Hepatitis CNCT03831555
Tool to Improve Treatment Adherence and Outcomes at Grady Liver Clinic
A study testing PREP-C in people with Hepatitis C, run by Emory University at 1 site in United States.
Trial summary
The purpose of this study is to learn more about what psychological and social factors affect people in how they take their hepatitis C medications. 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?
- PREP-C
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2017to 30 Jun 2018
- 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
- seen in the Grady Liver Clinic during the study time period
- have a confirmed chronic hepatitis C infection (hepatitis C antibody positive and detectable hepatitis C viral load)
Who cannot join
- no chronic hepatitis C infection
- co-infection with HIV or hepatitis B
- non-English speaking
- unable to consent to participate
- already started HCV therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of a Psychosocial Readiness Tool to Improve Hepatitis C Treatment Adherence and Outcomes at the Grady Liver Clinic
The purpose of this study is to learn more about what psychological and social factors affect people in how they take their hepatitis C medications.
Read the detailed description
The goal of this study is to determine if a qualitative survey that assesses a patient's readiness for treatment of Hepatitis C (HCV) and associated interventions based on identified barriers can improve treatment adherence and outcomes. HCV remains a leading cause of liver cancer and end stage liver disease despite greater than 90% cure rates with new, all-oral antiviral medications. While these new medications are easier to tolerate and access than previous treatment regimens, medication adherence still remains a great barrier to cure. In this study, we will administer the Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment (PREP-C) tool, a free, online survey developed at the Mount Sinai School of Medicine to determine psychosocial readiness for treatment.
- Conditions
- Hepatitis C
- Being tested
- PREP-C
- Keywords
- Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment tool
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREP-CBehavioural
The Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment (PREP-C) tool assesses a patient's psychosocial readiness to start HCV treatment. There are nine sections in the survey:
- Motivation: reasons client wants to begin HCV treatment, concerns about treatment, and the importance of treatment
- Information: knowledge about HCV treatment and one's own HCV disease status
- Medication Adherence: current prescribed medications and adherence to them in the prior month
- Self-efficacy: self-confidence about adhering to HCV treatment
- Social Support and Stability: stability of financial, housing, and social support resources
- Alcohol and substance use: alcohol and substance use behaviors and current treatment
- Psychiatric Stability: current psychiatric status, previous and current treatment
- Energy Level: sleep and fatigue
- Cognitive Functioning: perceived difficulty with communication in health care setting, problem-solving ability, and memory.
| Study group | Role | What they receive |
|---|---|---|
| PREP-C | Active comparator | The research assistant will complete the abbreviated PREP-C survey with the study participants either before or after their medical appointment. The PREP-C tool is accessed online at https://prepc.org/. Receives: Behavioral: PREP-C |
| Standard of care | No intervention | Participants will receive the standard of care (usual care) for chronic HCV infection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants keeping follow-up appointments
Adherence to HCV treatment will be measured by documenting the number of participants keeping their follow-up appointments. This data will be collected from chart reviews.
Measured: At 4 months
Number of participants keeping follow-up appointments
Adherence to HCV treatment will be measured by documenting the number of participants keeping their follow-up appointments. This data will be collected from chart reviews.
Measured: At 8 months
Number of participants refilling medications
Adherence to HCV treatment will be measured by documenting the number of participants who refill their medications. This data will be collected from chart reviews.
Measured: At 4 months
Number of participants refilling medications
Adherence to HCV treatment will be measured by documenting the number of participants who refill their medications. This data will be collected from chart reviews.
Measured: At 8 months
Number of participants who keep lab visits
Adherence to HCV treatment will be measured by documenting the number of participants who keep their lab visits.This data will be collected from chart reviews.
Measured: At 4 months
Number of participants who keep lab visits
Adherence to HCV treatment will be measured by documenting the number of participants who keep their lab visits.This data will be collected from chart reviews.
Measured: At 8 months
Rapid virologic response (RVR)
The treatment outcome will be measured by analyzing the rapid virologic response (RVR) at 4 weeks after completion of treatment. Rapid virologic response (RVR) is defined as an undetectable serum hepatitis C virus (HCV) RNA. This data will be collected from chart reviews.
Measured: At 4 weeks
Sustained virologic response (SVR)
The treatment outcome will be measured by analyzing the sustained virologic response (SVR) at 12 weeks after completion of treatment. SVR is defined as aviremia 12 weeks after completion of antiviral therapy. This data will be collected from chart reviews.
Measured: At 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start5 Jun 2017
- Primary completion1 May 2018
- Study completion30 Jun 2018
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.
- More trials run by Emory UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lesley Miller, Emory University
- Investigators
- Lesley Miller, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831555
- Sponsor's protocol ID
- IRB00093687
- Status last verified
- Feb 2019
- First submitted
- 31 Jan 2019
- Last updated
- 6 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Psychosocial Readiness Tool to Improve Hepatitis C Treatment Adherence and Outcomes at the Grady Liver Clinic
- ClinicalTrials.gov ID
- NCT03831555
- Acronym / sponsor ID
- IRB00093687
- Conditions
- Hepatitis C
- Keywords
- Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment tool
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 6 Feb 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 purpose of this study is to learn more about what psychological and social factors affect people in how they take their hepatitis C medications.
Detailed description
The goal of this study is to determine if a qualitative survey that assesses a patient's readiness for treatment of Hepatitis C (HCV) and associated interventions based on identified barriers can improve treatment adherence and outcomes. HCV remains a leading cause of liver cancer and end stage liver disease despite greater than 90% cure rates with new, all-oral antiviral medications. While these new medications are easier to tolerate and access than previous treatment regimens, medication adherence still remains a great barrier to cure. In this study, we will administer the Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment (PREP-C) tool, a free, online survey developed at the Mount Sinai School of Medicine to determine psychosocial readiness for treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PREP-C | Active comparator | Behavioral: PREP-CThe research assistant will complete the abbreviated PREP-C survey with the study participants either before or after their medical appointment. The PREP-C tool is accessed online at https://prepc.org/. |
| Standard of care | No intervention | –Participants will receive the standard of care (usual care) for chronic HCV infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- seen in the Grady Liver Clinic during the study time period
- have a confirmed chronic hepatitis C infection (hepatitis C antibody positive and detectable hepatitis C viral load)
Key exclusion criteria (5 listed)
- no chronic hepatitis C infection
- co-infection with HIV or hepatitis B
- non-English speaking
- unable to consent to participate
- already started HCV therapy
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 |
|---|---|---|
| PREP-CThe Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment (PREP-C) tool assesses a patient's psychosocial readiness to start HCV treatment. There are nine sections in the survey: 1. Motivation: reasons client wants to begin HCV treatment, concerns about treatment, and the importance of treatment 2. Information: knowledge about HCV treatment and one's own HCV disease status 3. Medication Adherence: current prescribed medications and adherence to them in the prior month 4. Self-efficacy: self-confidence about adhering to HCV treatment 5. Social Support and Stability: stability of financial, housing, and social support resources 6. Alcohol and substance use: alcohol and substance use behaviors and current treatment 7. Psychiatric Stability: current psychiatric status, previous and current treatment 8. Energy Level: sleep and fatigue 9. Cognitive Functioning: perceived difficulty with communication in health care setting, problem-solving ability, and memory. | Behavioural | PREP-C |
Primary outcome
Number of participants keeping follow-up appointments
Time frame: At 4 months
Adherence to HCV treatment will be measured by documenting the number of participants keeping their follow-up appointments. This data will be collected from chart reviews.
Number of participants keeping follow-up appointments
Time frame: At 8 months
Adherence to HCV treatment will be measured by documenting the number of participants keeping their follow-up appointments. This data will be collected from chart reviews.
Number of participants refilling medications
Time frame: At 4 months
Adherence to HCV treatment will be measured by documenting the number of participants who refill their medications. This data will be collected from chart reviews.
Number of participants refilling medications
Time frame: At 8 months
Adherence to HCV treatment will be measured by documenting the number of participants who refill their medications. This data will be collected from chart reviews.
Number of participants who keep lab visits
Time frame: At 4 months
Adherence to HCV treatment will be measured by documenting the number of participants who keep their lab visits.This data will be collected from chart reviews.
Number of participants who keep lab visits
Time frame: At 8 months
Adherence to HCV treatment will be measured by documenting the number of participants who keep their lab visits.This data will be collected from chart reviews.
Rapid virologic response (RVR)
Time frame: At 4 weeks
The treatment outcome will be measured by analyzing the rapid virologic response (RVR) at 4 weeks after completion of treatment. Rapid virologic response (RVR) is defined as an undetectable serum hepatitis C virus (HCV) RNA. This data will be collected from chart reviews.
Sustained virologic response (SVR)
Time frame: At 12 weeks
The treatment outcome will be measured by analyzing the sustained virologic response (SVR) at 12 weeks after completion of treatment. SVR is defined as aviremia 12 weeks after completion of antiviral therapy. This data will be collected from chart reviews.
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 6 Feb 2019.
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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.
Lesley Miller, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PREP-C in people with Hepatitis C, run by Emory University at 1 site in United States.
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: finished, as of the sponsor's last update on 6 Feb 2019. 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 States. 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?
Number of participants keeping follow-up appointments (time frame: At 4 months). The study lists 8 primary outcomes in all. 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 6 Feb 2019.