Mater-Bronx Rapid HIV Testing Project.

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: Single (Participant)
  • Study Primary Completion Date: July 2020

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University College Dublin
  • Provider of Information About this Clinical Study
    • Principal Investigator: 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
  • Overall Official(s)
    • Patrick WG Mallon, MB, BCh, BAO, FRACP, FRCPI,PhD, Principal Investigator, Group Leader, HIV Molecular Research Group, University College Dublin
    • Gerard S O’Connor, MB, BCh, BAO, MCEM, MMed, Study Director, Project Lead M-BRiHT, HIV Molecular Research Group, University College Dublin.
    • Yvette Calderon, MD, Study Director, Jacobi Medical Centre, New York
  • Overall Contact(s)
    • Gerard S O’Connor, MB, MCEM, +353861732060, geroconnor@me.com

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