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
Protocol serial number	N/A
Sponsor	Development Cooperation Ireland (South Africa)
Funders	Canadian International Development Agency (02/2006) (Canada), Irish Aid (Ireland)

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

Primary study design	Interventional
Study design	Pragmatic, two-arm, cluster randomised controlled trial.
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	STRETCH
Study objectives	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(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) studied	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 / device / biological / vaccine name(s)	antiretroviral treatment (HAART)
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
Key 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
Completion date	30/06/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	11000
Key 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.
Key exclusion criteria	Clinics: None Patients: Patients younger than 18 years
Date of first enrolment	01/07/2007
Date of final enrolment	30/06/2009

Locations

Countries of recruitment

South Africa

Study participating centre

Knowledge Translation Unit

Cape Town
7937
South Africa

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	08/09/2012		Yes	No
Other publications	process evaluation	16/07/2012		Yes	No