Clinical trial NCT01778374: Mater-Bronx Rapid HIV Testing Project.
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
Overall status: UNKNOWN
Phase: NA
Conditions: Human Immunodeficiency Virus
Keywords: Emergency Medicine
Screening
Point of care testing
Video assisted counseling
Lead sponsor: University College Dublin
Sponsor class: OTHER
First posted: 2013-01-29
Enrollment: 17000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


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

Primary outcomes:
measure: Number of patients agreeing to undergo a HIV screening test in the Emergency Department
timeFrame: 24 months
Secondary outcomes:
measure: 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.
timeFrame: 24 months
measure: Absolute numbers of those attending the ED who consent to watching the interactive information video about rapid HIV test screening.
timeFrame: 24 months
measure: Absolute number and proportion of HIV positive test results
timeFrame: 24 months
measure: CD4 count and viral load of newly diagnosed HIV positive patients
timeFrame: 24 months
measure: Number of those testing positive who have acute seroconversion illness
timeFrame: 24 months
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Emergency Department, Mater Misericordiae University Hospital.
Study officials:
affiliation: Group Leader, HIV Molecular Research Group, University College Dublin
name: Patrick WG Mallon, MB, BCh, BAO, FRACP, FRCPI,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Project Lead M-BRiHT, HIV Molecular Research Group, University College Dublin.
name: Gerard S O'Connor, MB, BCh, BAO, MCEM, MMed
role: STUDY_DIRECTOR
affiliation: Jacobi Medical Centre, New York
name: Yvette Calderon, MD
role: STUDY_DIRECTOR
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