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 |
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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
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 |
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lfairall@uctgsh1.uct.ac.za |
Study information
Study design | Pragmatic, two-arm, cluster randomised controlled trial. |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | antiretroviral treatment (HAART) |
Primary outcome measure | 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 study start date | 01/07/2007 |
Completion date | 30/06/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | Clinics: 31; Cohort 1: 7000 patients; Cohort 2: 4000 patients |
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
7937
South Africa
Sponsor information
Development Cooperation Ireland (South Africa)
Government
Government
Embassy of Ireland
1st Floor
Southern Life Plaza
1059 Schoeman Street
Arcadia
Pretoria
0083
South Africa
Phone | +27 12 342 5062 |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Other publications | process evaluation | 16/07/2012 | Yes | No | |
Results article | results | 08/09/2012 | Yes | No |