Two Approaches to Routine HIV Testing in a Hospital Emergency Department

Study Overview
=================
Brief Summary
-----------------
This study was initially designed to compare the effectiveness of two different approaches to providing routine HIV counseling, testing, and referral services in an urban hospital emergency department setting. The initial phase was closed in July 2008. The second phase of this trial consists of establishing the differences in acceptability of HIV testing based on the method of testing offered (rapid oral fluid vs. fingerstick).

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. In the original proposal, we chose oral rapid HIV testing as we felt that this technique is noninvasive, acceptable to both patients and health care workers (without body fluid risk), and would maximize rates of HIV testing. This study directly compares acceptance rates of HIV testing as a function of the test type offered (oral vs. fingerstick) in a randomized controlled fashion. 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 oral vs. fingerstick HIV testing by a designated HIV counselor and to fill out a questionnaire while waiting in the emergency room. The questionnaire will be anonymous. Participants will then be offered a rapid HIV test. Test results will be available in about 20 minutes and will be provided to participants by the 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
-----------------
Optimizing Strategies for Universal HIV Testing (The USHER Trial): Phase II

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Procedure: Oral HIV screening
* Procedure: Fingerstick HIV screening


Participation Criteria
=================
Eligibility Criteria
-----------------
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
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral HIV testing<br> | Procedure: Oral HIV screening<br>* Participants will undergo oral HIV screening and, if positive, further study visits for up to 6 months<br>|
| Active Comparator: Fingerstick HIV testing<br> | Procedure: Fingerstick HIV screening<br>* Participants will undergo fingerstick HIV screening and, if positive, further study visits for up to 6 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of the HIV Test | The primary outcome measure was HIV test acceptance rate defined by the proportion of participants whom accepted HIV testing among those randomized within each trial arm (fingerstick or oral fluid). | Assess on day subject enrolled into the study | 

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