Persuasive Health Communication Intervention for HIV/HCV

Study Overview
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Brief Summary
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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 two 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) to a PHCI delivered by: (1) a video, or (2) an HIV/HCV counselor. This R01 project will be conducted at The Mount Sinai Hospital and Mount Sinai Beth Israel Hospital EDs. For Aim 1, the research team will determine which delivery form of the PHCI (video or HIV/HCV counselor) results in more ED patients accepting HIV/HCV screening, independent of their history of IDU. 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
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As part of routine practice at The Mount Sinai Hospital and Mount Sinai Beth Israel Emergency Departments, 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 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.

Official Title
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Evaluation of a Persuasive Health Communication Intervention Designed to Increase HIV/HCV Screening Among Emergency Departments Patients Who Currently, Formerly or Never Injected Drugs.

Conditions
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Human Immunodeficiency Virus (HIV), Hepatitis C (HCV)

Intervention / Treatment
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* Other: Video Format
* Other: Health Educator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Persuasive Health Communication Intervention delivered in video format<br>A video created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening. | Other: Video Format<br>* A video created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening.<br>|
| Active Comparator: Persuasive Health Communication Intervention delivered by Health Educator<br>Healthcare provider educator getting patients screened for HIV/HCV. | Other: Health Educator<br>* The video created by the research will be compared to a healthcare provider in terms of effectiveness in getting patients screened for HIV/HCV.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who accept HIV/HCV testing after watching the video | The number of patients who accept HIV/HCV testing after watching the video | Day 1, up to 5 minutes after intervention | 
| Number of patients who accept HIV/HCV testing after speaking with a health educator | The number of patients who accept HIV/HCV testing after speaking with a health educator. | Day 1, up to 5 minutes after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 no prior 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 | 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 current injection-drug use | The number of patients that accept HIV/HCV testing by current injection-drug use | Day 1, up to 5 minutes after intervention | 
| Health economics assessment of PHCI | 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. | End of study, at 5 years |