Voices From the Black Community: Hepatitis C Research Participation

NCT04202081 | Completed

• 1 other identifier: 18-0662
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C, Chronic

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, an average of 1 day

Secondary Outcomes (6)

• Perceived Benefits/Advantages of Participating in Health/Medical Research Mean Score

  through study completion, an average of 1 day

• Perceived Barriers/Disadvantages of Participating in Health/Medical Research Mean Score

  through study completion, an average of 1 day

• Perceived Trust in Doctors Mean Score

  through study completion, an average of 1 day

• Perceived Health Literacy Mean Score

  through study completion, an average of 1 day

• Subjective Knowledge of Health/Medical Research Mean Score

  through study completion, an average of 1 day

Other Outcomes (1)

• Proportion of Participant Recommendations for Strategies

  through study completion, an average of 1 day

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C; Liver Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Donna M Evon, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 17, 2019
• Study Start: February 21, 2019
• Primary Completion: May 15, 2020
• Study Completion: June 19, 2020
• Last Updated: July 1, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)