Addressing the quality of paediatric primary care: health worker and caregiver perspectives from a process evaluation of PACK child, a health systems intervention in South Africa.

BACKGROUND: The WHO's Integrated Management of Childhood Illness (IMCI) has resulted in progress in addressing infant and child mortality. However, unmet needs of children continue to present a burden upon primary healthcare services. The capacity of services and quality of care offered require greater support to address these needs by extending and integrating curative and preventive care for the child with a long-term health condition and the child older than 5, not prioritised in IMCI. In response to these needs, the PACK Child intervention was developed and piloted in October 2017-February 2019 in the Western Cape Province of South Africa. We report health worker and caregiver perspectives of the existing paediatric primary care context as well as the extent to which PACK Child functions to address perceived problems within the current local healthcare system. METHODS: This process evaluation involved 52 individual interviews with caregivers, 10 focus group discussions with health workers, 3 individual interviews with trainers, and 31 training observations. Interviews and focus groups explored participants' experiences of paediatric primary care, perspectives of the PACK Child intervention, and tensions with implementation in each context. Inductive thematic analysis was used to analyse verbatim interview and discussion transcripts. RESULTS: Perspectives of caregivers and health workers suggest an institutionalised focus of paediatric primary care to treating children's symptoms as acute episodic conditions. Health workers' reports imply that this focus is perpetuated by interactions between contextual features such as, IMCI policy, documentation-driven consultations, overcrowded clinics and verticalised care. Whilst these contextual conditions constrained health workers' ability to translate skills developed within PACK Child training into practice, the intervention initiated expanded care of children 0-13 years and those with long-term health conditions, enhanced professional competence, improved teamwork and referrals, streamlined triaging, and facilitated probing for psychosocial risk. CONCLUSION: PACK Child appears to be catalysing paediatric primary care to address the broader needs of children, including long-term health conditions and the identification of psychosocial problems. However, to maximise this requires primary care to re-orientate from risk minimisation on the day of attendance towards a view of the child beyond the day of presentation at clinics.

Addressing the quality and scope of paediatric primary care in South Africa: evaluating contextual impacts of the introduction of the Practical Approach to Care Kit for children (PACK Child).

BACKGROUND: Despite significant reductions in mortality, preventable and treatable conditions remain leading causes of death and illness in children in South Africa. The PACK Child intervention, comprising clinical decision support tool (guide), training strategy and health systems strengthening components, was developed to expand on WHO's Integrated Management of Childhood Illness programme, extending care of children under 5 years to those aged 0-13 years, those with chronic conditions needing regular follow-up, integration of curative and preventive measures and routine care of the well child. In 2017-2018, PACK Child was piloted in 10 primary healthcare facilities in the Western Cape Province. Here we report findings from an investigation into the contextual features of South African primary care that shaped how clinicians delivered the PACK Child intervention within clinical consultations. METHODS: Process evaluation using linguistic ethnographic methodology which provides analytical tools for investigating human behaviour, and the shifting meaning of talk and text within context. Methods included semi-structured interviews, focus groups, ethnographic observation, audio-recorded consultations and documentary analysis. Analysis focused on how mapped contextual features structured clinician-caregiver interactions. RESULTS: Primary healthcare facilities demonstrated an institutionalised orientation to minimising risk upheld by provincial documentation, providing curative episodic care to children presenting with acute symptoms, and preventive care including immunisations, feeding and growth monitoring, all in children 5 years or younger. Children with chronic illnesses such as asthma rarely receive routine care. These contextual features constrained the ability of clinicians to use the PACK Child guide to facilitate diagnosis of long-term conditions, elicit and manage psychosocial issues, and navigate use of the guide alongside provincial documentation. CONCLUSION: Our findings provide evidence that PACK Child is catalysing a transition to an approach that strikes a balance between assessing and minimising risk on the day of acute presentation and a larger remit of care for children over time. However, optimising success of the intervention requires reviewing priorities for paediatric care which will facilitate enhanced skills, knowledge and deployment of clinical staff to better address acute illnesses and long-term health conditions of children of all ages, as well as complex psychosocial issues surrounding the child.

Effects of PACK guide training on the management of asthma and chronic obstructive pulmonary disease by primary care clinicians: a pragmatic cluster randomised controlled trial in Florianópolis, Brazil.

INTRODUCTION: The Practical Approach to Care Kit (PACK) guide was localised for Brazil, where primary care doctors and nurses were trained to use it. METHODS: Twenty-four municipal clinics in Florianópolis were randomly allocated to receive outreach training and the guide, and 24 were allocated to receive only the guide. 6666 adult patients with asthma or chronic obstructive pulmonary disease (COPD) were enrolled, and trial outcomes were measured over 12 months, using electronic medical records. The primary outcomes were composite scores of treatment changes and spirometry, and new asthma and COPD diagnosis rates. RESULTS: Asthma scores in 2437 intervention group participants were higher (74.8%, 20.4% and 4.8% with scores of 0, 1 and 2, respectively) than in 2633 control group participants (80.0%, 16.8% and 3.2%) (OR for higher score 1.32, 95% CI 1.08 to 1.61, p=0.006). Adjusted for asthma scores recorded in each clinic before training started, the OR was 1.24 (95% CI 1.03 to 1.50, p=0.022). COPD scores in 1371 intervention group participants (77.7%, 17.9% and 4.3% with scores of 0, 1 and 2) did not differ from those in 1181 control group participants (80.5%, 15.8% and 3.7%) (OR 1.21, 95% CI 0.94 to 1.55, p=0.142). Rates of new asthma and COPD diagnoses, and hospital admission, and indicators of investigation, diagnosis and treatment of comorbid cardiovascular disease, diabetes and depression, and tobacco cessation did not differ between trial arms. CONCLUSION: PACK training increased guideline-based treatment and spirometry for asthma but did not affect COPD or comorbid conditions, or diagnosis rates. TRIAL REGISTRATION: NCT02786030 (https://clinicaltrials.gov/).

Using a mentorship model to localise the Practical Approach to Care Kit (PACK): from South Africa to Ethiopia.

The Federal Ministry of Health, Ethiopia, recognised the potential of the Practical Approach to Care Kit (PACK) programme to promote integrated, comprehensive and evidence-informed primary care as a means to achieving universal health coverage. Localisation of the PACK guide to become the 'Ethiopian Primary Health Care Clinical Guidelines' (PHCG) was spearheaded by a core team of Ethiopian policy and technical experts, mentored by the Knowledge Translation Unit, University of Cape Town. A research collaboration, ASSET (heAlth Systems StrEngThening in sub-Saharan Africa), has brought together policy-makers from the Ministry of Health and health systems researchers from Ethiopia (Addis Ababa University) and overseas partners for the PACK localisation process, and will develop, implement and evaluate health systems strengthening interventions needed for a successful scale-up of the Ethiopian PHCG. Localisation of PACK for Ethiopia included expanding the guide to include a wider range of infectious diseases and an expanded age range (from 5 to 15 years). Early feedback from front-line primary healthcare (PHC) workers is positive: the guide gives them greater confidence and is easy to understand and use. A training cascade has been initiated, with a view to implementing in 400 PHC facilities in phase 1, followed by scale-up to all 3724 health centres in Ethiopia during 2019. Monitoring and evaluation of the Ministry of Health implementation at scale will be complemented by indepth evaluation by ASSET in demonstration districts. Anticipated challenges include availability of essential medications and laboratory investigations and the need for additional training and supervisory support to deliver care for non-communicable diseases and mental health. The strong leadership from the Ministry of Health of Ethiopia combined with a productive collaboration with health systems research partners can help to ensure that Ethiopian PHCG achieves standardisation of clinical practice at the primary care level and quality healthcare for all.

The Practical Approach to Care Kit (PACK) training programme: scaling up and sustaining support for health workers to improve primary care.

There is an urgent need to depart from in-service training that relies on distance and/or intensive off-site training leading to limited staff coverage at clinical sites. This traditional approach fails to meet the challenge of improving clinical practice, especially in low-income and middle-income countries where resources are limited and disease burden high. South Africa's University of Cape Town Lung Institute Knowledge Translation Unit has developed a facility-based training strategy for implementation of its Practical Approach to Care Kit (PACK) primary care programme. The training has been taken to scale in primary care facilities throughout South Africa and has shown improvements in quality of care indicators and health outcomes along with end-user satisfaction. PACK training uses a unique approach to address the needs of frontline health workers and the health system by embedding a health intervention into everyday clinical practice at facility level. This paper describes the features of the PACK training strategy: PACK training is scaled up using a cascade model of training using educational outreach to deliver PACK to clinical teams in their health facilities in short, regular sessions. Drawing on adult education principles, PACK training empowers clinicians by using experiential and interactive learning methodologies to draw on existing clinical knowledge and experience. Learning is alternated with practice to improve the likelihood of embedding the programme into everyday clinical care delivery.

PACK Child: the development of a practical guide to extend the scope of integrated primary care for children and young adolescents.

Pioneering strategies like WHO's Integrated Management of Childhood Illness (IMCI) have resulted in substantial progress in addressing infant and child mortality. However, large inequalities exist in access to and the quality of care provided in different regions of the world. In many low-income and middle-income countries, childhood mortality remains a major concern, and the needs of children present a large burden upon primary care services. The capacity of services and quality of care offered require greater support to address these needs and extend integrated curative and preventive care, specifically, for the well child, the child with a long-term health need and the child older than 5 years, not currently included in IMCI. In response to these needs, we have developed an innovative method, based on experience with a similar approach in adults, that expands the scope and reach of integrated management and training programmes for paediatric primary care. This paper describes the development and key features of the PACK Child clinical decision support tool for the care of children up to 13 years, and lessons learnt during its development.

Strengthening the quality of paediatric primary care: protocol for the process evaluation of a health systems intervention in South Africa.

BACKGROUND: Despite significant reductions in mortality, preventable and treatable conditions remain the leading causes of death in children under five within South Africa. The WHO's Integrated Management of Childhood Illness (IMCI) programme has been widely implemented to address the most common causes of mortality in children under five. Although effective, limitations in IMCI scope and adherence have emerged. The Practical Approach to Care Kit (PACK) Child guide has been developed to expand on IMCI and address these limitations. It is intended as a clinical decision support tool for health workers with additional systems strengthening components, including active implementation and training strategy to address contextual and organisational factors hindering quality of care for children. Implementation is complex, requiring comprehensive pilot and process evaluation. The PACK Child pilot and feasibility study will sample 10 primary care facilities in the Western Cape Province. Staff will be trained to integrate the PACK Child guide into routine practice. The process evaluation will investigate implementation and health systems components to establish how to optimise delivery, strengthen IMCI principles and factors required to support effective and sustained uptake into everyday practice. METHODS: Mixed method process evaluation. Qualitative data include interviews with managers, staff, caregivers and policymakers; observations of training, consultations and clinic flow. Quantitative data include training logs and staff questionnaires. Quantitative and qualitative analysis will be integrated to describe study sites and develop explanations for implementation variation. DISCUSSION: The process evaluation will provide the opportunity to document implementation and refine the programme prior to a larger pragmatic trial or scale-up.

Using a mentorship model to localise the Practical Approach to Care Kit (PACK): from South Africa to Nigeria.

Nigeria, in its quest to strengthen its primary healthcare system, is faced with a number of challenges including a shortage of clinicians and skills. Methods are being sought to better equip primary healthcare clinicians for the clinical demands that they face. Using a mentorship model between developers in South Africa and Nigerian clinicians, the Practical Approach to Care Kit (PACK) for adult patients, a health systems strengthening programme, has been localised and piloted in 51 primary healthcare facilities in three Nigerian states. Lessons learnt from this experience include the value of this remote model of localisation for rapid localisation, the importance of early, continuous stakeholder engagement, the need expressed by Nigeria's primary healthcare clinicians for clinical guidance that is user friendly and up-to-date, a preference for the tablet version of the PACK Adult guide over hard copies and the added value of WhatsApp groups to complement the programme of face-to-face continuous learning. Introduction of the PACK programme in Nigeria prompted uptake of evidence-informed recommendations within primary healthcare services.

Using a mentorship model to localise the Practical Approach to Care Kit (PACK): from South Africa to Brazil.

Brazil's Sistema Único de Saúde, or Unified Health System policy, has delivered major improvements in health coverage and outcomes, but challenges remain, including the rise of non-communicable diseases (NCDs) and variations in quality of care across the country. Some of these challenges may be met through the adaptation and implementation of a South African primary care strategy, the Practical Approach to Care Kit (PACK). Developed by the University of Cape Town's Knowledge Translation Unit (KTU), PACK is intended for in-country adaptation by employing a mentorship model. Using this approach, the PACK Adult guide and training materials were localised for use in Florianópolis, Santa Catarina, Brazil, as part of an initiative to reform primary care, expand care for NCDs and make services more accessible and equitable. The value of the collaboration between the KTU and Florianópolis municipality is the transfer of skills and avoidance of duplication of effort involved in de-novo guide development, while ensuring that materials are locally acceptable and applicable. The collaboration has informed the development of the KTU's PACK mentorship package and led to a relationship between the groups of developers, ensuring ongoing learning and research, with the potential of assisting the further scale-up of PACK in Brazil.

Crossing borders: the PACK experience of spreading a complex health system intervention across low-income and middle-income countries.

Developing a health system intervention that helps to improve primary care in a low-income and middle-income country (LMIC) is a considerable challenge; finding ways to spread that intervention to other LMICs is another. The Practical Approach to Care Kit (PACK) programme is a complex health system intervention that has been developed and adopted as policy in South Africa to improve and standardise primary care delivery. We have successfully spread PACK to several other LMICs, including Botswana, Brazil, Nigeria and Ethiopia. This paper describes our experiences of localising and implementing PACK in these countries, and our evolving mentorship model of localisation that entails our unit providing mentorship support to an in-country team to ensure that the programme is tailored to local resource constraints, burden of disease and on-the-ground realities. The iterative nature of the model's development meant that with each country experience, we could refine both the mentorship package and the programme itself with lessons from one country applied to the next-a 'learning health system' with global reach. While not yet formally evaluated, we appear to have created a feasible model for taking our health system intervention across more borders.

The Practical Approach to Care Kit (PACK) guide: developing a clinical decision support tool to simplify, standardise and strengthen primary healthcare delivery.

For the primary health worker in a low/middle-income country (LMIC) setting, delivering quality primary care is challenging. This is often complicated by clinical guidance that is out of date, inconsistent and informed by evidence from high-income countries that ignores LMIC resource constraints and burden of disease. The Knowledge Translation Unit (KTU) of the University of Cape Town Lung Institute has developed, implemented and evaluated a health systems intervention in South Africa, and localised it to Botswana, Nigeria, Ethiopia and Brazil, that simplifies and standardises the care delivered by primary health workers while strengthening the system in which they work. At the core of this intervention, called Practical Approach to Care Kit (PACK), is a clinical decision support tool, the PACK guide. This paper describes the development of the guide over an 18-year period and explains the design features that have addressed what the patient, the clinician and the health system need from clinical guidance, and have made it, in the words of a South African primary care nurse, 'A tool for every day for every patient'. It describes the lessons learnt during the development process that the KTU now applies to further development, maintenance and in-country localisation of the guide: develop clinical decision support in context first, involve local stakeholders in all stages, leverage others' evidence databases to remain up to date and ensure content development, updating and localisation articulate with implementation.

Integrating primary care of chronic respiratory disease, cardiovascular disease and diabetes in Brazil: Practical Approach to Care Kit (PACK Brazil): study protocol for randomised controlled trials.

BACKGROUND: Multimorbidity is increasing common in Brazilian adults. Comorbid chronic lung disease, cardiovascular disease and diabetes are often inaccurately diagnosed or ineffectively treated. The Global Alliance against Chronic Respiratory Diseases (GARD) aims to strengthen health systems to prevent and control non-communicable diseases through primary health care. The Practical Approach to Care Kit (PACK Adult) is a clinical decision support tool that provides evidence-supported algorithmic guidelines for screening, diagnosis and treatment of chronic diseases, and is widely used in South Africa. It was adapted for Brazil by family physicians in the Florianopolis City Health Department, which trains clinic doctors and nurses to use it. METHODS: Effectiveness of PACK Adult training will be evaluated in two pragmatic cluster randomised trials, one enrolling adults with chronic lower respiratory diseases and the other enrolling adults with cardiovascular disease or diabetes. Forty-eight municipal clinics in Florianopolis were randomly allocated to intervention or control arms. In intervention arm clinics, doctors and nurses will receive educational outreach training and the PACK Adult clinical decision support tool. In control arm clinics, doctors and nurses will receive only the tool. Trial outcomes will be measured using patients' electronic medical records during 12 months after completion of basic training. Primary outcomes for the respiratory trial are appropriate prescribing, spirometry and diagnosis rates. Primary outcomes for the cardiovascular trial are testing for cardiovascular risk and diabetes, and systolic blood pressure. Educational outreach to primary care professionals could improve respiratory, cardiovascular and diabetes care in Brazil. TRIAL REGISTRATION: NCT02786030 and NCT02795910 (https://clinicaltrials.gov/).

e-PC101: an electronic clinical decision support tool developed in South Africa for primary care in low-income and middle-income countries.

Health technology is increasingly recognised as a feasible method of addressing health needs in low and middle-income countries (LMICs). Primary Care 101, now known as PACK (Practical Approach to Care Kit), is a printed, algorithmic, checklist-based, comprehensive clinical decision support tool. It assists clinicians with delivering evidence-based medicine for common primary care presentations and conditions. These assessment and treatment guides have been adopted widely in primary care clinics across South Africa. This paper focuses on the process of designing, developing, and implementing a digital version of the clinical decision support tool for use on a tablet computer. Lessons learnt throughout its development and pilot implementation could apply to the creation of electronic health interventions and the digitisation of clinical tools in LMICs.

Roadmap to Achieve 25% Hypertension Control in Africa by 2025.

BACKGROUND: The Pan-African Society of Cardiology (PASCAR) has identified hypertension as the highest area of priority action to reduce heart disease and stroke on the continent. OBJECTIVES: The aim of this PASCAR roadmap on hypertension was to develop practical guidance on how to implement strategies that translate existing knowledge into effective action and improve detection, treatment and control of hypertension and cardiovascular health in sub-Saharan Africa (SSA) by the year 2025. METHODS: Development of this roadmap started with the creation of a consortium of experts with leadership skills in hypertension. In 2014, experts in different fields, including physicians and nonphysicians, were invited to join. Via face-to-face meetings and teleconferences, the consortium made a situation analysis, set a goal, identified roadblocks and solutions to the management of hypertension and customized the World Heart Federation roadmap to Africa. RESULTS: Hypertension is a major crisis on the continent but very few randomized controlled trials have been conducted on its management. Also, only 25.8% of the countries have developed or adopted guidelines for management of hypertension. Other major roadblocks are either government and health-system related or health care professional or patient related. The PASCAR hypertension task force identified a 10-point action plan to be implemented by African ministries of health to achieve 25% control of hypertension in Africa by 2025. CONCLUSIONS: Hypertension affects millions of people in SSA and if left untreated, is a major cause of heart disease and stroke. Very few SSA countries have a clear hypertension policy. This PASCAR roadmap identifies practical and effective solutions that would improve detection, treatment and control of hypertension on the continent and could be implemented as is or adapted to specific national settings.

Roadmap to achieve 25% hypertension control in Africa by 2025.

BACKGROUND AND AIM: The Pan-African Society of Cardiology (PASCAR) has identified hypertension as the highest area of priority for action to reduce heart disease and stroke on the continent. The aim of this PASCAR roadmap on hypertension was to develop practical guidance on how to implement strategies that translate existing knowledge into effective action and improve detection, treatment and control of hypertension and cardiovascular health in sub-Saharan Africa (SSA) by the year 2025. METHODS: Development of this roadmap started with the creation of a consortium of experts with leadership skills in hypertension. In 2014, experts in different fields, including physicians and non-physicians, were invited to join. Via faceto-face meetings and teleconferences, the consortium made a situation analysis, set a goal, identified roadblocks and solutions to the management of hypertension and customised the World Heart Federation roadmap to Africa. RESULTS: Hypertension is a major crisis on the continent but very few randomised, controlled trials have been conducted on its management. Also, only 25.8% of the countries have developed or adopted guidelines for the management of hypertension. Other major roadblocks are either government and health-system related or healthcare professional or patient related. The PASCAR hypertension task force identified a 10-point action plan to be implemented by African ministries of health to achieve 25% control of hypertension in Africa by 2025. CONCLUSIONS: Hypertension affects millions of people in SSA and if left untreated, is a major cause of heart disease and stroke. Very few SSA countries have a clear hypertension policy. This PASCAR roadmap identifies practical and effective solutions that would improve detection, treatment and control of hypertension on the continent and could be implemented as is or adapted to specific national settings.

Educational Outreach with an Integrated Clinical Tool for Nurse-Led Non-communicable Chronic Disease Management in Primary Care in South Africa: A Pragmatic Cluster Randomised Controlled Trial.

BACKGROUND: In many low-income countries, care for patients with non-communicable diseases (NCDs) and mental health conditions is provided by nurses. The benefits of nurse substitution and supplementation in NCD care in high-income settings are well recognised, but evidence from low- and middle-income countries is limited. Primary Care 101 (PC101) is a programme designed to support and expand nurses' role in NCD care, comprising educational outreach to nurses and a clinical management tool with enhanced prescribing provisions. We evaluated the effect of the programme on primary care nurses' capacity to manage NCDs. METHODS AND FINDINGS: In a cluster randomised controlled trial design, 38 public sector primary care clinics in the Western Cape Province, South Africa, were randomised. Nurses in the intervention clinics were trained to use the PC101 management tool during educational outreach sessions delivered by health department trainers and were authorised to prescribe an expanded range of drugs for several NCDs. Control clinics continued use of the Practical Approach to Lung Health and HIV/AIDS in South Africa (PALSA PLUS) management tool and usual training. Patients attending these clinics with one or more of hypertension (3,227), diabetes (1,842), chronic respiratory disease (1,157) or who screened positive for depression (2,466), totalling 4,393 patients, were enrolled between 28 March 2011 and 10 November 2011. Primary outcomes were treatment intensification in the hypertension, diabetes, and chronic respiratory disease cohorts, defined as the proportion of patients in whom treatment was escalated during follow-up over 14 mo, and case detection in the depression cohort. Primary outcome data were analysed for 2,110 (97%) intervention and 2,170 (97%) control group patients. Treatment intensification rates in intervention clinics were not superior to those in the control clinics (hypertension: 44% in the intervention group versus 40% in the control group, risk ratio [RR] 1.08 [95% CI 0.94 to 1.24; p = 0.252]; diabetes: 57% versus 50%, RR 1.10 [0.97 to 1.24; p = 0.126]; chronic respiratory disease: 14% versus 12%, RR 1.08 [0.75 to 1.55; p = 0.674]), nor was case detection of depression (18% versus 24%, RR 0.76 [0.53 to 1.10; p = 0.142]). No adverse effects of the nurses' expanded scope of practice were observed. Limitations of the study include dependence on self-reported diagnoses for inclusion in the patient cohorts, limited data on uptake of PC101 by users, reliance on process outcomes, and insufficient resources to measure important health outcomes, such as HbA1c, at follow-up. CONCLUSIONS: Educational outreach to primary care nurses to train them in the use of a management tool involving an expanded role in managing NCDs was feasible and safe but was not associated with treatment intensification or improved case detection for index diseases. This notwithstanding, the intervention, with adjustments to improve its effectiveness, has been adopted for implementation in primary care clinics throughout South Africa. TRIAL REGISTRATION: The trial is registered with Current Controlled Trials (ISRCTN20283604).

Innovating to improve primary care in less developed countries: towards a global model.

One of the biggest problems in global health is the lack of well trained and supported health workers in less developed settings. In many rural areas there are no physicians, and it is important to find ways to support and empower nurses and other health workers. The Knowledge Translation Unit of the University of Cape Town Lung Institute has spent 14 years developing a series of innovative packages to support and empower nurses and other health workers. PACK (Practical Approach to Care Kit) Adult comprises policy-based and evidence-informed guidelines; onsite, team and case-based training; non-physician prescribing; and a cascade system of scaling up. A series of randomised trials has shown the effectiveness of the packages, and methods are now being developed to respond cost-effectively and sustainably to global demand for implementing PACK Adult. Global health would probably benefit from less time and money spent developing new innovations and more spent on finding ways to spread those we already have.

Task shifting of antiretroviral treatment from doctors to primary-care nurses in South Africa (STRETCH): a pragmatic, parallel, cluster-randomised trial.

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.