Mater-Bronx Rapid HIV Testing Project. - Full Text View

Purpose

In the M-BRiHT study we aim to implement a programme of opportunistic HIV screening in the Emergency Department, Mater Misericordiae University Hospital. We hypothesize that such a programme will be acceptable in an Irish setting. We also wish to study the factors that influence test completion or acceptance. We will utilise informative interactive video media via a touch-screen tablet device to provide pre-test counselling and then offer rapid minimally invasive testing with a cotton-bud type swab of the buccal mucosa. In doing so we will to determine absolute numbers of those attending the ED who consent to watching the interactive information video about rapid HIV test screening. We will describe the absolute number and proportion of those who watch the interactive video who subsequently proceed to have the rapid HIV test. The primary aim is to determine the cultural, gender and ethnic factors which influence the completion of such rapid HIV testing with the future objective of maximising test completion in this crucial public health area.

Condition	Intervention
Human Immunodeficiency Virus	Other: No participant choice of counselor Other: Participant choice of counselor

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Screening
Official Title:	Mater _Bronx Rapid HIV Testing Project. Prospective Randomised Trial of Recruitment Methods in Implementation of a HIV Screening Programme in the Emergency Department.

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by University College Dublin:

Primary Outcome Measures:

Number of patients agreeing to undergo a HIV screening test in the Emergency Department [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Establish a programme of HIV screening in the Emergency Department, Mater Misericordiae University Hospital. Acceptability of the programme will be judged in terms of absolute numbers of patients consenting to the test.

Secondary Outcome Measures:

To determine the proportions of those who test negative who may fall in to the three month seroconversion window and to determine the proportion of those who return for repeat/multiple HIV tests at three months or other time in the future. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Absolute numbers of those attending the ED who consent to watching the interactive information video about rapid HIV test screening. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Absolute number and proportion of HIV positive test results [ Time Frame: 24 months ] [ Designated as safety issue: No ]
CD4 count and viral load of newly diagnosed HIV positive patients [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Number of those testing positive who have acute seroconversion illness [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	17000
Study Start Date:	September 2012
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: No participant choice of counselor Participants in this arm of the study are randomized to an interactive video counselor with no choice of counselor. This is delivered via a touchscreen tablet device.	Other: No participant choice of counselor Participants in this arm of the study are randomized to an interactive video counselor with no choice of counselor. This is delivered via a touchscreen tablet device.
Experimental: Participant choice of counselor Participants in this arm of the study are randomized to an interactive video counselor with a choice of four different counselors. These gender and ethnically diverse counselors are delivered via a touchscreen tablet device.	Other: Participant choice of counselor Participants in this arm of the study are randomized to an interactive video counselor with a choice of four different counselors. These gender and ethnically diverse counselors are delivered via a touchscreen tablet device.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

All adults greater than 18 years of age who present to the Emergency Department, Mater Misericordiae University Hospital
Must have capacity to consent to watch an interactive video tablet device about HIV and HIV screening test.

Exclusion Criteria:

HIV positive patients (known previous HIV positive patients).
Acute intoxication in which capacity is impaired
Critically unwell patients who require active or intensive resuscitation.
Acute psychiatric disturbance in which capacity is impaired

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01778374

Contacts

Contact: Gerard S O'Connor, MB, MCEM	+353861732060	geroconnor@me.com
Contact: Patrick WG Mallon, MB,FRCPI,PhD	+35317166311	Paddy.Mallon@ucd.ie

Locations

Ireland
Emergency Department, Mater Misericordiae University Hospital.	Recruiting
Dublin, Ireland, Dublin 7
Principal Investigator: Patrick WG Mallon
Sub-Investigator: Gerard S O'Connor

Sponsors and Collaborators

University College Dublin

Investigators

Principal Investigator:	Patrick WG Mallon, MB, BCh, BAO, FRACP, FRCPI,PhD	Group Leader, HIV Molecular Research Group, University College Dublin
Study Director:	Gerard S O'Connor, MB, BCh, BAO, MCEM, MMed	Project Lead M-BRiHT, HIV Molecular Research Group, University College Dublin.
Study Director:	Yvette Calderon, MD	Jacobi Medical Centre, New York

More Information

Publications:

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Calderon Y, Haughey M, Leider J, Bijur PE, Gennis P, Bauman LJ. Increasing willingness to be tested for human immunodeficiency virus in the emergency department during off-hour tours: a randomized trial. Sex Transm Dis. 2007 Dec;34(12):1025-9.

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White DA, Scribner AN, Schulden JD, Branson BM, Heffelfinger JD. Results of a rapid HIV screening and diagnostic testing program in an urban emergency department. Ann Emerg Med. 2009 Jul;54(1):56-64. doi: 10.1016/j.annemergmed.2008.09.027. Epub 2008 Nov 5.

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Calderon Y, Haughey M, Bijur PE, Leider J, Moreno-Walton L, Torres S, Gennis P, Bauman LJ. An educational HIV pretest counseling video program for off-hours testing in the emergency department. Ann Emerg Med. 2006 Jul;48(1):21-7. Epub 2006 Mar 13.

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Responsible Party:	Patrick Mallon, Associate Dean for Research and Innovation UCD School of Medicine and Medical Sciences, Consultant Infectious Diseases Physician, Head of HIV Molecular Research Group (HMRG)., University College Dublin
ClinicalTrials.gov Identifier:	NCT01778374 History of Changes
Other Study ID Numbers:	M-BRiHT
Study First Received:	January 25, 2013
Last Updated:	January 25, 2013
Health Authority:	Ireland: Research Ethics Committee

Keywords provided by University College Dublin:

Emergency Medicine
Screening
Point of care testing
Video assisted counseling

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections

Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013

Mater-Bronx Rapid HIV Testing Project. (M-BRiHT)