NCT00987194

Brief Summary

Background Recently, the CDC issued recommendations calling for HIV screening for patients aged 13-64, when the individual accesses the health care system. For many patients, the emergency department (ED) is the primary or only contact point for health care. The rapid HIV test can be done as a point of care test in the ED. Study Objectives A. Primary: 1\. To initiate HIV testing in the Baystate ED. B. Secondary:

  1. 1.To estimate the resources involved in initiating a rapid HIV testing program in the ED.
  2. 2.To describe the process of initiating a rapid HIV testing program.
  3. 3.To compare the yield of testing for HIV in patients with known HIV risk factors compared to those without known risk factors.
  4. 4.To describe the characteristics of the population tested for HIV in the ED.
  5. 5.To determine the number of patients who declined testing and the reasons for declining testing.
  6. 6.To analyze ED staff attitudes re: HIV rapid testing in the ED.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,087

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 30, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

July 14, 2010

Status Verified

July 1, 2010

Enrollment Period

1 year

First QC Date

September 25, 2009

Last Update Submit

July 13, 2010

Conditions

Keywords

HIVrapid testingHIV seronegativity

Outcome Measures

Primary Outcomes (1)

  • The feasibility of initiating a rapid HIV testing program in the emergency department of a community teaching hospital in an a medium size city.

    2 years

Secondary Outcomes (1)

  • To determine the number of newly diagnosed individuals who were successfully linked to an HIV provider and the number who received antiretroviral therapy within one year of initial diagnosis.

    2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Emergency department patients aged 18 years or older

You may qualify if:

  • Emergency department patients aged 18 years or older, appropriate for HIV testing will be identified by the HIV health educator.
  • Patients who are not otherwise occupied and who are not known to be HIV+ will be approached for consent to the study and for rapid HIV testing.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Related Publications (12)

  • Branson BM, Handsfield HH, Lampe MA, Janssen RS, Taylor AW, Lyss SB, Clark JE; Centers for Disease Control and Prevention (CDC). Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Recomm Rep. 2006 Sep 22;55(RR-14):1-17; quiz CE1-4.

    PMID: 16988643BACKGROUND
  • Palella FJ Jr, Deloria-Knoll M, Chmiel JS, Moorman AC, Wood KC, Greenberg AE, Holmberg SD; HIV Outpatient Study Investigators. Survival benefit of initiating antiretroviral therapy in HIV-infected persons in different CD4+ cell strata. Ann Intern Med. 2003 Apr 15;138(8):620-6. doi: 10.7326/0003-4819-138-8-200304150-00007.

    PMID: 12693883BACKGROUND
  • Keiser P, Nassar N, Kvanli MB, Turner D, Smith JW, Skiest D. Long-term impact of highly active antiretroviral therapy on HIV-related health care costs. J Acquir Immune Defic Syndr. 2001 May 1;27(1):14-9. doi: 10.1097/00126334-200105010-00003.

    PMID: 11404515BACKGROUND
  • Centers for Disease Control and Prevention (CDC). False-positive oral fluid rapid HIV tests--New York City, 2005-2008. MMWR Morb Mortal Wkly Rep. 2008 Jun 20;57(24):660-5.

    PMID: 18566566BACKGROUND
  • Hutchinson AB, Branson BM, Kim A, Farnham PG. A meta-analysis of the effectiveness of alternative HIV counseling and testing methods to increase knowledge of HIV status. AIDS. 2006 Aug 1;20(12):1597-604. doi: 10.1097/01.aids.0000238405.93249.16.

    PMID: 16868440BACKGROUND
  • Lubelchek R, Kroc K, Hota B, Sharief R, Muppudi U, Pulvirenti J, Weinstein RA. The role of rapid vs conventional human immunodeficiency virus testing for inpatients: effects on quality of care. Arch Intern Med. 2005 Sep 26;165(17):1956-60. doi: 10.1001/archinte.165.17.1956.

    PMID: 16186464BACKGROUND
  • Marks G, Crepaz N, Senterfitt JW, Janssen RS. Meta-analysis of high-risk sexual behavior in persons aware and unaware they are infected with HIV in the United States: implications for HIV prevention programs. J Acquir Immune Defic Syndr. 2005 Aug 1;39(4):446-53. doi: 10.1097/01.qai.0000151079.33935.79.

    PMID: 16010168BACKGROUND
  • Holtgrave DR. Costs and consequences of the US Centers for Disease Control and Prevention's recommendations for opt-out HIV testing. PLoS Med. 2007 Jun;4(6):e194. doi: 10.1371/journal.pmed.0040194.

    PMID: 17564488BACKGROUND
  • Bogart LM, Howerton D, Lange J, Setodji CM, Becker K, Klein DJ, Asch SM. Provider-related barriers to rapid HIV testing in U.S. urban non-profit community clinics, community-based organizations (CBOs) and hospitals. AIDS Behav. 2010 Jun;14(3):697-707. doi: 10.1007/s10461-008-9456-3. Epub 2008 Sep 3.

    PMID: 18770022BACKGROUND
  • Ehrenkranz PD, Ahn CJ, Metlay JP, Camargo CA Jr, Holmes WC, Rothman R. Availability of rapid human immunodeficiency virus testing in academic emergency departments. Acad Emerg Med. 2008 Feb;15(2):144-50. doi: 10.1111/j.1553-2712.2008.00028.x.

    PMID: 18275444BACKGROUND
  • Centers for Disease Control and Prevention (CDC). Missed opportunities for earlier diagnosis of HIV infection--South Carolina, 1997-2005. MMWR Morb Mortal Wkly Rep. 2006 Dec 1;55(47):1269-72.

    PMID: 17136020BACKGROUND
  • Rothman RE, Ketlogetswe KS, Dolan T, Wyer PC, Kelen GD. Preventive care in the emergency department: should emergency departments conduct routine HIV screening? a systematic review. Acad Emerg Med. 2003 Mar;10(3):278-85. doi: 10.1111/j.1553-2712.2003.tb02004.x.

    PMID: 12615596BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Daniel J Skiest, MD

    Baystate Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 25, 2009

First Posted

September 30, 2009

Study Start

March 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

July 14, 2010

Record last verified: 2010-07

Locations