Contact information
Type
Scientific
Primary contact
Dr Lara Fairall
ORCID ID
Contact details
University of Cape Town Lung Institute
PO Box 34560
Groote Schuur
Cape Town
7937
South Africa
+27 21 4066919
lfairall@uctgsh1.uct.ac.za
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
PALSA PLUS
Study hypothesis
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
Not provided at time of registration
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
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/08/2004
Overall trial end date
01/08/2006
Reason abandoned
Eligibility
Participant 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).
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
15 clinics (PALSA PLUS) and 45 clinics (PALSA PLUS Western Cape)
Participant exclusion criteria
None
Recruitment start date
01/08/2004
Recruitment end date
01/08/2006
Locations
Countries of recruitment
South Africa
Trial participating centre
University of Cape Town Lung Institute
Cape Town
7937
South Africa
Sponsor information
Organisation
University of Cape Town Lung Institute (South Africa)
Sponsor details
University of Cape Town Lung Institute
PO Box 34560
Groote Schuur
Cape Town
7937
South Africa
+27 21 4066919
lfairall@uctgsh1.uct.ac.za
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
International Development Research Centre Canada (Grant no: 102770-001)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21511783
Publication citations
-
Results
Zwarenstein M, Fairall LR, Lombard C, Mayers P, Bheekie A, English RG, Lewin S, Bachmann MO, Bateman E, Outreach education for integration of HIV/AIDS care, antiretroviral treatment, and tuberculosis care in primary care clinics in South Africa: PALSA PLUS pragmatic cluster randomised trial., BMJ, 2011, 342, d2022.