Mater-Bronx Rapid HIV Testing Project.

Study Overview
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Brief Summary
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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.

Official Title
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Mater _Bronx Rapid HIV Testing Project. Prospective Randomised Trial of Recruitment Methods in Implementation of a HIV Screening Programme in the Emergency Department.

Conditions
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Human Immunodeficiency Virus

Intervention / Treatment
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* Other: No participant choice of counselor
* Other: Participant choice of counselor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No participant choice of counselor<br>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<br>* 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.<br>|
| Experimental: Participant choice of counselor<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emergency Medicine, Screening, Point of care testing, Video assisted counseling