Increasing Viral Testing in the Emergency Department

HIV Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01419899
• Other study ID #: 5R21DA28645-2
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 6, 2011
• Last updated: August 5, 2013
• Start date: January 2011
• Est. completion date: January 2012

Study information

• Verified date: August 2013
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 398
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Drug Use
• Hepatitis
• Hepatitis C
• HIV

Intervention

Behavioral:
• Brief motivational intervention
A 20-30 minute motivational based discussion

Locations

Country	Name	City	State
United States	Rhode Island Hospital Emergency Department	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Rhode Island Hospital	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No