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ISRCTN
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ISRCTN17184129
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ClinicalTrials.gov identifier
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Public title
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Comparison of facility and home-based antiretroviral therapy delivery systems in Uganda
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Scientific title
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Comparison of facility and home-based antiretroviral therapy delivery systems in Uganda: a randomised controlled trial
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Acronym
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N/A
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Serial number at source
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4371
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Study hypothesis
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That home-based human immunodeficiency virus (HIV) care is approximately equivalent in effectiveness to facility-based HIV care.
As of 14/04/2009 this record was updated; all updates can be found under the relevant field. At this time, the anticipated end date was also amended; the initial anticipated end date was 15/02/2009.
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Lay summary
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Ethics approval
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Added 14/04/2009:
1. London School of Hygiene and Tropical Medicine Ethics Committee approved on the 25th November 2004 (ref: 2058)
2. Uganda Virus Research Institute Science and Ethics Committee approved on the 20th August 2004 (ref: "A randomised trial of home or facility-based AIDS care")
3. US Centers for Disease Control and Prevention approved on the 18th January 2005 (ref: 4371)
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Study design
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Randomised controlled trial
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Countries of recruitment
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Uganda
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Disease/condition/study domain
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Human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS)
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Participants - inclusion criteria
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All HIV-infected adults (aged 18 years or more) who are started on antiretroviral therapy (ART) by a service provider (The acquired immunodeficiency syndrome [AIDS] Support Organisation) and who plan to remain in the study area for 12 months.
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Participants - exclusion criteria
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1. Already on ART and transferred from another centre
2. Live on islands and are difficult to follow-up
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Anticipated start date
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15/02/2005
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Anticipated end date
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31/01/2009
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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1000
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Interventions
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A comparison of two different ways of providing ART in an African setting - home-based versus facility-based HIV care
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Primary outcome measure(s)
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Time to detectable viral load
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Secondary outcome measure(s)
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1. Adherence
2. Cost effectiveness
3. Treatment failure
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Sources of funding
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1. Centers for Disease Control (CDC) (USA) - Co-operative Agreement (ref: IU01-PS000065-01)
2. Medical Research Council (MRC) (UK)
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Trial website
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Publications
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1. 2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/18923692
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19939445
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Contact name
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Dr
Shabbar
Jaffar
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Address
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London School of Hygiene and Tropical Medicine (LSHTM)
Keppel Street
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City/town
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London
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Zip/Postcode
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WC1E 7HT
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Country
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United Kingdom
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Tel
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+44 (0)20 7927 2418
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Email
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shabbar.jaffar@lshtm.ac.uk
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Sponsor
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Medical Research Council Unit on AIDS (Uganda)
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Address
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c/o Uganda Virus Research Institute
P.O. Box 49
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City/town
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Entebbe
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Zip/Postcode
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-
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Country
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Uganda
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Tel
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+256 (0)43 120 764
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Email
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shabbar.jaffar@lshtm.ac.uk
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Date applied
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06/08/2005
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Last edited
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30/11/2009
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Date ISRCTN assigned
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26/09/2005
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