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

March 24, 2020 updated by: Patrick Mallon, University College Dublin

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

17000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
24 months
Absolute number and proportion of HIV positive test results
Time Frame: 24 months
24 months
CD4 count and viral load of newly diagnosed HIV positive patients
Time Frame: 24 months
24 months
Number of those testing positive who have acute seroconversion illness
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

January 25, 2013

First Submitted That Met QC Criteria

January 25, 2013

First Posted (Estimate)

January 29, 2013

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-BRiHT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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