NCT05968573

Persuasive Health Communication Intervention for HIV/HCV

Recruiting now NA Last updated 8 April 2026

What this trial tests

NA trial testing Video Format with Captions in Human Immunodeficiency Virus (HIV) in 2,000 participants. Currently enrolling.

Timeline

4 December 2023

Primary endpoint
1 August 2026

1 August 2026

Quick facts

Lead sponsor	University of South Florida
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	2,000
Start date	4 December 2023
Primary completion	1 August 2026
Estimated completion	1 August 2026
Sites	1 location across United States

Drugs / interventions tested

• Video Format with Captions
• Video Format without Captions
• Health Educator

Conditions studied

• Human Immunodeficiency Virus (HIV) — all drugs for Human Immunodeficiency Virus (HIV) →
• Hepatitis C (HCV) — all drugs for Hepatitis C (HCV) →

Sponsor

University of South Florida

Who can join

18 and older, any sex, with Human Immunodeficiency Virus (HIV) or Hepatitis C (HCV). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Testing a persuasive health communication intervention (PHCI) for emergency department patients who declined rapid HIV/HCV screening: a randomised controlled trial study protocol.
   Merchant RC, Harrington N, Clark MA, Liu T, et al · · 2024 · cited 1× · PMID 39134444 · DOI 10.1136/bmjopen-2024-089265