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Increasing Viral Testing in the Emergency Department (InVITED)

Primary Purpose

Drug Use, HIV, Hepatitis C

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Brief motivational intervention
Sponsored by
Rhode Island Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Drug Use focused on measuring Brief intervention, Rapid testing

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rhode Island Hospital Emergency Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Brief Intervention

Standard Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
July 6, 2011
Last Updated
August 5, 2013
Sponsor
Rhode Island Hospital
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01419899
Brief Title
Increasing Viral Testing in the Emergency Department
Acronym
InVITED
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 Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rhode Island Hospital
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Use, HIV, Hepatitis C
Keywords
Brief intervention, Rapid testing

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
398 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brief Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brief motivational intervention
Intervention Description
A 20-30 minute motivational based discussion
Primary Outcome Measure Information:
Title
The agreement of the participant to be tested for HIV and hepatitis C
Description
We will measure the acceptance of free rapid testing for HIV and hepatitis C among the intervention and control groups
Time Frame
Within four hours of being consented into the study
Secondary Outcome Measure Information:
Title
Identifying risky sexual behaviors of study participants
Description
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.
Time Frame
Within four hours of being consented into the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland C Merchant, MD, ScD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ted D Nirenberg, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital Emergency Department
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25125271
Citation
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.
Results Reference
derived
PubMed Identifier
24983020
Citation
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.
Results Reference
derived
PubMed Identifier
25830171
Citation
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.
Results Reference
derived

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Increasing Viral Testing in the Emergency Department

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