Two Approaches to Routine HIV Testing in a Hospital Emergency Department

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optimizing Strategies for Universal HIV Testing (The USHER Trial)

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: Counselor-based HIV screening
* Behavioral: Emergency staff member-based HIV screening


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Counselor-based HIV screening<br> | Behavioral: Counselor-based HIV screening<br>* Participants will undergo oral HIV screening by HIV counselor and, if positive, further study visits for up to 6 months<br>|
| Active Comparator: Emergency staff member-based HIV screening<br> | Behavioral: Emergency staff member-based HIV screening<br>* Participants will undergo oral HIV screening by emergency staff member and, if positive, further study visits for up to 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Linkage to Care of Newly Diagnosed HIV Infected Participants | 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. | Assessed within 8 weeks after receipt of reactive rapid HIV test results | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Rapid HIV Testing Rate | We defined the overall rapid HIV testing rate as the number of participants tested for HIV using the rapid test among those randomized to potentially be tested in each arm. | Assess on day subject enrolled into the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Testing, HIV Seronegativity