Two Approaches to Routine HIV Testing in a Hospital Emergency Department

• ClinicalTrials.gov Identifier: NCT00502944
• Recruitment Status: Completed
• First Posted: July 18, 2007
• Results First Posted: July 13, 2012
• Last Update Posted: July 19, 2012
• Sponsor: Massachusetts General Hospital
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Rochelle Walensky, Massachusetts General Hospital

Tracking Information

• First Submitted Date: July 16, 2007
• First Posted Date: July 18, 2007
• Results First Submitted Date: May 3, 2012
• Results First Posted Date: July 13, 2012
• Last Update Posted Date: July 19, 2012
• Study Start Date: February 2007
• Actual Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 10, 2012)

Linkage to Care of Newly Diagnosed HIV Infected Participants [ Time Frame: 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.

• Original Primary Outcome Measures (submitted: July 16, 2007): Linkage to care of newly diagnosed HIV infected participants [ Time Frame: throughout study and at Year 4.5 of the study ]

Current Secondary Outcome Measures (submitted: July 16, 2012)

Overall Rapid HIV Testing Rate [ Time Frame: 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.

• Original Secondary Outcome Measures (submitted: July 16, 2007): Test offer rate, test acceptability, maintenance of care, and medical personnel resource utilization [ Time Frame: throughout study ]

Current Other Pre-specified Outcome Measures (submitted: June 10, 2012)

• Test Offer Rate [ Time Frame: Assess on day subject enrolled into the study ]
  The offer rate of the HIV test was defined as the proportion of enrolled study participants who were actually offered a test.
• Test Acceptance Rate [ Time Frame: Assess on day subject enrolled into the study ]
  Acceptance of the HIV test was defined as the proportion of study participants who received the HIV test among those offered the test.

• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Two Approaches to Routine HIV Testing in a Hospital Emergency Department
• Official Title: Optimizing Strategies for Universal HIV Testing (The USHER Trial)
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Screening
• Condition: HIV Infections

Intervention

• Behavioral: Counselor-based HIV screening
  Participants will undergo oral HIV screening by HIV counselor and, if positive, further study visits for up to 6 months
• Behavioral: Emergency staff member-based HIV screening
  Participants will undergo oral HIV screening by emergency staff member and, if positive, further study visits for up to 6 months

Study Arms

• Experimental: Counselor-based HIV screening
  Intervention: Behavioral: Counselor-based HIV screening
• Active Comparator: Emergency staff member-based HIV screening
  Intervention: Behavioral: Emergency staff member-based HIV screening

Publications *

• Millen JC, Arbelaez C, Walensky RP. Implications and impact of the new US Centers for Disease Control and prevention HIV testing guidelines. Curr Infect Dis Rep. 2008 May;10(2):157-63. doi: 10.1007/s11908-008-0027-6.
• Walensky RP, Freedberg KA, Weinstein MC, Paltiel AD. Cost-effectiveness of HIV testing and treatment in the United States. Clin Infect Dis. 2007 Dec 15;45 Suppl 4(Suppl 4):S248-54. doi: 10.1086/522546.
• Ganguli I, Bassett IV, Dong KL, Walensky RP. Home testing for HIV infection in resource-limited settings. Curr HIV/AIDS Rep. 2009 Nov;6(4):217-23. doi: 10.1007/s11904-009-0029-5.
• Reichmann WM, Losina E, Seage GR, Arbelaez C, Safren SA, Katz JN, Hetland A, Walensky RP. Does modality of survey administration impact data quality: audio computer assisted self interview (ACASI) versus self-administered pen and paper? PLoS One. 2010 Jan 15;5(1):e8728. doi: 10.1371/journal.pone.0008728.
• Donnell-Fink L, Reichmann WM, Arbelaez C, Case AL, Katz JN, Losina E, Walensky RP. Patient satisfaction with rapid HIV testing in the emergency department. Ann Emerg Med. 2011 Jul;58(1 Suppl 1):S49-52. doi: 10.1016/j.annemergmed.2011.03.024.
• Reichmann WM, Walensky RP, Case A, Novais A, Arbelaez C, Katz JN, Losina E. Estimation of the prevalence of undiagnosed and diagnosed HIV in an urban emergency department. PLoS One. 2011;6(11):e27701. doi: 10.1371/journal.pone.0027701. Epub 2011 Nov 16.
• Pisculli ML, Reichmann WM, Losina E, Donnell-Fink LA, Arbelaez C, Katz JN, Walensky RP. Factors associated with refusal of rapid HIV testing in an emergency department. AIDS Behav. 2011 May;15(4):734-42. doi: 10.1007/s10461-010-9837-2.
• Walensky RP, Arbelaez C, Reichmann WM, Walls RM, Katz JN, Block BL, Dooley M, Hetland A, Kimmel S, Solomon JD, Losina E. Revising expectations from rapid HIV tests in the emergency department. Ann Intern Med. 2008 Aug 5;149(3):153-60. doi: 10.7326/0003-4819-149-3-200808050-00003.
• Arbelaez C, Block B, Losina E, Wright EA, Reichmann WM, Mikulinsky R, Solomon JD, Dooley MM, Walensky RP. Rapid HIV testing program implementation: lessons from the emergency department. Int J Emerg Med. 2009 Sep 1;2(3):187-94. doi: 10.1007/s12245-009-0123-x.
• Arbelaez C, Wright EA, Losina E, Millen JC, Kimmel S, Dooley M, Reichmann WM, Mikulinsky R, Walensky RP. Emergency provider attitudes and barriers to universal HIV testing in the emergency department. J Emerg Med. 2012 Jan;42(1):7-14. doi: 10.1016/j.jemermed.2009.07.038. Epub 2009 Oct 14.
• Walensky RP, Morris BL, Reichmann WM, Paltiel AD, Arbelaez C, Donnell-Fink L, Katz JN, Losina E. Resource utilization and cost-effectiveness of counselor- vs. provider-based rapid point-of-care HIV screening in the emergency department. PLoS One. 2011;6(10):e25575. doi: 10.1371/journal.pone.0025575. Epub 2011 Oct 12.
• Walensky RP, Reichmann WM, Arbelaez C, Wright E, Katz JN, Seage GR 3rd, Safren SA, Hare AQ, Novais A, Losina E. Counselor- versus provider-based HIV screening in the emergency department: results from the universal screening for HIV infection in the emergency room (USHER) randomized controlled trial. Ann Emerg Med. 2011 Jul;58(1 Suppl 1):S126-32.e1-4. doi: 10.1016/j.annemergmed.2011.03.023.
• Ganguli I, Collins JE, Reichmann WM, Losina E, Katz JN, Arbelaez C, Donnell-Fink LA, Walensky RP. Missed opportunities: refusal to confirm reactive rapid HIV tests in the emergency department. PLoS One. 2013;8(1):e53408. doi: 10.1371/journal.pone.0053408. Epub 2013 Jan 8.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 10, 2012): 4855
• Original Estimated Enrollment (submitted: July 16, 2007): 34200
• Actual Study Completion Date: July 2008
• Actual Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00502944
• Other Study ID Numbers: R01MH073445( U.S. NIH Grant/Contract ); R01MH073445 ( U.S. NIH Grant/Contract ); DAHBR 9A-ASPQ
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Rochelle Walensky, Massachusetts General Hospital
• Original Responsible Party: Not Provided
• Current Study Sponsor: Massachusetts General Hospital
• Original Study Sponsor: National Institute of Mental Health (NIMH)
• Collaborators: National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Rochelle P. Walensky, MD, MPH; Massachusetts General Hospital

• PRS Account: Massachusetts General Hospital
• Verification Date: July 2012