About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
≥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)
Disqualifiers
<18 years old
Unable to speak Spanish or English
HIV or HCV positive
Currently enrolled in another HIV or HCV research study
Trial design
Parallel
Treatments tested in this trial
Video Format with Captions
Other interventionA 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 interventionA 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 interventionThe video created by the research will be compared to a healthcare provider in terms of effectiveness in getting patients screened for HIV/HCV.
Treatment groups
Trial outcomes
Primary outcomes
Number of patients who accept HIV/HCV testing after watching the video with captions
The number of patients who accept HIV/HCV testing after watching the video with captions
Number of patients who accept HIV/HCV testing after watching the video without captions
The number of patients who accept HIV/HCV testing after watching the video captions
Number of patients who accept HIV/HCV testing after speaking with a health educator
The number of patients who accept HIV/HCV testing after speaking with a health educator.
Secondary outcomes
The number of patients that accept HIV/HCV testing by no prior injection-drug use
The number of patients that accept HIV/HCV testing by no prior injection-drug use
The number of patients that accept HIV/HCV testing by former injection-drug use
The number of patients that accept HIV/HCV testing by former injection-drug use
The number of patients that accept HIV/HCV testing by current injection-drug use
The number of patients that accept HIV/HCV testing by current injection-drug use
Health economics assessment of PHCI
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. This will measure cost-benefit analysis in terms of cost of each intervention in relation to how effective it is on persuading real world populations to test for HIV and HCV.
Sponsors and contacts
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University of South Florida
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
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