NCT05968573 Persuasive Health Communication Intervention for HIV/HCV
| NCT ID | NCT05968573 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of South Florida |
| Condition | Human Immunodeficiency Virus (HIV) |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2023-12-04 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,000 participants in total. It began in 2023-12-04 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Roland C Merchant, MD
PRINCIPAL INVESTIGATOR
University of South Florida
Frequently Asked Questions
Who can join the NCT05968573 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Human Immunodeficiency Virus (HIV). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05968573 currently recruiting?
Yes, NCT05968573 is actively recruiting participants. Contact the research team at Roland.Merchant@mountsinai.org for enrollment information.
Where is the NCT05968573 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05968573 clinical trial?
NCT05968573 is sponsored by University of South Florida. The principal investigator is Roland C Merchant, MD at University of South Florida. The trial plans to enroll 2,000 participants.
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