Trial Outcomes & Findings for Two Approaches to Routine HIV Testing in a Hospital Emergency Department (NCT NCT00502944)

Last Updated: 2012-07-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

4855 participants

Primary outcome timeframe

Assessed within 8 weeks after receipt of reactive rapid HIV test results

Results posted on

2012-07-19

Participant Flow

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).

Participant milestones

Participant milestones
Measure	Counselor Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.	Provider Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
Overall Study STARTED	2446	2409
Overall Study COMPLETED	1382	643
Overall Study NOT COMPLETED	1064	1766

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Two Approaches to Routine HIV Testing in a Hospital Emergency Department

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Counselor n=2446 Participants Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.	Provider n=2409 Participants Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.	Total n=4855 Participants Total of all reporting groups
Age Continuous	37.1 years STANDARD_DEVIATION 14 • n=5 Participants	37.1 years STANDARD_DEVIATION 14 • n=7 Participants	37.1 years STANDARD_DEVIATION 14 • n=5 Participants
Gender Female	1585 participants n=5 Participants	1554 participants n=7 Participants	3139 participants n=5 Participants
Gender Male	849 participants n=5 Participants	832 participants n=7 Participants	1681 participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic White	938 participants n=5 Participants	928 participants n=7 Participants	1866 participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic Black	526 participants n=5 Participants	546 participants n=7 Participants	1072 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	707 participants n=5 Participants	670 participants n=7 Participants	1377 participants n=5 Participants
Race/Ethnicity, Customized Asian/Asian-American	66 participants n=5 Participants	59 participants n=7 Participants	125 participants n=5 Participants
Race/Ethnicity, Customized Native American/Alaskan Native	12 participants n=5 Participants	8 participants n=7 Participants	20 participants n=5 Participants
Race/Ethnicity, Customized Multi-racial/Other	176 participants n=5 Participants	164 participants n=7 Participants	340 participants n=5 Participants
Race/Ethnicity, Customized Missing	21 participants n=5 Participants	34 participants n=7 Participants	55 participants n=5 Participants
Primary Language English	1788 participants n=5 Participants	1807 participants n=7 Participants	3595 participants n=5 Participants
Primary Language Spanish	483 participants n=5 Participants	448 participants n=7 Participants	931 participants n=5 Participants
Primary Language Other	154 participants n=5 Participants	137 participants n=7 Participants	291 participants n=5 Participants
Primary Language Missing	21 participants n=5 Participants	17 participants n=7 Participants	38 participants n=5 Participants
Education Less than High School	310 participants n=5 Participants	310 participants n=7 Participants	620 participants n=5 Participants
Education High School Degree	566 participants n=5 Participants	575 participants n=7 Participants	1141 participants n=5 Participants
Education Some College	696 participants n=5 Participants	713 participants n=7 Participants	1409 participants n=5 Participants
Education College Degree	517 participants n=5 Participants	438 participants n=7 Participants	955 participants n=5 Participants
Education Some Post-College/Graduate Degree	342 participants n=5 Participants	347 participants n=7 Participants	689 participants n=5 Participants
Education Missing	15 participants n=5 Participants	26 participants n=7 Participants	41 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed within 8 weeks after receipt of reactive rapid HIV test results

Population: 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.

Outcome measures

Outcome measures
Measure	Counselor n=2446 Participants Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.	Provider n=2409 Participants Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
Linkage to Care of Newly Diagnosed HIV Infected Participants Positive HIV Test	0 participants	7 participants
Linkage to Care of Newly Diagnosed HIV Infected Participants Linked to Care	0 participants	4 participants

SECONDARY outcome

Timeframe: Assess on day subject enrolled into the study

Population: Intention to treat analysis

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.

Outcome measures

Outcome measures
Measure	Counselor n=2446 Participants Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.	Provider n=2409 Participants Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
Overall Rapid HIV Testing Rate	1382 participants	643 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Counselor n=2446 Participants Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.	Provider n=2409 Participants Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
Test Offer Rate	1959 participants	861 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Assess on day subject enrolled into the study

Population: 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.

Acceptance of the HIV test was defined as the proportion of study participants who received the HIV test among those offered the test.

Outcome measures

Outcome measures
Measure	Counselor n=1959 Participants Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.	Provider n=861 Participants Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
Test Acceptance Rate	1382 participants	643 participants

Adverse Events

Counselor

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Provider

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Counselor n=1382 participants at risk Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.	Provider n=643 participants at risk Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
Investigations False-positive rapid test result	2.0% 27/1382 • Number of events 27 • 1 week after rapid HIV testing.	1.4% 9/643 • Number of events 9 • 1 week after rapid HIV testing.
Investigations Subject did not follow-up after reactive test	0.43% 6/1382 • Number of events 6 • 1 week after rapid HIV testing.	0.78% 5/643 • Number of events 5 • 1 week after rapid HIV testing.

Additional Information

Rochelle P. Walensky, MD, MPH

Massachusetts General Hospital

Phone: (617) 724-8445

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place