Increasing Viral Testing in the Emergency Department (InVITED)

Phase 2/3 Clinical Trial of the Effect of a Brief Intervention on Uptake of Rapid Testing for HIV and Hepatitis C Among Emergency Department Patients

The purpose of this study is to determine if a brief intervention delivered to emergency department patients increases the uptake of rapid HIV and hepatitis C testing in comparison to no brief intervention.

Study Overview

• Status: Completed
• Conditions: Hepatitis C; HIV; Drug Use
• Intervention / Treatment: Behavioral: Brief motivational intervention

• Study Type: Interventional
• Enrollment (Actual): 398
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital Emergency Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Emergency department patient.
• Does not know HIV or hepatitis C status.
• Has an ASSIST V3 score that indicates recent illicit and/or prescription drug use.
• Fluency in English or Spanish.

Exclusion Criteria:

• Critically ill or injured.
• Homicidal and/or suicidal intention.
• Age < 18 years or > 64 years.
• Does not speak English or Spanish.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brief Intervention; This arm of the study will receive an assessments survey followed by a brief intervention concerning the relationship between the participants use of drugs and/or sexual risk and rik for HIV and hepatitis C infections. Following the intervention the participants will be offered free rapid testing for HIV and hepatitis C.	Behavioral: Brief motivational intervention; A 20-30 minute motivational based discussion
No Intervention: Standard Care; This arm of the study will receive an assessments survey. Following the assessment the participants will be offered free rapid testing for HIV and hepatitis C.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The agreement of the participant to be tested for HIV and hepatitis C	We will measure the acceptance of free rapid testing for HIV and hepatitis C among the intervention and control groups	Within four hours of being consented into the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identifying risky sexual behaviors of study participants	Identify factors that influence the relationship of BI and risk assessment vs. risk assessment alone on uptake of combined HIV and hepatitis C screening in the ED.	Within four hours of being consented into the study

Collaborators and Investigators

• Sponsor: Rhode Island Hospital
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Roland C Merchant, MD, ScD, Brown University; Principal Investigator: Ted D Nirenberg, PhD, Brown University

Publications and helpful links

General Publications

• Merchant RC, Baird JR, Liu T, Taylor LE. HCV among The Miriam Hospital and Rhode Island Hospital Adult ED Patients. R I Med J (2013). 2014 Jul 1;97(7):35-9.
• Bernardino VL, Baird JR, Liu T, Merchant RC. Comparison of substance-use prevalence among Rhode Island and The Miriam Hospital Emergency Department patients to state and national general population prevalence estimates. R I Med J (2013). 2014 Apr 1;98(4):30-4.
• Merchant RC, Baird JR, Liu T, Taylor LE, Montague BT, Nirenberg TD. Brief intervention to increase emergency department uptake of combined rapid human immunodeficiency virus and hepatitis C screening among a drug misusing population. Acad Emerg Med. 2014 Jul;21(7):752-67. doi: 10.1111/acem.12419.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: July 6, 2011
• First Submitted That Met QC Criteria: August 16, 2011
• First Posted (Estimate): August 18, 2011

Study Record Updates

• Last Update Posted (Estimate): August 7, 2013
• Last Update Submitted That Met QC Criteria: August 5, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Brief intervention; Rapid testing
• 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; Emergencies; Hepatitis; Hepatitis C
• Other Study ID Numbers: 5R21DA28645-2