Evaluating Progress on International Commitments:

HIV Vaccine and Biomedical Prevention Research

ICASO Discussion Paper (February 2011)

About the International Council of AIDS Service Organizations (ICASO): Founded in 1991, the mission of ICASO is to mobilize and support diverse community organizations to build an effective global response to HIV and AIDS. As the worlds leading network of AIDS organizations, ICASOs network of secretariats operates globally, regionally and locally, and reaches over 100 countries. ICASOs International Secretariat based in works with its Regional Secretariats based on five continents: AfriCASO, AAE, APCASO, LACCASO, and NACASO. In reaching over 100 countries, we actively communicate with thousands of people, community organizations and networks across the world through our global network of civil society organizations. ICASO Discussion Papers: ICASO discussion papers are intended to stimulate debate, foster consultations, and to facilitate policy dialogue amongst various stakeholders involved in developing and deciding policy on HIV and AIDS globally. ICASO is seeking direct feedback and discussion on the content of discussion papers (email: feedback@icaso.org). This ICASO Discussion Paper on Evaluating Progress on International Commitments to HIV Vaccine and Biomedical Prevention Research (February 2011) was prepared by Rodney Kort (Kort Consulting) and edited by Mary Ann Torres (ICASO). We are grateful for the financial support provided by the International AIDS Vaccine Initiative (IAVI) and the Canadian International Development Agency of the Government of Canada (CIDA). The views expressed within this publication do not necessarily represent the views of the IAVI or CIDA.

ICASO International Secretariat 65 Wellesley Street East, Suite 403, Toronto, Ontario, Canada M4Y 1G7 Phone: +1-416-921-0018 | Fax: +1-416-921-9979 icaso@icaso.org | www.icaso.org Copyright 2011 by the International Council of AIDS Service Organizations (ICASO). Information contained within this publication may be freely reproduced, published or otherwise used for non-profit purposes. The International Council of AIDS Service Organizations should be cited as the source of the information.

Evaluating Progress on International Commitments to HIV Vaccine and Biomedical Prevention Research

Introduction
Where We Are Now: HIV Prevention Research and the AIDS Response in 2010
Since the first reports of a new and lethal infectious disease appeared in 1981, our knowledge about HIV and how to prevent, treat and control it has expanded exponentially. Yet although we have known since the mid-1980s how to prevent HIV transmission, almost 30 years later the epidemic continues to outpace our best efforts to contain it. While recent epidemiological data indicates a global 20% decline in new HIV infections over the past 10 years, HIV incidence in some regions (most notably among countries in Eastern Europe and central Asia) is increasing.1 Globally, an estimated 2.6 million people were newly infected in 2009, a modest decrease from the 2.7 million in 2008; 33 million people worldwide are now living with HIV, with 1.8 million dying from AIDS in 2009 alone.2 While redoubling efforts to reach key populations3 with existing, proven prevention interventions (such as male and female condoms and harm reduction services) is critical, there are many settings and contexts where this remains challenging. Negotiating condom use, for example, is enormously difficult for women in settings where sexual decision-making is undermined by vast disparities in socioeconomic status, financial dependence, or intimate partner violence. The impact of stigma, discrimination and violence on socially marginalized populations with high rates of HIV prevalence such as men who have sex with men, people who use drugs, sex workers and prisoners reinforced by laws criminalizing sex work, homosexuality or drug possession, present additional barriers to HIV prevention. Combination prevention approaches, which incorporate structural interventions, along with social, behavioural and biomedical interventions are urgently required. However, structural changes often face stiff political opposition due to prevailing cultural values and systemic social inequities. The implications for global efforts to halt the epidemic are clear; many lives will depend on the research, development, regulatory approval and delivery of a highly effective HIV vaccine or biomedical prevention tool that is able to meet some of the current challenges in HIV prevention. Yet while substantial attention and advocacy has focused on evaluating progress in HIV prevention and treatment coverage and impact, or in establishing an enabling environment as measured by the policy indicators contained in the National Composite Policy Index (NCPI), relatively little attention has been paid to formally evaluating progress on commitments made by the international community on HIV vaccines and other biomedical prevention interventions. UN Member States must be accountable for all of their commitments on HIV and AIDS, none less so than the investments in scientific research on which the development of future prevention and treatment interventions heavily depend.

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UNAIDS, Report on the Global AIDS Epidemic 2010, 2010. UNAIDS, Report on the Global AIDS Epidemic: 2010, 2010. Key populations include women, girls, men who have sex with men, people who inject drugs, sex workers, migrants, prisoners, refugees, young people and indigenous peoples.

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Domestic, bilateral and multilateral AIDS financing has increased steadily over the past decade, and those investments are having an impact in both reducing HIV transmission and expanding treatment access for those infected; by the end of 2009, 5.25 million people were on antiretroviral therapy (ART), up from only a few hundred thousand in 2003; 53% of pregnant women living with HIV received antiretroviral (ARV) drugs to prevent vertical transmission, up from 45% only a year before, and programmes financed by the Global Fund to Fight AIDS, Tuberculosis and Malaria alone had saved five million lives.4 This progress is the result of a remarkable evolution in how the international community tackles global health challenges, spurred by targets contained in eight Millennium Development Goals (MDGs), established in a UN summit held in 2000, and by commitments in the United Nations General Assembly Special Session (UNGASS) 2001 Declaration of Commitment on HIV/AIDS and 2006 Political Declaration on HIV/AIDS.5 Global action on AIDS was further strengthened by the commitment by G8 nations at the 2005 G8 Summit in Gleneagles (and later that year by all UN Member States) to reach the goal of universal access to HIV prevention, care, treatment and support for all those in need by 2010.6

Establishing Targets, Evaluating Progress

Scaled up investments in HIV research, prevention, care and treatment have resulted in a robust body of programmatic and scientific evidence from a range of disciplines confirming the interrelatedness of global health and development goals, such as the evidence linking increased AIDS financing and expanded coverage of priority HIV interventions to improvements in maternal and child health (MDGs 4 and 5), outlined in a recent ICASO discussion paper,7 or the impact of scaling up access to ART in reducing the incidence of tuberculosis (TB) and malaria in endemic countries.8 These links are reflected in the scope of the MDGs and UNGASS declarations, which include commitments to address a wide range of social, legal, economic and human rights issues required to enable an effective AIDS response.

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WHO/UNAIDS, Towards Universal Access: Scaling up Priority HIV Interventions in the Health Sector. Progress Report 2010, 2010. See also, The Global Fund to Fight AIDS, Tuberculosis and Malaria. The Global Fund 2010: Innovation and Impact, 2010. United Nations General Assembly Special Session on HIV/AIDS, Declaration of Commitment on HIV/AIDS, 2001. G8, The Gleneagles Communiqu, 2005. See also United Nations General Assembly, 2005 World Summit Outcome, 2005. International Council of AIDS Service Organizations (ICASO), Accelerating Progress on AIDS and Maternal and Child Health, September 2010 See also Dembele M, Saleri N, Carvalho AC, Saouadogo T, Hien AD, Zabsonre I, et al, Incidence of tuberculosis after HAART initiation in a cohort of HIV-positive patients in Burkina Faso. Int J Tuberc Lung Dis. 2010; 14(3): 31823. See also International AIDS Society, Universal access by 2010: Scaling up for success, 2010.

5 6 7 8

Evaluating Progress on International Commitments to HIV Vaccine and Biomedical Prevention Research

To meet those commitments, countries are responsible for setting concrete, timebound targets within national AIDS plans and strategies (guided by the three ones principles9), and submitting progress reports on their targets in preparation for MDG Summits and UNGASS Review meetings. National AIDS authorities are guided by technical support and normative guidance from UNAIDS, WHO and other UN agencies in setting targets and preparing progress reports. Standardized indicators are established by the UNAIDS Monitoring and Evaluation Reference Group (MERG) to help countries benchmark their progress on specific targets. These indicators are used to measure progress on a number of different components of national and global AIDS responses; they include quantifying AIDS funding, identifying policies and laws that impede or facilitate national AIDS responses, and evaluating coverage of HIV prevention, treatment and care interventions. The use of common indicators (which are available in the HIV Indicator Registry) ensure comparability and consistency in assessing country-level and global progress on those commitments. Civil society has been a driving force in ensuring accountability for both the commitments and reported results at the national and international level, contributing to country progress reports and occasionally drafting shadow reports of official government reports in cases where there are divergent opinions among stakeholders on actual versus reported progress. ICASO believes that progress in meeting international commitments on HIV vaccine and biomedical prevention research should receive similar scrutiny.

Evaluating Progress in Prevention Research:

This ICASO Discussion Paper identifies HIV vaccine and biomedical prevention research commitments made by the international community, draws on recent scientific and grey literature to provide a brief overview of the current status of these research areas, and proposes indicators for use by the community-based and NGO sector to assess national and global progress in achieving those commitments. The indicators are informed by recent guidance from UNAIDS: Monitoring the Declaration of Commitment on HIV/AIDS: Guidelines on Construction of Core Indicators 2010 Reporting, and Indicator Standards: Operational Guidance for Selecting New Indicators (January 2010), and are intended to provide additional specificity and a standardized approach to assessing progress in this area of the AIDS response. ICASOs work in this area aims to strengthen the capacity of the community sector to participate meaningfully in setting vaccine and biomedical prevention research targets and indicators, and in evaluating progress on national and international commitments.

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The Three Ones principles are: One agreed HIV/AIDS Action Framework that provides the basis for coordinating the work of all partners; One National AIDS Coordinating Authority, with a broad-based multi-sectoral mandate; One agreed country-level Monitoring and Evaluation System.

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The tools developed by ICASO are: 1. A discussion paper that community organizations can use to inform policy dialogue with government, donors, multilateral agencies and researchers, with the intent of: a. including ambitious, concrete, time-bound targets aimed at accelerating vaccine and biomedical prevention research within national AIDS plans and strategies, and b. establishing consensus on indicators or other benchmarks to measure progress in achieving those targets, as part of the national monitoring and evaluation system 2. A sample report card, developed in conjunction with this discussion paper, that is designed for use as a basic, standardized report, using the proposed indicators, for evaluating national and global progress on vaccine and biomedical prevention research, based on national targets.

ICASO hopes this paper and associated sample report card will be useful as a first step to developing additional indicators for adoption by those working in national and global responses to AIDS. Ultimately, the goal is to increase awareness among key stakeholders that scaling up coordinated and strategic investments in HIV vaccine and biomedical prevention research are critical to halting the AIDS epidemic.

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Evaluating Progress on International Commitments to HIV Vaccine and Biomedical Prevention Research

Commitments
Below are excerpts from the numbered paragraphs of the 2001 Declaration of Commitment on HIV/AIDS, 2006 Political Declaration on HIV/AIDS and 2010 MDG Review Summit outcome document that relate to commitments on HIV vaccines and biomedical prevention research (bolded phrases are ICASOs).10 These broad commitments are the basis of the indicators outlined in Section 4.0 of this briefing.

2001 Declaration of Commitment on HIV/AIDS

(70) Increase investment in and accelerate research on the development of HIV vaccines, while building national research capacity, especially in developing countries, and especially for viral strains prevalent in highly affected regions; in addition, support and encourage increased national and international investment in HIV/AIDS- related research and development... accelerate access to prevention, care and treatment and care technologies for HIV/AIDS ... including female-controlled methods and microbicides, and in particular, appropriate, safe and affordable HIV vaccines and their delivery...; and create a conducive environment for research and ensure that it is based on the highest ethical standards. (71) Support and encourage the development of national and international research infrastructures, laboratory capacity, ... and the training of basic and clinical researchers, social scientists, health care providers and technicians, with a focus on the countries most affected by HIV/AIDS, particularly developing countries and those countries experiencing or at risk of a rapid expansion of the epidemic. The Declaration of Commitment also recognizes the key role that collaboration will play in the exchange and transfer of research findings and technologies, committing to: (73) Strengthen international and regional cooperation, in particular North-South, South-South and triangular HIV/AIDS cooperation, related to the transfer of relevant technologies suitable to the environment in the prevention and care of HIV/AIDS, the exchange of experiences and best practices, researchers and research findings.... In this context, encourage ownership of the end results of these cooperative research findings and technologies by all parties to the research, reflecting their relevant contribution. Of particular interest to the community sector is the final research-related commitment: (74) By 2003, ensure that all research protocols for the investigation of HIV-related treatment, including antiretroviral therapies and vaccines, based on international guidelines and best practices, are evaluated by independent committees of ethics, in which persons living with HIV/AIDS and caregivers for anti-retroviral therapy participate.

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10 United Nations General Assembly. Keeping the promise: united to achieve the Millennium Development Goals. New York; 17 September 2010.

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2006 Political Declaration on HIV/AIDS

The 2006 Declaration reaffirmed the commitments outlined in the 2001 Declaration, with the following specific references to vaccines and new prevention technologies: (15) Do everything necessary to ensure access to life-saving drugs and prevention tools; and develop with equal urgency better tools drugs, diagnostics and prevention technologies, including vaccines and microbicides for the future; (42) Commit ourselves also to finding appropriate solutions to overcome barriers in pricing, tariffs and trade agreements, and to making improvements to legislation, regulatory policy, procurement and supply chain management in order to accelerate and intensify access to affordable and quality HIV/ AIDS prevention products, diagnostics, medicines and treatment commodities (45) ...Commit ourselves to intensifying investment in and efforts towards the research and development of new, safe and affordable HIV/AIDS-related medicines, products and technologies, such as vaccines, female-controlled methods and microbicides...

MDG Review Summit- Outcome Document

Although there was no specific reference to vaccine or biomedical prevention research in the original health MDG targets, in a section on promoting global public health the outcome document from the 2010 MDG Review Meeting committed to: (73) (m) Further strengthening international cooperation, inter alia, through exchange of best practices in strengthening health systems, ... fostering the production of innovative medicines, generics, vaccines and other health commodities.. [and] encouraging the development of new and affordable technologies and their innovative application and development of new and affordable vaccines and medicines needed, particularly in developing countries. Reflecting the need to build on momentum from recent scientific advances and the urgency of getting new prevention options into the field, under MDG 6 the international community committed to: (76) (b) Significantly intensifying prevention efforts and increasing access to treatment by scaling up strategically aligned programmes aimed at reducing the vulnerability of persons more likely to be infected with HIV, combining biomedical, behavioural and social and structural interventions... Prevention programmes ...should promote policies that ensure effective prevention and accelerate research and development into new tools for prevention, including microbicides and vaccines.

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Evaluating Progress on International Commitments to HIV Vaccine and Biomedical Prevention Research

Assessing Progress
The End of the Beginning: Recent Advances in Biomedical Prevention Science
The past 14 months have been marked by some of the most significant scientific advances in vaccine and biomedical prevention research since the epidemic began. In October 2009, a Phase III AIDS vaccine trial in Thailand (which included a combination of ALVAC-HIV and AIDSVAX B/E vaccines), also known as RV144, reduced HIV incidence by 31.2% among study participants in the intervention arm.11 Although the vaccine was only modestly efficacious, the results represented an important advance because RV144 was the first AIDS vaccine trial in history to demonstrate any level of efficacy. In July 2010, investigators from a research consortium led by the International AIDS Vaccine Initiative (IAVI) and the NIH Vaccine Research Center (VRC) announced the discovery of two broadly neutralizing antibodies that prevented 91% of the HIV-1 strains they tested from entering cells in vitro.12 In his plenary lecture at the XVIII International AIDS Conference (AIDS 2010), Anthony Fauci, long-time Director of the US Institute of Allergy and Infectious Disease (National Institutes of Health), described these results as very exciting data for vaccine development.13 Arguably the most important findings from biomedical prevention research in years were also announced at AIDS 2010; after decades of false starts and disappointing results, a 1% tenofovir vaginal gel microbicide proved effective in reducing HIV infection among women in the Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004 trial.14 After 30 months of follow-up, the microbicide lowered the rate of HIV infection 39%. In women with better than 80% adherence, HIV incidence was 54% lower. The CAPRISA results were a particularly important benchmark in prevention science because unlike the male condom it is a female-controlled intervention that would help protect women from HIV infection in settings where they have limited agency in sexual decision-making.15 In November 2010 even stronger efficacy data were reported from a Phase III clinical trial of ARV-based oral pre-exposure prophylaxis (PrEP). The iPrEx study of PrEP among MSM in Brazil, Peru and Ecuador found that it reduced HIV incidence by 44%, up to 73% among study participants with over

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11 Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Kaewkungwal J, Chiu J, Paris R, et al. Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand. N Engl J Med. 2009; 361(23): 2209-20. 12 Wu X YZ, Li Y, et al:. Rational design of envelope surface identifies broadly neutralizing human monoclonal antibodies to HIV-1. Science. 2010. See also Zhou T GI, Wu X, et al:. Structural basis for broad and potent neutralization of HIV-1 by antibody VRC01. Science. 2010. 13 Fauci, A, New concepts in HIV/AIDS pathogenesis: implications for interventions. XVIII International AIDS Conference; Vienna, Austria, 2010. 14 Abdool Karim Q AKS, Frohlich JA, et al. Effectiveness of 1% tenofovir vaginal microbicide gel in South African women: results of the CAPRISA 004 trial. XVIII International AIDS Conference; 2010; Vienna, Austria; 2010. 15 International Council of AIDS Service Organizations, Accelerating Progress on AIDS and Maternal and Child Health, September 2010.

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90% adherence.16 Results of Phase III PrEP trials among people who inject drugs (in Thailand) and heterosexually active young men and women (in South Africa) are expected in 2011.17 There are many outstanding questions regarding these studies; results are generally considered too modestly efficacious to proceed immediately to regulatory approval, and a number of important questions remain, such as: What is the most efficient approach to translating laboratory discoveries about neutralizing antibodies into compounds that can be tested in pre-clinical trials (e.g., testing in macaques or other mammals) and eventually Phase IIb or III clinical trials in humans? What confirmatory trial designs, compounds and dosing strategies can best leverage RV144, CAPRISA, iPrEx and other clinical trial results in the next series of trials to produce a highly effective vaccine or biomedical prevention intervention? How can laboratory benchwork, preclinical and clinical trials (and the questions they attempt to answer) be best communicated and coordinated across the complex number of laboratories, clinical trial networks, academic institutions, and private and public-sector research granting agencies? While these are not simple or straightforward questions, the community sector has a vital role and unique expertise required to both inform research efforts and advocate for the investment, collaboration and coordination required to answer them.

Financing
These advances in HIV vaccine and other biomedical prevention research are happening at a critical period in global health and development, amid signs that political and financial support for AIDS is waning. A recent WHO report confirmed that the international community will not meet the goal of universal access to a package of HIV prevention, care, treatment and support for all in need by 2010.18 The Pledging Meeting of the Third Voluntary Replenishment of the Global Fund to Fight AIDS, Tuberculosis and Malaria (2 3 October 2010) resulted in pledges totalling US$11.7 billion, well short of the US$13 billion dollars the organization said was the minimum level required to support and allow for modest expansion of existing programmes.19 Scientists have warned that investments in capital-intensive vaccine and biomedical prevention research are also in jeopardy in the current economic context.20 Like other areas of AIDS financing, total global investment in vaccine research and development

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16 Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, et al., Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men. N Engl J Med. 2010. 17 AVAC, Global Advocacy for HIV Prevention. Data Dispatch. Px Wire: A Quartery Update on HIV Prevention Research, 2010. 18 WHO/UNAIDS, Towards Universal Access: Scaling up Priority HIV Interventions in the Health Sector. Progress Report 2010, 2010. 19 The Global Fund to Fight AIDS, Tuberculosis and Malaria, Donors Commit US$11.7 Billion to the Global Fund for Next Three Years, 5 October 2010. 20 Abano I., AIDS vaccine funding waning, scientists warn. Science and Development Network; 1 October 2010.

Evaluating Progress on International Commitments to HIV Vaccine and Biomedical Prevention Research

remained roughly flat between 2008 and 2009 at US$868 million.21 Overall financing for all biomedical prevention research (including vaccine R&D) remained flat at US$1.165 billion between 2008 and 2009.22 In some areas, increases in financing (e.g., shortterm economic stimulus funding for the US National Institutes of Health) were offset by decreases among other donors (e.g. decreases in private/philanthropic funding between 2008 and 2009). This relative overall funding plateau follows several years (with one or two exceptions) of steady and significant increases in funding for vaccines and biomedical prevention research.23 In a research area with limited commercial appeal, where an estimated US$100 million is required to support confirmatory studies for the CAPRISA 004 trial results alone24, tracking progress and ensuring the international community meets it obligations will be vital to accelerate vaccine and biomedical prevention R&D efforts. Given the current global economic environment, research must be strategic, welldesigned, and carefully coordinated to best capitalize on recent scientific advances and make best use of available resources. As the AVAC 2010 Turning the Page report makes clear, improvements are also required in trial designs to include complex, longterm, multi-layered community engagement strategies.25 Collaboration and information sharing among NGOs, community representatives, donors, investigators and public and private academic institutions and laboratories will be essential in moving from the tantalizing promise held out by recent scientific findings to an effective and accessible new intervention on the frontlines of the epidemic. It is worth noting that the US contributes the vast majority of preventive vaccine funding (US$624 million, compared to US$76.8 million from the second largest donor: the Bill & Melinda Gates Foundation). The need to diversify the donor base particularly given the troubled US economy and its domestic political vicissitudes - is an important strategic consideration for the HIV field, adding urgency to the need for increased investments from other national governments.

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21 Kresge KJ. Microbicides Finally Gel, Securing Spotlight in Vienna. VAX: The Bulletin on AIDS Vaccine Research. 2010; 8(5). 22 HIV Vaccines and Microbicides Resource Tracking Working Group, Advancing the Science in a Time of Fiscal Constraint: Funding for HIV Prevention Technologies in 2009, 2010.The HIV Vaccines and Microbicides Resource Tracking Group monitors and reports on financing for all HIV biomedical prevention research, including preventive vaccines, microbicides, PrEP using ARVs and operations research related to male circumcision. Additional detail and information is available at: www.hivresourcetracking.org. 23 UNAIDS, Report on the Global AIDS Epidemic. Geneva; 2008. 24 AVAC: Global Advocacy for HIV Prevention, AVAC Calls for Speedy Funding of Critical Microbicide Follow-Up Studies, 2010. 25 AVAC: Global Advocacy for HIV Prevention, Turning the Page: Report 2010.

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Tools for Evaluating Progress

Countries are encouraged to report on their progress in responding to AIDS using indicators from the UNAIDS HIV Indicator Registry and associated guidance documents.26 The HIV Indicator Registry includes the indicator number, definition and a variety of fields outlining the elements of each indicator, including suggested measurement tools (e.g., Demographic Health Surveys for population level information), potential data sources and strengths and limitations of the indicator. Using a common set of indicators allows for consistent, comparative evaluation and trend tracking within and across national AIDS responses. There is only one UNGASS indicator which includes information related to HIV vaccine or biomedical prevention research in the 2010 guidance document on the construction of core indicators: Financing for AIDS Research, currently included as part of Indicator 1: Domestic and International AIDS Spending by Categories. The purpose of the indicator is to collect accurate, consistent data on how funds are spent at the national level and where those funds are sourced (from international, domestic-public or domestic-private donors).27 Financing for AIDS Research is one of eight categories of national spending for this indicator. The National Funding Matrix subdivides the Financing for AIDS Research category into seven types of research, including vaccinerelated research and biomedical research (which includes all types of biomedical research of which biomedical prevention research is a subset). While identifying the amount and source of vaccine and biomedical prevention research funding is important, it is inadequate to support evaluation of the full range of HIV vaccine and biomedical research commitments outlined in the Declaration of Commitment, the Political Declaration and MDG Review Outcome Document. To address this evaluation gap and facilitate the inclusion of national and international targets on HIV vaccine and biomedical prevention research in multi-sectoral national AIDS plans, ICASO encourages NGO and community sector organisations to work with: 1. investigators, policymakers, donors and academic institutions to establish targets for HIV vaccine and biomedical prevention research within national AIDS plans, and track progress in meeting those targets in national monitoring and evaluation systems; and policymakers, investigators, academic institutions and donors to ensure that Good Participatory Practice Guidelines for Biomedical Prevention Trials (2nd ed.) are followed in the design, planning, implementation, closure and results dissemination of clinical trials.28

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2.

Before outlining what the indicators could measure (recognizing that this work still have some gaps in the definitions and other areas, such as strengthens and weaknesses), it is important to note that not all indicators will be relevant for all countries; there are wide

26 The HIV Indicator Registry can be viewed online at http://www.indicatorregistry.org. 27 Izazola JA., Monitoring the Declaration of Commitment on HIV/AIDS & UNGASS indicators, UNAIDS, 2007. 28 Good participatory practice guidelines for biomedical HIV prevention trials, UNAIDS/AVAC, 2nd edition, 2010 (draft for comment); a final version will be released later this year, incorporating public input.

Evaluating Progress on International Commitments to HIV Vaccine and Biomedical Prevention Research

disparities in the resources, trained personnel and capital infrastructure available to support vaccine or other biomedical research, particularly among low-income countries. Significant investments in laboratory and other research infrastructure may not be feasible for some low and middle-income countries. However, every UN Member State has a stake in vaccine and biomedical prevention research and in the commitments to which all are collectively bound; further, the commitments outlined in Section 2.0 of this discussion document identify the need for high-burden countries to strengthen and expand infrastructure, training and engagement in HIV biomedical and social sciences research using a variety of strategies. Some of the proposed indicators (or what the indicator would measure) in this document focus on international collaboration and data-sharing, and ensuring that regulatory agencies and health systems are prepared to move from evidence of efficacy to an accessible and affordable new intervention in the field as quickly, efficiently and cost-effectively as possible. These are relatively low-cost activities that are nevertheless essential to ensure national preparedness for vaccines and new prevention technologies. What is important is establishing national targets that are relevant, feasible, concrete and time-bound against which progress using the preliminary issues that could be measured, proposed below. UNAIDS groups indicators into four broad reporting categories:29 1. 2. 3. 4. National Commitment and Action (including AIDS Research Funding sub-category) National Knowledge and Behaviour National Impact Global Commitment and Action

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29 UNAIDS. Monitoring the Declaration of Commitment on HIV/AIDS: Guidelines on Construction of Core Indicators 2010 Reporting. Geneva; March 2009.

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Indicators on vaccine and biomedical prevention research commitments would fall into either the first or fourth category above. What we are proposing to be measured below is intended as a starting point for discussion. Indicators to measure these issues will need to be designed, revised and field-tested before potential inclusion in the UNAIDS Indicator Registry (subject to review and approval by the UNAIDS MERG). In the interim, ICASO encourages community sector organizations to initiate discussion with evaluation experts, investigators, policymakers and other stakeholders on the proposed indicators (or other evaluation tools) and the merits of their inclusion in the HIV Indicator Registry, including the strengths and weaknesses of each indicator, as an important first step towards developing concrete, time-bound targets on HIV vaccine and biomedical prevention research at the national and global levels.

National Commitment and Action

The Financing for AIDS Research sub-category already includes an indicator for HIV vaccine research financing, but a parallel indicator is required to track funding for other biomedical prevention research, separate from biomedical treatment research (such as clinical research on new ARVs). It is particularly important for high-income countries to report on these two streams of HIV research financing given they provide the vast majority of research funding.

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Evaluating Progress on International Commitments to HIV Vaccine and Biomedical Prevention Research

To be measured: Spending on biomedical prevention research What an indicator would measure: Total expenditures on biomedical prevention research (excluding HIV vaccine research), including operations research related to male circumcision, oral prophylaxis and microbicides, from domestic-public, domestic-private and international sources. Assessment tool/survey National AIDS Spending Assessment National Health Accounts AIDS Above tools to be used to collect data on this indicator for output to an expanded National AIDS Financing Matrix and included in national progress reports National Biannual

Data Collection Method: Data Collection Tool: Method of Measurement: Level: Frequency:

To be measured: Spending on research infrastructure and training What an indicator would measure: Total expenditures on research infrastructure dedicated to laboratory (basic science), pre-clinical and clinical HIV research, including relevant capital equipment (e.g., flow cytometers, assays, and related laboratory equipment), as well as funded dedicated to HIV-specific training of research staff. Assessment tool/survey National AIDS Spending Assessment National Health Accounts AIDS Above tools to be used to collect data on this indicator for output to an expanded National AIDS Financing Matrix and included in national progress reports National Biannual

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Data Collection Method: Data Collection Tool: Method of Measurement: Level: Frequency:

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To be measured: Preparedness planning for HIV vaccine and biomedical prevention interventions What an indicator would measure: Level of preparedness within national regulatory agencies and health systems, and is aimed at expediting international data-sharing, purchase, supply chain management and delivery of new prevention interventions, including establishing protocols for: formal regional/international agreements/MOUs to expedite research data-sharing and analysis of Phase III clinical trial results of vaccine or biomedical prevention tools training with regulatory agency staff on expedited review procedures for evaluating HIV prevention vaccines and biomedical prevention technologies ensuring essential elements and data requirements of regulatory submission packages are clearly defined, accessible and relevant for vaccines and biomedical prevention products disseminating best practices/SOPs to deliver new vaccine/biomedical prevention tools, including procurement and supply chain management developing and implementing national communications/ media relations strategies for public, key populations and health care providers relevant to the delivery and uptake of new prevention interventions Data Collection Method: Data Collection Tool: Method of Measurement: Level: Frequency: Assessment tool/survey National AIDS Spending Assessment National Health Accounts AIDS Above tools to be used to collect data on this indicator for output to an expanded National AIDS Financing Matrix and included in national progress reports National Biannual

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Evaluating Progress on International Commitments to HIV Vaccine and Biomedical Prevention Research

To be measured: Adherence to good participatory practice guidelines for biomedical prevention trials What an indicator would measure: Whether clinical trials of human subjects currently operating in the country comply with the 15 standards established in GPP Guidelines for biomedical HIV prevention trials (2nd Ed. in process). Assessment tool/survey Institutional Review Boards Community Advisory Boards National HIV Vaccine Networks National HIV Clinical Trials Networks Method of Measurement: Level: Frequency: Above tools to be used to collect data on this indicator for output to an expanded National AIDS Financing Matrix and included in national progress reports National Biannual

Data Collection Method: Data Collection Tool:

Global Commitment and Action

Annual reports issued by the HIV Vaccines and Microbicides Resource Tracking Group provide an excellent overview of funding for global HIV vaccine and biomedical prevention research, including trends in financing over time. The proposed issues to be measured are, as with the national level indicators, intended as a starting point for discussion and aim to provide additional strategic information on a key component of the global AIDS response. Civil society organizations that address vaccine and biomedical prevention research issues as part of their global policy priorities are encouraged to join ICASO in working towards developing consensus recommendations to the MERG on the most useful indicators to include in the UNAIDS HIV Indicator Registry. While it will not be possible to review, elaborate and include these indicators as a formal component of the UNGASS process for the 2011 indicator review process, ICASO encourages civil society organizations to use them in framing discussion, debate and advocacy on a topic that has received insufficient analysis and attention to date in the UNGASS reporting process.

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To be measured: Spending on HIV vaccine research What an indicator would measure: Data Collection Method: Data Collection Tool: Method of Measurement: Level: Frequency: Above tools to be used to collect data on this indicator for output to an expanded National AIDS Financing Matrix and included in national progress reports International Biannual This indicator measures total annual global expenditures on HIV vaccine research from public and private-sector sources. The indicator will be an aggregate rollup of data from national progress reports

To be measured: Investments in biomedical prevention research What an indicator would measure: This indicator measures total annual global expenditures on biomedical prevention research, including operations research related to male circumcision, oral prophylaxis and microbicides, from domestic-public, domestic-private and international sources. The indicator will be an aggregate rollup of data from national progress reports

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Data Collection Method: Data Collection Tool: Method of Measurement: Level: Frequency:

International Biannual

The above issues correlate with key aspects of the commitments on vaccine and biomedical prevention research outlined in Section 2.0 of this discussion paper. They are included in the draft sample report card (included as an annex), which is intended to help community sector organizations develop an evidence-based platform for policy dialogue.

Evaluating Progress on International Commitments to HIV Vaccine and Biomedical Prevention Research

Beyond 2010: Capitalizing on Success

Capitalizing on research investments to date and recent scientific advances requires a community sector that is well-informed and prepared to participate meaningfully on a technically complex topic. Building vaccine/biomedical prevention research literacy among community organizations is a prerequisite for effective policy analysis, dialogue and advocacy, and for effective participation on community advisory boards and other community input mechanisms for clinical trials. The key elements for successful community engagement, outlined in the 2006 ICASO report, Community Involvement in Vaccine Research: Making it Work for Communities are as true now as when the report was first released: 1. 2. 3. 4. Education and capacity building for community leaders Awareness and education of potential trial participants Structured mechanisms for consultation (such as Community Advisory Boards) Monitoring, advocacy and partnership-building

Responsibility for this rests with all clinical trial stakeholders: donors, investigators, site sponsors and staff and community representatives, each of which brings specialized areas of expertise to the table. These elements are covered in detail in the draft Good Participatory Practice Guidelines (2nd edition draft for review), which outlines 16 standards of good participatory practice and should be required reading for all community advocates working on vaccine and biomedical prevention research issues, particularly those serving or considering serving on Community Advisory Boards or related stakeholder advisory mechanisms for clinical trials. The discontinued PrEP trials in Cambodia, Malawi and Cameroon are object lessons in how inadequate planning, poor communications and distrust among stakeholders can combine to set back the clock several years on important scientific questions.30 In their 2010 report, the Vaccines and Microbicide Resource Tracking Working Group warns that the overall financing stability could change quickly, and increasing and diversifying the donor base particularly in the uncertain global economic context should be an important priority. Moving forward in placing this area of research as one of the key commitments from UNGASS, and establishing appropriate indicators so that progress at the national and global level can be monitored and evaluated will ensure greater visibility and accountability for those commitments. At AIDS 2010, President William J. Clinton commented on recent scientific advances using a well-known paraphrase from T. S. Eliots Little Gidding, noting, We are not at the end; we are not even at the beginning of the end; but we are at the end of the beginning.31

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30 Two excellent analyses of the series of events that resulted in the cancellation of the Cambodian and Cameroonian PrEP trials are available on the GCM website at http://www.global-campaign.org/ethics-resources.htm. 31 Clinton WJ. Keynote Address. XVIII International AIDS Conference; 2010; Vienna, Austria; 2010.

ICASO Discussion Paper

ANNEX 1 - Sample Report Card on National and Global Investment and Action
Introduction
This sample report card, developed in conjunction with the ICASOs Discussion Paper Evaluating Progress on International Commitments: HIV Vaccine and Biomedical Prevention Research is designed to evaluate national and global progress on vaccine and biomedical prevention research. This evaluation is based on commitments by the international community to vaccine and biomedical prevention research outlined in the 2001 UNGASS Declaration of Commitment, 2006 Political Declaration and MDG Review Summit Outcome Document.

National Commitment and Action

Spending on biomedical prevention research
GRADE (A, B, C, D, F) COMMENT
Brief analysis & rationale, including steps to improve performance

Spending on research infrastructure and training GRADE (A, B, C, D, F) COMMENT

Brief analysis & rationale, including steps to improve performance

Preparedness planning for HIV vaccine and biomedical prevention interventions

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GRADE (A, B, C, D, F)

COMMENT
Brief analysis & rationale, including steps to improve performance

Adherence to good participatory practice guidelines for biomedical prevention trials

GRADE (A, B, C, D, F) COMMENT
Brief analysis & rationale, including steps to improve performance

Global Commitment and Action

Spending on HIV vaccine research
GRADE (A, B, C, D, F) COMMENT
Brief analysis & rationale, including steps to improve performance

Investments in biomedical prevention research

GRADE (A, B, C, D, F) COMMENT
Brief analysis & rationale, including steps to improve performance

Evaluating Progress on International Commitments to HIV Vaccine and Biomedical Prevention Research

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