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 https://doi.org/10.1186/ISRCTN46836853
Secondary identifying numbers N/A
Submission date
26/04/2007
Registration date
07/08/2007
Last edited
21/01/2013
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

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

Phone +27 21 406 6979
Email lfairall@uctgsh1.uct.ac.za

Study information

Study designPragmatic, two-arm, cluster randomised controlled trial.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymSTRETCH
Study objectivesThat 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(s)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
Health condition(s) or problem(s) studiedHIV/ AIDS
InterventionComplex 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)antiretroviral treatment (HAART)
Primary outcome measureThe 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 measuresThe 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 study start date01/07/2007
Completion date30/06/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsClinics: 31; Cohort 1: 7000 patients; Cohort 2: 4000 patients
Key inclusion criteriaClinics: 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.
Key exclusion criteriaClinics: None
Patients: Patients younger than 18 years
Date of first enrolment01/07/2007
Date of final enrolment30/06/2009

Locations

Countries of recruitment

  • South Africa

Study participating centre

Knowledge Translation Unit
Cape Town
7937
South Africa

Sponsor information

Development Cooperation Ireland (South Africa)
Government

Embassy of Ireland
1st Floor
Southern Life Plaza
1059 Schoeman Street
Arcadia
Pretoria
0083
South Africa

Phone +27 12 342 5062
Email annalize.fourie@dfa.ie
Website http://www.embassyireland.org.za/

Funders

Funder type

Government

Canadian International Development Agency (02/2006) (Canada)

No information available

Irish Aid (Ireland)

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?
Other publications process evaluation 16/07/2012 Yes No
Results article results 08/09/2012 Yes No