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Clinical Trials/NCT00502944
NCT00502944CompletedNot Applicable

Optimizing Strategies for Universal HIV Testing (The USHER Trial)

Massachusetts General Hospital1 site in 1 country4,855 target enrollmentStarted: February 1, 2007Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
4,855
Locations
1
Primary Endpoint
Linkage to Care of Newly Diagnosed HIV Infected Participants

Study Overview

Brief Summary

This study will compare the effectiveness of two different approaches to providing routine HIV counseling, testing, and referral services in an urban hospital emergency department setting.

Detailed Description

About 25% of HIV infected people do not know that they are infected. These people lack medical care that could prolong their lives and access to counseling services that could prevent further spread of HIV. With so many people unaware of their HIV status, there is a clear need for more readily available HIV counseling, testing, and referral services throughout the United States. The Centers for Disease Control and Prevention (CDC) recommends routine HIV testing in U.S. hospitals in which HIV infected patients make up at least 1% of the total patient population for that hospital. However, routine HIV testing in such hospitals is rarely carried out, which might be because the CDC has not specified who should perform routine HIV testing. The purpose of this study is to compare the effectiveness of two different approaches to providing routine HIV counseling, testing, and referral services in an urban hospital emergency department setting. One approach will be led by an HIV counselor, and the other approach will be led by an emergency department staff member. For both approaches, the study will evaluate to what extent patients accept HIV testing, how well follow-up care is established, and the cost-effectiveness of the approach.

Participants in this study will include adults who visit Brigham and Women's Hospital emergency department in Boston, Massachusetts. Participants will be randomly assigned to a counselor versus provider and will be asked to fill out a questionnaire while waiting in the emergency room. The questionnaire will be anonymous. Participants will then be offered an oral rapid HIV test. Test results will be available in about 20 minutes and will be provided to participants by either their assigned HIV counselor. Participants who test positive for HIV will be offered a more definitive blood test to confirm HIV infection. The blood test results will be available 2 weeks from testing, and participants must return to the hospital to get their test results. Participants who test positive for HIV will be offered counseling support and referral services by either their assigned HIV counselor or emergency department staff member. Follow-up care appointments will also be initiated at this time. For participants who test positive for HIV, the study will last about 6 months. There will be no follow-up visits for participants who do not test positive for HIV during their emergency room visit.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Waiting to receive care in the Brigham and Women's Hospital emergency room
  • •English- or Spanish-speaking
  • •Enters the emergency room when an HIV counselor is available

Exclusion Criteria

  • •An estimated severity index score of 1 or 2 who have mechanical ventilation or are not deemed alert, awake, and oriented to person, place and time by the triage nurse
  • •HIV infected

Arms & Interventions

Emergency staff member-based HIV screening

Active Comparator

Intervention: Emergency staff member-based HIV screening (Behavioral)

Counselor-based HIV screening

Experimental

Intervention: Counselor-based HIV screening (Behavioral)

Outcomes

Primary Outcomes

Linkage to Care of Newly Diagnosed HIV Infected Participants

Time Frame: Assessed within 8 weeks after receipt of reactive rapid HIV test results

We define linkage to care as attendance at a first HIV clinic appointment where the following 3 events occur: 1) introduction to an HIV care primary provider; 2) receipt of confirmatory Western Blot HIV test results; and 3) phlebotomy for CD4 cell count and HIV RNA level.

Secondary Outcomes

  • Overall Rapid HIV Testing Rate(Assess on day subject enrolled into the study)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rochelle Walensky

Associate Professor

Massachusetts General Hospital

Study Sites (1)

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