Clinical trial NCT04202081: Voices From the Black Community: Hepatitis C Research Participation
Official title: Voices From the Black Community: Beliefs and Attitudes on Participating in Research Studies for Chronic Hepatitis C
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Keywords: patient-reported outcomes
observational
HCV
Hepatitis C
Chronic Liver Disease
Liver Disease
Research
Participation
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2019-12-17
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria

* 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

Exclusion Criteria

* 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

Primary outcomes:
measure: Overall Willingness to Participate (WTP) Mean Score
timeFrame: through study completion, an average of 1 day
Secondary outcomes:
measure: Perceived Benefits/Advantages of Participating in Health/Medical Research Mean Score
timeFrame: through study completion, an average of 1 day
measure: Perceived Barriers/Disadvantages of Participating in Health/Medical Research Mean Score
timeFrame: through study completion, an average of 1 day
measure: Perceived Trust in Doctors Mean Score
timeFrame: through study completion, an average of 1 day
measure: Perceived Health Literacy Mean Score
timeFrame: through study completion, an average of 1 day
measure: Subjective Knowledge of Health/Medical Research Mean Score
timeFrame: through study completion, an average of 1 day
measure: Objective Knowledge of Health/Medical Research Mean Score
timeFrame: through study completion, an average of 1 day
Other outcomes:
measure: Proportion of Participant Recommendations for Strategies
timeFrame: through study completion, an average of 1 day
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Donna M Evon, PhD
role: PRINCIPAL_INVESTIGATOR
References: