Hepatitis CNCT04153708
Retrieval of Hepatitis C Patients Lost to Follow-up
A study testing Retrieval patients lost to follow-up with positive HCV antibodies without RNA request or positive RNA by phone call. and Retrieval patients lost to follow-up with positive HCV antibodies without RNA request or positive RNA by mail letter 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 compare the efficacy of two strategies aimed to rescue patients lost to follow-up with active infection or with positive HCV antibodies without RNA request to complete evaluation and prescription of treatment in cases of chronic infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Retrieval patients lost to follow-up with positive HCV antibodies without RNA request or positive RNA by phone call. and Retrieval patients lost to follow-up with positive HCV antibodies without RNA request or positive RNA by mail letter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 1 siteSpain
- Study dates
- 3 Nov 2019to 1 Sep 2021
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Record of positive HCV antibodies without RNA request or positive RNA lost to follow-up (non-treated patients with an active infection, without surveillance by any HCV specialist)
- Patients a valid sanitary card in our public health system
- Patients with available data for contact)
Who cannot join
- Belong to another catchment area. Current surveillance by any HCV specialist and/or record of sustained virological response.
- Severe comorbidity with an expected survival lower than 1 year.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Manuel Hernandez-Guerra
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
Manuel Hernandez-guerra, MD, 666866237, mhernand@ull.edu.es
About this study
Official title: A Clinical Trial to Evaluate the Efficacy of Two Strategies to Linkage to Care Patients With Hepatitis C Lost to Follow-up
The main purpose of the study is to compare the efficacy of two strategies aimed to rescue patients lost to follow-up with active infection or with positive HCV antibodies without RNA request to complete evaluation and prescription of treatment in cases of chronic infection. After patient identification from data files of laboratory and microbiology charts, patients will be randomized to: a) phone call, and b) invitation letter, both of two strategies including a scheduled appointment with the hepatologist.
Read the detailed description
This is a prospective, randomized study in which subjects lost to follow-up with positive HCV antibodies without RNA request or positive RNA will be proposed to be brought back into care.
After patients identification from data files of laboratory and microbiology charts using three different cohorts in time (2005-07, 2011-11 and 2015-17), eligible patients (18 years of age or older, patients positive for HCV antibodies without RNA request or positive RNA lost to follow-up, with a valid sanitary card in our public health system and with available data for contact) will be randomized to: a) phone call (Strategy 1), and b) invitation letter (Strategy 2), both of two strategies including a scheduled appointment with the hepatologist.
Strategy 1 includes until three phone calls to contact patients and provide them with an appointment with the hepatologist (tertiary care center) over a period of 14 days according to patient availability. Instead, strategy 2 includes an invitation letter providing patients with the appointment with the hepatologist over a same period of time than strategy 1. If there is no response to calls or no attendance to the appointment after the letter (randomized strategy), the strategy will be switched to the another one.
Epidemiological, clinical, and laboratory variables will be registered.
The hypothesis of the study is that phone calls will improve the rate of linkage to care among HCV patients lost to follow-up compared to the invitation letter shipment. Therefore, call would be an effective strategy to rescue these patients.
For the present study, a 15% of improvement in linkage to care was hypothesized in the group of patients receiving the strategy 1 compared with the strategy 2. Taking into account a power of 80%, alpha error of 5% and losses of 10% will require 176 patients per strategy.
- Conditions
- Hepatitis C
- Being tested
- Retrieval patients lost to follow-up with positive HCV antibodies without RNA request or positive RNA by phone call., Retrieval patients lost to follow-up with positive HCV antibodies without RNA request or positive RNA by mail letter
- Keywords
- hepatitis C, lost to follow-up, microelimination
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrieval patients lost to follow-up with positive HCV antibodies without RNA request or positive RNA by phone call.Behavioural
Patients assigned to strategy 1 will be called to schedule an appointment with the hepatologist over a period of 14 days.
Retrieval patients lost to follow-up with positive HCV antibodies without RNA request or positive RNA by mail letterBehavioural
Patients assigned to strategy 2 will receive an invitation letter with an appointment with the hepatologist over a period of 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Retrieval by phone call. | Experimental | Patients assigned to strategy 1 will be called to schedule an appointment with the hepatologist over a period of 14 days. Receives: Behavioral: Retrieval patients lost to follow-up with positive HCV antibodies without RNA request or positive RNA by phone call. |
| Retrieval by mail letter | Active comparator | Patients assigned to strategy 2 will receive an invitation letter with an appointment with the hepatologist over a period of 14 days. Receives: Behavioral: Retrieval patients lost to follow-up with positive HCV antibodies without RNA request or positive RNA by mail letter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance of the intervention
Number of patients and % attending the clinic (linkage to care rate)
Measured: One month after the intervention
Secondary outcomes (3)
Effectiveness of the intervention
Number of patients and % that cure the infection due to intervention (complete assessment and treatment rate).
Measured: 6 months after starting treatment
Viability of the intervention
Number of patients with unavailable or inaccurate data for contact
Measured: 1 week
Factors associated with viability of the strategies
Rate of patients with predictive factors associated to outcome 1
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 posted6 Nov 2019
- Study start3 Nov 2019
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to either call or mail invitation
- Masking
- None (open label)
- Enrolment
- 352 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
- Investigators
- Enrique Quintero Carrion, MD, Study chair, Hospital Universitario de Canarias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153708
- Sponsor's protocol ID
- CHUC_2019 23
- Status last verified
- Apr 2021
- First submitted
- 3 Nov 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
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
- A Clinical Trial to Evaluate the Efficacy of Two Strategies to Linkage to Care Patients With Hepatitis C Lost to Follow-up
- ClinicalTrials.gov ID
- NCT04153708
- Acronym / sponsor ID
- CHUC_2019 23
- Conditions
- Hepatitis C
- Keywords
- hepatitis C, lost to follow-up, microelimination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 352 participants (estimated)
- Lead sponsor
- University of La LagunaUniversity, hospital or other
- Study start
- 3 Nov 2019 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 6 Nov 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 efficacy of two strategies aimed to rescue patients lost to follow-up with active infection or with positive HCV antibodies without RNA request to complete evaluation and prescription of treatment in cases of chronic infection. After patient identification from data files of laboratory and microbiology charts, patients will be randomized to: a) phone call, and b) invitation letter, both of two strategies including a scheduled appointment with the hepatologist.
Detailed description
This is a prospective, randomized study in which subjects lost to follow-up with positive HCV antibodies without RNA request or positive RNA will be proposed to be brought back into care.
After patients identification from data files of laboratory and microbiology charts using three different cohorts in time (2005-07, 2011-11 and 2015-17), eligible patients (18 years of age or older, patients positive for HCV antibodies without RNA request or positive RNA lost to follow-up, with a valid sanitary card in our public health system and with available data for contact) will be randomized to: a) phone call (Strategy 1), and b) invitation letter (Strategy 2), both of two strategies including a scheduled appointment with the hepatologist.
Strategy 1 includes until three phone calls to contact patients and provide them with an appointment with the hepatologist (tertiary care center) over a period of 14 days according to patient availability. Instead, strategy 2 includes an invitation letter providing patients with the appointment with the hepatologist over a same period of time than strategy 1. If there is no response to calls or no attendance to the appointment after the letter (randomized strategy), the strategy will be switched to the another one.
Epidemiological, clinical, and laboratory variables will be registered.
The hypothesis of the study is that phone calls will improve the rate of linkage to care among HCV patients lost to follow-up compared to the invitation letter shipment. Therefore, call would be an effective strategy to rescue these patients.
For the present study, a 15% of improvement in linkage to care was hypothesized in the group of patients receiving the strategy 1 compared with the strategy 2. Taking into account a power of 80%, alpha error of 5% and losses of 10% will require 176 patients per strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized to either call or mail invitation
| Arm | Type | Receives |
|---|---|---|
| Retrieval by phone call. | Experimental | Behavioral: Retrieval patients lost to follow-up with positive HCV antibodies without RNA request or positive RNA by phone call.Patients assigned to strategy 1 will be called to schedule an appointment with the hepatologist over a period of 14 days. |
| Retrieval by mail letter | Active comparator | Behavioral: Retrieval patients lost to follow-up with positive HCV antibodies without RNA request or positive RNA by mail letterPatients assigned to strategy 2 will receive an invitation letter with an appointment with the hepatologist over a period of 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Record of positive HCV antibodies without RNA request or positive RNA lost to follow-up (non-treated patients with an active infection, without surveillance by any HCV specialist)
- Patients a valid sanitary card in our public health system
- Patients with available data for contact)
Key exclusion criteria (2 listed)
- Belong to another catchment area. Current surveillance by any HCV specialist and/or record of sustained virological response.
- Severe comorbidity with an expected survival lower than 1 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 |
|---|---|---|
| Retrieval patients lost to follow-up with positive HCV antibodies without RNA request or positive RNA by phone call.Patients assigned to strategy 1 will be called to schedule an appointment with the hepatologist over a period of 14 days. | Behavioural | Retrieval by phone call. |
| Retrieval patients lost to follow-up with positive HCV antibodies without RNA request or positive RNA by mail letterPatients assigned to strategy 2 will receive an invitation letter with an appointment with the hepatologist over a period of 14 days. | Behavioural | Retrieval by mail letter |
Primary outcome
Acceptance of the intervention
Time frame: One month after the intervention
Number of patients and % attending the clinic (linkage to care rate)
3 secondary outcomes
Effectiveness of the intervention
Time frame: 6 months after starting treatment
Viability of the intervention
Time frame: 1 week
Factors associated with viability of the strategies
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 30 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
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.
Enrique Quintero Carrion, MD study chair
Hospital Universitario de Canarias
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retrieval patients lost to follow-up with positive HCV antibodies without RNA request or positive RNA by phone call. and Retrieval patients lost to follow-up with positive HCV antibodies without RNA request or positive RNA by mail letter 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 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 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?
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 (666866237, 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: One month after the intervention). 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 30 Apr 2021.