Comparison of facility and home-based antiretroviral therapy delivery systems in Uganda
| ISRCTN | ISRCTN17184129 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17184129 |
| Secondary identifying numbers | 4371 |
- Submission date
- 06/08/2005
- Registration date
- 26/09/2005
- Last edited
- 30/11/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Shabbar Jaffar
Scientific
Scientific
London School of Hygiene and Tropical Medicine (LSHTM)
Keppel Street
London
WC1E 7HT
United Kingdom
| Phone | +44 (0)20 7927 2418 |
|---|---|
| shabbar.jaffar@lshtm.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | Time to detectable viral load |
| Secondary outcome measures | 1. Adherence 2. Cost effectiveness 3. Treatment failure |
| Overall study start date | 15/02/2005 |
| Completion date | 31/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- Uganda
- United Kingdom
Study participating centre
London School of Hygiene and Tropical Medicine (LSHTM)
London
WC1E 7HT
United Kingdom
WC1E 7HT
United Kingdom
Sponsor information
Medical Research Council Unit on AIDS (Uganda)
Research council
Research council
c/o Uganda Virus Research Institute
P.O. Box 49
Entebbe
-
Uganda
| Phone | +256 (0)43 120 764 |
|---|---|
| shabbar.jaffar@lshtm.ac.uk |
Funders
Funder type
Research council
Centers for Disease Control (CDC) (USA) - Co-operative Agreement (ref: IU01-PS000065-01)
No information available
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/11/2007 | Yes | No | |
| Results article | results | 19/12/2009 | Yes | No |
