HIV InfectionsUSHERNCT01258582
Two Approaches to Routine HIV Testing in a Hospital Emergency Department
A study testing Oral HIV screening and Fingerstick HIV screening in people with HIV Infections, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Oral HIV screening and Fingerstick HIV screening
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,651 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Jan 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Optimizing Strategies for Universal HIV Testing (The USHER Trial): Phase II
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).
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Oral HIV screening, Fingerstick HIV screening
- Keywords
- HIV, Testing, HIV Seronegativity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral HIV screeningProcedure or surgery
Participants will undergo oral HIV screening and, if positive, further study visits for up to 6 months
Fingerstick HIV screeningProcedure or surgery
Participants will undergo fingerstick HIV screening and, if positive, further study visits for up to 6 months
| Study group | Role | What they receive |
|---|---|---|
| Oral HIV testing | Experimental | Not described Receives: Procedure: Oral HIV screening |
| Fingerstick HIV testing | Active comparator | Not described Receives: Procedure: Fingerstick HIV screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Assess on day subject enrolled into the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2010 (estimated)
- Study startMay 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,651 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Rochelle Walensky, Massachusetts General Hospital
- Investigators
- Rochelle P Walensky, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258582
- Sponsor's protocol ID
- R01 MH073445 (Phase II)
- Other IDs
- R01MH073445
- Acronym
- USHER
- Status last verified
- May 2012
- First submitted
- 10 Dec 2010
- Last updated
- 13 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 23308216
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Strategies for Universal HIV Testing (The USHER Trial): Phase II
- ClinicalTrials.gov ID
- NCT01258582
- Acronym / sponsor ID
- USHER / R01 MH073445 (Phase II)
- Conditions
- HIV Infections
- Keywords
- HIV, Testing, HIV Seronegativity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,651 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 13 Dec 2010 (estimated)
- Results
- Posted 5 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral HIV testing | Experimental | Procedure: Oral HIV screening |
| Fingerstick HIV testing | Active comparator | Procedure: Fingerstick HIV screening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral HIV screeningParticipants will undergo oral HIV screening and, if positive, further study visits for up to 6 months | Procedure or surgery | Oral HIV testing |
| Fingerstick HIV screeningParticipants will undergo fingerstick HIV screening and, if positive, further study visits for up to 6 months | Procedure or surgery | Fingerstick HIV testing |
Primary outcome
Acceptability of the HIV Test
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23308216Ganguli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rochelle P Walensky, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral HIV screening and Fingerstick HIV screening in people with HIV Infections, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the HIV Test (time frame: Assess on day subject enrolled into the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01258582, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2012.