Clinical trial NCT00502944: Two Approaches to Routine HIV Testing in a Hospital Emergency Department
Official title: Optimizing Strategies for Universal HIV Testing (The USHER Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV
Testing
HIV Seronegativity
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2007-07-18
Enrollment: 4855
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Linkage to Care of Newly Diagnosed HIV Infected Participants
timeFrame: Assessed within 8 weeks after receipt of reactive rapid HIV test results
Secondary outcomes:
measure: Overall Rapid HIV Testing Rate
timeFrame: Assess on day subject enrolled into the study
Other outcomes:
measure: Test Offer Rate
timeFrame: Assess on day subject enrolled into the study
measure: Test Acceptance Rate
timeFrame: Assess on day subject enrolled into the study
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Rochelle P. Walensky, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.