Persuasive Health Communication Intervention for HIV/HCV

NCT05968573 | Recruiting DMC

• 2 other identifiers: STUDY-22-011621R01DA055533-01
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (3)

• 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

• 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

Secondary Outcomes (4)

• 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

  Day 1, up to 5 minutes after intervention

• 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

  End of study, at 5 years

Study Arms (3)

Persuasive Health Communication Intervention delivered in video format with captions

ACTIVE COMPARATOR

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

Persuasive Health Communication Intervention delivered in video format without captions

ACTIVE COMPARATOR

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

Persuasive Health Communication Intervention delivered by Health Educator

ACTIVE COMPARATOR

Healthcare provider educator getting patients screened for HIV/HCV.

Other: Health Educator

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.

Persuasive Health Communication Intervention delivered in video format with captions

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.

Persuasive Health Communication Intervention delivered in video format without captions

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.

Persuasive Health Communication Intervention delivered by Health Educator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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)

You may not qualify if:

• \<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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): collaborator
• University of South Florida: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10128, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 39134444 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Hepatitis C

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepatitis, Viral, Human; Flaviviridae Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Roland C Merchant, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roland C Merchant, MD

CONTACT

(212) 524-9814; Roland.Merchant@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants will be told during consent that they will be randomized and assigned to a group. Participants will be told that the two groups are to watch a video or listen to a health educator. Therefore, participants are not prevented from having knowledge of the interventions assigned to them.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study has two parts: Part A: Modification of the PHCI with the assistance of current and former people who inject drugs (PWID) ED patients. Part B: Randomized Controlled Trial - this will only be conducted after completion of Part A.

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 1, 2023
• Study Start: December 4, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Specify Other Time FrameAfter last patient enrolled up to a year from that time point.
• 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.

Locations

US (1)