Clinical trial NCT05968573: Persuasive Health Communication Intervention for HIV/HCV
Official title: Evaluation of a Persuasive Health Communication Intervention Designed to Increase HIV/HCV Screening Among Emergency Departments Patients Who Currently, Formerly or Never Injected Drugs.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Human Immunodeficiency Virus (HIV)
Hepatitis C (HCV)
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-08-01
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study has two parts:

Part A: Modification of the PHCI with the assistance of current and former people who inject drugs (PWID) ED patients.

Part B: Randomized Controlled Trial - this will only be conducted after completion of Part A.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: As part of routine practice at Mount Sinai Health System EDs, the ED Nurses initiate HIV/HCV screening for all patients able to provide consent. ED patients eligible for recruitment into the RCT portion of the study are those who declined HIV/HCV screening. RCs will review the electronic health records (EHRs) of patients present in the ED during data collection periods and determine which patients are potentially eligible.

Participation in the RCT involves a one-time encounter. All research-related activities will occur in the ED. As such, drop-out during this brief RCT (\<30 minutes from recruitment through final study questionnaires) is expected to be minimal (\<5%). RCs will coordinate with participants and ED staff to facilitate participant involvement while they are receiving medical care. If necessary, participants can continue participating in designated areas of the ED (e.g., waiting room, family room) after they are discharged and there are study-related tasks remaining. There are no research related follow-ups needed.

The research team will enroll a total of 2,000 adult ED patients who meet all study criteria and agree to participate in the RCT, stratified by IDU history. Assuming 0.6 participants completing the study/hour (1 study completion/75 minutes of recruitment, enrollment, and data collection), the research team could recruit up to ≈5,184 participants (720 collection days x 12 hours/data collection/day x 0.6 participants/hour) over 3 years.

The research team will be collecting data using the QDS™ (NOVA Research Company) program installed on a tablet computer. The program has the ability to encrypt collected data, to which only the researcher has ability to de-crypt data sets (NOVA Research cannot recover lost passwords for the researcher). The program also has a data management system, allowing data export for use in analytical packages like SPSS, Stata. Internet access is not necessary for this program to function. The data can be stored on the tablet computer for the meantime, then synced once internet is available.

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

Primary outcomes:
measure: Number of patients who accept HIV/HCV testing after watching the video with captions
timeFrame: Day 1, up to 5 minutes after intervention
measure: Number of patients who accept HIV/HCV testing after watching the video without captions
timeFrame: Day 1, up to 5 minutes after intervention
measure: Number of patients who accept HIV/HCV testing after speaking with a health educator
timeFrame: Day 1, up to 5 minutes after intervention
Secondary outcomes:
measure: The number of patients that accept HIV/HCV testing by no prior injection-drug use
timeFrame: Day 1, up to 5 minutes after intervention
measure: The number of patients that accept HIV/HCV testing by former injection-drug use
timeFrame: Day 1, up to 5 minutes after intervention
measure: The number of patients that accept HIV/HCV testing by current injection-drug use
timeFrame: Day 1, up to 5 minutes after intervention
measure: Health economics assessment of PHCI
timeFrame: End of study, at 5 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Roland C Merchant, MD
role: PRINCIPAL_INVESTIGATOR
References: