Introduction

The fight against AIDS was set out as a global commitment by the United Nations (UN) Millennium Declaration and in the landmark UN Declaration of Commitment on HIV/AIDS (2001) which recognizes “that access to medication in the context of pandemics such as HIV/AIDS is one of the fundamental elements to achieve…” the realization of the right to health^1,2. In 2006, UN Members move towards Universal Access to HIV prevention, treatment and care by 2010. By the end of 2011, around eight million (54%) eligible people living with HIV (PLHIV) were receiving antiretroviral therapy (ART) in low and middle-income countries (LMIC). As a consequence, AIDS-related illnesses and mortality dropped by more than 50%. The 2011 UN High Level Meeting reaffirms previous commitments and establishes, inter alia, the target of treating 15 million PLHIV by 2015³.

Despite major advances and successes achieved in the last ten years, problems related with access to antiretroviral medicines (ARV) still persist and tend to increase in many developing countries: the maintenance and expansion of long-term financing; reducing early mortality by promptly starting ART and other medications against co-morbidities; implementation of novel 2010 WHO guidelines, which are more comprehensive and include costlier medicines in early treatment stages; improving the management of long-term treatment, which includes access to viral load tests needed for better clinical assessment and progression to second and third-line regimens⁴.

Although ARV prices have been decreasing over time^5-7, population treatment-associated expenses are steeper each year, especially in face of new and costly medicines incorporated in treatment guidelines, most of which present very limited competition or none at all⁸. According to Hoen et al.⁸ the “policy space to produce or import generic versions (…) is shrinking” in developing countries, due to patent regimen pressures.

Provision of antiretroviral medicines includes procurement, supply chains, and operational and information systems, in order to ensure high quality services. Upscaling AIDS care and prevention is a complex and dynamic process that depends upon countries’ capacity to adopt new interventions and assess interactions among the interventions’ key components as well as between programs and health systems⁹.

This transition from emergency AIDS response to long-term response of large treatment cohorts requires health systems strengthening⁹ and regular access to ART⁵. Sustainability of ART provision has been pointed out as a major concern^9-12.

Schell et al.¹³ point out that a minority of sustainability studies makes attempts at conceptualizing sustainability and at developing assessment tools accordingly. Stirman et al.¹⁴ argue that the absence of a working definition of sustainability and of guidance by an explicit theoretical model is an important limitation to the body of research. Scheirer¹⁵ suggests that the use of conceptual frameworks¹⁶, as well as in-depth assessments on program implementation, could help overcome limitations in sustainability studies.

The objective of this study was to challenge a conceptual framework applied to assess ARV provision sustainability in Peru, Bolivia and Mozambique.

Methodology

Results

Discussion

The main goal of this study was to challenge a sustainability assessment framework, which involved the identification and hierarchization of key conceptual elements, the building of an operational definition of sustainability, and the translation of those theoretical developments into assessment tools. Guidance by an explicit theoretical framework, adoption of clear working definitions, and use of adequate coherent-to-theory tools are pointed out as critical to further develop sustainability research and evaluation^13-15.

The choice for research strategy and the selection of factors to be investigated should be determined by the type of intervention. Scheirer¹⁵ proposes six different intervention types, including Interventions Requiring Coordination Among Multiple Staff. Aspects pertaining to the sustainability of this type of intervention comprise: administrative support; the role of program champions; culture and mission compatibility between the intervention and the organization; consonance of specific tasks related to the intervention with other organizational procedures; and continuity of financial resources. This type of intervention as well as the above-mentioned aspects may be recognized in Pluye’s proposal²⁴.

Our study’s object was ARV provision, an intervention that requires coordination between multiple organizations, stakeholders, staff etc. As such, our choice of Pluye’s proposal as a reference for building our framework is also supported by Sheirer’s analysis.

The multiple components involved in ARV provision may or may not be recurrent in different scenarios over time. The three countries in which provision was studied presented different income levels, different health system structure, very different levels of HIV prevalence, different forms of organizing HIV/AIDS initiatives, and therefore of ARV provision^3,30-34.

This variability hinders the use of classic theory-driven evaluation standardized logic models for programs^16,35,36. We preferred to adopt the idea that the program is “a set of resources and activities directed toward one or more common goals”¹⁸, the goal in this case being ARV provision. Furthermore, such variability also requires the need for an appropriate data collection approach¹⁵. We believe that in focusing on program history²⁴ we were able to better grasp and understand differing internal developments, rather than using a one-fits-all logic model.

In a literature review on the sustainability of new programs and innovations, which included 125 health related studies, Stirman et al.¹⁴ point out that the majority of studies neither explore the nature and reasons for changes, nor the process by which adaptations and key decisions are made. By focusing on critical events that build program history, this approach specifically searches for patterns of change, their reasons – identified through key-stakeholders’ perspectives – and aim at analyzing underlying processes that help to explain program development and trends, i.e. process tracing²⁵.

By assuming implementation as a general process we strove not only to open interventions’ black boxes^15,16,18,36, but also to analyze which program components and processes of change had in fact been mobilized^37,38. By the adoption of Pluye’s focus on organizational routines³⁹, we were able to assess whether or not program pathways were put in place in a manner that favored program continuation, i.e. building program capacity for sustainability^13,17.

The framework also inserts sustainability-related conceptual events – implementation and routinization events²⁴ – into an identifiable interface, which can be more easily perceived at data collection.

The interview process stimulated key informants to retell program history emphasizing each of the four dimensions: Program Resources; Activities; Reinforcement Strategies; and, Context and Organizational Culture. By revisiting their own narratives, informants were able to detail events and reflect upon the way in which context shaped program history. This strategy was enhanced by confrontation with the supplied documentation. As such we were able to detect a considerable number of critical events in each country, which in turn led to greater data consistency and internal validity. Moreover, the detection of more events enhanced the potential to explain sustainability in different scenarios. The exhaustive nature of the framework helped overcome the relative difficulty to identify critical events reported by Pluye²⁴.

Informant selection was based on the best possible information retrieval when process tracing is required⁴⁰. The key process being traced was the carrying out of activities and flow of resources aimed at ARV provision, i.e. the implementation of ARV provision. Key informants were, or had been, very much involved in ARV provision with central participation in program history.

The framework allowed us to observe the differing trends towards resource sustainability. In Bolivia, the dependence on external grants and various changes in program coordination may have resulted in lack of access to ARVs⁴¹. These aspects show insufficient investment and lack of resources stability. In Mozambique, heavy dependence on foreign aid⁴² put resource stability at risk. Notwithstanding, government agents planned an increase in treatment numbers over the years, avoiding large leaps, which in turn has favored continuity in mobilization of resources from external donors⁴³. In five years (2008-2013) coverage has doubled^41,44,45. The involvement of the Clinton Health Access Initiative (CHAI) has been tantamount in helping to better ARV provision, by more efficient procurement schemes, resulting in better resource investment. Initiatives in continuous training of health professionals illustrate constant investment in human resources. In Peru a gradual but constant increase in ARV coverage was observed⁴⁵, and this was associated with a progressive scaling-up of resource investment over the years⁴⁶. Also, changes in employment contract schemes and the building of autonomous ARV financing have resulted in greater stability of government staff and of flow of resources^46,47.

Low-income countries are more prone to rely on donations and international aid^19,42. It is noteworthy that even though the dependence of external aid means a risk to resource stability⁴, the classical teach a man to fish doctrine of external donor aid¹⁹ has suffered severe criticism^42,48 and seems to be changing⁴³. The GFATM has adhered to “a new form of sustainability that relies on a combination of domestic resources and predictable, open-ended foreign assistance”⁴³. The increase in demand for all aspects of HIV/AIDS care is bound to produce greater competition for international funds⁴.

The existence of external agents involved in ARV provision in Bolivia indicates that the activities required for ARV provision were not compatible with the MoH activities. Many changes in management of ARV provision throughout the years indicate successive activity failures. A 2012 UNDP audit of GFATM grants reports persisting difficulties in cooperation and coordination and partial compliance to procurement and supply management of health products⁴⁹. Initially, the introduction of ARV purchases into Mozambican MoH procurement organizations didn’t change their activity profile (compatibility). In spite of changes in procurement responsibilities, observed continuity in work processes showed successful adaptation of activities. Provincial storage and distribution systems failed to adapt to rapid expansion and decentralization of treatment coverage⁵⁰. In Peru, no adaptation of activities seemed to be necessary. Organizations involved in ARV provision had been working in partnership and kept true to their original activities profiles, indicating compatibility⁵¹.

In Bolivia, risk taking procedures were established by new activities regarding customs clearance, which were enforced by means of new legislation⁵². In Mozambique, integration of rules may be perceived by heavily centralized treatment standards and guidelines. Health professionals perceived the recruitment policies enforced by the government as incentives. This was considered an important strategy to overcome a health workforce gap in Mozambique⁵³. These incentives were abandoned in 2008 when Day Hospitals were discontinued. From that time on, the government took risks by integrating HIV/AIDS and Primary Health Care. Pfeiffer et al.³², defend this step as a positive measure to enhance all aspects of HIV AIDS care and ARV provision.

In Peru, an adequate level of communication was achieved by cooperation between MoH and other organizations involved in ARV provision⁵¹. Career benefits worked as incentives, fostering program routines. Engagement in multinational price negotiations was an innovation that resulted in the definition of ceiling prices for future purchases, which may explain lower prices of ARV procured by MoH⁵⁴. The success of these price negotiations, however, depend upon coordination of pharmaceutical regulations and policies, and/or pooled procurement schemes^55,56. Additionally, the enactment of legislation illustrates initiatives to standardize HIV/Aids response in the country (integration of rules).

The end of Day Hospitals in Mozambique resulted in reduction of professionals’ time for HIV/Aids-related activities. This program reorientation also led to dissatisfaction from local-level professionals and PLHIV⁵⁷. In Peru, programmatic objectives were adjusted to MoH organizations’ institutional missions.

By selecting representatives of high level bureaucracy as key informants, local dynamics and their feedback effects, that are important in implementation analysis^38,58-61, may have become underrepresented in program history accounts. Some particular elements that arise from vertical relations, such as the existence and use of communication channels, may have not been well detected. Additionally, the focus on organizational processes shift attention from the broader context, such as political support, that is important to explain sustainability^13,17.

By contrasting the three program histories it was possible to infer relative trends of sustainability. Overall, stronger routines and more established standards found in Peru put this country in a good position regarding sustainability. Distribution of events over time may be interpreted as a trend of strengthening ARV provision sustainability in that country. Many events identified in Mozambique indicate the development of routines and standards, but there are some bottlenecks and difficulties, specially regarding availability of resources and health system structure, which challenge program sustainability. Considering the great deal of effort in program planning, scaling-up and adapting to an ever-changing international donor context, trends over time seem to be positive. ARV provision in Bolivia has been going through many organizational and institutional changes, which has led to unstable routines, few standards and, therefore, weaker capacity for sustainability.

Conclusions

The conceptual framework was useful in recognizing events that may influence sustainable ARV provision in assessed countries. The application of our framework and its tools in the assessment of ARV provision resulted in three thorough accounts of program history, in which country specificities and internal development explanatory elements were explored. This approach was successful in capturing relevant data (critical events). The analytical matrix provided by the framework made it easier to organize and categorize data in a way that country-specific narratives could be translated into explanatory accounts. Processes and mechanisms leading to development of routines and establishment of standards could be, then, identified.

Our objective was not to propose a synthetic judgment of sustainability levels. We believe that the analysis of each program’s dynamics allows for the identification of strengths, challenges and opportunities, which, in turn, can contribute for better planning for sustainable ARV provision.