Contact information
Type
Scientific
Primary contact
Dr Lara Fairall
ORCID ID
Contact details
Knowledge Translation Unit
University of Cape Town Lung Institute
PO Box 34560
Groote Schuur
Cape Town
7937
South Africa
+27 21 406 6979
lfairall@uctgsh1.uct.ac.za
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
STRETCH
Study hypothesis
That the decentralisation of antiretroviral treatment services from doctors at hospitals to nurses at clinics, supported by appropriate training and supervision, expands treatment access, reducing mortality among enrolled patients waiting for HAART (Highly Active AntiRetroviral Treatment), without compromising HAART treatment outcomes.
Ethics approval
1. Ethics Committee of the Faculty of Health Sciences, University of the Free State (South Africa) (ref: ETOVS NR 75/07)
2. Ethics Committee of the Faculty of Health Sciences, University of Cape Town (South Africa), approval pending as of 16/07/2007
Study design
Pragmatic, two-arm, cluster randomised controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
HIV/ AIDS
Intervention
Complex health systems intervention comprising:
1. Clinical algorithm to triage AntiRetroViral (ARV) patients for nurse- or doctor-managed care
2. Educational outreach training to nurses
3. Expanded prescribing provisions to permit trained nurse practitioners to prescribe ARVs
4. Re-defining roles of clinical staff:
4.1. Generalist nurses: pre-ARV HIV care
4.2. ARV nurses: monitoring of stable ARV patients, ARV initiation in selected adults
4.3. ARV doctors: review problem cases
5. Systems toolkit: a guideline for managers on how to implement STRETCH
6. Provincial STRETCH co-ordinators
7. STRETCH facility support teams - facilitate changes and provide support
Intervention type
Drug
Phase
Not Specified
Drug names
antiretroviral treatment (HAART)
Primary outcome measures
The following will be analysed at 1 year (interim analysis) and 2 years (final analysis):
Cohort 1: Survival
Cohort 2: Viral load suppression rates
Secondary outcome measures
The following will be measured at 2 years (or 1 year if the trial should be discontinued):
Cohort 1:
1. Viral load suppression rates
2. Duration between enrolment and starting HAART
3. Proportion of patients with CD4 count <=350 who start HAART during the study period
4. Median baseline CD4 count of patients starting HAART
5. Tuberculosis (TB) case detection
6. Screening for TB (sputum tests)
7. Cotrimoxazole prophylaxis provision
8. Changes in CD4 and weight, hospital admissions
9. Number of nurse and doctor visits
Cohort 2:
1. Survival
2. Programme retention (the proportion of patients remaining alive and in care)
3. Duration of viraemia prior to switch to second-line treatment
4. TB case detection
5. Screening for TB (sputum tests)
6. Cotrimoxazole prophylaxis provision
7. Changes in CD4 and weight
8. Hospital admissions
9. Number of nurse and doctor visits
Overall trial start date
01/07/2007
Overall trial end date
30/06/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Clinics: All 31 public sector clinics currently offering antiretroviral treatment in the Free State province, South Africa.
Patients:
Cohort 1: All patients enrolled at the 31 facilities with a CD4 count of 350 cells/ul or less not yet on HAART.
Cohort 2: All patients enrolled at the 31 facilities already on HAART for 6 months or longer, and alive and in care at the start of the trial.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Clinics: 31; Cohort 1: 7000 patients; Cohort 2: 4000 patients
Participant exclusion criteria
Clinics: None
Patients: Patients younger than 18 years
Recruitment start date
01/07/2007
Recruitment end date
30/06/2009
Locations
Countries of recruitment
South Africa
Trial participating centre
Knowledge Translation Unit
Cape Town
7937
South Africa
Sponsor information
Organisation
Development Cooperation Ireland (South Africa)
Sponsor details
Embassy of Ireland
1st Floor
Southern Life Plaza
1059 Schoeman Street
Arcadia
Pretoria
0083
South Africa
+27 12 342 5062
annalize.fourie@dfa.ie
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Canadian International Development Agency (02/2006) (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Irish Aid (Ireland)
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. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22901955
2. 2012 process evaluation in http://www.ncbi.nlm.nih.gov/pubmed/22800379
Publication citations
-
Results
Fairall L, Bachmann MO, Lombard C, Timmerman V, Uebel K, Zwarenstein M, Boulle A, Georgeu D, Colvin CJ, Lewin S, Faris G, Cornick R, Draper B, Tshabalala M, Kotze E, van Vuuren C, Steyn D, Chapman R, Bateman E, Task shifting of antiretroviral treatment from doctors to primary-care nurses in South Africa (STRETCH): a pragmatic, parallel, cluster-randomised trial., Lancet, 2012, 380, 9845, 889-898, doi: 10.1016/S0140-6736(12)60730-2.
-
Process evaluation
Georgeu D, Colvin CJ, Lewin S, Fairall L, Bachmann MO, Uebel K, Zwarenstein M, Draper B, Bateman ED, Implementing nurse-initiated and managed antiretroviral treatment (NIMART) in South Africa: a qualitative process evaluation of the STRETCH trial., Implement Sci, 2012, 7, 66, doi: 10.1186/1748-5908-7-66.