The Politics and Epidemiology of Transition

As South Africa (SA) and the US craft a new political relationship on AIDS, the stakes of success have never been higher. SA remains the country with the largest HIV epidemic in the world; yet, new science shows that an aggressive response could enable an epidemiologic transition, cutting HIV incidence and substantially improving overall population mortality. One of the most effective foreign aid efforts in history, the US President's Emergency Plan for AIDS Relief (PEPFAR) SA, now is managing the largest “transition” of a global health program—withdrawing direct staff and funding for the treatment of hundreds of thousands of HIV-positive patients as the SA public sector takes over. Recent commentary has painted an optimistic picture of the transition and “country ownership” in SA. 1, 2 In important ways, however, the politics are outpacing effective health policy and the accelerated process is undermining the prospects for “getting to zero. ” Thousands of patients and the health system have experienced significant disruption. PEPFAR should take urgent steps to ensure that the transition does not undermine hard-fought gains in SA. More broadly, the SA experience has important lessons for the future of aid to fight global HIV. PEPFAR AND THE CHANGING SA AIDS RESPONSE When PEPFAR arrived in SA in 2004, rollout of antiretroviral (ARVs) relied on a sustained effort from civil society led by the Treatment Action Campaign, NGOs, and provincial officials. The Mbeki government's denialist response to AIDS had cost more than 3. 8 million lost “person-years” by one estimate. 3 PEPFAR invested more than 3. 2 billion in the country to fund parastatals, NGOs, unions, private doctors, and universities to tackle the AIDS crisis. 4 By the end of 2010, the program reported “directly” supporting a million people on ARVs. 5 PEPFAR also helped to build much of the AIDS workforce, including thousands of doctors, nurses, adherence counselors, and data capturers. In recent years, the Presidency and Department of Health have reset SA AIDS policy, speeding ART rollout begun under activist pressure, increasing domestic funding, and building a new science-based National Strategic Plan to reshape the role of the SA public health sector on HIV. 6 SA's HIV treatment program is now the largest in the world. Household surveys confirm that more than 2 million people received ARVs in 2012. 7, 8 However, to reach the goal of universal access under the new World Health Organization guidelines, 9 the country needs to double the number of people who have access to treatment for HIV, as Figure 1 shows. FIGURE 1: Source: Treatment scale up, incidence, and mortality, 1990-2016. Graph is based on achieving 80% of the total 5. 3 million people in need as per US Agency for International Development (USAID) 2013. 10 New World Health Organization guidelines recommend treatment initiation at any CD4 cell count for children under 5, pregnant women, patients coinfected with tuberculosis (TB) or hepatitis, or seropositive persons in a serodiscordant relationship; all other patients testing positive should initiate treatment at CD4 counts <500. The good news is that the AIDS response is already decreasing mortality and incidence, increasing life expectancy, 11 and driving down child mortality. 12 If scale-up continues, modeling suggests for every 1% increase in ART coverage in highly affected areas, and risk of acquiring HIV declines by 1. 4%. 13 A model of combination prevention, especially with attention to key populations, could end SA's AIDS crisis, but it requires unprecedented scale. A NEW POLITICAL PARTNERSHIP PEPFAR was created as an emergency response with little coordination with the public sector. The program shifted under Ambassador Eric Goosby to work within the SA response, supporting more indigenous organizations and putting PEPFAR-funded staff and infrastructure into public health facilities. With public nurses working side by side PEPFAR-funded staff in the AIDS response while also providing antenatal care, the health effects from PEPFAR have cascaded. 14, 15 By the time the new PEPFAR Partnership Framework was signed in December 2010, SA was committed to supplying first-line ART to its population. As the country also joined the BRICS (Brazil, Russia, India, China, and South Africa) alliance of emerging economies, some in the US government questioned investments in treatment in the country. The new agreement called for a shift to shared governance and a transition of direct service “responsibility” to the SA government. 16 An immediate positive effect of the PEPFAR transition has been in governance. At the highest levels of the SA and American governments, a new commitment to shared leadership is yielding results. For the first time, the SA national plan is the driving force for US-funded programs. The Partnership Framework created new shared decision-making structures that are unique in the health aid. The Steering Committee, cochaired by the US Ambassador and the Minister of Health, provides high-level political oversight, whereas a Management Committee of US and SA officials makes key decisions about US-funded programs. 17 These bodies evaluate plans and even set the scope of Centers for Disease Control and Prevention and US Agency for International Development (USAID) grants and contracts. Decisions about PEPFAR SA increasingly come from Pretoria rather than Washington. The role of civil society in shared governance is still missing, however. CARE DISRUPTIONS With the new political agreement, PEPFAR systems began a process of transition from direct service provision with a speed that outstripped their ability to ensure positive patient and health system outcomes, as Ambassador Goosby recently recognized. 18 From both an ethical and a public health perspective, the biggest breakdown is perhaps the most critical: despite pledges to do so in the Partnership Framework, PEPFAR failed to ensure that patients did not experience disruption in ART and pre-ART care. During the transition, no systemic plan or PEPFAR-funded capacity to track supported patients was put in place to ensure, or determine, if they continued in care. The most significant problems occurred where patients were transferred out of NGO clinics, private medical practices, or public sector facilities because of the end of PEPFAR direct support. Evidence gathered by the author (the author conducted interviews in SA and the United States with over 75 people directly involved in the transition between July and September 2013) and reported in the media19–21 shows that some patients experienced dauntingly long waits, intense stigma, and poorly prepared staff. Clinics in many regions experienced stock-outs of ARV and tuberculosis (TB) drugs at the time of transition. 22 Some patients were turned away from overwhelmed public sector clinics that largely did not receive increased staff to deal with the influx of patients. Marginalized populations and pediatric patients have been especially at risk. Where PEPFAR was supporting public sector clinics that did not transfer patients out, PEPFAR-funded direct service staff were pulled out, including doctors, nurses, adherence counselors, and data administrators. In at least some of these clinics, “lost-to-follow-up” rates have risen and disrupted care in ways that could have been avoided. People in pre-ART care—a critical epidemiological group highly vulnerable to attrition23—have also not been systematically tracked to see if they remained connected to care. The only known estimate of patients lost to follow-up in the transition comes from a study by Harvard researchers Bassett et al in Durban showing that 19% of patients on ART who were transferred from a major PEPFAR site did not make even a first visit in the public sector. 24, 25 As this study measured only first visits, did not consider people in pre-ART care, and included subjects who were among the most motivated patients, paying out of pocket for part of their care, it likely does not show the full impact of the transition on transferred patients. 1 Table 1 summarizes a range of possible numbers of patients “lost” during the transition. As the transition began, PEPFAR reported providing “direct” treatment support to 1. 1 million people. 4 Today, officials report that PEPFAR directly supports only about 30, 000 patients and is in the process of transferring many of these. Although the Harvard study is likely conservative in estimating loss among transferred patients, it is possible that those supported in the public sector, despite withdrawal of direct service staff, experienced substantially less disruption than those at semiprivate facilities. It is noteworthy, though, that the estimates of Basset et al are consistent with research showing substantial patient “loss” at each step in the SA AIDS system and thus could be foreseen in a major transition. 23, 26, 27 However, even if we assume a fraction of the disruption, as illustrated in Figure 1, this still suggests tens of thousands experienced disruption. Estimates of the impact on those in pre-ART care—thousands more—are not available. TABLE 1: Estimated Patient “Loss” in Transition, Not Including Pre-ART CareStrategic implementation research before transition to develop best practices could well have avoided problems described here. In Western Cape, provincial government and PEPFAR officials ensured that a clear accounting of patients, staff, and public sector capacity was made before transition began. In most of the rest of the country, however, the pace of the transition was driven by contract end dates rather than readiness of the public sector. Though USAID and Centers for Disease Control and Prevention did grant case-by-case extensions, many contracts were rewritten to transition patients and staff by September 2012, before even a PEPFAR assessment of how many patients and staff positions needed to be absorbed by the public sector could be completed in November. 28 Retaining trained staff in the AIDS response has been a problem as slow public sector systems and hiring freezes have prevailed in much of the country. 29 Many physicians and nurses have moved out of direct services into “mentoring, ” whereas others have left the AIDS sector. In addition, PEPFAR and the SA government plans30 lack a coordinated strategy to retain thousands of the community health workers who have been critical to PEPFAR's success. A clear set of indicators and goals remain missing for technical assistance, and the move to make this the primary “treatment” intervention is jeopardizing PEPFAR's focused mission. In many facilities, staffing shortages mean nurses and administrators are so overwhelmed and “capacity building” in the form of training or improving record-keeping systems is ineffective. AN ALTERNATIVE APPROACH PEPFAR should identify ways to restructure its transition in SA to address the problems described here. As a first-order priority, PEPFAR should track previously PEPFAR-supported people living with HIV/AIDS from both the public and the NGO sectors and identify those who have fallen out of care. In addition to addressing the needs of those patients, this provides an opportunity to identify problems that can be addressed by capacity building. PEPFAR should also work quickly with the Department of Health to retain or recapture HIV-proficient staff for the AIDS response, even if it means continuing PEPFAR support for positions in provinces like Gauteng where hiring freezes are in place. PEPFAR can address the workforce deficit created by the transition with a blended model at the site level in which capacity building happens as clinicians provide direct service. A more nuanced overall strategy in SA would combine direct services and technical assistance. While moving away from first-line ART, PEPFAR could focus on excellence where the public sector struggles. PEPFAR could continue to build capacity while providing clinical services for key populations, second- and third-line ARTs, complex and pediatric cases, and TB–HIV needs. Outside the country, the PEPFAR SA experience suggests an important reality: transitioning away from direct services is not compatible with scaling up to reach an “AIDS-free generation. ” In the wealthiest middle-income country in Sub-Saharan Africa, with a comparatively strong infrastructure, the struggle to reach universal access is straining the health system to near breaking. 29 Even if Uganda or Malawi could scale their economic growth rates to 10% a year, it would be more than a decade before they would qualify as middle income. 31 The limits of gross domestic product as an indicator of a country's ability to finance the HIV response, meanwhile, are obvious in Nigeria where the health system ranks among the worst performing in the world. 32 Talk of transition is premature but common in planning discussions in most PEPFAR-supported countries and risks sacrificing the potential for major epidemiological impact. It is time for the US government to publicly clarify that PEPFAR will remain focused on service delivery scale-up in low- and lower middle–income countries and is not “transitioning” before the epidemic does. Building on the strengths of the SA transition, PEPFAR can refocus country ownership on governance and show how comanagement with government breeds success. If PEPFAR also incorporates civil society, as a recent State Department communication outlined, 33 it could build a transformative model of global health aid. How SA succeeds or stumbles in responding to HIV echoes far beyond SA. With the largest HIV treatment program in the world, SA is the example for the world and it is innovating rapidly. If scale-up succeeds, the benefits will be felt throughout SA—but so too will failures. As such, the United States has a continuing essential role in helping ensure success in the country to achieve the US policy goal of AIDS-free generation.