Mater-Bronx Rapid HIV Testing Project.

NCT01778374 | Unknown DMC

• 1 other identifier: M-BRiHT
• Study Type: interventional
• Target: 17,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus

Keywords

Emergency Medicine; Screening; Point of care testing; Video assisted counseling

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (5)

• 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.

  24 months

• Absolute numbers of those attending the ED who consent to watching the interactive information video about rapid HIV test screening.

  24 months

• Absolute number and proportion of HIV positive test results

  24 months

• CD4 count and viral load of newly diagnosed HIV positive patients

  24 months

• Number of those testing positive who have acute seroconversion illness

  24 months

Study Arms (2)

No participant choice of counselor

EXPERIMENTAL

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

Participant choice of counselor

EXPERIMENTAL

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

Interventions

No participant choice of counselor OTHER

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.

No participant choice of counselor

Participant choice of counselor OTHER

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.

Participant choice of counselor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University College Dublin: lead

Study Sites (1)

Emergency Department, Mater Misericordiae University Hospital.

Dublin, Dublin 7, Ireland

RECRUITING

Related Publications (27)

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MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Patrick WG Mallon, MB, BCh, BAO, FRACP, FRCPI,PhD

  Group Leader, HIV Molecular Research Group, University College Dublin

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Central Study Contacts

Gerard S O'Connor, MB, MCEM

CONTACT

+353861732060; geroconnor@me.com

Patrick WG Mallon, MB,FRCPI,PhD

CONTACT

+35317166311; Paddy.Mallon@ucd.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean for Research and Innovation UCD School of Medicine and Medical Sciences, Consultant Infectious Diseases Physician, Head of HIV Molecular Research Group (HMRG).

Study Record Dates

• First Submitted: January 25, 2013
• First Posted: January 29, 2013
• Study Start: September 1, 2012
• Primary Completion: July 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

IE (1)