Voices From the Black Community: Hepatitis C Research Participation
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Observational

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.
    

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.
      
Keywords: patient-reported outcomes; observational; HCV; Hepatitis C; Chronic Liver Disease; Liver Disease; Research; Participation