Mater _Bronx Rapid HIV Testing Project. Prospective Randomised Trial of Recruitment Methods in Implementation of a HIV Screening Programme in the Emergency Department.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University College Dublin
- Enrollment
- 17,000
- Locations
- 1
- Primary Endpoint
- Number of patients agreeing to undergo a HIV screening test in the Emergency Department
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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: No participant choice of counselor (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.
Intervention: Participant choice of counselor (Other)
Outcomes
Primary Outcomes
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 Outcomes
- Absolute number and proportion of HIV positive test results(24 months)
- 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)
- 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)
Investigators
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