HIV Infections
Conditions
Keywords
HIV, Testing, HIV Seronegativity
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.
Interventions
BEHAVIORALCounselor-based HIV screening
Participants will undergo oral HIV screening by HIV counselor and, if positive, further study visits for up to 6 months
BEHAVIORALEmergency 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
Sponsors
National Institute of Mental Health (NIMH)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Linkage to Care of Newly Diagnosed HIV Infected Participants | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Rapid HIV Testing Rate | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Test Offer Rate | 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 | 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. |
Countries
United States
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).
Participants by arm
| Arm | Count |
|---|---|
| Counselor Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening. | 2,446 |
| Provider Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening. | 2,409 |
| Total | 4,855 |
Baseline characteristics
| Characteristic | Total | Counselor | Provider |
|---|---|---|---|
| Age Continuous | 37.1 years STANDARD_DEVIATION 14 | 37.1 years STANDARD_DEVIATION 14 | 37.1 years STANDARD_DEVIATION 14 |
| Education College Degree | 955 participants | 517 participants | 438 participants |
| Education High School Degree | 1141 participants | 566 participants | 575 participants |
| Education Less than High School | 620 participants | 310 participants | 310 participants |
| Education Missing | 41 participants | 15 participants | 26 participants |
| Education Some College | 1409 participants | 696 participants | 713 participants |
| Education Some Post-College/Graduate Degree | 689 participants | 342 participants | 347 participants |
| Gender Female | 3139 participants | 1585 participants | 1554 participants |
| Gender Male | 1681 participants | 849 participants | 832 participants |
| Primary Language English | 3595 participants | 1788 participants | 1807 participants |
| Primary Language Missing | 38 participants | 21 participants | 17 participants |
| Primary Language Other | 291 participants | 154 participants | 137 participants |
| Primary Language Spanish | 931 participants | 483 participants | 448 participants |
| Race/Ethnicity, Customized Asian/Asian-American | 125 participants | 66 participants | 59 participants |
| Race/Ethnicity, Customized Hispanic | 1377 participants | 707 participants | 670 participants |
| Race/Ethnicity, Customized Missing | 55 participants | 21 participants | 34 participants |
| Race/Ethnicity, Customized Multi-racial/Other | 340 participants | 176 participants | 164 participants |
| Race/Ethnicity, Customized Native American/Alaskan Native | 20 participants | 12 participants | 8 participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 1072 participants | 526 participants | 546 participants |
| Race/Ethnicity, Customized Non-Hispanic White | 1866 participants | 938 participants | 928 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 33 / 1,382 | 14 / 643 |
| serious Total, serious adverse events | 0 / 1,382 | 0 / 643 |
Outcome results
Primary
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Counselor | Linkage to Care of Newly Diagnosed HIV Infected Participants | Linked to Care | 0 participants |
| Counselor | Linkage to Care of Newly Diagnosed HIV Infected Participants | Positive HIV Test | 0 participants |
| Provider | Linkage to Care of Newly Diagnosed HIV Infected Participants | Positive HIV Test | 7 participants |
| Provider | Linkage to Care of Newly Diagnosed HIV Infected Participants | Linked to Care | 4 participants |
Secondary
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.
Time frame: Assess on day subject enrolled into the study
Population: Intention to treat analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Counselor | Overall Rapid HIV Testing Rate | 1382 participants |
| Provider | Overall Rapid HIV Testing Rate | 643 participants |
Comparison: HIV test completed among patients randomizedp-value: <0.00195% CI: [27, 32]Chi-squared
Other Pre-specified
Test Acceptance Rate
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Counselor | Test Acceptance Rate | 1382 participants |
| Provider | Test Acceptance Rate | 643 participants |
Comparison: HIV test accepted among patients offeredp-value: 0.0295% CI: [-8, -1]Chi-squared
Other Pre-specified
Test Offer Rate
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Counselor | Test Offer Rate | 1959 participants |
| Provider | Test Offer Rate | 861 participants |
Comparison: HIV test offeredp-value: <0.00195% CI: [42, 47]Chi-squared