Persuasive Health Communication Intervention for HIV/HCV

Part of paid clinical trials in New York, New York.

Sponsor
University of South Florida
Study ID
NCT05968573
Status
Recruiting
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Conditions

  • Hepatitis C (HCV)
  • Human Immunodeficiency Virus (HIV)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Video Format with Captions — OTHER
    A video with captions created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening.
  • Video Format without Captions — OTHER
    A video without captions created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening.
  • Health Educator — OTHER
    The video created by the research will be compared to a healthcare provider in terms of effectiveness in getting patients screened for HIV/HCV.

Study Details

A major impediment to emergency department (ED)-based HIV/HCV screening success is that often ED patients at risk for, or later diagnosed with, HIV and HCV decline testing. In this R01 project, the research team will assess how well a promising, easy-to-use, one-time, minimal-training-needed, very brief persuasive health communication intervention (PHCI) increases acceptance of testing among adult ED patients who either currently, formerly or never injected drugs and initially declined HIV/HCV screening. The research team will conduct a randomized, controlled trial (RCT) at EDs within the Mount Sinai Health System to compare the efficacy of the PHCI when delivered by a video vs. an HIV/HCV counselor. Patients who initially declined HIV/HCV screening will be stratified by injection-drug use (IDU) history cohorts: (1) current/former PWIDs, (2) never/non-PWIDs. Within each IDU history cohort, the research team will randomly assign participants (1:1:1) to a PHCI delivered by: (1) a video with captions, (2) a video without captions, (3) an HIV/HCV counselor. This R01 project will be conducted at Mount Sinai affiliate hospitals EDs. For Aim 2, the research team will determine if screening acceptance is similar across IDU history cohorts. For Aim 3, the research team will further compare the two delivery forms of the PHCI through a health economics assessment, both independent of IDU history and within each IDU history cohort.

Key Dates

Start date
Dec 4, 2023
Status verified
Jul 2025
Primary completion
Aug 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
2,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Persuasive Health Communication Intervention delivered in video format with captions
    A video with captions created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening.
  • Active Comparator: Persuasive Health Communication Intervention delivered in video format without captions
    A video with captions created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening.
  • Active Comparator: Persuasive Health Communication Intervention delivered by Health Educator
    Healthcare provider educator getting patients screened for HIV/HCV.

Primary Outcome Measure

Number of patients who accept HIV/HCV testing after watching the video with captions [ Time Frame: Day 1, up to 5 minutes after intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10128
Roland C Merchant, MD
[email protected]
(212) 524-9814

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By research site
Icahn School of Medicine at Mount Sinai· New York, NY

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