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

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Screening
• Condition: HIV Infections
• Interventions: Behavioral: Counselor-based HIV screening; Behavioral: Emergency staff member-based HIV screening
• Enrollment: 4855

Participant Flow

Recruitment Details	Recruitment took place from February 7, 2007 to July 9, 2008 at Brigham and Women's Hospital emergency department. Oral HIV testing was offered to eligible patients by either HIV counselors or emergency service assistants (existing members of emergency department personnel).
Pre-assignment Details

Arm/Group Title	Counselor	Provider
Arm/Group Description	Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.	Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
Period Title: Overall Study
Started	2446	2409
Completed	1382	643
Not Completed	1064	1766

Baseline Characteristics

Arm/Group Title		Counselor	Provider	Total
Arm/Group Description		Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.	Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.	Total of all reporting groups
Overall Number of Baseline Participants		2446	2409	4855
Baseline Analysis Population Description		[Not Specified]
Age Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	2446 participants	2409 participants	4855 participants
		37.1 (14)	37.1 (14)	37.1 (14)
Gender [1]; Measure Type: Number; Unit of measure: Participants	Number Analyzed	2446 participants	2409 participants	4855 participants
Female		1585	1554	3139
Male		849	832	1681
		[1] Measure Description: Numbers within the gender category do not add up to total number randomized due to missing data/numbers.
Race/Ethnicity, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	2446 participants	2409 participants	4855 participants
Non-Hispanic White		938	928	1866
Non-Hispanic Black		526	546	1072
Hispanic		707	670	1377
Asian/Asian-American		66	59	125
Native American/Alaskan Native		12	8	20
Multi-racial/Other		176	164	340
Missing		21	34	55
Primary Language; Measure Type: Number; Unit of measure: Participants	Number Analyzed	2446 participants	2409 participants	4855 participants
English		1788	1807	3595
Spanish		483	448	931
Other		154	137	291
Missing		21	17	38
Education; Measure Type: Number; Unit of measure: Participants	Number Analyzed	2446 participants	2409 participants	4855 participants
Less than High School		310	310	620
High School Degree		566	575	1141
Some College		696	713	1409
College Degree		517	438	955
Some Post-College/Graduate Degree		342	347	689
Missing		15	26	41

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

DSMB recommended the trial be ended early for likely inability to obtain this primary outcome. Thus the outcomes reported in paper are the secondary and other pre-specified outcomes listed.

Arm/Group Title	Counselor	Provider
Arm/Group Description:	Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.	Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
Overall Number of Participants Analyzed	2446	2409
Measure Type: Number; Unit of Measure: participants
Positive HIV Test	0	7
Linked to Care	0	4

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Intention to treat analysis

Arm/Group Title	Counselor	Provider
Arm/Group Description:	Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.	Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
Overall Number of Participants Analyzed	2446	2409
Measure Type: Number; Unit of Measure: participants
	1382	643

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Counselor, Provider
	Comments	HIV test completed among patients randomized
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Rate Difference (%)
	Estimated Value	30
	Confidence Interval	(2-Sided) 95%; 27 to 32
	Estimation Comments	[Not Specified]

3. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Counselor	Provider
Arm/Group Description:	Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.	Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
Overall Number of Participants Analyzed	2446	2409
Measure Type: Number; Unit of Measure: participants
	1959	861

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Counselor, Provider
	Comments	HIV test offered
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Rate Difference (%)
	Estimated Value	44
	Confidence Interval	(2-Sided) 95%; 42 to 47
	Estimation Comments	[Not Specified]

4. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

Number of participants analyzed equals the number of participants offered a rapid HIV test. Many participants left the ED before the opportunity was available to offer the test.

Arm/Group Title	Counselor	Provider
Arm/Group Description:	Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.	Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
Overall Number of Participants Analyzed	1959	861
Measure Type: Number; Unit of Measure: participants
	1382	643

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Counselor, Provider
	Comments	HIV test accepted among patients offered
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.02
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Rate Difference (%)
	Estimated Value	-4
	Confidence Interval	(2-Sided) 95%; -8 to -1
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	1 week after rapid HIV testing.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Counselor		Provider
Arm/Group Description	Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.		Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
All-Cause Mortality
	Counselor		Provider
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	Counselor		Provider
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1382 (0.00%)		0/643 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Counselor		Provider
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	33/1382 (2.39%)		14/643 (2.18%)
Investigations
False-positive rapid test result *	27/1382 (1.95%)	27	9/643 (1.40%)	9
Subject did not follow-up after reactive test *	6/1382 (0.43%)	6	5/643 (0.78%)	5
* Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Rochelle P. Walensky, MD, MPH
• Organization: Massachusetts General Hospital
• Phone: (617) 724-8445
• EMail: rwalensky@partners.org

Publications of Results:

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.

Other 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Rochelle Walensky, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT00502944
• Other Study ID Numbers: R01MH073445 ( U.S. NIH Grant/Contract ); R01MH073445 ( U.S. NIH Grant/Contract ); DAHBR 9A-ASPQ
• First Submitted: July 16, 2007
• First Posted: July 18, 2007
• Results First Submitted: May 3, 2012
• Results First Posted: July 13, 2012
• Last Update Posted: July 19, 2012