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NCT05968573Completed

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.

Source: ClinicalTrials.gov · Last updated 13 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
2000 (actual)
First submitted
21 Jul 2023
Start date
4 Dec 2023
Primary completion date
31 Jul 2026
Lead sponsor
University of South Florida
Diseases
HIV
NCT number
NCT05968573

What you commit to

  • Study type: Interventional
  • Participants enrolled: 2000
  • From 4 Dec 2023 to the primary completion date, 31 Jul 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • HIV or HCV positive
  • Currently enrolled in another HIV or HCV research study
  • Has tested for HIV or HCV in the past 12 months

Age

  • \<18 years old

Other

  • Unable to speak Spanish or English

Who the study is looking for

  • ≥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)

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Icahn School of Medicine at Mount Sinai
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.