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Two Approaches to Routine HIV Testing in a Hospital Emergency Department

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Counselor-based HIV screening
Emergency staff member-based HIV screening
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for HIV Infections focused on measuring HIV, Testing, HIV Seronegativity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Counselor-based HIV screening

Emergency staff member-based HIV screening

Arm Description

Outcomes

Primary Outcome Measures

Linkage to Care of Newly Diagnosed HIV Infected Participants
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.

Secondary Outcome Measures

Overall Rapid HIV Testing Rate
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.

Full Information

First Posted
July 16, 2007
Last Updated
July 16, 2012
Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00502944
Brief Title
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

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Testing, HIV Seronegativity

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4855 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Counselor-based HIV screening
Arm Type
Experimental
Arm Title
Emergency staff member-based HIV screening
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Counselor-based HIV screening
Intervention Description
Participants will undergo oral HIV screening by HIV counselor and, if positive, further study visits for up to 6 months
Intervention Type
Behavioral
Intervention Name(s)
Emergency staff member-based HIV screening
Intervention Description
Participants will undergo oral HIV screening by emergency staff member and, if positive, further study visits for up to 6 months
Primary Outcome Measure Information:
Title
Linkage to Care of Newly Diagnosed HIV Infected Participants
Description
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.
Time Frame
Assessed within 8 weeks after receipt of reactive rapid HIV test results
Secondary Outcome Measure Information:
Title
Overall Rapid HIV Testing Rate
Description
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.
Time Frame
Assess on day subject enrolled into the study
Other Pre-specified Outcome Measures:
Title
Test Offer Rate
Description
The offer rate of the HIV test was defined as the proportion of enrolled study participants who were actually offered a test.
Time Frame
Assess on day subject enrolled into the study
Title
Test Acceptance Rate
Description
Acceptance of the HIV test was defined as the proportion of study participants who received the HIV test among those offered the test.
Time Frame
Assess on day subject enrolled into the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rochelle P. Walensky, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18462591
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.
Results Reference
background
PubMed Identifier
18190295
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.
Results Reference
background
PubMed Identifier
19849965
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.
Results Reference
background
PubMed Identifier
20090953
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.
Results Reference
background
PubMed Identifier
21684408
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.
Results Reference
background
PubMed Identifier
22110730
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.
Results Reference
background
PubMed Identifier
20978834
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.
Results Reference
background
PubMed Identifier
18678842
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.
Results Reference
result
PubMed Identifier
20157472
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.
Results Reference
result
PubMed Identifier
19828278
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.
Results Reference
result
PubMed Identifier
22022415
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.
Results Reference
result
PubMed Identifier
21684391
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.
Results Reference
result
PubMed Identifier
23308216
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.
Results Reference
derived

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Two Approaches to Routine HIV Testing in a Hospital Emergency Department

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