HIV Infections
Conditions
Keywords
HIV, Testing, HIV Seronegativity
Brief summary
This study was initially designed to compare the effectiveness of two different approaches to providing routine HIV counseling, testing, and referral services in an urban hospital emergency department setting. The initial phase was closed in July 2008. The second phase of this trial consists of establishing the differences in acceptability of HIV testing based on the method of testing offered (rapid oral fluid vs. fingerstick).
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. In the original proposal, we chose oral rapid HIV testing as we felt that this technique is noninvasive, acceptable to both patients and health care workers (without body fluid risk), and would maximize rates of HIV testing. This study directly compares acceptance rates of HIV testing as a function of the test type offered (oral vs. fingerstick) in a randomized controlled fashion. 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 oral vs. fingerstick HIV testing by a designated HIV counselor and to fill out a questionnaire while waiting in the emergency room. The questionnaire will be anonymous. Participants will then be offered a rapid HIV test. Test results will be available in about 20 minutes and will be provided to participants by the 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
PROCEDUREOral HIV screening
Participants will undergo oral HIV screening and, if positive, further study visits for up to 6 months
PROCEDUREFingerstick HIV screening
Participants will undergo fingerstick HIV screening 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 |
|---|---|---|
| Acceptability of the HIV Test | Assess on day subject enrolled into the study | The primary outcome measure was HIV test acceptance rate defined by the proportion of participants whom accepted HIV testing among those randomized within each trial arm (fingerstick or oral fluid). |
Countries
United States
Participant flow
Recruitment details
The USHER-Phase II study was conducted in the emergency department at Brigham and Women's Hospital, Boston, MA. Between May 5, 2009 and January 4, 2010, USHER-Phase II consented eligible patients for the opportunity to be offered routine opt-in, rapid HIV screening. Enrolled subjects were randomized to fingerstick or oral specimen collection.
Participants by arm
| Arm | Count |
|---|---|
| Fingerstick Fingerstick rapid HIV testing | 830 |
| Oral Fluid Oral fluid rapid HIV testing | 821 |
| Total | 1,651 |
Baseline characteristics
| Characteristic | Total | Fingerstick | Oral Fluid |
|---|---|---|---|
| Age Continuous | 33 years STANDARD_DEVIATION 13 | 34 years STANDARD_DEVIATION 13 | 33 years STANDARD_DEVIATION 13 |
| Education College Degree | 317 participants | 173 participants | 144 participants |
| Education High School/General Education Diploma | 516 participants | 255 participants | 261 participants |
| Education Less than High School | 212 participants | 116 participants | 96 participants |
| Education Missing | 37 participants | 21 participants | 16 participants |
| Education Some College | 420 participants | 198 participants | 222 participants |
| Education Some Post-College/Graduate Degree | 149 participants | 67 participants | 82 participants |
| Gender Female | 1065 participants | 536 participants | 529 participants |
| Gender Male | 571 participants | 283 participants | 288 participants |
| Primary Language English | 1287 participants | 643 participants | 644 participants |
| Primary Language Missing | 12 participants | 5 participants | 7 participants |
| Primary Language Other | 63 participants | 34 participants | 29 participants |
| Primary Language Spanish | 289 participants | 148 participants | 141 participants |
| Race/Ethnicity, Customized Asian/Asain-American | 44 participants | 22 participants | 22 participants |
| Race/Ethnicity, Customized Hispanic | 626 participants | 329 participants | 297 participants |
| Race/Ethnicity, Customized Missing | 12 participants | 7 participants | 5 participants |
| Race/Ethnicity, Customized Multi-racial/Other | 177 participants | 85 participants | 92 participants |
| Race/Ethnicity, Customized Native American/Alaskan Native | 5 participants | 1 participants | 4 participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 388 participants | 188 participants | 200 participants |
| Race/Ethnicity, Customized Non-Hispanic White | 399 participants | 198 participants | 201 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 553 | 1 / 565 |
| serious Total, serious adverse events | 0 / 553 | 0 / 565 |
Outcome results
Primary
Acceptability of the HIV Test
The primary outcome measure was HIV test acceptance rate defined by the proportion of participants whom accepted HIV testing among those randomized within each trial arm (fingerstick or oral fluid).
Time frame: Assess on day subject enrolled into the study
Population: Intent to treat analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fingerstick HIV Testing | Acceptability of the HIV Test | 0.67 proportion of participants |
| Oral HIV Testing | Acceptability of the HIV Test | 0.69 proportion of participants |
Comparison: Sample size was chosen to detect a 10% difference in acceptance rates between two testing modality arms (90% power, 0.05 level of significance).p-value: 0.3495% CI: [-0.067, 0.023]Chi-squared