Pragmatic Cluster Randomised Controlled Trial of the Practical Approach to Lung Health and Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS) in South Africa (PALSA PLUS) Educational Outreach Intervention
| ISRCTN | ISRCTN24820584 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24820584 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/09/2005
- Registration date
- 10/02/2006
- Last edited
- 27/04/2011
- 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 Lara Fairall
Scientific
Scientific
University of Cape Town Lung Institute
PO Box 34560
Groote Schuur
Cape Town
7937
South Africa
| Phone | +27 21 4066919 |
|---|---|
| lfairall@uctgsh1.uct.ac.za |
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 | |
| Study acronym | PALSA PLUS |
| Study objectives | Educational outreach, based on symptom and sign-based guidelines, improves the quality of respiratory and HIV/AIDS primary care in comparison with usual training. PALSA PLUS Western Cape trial: This is an offshoot of the primary PALSA PLUS trial that will be taking place in the Western Cape province of South Africa. The hypothesis is the same as for the intial PALSA PLUS trial, but will also include the following hypotheses: 1. Educational outreach, based on symptom and sign-based guidelines, improves the quality of Tuberculosis (TB) respiratory illness and Sexually Transmitted Infections (STI) in comparison with usual training. Any other differences can be seen under the heading PALSA PLUS Western Cape trial. This trial took place between the dates of 06/03/2006 and 15/10/2007. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | HIV/AIDS, Tuberculosis (TB), and STIs. |
| Intervention | The trial is comparing educational outreach (based on guidelines) to passive dissemination of these guidelines to all nurses in control clinics combined with traditional off-site didactic training of selected nurse practitioners working directly in the ARV programme (i.e. usual training). |
| Intervention type | Other |
| Primary outcome measure | 1. TB case detection 2. Voluntary counselling and testing uptake 3. Cotrimoxazole prophylaxis provision |
| Secondary outcome measures | 1. TB screening (sputum sampling) 2. Proportion of ART patients with undetectable viral loads at 6,12 and 18 months 3. Health-related quality of life 4. Hospitalisation 5. Mortality 6. Antiretroviral treatment interruptions |
| Overall study start date | 01/08/2004 |
| Completion date | 01/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 15 clinics (PALSA PLUS) and 45 clinics (PALSA PLUS Western Cape) |
| Key inclusion criteria | Clusters: primary care clinics participating in the first phases of the rollout of the national AntiRetroviral Treatment (ART) programme in the Free State province, South Africa Patients: All patients enrolled in the national ART programme at these clinics PALSA PLUS Western Cape trial: In addition to the above inclusion criteria, the PALSA PLUS Western Cape trial will also include primary care facilities where care for HIV and TB is provided. Patients: all patients 15 years or older attending these facilities for the trial duration (36 weeks). |
| Key exclusion criteria | None |
| Date of first enrolment | 01/08/2004 |
| Date of final enrolment | 01/08/2006 |
Locations
Countries of recruitment
- South Africa
Study participating centre
University of Cape Town Lung Institute
Cape Town
7937
South Africa
7937
South Africa
Sponsor information
University of Cape Town Lung Institute (South Africa)
University/education
University/education
University of Cape Town Lung Institute
PO Box 34560
Groote Schuur
Cape Town
7937
South Africa
| Phone | +27 21 4066919 |
|---|---|
| lfairall@uctgsh1.uct.ac.za | |
"ROR" |
https://ror.org/03p74gp79 |
Funders
Funder type
Charity
International Development Research Centre Canada (Grant no: 102770-001)
No information available
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? |
|---|---|---|---|---|---|
| Results article | results | 21/04/2011 | Yes | No |
