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Task shifting of antiretroviral treatment from doctors to primary-care nurses in South Africa (STRETCH): a pragmatic, parallel, cluster randomised trial
Open accessAbstract
Background Robust evidence of the effectiveness of task shifting of antiretroviral therapy (ART) from doctors to other health workers is scarce. We aimed to assess the effects on mortality, viral suppression, and other health outcomes and quality indicators of the Streamlining Tasks and Roles to Expand Treatment and Care for HIV (STRETCH) programme, which provides educational outreach training of nurses to initiate and represcribe ART, and to decentralise care.Methods We undertook a pragmatic, parallel, cluster-randomised trial in South Africa between Jan 28, 2008, and June 30, 2010. We randomly assigned 31 primary-care ART clinics to implement the STRETCH programme (intervention group) or to continue with standard care (control group). The ratio of randomisation depended on how many clinics were in each of nine strata. Two cohorts were enrolled: eligible patients in cohort 1 were adults (aged ≥16 years) with CD4 counts of 350 cells per μL or less who were not receiving ART; those in cohort 2 were adults who had already received ART for at least 6 months and were being treated at enrolment. The primary outcome in cohort 1 was time to death (superiority analysis). The primary outcome in cohort 2 was the proportion with undetectable viral loads (<400 copies per mL) 12 months after enrolment (equivalence analysis, prespecified difference <6%). Patients and clinicians could not be masked to group assignment. The interim analysis was blind, but data analysts were not masked after the database was locked for final analysis. Analyses were done by intention to treat. This trial is registered, number ISRCTN46836853.Findings 5390 patients in cohort 1 and 3029 in cohort 2 were in the intervention group, and 3862 in cohort 1 and 3202 in cohort 2 were in the control group. Median follow-up was 16·3 months (IQR 12·2-18·0) in cohort 1 and 18·0 months (18·0-18·0) in cohort 2. In cohort 1, 997 (20%) of 4943 patients analysed in the intervention group and 747 (19%) of 3862 in the control group with known vital status at the end of the trial had died. Time to death did not differ (hazard ratio [HR] 0·94, 95% CI 0·76-1·15). In a preplanned subgroup analysis of patients with baseline CD4 counts of 201-350 cells per μL, mortality was slightly lower in the intervention group than in the control group (0·73, 0·54-1.00; p=0·052), but it did not differ between groups in patients with baseline CD4 of 200 cells per μL or less (0·94, 0·76-1·15; p=0·577). In cohort 2, viral load suppression 12 months after enrolment was equivalent in intervention (2156 [71%] of 3029 patients) and control groups (2230 [70%] of 3202; risk difference 1·1%, 95% CI -2·4 to 4·6).Interpretation Expansion of primary-care nurses' roles to include ART initiation and represcription can be done safely, and improve health outcomes and quality of care, but might not reduce time to ART or mortality.Funding UK Medical Research Council, Development Cooperation Ireland, and Canadian International Development Agency.
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“Risk of bias overall Low risk 3 criteria unclear risk”
From Tailored interventions to address determinants of practice (2015) · cites this paper as Fairall 2012
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“In the field of dermatology, unlike in HIV or obstetrics (53–56), there are few examples of task shifting in resource-poor settings”
From Global Burden of Skin Disease: Inequities and Innovations (2017) · cites this paper as [54]
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“Clear positive impacts on health worker morale have been documented in parallel qualitative evaluations, with non-physician clinicians reporting a sense of empowerment and improved agency to manage patients 92,93 .”
From Integrated care for people with long-term mental and physical health conditions in low-income and middle-income countries (2019) · cites this paper as [93]
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Metadata
- Authors
- Fairall, L., Bachmann, M. O., Lombard, C., Timmerman, V., Uebel, K., Zwarenstein, M., Boulle, A., Georgeu, D., Colvin, C. J., Lewin, S., Faris, G., Cornick, R., Draper, B., Tshabalala, M., Kotze, E., van Vuuren, C., Steyn, D., Chapman, R., & Bateman, E.
- Affiliations
- University of Cape Town (ZA)
- University of East Anglia (GB)
- South African Medical Research Council (ZA)
- Western University (CA)
- University of the Free State (ZA)
- Medical Research Council (GB)
- Corresponding author
- Bachmann, Max O
- ORCID
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2012-09
- Volume
- 380
- Issue
- 9845
- Pages
- 889-898
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- PMC
- PMC3442223
- OpenAlex
- W2128478603
- Cited by
- 302
- References
- 23
- Citations by year
- 2026: 4 · 2025: 9 · 2024: 26 · 2023: 8 · 2022: 7 · 2021: 12 · 2020: 26 · 2019: 16 · 2018: 34 · 2017: 26 · 2016: 27 · 2015: 34 · 2014: 38 · 2013: 27 · 2012: 6
- FWCI
- 23.19
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- The Lancet (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- UEA Digital Repository (University of East Anglia) (submittedVersion)
- Funders
- National Health Laboratory Service
- Medical Research Council
- Topics
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
- Health Sciences › Health Professions › General Health Professions › Nursing Roles and Practices
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS drug development and treatment
- Keywords
- task shifting, antiretroviral therapy, primary care nurses, HIV, decentralization of care, viral suppression, mortality, CD4 count, healthcare workers, South Africa, quality indicators
- MeSH terms
- Adult, Delivery of Health Care, Female, Humans, Male, Middle Aged, Drug Prescriptions, Primary Health Care, South Africa, HIV Infections, Treatment Outcome, CD4 Lymphocyte Count, Anti-HIV Agents, Viral Load, Primary Care Nursing
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