; WHO Strategic and Technical Advisory Group for Infectious Hazards. COVID-19: towards controlling of a pandemic. Lancet. 2020 Mar 28;395(10229):1015-1018. doi: 10.1016/S0140-6736(20)30673-5. Epub 2020 Mar 17. No abstract available.
- Background: PubMed 32777322Blach S, Kondili LA, Aghemo A, Cai Z, Dugan E, Estes C, Gamkrelidze I, Ma S, Pawlotsky JM, Razavi-Shearer D, Razavi H, Waked I, Zeuzem S, Craxi A. Impact of COVID-19 on global HCV elimination efforts. J Hepatol. 2021 Jan;74(1):31-36. doi: 10.1016/j.jhep.2020.07.042. Epub 2020 Aug 7.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening HCV. HR-HOSPITAL, Screening HCV. HR-DDP and Screening HCV. GP-HOSPITAL in people with Hepatitis C, run by University of La Laguna at 1 site in Spain.
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 5 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 5 Dec 2023. 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 Spain. 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 Manuel Hernandez-Guerra, MD (+34922678559, mhernand@ull.edu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance of the intervention (time frame: 12 months). 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 NCT05146609, which also lists 12 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 5 Dec 2023.