Two Approaches to Routine HIV Testing in a Hospital Emergency Department (USHER)
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|ClinicalTrials.gov Identifier: NCT01258582|
Recruitment Status : Completed
First Posted : December 13, 2010
Results First Posted : June 5, 2012
Last Update Posted : June 13, 2012
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Procedure: Oral HIV screening Procedure: Fingerstick HIV screening||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1651 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Optimizing Strategies for Universal HIV Testing (The USHER Trial): Phase II|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
|Experimental: Oral HIV testing||
Procedure: Oral HIV screening
Participants will undergo oral HIV screening and, if positive, further study visits for up to 6 months
|Active Comparator: Fingerstick HIV testing||
Procedure: Fingerstick HIV screening
Participants will undergo fingerstick HIV screening and, if positive, further study visits for up to 6 months
- Acceptability of the HIV Test [ Time Frame: Assess on day subject enrolled into the study ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01258582
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Rochelle P Walensky, MD, MPH||Massachusetts General Hospital|