Development and Pilot Testing of a PHCI for Emergency Department Patients Who Decline Rapid HIV/ HCV Screening

Development and Pilot Testing of a Persuasive Health Communication Intervention for Emergency Department Patients Who Decline Rapid HIV/ HCV Screening

The Centers for Disease Control and Prevention (CDC) recommends that emergency departments (EDs) and other health care facilities conduct HIV and HCV screening to identify and link to care those with undiagnosed infections. Screening for both infections in EDs is preferable due to: the shared overlap of some risk behaviors for HIV and HCV acquisition (e.g., drug use) the relatively high co-occurrence of these infections in some populations the more complex medical needs and worse sequelae for those co-infected, and efficiency. Although some EDs have experimented with dual HIV and HCV screening, best practices on how to conduct screening so as to maximize patient screening uptake have yet to be identified.

In this pilot RCT, the investigators will examine the efficacy of the persuasive health communication intervention in convincing adult ED patients who decline rapid HIV/HCV screening to be tested for these infections. Adult ED patients who decline rapid HIV/HCV screening will be randomly assigned to the ED medical staff arm or the HIV/HCV counselor arm. Within each arm, participants further will be randomly assigned to receive the persuasive health communication intervention or to watch a CDC HIV/HCV testing brochures-based video. Following the intervention or control condition, all participants will be offered rapid HIV/HCV testing again.

Study Overview

• Status: Completed
• Conditions: Hepatitis C; Hiv
• Intervention / Treatment: Behavioral: Persuasive Health Communication Intervention

Detailed Description

The investigators will conduct this R34 project at the Rhode Island Hospital ED, the primary site for many of the research team's previous HIV (Human Immunodeficiency Virus) and HCV (Hepatitis C Virus) testing studies. Dr. Beaudoin (PI) is an attending physician at the Rhode Island Hospital ED. Our multi-disciplinary team consists of researchers with extensive experience in HIV and HCV testing research, intervention development and testing, and qualitative, quantitative and cost-effectiveness research.

First, the investigators will examine our primary objective in this R34 pilot RCT( Randomized Controlled Trial) of comparing the persuasive health communication intervention to the video. Second, the investigators can compare WITHIN study arms (HIV/HCV counselor arm, ED medical staff arm) and ACROSS these study arms uptake of HIV/HCV testing among participants. Second, the design permits the investigators to obtain initial efficacy data of the persuasive health communication intervention when used by HIV/HCV counselors vs. ED medical staff (ACROSS study arms), as well as compared to the video (WITHIN study arms). Third, the design replicates our subsequent R01 RCT when the investigators compare HIV/HCV screening uptake when conducted solely by HIV/HCV counselors vs. ED medical staff.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02907
      • Rhode Island Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18-64 years old
• English or Spanish speaking

Exclusion Criteria:

• HIV positive; HCV positive In an HIV vaccine trial
• On HIV pre-exposure prophylaxis medication
• In an HIV or HCV testing study
• Tested for HIV AND HCV within the past year (per EMR(Electronic Medical Record) review and patient report)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PHCI with HIV/HCV counselor; A persuasive health communication intervention will be performed by a community HIV/HCV test counselor	Behavioral: Persuasive Health Communication Intervention; A persuasive health communication intervention will be performed
Experimental: PHCI with ED Medical Staff; A persuasive health communication intervention will be performed by ED medical staff	Behavioral: Persuasive Health Communication Intervention; A persuasive health communication intervention will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV/HCV testing uptake	HIV/HCV testing will be remeasured via questionnaire following the intervention	10 minutes

Collaborators and Investigators

• Sponsor: Rhode Island Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2019
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: October 21, 2019
• First Posted (Actual): October 23, 2019

Study Record Updates

• Last Update Posted (Actual): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Disease Attributes; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Emergencies; Hepatitis C
• Other Study ID Numbers: 1301303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No