Condition category
Infections and Infestations
Date applied
06/08/2005
Date assigned
26/09/2005
Last edited
30/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Shabbar Jaffar

ORCID ID

Contact details

London School of Hygiene and Tropical Medicine (LSHTM)
Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)20 7927 2418
shabbar.jaffar@lshtm.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4371

Study information

Scientific title

Comparison of facility and home-based antiretroviral therapy delivery systems in Uganda: a randomised controlled trial

Acronym

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Time to detectable viral load

Secondary outcome measures

1. Adherence
2. Cost effectiveness
3. Treatment failure

Overall trial start date

15/02/2005

Overall trial end date

31/01/2009

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1000

Participant exclusion criteria

1. Already on ART and transferred from another centre
2. Live on islands and are difficult to follow-up

Recruitment start date

15/02/2005

Recruitment end date

31/01/2009

Locations

Countries of recruitment

Uganda

Trial participating centre

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

Sponsor information

Organisation

Medical Research Council Unit on AIDS (Uganda)

Sponsor details

c/o Uganda Virus Research Institute
P.O. Box 49
Entebbe
-
Uganda
+256 (0)43 120 764
shabbar.jaffar@lshtm.ac.uk

Sponsor type

Research council

Website

Funders

Funder type

Research council

Funder name

Centers for Disease Control (CDC) (USA) - Co-operative Agreement (ref: IU01-PS000065-01)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/18923692
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19939445

Publication citations

  1. Protocol

    Amuron B, Coutinho A, Grosskurth H, Nabiryo C, Birungi J, Namara G, Levin J, Smith PG, Jaffar S, A cluster-randomised trial to compare home-based with health facility-based antiretroviral treatment in Uganda: study design and baseline findings., Open AIDS J, 2007, 1, 21-27, doi: 10.2174/1874613600701010021.

  2. Results

    Jaffar S, Amuron B, Foster S, Birungi J, Levin J, Namara G, Nabiryo C, Ndembi N, Kyomuhangi R, Opio A, Bunnell R, Tappero JW, Mermin J, Coutinho A, Grosskurth H, , Rates of virological failure in patients treated in a home-based versus a facility-based HIV-care model in Jinja, southeast Uganda: a cluster-randomised equivalence trial., Lancet, 2009, 374, 9707, 2080-2089, doi: 10.1016/S0140-6736(09)61674-3.

Additional files

Editorial Notes