Recruiting

Health Communication

Sponsor:

University of South Florida

Code:

NCT05968573

Conditions

Human Immunodeficiency Virus (HIV)

Hepatitis C (HCV)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Video Format with Captions

Video Format without Captions

Health Educator

Study Details

Brief summary:

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.

Conditions

Human Immunodeficiency Virus (HIV)

Hepatitis C (HCV)

Study ID

NCT05968573

Start date

Dec 4, 2023

Status verified date

Jul, 2025

Completion date

Aug 1, 2026

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • ≥18 years-old
  • Speak English or Spanish, and able to provide informed consent for study participation
  • Not HIV AND HCV infected/Antibody+ (per EHR review and patient report)
  • Not already participating in a HIV or HCV study (e.g., HIV PrEP, HIV vaccine)
  • Not tested for HIV OR HCV within the past 12 months (per EHR review and patient report)

Exclusion Criteria:

  • <18 years old
  • Unable to speak Spanish or English
  • HIV or HCV positive
  • Currently enrolled in another HIV or HCV research study
  • Has tested for HIV or HCV in the past 12 months

Study Design

Enrollment

2000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

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.

Video Format without Captions

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

The video created by the research will be compared to a healthcare provider in terms of effectiveness in 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 ]
  • Number of patients who accept HIV/HCV testing after watching the video without captions [ Time Frame: Day 1, up to 5 minutes after intervention ]
  • Number of patients who accept HIV/HCV testing after speaking with a health educator [ Time Frame: Day 1, up to 5 minutes after intervention ]

Central Contacts and Locations

Central contacts

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10128

Contacts

More Information

Sponsor

University of South Florida

Last update posted

Apr 8, 2026

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2026-04-08.