HIV InfectionsNCT00502944

Two Approaches to Routine HIV Testing in a Hospital Emergency Department

A study testing Counselor-based HIV screening and Emergency staff member-based HIV screening in people with HIV Infections, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. 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?: Counselor-based HIV screening and Emergency staff member-based HIV screening
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4,855 participants
Where: 1 siteUnited States
Study dates: Feb 2007to Jul 2008
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

Other trials in United States

About this study

Official title: Optimizing Strategies for Universal HIV Testing (The USHER Trial)

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.

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. 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.

Conditions: HIV Infections
Being tested: Counselor-based HIV screening, Emergency staff member-based 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.

Counselor-based HIV screeningBehavioural
Participants will undergo oral HIV screening by HIV counselor and, if positive, further study visits for up to 6 months
Emergency staff member-based HIV screeningBehavioural
Participants will undergo oral HIV screening by emergency staff member and, if positive, further study visits for up to 6 months

Study groups in NCT00502944
Study group	Role	What they receive
Counselor-based HIV screening	Experimental	Not described Receives: Behavioral: Counselor-based HIV screening
Emergency staff member-based HIV screening	Active comparator	Not described Receives: Behavioral: Emergency staff member-based HIV screening

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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.
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.

Feb 2007Jul 2008

First posted18 Jul 2007 (estimated)
Study startFeb 2007
Primary completionJul 2008
Study completionJul 2008

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 (13)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: 4,855 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00502944
Sponsor's protocol ID: R01MH073445
Other IDs: R01MH073445, DAHBR 9A-ASPQ
Status last verified: Jul 2012
First submitted: 16 Jul 2007
Last updated: 19 Jul 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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.
PubMed 18462591
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.
PubMed 18190295
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.
PubMed 19849965
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.
PubMed 20090953
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.
PubMed 21684408
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.
PubMed 22110730
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.
PubMed 20978834
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.
PubMed 18678842
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.
PubMed 20157472
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.
PubMed 19828278
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.
PubMed 22022415
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.
PubMed 21684391
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 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)
ClinicalTrials.gov ID: NCT00502944
Acronym / sponsor ID: R01MH073445
Conditions: HIV Infections
Keywords: HIV, Testing, HIV Seronegativity
Study type: Interventional
Recruitment status: Completed
Enrolment: 4,855 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: Feb 2007
Primary completion: Jul 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 18 Jul 2007 (estimated)
Results: Posted 13 Jul 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 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

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Counselor-based HIV screening	Experimental	Behavioral: Counselor-based HIV screening
Emergency staff member-based HIV screening	Active comparator	Behavioral: Emergency staff member-based 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
Counselor-based HIV screeningParticipants will undergo oral HIV screening by HIV counselor and, if positive, further study visits for up to 6 months	Behavioural	Counselor-based HIV screening
Emergency staff member-based HIV screeningParticipants will undergo oral HIV screening by emergency staff member and, if positive, further study visits for up to 6 months	Behavioural	Emergency staff member-based HIV screening

Primary outcome

Linkage to Care of Newly Diagnosed HIV Infected Participants
Time frame: 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.

1 secondary outcome

Overall Rapid HIV Testing Rate
Time frame: Assess on day subject enrolled into the study

Results and safety

Results posted to the registry on 13 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Counselor	2,446	1,382
Provider	2,409	643

Primary outcome: Linkage to Care of Newly Diagnosed HIV Infected Participants

Time frame: Assessed within 8 weeks after receipt of reactive rapid HIV test results. Number. Unit: participants

Measure	Counselor n = 2446	Provider n = 2409
Positive HIV Test	0	7
Linked to Care	0	4

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 week after rapid HIV testing.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Counselor	0 of 1,382 (0%)	33 of 1,382 (2.4%)	Not reported
Provider	0 of 643 (0%)	14 of 643 (2.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18462591Millen 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.
Background: PubMed 18190295Walensky 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.
Background: PubMed 19849965Ganguli 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.
Background: PubMed 20090953Reichmann 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.
Background: PubMed 21684408Donnell-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.
Background: PubMed 22110730Reichmann 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.
Background: PubMed 20978834Pisculli 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.
Results publication: PubMed 18678842Walensky 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.
Results publication: PubMed 20157472Arbelaez 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.
Results publication: PubMed 19828278Arbelaez 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.
Results publication: PubMed 22022415Walensky 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.
Results publication: PubMed 21684391Walensky 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.

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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 Counselor-based HIV screening and Emergency staff member-based 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 19 Jul 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 13 Jul 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?

Linkage to Care of Newly Diagnosed HIV Infected Participants (time frame: Assessed within 8 weeks after receipt of reactive rapid HIV test results). 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 NCT00502944, which also lists 13 linked publications.

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 19 Jul 2012.