AzTrials
AzTrials

Human Immunodeficiency VirusM-BRiHTNCT01778374

Mater-Bronx Rapid HIV Testing Project.

A study testing No participant choice of counselor and Participant choice of counselor in people with Human Immunodeficiency Virus, run by University College Dublin at 1 site in Ireland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Human Immunodeficiency Virus
What is being tested?
No participant choice of counselor and Participant choice of counselor
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17,000 participants
Where
1 siteIreland
Study dates
Sep 2012to Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Gerard S O'Connor, MB, MCEM contact

+353861732060

geroconnor@me.com

Patrick WG Mallon, MB,FRCPI,PhD contact

+35317166311

Paddy.Mallon@ucd.ie

Ireland1 site, 1 recruiting

  • Emergency Department, Mater Misericordiae University Hospital.

    Dublin, Dublin 7

    Patrick WG Mallon

    Gerard S O'Connor

    Recruiting

Other trials in Ireland

About this study

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.

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.

Being tested
No participant choice of counselor, Participant choice of counselor
Keywords
Emergency Medicine, Screening, Point of care testing, Video assisted counseling
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No participant choice of counselorOther

    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.

  • Participant choice of counselorOther

    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.

Study groups in NCT01778374
Study groupRoleWhat they receive
No participant choice of counselorExperimentalParticipants 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.
Receives: Other: No participant choice of counselor
Participant choice of counselorExperimentalParticipants 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.
Receives: Other: Participant choice of counselor

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 months

Secondary outcomes (5)

  1. 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.

    Measured: 24 months

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

    Measured: 24 months

  3. Absolute number and proportion of HIV positive test results

    Measured: 24 months

  4. CD4 count and viral load of newly diagnosed HIV positive patients

    Measured: 24 months

  5. Number of those testing positive who have acute seroconversion illness

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2013 (estimated)
  2. Study startSep 2012
  3. Primary completionJul 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
17,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01778374
Sponsor's protocol ID
M-BRiHT
Acronym
M-BRiHT
Status last verified
Mar 2020
First submitted
25 Jan 2013
Last updated
25 Mar 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Centers for Disease Control (CDC). Pneumocystis pneumonia--Los Angeles. MMWR Morb Mortal Wkly Rep. 1981 Jun 5;30(21):250-2. No abstract available.

    PubMed 6265753

  • Wilson JM, Jungner YG. [Principles and practice of mass screening for disease]. Bol Oficina Sanit Panam. 1968 Oct;65(4):281-393. No abstract available. Spanish.

    PubMed 4234760

  • Jacquez JA, Koopman JS, Simon CP, Longini IM Jr. Role of the primary infection in epidemics of HIV infection in gay cohorts. J Acquir Immune Defic Syndr (1988). 1994 Nov;7(11):1169-84.

    PubMed 7932084

  • Pilcher CD, Tien HC, Eron JJ Jr, Vernazza PL, Leu SY, Stewart PW, Goh LE, Cohen MS; Quest Study; Duke-UNC-Emory Acute HIV Consortium. Brief but efficient: acute HIV infection and the sexual transmission of HIV. J Infect Dis. 2004 May 15;189(10):1785-92. doi: 10.1086/386333. Epub 2004 Apr 28.

    PubMed 15122514

  • Wawer MJ, Gray RH, Sewankambo NK, Serwadda D, Li X, Laeyendecker O, Kiwanuka N, Kigozi G, Kiddugavu M, Lutalo T, Nalugoda F, Wabwire-Mangen F, Meehan MP, Quinn TC. Rates of HIV-1 transmission per coital act, by stage of HIV-1 infection, in Rakai, Uganda. J Infect Dis. 2005 May 1;191(9):1403-9. doi: 10.1086/429411. Epub 2005 Mar 30.

    PubMed 15809897

  • Chakraborty H, Sen PK, Helms RW, Vernazza PL, Fiscus SA, Eron JJ, Patterson BK, Coombs RW, Krieger JN, Cohen MS. Viral burden in genital secretions determines male-to-female sexual transmission of HIV-1: a probabilistic empiric model. AIDS. 2001 Mar 30;15(5):621-7. doi: 10.1097/00002030-200103300-00012.

    PubMed 11317000

  • Gray RH, Wawer MJ, Brookmeyer R, Sewankambo NK, Serwadda D, Wabwire-Mangen F, Lutalo T, Li X, vanCott T, Quinn TC; Rakai Project Team. Probability of HIV-1 transmission per coital act in monogamous, heterosexual, HIV-1-discordant couples in Rakai, Uganda. Lancet. 2001 Apr 14;357(9263):1149-53. doi: 10.1016/S0140-6736(00)04331-2.

    PubMed 11323041

  • Attia S, Egger M, Muller M, Zwahlen M, Low N. Sexual transmission of HIV according to viral load and antiretroviral therapy: systematic review and meta-analysis. AIDS. 2009 Jul 17;23(11):1397-404. doi: 10.1097/QAD.0b013e32832b7dca.

    PubMed 19381076

  • Daar ES, Pilcher CD, Hecht FM. Clinical presentation and diagnosis of primary HIV-1 infection. Curr Opin HIV AIDS. 2008 Jan;3(1):10-5. doi: 10.1097/COH.0b013e3282f2e295.

    PubMed 19372938

  • Schacker T, Collier AC, Hughes J, Shea T, Corey L. Clinical and epidemiologic features of primary HIV infection. Ann Intern Med. 1996 Aug 15;125(4):257-64. doi: 10.7326/0003-4819-125-4-199608150-00001.

    PubMed 8678387

  • Greenwald JL, Burstein GR, Pincus J, Branson B. A rapid review of rapid HIV antibody tests. Curr Infect Dis Rep. 2006 Mar;8(2):125-31. doi: 10.1007/s11908-006-0008-6.

    PubMed 16524549

  • Branson BM, Handsfield HH, Lampe MA, Janssen RS, Taylor AW, Lyss SB, Clark JE; Centers for Disease Control and Prevention (CDC). Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Recomm Rep. 2006 Sep 22;55(RR-14):1-17; quiz CE1-4.

    PubMed 16988643

  • Centers for Disease Control and Prevention (CDC). Expanded HIV testing and trends in diagnoses of HIV infection - District of Columbia, 2004-2008. MMWR Morb Mortal Wkly Rep. 2010 Jun 25;59(24):737-41.

    PubMed 20577154

  • Donnell D, Baeten JM, Kiarie J, Thomas KK, Stevens W, Cohen CR, McIntyre J, Lingappa JR, Celum C; Partners in Prevention HSV/HIV Transmission Study Team. Heterosexual HIV-1 transmission after initiation of antiretroviral therapy: a prospective cohort analysis. Lancet. 2010 Jun 12;375(9731):2092-8. doi: 10.1016/S0140-6736(10)60705-2. Epub 2010 May 26.

    PubMed 20537376

  • Calderon Y, Haughey M, Leider J, Bijur PE, Gennis P, Bauman LJ. Increasing willingness to be tested for human immunodeficiency virus in the emergency department during off-hour tours: a randomized trial. Sex Transm Dis. 2007 Dec;34(12):1025-9. doi: 10.1097/OLQ.0b013e31814b96bb.

    PubMed 18032992

Questions about this trial

What is this clinical trial studying?

A study testing No participant choice of counselor and Participant choice of counselor in people with Human Immunodeficiency Virus, run by University College Dublin at 1 site in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gerard S O'Connor, MB, MCEM (+353861732060, geroconnor@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients agreeing to undergo a HIV screening test in the Emergency Department (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01778374, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in