President's Emergency Program For AIDS Relief Research Articles

PabloYanguasWhy We Lie About AidLondon: Zed Books, 2018. 275 p.

Development aid is so riddled with contradictions, controversies, equivocation, and hypocrisy that almost any critique, left or right, is welcome—as is this one. The basic argument presented here is that development is a transformational process that requires institutional change. As such, it creates winners and losers. Therefore, only a political understanding of the development process and an approach to supporting it rooted in political analysis can achieve desired change. The author offers his own understanding of how such an approach, which he styles “contentious development politics,” should be designed. Foreign aid is a political football in donor countries, instrumentalized by political forces to project their values and priorities. The usual fracture is between a conservative view that aid is a disincentivizing boondoggle and a progressive one that it is a moral imperative that can deliver tangible results for both donor and beneficiary. Some implications are straightforward and obvious: the Americans are big on private sector development and civil society, the Swedes on gender equality, the Danes on human rights, for example. But there are aberrations: on the right, for example, President George W. Bush's PEPFAR (President's Emergency Program for AIDS Relief) and the catalyst that that conservative president provided for the Millennium Development Goals in Monterrey in 1999. Caught up in the political winds of development assistance is the aid establishment, whose members depend for a living on the fiscal largesse and ideological stance of donor governments. But the fact that aid is used to pursue favored political objectives or please selected political constituencies is not the main point of the book. The main point is that the implementation of aid programs and projects has become dominated by (Tony) Blairite New Public Management or, to use the author's preferred term, Value for Money (VfM). The VfM hydra has many heads, but prominent among them are logical frameworks (“logframes”), theories of change, SMART (Specific Measurable Assignable Realistic Time-related) indicators, Results-oriented Monitoring (RoM), randomized control trials (RCTs), “lessons learnt,” etc. Taken as a whole, these are supposed to promote a culture of tracking whether and why assistance, translated into actions, translated into results, translated into tangible beneficial impacts on target populations—or did not, as the case may be. The problem, the author argues, is that fetishization of efficiency along these lines— John Foster Dulles called it “bang for the buck” in the nuclear strategic context, and the phrase travels well—distorts aid in the direction of interventions with quantifiable bang (and, the author might have added, good photo ops for the Ambassador and funding agency representatives). More transformational, long-term, long-shot, interventions—say in rule of law or democratic governance or conflict prevention or gender or civil society strengthening; where an entire way of life is being interrogated—are underfunded unless there is a tight security sector link. The argument is supported by credible, in-depth case studies on Sierra Leone, Liberia, and Honduras. The symbiotic relationship between aid providers and recipients is analyzed, yet somehow lacking in the analysis is global realpolitik: the money has to flow. It has to flow to strengthen strategic relations between donor and recipient countries. It has to flow to support an important client class. The theme of subalternity is never pursued in depth and that most overused word in the aid world, “partnership,” is never really queried, although the author is well positioned to do both. Despite his experience treading the halls of major development agencies, the author never quite comes to grips with the micro-experience of the program officer, tasked with pushing massive amounts of money out the door under time pressure and the exquisite scrutiny of auditors, evaluators, politicians, and civil society organizations. It is only at the level of individual incentives that the question why we lie about aid is best engaged. So, some critical opportunities were missed. But that said, the book is well written, informative, and entertaining. Its strongest point is that the author, a researcher at the University of Manchester, is also an experienced consultant to aid agencies, giving him a perceptive combined town-and-gown perspective. Bibliography; index.

Men with Money and the “Vulnerable Women” Client Category in an AIDS Epidemic

Why have African men been largely overlooked in HIV policy and programs, while poor women are almost always targeted? Men are more likely to die of AIDS than women, and multiple studies in Africa find that wealthier men are more likely to be infected with HIV than are poor men. We draw on survey and ethnographic data from rural Malawi, a country in southeastern Africa that has experienced a major AIDS epidemic, to examine this puzzle of the “missing men.” Using longitudinal survey data collected at the height of Malawi’s epidemic, we find that not only are wealthy urban men more likely to be HIV positive, but so too are rural men who are wealthy by rural standards. We further advance our argument using ethnographic data to show that rural Malawians understand that men with money are a risk, both to themselves and others. We then systematically analyze HIV policies and documents from the World Health Organization (WHO), UNAIDS, and the President’s Emergency Program for AIDS Relief (PEPFAR)—large international organizations at the forefront of responding to AIDS—to identify the extent to which women and men and poverty and wealth appear as targets. We present evidence showing that women, who appear in these documents more than twice than do men, are framed as unquestionably vulnerable and in need of aid, whereas men are overlooked. We argue that the international discourse on AIDS in Africa cannot be conceived of as separate from the broader discourses of economic development. The campaigns by international donors and NGOs to protect poor women while sidelining men with money gives an incomplete picture of AIDS epidemics.

Implementing the global health security agenda: lessons from global health and security programs.

The Global Health Security Agenda (GHSA) describes a vision for a world that is safe and secure from infectious disease threats; it underscores the importance of developing the international capacity to prevent, detect, and respond to pandemic agents. In February 2014, the United States committed to support the GHSA by expanding and intensifying ongoing efforts across the US government. Implementing these goals will require interagency coordination and harmonization of diverse health security elements. Lessons learned from the Global Health Initiative (GHI), the President's Emergency Program for AIDS Relief (PEPFAR), and the Cooperative Threat Reduction (CTR) program underscore that centralized political, technical, and fiscal authority will be key to developing robust, sustainable, and integrated global health security efforts across the US government. In this article, we review the strengths and challenges of GHI, PEPFAR, and CTR and develop recommendations for implementing a unified US global health security program.

The Expanding Role of Civil Society in the Global HIV/AIDS Response

Civil society has been part of the HIV/AIDS response from the very beginning of the epidemic, often becoming engaged before national governments. Traditional roles of civil society--advocacy, activism, serving as government watchdog, and acting as community caretaker--have been critical to the response. In addition, civil society organizations (CSOs) play an integral part in providing world-class HIV prevention and treatment services and helping to ensure continuity of care. The President's Emergency Program for AIDS Relief (PEPFAR) has significantly increased the global scale-up of combination antiretroviral therapy reaching for more than 5 million people in developing countries, as well as implementation of effective evidence-based combination prevention approaches. PEPFAR databases in 5 countries and annual reports from a centrally managed initiative were mined and analyzed to determine the numbers and types of CSOs funded by PEPFAR over a 5-year period (2006-2011). Data are also presented from Uganda showing the overall resource growth in CSO working for HIV. Case studies document the evolution of 3 indigenous CSOs that increased the capacity to implement activities with PEPFAR funding. A legacy of PEPFAR has been the growth of civil society to address social and health issues as well as recognition by governments that partnerships with beneficiaries and civil society result in better outcomes. Scale-up of the global response could not have happened without the involvement of civil society and people living with HIV. This game changing partnership to jointly tackle the problems that countries face may well be the greatest benefit emerging from the HIV epidemic.

Pharmacovigilance and global HIV/AIDS

This review focuses on current status, progress, challenges and opportunities in global pharmacovigilance for HIV/AIDS treatment. Over 6 million HIV-infected individuals worldwide are on treatment with more than 150 innovator and generic antiretroviral drug products. This achievement is made possible through sponsorship of HIV/AIDS programs [The Global Fund to Fight AIDS, Tuberculosis and Malaria; the President's Emergency Program for AIDS Relief (PEPFAR)] and the availability of generic fixed-dose combination products. The WHO prequalifies generic drug products used by Global Fund programs; the US Food and Drug Administration tentatively approves generic products used by PEPFAR programs through a fast-track review process. Adequate national or regional quality and safety monitoring systems after drug distribution are lacking. The pharmaceutical sector, a significant player in pharmacovigilance in the developed world, has not been engaged. Innovative approaches based on collaboration and partnerships will be needed. Clinic-based or program-based cohort studies, randomized clinical trials and electronic medical records may contribute pharmacovigilance-relevant information. Attention to drug quality and safety is obligatory for long-term program sustainability. Systematic approaches to regional pharmacovigilance that make use of diverse data sources, and collaborative partnerships between industry, clinical and/or research programs and national health authorities can potentially contribute to overall health system strengthening.

HIV and cancer in Africa: mutual collaboration between HIV and cancer programs may provide timely research and public health data

The eruption of Kaposi sarcoma (KS) and aggressive non-Hodgkin lymphoma (NHL) in young homosexual men in 1981 in the West heralded the onset of the human immunodeficiency virus (HIV) infection epidemic, which remains one of the biggest challenges to global public health and science ever. Because KS and NHL were increased >10,000 and 50-600 times, respectively, with HIV, they were designated AIDS defining cancers (ADC). Cervical cancer (CC), increased 5-10 times was also designated as an ADC. A few other cancers are elevated with HIV, including Hodgkin lymphoma (10 times), anal cancer (15-30 times), and lung cancer (4 times) are designated as non-AIDS defining cancers (NADCs). Since 1996 when combination antiretroviral therapy (cART) became widely available in the West, dramatic decreases in HIV mortality have been observed and substantial decrease in the incidence of ADCs. Coincidentally, the burden of NADCs has increased as people with HIV age with chronic HIV infection. The impact of HIV infection on cancer in sub-Saharan Africa, where two thirds of the epidemic is concentrated, remains poorly understood. The few studies conducted indicate that risks for ADCs are also increased, but quantitatively less so than in the West. The risks for many cancers with established viral associations, including liver and nasopharynx, which are found in Africa, do not appear to be increased. These data are limited because of competing mortality, and cancer is under diagnosed, pathological confirmation is rare, and cancer registration not widely practiced. The expansion of access to life-extending cART in sub-Saharan Africa, through programs such as the Global Fund for AIDS, Malaria, and Tuberculosis and the US President's Emergency Program for AIDS Relief (PEPFAR), is leading to dramatic lengthening of life of HIV patients, which will likely influence the spectrum and burden of cancer in patients with HIV. In this paper, we review current literature and explore merits for integrating cancer research in established HIV programs to obtain timely data about the incidence and burden of cancer in HIV-infected persons in Africa.

One Casualty of Global Economic Crisis: Uncertain Finances for HIV/AIDS Programs

IN LESS THAN A DECADE, IMPOSSIBILity turned the corner into reality. Infusions of cash and technical support from international donors, as well as growing political will in some developing countries, have provided lifesaving antiretroviral drugs to an estimated 5 million people living with HIV/ AIDS in resource-poor regions. But now the global HIV/AIDS community must find a way to turn yet another corner by maintaining those 5 million patients on antiretrovirals and offering the drugs to millions more in the midst of a persistent global economic crisis. Even though the downward economic spiral began nearly 2 years ago, AIDS officials say the impact on international donors’ ability to meet funding and treatment goals for the next 4 to 5 years still is not clear. In 2008, the last full year for which data on funding commitments and actual disbursements are available, international donors promised US $8.7 billion for HIV/ AIDS programs. They delivered $7.7 billion. The gap between promises made and promises kept was substantially smaller in 2008 than in recent years. For example, international donors had committed to $6.6 billion in 2007 but paid $4.9 billion; in 2006, commitments totaled $5.6 billion compared with $3.9 billion paid out. International donors’ commitments in 2009 were nearly the same as in 2008, said Paul DeLay, MD, deputy executive director of the programme branch at the Joint United Nations Programme on HIV/AIDS (UNAIDS), which compiles the data. “But that’s because of money that was already in the pipeline,” he noted. Release of data on disbursements in 2009 is expected to coincide with the XVIII International AIDS Conference in Vienna, Austria, in July. For 2010, DeLay said, all commitments for HIV/AIDS, including funds from international donors, private sources such as philanthropic foundations, and the countries themselves, total about $16 billion. But UNAIDS has estimated that about $25 billion is needed this year to meet HIV/AIDS needs in lowand middle-income countries. “I don’t think that within the year we’ll be able to catch up; that’s about 35% to 40% that we still need to go,” he said. “When we ask [international donors] about future commitments, because of political implications, the donors are a little hesitant to give us real numbers,” he added. A couple of exceptions are Italy and Ireland, which have informed UNAIDS that they will reduce assistance they provide for global HIV/AIDS programs. “I’m struck by the realities of how long this economic crisis has lasted and we still don’t understand the longterm implications,” DeLay said. “The damage done to developing countries or the resilience of developing countries—we still don’t understand that.” WORLD’S MAJOR PLAYERS The 2 largest international donors for global HIV/AIDS programs are the United States, which provided about 51%, and the United Kingdom, about 13%, of the $7.7 billion paid out in 2008. The President’s Emergency Program for AIDS Relief (PEPFAR), which was initiated in 2003 by former US President George W. Bush, and the Global Fund to Fight AIDS, Tuberculosis and Malaria, which was created in 2002, provided the kick-start needed to provide antiretrovirals and to scale up health care capacity in developing nations. Since its inception, PEPFAR has provided about $32 billion, including $5 billion for the Global Fund and $950 million for tuberculosis programs. The Global Fund acts as a financier that takes in donor pledges and awards grants to support services in developing nations. Awards from the Fund represent about 20% of all HIV/AIDS funding from donor countries. Their results are impressive. The Global Fund, since its beginning, has disbursed funds that provide antiret-

HIV/AIDS-related Human Security Risks for Young Women in Rural Uganda

Structural inequities, violence and oppression render young women in rural Uganda highly vulnerable to HIV/AIDS. Their decision-making powers, control over their bodies and sexuality, and access to sexual health resources are critically limited or wholly absent. Yet, prevailing HIV/AIDS programming, notably the President's Emergency Program for AIDS Relief (PEPFAR), emphasizes individual behaviour change to combat HIV/AIDS at the expense of wider societal considerations. This study explores the life experiences of a group of young Ugandan women and argues that the political and ideological battle of ownership - national as well as global - over the HIV/AIDS prevention discourse not only disregards these young women's experiences, but also undermines their human security by further exacerbating their vulnerability to the disease. I maintain that if HIV/AIDS interventions are to be effective, the complex and nuanced socio-economic and cultural factors of local context must inform national and distal global policies and programming priorities.

Outcomes of a young ARV clinic within an established Family Practice

The letter reports on outcomes of a private HIV/AIDS clinic and questions its safety. The clinic (site 282) is a satellite to a PEPFAR (presidents emergency program for aids relief) funded and AURUM health supervised program. The clinic identifies itself from being different to the other programs in that it operates from within an established private Family Practice, has two specific doctors and limited counseling and no nurse support. In the rest of its content it has the same constraints as the government clinics. Using four recently published reports on HIV/AIDS programs it compares and comments on early outcome data. The conclusion is that provided good data are kept and improved with time, it would be safe to continue in this model.

Ritonavir/saquinavir safety concerns curtail antiretroviral therapy options for tuberculosis–HIV-co-infected patients in resource-constrained settings

Tuberculosis is the most common serious opportunistic infection associated with HIV infection in sub-Saharan Africa, and a strong case has been made for integrating tuberculosis and HIV care [1]. In those settings where the tuberculosis and HIV epidemics converge, existing tuberculosis programmes provide an opportunity for efficiently identifying those HIV-infected patients who are eligible for antiretroviral therapy (ART), as well as for initiating this therapy in order to utilize the existing tuberculosis directly observed therapy infrastructure. This approach is, however, dependent on the availability of effective, safe and affordable antiretroviral regimens that are compatible with the standard treatments for tuberculosis, including rifampicin. As a result of cost considerations, the widespread use of alternative rifamycins, such as rifapentine or rifabutin, is not feasible in resource-constrained settings. Current guidelines, such as those from the US Department of Health and Human Services, suggest that regimens based on the non-nucleoside reverse transcriptase inhibitor efavirenz be used as first-line choices in patients receiving concomitant rifampicin [2]. Therapy choices become far more difficult in the face of treatment-limiting toxicities, virological failure or pregnancy. In these cases, a protease inhibitor-based regimen is needed as nevirapine may not be an appropriate option because of its interaction with rifampicin and additive hepatic toxicity. The guidelines suggested the use of ritonavir-boosted saquinavir [2]. Although the ability of ritonavir to boost plasma concentrations of saquinavir is well described, there is only limited evidence that this combination is adequate to counteract the enzyme induction caused by rifampicin and is clinically effective [3,4]. The issue of a ‘Dear Health Care Provider' letter by Roche Pharmaceuticals on 7 February 2005 has now caused considerable additional uncertainty [5]. The manufacturers have informed the US Food and Drug Administration of problems experienced in a phase I, randomized, open-label, multiple-dose clinical pharmacology study in healthy volunteers. Of 28 patients given rifampicin 600 mg once a day together with ritonavir 100 mg and saquinavir 1000 mg twice a day, 11 (39.3%) had developed significant hepatocellular toxicity during the 28-day study period. In the light of this evidence, the continued use of this combination cannot be supported. As a consequence, the US Food and Drug Administration Advisory has now removed the only protease inhibitor-containing regimen recommended for use concurrently with rifampicin containing tuberculosis treatment, and has thereby reduced the therapeutic options available for those requiring ART beyond standard first-line therapy options. In the absence of direct advice to the contrary, two options are being explored that we feel to be questionable. Some have argued that the exact doses of ritonavir and saquinavir used in the pharmacokinetic study (100 mg and 1000 mg, respectively) were different from those used in practice (400 mg and 400 mg, given twice a day), thus justifying thte continued use of this combination. Others have argued that adding additional ritonavir to co-formulated lopinavir–ritonavir would be sufficient to overcome the hepatic enzyme induction caused by concomitant rifampicin. However, in an open-label, randomized trial of two such dosing regimens in health volunteers, 12 out of 32 subjects withdrew from the study [6]. For nine of these, the co-administration of lopinavir–ritonavir and rifampicin was associated with elevations in liver enzyme levels. The similarity to the outcome of the saquinavir–ritonavir pharmacokinetic study cannot be ignored. The remaining options are, thus, either to switch to a triple nucleoside regimen or to cease further antiretroviral therapy until the completion of the rifampicin-containing tuberculosis treatment. Until recently, the multitude of studies on alternative treatment regimens has focused on the needs of the developed world where ART has been widely available and switching options are increasingly important. The Global Fund Against AIDS, TB and Malaria, the WHO's 3-by-5 programme, the US President's Emergency Program For AIDS Relief (PEPFAR) and local efforts are slowly increasing access to ART in resource-constrained regions such as sub-Saharan Africa. The newly described toxicity of the rifampin, saquinavir, ritonavir regimen thus vividly highlights the great need for research, particularly pharmacokinetic studies, also to address the ART options appropriate for resource-limited settings, and in particular, in this instance, for co-administration with rifampicin-containing tuberculosis treatment. Sponsorship: The START trial is supported as part of CAPRISA by the National Institute of Allergy and Infectious Diseases, National Institutes of Health, US Department of Health and Human Services (grant no. U19AI51794).