Hepatitis C Virus InfectionNCT04037046
Integrating Hepatitis C Screening With Dried Blood Spot Testing Into Colorectal Cancer Screening
A study testing Screening HCV attached onto CCR screening, Screening HCV attached onto CCR screening by self-testing and Screening HCV at primary care center in people with Hepatitis C Virus Infection, run by University of La Laguna at 1 site in Spain.
Trial summary
The main purpose of the study is to compare the acceptance and viability of three strategies aimed to screen hepatitis C virus (HCV) infection in a birth cohort by: a) invitation letter offering HCV screening with dried blood spot (DBS) testing at the primary care center, b) invitation letter offering both HCV and… Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Hepatitis C Virus Infection
- What is being tested?
- Screening HCV attached onto CCR screening, Screening HCV attached onto CCR screening by self-testing and Screening HCV at primary care center
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 609 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2019to 1 Nov 2019
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50-70 years
- Subjects attending selected primary care centers
- Willing to participate (informed consent signed)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Spain1 site
Manuel Hernandez-Guerra, MD
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
About this study
Official title: Clinical Trial to Evaluate the Acceptance and Viability of Three Strategies in Birth Cohort Hepatitis C Screening
The main purpose of the study is to compare the acceptance and viability of three strategies aimed to screen hepatitis C virus (HCV) infection in a birth cohort by: a) invitation letter offering HCV screening with dried blood spot (DBS) testing at the primary care center, b) invitation letter offering both HCV and colorectal cancer (CCR) screening with faecal occult test (FOT) at the primary care center, and c) invitation letter offering self-collected screening at home for HCV and CCR.
Read the detailed description
This is a prospective, randomized, study in which subjects of four different health areas will be invited to participate in three different screening strategies for HCV.
Hepatologists from a tertiary care hospital and general practitioners from four health areas will participate coordinating the study, to first select potential candidates for the study (subjects between 50 and 70 years old of the four areas) and secondly, randomize and include 150 subjects of each area into the three strategies (50 subjects each). The strategies include offering by letter screening at the local primary care center for HCV by using dried blood spot (DBS) testing, screening for HCV and colorectal cancer (CCR) using faecal occult test (FOT) at the primary care center, and self-testing at home-collection with DBS and FOT to be performed by the subject and sent by postal office. Subjects will receive an invitation and informative letter and will be ask to sign the informed consent to participate.
In all the planned strategies subjects will be asked to complete a questionnaire that includes demographic variables. After two months of sending the letters without response, researchers will contact subjects by phone to complete a survey to confirm they received the letter and asking for factors of non-participation.
The hypothesis of the study is that subjects in the risk of having HCV are willing to be screened for HCV infection if offered and that the acceptance will be improved if attached to CCR screening and even higher if the tests are offered to be self-screened.
For the present study, a 15% improvement in the participation (acceptance of the screening strategy) was hypothesized in the group of patients receiving the strategy 2 (and 3) compared to the strategy 1. Taking into account a power of 80%, alpha error of 5% and losses of 20% will require 200 patients per group.
- Conditions
- Hepatitis C Virus Infection
- Being tested
- Screening HCV attached onto CCR screening, Screening HCV attached onto CCR screening by self-testing, Screening HCV at primary care center
- 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 attached onto CCR screeningBehavioural
Patients assigned to this strategy will receive an invitation letter for HCV screening with DBS and CCR screening with FOT at the primary care center to be performed by the general practitioner
Screening HCV attached onto CCR screening by self-testingBehavioural
Patients assigned to this strategy will receive an invitation letter for self-testing for HCV screening with DBS, and CCR screening with FOT
Screening HCV at primary care centerBehavioural
DBS for HCV screening at primary care center
| Study group | Role | What they receive |
|---|---|---|
| Screening HCV with DBS at primary care centers | Experimental | Patients assigned to the strategy 1 will receive an invitation letter for HCV screening with DBS at the primary care center to be performed by the general practitioner Receives: Behavioral: Screening HCV at primary care center |
| Screening HCV and CCR with FOT at primary care centers | Active comparator | Patients assigned to the strategy 2 will receive an invitation letter for HCV screening with DBS and CCR screening with FOT at the primary care center to be performed by the general practitioner Receives: Behavioral: Screening HCV attached onto CCR screening |
| Self-testing at home for screening HCV and CCR | Active comparator | Patients assigned to the strategy 3 will receive an invitation letter for self-testing at home for HCV screening with DBS, and CCR screening with FOT Receives: Behavioral: Screening HCV attached onto CCR screening by self-testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance of the interventions
overall screening rate (number of subjects participating after enrollment)
Measured: 12 months
Secondary outcomes (3)
Feasibility of the intervention measuring quality of spotted cards
the validity of specimens (defined as enough blood sample to fill at least one spot in the card) of DBS tests performed at primary care centers and by self-testing at home
Measured: 12 months
Subject characteristics associated with participation and feasibility of the different strategies
Demographic characteristics associated with participation and feasibility of the different strategies
Measured: 12 months
Effectiveness of each strategy: rate of HCV positivity
rate of HCV positivity
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 posted30 Jul 2019
- Study start1 Mar 2019
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 609 participants (actual)
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
- Investigators
- Manuel Hernandez-Guerra, MD, Principal investigator, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037046
- Sponsor's protocol ID
- DBS_FOT
- Status last verified
- Apr 2021
- First submitted
- 23 Jul 2019
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buti 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 30485377Zuure FR, Urbanus AT, Langendam MW, Helsper CW, van den Berg CH, Davidovich U, Prins M. Outcomes of hepatitis C screening programs targeted at risk groups hidden in the general population: a systematic review. BMC Public Health. 2014 Jan 22;14:66. doi: 10.1186/1471-2458-14-66.
PubMed 24450797Tuaillon E, Mondain AM, Meroueh F, Ottomani L, Picot MC, Nagot N, Van de Perre P, Ducos J. Dried blood spot for hepatitis C virus serology and molecular testing. Hepatology. 2010 Mar;51(3):752-8. doi: 10.1002/hep.23407.
PubMed 20043287
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Acceptance and Viability of Three Strategies in Birth Cohort Hepatitis C Screening
- ClinicalTrials.gov ID
- NCT04037046
- Acronym / sponsor ID
- DBS_FOT
- Conditions
- Hepatitis C Virus Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 609 participants (actual)
- Lead sponsor
- University of La LagunaUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 30 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.
The main purpose of the study is to compare the acceptance and viability of three strategies aimed to screen hepatitis C virus (HCV) infection in a birth cohort by: a) invitation letter offering HCV screening with dried blood spot (DBS) testing at the primary care center, b) invitation letter offering both HCV and colorectal cancer (CCR) screening with faecal occult test (FOT) at the primary care center, and c) invitation letter offering self-collected screening at home for HCV and CCR.
Detailed description
This is a prospective, randomized, study in which subjects of four different health areas will be invited to participate in three different screening strategies for HCV.
Hepatologists from a tertiary care hospital and general practitioners from four health areas will participate coordinating the study, to first select potential candidates for the study (subjects between 50 and 70 years old of the four areas) and secondly, randomize and include 150 subjects of each area into the three strategies (50 subjects each). The strategies include offering by letter screening at the local primary care center for HCV by using dried blood spot (DBS) testing, screening for HCV and colorectal cancer (CCR) using faecal occult test (FOT) at the primary care center, and self-testing at home-collection with DBS and FOT to be performed by the subject and sent by postal office. Subjects will receive an invitation and informative letter and will be ask to sign the informed consent to participate.
In all the planned strategies subjects will be asked to complete a questionnaire that includes demographic variables. After two months of sending the letters without response, researchers will contact subjects by phone to complete a survey to confirm they received the letter and asking for factors of non-participation.
The hypothesis of the study is that subjects in the risk of having HCV are willing to be screened for HCV infection if offered and that the acceptance will be improved if attached to CCR screening and even higher if the tests are offered to be self-screened.
For the present study, a 15% improvement in the participation (acceptance of the screening strategy) was hypothesized in the group of patients receiving the strategy 2 (and 3) compared to the strategy 1. Taking into account a power of 80%, alpha error of 5% and losses of 20% will require 200 patients per group.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Screening HCV with DBS at primary care centers | Experimental | Behavioral: Screening HCV at primary care centerPatients assigned to the strategy 1 will receive an invitation letter for HCV screening with DBS at the primary care center to be performed by the general practitioner |
| Screening HCV and CCR with FOT at primary care centers | Active comparator | Behavioral: Screening HCV attached onto CCR screeningPatients assigned to the strategy 2 will receive an invitation letter for HCV screening with DBS and CCR screening with FOT at the primary care center to be performed by the general practitioner |
| Self-testing at home for screening HCV and CCR | Active comparator | Behavioral: Screening HCV attached onto CCR screening by self-testingPatients assigned to the strategy 3 will receive an invitation letter for self-testing at home for HCV screening with DBS, and CCR screening with FOT |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 50-70 years
- Subjects attending selected primary care centers
- Willing to participate (informed consent signed)
Key exclusion criteria (1 listed)
- -
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 attached onto CCR screeningPatients assigned to this strategy will receive an invitation letter for HCV screening with DBS and CCR screening with FOT at the primary care center to be performed by the general practitioner | Behavioural | Screening HCV and CCR with FOT at primary care centers |
| Screening HCV attached onto CCR screening by self-testingPatients assigned to this strategy will receive an invitation letter for self-testing for HCV screening with DBS, and CCR screening with FOT | Behavioural | Self-testing at home for screening HCV and CCR |
| Screening HCV at primary care centerDBS for HCV screening at primary care center | Behavioural | Screening HCV with DBS at primary care centers |
Primary outcome
Acceptance of the interventions
Time frame: 12 months
overall screening rate (number of subjects participating after enrollment)
3 secondary outcomes
Feasibility of the intervention measuring quality of spotted cards
Time frame: 12 months
Subject characteristics associated with participation and feasibility of the different strategies
Time frame: 12 months
Effectiveness of each strategy: rate of HCV positivity
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- 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 24450797Zuure FR, Urbanus AT, Langendam MW, Helsper CW, van den Berg CH, Davidovich U, Prins M. Outcomes of hepatitis C screening programs targeted at risk groups hidden in the general population: a systematic review. BMC Public Health. 2014 Jan 22;14:66. doi: 10.1186/1471-2458-14-66.
- Background: PubMed 20043287Tuaillon E, Mondain AM, Meroueh F, Ottomani L, Picot MC, Nagot N, Van de Perre P, Ducos J. Dried blood spot for hepatitis C virus serology and molecular testing. Hepatology. 2010 Mar;51(3):752-8. doi: 10.1002/hep.23407.
- 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.
Manuel Hernandez-Guerra, MD principal investigator
MD
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 attached onto CCR screening, Screening HCV attached onto CCR screening by self-testing and Screening HCV at primary care center in people with Hepatitis C Virus Infection, 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 3 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: finished, as of the sponsor's last update on 30 Apr 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance of the interventions (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 NCT04037046, 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 30 Apr 2021.