Mater-Bronx Rapid HIV Testing Project. (M-BRiHT)
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ClinicalTrials.gov Identifier: NCT01778374 |
Recruitment Status
: Unknown
Verified January 2013 by Patrick Mallon, University College Dublin.
Recruitment status was: Recruiting
First Posted
: January 29, 2013
Last Update Posted
: January 29, 2013
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Condition or disease | Intervention/treatment | Phase |
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Human Immunodeficiency Virus | Other: No participant choice of counselor Other: Participant choice of counselor | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 17000 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
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. |
Study Start Date : | September 2012 |
Estimated Primary Completion Date : | March 2014 |
Estimated Study Completion Date : | March 2014 |

Arm | Intervention/treatment |
---|---|
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.
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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.
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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.
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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.
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- Number of patients agreeing to undergo a HIV screening test in the Emergency Department [ Time Frame: 24 months ]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.
- 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 ]
- Absolute numbers of those attending the ED who consent to watching the interactive information video about rapid HIV test screening. [ Time Frame: 24 months ]
- Absolute number and proportion of HIV positive test results [ Time Frame: 24 months ]
- CD4 count and viral load of newly diagnosed HIV positive patients [ Time Frame: 24 months ]
- Number of those testing positive who have acute seroconversion illness [ Time Frame: 24 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778374
Contact: Gerard S O'Connor, MB, MCEM | +353861732060 | geroconnor@me.com | |
Contact: Patrick WG Mallon, MB,FRCPI,PhD | +35317166311 | Paddy.Mallon@ucd.ie |
Ireland | |
Emergency Department, Mater Misericordiae University Hospital. | Recruiting |
Dublin, Ireland, Dublin 7 | |
Principal Investigator: Patrick WG Mallon | |
Sub-Investigator: Gerard S O'Connor |
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 |
Publications:
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 |
First Posted: | January 29, 2013 Key Record Dates |
Last Update Posted: | January 29, 2013 |
Last Verified: | January 2013 |
Keywords provided by Patrick Mallon, 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 Immune System Diseases Lentivirus Infections Retroviridae Infections |
RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases |