Comparison of facility and home-based antiretroviral therapy delivery systems in Uganda

ISRCTN	ISRCTN17184129
DOI	https://doi.org/10.1186/ISRCTN17184129
Protocol serial number	4371
Sponsor	Medical Research Council Unit on AIDS (Uganda)
Funders	Centers for Disease Control (CDC) (USA) - Co-operative Agreement (ref: IU01-PS000065-01), Medical Research Council (MRC) (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Shabbar Jaffar
Scientific

London School of Hygiene and Tropical Medicine (LSHTM)
Keppel Street
London
WC1E 7HT
United Kingdom

Phone	+44 (0)20 7927 2418
Email	shabbar.jaffar@lshtm.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Comparison of facility and home-based antiretroviral therapy delivery systems in Uganda: a randomised controlled trial
Study objectives	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.
Ethics approval(s)	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)
Health condition(s) or problem(s) studied	Human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS)
Intervention	A comparison of two different ways of providing ART in an African setting - home-based versus facility-based HIV care
Intervention type	Other
Primary outcome measure(s)	Time to detectable viral load
Key secondary outcome measure(s)	1. Adherence 2. Cost effectiveness 3. Treatment failure
Completion date	31/01/2009

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	1000
Key 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.
Key exclusion criteria	1. Already on ART and transferred from another centre 2. Live on islands and are difficult to follow-up
Date of first enrolment	15/02/2005
Date of final enrolment	31/01/2009

London School of Hygiene and Tropical Medicine (LSHTM)

London
WC1E 7HT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	19/12/2009		Yes	No
Protocol article	protocol	01/11/2007		Yes	No