Condition category
Infections and Infestations
Date applied
09/09/2005
Date assigned
10/02/2006
Last edited
27/04/2011
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 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

  1. 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.

Additional files

Editorial Notes