Persuasive Health Communication Intervention for HIV/HCV

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-04

Study Completion Date

2026-08-01

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 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.

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Detailed Description

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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.

Conditions

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Human Immunodeficiency Virus (HIV) Hepatitis C (HCV)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Participants will be told during consent that they will be randomized and assigned to a group. Participants will be told that the two groups are to watch a video or listen to a health educator. Therefore, participants are not prevented from having knowledge of the interventions assigned to them.

Study Groups

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Persuasive Health Communication Intervention delivered in 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.

Group Type ACTIVE_COMPARATOR

Video Format with Captions

Intervention Type OTHER

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

A video with captions created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening.

Group Type ACTIVE_COMPARATOR

Video Format without Captions

Intervention Type OTHER

A video without 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

Healthcare provider educator getting patients screened for HIV/HCV.

Group Type ACTIVE_COMPARATOR

Health Educator

Intervention Type OTHER

The video created by the research will be compared to a healthcare provider in terms of effectiveness in getting patients screened for HIV/HCV.

Interventions

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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.

Intervention Type OTHER

Video Format without Captions

A video without captions created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening.

Intervention Type OTHER

Health Educator

The video created by the research will be compared to a healthcare provider in terms of effectiveness in getting patients screened for HIV/HCV.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes