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Treatment 2.0: The Next Phase of HIV Treatment and Prevention Scale-Up

A Community-Based Response

Table of Contents

1. Project Background: Ensuring Communities’ Place at the Heart of the Future Response ....... 3 1.1 Underlying principles and focus areas ................................................................................ 3

2. Opportunities and Challenges for the Next Phase of Treatment and Prevention Scale-up ..... 4

2.1 Innovative models and approaches: Treatment 2.0 ............................................................ 6 3. Role of Affected Communities in HIV Response ...................................................................... 7

3.1 Advocacy roles and engagement ........................................................................................ 7 3.1.1 Human rights and rights-based approaches ................................................................. 8 3.1.2 Accountability and monitoring ..................................................................................... 10 3.1.3 Intellectual property and trade issues ......................................................................... 11

3.2 Service provision roles and engagement .......................................................................... 12 4. Funding Mechanisms: Meeting the Needs for the Next Phase of Scale-up ........................... 14

4.1 Resource development for increased community capacity ............................................... 16 5. Key Issues and Recommendations from Community Consultations ...................................... 17 6. Conclusion .............................................................................................................................. 19    

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Acronyms and abbreviations ART = antiretroviral treatment ARV = antiretroviral drug CBO = community-based organisation CSS = community systems strengthening Global Fund = Global Fund to Fight AIDS, Tuberculosis and Malaria ITPC = International Treatment Preparedness Coalition MSM = men who have sex with men PEPFAR = U.S. President’s Emergency Plan for AIDS Relief PLHIV = people living with HIV TB = tuberculosis UNAIDS = Joint United Nations Programme on HIV/AIDS WHO = World Health Organization Presentations, background materials, agenda and participant lists from the consultations referred to in this report can be found at: http://itpc.wikispaces.com/Treatment2.0 Acknowledgements Many people contributed to the development of this project and ITPC would like to thank them here for their support and hard work, including all those who presented and attended the meetings. We are grateful to Open Society Foundations and UNAIDS for financial support. We send a particular note of thanks to Jeff Hoover and Julia Greenberg. Moises Agosto Joseph Amon Sam Avrett Sylvère Bukiki Thomas Cai Robert Carr Michaela Clayton Jonathan Cohen Karl Lorenz Dehne Cynthia Eyakuze Loon Gangte Gregg Gonsalves Rico Gustav Fatima Hassan Jennifer Ho David Hoos

Rose Kaberia James Kayo Loide Iipinge Sharonann Lynch Chris Mallouris Lillian Mworeko Rolake Odetoyinbo Shiba Phurailatpam Bernhard Schwartlander Boniswa Seti Mariangela Simao Kate Thomson Gregory Vergus Pat Zerenga Andrei Zlobin

The following ITPC staff contributed to this project: Solange Baptiste – Program Director David Barr – Senior Consultant Bactrin Killingo – Africa Program Manager Howard Lee – Administrative Support Michael Quan – Finance Director Ed Attapon Ngoksin – Communications Coordinator Sarah Zaidi – Executive Director

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1. Project Background: Ensuring Communities’ Place at the Heart of the Future Response With support from the Joint UN Programme on HIV/AIDS (UNAIDS) and the Open Society Foundations (OSF), the International Treatment Preparedness Coalition (ITPC) was asked to ensure that community mobilization, advocacy and service delivery are supported as a central strategy of the next phase of HIV treatment and prevention scale-up. To that end, ITPC in January 2011 convened a Planning Committee of experts in the fields of HIV/AIDS service delivery, HIV policy, community organizing, and human rights to create a conceptual framework for a project focusing on such critical issues. This was followed by a series of meetings of community constituents to develop recommendations on how best to support community mobilization for the dramatic scale-up of treatment that is required to reach universal access goals. The initial findings of HPTN 052 noting the prevention benefits of treatment were released during the planning phase of this project, and the scope was widened to also incorporate this new evidence and the roles of communities and programs. This report summarizes some of the main discussion areas and outcomes from the two meetings1 that had been held as of September 2011. The first, which took place 3-5 May 2011 in Bangkok, Thailand, brought together nearly 50 representatives from Asia and Eastern Europe. A second community meeting held 1-3 June 2011 in Johannesburg, South Africa included a similar number of representatives from across Africa. The Asia-Pacific Network of People Living with HIV (APN+) co-hosted the Bangkok meeting with ITPC, while the AIDS and Rights Alliance for Southern Africa (ARASA) served as co-host for the Johannesburg meeting. The overall goals of the community meetings were to:

A. Identify the key roles as advocates and service providers that communities can play in meeting universal access targets and Treatment 2.0 goals and what types of support communities will need to fulfil these roles

B. Identify the main challenges that communities face with regards to scaling up HIV services and maximizing opportunities raised by emerging scientific developments

1.1 Underlying principles and focus areas The challenges raised at the two community meetings underscore the major unmet needs and priorities in local and national HIV/AIDS responses. However, participants recognized that they can and must be drivers of change moving forward. They therefore also focused on identifying potential solutions and priority activities aimed to overcome some of these challenges. The recommendations developed at the meetings are described in Section 5 of this report. Most notably, the meeting participants agreed that the following broad factors are (or should be) true in all contexts:

• Governments have a responsibility to meet the needs of their people and communities. • Community-based service provision can provide unique and particular knowledge and

expertise. Community-based service approaches are often better able to build and sustain trust, which can provide effective ways for people to access and stay in care.

                                                                                                                         1 A third meeting was initially scheduled for representatives from the Caribbean and Latin America, but funding was not available. ITPC still plans to hold this third consultation when possible.

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• Community advocates work to ensure that governments meet their responsibilities. Their input and roles may vary, but in no circumstance are community groups anything less than essential elements of an effective HIV/AIDS response.

• A ‘rights-based’ approach to policy and service delivery provides the most effective way for people living with and at risk for HIV to effectively seek and utilize health and support services.

With these basic principles in mind, participants at the community meetings were asked to consider some key questions when considering priority engagement areas and solutions. Among those questions were the following:

• How do we solidify and continue the gains made in access to HIV treatment and prevention?

• How do we ensure that all of our work is done within the context of human rights? • What can be done to improve access to services for members of key affected

populations? • Irrefutable evidence now exists that treatment can be among the most important

elements of comprehensive HIV prevention. How do we incorporate this into our work?  • How do we identify and meet the needs of the large number of people who would benefit

from beginning ART, many of whom are asymptomatic and have less incentive to seek HIV testing and may have less perceived reasons to remain in HIV care and treatment?  

2. Opportunities and Challenges for the Next Phase of Treatment and Prevention Scale-up  The advent of triple-combination antiretroviral treatment (ART) in the late 1990s changed the course of the AIDS epidemic. Reductions in morbidity and mortality with the use of ART have long been demonstrated for people living with HIV (PLHIV) who initiate treatment with fewer than 200 CD4 cells/mm. The World Health Organization (WHO) and other treatment guidelines have changed as evidence accumulates that starting treatment earlier provides better health outcomes for people with fewer than 350 CD4 cells. As a result of the change in WHO guidelines, which now recommend starting ART at <350 CD4 cells, the number of people recommended to begin ART by 2015 doubled. In May 2011, the results of a groundbreaking study begun in 2005 (known as HPTN 052) were released confirming that successful suppression of HIV viral replication with ARV drugs can prevent sexually transmitted HIV infection. The HPTN 052 results confirmed indications from less rigorous trials and observations showing that high rates of ART use by PLHIV cause a significant drop in subsequent HIV infection rates in certain populations and cohorts.2 Altogether, the findings offer clear proof that population-wide access to treatment with ARV drugs could be an important new addition to the toolkit of HIV prevention interventions.3 The

                                                                                                                         2 See UNAIDS Outlook Report 2010; available at http://data.unaids.org/pub/Outlook/2010/20100713_outlook_report_web_en.pdf. 3 The HPTN 052 study was a prospective, randomized trial (the “gold standard” of clinical trials). It compared two groups of heterosexual couples (a total of 1,750 couples in all) in which one partner was living with HIV, with the important caveat that at enrolment the HIV-positive partner was required to have a CD4 count above 350 cells/mm. In one group, the person living with HIV was immediately provided with ART; in the other group, treatment was delayed unless and until the CD4 cell level dropped to <250 or clinical symptoms of AIDS developed. Interim results announced in May 2011 showed a 96 percent

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findings that support the value of “treatment as prevention” are particularly important given the limitations of current prevention efforts.4 These new findings and their potential implications were discussed at length during the Bangkok and Johannesburg consultations organised by ITPC. Many participants were not aware of the HPTN 052 findings. Several expressed concern about a potential shift in resources, moving away from treating those most in need and towards a primary focus on the prevention-related use of ART. Currently, there are no known proposals to shift funding for treatment for ART-related prevention. However, such perceptions indicate that the concept of treatment as prevention will need to be better and more clearly explained to all actors in national and local HIV/AIDS responses, from community groups to policymakers. The impact of ART on prevention can be seen as an important component to provide combination prevention packages that will lead to reduced HIV transmission and incidence. This opportunity is further bolstered by other new prevention approaches including male circumcision; microbicides; and oral pre-exposure prophylaxis, also known as PrEP. Already in the prevention toolkit and implemented with varying impact were awareness and behaviour-change programmes; male and female condoms; interventions aimed to prevent mother-to-child transmission; and access to clean needles and other drug-injecting paraphernalia. Perhaps most important, the role of treatment as a prevention intervention offers a new way to conceptualize how AIDS services are delivered. In particular, it provides new opportunities to integrate HIV treatment and prevention services, which may require significant altering of current programmes, structures and approaches that consider them distinct and separate HIV service domains. HIV service delivery can be re-configured with a primary focus on ensuring that all those who meet current treatment guidelines have access to ART—along with the scale-up in HIV testing this requires. This will not only maximize the prevention benefit that treatment provides, but also provide a more efficient framework through which a combination of additional prevention interventions can be offered to people testing either positive or negative. In June 2011, at the UN General Assembly High Level Meeting on AIDS, member states committed to an ambitious set of goals including a 50 percent reduction in new sexual transmissions, elimination of vertical transmission and a total of 15 million people on ART by 2015.5 That commitment was secured partly in response to the promising new reports and developments. The good news and ambitious targets may not necessarily translate into success, however. The goals agreed to at the UN High Level Meeting are challenged by several longstanding and new obstacles. Perhaps the biggest one is the willingness of governments to provide sufficient resources to meet the goals and realize the potential. Billions of dollars have been spent over the past 10 years in scaling up HIV prevention, treatment, care and support; approximately $20

                                                                                                                                                                                                                                                                                                                                                                                                       reduction in risk of HIV transmission in favour of the group receiving ART. The findings were so overwhelmingly positive and statistically significant that the trial was immediately stopped four years ahead of schedule. More in-depth information about the results of HPTN 052 may be found online at The Lancet: www.thelancet.com/journals/lancet/article/PIIS0140-6736%2811%2960713-7/fulltext?rss=yes. 4 Issues regarding ARV pre-exposure prophylaxis (PrEP) are beyond the scope of this document and were not discussed in detail at the community consultations around which this document is based. 5 As cited in “Political Declaration on HIV/AIDS: Intensifying our Efforts to Eliminate HIV/AIDS” approved during the meeting. See www.un.org/ga/search/view_doc.asp?symbol=A/65/L.77.

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billion a year is needed through 2020 to speed up the process and reach all of those in need. This is a daunting goal in every respect. In terms of HIV treatment access alone, it is estimated that the number of people receiving ART should more than double from the current 6.5 million. The financial needs are greater at the very time that HIV/AIDS funding is stagnant and most traditional donors are reluctant to commit to increased finances. Governments in many high-burden countries are also not meeting commitments to boost health spending, including for HIV/AIDS. In addition to more funding, meeting treatment and prevention targets requires substantially increased scale-up of service provision and greater flexibility in how services are provided. Systems, structures, policies and advocacy must be strengthened to increase the availability and use of HIV testing and prevention services, to ensure good linkage to care and treatment, and to support people so that they can remain in care and use treatment effectively. People living with and affected by HIV and the organisations that represent them should be at the forefront of all of these efforts as both advocates for improved access and as critical contributors to service provision. The history and effectiveness of HIV community-based advocacy for treatment access and stigma reduction is well documented. In addition, evidence from around the world indicates that community-based service provision—for example, services provided in the community by community-based organisations (CBOs) as well as services provided by community members within health facilities—are crucial components of rights-based, high quality HIV services. CBOs have skills and access that can provide comparative advantages over services provided by traditional health care providers. While this is often the case in generalized epidemics, the community sector is often a primary source for services and support for members of key affected populations such as men who have sex with men (MSM), sex workers, and drug users. The growing recognition of the primary role of community engagement in the next phase of scale-up is a vital development for millions of people living with and affected by HIV. They comprise and rely on community groups for advocacy, services and support that other actors (including governments) are often unwilling or unable to provide effectively, if at all. The timing is right to make these advantages known and shift priorities accordingly. Community-based AIDS advocates and service providers understand that the confluence of treatment as prevention, the new WHO treatment guidelines, and the welcome emphasis on community mobilization among the HIV/AIDS donors and policymakers is an opportunity to demand a prominent increase in resources for community-based HIV responses.

2.1 Innovative models and approaches: Treatment 2.0

In the Indian context, if you are HIV-positive, lack of availability of treatment is not an issue. There are millions on treatment in India. The issue is that many people who test are not reaching ARV centres. Treatment 2.0 provides an opportunity to talk about civil society treatment services and greater involvement of PLHIV…including in helping overcome the gap between testing and actually getting on ART. —Loon Gangte, president of Delhi Network of Positive People, at community meeting in Thailand (May 2011)  

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Many of these priorities and challenges are carefully considered in the Treatment 2.0 agenda, which was initiated by UNAIDS and WHO in 2010 as part of an effort to rejuvenate efforts to achieve universal access to HIV prevention, treatment and care.6 The Treatment 2.0 initiative provides a solid framework for further scale-up of ART access based on current information and available resources. It aims to radically simplify HIV treatment in order to deliver the benefits to as many people as possible while reducing costs. To that end, UNAIDS, WHO and their partners have identified five pillars of Treatment 2.0 (which the agencies also call “priority work streams”):

• Optimizing drug regimens—making drug regimens less toxic, more effective, and easier to adhere to

• Providing point of care diagnostics—making viral load, CD4 cell test and other diagnostic and monitoring tools readily available and easier to use

• Reducing costs— an overarching workstream that comprises more efficient service delivery including task shifting, increasing access to and use of generic medicines, and encouraging price competition for drugs

• Adapting delivery systems—decentralizing treatment services and integrating with primary care services

• Mobilizing communities—scaling up community-based advocacy and service delivery to promote access to care and protect human rights

3. Role of Affected Communities in HIV Response Discussion at the ITPC-led community meetings centred around two overarching and complementary areas where community engagement is essential: advocacy (Section 3.1) and direct service provision (Section 3.2). Many community groups are already providing invaluable support and leadership in one or both areas. Yet the sector will need greater and more consistent resources in order to maximize its impact. 3.1 Advocacy roles and engagement  The role of HIV-affected communities as advocates is well documented, and includes:

• Monitoring and accountability of health systems and government responses • Ensuring access to high quality and equitable health services • Protection against stigma, discrimination, and criminalization efforts • Resource mobilization • Policy analysis regarding the development and delivery of essential medicines • Ensuring the meaningful involvement of PLHIV in policy and programme development

                                                                                                                         6 Other core partners in the Treatment 2.0 agenda include WHO; the world’s two largest sources of HIV/AIDS assistance—the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) and the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR); and numerous not-for-profit entities including ITPC and the Bill & Melinda Gates Foundation.

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Community advocacy responds to some of the most intractable reasons for gaps in access to HIV treatment and prevention services. The following challenges (many of which are interrelated) are common and ongoing in many contexts:

• infrastructure-related problems (especially those associated with transportation), • drug stock-outs (including for ARVs and medicines to treat opportunistic infections), • lack of access to diagnostic equipment, • inadequate nutrition, • lack of mobile facilities, • corruption, and • lack of awareness about HIV in general, which allows myths and misunderstandings to

flourish. Such challenges are often the result not only of limited financial resources, but also poor planning and organisation on the part of responsible health systems. Incompetence and corruption are often intensified by human resource constraints, especially when facilities are understaffed. Whatever the reason(s), the result is usually low quality or essentially nonexistent health services, including those related to HIV treatment, care and prevention.

3.1.1 Human rights and rights-based approaches An environment of safety in which people at risk for HIV can demand and use services without fear of stigma, discrimination and abuse of their human rights is a necessary prerequisite for implementation of all HIV treatment services, including those for prevention. Without sufficient human rights protection, seeking HIV services can often be more immediately dangerous than HIV itself. Meeting universal access targets requires both top-down programmes including legal reform and ground-up empowerment and mobilization programmes. Both are essential to ensuring that the rights of HIV-affected people and communities are protected and to ensuring the long-term success and sustainability of health services. What are “rights-based” services? Increasing demand for HIV care in a context that protects human rights. Rights-based services constitute services and advocacy activities that seek to strengthen and protect human rights. They can also refer to the provision of health and social services in ways that support and respect human rights. For example, a “rights-based” approach to HIV testing is one that respects confidentiality, provides appropriate information about the test and its consequences, and provides linkage to care and other support services. Mandatory testing, the release of test results to others without permission, and the failure to link testing to care lead to further stigma and discrimination and make it difficult if not impossible for patients to utilize HIV testing services effectively.  Some basic principles were outlined at the meetings:

• Guidelines determining the optimal time to start ART must be based on what is best for the individual patient. People living with HIV should not be expected to begin therapy for the primary purpose of preventing HIV transmission; the primary purpose of treatment is treatment. Patients should not be compelled to risk earlier development of ARV resistance and/or suffer drug-related side effects unless there is clear evidence that

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earlier use of ART can be beneficial for the patient in prolonging life and improving the quality of life.

• If resources are limited, decisions about who should receive ART must be based on the need to treat the sickest patients first and not based on perceived opportunities to prevent new infections. The best way to address this is to ensure that all those meeting current treatment guidelines have adequate access to ART and other health care services.

• The choice to use ART remains a personal choice. Patients have the right to decide not to take ART.

• The availability of second- and third-line treatment combinations is essential to long-term use of ART. This will be especially important as earlier treatment is considered to maximize both treatment and prevention benefits of ART.

• Access to HIV testing and linkage to care are human rights. A reframing of the global discussion about testing is needed in which early initiation of treatment, and thus testing, is recognized as a right. The role of communities is to remove the barriers that act as impediments to realizing that right.

• Access to information about the benefits and availability of treatment is also a human right. There has been reluctance in many countries to raise awareness about the availability and benefits of treatment. Meeting participants speculated that this is because governments do not want to increase demand that they do not have the resources to meet. However, increased awareness about the benefits of treatment should be seen not only as a right to information, but also as an important incentive to increase the use of testing and health services.

The following are recommendations from the consultations of advocacy-oriented human rights interventions for community organisations to take on that contribute to the realization of universal access treatment and prevention targets:

• Address factors outside the health system that impede access to care such as police violence, violence in the home, pervasive stigma, and fear and discrimination in employment

• Educate police, health care workers, local and religious leaders, and business leaders in order to change attitudes about living with HIV and about the people most vulnerable to HIV infection

• Hold global funding institutions like PEPFAR and the Global Fund accountable for their roles in funding governments whose HIV/AIDS policies violate human rights

• Document rights violations against PLHIV and key populations • Mobilize demand for the right to health

We talk a lot but don’t really act, including regarding stigma and discrimination and human rights violations. In most of West Africa for example, there is no treatment in prisons and we have reports showing high rates of HIV (around 30 percent) in prisons…but nothing is done. —Sylvère Bukiki, coordinator of ITPC’s West Africa region (based in Côte d’Ivoire), at community meeting in Johannesburg (June 2011)

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One of the most important human rights-related advocacy roles that communities can play is to combat HIV-related stigma and discrimination on the part of health care workers. Meeting participants considered this one of the biggest challenges to effective scale-up of comprehensive HIV services. Examples range from judgmental attitudes to breaches of confidentiality to outright denial of services. Such rights violations are seen as a key reason many people are reluctant to be tested for HIV or to seek care if needed. Key affected populations—e.g., men who have sex with men, sex workers, drug users, prisoners and migrants—often have insufficient access to essential HIV services, from prevention information to treatment. This happens in countries with generalized epidemics where the needs of key populations are often ignored, as well as in countries with concentrated epidemics, where key populations are most in need of services but discrimination against them is rife. Rights-based HIV programming often does not exist, or is only interpreted to extend to “regular” or “responsible” people who do not engage in controversial or criminalized behaviours. Resources are often not targeted toward those populations that most require services.  The lack of women’s rights and gender equity is an equally massive barrier and thus an essential advocacy priority. Women bear the brunt of HIV epidemics in many countries. Their vulnerability is particularly intense in Africa, where women comprise about 60 percent of all people living with HIV. Rapid scale-up of comprehensive HIV services will never succeed without addressing directly the issues that create and sustain this vulnerability. Community representatives acknowledge that women’s lack of power and rights is particularly pronounced in rural areas of many countries where traditional customs hold sway. Some of those customs cited during the community meetings, such as widow inheritance and wife cleansing, are not only violations of women’s rights but also pose major HIV transmission risks. Women are often forced or coerced into other risky situations by economic necessity. In some countries, such as South Africa, intergenerational sex is relatively common; young women often have little choice but to accept support from (and consequently have sex with) older men simply in order to survive. Women have fewer legal rights in many countries as well, a situation that further limits their ability to make independent choices for themselves and their families. When faced with gender-based violence and abuse they may have little or no realistic recourse due to social and legal conditions that isolate and shame them, even though they are victims. Stubbornly high levels of mother-to-child transmission of HIV in some countries also underscore the need for better advocacy and services for women. This persistent occurrence is especially outrageous because such transmission is easily and cheaply prevented when women and their families have access to even a basic level of services. The only excuse for continued high rates of vertical transmission—or, really, any vertical transmission at all—is lack of political will and prioritization by, in most instances, governments.

3.1.2 Accountability and monitoring Monitoring is a role of civil society groups everywhere. It promotes accountability—within government and within civil society itself—to expose corruption, rights violations, and poor performance. Independent monitoring also helps citizens recognize the recipients of public funds and priorities; increased transparency in this regard can help force allocations more in line with social needs, such as health. Monitoring is difficult and time-consuming. As many meeting representatives stressed, they and their counterparts often lack the capacity or understanding of how to do it efficiently (e.g.,

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monitoring expenditures and deciphering government budgets). They need adequate training and financial support to conduct this role adequately. Only a handful of governments in Africa, for example, have ever met their Abuja Declaration commitment (agreed to in 2001) to allocate at least 15 percent of their national budgets to health. Community advocates are already railing against their leaders for this failure, but they need additional support to make the campaigns more effective. Similarly, community groups need sufficient capacity to monitor the quality of services provided at all levels. This, along with systematic efforts to identify rights violations, is a role that only community groups can be expected to play effectively. No other sector has the requisite independence or trust among people living with and affected by HIV.

3.1.3 Intellectual property and trade issues  One of the most important trends in recent years has been the steep reduction—in some cases by more than 90 percent—in the price of many individual ARVs (at least those for first-line regimens). This trend stemmed from two complementary developments: strong and relentless community-based advocacy, and the growing availability of generic, lower-cost ARVs. Generic ARVs currently comprise some 90 percent of all HIV drugs procured and distributed in Africa; their lower costs are critical for the financial viability of many countries’ treatment programmes. Continued and improved access to generic ARVs is under threat, however. Many manufacturers of originator-brand medicines are strong supporters of proposed trade agreements between developed and emerging economies that require the latter to tighten patent laws. The European Union, for example, for many years sought to include provisions in a trade agreement being negotiated with India that would have crippled Indian generic drug manufacturers and severely constrained access to cheaper ARVs worldwide. The government refused to accept such demands, a decision it made at least partly in response to pressure from community-based activists in India and around the region. Another threat to access to generic ARVs is coming from national governments in some developing countries themselves. Most notably, the Kenyan government passed a law in 2009 that takes aim at “counterfeit” medicines. While these are usually defined as “fake” drugs, an unintended potential consequence of this new legislation and its poorly worded language is that generic medicines (including ARVs) can be considered “fake” and can be seized and prevented from distribution if charged with being counterfeit. This possibility has prompted some Indian drug companies to threaten to halt shipments to Kenya. If this happens, the Kenyan HIV programme would probably collapse: more than 300,000 Kenyans are now on ART regimens that are nearly exclusively composed of Indian-made generics. Activists in Kenya filed petitions against the new law and have secured a public hearing for later in 2011.7 If the petitioners succeed, their efforts will lead to amendments that clearly state that “generic” does not equal “counterfeit”. This potential outcome may only represent an initial victory in a much longer series of battles. The Kenya law has unfortunately spawned copycat bills in neighbouring Tanzania and Uganda, and officials in those two countries are so far impervious to opponents’ complaints.

                                                                                                                         7 The hearing at the High Court was originally scheduled for July 2011, but was subsequently delayed for at least two months. See www.anticounterfeitconcerns.info/news/123-new-dates-set-for-hearing-of-the-anti-counterfeit-court-case.

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Global and national advocates are increasingly worried that this trend will spread elsewhere. The EU-India dispute regarding patents and intellectual property issues, efforts by the United States to negotiate bilateral free trade agreements that sidestep international treaties, and the efforts to pass misguided anti-counterfeiting laws highlight the importance of ensuring that community groups have the knowledge and ability to conduct advocacy in complex areas such as international trade laws, intellectual property and patent protection. They are far more likely than national governments to approach such issues from the perspective of PLHIV and those in need of essential services, including affordable and accessible essential medicines.  

3.2 Service provision roles and engagement Despite the tremendous success over the past eight years in both increasing use of ART and reducing new infection rates, HIV testing rates are low, millions of people still need access to treatment, and new infection rates are unconscionably high. Meeting the UN High Level Meeting goals—by 2015: 15 million on ART, a 50 percent reduction in sexual transmission and elimination of vertical transmission—will require a large increase in service delivery. Figure 2 below illustrates the difficulties encountered in initiating and retaining people on ART. It provides an example from Mozambique that shows the attrition along the “cascade” of care from testing from HIV to being adherent on ART. The challenges presented here must be addressed if the High Level Meeting goals are to be met. Figure 2. Example of attrition in “cascade” of care

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Community-based providers can play a central role in efforts to increase demand for and use of HIV testing, prevention, treatment, care, and support services, including services to support retention in care and adherence to treatment. There is no single model applicable for every context or country; communities have different strengths and responsibilities depending on the nature of both the epidemic and the government response in their country or region. For example, some communities may prioritize community-based services through independent organisations reaching populations that cannot access government services, while others may prioritize strengthening community-based responses within the capacities of government health services through utilization of community health workers. Yet in general, community-based providers in all countries and regions have skills and reach that can augment those of traditional health care providers. Some of the more important of those advantages were identified by meeting participants and are highlighted in Table 1. Many of the treatment and prevention services listed in Table 1 are currently provided (if at all) exclusively by a specific type or level of health care worker within the formal health system. Often this stems from policies and traditions that may once have made sense, but are

increasingly obstacles to improved access. For example, there is little rationale for mandating that only doctors can administer and monitor ART. Such policies create bottlenecks and delays nearly everywhere, and the negative impact is especially problematic in places with shortages of health care personnel. The situation is exacerbated by the fact that such places tend to be where HIV is particularly burdensome across society. Task-shifting is therefore an essential priority. The shifting need not be only within formal health structures, but can be expanded to utilize the capacities, energy and knowledge

Table 1. HIV services and activities that community-based providers are uniquely placed to deliver

Treatment Prevention Advocacy

• Adherence support • Testing and counselling • Treatment literacy • Linkage to care/support services • Linkages to harm reduction

services • Management of health and

psycho-social needs following testing

• Disclosure support • Treatment delivery (a treatment

extension role for community organisations)

• Case management • Nutritional support

• Prevention of vertical transmission

• Harm reduction services (syringe exchange, opioid substitution therapy [OST], etc.)

• Sexuality education • Sexual and reproductive health

and rights awareness • Condom distribution • PrEP (pre-exposure prophylaxis)

education • Education on TB infection control • Contact tracing/partner

notification support • Client negotiation,

collectivization, peer outreach skills for sex workers

• Promotion of male circumcision • Post-exposure prophylaxis (PEP)

for sexual assault survivors

• Monitoring and accountability (health systems, government responses, rights abuses, quality of services)

• Quality assurance of health services

• Anti-stigma, anti- discrimination, and decriminalization efforts(legal support, law reform, lobbying)

• Policy analysis around access to and development of essential medicines

• Ensuring the meaningful involvement of people living with HIV in policy and programme development.

Testing…is key for underpinning the success of treatment scale-up. In Africa, we see that only perhaps 1 in 10 people know their status. But if people don’t know their status, there’s not much that can be done. This points to the need for greater treatment understanding and awareness. —Bactrin Killingo, ITPC’s Africa coordinator (based in South Africa), at community meeting in Johannesburg (June 2011)  

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available throughout society, especially among people directly affected by HIV. In regards to the ART example mentioned in the previous paragraph, with proper training and supervision, nurses and peer counsellors in health facilities and CBOs can prepare patients for treatment, dispense drugs regularly, and monitor their use (e.g., through diagnostic tests and regular follow-ups). More broadly, communities are well-placed to play more extensive roles in facilitating the initial engagement of patients into prevention and testing; assisting in the linkage from testing to health care and treatment; and providing support services to ensure sustainability and retention on treatment. They can also be directly involved in improving all aspects of a combination prevention approach, including the design and roll out of targeted behaviour-change support programmes, raising awareness about and providing linkage to male circumcision programmes, implementing syringe exchange and harm reduction programmes, and (ideally) explaining the rationale for and effectiveness of the treatment as prevention approach to patients. (The Web annex to this report contains numerous examples of community-based service delivery approaches, including several of the sort that are currently undertaken by participants at the ITPC-led community meetings.)

With adequate support, communities are often the best resource for monitoring and addressing the gaps in services for prevention, treatment and care such as low testing rates; lack of sustained prevention interventions; lack of appropriate pre-ART care, including TB screening and management of opportunistic infections; and lack of follow up for those for whom ART is indicated. The results of a recent study, for example, clearly indicate the benefits of community-based services to increase testing uptake (see Box 1.)

4. Funding Mechanisms: Meeting the Needs for the Next Phase of Scale-up  Unfortunately money (notably, lack thereof) is a major concern both globally and locally vis-à-vis the HIV/AIDS response. Collectively, major donors have failed to fulfil promises to continue increasing HIV funding in order to achieve universal access. Flat funding and cutbacks are occurring at the very moment when greater resources are needed to sustain recent

Box 1. Study highlights benefits of community-based services to increase HIV testing uptake Recent findings from an ongoing study (HPTN 043) underscore the benefits of community-based intervention to increase HIV testing and case detection. The randomised trial compared clinic-based versus community-based voluntary counselling and testing (VCT) in different communities in three countries, Tanzania, Thailand and Zimbabwe. Over a three-year period (2006-2009), the number of people having a first ever test for HIV was significantly higher at community-based sites (many of which included mobile services) compared with fixed site clinics in hospitals and health centres in all three countries. The difference was major in all three places: 10 times as many first HIV tests through community-based sites in Zimbabwe and four times and three times as many in Tanzania and Thailand, respectively. Researchers concluded that in all three settings, people were far more likely to be tested when such services were convenient and offered by providers not associated with formal health facilities. It is also notable that the findings focused only on clients aged 16-32, an age group particularly susceptible to HIV. (The results were reported in the July 2011 issue of The Lancet. For an abstract, see www.ncbi.nlm.nih.gov/pubmed/21546309.)  

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developments and begin the process of implementing programmes aimed at maximizing the potential of treatment as prevention and putting the Treatment 2.0 agenda into place. The slowdown in donor spending is not being compensated for by increases in government spending, even in countries that could clearly afford to allocate more for health in general and for HIV specifically. The failures are particularly pronounced in sub-Saharan Africa, as community representatives from that region regularly pointed out during the ITPC consultations. As noted in Section 3.1.2, governments across Africa in 2001 signed the Abuja Declaration, one key provision of which committed them to allocate at least 15 percent of their national budgets to health every year. Of the more than 50 signatories, fewer than 10 have met that commitment even once since 2001. The funding challenges are critical not only in regards to scaling up further, but just to maintain current levels. In the most dire cases, donors’ funding decisions can devastate poor countries that have long been reliant on external support for health and HIV programming. Recent strategic decisions by the UK Department for International Development (DFID), for example, are likely to prove catastrophic for people in need in Malawi and Nepal. After years of providing hundreds of millions of dollars in aid, the agency is withdrawing most support from those two countries. Ninety percent of Malawi’s health budget is provided by external donors, principally DFID, and in the current funding climate the government is unlikely to cover even a reasonable portion of the gap in the short- and medium-term. Comments from two consultation participants illustrate the concerns:

Once donors leave, what happens to programmes on the ground? In most cases, they will probably just die. This is a major concern. The question is whether governments have the willingness and capacity to take control of these programmes. —Boniswa Seti, TB/HIV training and advocacy officer of the AIDS and Rights Alliance for Southern Africa (ARASA), at community meeting in Johannesburg (June 2011) In Nepal there were over 150 support groups across the country…but most were shut down due to a lack of funding after DFID withdrew its support. There are many other examples across the region demonstrating that little attention is being paid to the sustainability of these services. —Shiba Phurailatpam, director of the Asia-Pacific Network of People Living with HIV/AIDS (APN+), at community meeting in Thailand (May 2011)

Increasing financial resources for HIV treatment, prevention and other services may be the best way to not only improve health outcomes, but also make resource investments cost-effective and reduce costs over time. A recently published model proposing new approaches to HIV investments, Towards an Improved Investment Approach for an Effective Response to HIV, provides an important framework for reallocation of HIV investments on evidence-based, epidemic-specific interventions coupled with a shift toward more community-based service delivery and support for advocacy and community systems strengthening.8 By increasing funding in the short term (2015) by one third, and in the medium term with annual funding 15 percent higher than current annual funding levels, considerable gains could be realized in                                                                                                                          8  The full text of the model, which appeared in The Lancet in June 2011, is available at www.pepfar.gov/documents/organization/166859.pdf.  

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infections averted and life years gained. The UNAIDS-sponsored model also concludes that these investments would also be remarkably cost-effective. This strategic investment framework provides an important for advocates as they seek to mobilize resources and re-prioritize spending.

4.1 Resource development for increased community capacity The impact of the global funding gap at local levels represents a clear obstacle to communities engaged in service provision and advocacy. Community representatives at the consultations stressed the need for additional financial and human resources not only to scale up to meet future needs (including as part of the Treatment 2.0 agenda), but also just to sustain current activities. If communities are to follow through on their roles as advocates and service providers, they need support to scale up their capacity. Following is a list of some of the main capacity building and funding needs of CBOs, as noted by meeting participants:

• Organizational development to strengthen administration and governance • Leadership renewal and development, including mentorship programmes • Support for relationship building, especially with human rights organisations • Network and communications infrastructure • Advocacy and research training, including on how international organisations and

funding mechanisms work • Treatment and research literacy • Fundraising and donor relations support • Quality assurance mechanisms for service delivery • Access to information about government policies and processes on issues such as

procurement, partnership agreements with donors, etc. • Capacity building on gender transformative approaches

Efforts have been made by some donor entities to support community-based work on HIV/AIDS. Most notably, the Global Fund has increased opportunities for funding to support community-based services, advocacy and capacity building through its community systems strengthening (CSS) framework9 as well as other structural and organisational mechanisms such as dual-track financing, targeted pool proposals, regional proposals, and non-CCM proposals.10 However, all these mechanisms have been under-utilized to date—and, where CSS activities have been proposed, they often end up strengthening the government sector instead.11 Global Fund support is potentially promising yet still imperfect. Community representatives involved in the ITPC-led process highlighted other needs and solutions to financing constraints, many of which are still in development, including:

                                                                                                                         9 Information about the Global Fund’s work in community systems strengthening is available at www.theglobalfund.org/en/civilsociety/reports/. An overview of its efforts and opportunities in this regard may be found in a document at that Web site called “Community Systems Strengthening Framework”. 10 Information about all of these mechanisms may be found at the Global Fund’s Web site: www.theglobalfund.org. 11 For example, see the Global Fund’s analysis of the amounts requested and types of CSS activities that were proposed by applicants in Round 10: www.theglobalfund.org/documents/civil_society/CivilSociety_Round10CommunitySystemsStrengthening_Analysis_en/.

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• Community groups need core funding to build and sustain their organisations. Project-specific funding is useful only when organisations have the ability to ability to maintain staff, have the flexibility to respond to emerging situations, and advocate for change. A combination of core and project funding is needed to build strong community organisations.

• Community groups need access to more funding from local and national sources, including governments and Global Fund grants. This would represent an important step away from dependence on often-fickle international donors. Many community representatives argue that there is plenty of money available in their own countries, including within the private sector, and that CBOs should focus more on such potential sources.

• Community groups need more information about what funds are available and how they are spent. Many multilateral and bilateral donors provide little or no information about where their money goes. This raises the likelihood that some is poorly spent or allocated, thereby reducing funding for community groups doing effective, efficient work. Community groups should insist on improved and transparent tracking of funds provided in-country by multilateral and bilateral entities. The Global Fund, for example, currently tracks funding only to the level of the Principal Recipient in most countries. There is no information easily available as to how much goes to individual sub-recipients or sub-sub-recipients; what types of activities these lower-level recipients spend it on; and whether these activities have any useful impact.

• Easier means of legal registration is an essential need for building strong and well-resourced community organisations.

5. Key Issues and Recommendations from Community Consultations

Many of the key recommended priority focus areas and activities noted by participants at the Bangkok and Johannesburg community meetings are listed below. All were considered important in terms of the successful eventual adoption of the Treatment 2.0 agenda, including treatment as prevention approaches. 1. Gather and disseminate more and improved evidence to:

a) highlight current gaps in HIV/AIDS programming, and b) demonstrate the impact of community-based advocacy and service delivery. Participants were particularly interested in spotlighting and perhaps replicating data from Mozambique showing the extent of “losses” from testing to care to ART (see Figure 2). Anecdotal evidence shows how and why greater community engagement can improve such poor outcomes, and for relatively small investments; more rigorous efforts can be made to show this impact. National and global advocates should therefore identify ways to design, fund and implement studies showing such impact.

We do everything in Bangladesh because our government is doing nothing….The government does not understand PLHIV needs or programmes, and it is difficult to teach them the issues every time. —Habiba Akter, Founder and Executive Director of Ashar Alo Society (AAS) in Bangladesh, at community meeting in Thailand (May 2011)  

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2. Develop improved tools to “know your epidemic” and identify effective interventions. Improved data collection is needed to better understand who is at risk of infection; the environment that creates HIV risk; and which interventions are most effective in reducing morbidity and mortality, improving quality of life and reducing HIV incidence. Resource allocations should then be prioritized based on the results of this information. Community groups are well placed to advocate for such evidence-gathering and participate in those efforts.

3. Increase investment now to save money in the long-term.

As the UNAIDS-sponsored strategic investment framework concluded (see Section 4), the most expensive thing a government can do is fail to scale-up HIV treatment and limit HIV funding. Failure to scale up services now will only increase costs for treatment, care and prevention in the long term. Advocates can and should make this case in their own countries as part of an effort to reorient global HIV/AIDS responses.

4. Develop and implement effective strategies and policies to address human rights

abuses and other violations perpetrated by health care workers. Most community representatives agree that these discriminatory attitudes and actions stem from lack of knowledge about HIV and the people who live with it. Models and approaches exist to deal with this problem. A consultation participant from Kenya noted that in Nairobi, it has been addressed by having fellow health workers educate other health workers. Other suggested approaches include mandatory classes on human rights in all medical schools; introducing courses on human rights in all primary and secondary school curriculums, and reinforcing the need for health care workers to abide by the core pillars of medical ethics (i.e., “do no harm” and respect the rights and privacy of all patients).

Whatever the approach, CBOs can play important roles in designing, implementing and monitoring impact. Their engagement is perhaps even more important earlier on, as they advocate with officials and authorities to recognize the need for such approaches.

5. Increase funding for research, testing and treatment for hepatitis C.

Hepatitis C rates are especially high among people living with HIV in many regions. Testing is often unavailable. Hepatitis C treatment should be considered a high priority in those regions and linked to HIV service delivery. Given the high costs of most current treatment options, community groups should collaborate regionally and internationally to advocate for lower prices for key therapies and greater access.

6. Health systems should prioritize task-shifting to meet universal access targets. Increasing the use of nurses, community health workers, peer educators and CBOs to provide HIV prevention, treatment and care is an essential component in meeting the universal access targets by 2015. UNAIDS and WHO should immediately develop a plan of action to fund, train, implement and support these efforts.

7. Integrate HIV services with other health services including TB, hepatitis C, maternal and child health, drug treatment and mental health services. The lack of integrated health services increases costs and redundancy. It also makes it considerably more difficult for people with HIV to engage in health care successfully. “One-stop shopping” models should be developed, and community members engaged to assist in navigating health services for patients.

8. Microbicides should be made available to women as soon as possible.

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In 2010, the results of the Caprisa 004 trial showed the benefits of tenofovir gel applied as a microbicide in prevention HIV transmission. This represents a vital breakthrough in longstanding efforts to identify a women-controlled preventive mechanism. Now that there is a viable product, getting effective microbicides into the hands of those who need them should be considered a high priority in the response to HIV.

9. Map and evaluate current capacity in the national NGO sector.

If communities and their organisations are going to fulfil their roles as advocates and service providers, they and their donors need a clearer picture of current capacity levels, gaps and redundancies

10. Train and support community advocates and organisations to better understand trade

and intellectual property issues. The continued and growing efforts to undermine protections of essential drugs in order to increase prices requires increased advocacy from affected communities. This is a complex area that requires training and support to ensure sophisticated advocacy approaches at country levels.

6. Conclusion The opportunity to drastically reduce deaths from AIDS and the further spread of HIV is within our grasp as never before. It is the lack of political will that is our greatest challenge. More than ever, people living with and directly affected by HIV will seek to overcome that challenge and stand at the forefront in responding to the AIDS epidemic. It is through their leadership that we can overcome stigma and discrimination, government neglect and corruption, and best meet the needs of the individuals and communities challenged by AIDS. Given the tools and resources they need to meet the challenge, these communities can lead toward an end to AIDS.

In December 2010, the UNAIDS adopted its new five-year strategy to realize its “Getting to Zero” goals. That strategy relies on the scale up of community mobilization, advocacy and service delivery for its success. Six months later, the UN General Assembly agreed on specific and ambitious goals to reduce HIV infections and AIDS deaths by 2015. Again, the success of these goals is dependent on community affected by HIV to mobilize, advocate and scale up service delivery. ITPC and the community participants involved in the development of this report call on UNAIDS to provide the coordination and leadership necessary to mobilize resources and implement policies that will allow communities to meet these challenges.