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Persuasive Health Communication Intervention for HIV/HCV

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Primary endpoints: details revised at 3 of 3 entries Show 7 more changesShow less
    • Trial completed
    • Primary and study completion dates changed from estimate of Aug 1, 2026 to Jul 31, 2026
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description revised
    • Site details revised
    • Publications: details revised at 1 of 1 entry
  2. Lead sponsor: Icahn School of Medicine at Mount Sinai to University of South Floridav6
  3. Primary and study completion dates: Dec 8, 2027 to Aug 1, 2026
    • Site contact updated
    v5
  4. Start date: Jan 25, 2024 to Dec 4, 2023v4
  5. Primary endpoints: 2 to 3
    • Interventions: Health Educator (Other), Video Format (Other) to Health Educator (Other), Video Format with Captions (Other), Video Format without Captions (Other)
    • Study arms: 2 to 3
    • Study description shortened, about 3 words
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 1, 2023 to Jan 25, 2024
    • Site details revised
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05968573
Lead Sponsor University of South Florida
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions
(from sponsor)		 Human Immunodeficiency Virus (HIV), Hepatitis C (HCV)
Related terms Acquired Immunodeficiency Syndrome, Hepatitis C
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov