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A cluster randomised controlled trial of an educational and organisational intervention to expand antiretroviral treatment access in public-sector primary care clinics in South Africa: the STRETCH (Streamlining Tasks and Roles to Expand Treatment and Care for HIV) trial
ISRCTN ISRCTN46836853
DOI 10.1186/ISRCTN46836853
ClinicalTrials.gov identifier
EudraCT number
Public title A cluster randomised controlled trial of an educational and organisational intervention to expand antiretroviral treatment access in public-sector primary care clinics in South Africa: the STRETCH (Streamlining Tasks and Roles to Expand Treatment and Care for HIV) trial
Scientific title
Acronym STRETCH
Serial number at source N/A
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.
Lay summary Not provided at time of registration
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.
Countries of recruitment South Africa
Disease/condition/study domain HIV/ AIDS
Participants - 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.
Participants - exclusion criteria Clinics: None
Patients: Patients younger than 18 years
Anticipated start date 01/07/2007
Anticipated end date 30/06/2009
Status of trial Completed
Patient information material
Target number of participants Clinics: 31; Cohort 1: 7000 patients; Cohort 2: 4000 patients
Interventions 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
Primary outcome measure(s) 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 measure(s) 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
Sources of funding 1. Canadian International Development Agency (02/2006) (Canada)
2. Irish Aid (Ireland)
Trial website
Publications 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
Contact name Dr  Lara  Fairall
  Address Knowledge Translation Unit
University of Cape Town Lung Institute
PO Box 34560
Groote Schuur
  City/town Cape Town
  Zip/Postcode 7937
  Country South Africa
  Tel +27 21 406 6979
  Fax +27 21 406 69991
  Email lfairall@uctgsh1.uct.ac.za
Sponsor Development Cooperation Ireland (South Africa)
  Address Embassy of Ireland
1st Floor
Southern Life Plaza
1059 Schoeman Street
Arcadia
  City/town Pretoria
  Zip/Postcode 0083
  Country South Africa
  Tel +27 12 342 5062
  Fax +27 12 342 3461
  Email annalize.fourie@dfa.ie
  Sponsor website: http://www.embassyireland.org.za/
Date applied 26/04/2007
Last edited 21/01/2013
Date ISRCTN assigned 07/08/2007
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