An adaptive approach to ARV-based prevention policy BACKGROUND
Policy debates about the possibilities and challenges of ARV-based prevention strategies are acute and urgent in all countries – especially in sub-Saharan Africa where the HIV/AIDS burden is heaviest and resources are limited. However, the contexts for HIV prevention initiatives vary greatly and change rapidly. A coherent understanding of different social, economic, political and clinical factors is needed to formulate sustainable strategies. The Mapping Pathways project takes a collaborative and multidisciplinary approach (see poster MOPE281) to provide a real-world, community-driven analysis to support policy decisions.
AN ADAPTIVE APPROACH TO POLICY DEVELOPMENT
Mapping Pathways employs an adaptive approach to policy development around ARV-based prevention strategies. The project has engaged various stakeholders from India, South Africa and the United States in surveys, interviews and iterative exchanges to understand local perspectives and the empirical evidence needed to develop appropriate policy pathways for different contexts. What will these pathways look like, how do we navigate them and where will they lead? We propose a framework* that distinguishes between:
Physical technologies which biologically prevent transmission (the protocols and clinical trials for developing safe and efficacious PrEP pills, microbicides or TLC+ – also known as “treatment as prevention”) Social technologies that must be culturally competent for effective implementation (such as program implementation and drug delivery, community education, and social marketing) Institutions which will support the technologies (such as formal funding structures, regulations and governance systems). Such a framework moves beyond clinical trial data to recognise the importance of human agency and local context in delivering effective HIV prevention strategies. This adaptive approach requires us to understand not only new ARV-based prevention strategies (the physical technologies), but also the social technologies needed to shape implementation in culturally appropriate ways. * Nelson, R and Sampta, B. (2001). 'Making sense of institutions as a factor shaping economic performance.' Research Policy. 44: 31-54. and Chataway, J et al. (2010.) 'Global social health technologies: Reflections on evolving theories and landscapes.' Research Policy. 39(10): 1277-1288
Social technology questions:
§ What is the patient population likely to be in your community context? § What is the current HIV/Aids prevention strategy? § What education is in place about HIV/AIDS in your community? § What is the acceptability of a new prevention strategy likely to be? § What additional education might be needed? § What is the medical and clinical health infrastructure in your community? § How will it need to change if ARV-based prevention strategies are introduced? § How can you make the investment cost-effective in the longrun? § What new partnerships are needed to deliver ARVs as prevention initiatives?
Physical technology questions:
§ What does the clinical trial evidence tell us about the clinical and biological reliability of ARV-based prevention strategies? § Does this evidence suggest efficacy will be the same in all patient populations? § Will drug resistance emerge? § What are the long term side effects anticipated from these strategies?
§ What funding commitments are needed to support prevention strategies? § What intellectual property regimes should apply to ARVs, especially in developing countries? § What policies and regulations should be fixed nationally, and which should be flexible for communities? § Are corruption or ‘black markets’ a problem in your country? If so, will there be policies in place to prevent these affecting the strategy? § How will the national healthcare system affect the implementation of prevention strategies?
Mapping Pathways is a two-phase project which is coming to the end of Phase 1. The next phase of the project will continue to build the adaptive approach to policy development and will see us pursuing three main streams of activity:
Recent trial data shows that our understanding of ARV technologies is constantly evolving. New understandings raise fresh questions about social technologies and institutions which might be needed to support them. By using a social technologies framework to understand innovation in drug regimes we gain better insight into the conditions that support successful innovation, and indeed what success in different contexts means. Perspectives from advocate groups, community leaders, clinicians, epidemiologists, policymakers and other stakeholders allow each policy pathway scenario to exemplify real-world concerns. Ongoing stakeholder engagement will change, adapt and enrich these pathways with new information and insights.
§ Disseminate Phase 1 findings and analyses through multiple platforms § Develop appropriate pathways with communities, experts and policymakers through workshops and online forums § Ask new questions of existing data and create evidencebased tools and models which will help people develop pathways and understand their implications. We are currently fundraising for Phase 2 and hope to begin the work in early 2012.
Mapping Pathways has six partner organisations: AIDS Foundation of Chicago, AIDS United, Baird's CMC, Desmond Tutu HIV Foundation, Naz India and RAND. Funding for year one was provided by Merck & Co.