Development and Pilot Testing of a PHCI for Emergency Department Patients Who Decline Rapid HIV/ HCV Screening
Primary Purpose
Hiv, Hepatitis C
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Persuasive Health Communication Intervention
Sponsored by
About this trial
This is an interventional other trial for Hiv
Eligibility Criteria
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)
Sites / Locations
- Rhode Island Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
PHCI with HIV/HCV counselor
PHCI with ED Medical Staff
Arm Description
A persuasive health communication intervention will be performed by a community HIV/HCV test counselor
A persuasive health communication intervention will be performed by ED medical staff
Outcomes
Primary Outcome Measures
HIV/HCV testing uptake
HIV/HCV testing will be remeasured via questionnaire following the intervention
Secondary Outcome Measures
Full Information
NCT ID
NCT04137094
First Posted
October 16, 2019
Last Updated
August 19, 2021
Sponsor
Rhode Island Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04137094
Brief Title
Development and Pilot Testing of a PHCI for Emergency Department Patients Who Decline Rapid HIV/ HCV Screening
Official Title
Development and Pilot Testing of a Persuasive Health Communication Intervention for Emergency Department Patients Who Decline Rapid HIV/ HCV Screening
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 16, 2019 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rhode Island Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hiv, Hepatitis C
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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 watch the CDC HIV/HCV testing brochures-based video.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PHCI with HIV/HCV counselor
Arm Type
Experimental
Arm Description
A persuasive health communication intervention will be performed by a community HIV/HCV test counselor
Arm Title
PHCI with ED Medical Staff
Arm Type
Experimental
Arm Description
A persuasive health communication intervention will be performed by ED medical staff
Intervention Type
Behavioral
Intervention Name(s)
Persuasive Health Communication Intervention
Intervention Description
A persuasive health communication intervention will be performed
Primary Outcome Measure Information:
Title
HIV/HCV testing uptake
Description
HIV/HCV testing will be remeasured via questionnaire following the intervention
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02907
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Development and Pilot Testing of a PHCI for Emergency Department Patients Who Decline Rapid HIV/ HCV Screening
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