Two Approaches to Routine HIV Testing in a Hospital Emergency Department

HIV Infections Clinical Trial

— USHER  

Official title:

Optimizing Strategies for Universal HIV Testing (The USHER Trial): Phase II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01258582
• Other study ID #: R01 MH073445 (Phase II)
• Secondary ID: R01MH073445
• Status: Completed
• Phase: N/A
• First received: December 10, 2010
• Last updated: June 10, 2012
• Start date: May 2009
• Est. completion date: January 2010

Study information

• Verified date: May 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1651
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• HIV Infections

Intervention

Procedure:
• Oral HIV screening
Participants will undergo oral HIV screening and, if positive, further study visits for up to 6 months
• Fingerstick HIV screening
Participants will undergo fingerstick HIV screening and, if positive, further study visits for up to 6 months

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No