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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University College Dublin
Sponsor:
Information provided by (Responsible Party):
Patrick Mallon, University College Dublin
ClinicalTrials.gov Identifier:
NCT01778374
First received: January 25, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted

January 25, 2013
January 25, 2013
September 2012
March 2014   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Mater-Bronx Rapid HIV Testing Project.
Mater _Bronx Rapid HIV Testing Project. Prospective Randomised Trial of Recruitment Methods in Implementation of a HIV Screening Programme in the Emergency Department.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
Human Immunodeficiency Virus
  • 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.
  • 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.
  • 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.
    Intervention: Other: No participant choice of counselor
  • 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.
    Intervention: Other: Participant choice of counselor

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
17000
March 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Gerard S O'Connor, MB, MCEM +353861732060 geroconnor@me.com
Contact: Patrick WG Mallon, MB,FRCPI,PhD +35317166311 Paddy.Mallon@ucd.ie
Ireland
 
NCT01778374
M-BRiHT
Yes
Patrick Mallon, University College Dublin
University College Dublin
Not Provided
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
University College Dublin
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP