Human Immunodeficiency Virus Clinical Trial
— M-BRiHTOfficial title:
Mater _Bronx Rapid HIV Testing Project. Prospective Randomised Trial of Recruitment Methods in Implementation of a HIV Screening Programme in the Emergency Department.
NCT number | NCT01778374 |
Other study ID # | M-BRiHT |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2012 |
Est. completion date | December 2020 |
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.
Status | Recruiting |
Enrollment | 17000 |
Est. completion date | December 2020 |
Est. primary completion date | July 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Ireland | Emergency Department, Mater Misericordiae University Hospital. | Dublin |
Lead Sponsor | Collaborator |
---|---|
University College Dublin |
Ireland,
Attia S, Egger M, Müller 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. Review. — View Citation
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. — View Citation
Calderon Y, Haughey M, Bijur PE, Leider J, Moreno-Walton L, Torres S, Gennis P, Bauman LJ. An educational HIV pretest counseling video program for off-hours testing in the emergency department. Ann Emerg Med. 2006 Jul;48(1):21-7. Epub 2006 Mar 13. — View Citation
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. — View Citation
Calderon Y, Leider J, Hailpern S, Chin R, Ghosh R, Fettig J, Gennis P, Bijur P, Bauman L. High-volume rapid HIV testing in an urban emergency department. AIDS Patient Care STDS. 2009 Sep;23(9):749-55. doi: 10.1089/apc.2008.0270. — View Citation
Calderon Y, Leider J, Hailpern S, Haughey M, Ghosh R, Lombardi P, Bijur P, Bauman L. A randomized control trial evaluating the educational effectiveness of a rapid HIV posttest counseling video. Sex Transm Dis. 2009 Apr;36(4):207-10. doi: 10.1097/OLQ.0b013e318191ba3f. — View Citation
Centers for Disease Control (CDC). Pneumocystis pneumonia--Los Angeles. MMWR Morb Mortal Wkly Rep. 1981 Jun 5;30(21):250-2. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Evans AE, Edmundson-Drane EW, Harris KK. Computer-assisted instruction: an effective instructional method for HIV prevention education? J Adolesc Health. 2000 Apr;26(4):244-51. — View Citation
Freeman AE, Sattin RW, Miller KM, Dias JK, Wilde JA. Acceptance of rapid HIV screening in a southeastern emergency department. Acad Emerg Med. 2009 Nov;16(11):1156-64. doi: 10.1111/j.1553-2712.2009.00508.x. — View Citation
Fureman I, Meyers K, McLellan AT, Metzger D, Woody G. Evaluation of a video-supplement to informed consent: injection drug users and preventive HIV vaccine efficacy trials. AIDS Educ Prev. 1997 Aug;9(4):330-41. — View Citation
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. — View Citation
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. — View Citation
Haukoos JS, Hopkins E, Byyny RL; Denver Emergency Department HIV Testing Study Group. Patient acceptance of rapid HIV testing practices in an urban emergency department: assessment of the 2006 CDC recommendations for HIV screening in health care settings. Ann Emerg Med. 2008 Mar;51(3):303-9, 309.e1. doi: 10.1016/j.annemergmed.2007.10.028. Epub 2008 Jan 11. — View Citation
Haukoos JS, Hopkins E, Conroy AA, Silverman M, Byyny RL, Eisert S, Thrun MW, Wilson ML, Hutchinson AB, Forsyth J, Johnson SC, Heffelfinger JD; Denver Emergency Department HIV Opt-Out Study Group. Routine opt-out rapid HIV screening and detection of HIV infection in emergency department patients. JAMA. 2010 Jul 21;304(3):284-92. doi: 10.1001/jama.2010.953. — View Citation
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. Review. — View Citation
Merchant RC, Clark MA, Mayer KH, Seage Iii GR, DeGruttola VG, Becker BM. Video as an effective method to deliver pretest information for rapid human immunodeficiency testing. Acad Emerg Med. 2009 Feb;16(2):124-35. doi: 10.1111/j.1553-2712.2008.00326.x. Epub 2008 Dec 18. — View Citation
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. Epub 2004 Apr 28. — View Citation
Reznik M, Sharif I, Ozuah PO. Use of interactive videoconferencing to deliver asthma education to inner-city immigrants. J Telemed Telecare. 2004;10(2):118-20. — View Citation
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. Erratum in: Ann Intern Med 1997 Jan 15;126(2):174. — View Citation
Torres M. Rapid HIV screening in the emergency department. Emerg Med Clin North Am. 2010 May;28(2):369-80, Table of Contents. doi: 10.1016/j.emc.2010.01.008. Review. — View Citation
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. Epub 2005 Mar 30. — View Citation
White DA, Scribner AN, Schulden JD, Branson BM, Heffelfinger JD. Results of a rapid HIV screening and diagnostic testing program in an urban emergency department. Ann Emerg Med. 2009 Jul;54(1):56-64. doi: 10.1016/j.annemergmed.2008.09.027. Epub 2008 Nov 5. — View Citation
Wilson JM, Jungner YG. [Principles and practice of mass screening for disease]. Bol Oficina Sanit Panam. 1968 Oct;65(4):281-393. Spanish. — View Citation
* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | ||
Secondary | Absolute numbers of those attending the ED who consent to watching the interactive information video about rapid HIV test screening. | 24 months | ||
Secondary | Absolute number and proportion of HIV positive test results | 24 months | ||
Secondary | CD4 count and viral load of newly diagnosed HIV positive patients | 24 months | ||
Secondary | Number of those testing positive who have acute seroconversion illness | 24 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03516318 -
Using Social Media to Improve ART Retention and Treatment Outcomes Among YLHIV in Nigeria
|
N/A | |
Completed |
NCT04653194 -
Efficacy of BIC/F/TAF Versus Standard of Care in the Treatment of New HIV Infection Diagnoses in the Context of 'Test and Treat'
|
Phase 3 | |
Completed |
NCT01792570 -
DRV/r + RPV QD: Efficacy and Toxicity Reduction
|
Phase 3 | |
Active, not recruiting |
NCT04826562 -
Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)
|
Phase 4 | |
Completed |
NCT04191967 -
Thermocoagulation for Treatment of Precancerous Cervical Lesions
|
N/A | |
Completed |
NCT02919306 -
Safety and Efficacy Study of Vaccine Schedule With Ad26.Mos.HIV and MVA-Mosaic in Human Immunodeficiency Virus (HIV)-Infected Adults
|
Phase 1/Phase 2 | |
Completed |
NCT02812329 -
Intervention to Encourage HIV Testing and Counseling Among Adolescents
|
Phase 1 | |
Completed |
NCT02516930 -
A Non-inferiority Randomized Controlled Trial to Evaluate Promoting Condom Use Among MSM and Transgender Individuals in China
|
N/A | |
Completed |
NCT02651376 -
Safety and Efficacy of Allogenic Adoptive Immune Therapy for Advanced AIDS Patients
|
Phase 1/Phase 2 | |
Recruiting |
NCT02392884 -
HIV Medication Adherence in Underserved Populations
|
N/A | |
Completed |
NCT01944371 -
Short-term Disulfiram Administration to Reverse Latent HIV Infection: a Dose Escalation Study
|
Phase 1/Phase 2 | |
Completed |
NCT00914225 -
Effect of Bednets and a Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya
|
N/A | |
Completed |
NCT01076179 -
Kaletra in Combination With Antiretroviral Agents
|
N/A | |
Completed |
NCT01460433 -
Problems With Immune Recovery in the Gut Tissue
|
N/A | |
Completed |
NCT01490346 -
Tissue Drug Levels of HIV Medications
|
N/A | |
Completed |
NCT00317460 -
Buprenorphine and Integrated HIV Care
|
Phase 4 | |
Terminated |
NCT04240210 -
Integrase Regimen Switch to Symtuza to Increase Tolerability/Adherence (SYMita)
|
Phase 4 | |
Active, not recruiting |
NCT04704336 -
Integration of Hypertension Management Into HIV Care in Nigeria
|
N/A | |
Completed |
NCT03254277 -
3BNC117-LS First-in-Human Phase 1 Study
|
Phase 1 | |
Terminated |
NCT01692236 -
Brain Imaging for HIV-Associated Thinking and Mood Disorders
|