NCT04204447

Brief Summary

The purpose of this study is to determine the most effective way to give patients information regarding hepatitis C virus infection. The investigators plan to compare the information retained by some patients who are given a brochure alone versus patients who watch an interactive video about hepatitis C.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 27, 2019

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 19, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

April 1, 2024

Enrollment Period

11 months

First QC Date

December 13, 2019

Results QC Date

November 1, 2022

Last Update Submit

April 23, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Improvement in Scores on HCV Knowledge Questionnaire

    The main outcome measure was a change in the mean score on a 25-item HCV knowledge assessment without subscales. The instrument values ranged from 0 to 25 with one point per correct answer to questions directly arising from the information contained in the video. One point was assigned to each correct answer, and an increase in the score indicated more correct responses.

    Pre-intervention, Immediate post-intervention, and 1 mo. follow up

Study Arms (2)

Brochure intervention

EXPERIMENTAL

Subjects will be asked to read an educational brochure about Hepatitis C

Other: Hepatitis C Educational Brochure

Video intervention

EXPERIMENTAL

Subjects will be asked to watch an educational video about Hepatitis C

Other: Hepatitis C Educational Video

Interventions

Subjects will receive information about Hepatitis C through a brochure

Brochure intervention

Subjects will receive information about Hepatitis C through a video

Video intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Currently on active treatment for opioid addiction/use
  • English as primary language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University at Buffalo

Buffalo, New York, 14203, United States

Location

BestSelf Behavioral Health

Orchard Park, New York, 14127, United States

Location

Related Publications (1)

  • Talal AH, Ding YX, Markatou M. Innovations in education: A prospective study of storytelling narratives to enhance hepatitis C virus knowledge among substance users. World J Hepatol. 2022 May 27;14(5):972-983. doi: 10.4254/wjh.v14.i5.972.

    PMID: 35721284BACKGROUND

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Results Point of Contact

Title
Andrew Talal
Organization
University at Buffalo

Study Officials

  • Andrew Talal, MD

    SUNY University at Buffalo

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 13, 2019

First Posted

December 19, 2019

Study Start

November 27, 2019

Primary Completion

October 31, 2020

Study Completion

October 31, 2020

Last Updated

September 19, 2024

Results First Posted

September 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

IPD will not be shared

Locations