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InVITED: Increasing Viral Testing in the Emergency Department

Sponsor
Rhode Island Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01419899
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
398
Enrollment
1
Location
2
Arms
12
Duration (Months)
33.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Behavioral: Brief motivational intervention
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
398 participants
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
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Jan 1, 2012

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. The agreement of the participant to be tested for HIV and hepatitis C [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

  1. Identifying risky sexual behaviors of study participants [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Roland C. Merchant, MD. MPH, ScD, Associate Professor, Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT01419899
Other Study ID Numbers:
  • 5R21DA28645-2
First Posted:
Aug 18, 2011
Last Update Posted:
Aug 7, 2013
Last Verified:
Aug 1, 2013
Keywords provided by Roland C. Merchant, MD. MPH, ScD, Associate Professor, Rhode Island Hospital
Brief intervention
Rapid testing
Additional relevant MeSH terms:
Hepatitis C
Hepatitis
Emergencies

Study Results

No Results Posted as of Aug 7, 2013