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Completed

NCT Number: NCT00502944

Two Approaches to Routine HIV Testing in a Hospital Emergency Department

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Counselor-based HIV screening

Behavioral

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 screening

Behavioral

Participants will undergo oral HIV screening by emergency staff member and, if positive, further study visits for up to 6 months

Primary outcomes

  1. 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.

Secondary outcomes

  1. Overall Rapid HIV Testing Rate

    Time frame: 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 outcomes

  1. Test Offer Rate

    Time frame: 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.

  2. Test Acceptance Rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Optimizing Strategies for Universal HIV Testing (The USHER Trial)

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 18, 2007
Registry last updated
Jul 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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