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Comparison of facility and home-based antiretroviral therapy delivery systems in Uganda
ISRCTN ISRCTN17184129
DOI 10.1186/ISRCTN17184129
ClinicalTrials.gov identifier
EudraCT number
Public title Comparison of facility and home-based antiretroviral therapy delivery systems in Uganda
Scientific title Comparison of facility and home-based antiretroviral therapy delivery systems in Uganda: a randomised controlled trial
Acronym N/A
Serial number at source 4371
Study hypothesis 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.
Lay summary
Ethics approval 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)
Study design Randomised controlled trial
Countries of recruitment Uganda
Disease/condition/study domain Human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS)
Participants - inclusion criteria 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.
Participants - exclusion criteria 1. Already on ART and transferred from another centre
2. Live on islands and are difficult to follow-up
Anticipated start date 15/02/2005
Anticipated end date 31/01/2009
Status of trial Completed
Patient information material
Target number of participants 1000
Interventions A comparison of two different ways of providing ART in an African setting - home-based versus facility-based HIV care
Primary outcome measure(s) Time to detectable viral load
Secondary outcome measure(s) 1. Adherence
2. Cost effectiveness
3. Treatment failure
Sources of funding 1. Centers for Disease Control (CDC) (USA) - Co-operative Agreement (ref: IU01-PS000065-01)
2. Medical Research Council (MRC) (UK)
Trial website
Publications 1. 2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/18923692
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19939445
Contact name Dr  Shabbar  Jaffar
  Address London School of Hygiene and Tropical Medicine (LSHTM)
Keppel Street
  City/town London
  Zip/Postcode WC1E 7HT
  Country United Kingdom
  Tel +44 (0)20 7927 2418
  Email shabbar.jaffar@lshtm.ac.uk
Sponsor Medical Research Council Unit on AIDS (Uganda)
  Address c/o Uganda Virus Research Institute
P.O. Box 49
  City/town Entebbe
  Zip/Postcode -
  Country Uganda
  Tel +256 (0)43 120 764
  Email shabbar.jaffar@lshtm.ac.uk
Date applied 06/08/2005
Last edited 30/11/2009
Date ISRCTN assigned 26/09/2005
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