Health systems implications of the 2013 WHO consolidated antiretroviral guidelines and strategies for successful implementation

Abstract

Introduction To successfully implement the 2013 WHO consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection at country level, the implications for national and regional health systems need to be considered and addressed. The guidelines target the entire continuum of care for the HIV-infected individual, and in some cases, their partners, and those with unknown status. The guidelines include not only a more inclusive treatment initiation threshold of CD4+ T-cell count of 500 cells/μl or less for adults and adolescents, treatment for life for pregnant and breastfeeding women (or treatment for the duration of pregnancy and breastfeeding regardless of CD4+ T-cell count), treatment regardless of CD4+ T-cell count for children under 5 years of age, discordant couples, those co-infected with either tuberculosis (TB) or severe hepatitis B virus (HBV), and diversification of effective strategies to reach those with unknown status through couples testing and community-based testing. These changes, if fully enacted, will lead to an increase in treatment eligibility of over 60%, from 17.6 million globally, to 28.6 million globally, with variation in that increase by epidemic type and other epidemiologic factors [1]. However, within these increases in volume, health systems will be serving a healthier mix of patients starting antiretroviral therapy (ART), and greater proportions of pregnant women and children, and sexual partners seeking care together. The increased patient volumes and changes in the composition of those seeking care will require rapid attention to existing care delivery strategies in order to ensure that newly diagnosed individuals are served with the maximum efficiency and effectiveness, and others entering or already within the system under existing guidelines are not harmed. Additionally, to be successful over the long term, health systems and HIV programs will need strengthened adherence-support strategies. Systems of care that may already be stressed need to be further augmented through innovations, and in many cases provided with additional resources in order to become more efficient, resilient, robust and effective. The ‘Operations’ and ‘Service delivery’ sections (Chapter 9) of the guidelines address these challenges through recommendations for innovations in the models of service delivery, laboratory diagnostics and treatment delivery in the form of fixed-dose combinations (FDCs) to improve the efficiency, reach and quality of the prevention, care and treatment cascade. There are also potential gains from implementing the guidelines that could accrue to and strengthen health systems and communities, such as a healthier and more productive workforce and fewer new HIV infections, especially in newborns, and HIV-related hospitalizations, and these benefits must also be factored into HIV program and country-level decision-making surrounding adoption and adaptation of the new guidelines [2]. Our objective was to examine the implications of the new guidelines across the continuum of care for each of the elements of national health systems, starting with governance and the role of strategic planning and policy, and including diversification of service delivery models, generation and use of data, healthcare financing, human resource capacity, and supply chains for therapeutic and diagnostic commodities. Governance, strategic planning and policy The progress of discovery and change in the HIV epidemic have demanded a high degree of engagement with evolving evidence, as reflected in part by the 10 guidance documents on antiretroviral drug use issued by WHO since 2000. To date, national governments, with the support of civil society and cooperative partners, have employed a variety of approaches to new guideline adoption. Whereas earlier approaches often focused largely on clinical issues, there is now a need for much broader adoption processes to consider the complex interplay between clinical objectives, operational feasibility, issues related to equity, affordability and health systems capacity. In order to consider, adopt and implement new national guidelines with a broad coalition of support, Ministries of Health must take a strong leadership and governance role. When performed well, the key elements of the process at national level include the following: An inclusive and transparent consultative process that draws upon the best available resources, including program experts and managers, healthcare providers, civil society including people living with HIV, community and faith-based groups, key populations, technical specialists, other relevant government Ministries (e.g. Finance), budget experts and economists, researchers, academics, and health-related professional associations. Assembly, analysis and presentation of relevant clinical, programmatic and financial information. Consideration of guidelines changes in light of broader strategic policy frameworks cross-cutting a broader array of health, human rights and development issues. Clear decision-making mechanisms that allow consideration of competing demands. Clear articulation of roles and responsibility of various partners, in order to ensure accountability and oversight of the processes of change. Ensuring that the case for health in national development, including the potential benefits and risks of potential guidelines changes, is clearly communicated early and often to political leadership and external development partners. The recent process of developing and adopting new guidelines for antiretroviral drug use in pregnant and breastfeeding women in Zambia provides an instructive example of the range of activities needed to ensure that guidelines changes are made with broad stakeholder and health systems support (Fig. 1) [3,4]. National governments and civil society are encouraged to learn lessons from peers, and to participate in WHO's regional guidelines dissemination workshops that are designed to support strong national processes of guidelines change.Fig. 1: The process of changing prevention of mother-to-child transmission (PMTCT) guidelines in Zambia.Diversification and integration of service delivery models to manage patient volumes and improve retention and quality The expansion of HIV testing, care and eligibility for ART will require national governments and partners to consider how best to augment or modify their current health systems to accommodate increased volumes and new categories of patients, and to ensure retention across the care and treatment cascade. There is currently an over-reliance on a limited number service delivery models in many countries. Maximum expansion capacity and quality can be achieved by ensuring that a carefully selected variety of models are put in place and adapted strategically to take account of geography, epidemiology and local needs. Thus, it is an opportune time for governments and funders to focus on previously piloted models that are appropriate for scale-up, and to ensure that the most effective models are scaled up systematically in order to provide substantial complementary capacity to absorb new patients and provide ongoing care. Within the new guidelines, there is an increased emphasis on the importance of expanded national HIV testing and counseling strategies in order to identify ‘as many people living with HIV as early as possible after acquiring HIV infection, and link them appropriately and in a timely manner to prevention, care and treatment services’. The reality of most HIV-testing programs in most generalized epidemics is that they have been largely dominated by provider-initiated testing (most typically healthcare provider-initiated), which has been favored because of the ease of linkage to services and for its high yield and cost-effectiveness. However, it often identifies people living with HIV late in the course of HIV disease, in particular, men and adolescents, as well as key populations, who have low utilization of healthcare services. With the guidelines’ strong recommendation for community-based HIV testing and counseling with linkage to prevention, care and treatment services, governments should consider systematically expanding a number of approaches tailored for their settings, including mobile, door-to-door, index, campaign, workplace and school-based HIV testing and counseling approaches, and other strategies that ensure the inclusion of underserved groups such as children, adolescents and men. It is also important to recognize that the yield of nonclinic-based testing can be lower and more expensive from a human resource perspective, requiring a careful balance to be struck. For concentrated and low-level epidemics, governments are urged to consider guidelines that reflect WHO's strong recommendation to increase the number and diversity of the facilities in which provider-initiated testing and counseling are available, including sexually transmitted infection clinics, hepatitis and TB sites, antenatal care settings and services for key populations, notably MSM, transgender people, sex workers and people who inject drugs (Fig. 2) [5].Fig. 2: Innovative service delivery models to increase diagnosis and early antiretroviral therapy (ART) initiation among key populations in Indonesia.The capacity of national health systems to absorb the greater numbers of healthier, pregnant and individuals accompanied by partners eligible for treatment will be directly related to the extent to which ART sites are diversified, decentralized (and in some cases integrated into primary care services) and generally expanded. Extending care through different models will also relieve traditional ART sites and higher-level facilities and allow a greater focus on the sickest patients, especially in high-burden generalized epidemics. Models for consideration and rapid scale-up include ART initiation and maintenance for mothers and children in high HIV-prevalence settings integrated into antenatal care, and maternal and child health clinics, and for HIV/TB co-infected individuals into TB clinics, and other approaches that reduce the need of patients to come to clinics through community-based treatment clubs with rotating antiretroviral drug pick-up and home delivery, especially in remote rural areas. A systematic review on the impact of decentralization of ART delivery identified evidence from both randomized controlled trials and observational studies, and found that patients initiated at a hospital and maintained at a health center were more likely to be retained [6]. No difference in attrition was observed between those initiated and maintained on ART at a hospital compared to at a health center. Comparable attrition was observed after 12 months in the two trials in which ART maintenance was in the community [6]. Regions with measurable injection drug use may also consider the new strong recommendation for ART initiation integrated into clinics and sites in which opioid substitution therapy (OST) is provided. In areas with strong general outpatient services, integration of HIV services may yield greater equity with other health services, and may more directly enable HIV's chronic care models to benefit care and management responses to other chronic diseases such as diabetes and hypertension. These integrated sites must also be capacitated with on-site laboratories and referrals with a rapid turnaround for results reporting, especially for viral load, CD4+ T-cell count testing, TB testing and safety laboratories. Tiered laboratory systems must work closely with program leadership to ensure strategic investments in the best technologies for sites providing ART. Intentional analyses should be conducted to balance the convenience of point-of-care (e.g. CD4+ T-cell testing) technologies with the use of centralized high-throughput instruments. With anticipated rapid expansion of demand for viral load testing, it is essential to use internationally acceptable methods to locally validate the use of dry blood spots, as a means of viral load testing, which will allow expansion of this capacity without phlebotomy and cold chain capacity – the imminent availability of point-of-care viral load testing will also strengthen the health system's ability to provide good quality care. It is also critical to close the loop with results reporting via short message service or other secure electronic communication. Existing and new models also need to be chosen in order to intentionally retain patients in care and treatment, and ensure adherence to ART. Structural interventions such as increasing access points and decentralization through community-based models can address some of the most commonly cited reasons for disengagement with care (e.g. transport expenses, overcrowding of vertical sites). At an individual level, substantial evidence has demonstrated the benefits of two-way mobile phone text message systems, and WHO has made a strong recommendation for consideration of this approach [7]. As with numerous other proven methodologies, very few countries have systematically evaluated the needs of various vulnerable groups such as pregnant women, adolescents, key populations and healthy individuals starting ART and systematically taken appropriate packages of cost-effective adherence and retention interventions from the pilot phase, to scale. Generation and use of data for monitoring, evaluation, efficiency and quality improvement National and regional health systems of program monitoring and evaluation are fundamental to public health approaches to HIV prevention, care and treatment, and other chronic illnesses. When they work well, systems of measurement serve to provide actionable data for decision-making, starting with the clinician and service delivery sites, to regional and national program managers, related sectors (e.g. Ministries of Finance), and development partners [8]. Although the HIV response has focused substantial investments on monitoring and evaluation, the nature of the emergency response combined with weak health systems and the sheer volume of chronically ill patients have resulted in greater than expected challenges for many national systems. These challenges have been highlighted in recent studies demonstrating serious gaps in the ability of these systems to report on indicators that meaningfully measure program quality, and a lack of consistent data use at the site and regional levels to improve program quality [9]. With the influx of individuals seeking testing and care, and through sites and models not traditionally reporting on ART use (e.g. community-based antiretroviral drug pick-up and antenatal care sites), there are actions that must be taken coincident with guidelines adoption to ensure effective monitoring and evaluation of program quality. National governments and supportive cooperative partners must redouble efforts to harmonize and strengthen platforms for the use of data at levels of the health system to ensure that guidelines changes are as expected and that quality of care and patient are not models include or by the of health and development partners their implementing to review care and treatment at the and local These processes should be to and quality improvement processes that ensure clinical sites review their on critical elements of the care and treatment and have to to to quality and access to technical as on data use also to attention on the volume and of indicators and the systems that data A of potential indicators over the years has in some cases attention from those indicators considered at regional and national and countries are encouraged to their most critical indicators with the and ensure in the WHO's early indicators for HIV drug system of key indicators designed to quality improvement of ART services at level, with for and of the results for program management National governments and development partners also need to ensure systems are to allow reporting and use of the There are numerous and systems in few are fully integrated across the of care and treatment and at a national WHO is with numerous countries to improve integration of systems the Systems for HIV a of and guidelines to countries and implement a system that patient and and the impact in an integrated across maternal and child health of mother-to-child transmission and In WHO will consolidated strategic guidance that will a of indicators across the continuum of prevention, treatment and these will the key of quality HIV With this HIV program will have access to the critical indicators within with other When data are not to and important areas of the other methods may be including use of to more on critical issues that can with program quality, and traditional indicators and studies to the of critical program changes (e.g. studies of pregnant women starting ART CD4+ T-cell count of models and efficiency The HIV response ongoing and attention to to ensure the availability of for effective and with the Although the new guidelines will have much greater impact on health and of new and have the potential to reduce the of their are [1]. Ministries of Health and have critical challenges with new guideline to the and financial of potential guidelines changes in order to with local planning and to secure to support ongoing and changes to and to ensure the use of available of the of potential guidelines changes can be a variety of models, and some countries have been these of for As in of the guidelines, the of models is of the most commonly and its and resource needs models can be to the impact of guidelines changes on number of number of infections, and the of changing guidelines or approaches in a variety of epidemic models include the Health and models by the Health and for each with various and potential are encouraged to consider that is only as good as its ease of level of support, and attention must be in to ensuring the of local programmatic and Although has the of for the HIV response over the 10 years of the response in many low and some national governments have to increase their The ability of the in low and countries to further support the HIV and broader health response will be especially if traditional to These new guidelines a case for changing the course of the HIV and further resource may be by the of (e.g. more in antiretroviral drugs in the may reduce HIV that are less at for These may also be in the of such as the for Health and as for development of national that have the potential to provide a more for the HIV response and general health The has a to with to increase for methods for the efficiency by which the healthcare system resources to key and will also to and further resource For to the range of to provide ART to an individual, or provide an HIV testing and counseling by or of and for activities partners have made investments in developing these methods over recent and national governments are encouraged to to and resource use as the new guidelines are Ensuring human resource capacity to support evolving service delivery models of to the range of services to quality healthcare are a chronic in many countries. in many low and with of patients, are in some cases by only clinical and to long and for patients and a lack of attention to quality the new guidelines have many of the HIV interventions (e.g. a available in for HIV-infected and a focus on ensuring patients ART they HIV-related illnesses. 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