Hepatitis C, ChronicNCT04202081
Voices From the Black Community: Hepatitis C Research Participation
An observational study of Hepatitis C, Chronic, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This is a one-time cross-sectional survey study of approximately 200 self-identified black or African-American patients who have had chronic hepatitis C viral infection (HCV) that will evaluate patients' willingness to participate (WTP) in health/medical research related to HCV and attitudinal factors that might be… Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Hepatitis C, Chronic
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2019to 19 Jun 2020
- Phase
- Observational
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who self-identify as black or African-American and have been infected with chronic hepatitis C viral (HCV) infection. Patients will be recruited from the Patient-Reported Outcomes Project (PROP UP) observational study (11 U.S. liver centers) and from a tertiary care liver HCV clinic.
Who may be able to join
- Previous enrollment in the Patient-Reported Outcomes Project (PROP UP) or recruited from HCV Liver Clinics at the University of North Carolina.
- Self-identified as African-American or Black during the PROP UP study or in-person
- Provide written or verbal permission to be contacted about future research studies
Who cannot join
- Express unwillingness to be contacted about future studies
- Withdrew from PROP UP post-enrollment (eg. death, patient withdrawal)
- Unwilling or unable to provide verbal consent
- Identifies during the phone survey or in-person that he/she is not African-American or Black
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Voices From the Black Community: Beliefs and Attitudes on Participating in Research Studies for Chronic Hepatitis C
This is a one-time cross-sectional survey study of approximately 200 self-identified black or African-American patients who have had chronic hepatitis C viral infection (HCV) that will evaluate patients' willingness to participate (WTP) in health/medical research related to HCV and attitudinal factors that might be associated with WTP, such as benefits and barriers to research participation, mistrust of physicians/researchers, health literacy, and knowledge of health/research studies.
Read the detailed description
Chronic hepatitis C viral (HCV) infection is three times more prevalent in the African American/black (AA) population than in white patients in the U.S.; yet minorities are woefully under-represented in HCV research, particularly in Phase III drug registration trials. A recent systematic review of randomized controlled clinical trials (RCT) of HCV treatments with interferon-based treatments from 2000 to 2011 found that the proportion of African-American patients in RCTs ranged from 0% - 11%. Despite significant increases in efficacy and reductions in adverse events associated with the new direct acting antiviral (DAA) regimens, the proportion of black patients enrolled in Phase II-III DAA registration trials has not increased dramatically and generally ranges from 1%-18%. Because participation rates in medical research do not fully represent the overall U.S. population or prevalence rates among various subgroups, the Food and Drug Administration (FDA) has mandated pharmaceutical companies to improve demographic subgroups included in clinical trials, to identify barriers to subgroup enrollment in clinical trials, and to employ strategies to encourage greater participation.
Enrolling more diverse patients in medical research, especially racial minorities, is a ubiquitous dilemma that has received a fair amount of scientific attention in the last 10 years. This research has found an important role for the perceptions and attitudes that people have about participating in clinical research. Negative perceptions serve as barriers to enrollment in clinical research, while positive attitudes are facilitators of research participation. Additionally, knowledge gaps, patient-provider communication, health literacy, and mistrust of research and scientists are a few of the commonly reported barriers to participation among minority patients. To our knowledge, no study has been undertaken with black patients with HCV to understand their specific attitudes and perspectives related to participation in HCV-related health or medical research. This information is a prerequisite to developing effective approaches to increasing participation of the black community in HCV-related health or medical research.
Two hundred Black patients will be recruited. Patients who participated in The Patient-Reported Outcomes Project of HCV-TARGET ("PROP UP TARGET") study will be invited to participate. Patients will also be recruited from liver clinics at one medical center. Patients will respond to several survey questions over the phone or in person related to WTP and attitudinal factors related to clinical research.
Participant responses and characteristics will be summarized using graphical and tabular descriptive statistical methods such as sample means, percentiles, frequencies, proportions and standard deviations. All statistical estimates will be reported with confidence intervals.
- Conditions
- Hepatitis C, Chronic
- Keywords
- patient-reported outcomes, observational, HCV, Hepatitis C, Chronic Liver Disease, Liver Disease, Research, Participation
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C, Liver Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Willingness to Participate (WTP) Mean Score
Overall Willingness to Participate Scale (WTP): WTP in research studies was evaluated using 13 items to assess WTP in different types of health/medical research studies. Responses were based on a five-point Likert scale from 1 (not at all willing) to 5 (very willing), with 3 connoting "unsure/neutral." The overall WTP score will be calculated for each participant by taking the mean of the 13 items. Higher scores indicate higher WTP.
Measured: through study completion, an average of 1 day
Secondary outcomes (6)
Perceived Benefits/Advantages of Participating in Health/Medical Research Mean Score
Perceived Benefits Scale: Patients respond to 16 items regarding perceived benefits or advantages of research participation. Each item is rated on a 5 point likert scale: 1=strongly disagree, 2=disagree, 3=unsure, 4=agree, 5=strongly agree. The average of all items will be used to create the total mean benefit score. Higher scores indicate higher Perceived Benefits.
Measured: through study completion, an average of 1 day
Perceived Barriers/Disadvantages of Participating in Health/Medical Research Mean Score
Perceived Barriers Scale: Patients respond to 12 items regarding barriers or disadvantages of research participation. Each item is rated on a 5 point likert scale: 1=strongly disagree, 2=disagree, 3=unsure, 4=agree, 5=strongly agree. The average of all items will be used to create the total mean barrier score. Higher scores indicate higher Perceived Barriers.
Measured: through study completion, an average of 1 day
Perceived Trust in Doctors Mean Score
Trust in Doctors Scale: Patients respond to 12 items regarding their trust or mistrust in their medical providers. Each item is rated on a 5 point likert scale: 1=strongly disagree, 2=disagree, 3=unsure, 4=agree, 5=strongly agree. Negative items were reverse scored. The average of all items will be used to create the total mean trust score. Higher scores indicate higher Perceived Trust.
Measured: through study completion, an average of 1 day
Perceived Health Literacy Mean Score
Perceived Health Literacy Scale: Three items assessed the health literacy of participants with a five-point response scale: 1 (Never), 2 (Rarely), 3 (Sometimes), 4 (Often), 5 (Always). Participants were asked (a) how frequently they asked others to help them read medical materials, (b) if they felt uncomfortable filling out medical forms, and (c) if they did not understand their medical condition due to difficulty reading medical materials. The average of all items will be used to create the total mean health literacy score. Lower scores indicate higher Perceived Health Literacy.
Measured: through study completion, an average of 1 day
Subjective Knowledge of Health/Medical Research Mean Score
Subjective Knowledge Scale: Participants were asked how well they felt they understood what health/medical research involved. This was assessed on a five-point response scale: 1 (Not at all), 2 (Not too well), 3 (Somewhat well), 4 (Pretty well), 5 (Very well). The average of all items will be used to create the total mean subjective knowledge score. Higher scores indicate higher subjective knowledge.
Measured: through study completion, an average of 1 day
Objective Knowledge of Health/Medical Research Mean Score
Objective Knowledge Scale: Knowledge of clinical trials was measured with 10 true/false questions about aspects of clinical trials. The proportion of correct responses per patient will be recorded. Higher proportion indicates higher objective knowledge.
Measured: through study completion, an average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start21 Feb 2019
- Primary completion15 May 2020
- Study completion19 Jun 2020
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.
- More trials run by University of North Carolina, Chapel HillThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Donna M Evon, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202081
- Sponsor's protocol ID
- 18-0662
- Status last verified
- Jun 2020
- First submitted
- 11 Dec 2019
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan at this time to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voices From the Black Community: Beliefs and Attitudes on Participating in Research Studies for Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT04202081
- Acronym / sponsor ID
- 18-0662
- Conditions
- Hepatitis C, Chronic
- Keywords
- patient-reported outcomes, observational, HCV, Hepatitis C, Chronic Liver Disease, Liver Disease, Research, Participation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 19 Jun 2020 (actual)
- First posted
- 17 Dec 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.
This is a one-time cross-sectional survey study of approximately 200 self-identified black or African-American patients who have had chronic hepatitis C viral infection (HCV) that will evaluate patients' willingness to participate (WTP) in health/medical research related to HCV and attitudinal factors that might be associated with WTP, such as benefits and barriers to research participation, mistrust of physicians/researchers, health literacy, and knowledge of health/research studies.
Detailed description
Chronic hepatitis C viral (HCV) infection is three times more prevalent in the African American/black (AA) population than in white patients in the U.S.; yet minorities are woefully under-represented in HCV research, particularly in Phase III drug registration trials. A recent systematic review of randomized controlled clinical trials (RCT) of HCV treatments with interferon-based treatments from 2000 to 2011 found that the proportion of African-American patients in RCTs ranged from 0% - 11%. Despite significant increases in efficacy and reductions in adverse events associated with the new direct acting antiviral (DAA) regimens, the proportion of black patients enrolled in Phase II-III DAA registration trials has not increased dramatically and generally ranges from 1%-18%. Because participation rates in medical research do not fully represent the overall U.S. population or prevalence rates among various subgroups, the Food and Drug Administration (FDA) has mandated pharmaceutical companies to improve demographic subgroups included in clinical trials, to identify barriers to subgroup enrollment in clinical trials, and to employ strategies to encourage greater participation.
Enrolling more diverse patients in medical research, especially racial minorities, is a ubiquitous dilemma that has received a fair amount of scientific attention in the last 10 years. This research has found an important role for the perceptions and attitudes that people have about participating in clinical research. Negative perceptions serve as barriers to enrollment in clinical research, while positive attitudes are facilitators of research participation. Additionally, knowledge gaps, patient-provider communication, health literacy, and mistrust of research and scientists are a few of the commonly reported barriers to participation among minority patients. To our knowledge, no study has been undertaken with black patients with HCV to understand their specific attitudes and perspectives related to participation in HCV-related health or medical research. This information is a prerequisite to developing effective approaches to increasing participation of the black community in HCV-related health or medical research.
Two hundred Black patients will be recruited. Patients who participated in The Patient-Reported Outcomes Project of HCV-TARGET ("PROP UP TARGET") study will be invited to participate. Patients will also be recruited from liver clinics at one medical center. Patients will respond to several survey questions over the phone or in person related to WTP and attitudinal factors related to clinical research.
Participant responses and characteristics will be summarized using graphical and tabular descriptive statistical methods such as sample means, percentiles, frequencies, proportions and standard deviations. All statistical estimates will be reported with confidence intervals.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who self-identify as black or African-American and have been infected with chronic hepatitis C viral (HCV) infection. Patients will be recruited from the Patient-Reported Outcomes Project (PROP UP) observational study (11 U.S. liver centers) and from a tertiary care liver HCV clinic.
Key inclusion criteria (3 listed)
- Previous enrollment in the Patient-Reported Outcomes Project (PROP UP) or recruited from HCV Liver Clinics at the University of North Carolina.
- Self-identified as African-American or Black during the PROP UP study or in-person
- Provide written or verbal permission to be contacted about future research studies
Key exclusion criteria (4 listed)
- Express unwillingness to be contacted about future studies
- Withdrew from PROP UP post-enrollment (eg. death, patient withdrawal)
- Unwilling or unable to provide verbal consent
- Identifies during the phone survey or in-person that he/she is not African-American or Black
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Willingness to Participate (WTP) Mean Score
Time frame: through study completion, an average of 1 day
Overall Willingness to Participate Scale (WTP): WTP in research studies was evaluated using 13 items to assess WTP in different types of health/medical research studies. Responses were based on a five-point Likert scale from 1 (not at all willing) to 5 (very willing), with 3 connoting "unsure/neutral." The overall WTP score will be calculated for each participant by taking the mean of the 13 items. Higher scores indicate higher WTP.
6 secondary outcomes
Perceived Benefits/Advantages of Participating in Health/Medical Research Mean Score
Time frame: through study completion, an average of 1 day
Perceived Barriers/Disadvantages of Participating in Health/Medical Research Mean Score
Time frame: through study completion, an average of 1 day
Perceived Trust in Doctors Mean Score
Time frame: through study completion, an average of 1 day
Perceived Health Literacy Mean Score
Time frame: through study completion, an average of 1 day
Subjective Knowledge of Health/Medical Research Mean Score
Time frame: through study completion, an average of 1 day
Objective Knowledge of Health/Medical Research Mean Score
Time frame: through study completion, an average of 1 day
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 1 Jul 2020.
- Individual participant dataSharing planned: No. There is no plan at this time to make individual participant data available to other researchers.
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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.
Donna M Evon, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, Chronic, run by University of North Carolina, Chapel Hill 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 3 inclusion and 4 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 1 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 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?
Overall Willingness to Participate (WTP) Mean Score (time frame: through study completion, an average of 1 day). 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 1 Jul 2020.