Persuasive Health Communication Intervention for HIV/HCV
- Conditions
- Hepatitis C (HCV)Human Immunodeficiency Virus (HIV)
- Interventions
- Other: Video Format with CaptionsOther: Video Format without CaptionsOther: Health Educator
- Registration Number
- NCT05968573
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2000
- ≥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)
- <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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Persuasive Health Communication Intervention delivered in video format with captions Video Format with Captions A video with captions created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening. Persuasive Health Communication Intervention delivered in video format without captions Video Format without Captions A video with captions created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening. Persuasive Health Communication Intervention delivered by Health Educator Health Educator Healthcare provider educator getting patients screened for HIV/HCV.
- Primary Outcome Measures
Name Time Method Number of patients who accept HIV/HCV testing after speaking with a health educator Day 1, up to 5 minutes after intervention The number of patients who accept HIV/HCV testing after speaking with a health educator.
Number of patients who accept HIV/HCV testing after watching the video with captions Day 1, up to 5 minutes after intervention The number of patients who accept HIV/HCV testing after watching the video with captions
Number of patients who accept HIV/HCV testing after watching the video without captions Day 1, up to 5 minutes after intervention The number of patients who accept HIV/HCV testing after watching the video captions
- Secondary Outcome Measures
Name Time Method Health economics assessment of PHCI End of study, at 5 years 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. This will measure cost-benefit analysis in terms of cost of each intervention in relation to how effective it is on persuading real world populations to test for HIV and HCV.
The number of patients that accept HIV/HCV testing by current injection-drug use Day 1, up to 5 minutes after intervention The number of patients that accept HIV/HCV testing by current injection-drug use
The number of patients that accept HIV/HCV testing by no prior injection-drug use Day 1, up to 5 minutes after intervention The number of patients that accept HIV/HCV testing by no prior injection-drug use
The number of patients that accept HIV/HCV testing by former injection-drug use Day 1, up to 5 minutes after intervention The number of patients that accept HIV/HCV testing by former injection-drug use
Trial Locations
- Locations (1)
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States