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Use the link below to share a full-text version of this article with your friends and colleagues. Learn more. The delivery of HIV care in the initial rapid scale-up of HIV care and treatment was based on existing clinic-based models, which are common in highly resourced settings and largely undifferentiated for individual needs. A new framework for treatment based on variable intensities of care tailored to the specific needs of different groups of individuals across the cascade of care is proposed here. Service intensity is characterised by four delivery components: i types of services delivered, ii location of service delivery, iii provider of health services and iv frequency of health services.

How these components are developed into a service delivery framework will vary across countries and populations, with the intention being to improve acceptability and care outcomes. The goal of getting more people on treatment before they become ill will necessitate innovative models of delivering both testing and care. To take the framework to scale, it will be important to: i define which individuals can be served by an alternative delivery framework; ii strengthen health systems that support decentralisation, integration and task shifting; iii make the supply chain more robust; and iv invest in data systems for patient tracking and for programme monitoring and evaluation.

The widespread devastation caused by the HIV pandemic has led to unprecedented increases in overseas development aid for health, much of it earmarked for care and treatment-related services in low- and middle-income countries 2. The magnitude of HIV funding allowed for rapid strengthening of under-resourced health systems unaccustomed to providing chronic care and enabled the successful expansion of care and treatment services that have averted an estimated 5.

Further expansion of the emergency scale-up, as currently constituted, is constrained by the donor funding environment 56and subsequent increases in donor resources are unlikely. A sequel of this success story, however, is that health systems have become even more overburdened. The models of delivery for HIV care developed for the initial rapid scale-up of HIV services were based on traditional clinic-based service models, common in highly resourced settings, and largely not modified to reflect individual needs.

Even as the of people on ART has grown to almost 12 million in low- and middle-income countries, protocols for frequent clinic follow-up have been perpetuated with very few changes, regardless of how long an individual has been on antiretroviral treatment ART or their clinical status. After the early rapid growth in clinic sites, expansion has slowed and ever-growing s of people receive care in clinics often with insufficient s of doctors, clinical officers and nurses 7. As a result of traditional care models, HIV clinics are crowded and waiting times are long with many people waiting solely to pick up drug refills.

Healthcare workers are overtaxed due to this high workload and, due to weak infrastructure, face challenges to provide care and follow-up according to the guidelines on which they have been trained. These challenges have led to a mixed picture of effectiveness among the HIV care and treatment systems.

On the one hand, individuals who have been linked to care and retained on ART achieve high rates of viral suppression 8 - However, studies report substantial loss to follow-up across all steps of the care cascade 6 Overburdened health systems, lack of patient-focused services, resource limitations and mixed quality of care have led to efforts to modify the delivery of HIV care in a framework that addresses the causes of poor retention.

Task shifting is one of the most common approaches WHO has included task shifting in the Consolidated Guidelines as a way of providing care to a greater of people at reduced cost or when there are insufficient healthcare workers in the public sector Other programmes have focused on decentralisation, shifting care to primary health clinics and to the communities in which people live We describe a delivery framework which provides differential care and treatment services for specific, well-defined groups of people in an effort to improve service quality and access, adherence and retention, outcomes, efficiency, and cost of services.

Problem statements 1. Driven by a desire to provide care which people will use and to increase the efficiency and effectiveness of HIV care delivery, this framework aims to vary the intensity of both ART and pre-ART care based on individual need and to create more flexible, convenient and acceptable models of service delivery for patients, healthcare workers and health systems.

In simple terms, the framework describes delivery of the right care at the right frequency to the right individuals by the right care providers in the right location at the right time. Although this concept is not new, it has not been extensively used by HIV care and treatment programmes in low- and middle-income countries to date.

The framework involves providing differential intensity of care and treatment services across defined patient strata. Service intensity is characterised by four components, all centred on the needs of individuals: i types of services delivered; ii location of service delivery; iii provider of health services; and iv frequency of health services Figure 1.

Each of these components represents a flexible lever for adjusting or modifying a model of care to serve a specific patient stratum in a given geographic or health system setting. How the framework is implemented will vary across countries and populations to best serve the needs of individuals. Similarly, individual eligibility criteria will vary by heath setting, with the intention being to improve patient acceptability and care outcomes.

Different intensities of service can be delivered within a single location or between locations. Distribution of individuals into strata for optimised care is determined by the needs and preferences as defined by specific characteristics Table 1. The distribution of individuals across care strata is dynamic due to the need for periodic up-referral or down-referral to more or less intensive care based on their current needs. Models of care can be organised into three based on the location at which people receive services. Centralised, facility-based models can provide differential care within a single health facility, such as reduced frequency of visits or substitution of a clinical assessment visit by a pharmacy-only medication refill visit.

Decentralised models of care provide pre-ART and ART services either by down-referring stable people or initiating and managing people at more peripheral health facilities 15 Other models decentralise care even further by providing care directly in the community or in the home Figure 2. There are critical enabling services that are levers for successful HIV health delivery regardless of location, intensity, and frequency of care and who delivers that care.

The need for psycho-social support, transportation, child care, nutrition, legal and other services may be as important as how long people wait in clinic. Application of individual elements of this care framework, notably decentralisation and task shifting, has increased ificantly during the past few years and has been widely endorsed by the WHO and other agencies. While not a systematic review, the examples presented in Appendix 1 illustrate the key dynamics and outcomes of innovative models of care in the real world.

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See Appendix 1 for a detailed listing of studies and. All of the models analysed differentiated individuals on the basis of clinical stability on treatment to determine eligibility for an alternative framework of care. One study examined the cost-effectiveness of the centralised, facility-based model in an urban HIV clinic This programme enrolled people stable on ART to receive 6-monthly clinical appointments with nurses and 3-monthly drug refill visits. Between January and mid, adults were enrolled in SMA. Reasons for SMA discontinuation and long-term treatment outcomes are being evaluated A of studies evaluated the impact of a decentralised, facility-based model in which stable individuals were down-referred from the HIV clinic where care was generally provided by a doctor or clinical officer to a primary care health centre where the care was generally provided by a nurse.

Among the 39 individuals included in a meta-analysis of this approach, loss to follow-up per patient years was 7. At the Themba Lethu Clinic in Johannesburg, South Africa, stable individuals were down-referred to nurse-managed primary care clinics for treatment maintenance rather than being maintained at the HIV clinic 19 - More than individuals were down-referred as ofand a matched cohort analysis found that down-referred people were less likely to die HR 0. Similar care models have been introduced in rural areas of South Africa with similar outcomes A of different approaches have decentralised care to the community or to the home.

These models minimise the of required clinic visits by utilising community health workers or peers to deliver care or treatment either at home or at a community meeting point. The community health workers ranged in education and training, and the qualifications and pay for community healthcare workers varied throughout the models. Some models used volunteers with few education requirements 22while others recruited paid staff with college degrees One model provided decision support tools to the community health workers Two models used groups of people living with HIV PLHIV 2526while others used community health workers to deliver medication directly to the house 222427 or distributed treatments in community meeting points All models reported reduced loss to follow-up and reduced of clinic visits among patients managed in the community or at home.

One decentralised model is of particular interest in urban, high-density areas due to the degree it has been scaled and evaluated.

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In the Western Cape of South Africa, MSF, driven by the need to provide better patient-centred care and to decongest over crowded HIV clinics, developed a model in which care, including ART drug refills, is provided either at the clinic or in community venues in a group setting These groups, referred to as ART adherence clubs, are facilitated by a community healthcare worker.

While there is selection bias as those eligible for club care are, by definition, stable and adherent, adherence and retention have remained high despite a reduction in clinic visits. This model has been adopted by the Metro District Health Services 1 1 Metro District Health Services provides comprehensive primary health service, mainly to lower income groups in the Cape Town metropolitan region.

Roll-out of the same care model has commenced in some districts in Gauteng and Free State provinces, while Swaziland is likely to implement the model in CAGs are groups of six individuals from which one rotating person in the group acts as the monthly ART collector for all members. Thus, each CAG member visits the clinic every 6 months. Retention at 12, 24, 36 and 48 months, respectively, has been The field of research on alternative delivery frameworks is nascent, and a of important questions remain.

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The articles we found did not discuss the impact on people who remained in standard clinic care or the impact on care providers. Only two studies were randomised, and most were retrospective cohort studies. While models have been implemented in a of countries, 6 of the 16 models and approximately 48 of the 68 people who were delivered care in this framework were in South Africa, often in urban settings.

A model that is effective in urban South Africa, where resources and infrastructure are generally better, may not be reproducible with similar in more resource-limited settings, such as Malawi, Mozambique, Zambia or even rural South Africa. Challenges to implementing this framework include defining the most appropriate selection criteria for reduced intensity or non-clinic care, national and local regulatory and policy frameworks around reduced intensity of services, supply chain management and data systems for patient tracking and programme monitoring and evaluation.

Each country has their own regulatory frameworks that establish the scope of work for each cadre of healthcare worker. Further, regulations stipulate the frequency at which medications may be dispensed.

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These regulations ificantly impact the ability to decentralise or temporally space care. For example, ARV dispensing for individual patients in Western Cape was maintained centrally at pharmacy level, while distribution of pre-packed and labelled ART was permitted at lower level facilities and through community-based adherence clubs. Supply chains and stock management must be sufficiently robust to ensure stable ART distribution for decentralised primary health centres and community-delivered ART along with longer durations of refills ideally three monthly.

Robust data systems are necessary to track individuals across care sites as well as monitor overall programme effectiveness, in particular to ensure that retention in care can be tracked as patients move between care facilities or settings.

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Community-delivered ART requires simple and robust data collection. Unique identifiers, referral tools and data management systems are needed. We believe this framework can guide policymakers into introducing and scaling up new approaches to delivery across the HIV cascade of care.

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The framework is driven by two needs: first, care that better meets the needs of people and assisting them to access care and remain in care for life; second, with donor funding for HIV expected to remain constant or decline in the coming years, this framework may provide a tool to provide this care more economically.

The cost and cost-effectiveness of innovative models delivery of care needs further evaluation. The framework, with its levers and patient-centredness, addresses the losses described by others across the cascade of testing, linkage and retention in care 6. Differentiated testing and linking strategies using new testing technologies such as oral self-test may hold promise in helping hard-to-reach populations know their HIV status 28 - Scale-up of innovative models of care should be monitored and evaluated through a robust implementation science framework targeting critical questions about most effective and efficient approaches to providing care in varied settings.

As best practices are identified, normative bodies and lead implementers should continue to develop toolkits 2 2 MSF has already developed a toolkit for the Khayelitsha ART adherence clubs and a toolkit for the CAGs. Monthly pickup of medication at pharmacy, where routine screening is completed. SOC is monthly visit to clinic with physician. Free State, South Africa In one cohort top row ART initiation and management was completed in nurse-led primary care clinic.

In the other cohort bottom row ART management provided in nurse-led primary care clinic. South Africa 3Malawi 1Swaziland 1Thailand 1 Partial decentralisation — treatment initiation in a hospital with follow-up care provided by a health centre. Note: these amounts are for month follow-up of four of six studies.

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