Hepatitis C, ChronicNCT04029246
Re-engaging Patients With Hepatitis C Into Care
A study testing Follow up phone call and Incentive in people with Hepatitis C, Chronic, run by Glasgow Royal Infirmary at 1 site in United Kingdom.
Trial summary
Aims: To evaluate the impact of a letter, phone call and incentive in re-engaging patients with hepatitis C care. Outcomes of interest: Primary outcome of interest: Attendance for assessment of liver disease within 4 months of being sent invitation letter. Read more about this study
- Who is it for?
- Ages 16 to 110 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- Follow up phone call and Incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2019to 1 Aug 2020
- 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 16 to 110 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 16 years or older
- Known hepatitis C infection which is either:
- untreated
- treated but the outcome of treatment unknown
Who cannot join
- Known HIV infection
- No longer resident within NHS Greater Glasgow and Clyde area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reengaging Patients With Previously Diagnosed Hepatitis C in to Care
Aims:
To evaluate the impact of a letter, phone call and incentive in re-engaging patients with hepatitis C care.
Read more
Outcomes of interest:
Primary outcome of interest:
- Attendance for assessment of liver disease within 4 months of being sent invitation letter.
Secondary outcomes of interest:
- Commencing treatment within 6 months of being sent invitation letter.
Methods:
Patient identification:
The local copy of the Scottish Hepatitis C database holds data regarding patients referred to secondary care for treatment of their hepatitis C, and holds ethics approval for research on treatment and patient outcomes. This will be used to identify patients with hepatitis C infection that is untreated, treatment has been unsuccessful, or the patient has been treated but the outcome is unknown (due to non attendance for blood tests). The database has been cross checked with virus lab results, to ensure infection status is up to date. Finally, the patient data has been checked by NHS GG\&C information team, to exclude patients who are deceased, or whom are no longer resident in NHS greater Glasgow and Clyde based on updated details obtained from SCIstore.
Inclusion criteria:
Patients (16 years and over) who have previously engaged with Hepatitis C services in Glasgow but who are either untreated, have been treated unsuccessfully, or have been treated but have not attended for blood tests to check for treatment success.
Exclusion criteria:
Patients with HIV. Patients no longer resident within NHS Greater Glasgow and Clyde area.
Allocation to contact groups:
Patients will be randomly distributed into 3 groups:
- Letter: Will be sent letter 1 (appendix)
- Letter plus telephone call: will be sent letter 2 (appendix) and be followed up with a telephone call from the treatment centre if no contact has been received after 4 weeks
- Letter plus incentive: will be sent letter 3 (appendix)
Process:
Patient letters will be sent out by GG\&C public health. For all 3 groups the letter will be sent with the small Hepatitis C Scotland booklet "Hepatitis C treatments have changed".
Letters will identify include the telephone number for the identified treatment centre which will be either, the last known treatment centre or a more local treatment centre were appropriate based on current residence.
Primary and secondary outcomes measures will be collected via the Scottish Hepatitis C database.
Lay Summary:
This study will test whether a letter alone, a letter plus follow up phone call or a letter with offer of incentive, will be most effective in re-engaging patients who are known to have hepatitis C but not yet received treatment.
- Conditions
- Hepatitis C, Chronic
- Being tested
- Follow up phone call, Incentive
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow up phone callBehavioural
Telephone call to ask if patient has received letter and whether they would like an appointment
IncentiveBehavioural
Offer of a shopping voucher if patient attends for appointment
| Study group | Role | What they receive |
|---|---|---|
| Letter only | No intervention | Not described |
| Letter plus phone call | Active comparator | Not described Receives: Behavioral: Follow up phone call |
| Letter plus incentive | Active comparator | Not described Receives: Behavioral: Incentive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of attendance for liver assessment
Rates of attendance for assessment of liver disease within a 4 month period, recorded as a binary (yes/no) outcome
Measured: 4 months
Secondary outcomes (1)
Rates of initiation of Hepatitis C treatment
Rates of initiation of treatment for hepatitis C within a 6 month period, recorded as a binary (yes/no) outcome.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start1 Nov 2019
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glasgow Royal Infirmary
- Sponsor type
- University, hospital or other
- Collaborators
- Glasgow Caledonian University
- Responsible party
- Principal investigator, stephen t barclay, Glasgow Royal Infirmary
- Investigators
- Stephen T Barclay, MBChB, Principal investigator, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029246
- Sponsor's protocol ID
- GN19ID200
- Status last verified
- Jul 2020
- First submitted
- 15 Jul 2019
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reengaging Patients With Previously Diagnosed Hepatitis C in to Care
- ClinicalTrials.gov ID
- NCT04029246
- Acronym / sponsor ID
- GN19ID200
- Conditions
- Hepatitis C, Chronic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Glasgow Royal InfirmaryUniversity, hospital or other
- Collaborators
- Glasgow Caledonian University
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 23 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.
Aims:
To evaluate the impact of a letter, phone call and incentive in re-engaging patients with hepatitis C care.
Outcomes of interest:
Primary outcome of interest:
- Attendance for assessment of liver disease within 4 months of being sent invitation letter.
Secondary outcomes of interest:
- Commencing treatment within 6 months of being sent invitation letter.
Methods:
Patient identification:
The local copy of the Scottish Hepatitis C database holds data regarding patients referred to secondary care for treatment of their hepatitis C, and holds ethics approval for research on treatment and patient outcomes. This will be used to identify patients with hepatitis C infection that is untreated, treatment has been unsuccessful, or the patient has been treated but the outcome is unknown (due to non attendance for blood tests). The database has been cross checked with virus lab results, to ensure infection status is up to date. Finally, the patient data has been checked by NHS GG\&C information team, to exclude patients who are deceased, or whom are no longer resident in NHS greater Glasgow and Clyde based on updated details obtained from SCIstore.
Inclusion criteria:
Patients (16 years and over) who have previously engaged with Hepatitis C services in Glasgow but who are either untreated, have been treated unsuccessfully, or have been treated but have not attended for blood tests to check for treatment success.
Exclusion criteria:
Patients with HIV. Patients no longer resident within NHS Greater Glasgow and Clyde area.
Allocation to contact groups:
Patients will be randomly distributed into 3 groups:
- Letter: Will be sent letter 1 (appendix)
- Letter plus telephone call: will be sent letter 2 (appendix) and be followed up with a telephone call from the treatment centre if no contact has been received after 4 weeks
- Letter plus incentive: will be sent letter 3 (appendix)
Process:
Patient letters will be sent out by GG\&C public health. For all 3 groups the letter will be sent with the small Hepatitis C Scotland booklet "Hepatitis C treatments have changed".
Letters will identify include the telephone number for the identified treatment centre which will be either, the last known treatment centre or a more local treatment centre were appropriate based on current residence.
Primary and secondary outcomes measures will be collected via the Scottish Hepatitis C database.
Lay Summary:
This study will test whether a letter alone, a letter plus follow up phone call or a letter with offer of incentive, will be most effective in re-engaging patients who are known to have hepatitis C but not yet received treatment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Letter only | No intervention | – |
| Letter plus phone call | Active comparator | Behavioral: Follow up phone call |
| Letter plus incentive | Active comparator | Behavioral: Incentive |
Who may qualify
- Ages
- 16 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age 16 years or older
- Known hepatitis C infection which is either:
- untreated
- treated but the outcome of treatment unknown
Key exclusion criteria (2 listed)
- Known HIV infection
- No longer resident within NHS Greater Glasgow and Clyde area
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 |
|---|---|---|
| Follow up phone callTelephone call to ask if patient has received letter and whether they would like an appointment | Behavioural | Letter plus phone call |
| IncentiveOffer of a shopping voucher if patient attends for appointment | Behavioural | Letter plus incentive |
Primary outcome
Rate of attendance for liver assessment
Time frame: 4 months
Rates of attendance for assessment of liver disease within a 4 month period, recorded as a binary (yes/no) outcome
1 secondary outcome
Rates of initiation of Hepatitis C treatment
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- 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.
Stephen T Barclay, MBChB principal investigator
NHS Greater Glasgow and Clyde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follow up phone call and Incentive in people with Hepatitis C, Chronic, run by Glasgow Royal Infirmary at 1 site in United Kingdom.
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 4 inclusion and 2 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 23 Jul 2020. 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 United Kingdom. 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?
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?
Rate of attendance for liver assessment (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2020; AzTrials last refreshed its copy on 4 Nov 2026.