Trial record 17 of 41 for:    " January 08, 2013":" February 07, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Mater-Bronx Rapid HIV Testing Project. (M-BRiHT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University College Dublin
Sponsor:
Information provided by (Responsible Party):
Patrick Mallon, University College Dublin
ClinicalTrials.gov Identifier:
NCT01778374
First received: January 25, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Human Immunodeficiency Virus
Other: No participant choice of counselor
Other: Participant choice of counselor

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
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.

Resource links provided by NLM:


Further study details as provided by University College Dublin:

Primary Outcome Measures:
  • Number of patients agreeing to undergo a HIV screening test in the Emergency Department [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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 Outcome 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 ] [ Designated as safety issue: Yes ]
  • Absolute numbers of those attending the ED who consent to watching the interactive information video about rapid HIV test screening. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Absolute number and proportion of HIV positive test results [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • CD4 count and viral load of newly diagnosed HIV positive patients [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Number of those testing positive who have acute seroconversion illness [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 17000
Study Start Date: September 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01778374

Contacts
Contact: Gerard S O'Connor, MB, MCEM +353861732060 geroconnor@me.com
Contact: Patrick WG Mallon, MB,FRCPI,PhD +35317166311 Paddy.Mallon@ucd.ie

Locations
Ireland
Emergency Department, Mater Misericordiae University Hospital. Recruiting
Dublin, Ireland, Dublin 7
Principal Investigator: Patrick WG Mallon         
Sub-Investigator: Gerard S O'Connor         
Sponsors and Collaborators
University College Dublin
Investigators
Principal Investigator: Patrick WG Mallon, MB, BCh, BAO, FRACP, FRCPI,PhD Group Leader, HIV Molecular Research Group, University College Dublin
Study Director: 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
  More Information

Publications:

Responsible Party: 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
ClinicalTrials.gov Identifier: NCT01778374     History of Changes
Other Study ID Numbers: M-BRiHT
Study First Received: January 25, 2013
Last Updated: January 25, 2013
Health Authority: Ireland: Research Ethics Committee

Keywords provided by University College Dublin:
Emergency Medicine
Screening
Point of care testing
Video assisted counseling

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 26, 2014