Persuasive Health Communication Intervention for HIV/HCV

Evaluation of a Persuasive Health Communication Intervention Designed to Increase HIV/HCV Screening Among Emergency Departments Patients Who Currently, Formerly or Never Injected Drugs.

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.

Study Overview

• Status: Recruiting
• Conditions: Human Immunodeficiency Virus (HIV); Hepatitis C (HCV)
• Intervention / Treatment: Other: Health Educator; Other: Video Format with Captions; Other: Video Format without Captions

Detailed Description

As part of routine practice at Mount Sinai Health System EDs, the ED Nurses initiate HIV/HCV screening for all patients able to provide consent. ED patients eligible for recruitment into the RCT portion of the study are those who declined HIV/HCV screening. RCs will review the electronic health records (EHRs) of patients present in the ED during data collection periods and determine which patients are potentially eligible.

Participation in the RCT involves a one-time encounter. All research-related activities will occur in the ED. As such, drop-out during this brief RCT (<30 minutes from recruitment through final study questionnaires) is expected to be minimal (<5%). RCs will coordinate with participants and ED staff to facilitate participant involvement while they are receiving medical care. If necessary, participants can continue participating in designated areas of the ED (e.g., waiting room, family room) after they are discharged and there are study-related tasks remaining. There are no research related follow-ups needed.

The research team will enroll a total of 2,000 adult ED patients who meet all study criteria and agree to participate in the RCT, stratified by IDU history. Assuming 0.6 participants completing the study/hour (1 study completion/75 minutes of recruitment, enrollment, and data collection), the research team could recruit up to ≈5,184 participants (720 collection days x 12 hours/data collection/day x 0.6 participants/hour) over 3 years.

The research team will be collecting data using the QDS™ (NOVA Research Company) program installed on a tablet computer. The program has the ability to encrypt collected data, to which only the researcher has ability to de-crypt data sets (NOVA Research cannot recover lost passwords for the researcher). The program also has a data management system, allowing data export for use in analytical packages like SPSS, Stata. Internet access is not necessary for this program to function. The data can be stored on the tablet computer for the meantime, then synced once internet is available.

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roland C Merchant, MD; Phone Number: (212) 524-9814; Email: Roland.Merchant@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10128
      • Recruiting
      • Icahn School Of Medicine At Mount Sinai
      • Contact: Roland C Merchant, MD; Phone Number: (212) 524-9814; Email: Roland.Merchant@mountsinai.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Persuasive Health Communication Intervention delivered by Health Educator; Healthcare provider educator getting patients screened for HIV/HCV.	Other: 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.
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.	Other: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1, up to 5 minutes after intervention
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	Day 1, up to 5 minutes after intervention
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	Day 1, up to 5 minutes after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 1, up to 5 minutes after intervention
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	Day 1, up to 5 minutes after intervention
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	Day 1, up to 5 minutes after intervention
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.	End of study, at 5 years

Collaborators and Investigators

• Sponsor: University of South Florida
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Roland C Merchant, MD, University of South Florida

Publications and helpful links

General Publications

• Merchant RC, Harrington N, Clark MA, Liu T, Morgan J, Cowan E, Solnick R, Wyler B. Testing a persuasive health communication intervention (PHCI) for emergency department patients who declined rapid HIV/HCV screening: a randomised controlled trial study protocol. BMJ Open. 2024 Aug 12;14(8):e089265. doi: 10.1136/bmjopen-2024-089265.

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: July 21, 2023
• First Submitted That Met QC Criteria: July 21, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; Flaviviridae Infections; Hepatitis; HIV Infections; Acquired Immunodeficiency Syndrome; Hepatitis C
• Other Study ID Numbers: STUDY-22-01162; 1R01DA055533-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Specify Other Time FrameAfter last patient enrolled up to a year from that time point.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.

To achieve aims in the approved proposal. Specify Other Mechanism Secured excel file sent through email.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No