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Increasing Viral Testing in the Emergency Department (InVITED)

This study is currently recruiting participants.
Verified July 2011 by Rhode Island Hospital
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT01419899
First received: July 6, 2011
Last updated: August 16, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Drug Use
HIV
Hepatitis C
 Behavioral: Brief motivational intervention
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • The agreement of the participant to be tested for HIV and hepatitis C [ Time Frame: Within four hours of being consented into the study ] [ Designated as safety issue: No ]
    We will measure the acceptance of free rapid testing for HIV and hepatitis C among the intervention and control groups


Secondary Outcome Measures:
  • Identifying risky sexual behaviors of study participants [ Time Frame: Within four hours of being consented into the study ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 328
Study Start Date: January 2011
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419899

Locations
United States, Rhode Island
Rhode Island Hospital Emergency Department Recruiting
Providence, Rhode Island, United States, 02903
Contact: Roland C Merchant, MD, ScD     401-444-5109     rmerchant@lifespan.org    
Contact: Janette Baird, PhD     401-444-2976     jbaird@lifespan.org    
Principal Investigator: Roland C Merchant, MD, ScD            
Principal Investigator: Ted Nirenberg, PhD            
Sub-Investigator: Janette Baird, PhD            
Sub-Investigator: Michael J Mello, Md, MPH            
Sponsors and Collaborators
Rhode Island Hospital
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Roland C Merchant, MD, ScD Brown University
Principal Investigator: Ted D Nirenberg, PhD Brown University
  More Information

No publications provided

Responsible Party: Roland C Merchant, Department of Emergency Medicine, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT01419899     History of Changes
Other Study ID Numbers: 5R21DA28645-2
Study First Received: July 6, 2011
Last Updated: August 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
Brief intervention
Rapid testing

Additional relevant MeSH terms:
Emergencies
Hepatitis
Hepatitis A
Hepatitis C
Disease Attributes
Pathologic Processes
Liver Diseases
 Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on March 03, 2013