Persuasive Health Communication Intervention for HIV/HCV
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 Start (Actual) 4 December 2023
🗓️ Primary Completion (Estimated) 8 December 2027
✅ Study Completion (Estimated) 8 December 2027
👥 Enrollment (Estimated) 2000
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 21 July 2023
  • First Submitted that Met QC Criteria 21 July 2023
  • First Posted 1 August 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 28 June 2024
  • Last Update Posted 1 July 2024
  • Last Verified June 2024