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CompletedNCT04204447Updated Sep 19, 2024Results posted

Hepatitis C-Video vs. Brochure Education Delivery

An interventional study of Hepatitis C Educational Brochure and Hepatitis C Educational Video in Hepatitis C, sponsored by State University of New York at Buffalo. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by State University of New York at Buffalo · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
176
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

Subjects will complete 3 questionnaires, including one about knowledge of Hepatitis C. The subject will then either watch a video or read a brochure about Hepatitis C, then take the same questionnaire again. The subject will then return in one month to take the Hepatitis C questionnaire again.

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Conditions studied

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In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 176 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

State University of New York at Buffalo is the lead sponsor of 287 studies on the registry; 65 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

-

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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
176 participants (actual)

Study arms

  • Experimental
    Brochure intervention

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

    Other: Hepatitis C Educational Brochure

  • Experimental
    Video intervention

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

    Other: Hepatitis C Educational Video

Interventions

  • OtherHepatitis C Educational Brochure

    Subjects will receive information about Hepatitis C through a brochure

  • OtherHepatitis C Educational Video

    Subjects will receive information about Hepatitis C through a video

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What researchers measure

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.

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

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Results

Posted Sep 19, 2024

Participant flow

Participant flow — Overall Study
MilestoneBrochure InterventionVideo Intervention
Started9086
Completed8381
Not completed75

Outcome measures

PrimaryImprovement 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.

Time frame:
Pre-intervention, Immediate post-intervention, and 1 mo. follow up
Reported as:
Mean · Improvement in scores
Improvement in Scores on HCV Knowledge Questionnaire
Improvement in scoresBrochure InterventionVideo Intervention
Pre-intervention18.45 ± .319 ± 0.25
Immiediate post-intervention20.3 ± .3521.75 ± 0.3
One month post-intervention20.2 ± .321.7 ± 0.2

Adverse events

Collected over 4-6 weeks-Time between the pre-intervention assessment and the post-intervention assessment obtained one month post-intervention.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Video Intervention0/86 (0%)0/86 (0%)0/86 (0%)
Brochure Intervention0/90 (0%)0/90 (0%)0/90 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Brochure InterventionVideo InterventionTotal
Mean43 ± 1141 ± 1242 ± 11
Sex: Female, Male
Sex: Female, Male(Participants)Brochure InterventionVideo InterventionTotal
Female5551106
Male353570
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Brochure InterventionVideo InterventionTotal
Other race — American Indian or Alaska Native101
Other race — Asian000
Other race — Native Hawaiian or Other Pacific Islander000
Other race — Black or African American12113
Other race — White7674150
Other race — More than one race000
Other race — Unknown or Not Reported11112
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Study locations

2 sites
  • University at Buffalo
    Buffalo, New York 14203, United States
  • BestSelf Behavioral Health
    Orchard Park, New York 14127, United States
09

References and documents

Publications

  • 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. PubMed 35721284 ↗

Study documents

  • Study protocol · Jun 30, 2018
  • Statistical analysis plan · Jun 30, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — IPD will not be shared

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04204447
Lead sponsor
State University of New York at Buffalo
Responsible party
Andrew Talal (Principal Investigator, State University of New York at Buffalo) — Principal investigator
First posted
Dec 19, 2019
Start date
Nov 27, 2019
Primary completion
Oct 31, 2020
Completion
Oct 31, 2020
Results posted
Sep 19, 2024
Last update
Sep 19, 2024

Study contacts

Andrew Talal, MD
principal investigator · SUNY University at Buffalo

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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