An observational study in Hepatitis C, Chronic, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 21 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-07-01.
Sponsored by University of North Carolina, Chapel Hill · Observational
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.
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 200 is below the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria
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.
Time frame: through study completion, an average of 1 day
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: through study completion, an average of 1 day
Proportion of Participant Recommendations for Strategies
Open-ended qualitative question to solicit participants' recommendations for strategies to enhance racial diversity in HCV-related research studies. Responses will be categorized into different recommendation strategies and proportion of patients who listed a strategy in that category will be reported.
Time frame: through study completion, an average of 1 day
Plan to share: No — There is no plan at this time to make individual participant data available to other researchers.
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This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill