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Increasing Viral Testing in the Emergency Department (InVITED)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01419899
First Posted: August 18, 2011
Last Update Posted: August 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Roland C. Merchant, MD. MPH, ScD, Rhode Island Hospital
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


Further study details as provided by Roland C. Merchant, MD. MPH, ScD, 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 ]
    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 ]
    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.


Enrollment: 398
Study Start Date: January 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01419899


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roland C. Merchant, MD. MPH, ScD, Associate Professor, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT01419899     History of Changes
Other Study ID Numbers: 5R21DA28645-2
First Submitted: July 6, 2011
First Posted: August 18, 2011
Last Update Posted: August 7, 2013
Last Verified: August 2013

Keywords provided by Roland C. Merchant, MD. MPH, ScD, Rhode Island Hospital:
Brief intervention
Rapid testing

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