Two Approaches to Routine HIV Testing in a Hospital Emergency Department

Not Applicable

Completed

Conditions: HIV Infections

Interventions: Behavioral: Counselor-based HIV screening
Behavioral: Emergency staff member-based HIV screening

Registration Number: NCT00502944

Lead Sponsor: Massachusetts General Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 4855

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Counselor-based HIV screening	Counselor-based HIV screening	-
Emergency staff member-based HIV screening	Emergency staff member-based HIV screening	-

Primary Outcome Measures

Name	Time	Method
Linkage to Care of Newly Diagnosed HIV Infected Participants	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 Outcome Measures

Name	Time	Method
Overall Rapid HIV Testing Rate	Assess on day subject enrolled into the study	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.