Persuasive Health Communication Intervention for HIV/HCV

Trial statusCompleted
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of South Florida

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 volunteers

Qualifiers

≥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

Design model

Parallel

Treatments tested in this trial

  • Video Format with Captions

    Other intervention

    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 intervention

    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 intervention

    The 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

2,000 Participants
are divided into 3 treatment groups
Group A: Persuasive Health Communication Intervention delivered in video format with captionsActive comparator 1 intervention
Group B: Persuasive Health Communication Intervention delivered in video format without captionsActive comparator 1 intervention
Group C: Persuasive Health Communication Intervention delivered by Health EducatorActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Day 1, up to 5 minutes after intervention
2

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

Time frame
Day 1, up to 5 minutes after intervention
3

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.

Time frame
Day 1, up to 5 minutes after intervention

Secondary outcomes

1

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

Time frame
Day 1, up to 5 minutes after intervention
2

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

Time frame
Day 1, up to 5 minutes after intervention
3

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

Time frame
Day 1, up to 5 minutes after intervention
4

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.

Time frame
End of study, at 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of South Florida

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: