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

University of Cape Town Lung Institute
PO Box 34560
Groote Schuur
Cape Town
7937
South Africa

Phone +27 21 4066919
Email lfairall@uctgsh1.uct.ac.za

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymPALSA PLUS
Study objectivesEducational 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) studiedHIV/AIDS, Tuberculosis (TB), and STIs.
InterventionThe 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 typeOther
Primary outcome measure1. TB case detection
2. Voluntary counselling and testing uptake
3. Cotrimoxazole prophylaxis provision
Secondary outcome measures1. 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 date01/08/2004
Completion date01/08/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants15 clinics (PALSA PLUS) and 45 clinics (PALSA PLUS Western Cape)
Key inclusion criteriaClusters: 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 criteriaNone
Date of first enrolment01/08/2004
Date of final enrolment01/08/2006

Locations

Countries of recruitment

  • South Africa

Study participating centre

University of Cape Town Lung Institute
Cape Town
7937
South Africa

Sponsor information

University of Cape Town Lung Institute (South Africa)
University/education

University of Cape Town Lung Institute
PO Box 34560
Groote Schuur
Cape Town
7937
South Africa

Phone +27 21 4066919
Email lfairall@uctgsh1.uct.ac.za
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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