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

Primary Purpose

Human Immunodeficiency Virus

Status
Unknown status
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
No participant choice of counselor
Participant choice of counselor
Sponsored by
University College Dublin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Human Immunodeficiency Virus focused on measuring Emergency Medicine, Screening, Point of care testing, Video assisted counseling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Emergency Department, Mater Misericordiae University Hospital.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

No participant choice of counselor

Participant choice of counselor

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of patients agreeing to undergo a HIV screening test in the Emergency Department
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.
Absolute numbers of those attending the ED who consent to watching the interactive information video about rapid HIV test screening.
Absolute number and proportion of HIV positive test results
CD4 count and viral load of newly diagnosed HIV positive patients
Number of those testing positive who have acute seroconversion illness

Full Information

First Posted
January 25, 2013
Last Updated
March 24, 2020
Sponsor
University College Dublin
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1. Study Identification

Unique Protocol Identification Number
NCT01778374
Brief Title
Mater-Bronx Rapid HIV Testing Project.
Acronym
M-BRiHT
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 Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Dublin

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
Keywords
Emergency Medicine, Screening, Point of care testing, Video assisted counseling

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
17000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No participant choice of counselor
Arm Type
Experimental
Arm Description
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.
Arm Title
Participant choice of counselor
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
No participant choice of counselor
Intervention Description
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 Type
Other
Intervention Name(s)
Participant choice of counselor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients agreeing to undergo a HIV screening test in the Emergency Department
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
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
Title
Absolute numbers of those attending the ED who consent to watching the interactive information video about rapid HIV test screening.
Time Frame
24 months
Title
Absolute number and proportion of HIV positive test results
Time Frame
24 months
Title
CD4 count and viral load of newly diagnosed HIV positive patients
Time Frame
24 months
Title
Number of those testing positive who have acute seroconversion illness
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gerard S O'Connor, MB, MCEM
Phone
+353861732060
Email
geroconnor@me.com
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick WG Mallon, MB,FRCPI,PhD
Phone
+35317166311
Email
Paddy.Mallon@ucd.ie
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick WG Mallon, MB, BCh, BAO, FRACP, FRCPI,PhD
Organizational Affiliation
Group Leader, HIV Molecular Research Group, University College Dublin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gerard S O'Connor, MB, BCh, BAO, MCEM, MMed
Organizational Affiliation
Project Lead M-BRiHT, HIV Molecular Research Group, University College Dublin.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yvette Calderon, MD
Organizational Affiliation
Jacobi Medical Centre, New York
Official's Role
Study Director
Facility Information:
Facility Name
Emergency Department, Mater Misericordiae University Hospital.
City
Dublin
ZIP/Postal Code
Dublin 7
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick WG Mallon
First Name & Middle Initial & Last Name & Degree
Gerard S O'Connor

12. IPD Sharing Statement

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Mater-Bronx Rapid HIV Testing Project.

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