5
Managing Scale-up of Antiretroviral Therapy

Antiretrovirals (ARVs) alone are not the answer to the HIV/AIDS pandemic. Linked inextricably to the ultimate success of these drug interventions are logistics systems that ensure the safe and timely procurement and delivery of the drugs and other commodities to their intended destinations, and to the people whose lives depend on them. Antiretrovial therapy (ART) scale-up will require tens of thousands of health care workers with the experience and training needed to treat so many people with a complex medical intervention. Well-functioning countrywide ART programs will also require significant investments to build the capacity of a broad range of other technical and managerial expertise, from data analysts to procurement strategists to supervisory personnel. Additionally, ART scale-up will require dedication of the necessary funds and other resources to the enormous task of securing and delivering effective drugs. Finally, both dedicated resources and processes will be needed to establish and maintain harmonized monitoring and evaluation systems that will not only measure the effectiveness of ART programs and outcomes, but also inform the ongoing improvement and optimization of the clinical and management operations of scale-up. An integrated management structure that includes these principal components will be necessary for the long-term success of ART programs.

BUILDING HUMAN RESOURCE CAPACITY

Although scientific data on health care personnel in resource-constrained settings, particularly sub-Saharan Africa, are extremely difficult



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Scaling Up Treatment for the Global AIDS Pandemic: Challenges and Opportunities 5 Managing Scale-up of Antiretroviral Therapy Antiretrovirals (ARVs) alone are not the answer to the HIV/AIDS pandemic. Linked inextricably to the ultimate success of these drug interventions are logistics systems that ensure the safe and timely procurement and delivery of the drugs and other commodities to their intended destinations, and to the people whose lives depend on them. Antiretrovial therapy (ART) scale-up will require tens of thousands of health care workers with the experience and training needed to treat so many people with a complex medical intervention. Well-functioning countrywide ART programs will also require significant investments to build the capacity of a broad range of other technical and managerial expertise, from data analysts to procurement strategists to supervisory personnel. Additionally, ART scale-up will require dedication of the necessary funds and other resources to the enormous task of securing and delivering effective drugs. Finally, both dedicated resources and processes will be needed to establish and maintain harmonized monitoring and evaluation systems that will not only measure the effectiveness of ART programs and outcomes, but also inform the ongoing improvement and optimization of the clinical and management operations of scale-up. An integrated management structure that includes these principal components will be necessary for the long-term success of ART programs. BUILDING HUMAN RESOURCE CAPACITY Although scientific data on health care personnel in resource-constrained settings, particularly sub-Saharan Africa, are extremely difficult

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Scaling Up Treatment for the Global AIDS Pandemic: Challenges and Opportunities to collect, WHO surveys and general reports indicate that human resource capacity is generally extremely weak in such settings and in many places is a critically limiting factor in providing access to ART. In fact, some evidence suggests that ART scale-up could fail on these grounds alone (Kober and Van Damme, 2004). Many of those countries with the highest numbers of people living with HIV/AIDS have very few health care providers trained in comprehensive care for the disease (Liese et al., 2003; USAID, 2003). Many health workers have died as a result of untreated AIDS, and others have moved to wealthier countries in search of better pay and job security (Padarath et al., 2003; Pang et al., 2002; Tawfik and Kinoti, 2001). (For an extended review of human resource capacity considerations, see Appendix C.) In acknowledgment of this situation, WHO’s 3-by-5 plan calls for the rapid training of tens of thousands of workers to aid in the delivery of ARVs. However, the medical complexity of HIV/AIDS therapy cannot be overestimated. Nor can the logistical complexity of reliably delivering ARVs to their intended destinations—a recurring process that can demand significant organizational skill and infrastructure—be ignored. Rapid scale-up will require sufficient expertise in all of the various nonmedical components of ART programming, as well as the more obvious health-sector roles. The problem is compounded not only by the shortage of trained workers with specific HIV/AIDS experience or expertise, but also by severe shortages in many resource-constrained settings of the well-trained professionals needed to handle other critical functions, such as commodity logistics, pharmaceutical regulation, laboratory support, information management, and operations research. The seriousness of the situation is illustrated by an October 2003 report analyzing the cost and resource requirements associated with providing ART through the Zambian public health sector (Kombe and Smith, 2003). Despite key findings indicating that the provision of highly active antiretroviral therapy (HAART) to all clinically eligible patients will be prohibitively expensive, the report suggests that human resource capacity may become the most critical rate-limiting factor. In the report, the estimated per-patient cost of the health care training necessary for public-sector ART scale-up in Zambia, with an initial goal of providing ARVs to 10,000 people, is US$3.70, which amounts to a total overall cost of $37,000 per year. That amount, which represents less than 1 percent of the estimated total per-patient cost (i.e., $488), would cover the marginal requirement for the estimated additional 13 full-time equivalent (FTE) doctors and nurses, 15 FTE pharmacists, and 32 FTE laboratory technicians needed to provide ART to 10,000 patients. Although the demand for laboratory technicians poses a challenge, meeting the overall workforce needs for achieving Zambia’s initial scale-up goal is quite fea-

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Scaling Up Treatment for the Global AIDS Pandemic: Challenges and Opportunities sible, and the amount of funding necessary to bring the workforce to full capacity is relatively minimal. The low per-patient cost of training compared with the cost of the drugs and other components of scale-up suggests that serious, well-planned investments in health worker training would be an extremely cost-effective move. On the other hand, 10,000 people still represent only about 10 percent of the total number of Zambians currently in need of ART, and many more infected but currently immunocompetent Zambians will join these ranks over the next decade. Providing full ARV coverage for the entire clinical population in need, as it stands now (i.e., about 100,000 people, rising to about 330,000 in 5 years, but also assuming a 20 percent mortality rate), would marginally require an additional 130 FTE nurses and physicians in the first year and 429 by the fifth year, and 316 laboratory technicians in the first year and more than a 1,000 by the fifth year. And these estimates do not even begin to address additional voluntary counseling and testing (VCT) staffing needs. Clearly, the human workforce needs for full coverage are immense. Throughout sub-Saharan Africa in particular, the reality of the human resource situation is sobering, as these accounts and a wealth of qualitative reports attest (Kober and Van Damme, 2004). Recent data related to the overall health-sector human resource crisis in Africa and collected for the U.S. Agency for International Development (USAID) reveal that newly constructed health facility structures, including clinics and hospitals, remain unstaffed or understaffed throughout sub-Saharan Africa, as general efforts to expand the network of such facilities have greatly outpaced efforts to build human resource capacity. For example, despite vigorous efforts by the government of Mali to expand the number of its community health centers to 533, 43 percent of these centers were not functioning as of January 2001, with the remainder not operating because of a shortage of personnel to staff them (Lynch and Diallo, 2001; USAID, 2003). As it takes 3 to 4 years to train and deploy nurses and 5 or more years to train and deploy physicians, it is clear that without sufficient and aggressive training initiatives, this gap between physical infrastructure and human resource capacity will continue to widen. Given the desperate and growing demand for health workers and the losses of trained workers to better jobs in more well-to-do countries, many African nations have reportedly been encouraged to adopt human resource policies that lead to the deliberate overproduction of health workers to fill the growing gaps in human resource capacity. Filling these gaps is not a simple task, however, as the African health sector’s human resource crisis is multidimensional and involves a complex set of underlying upstream and more-proximal causal factors (Puku, 2002; Narasimhan et al., 2004; Schwab, 2001). The problem encompasses not just the scarcity of well-

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Scaling Up Treatment for the Global AIDS Pandemic: Challenges and Opportunities trained health workers, but also generally poor morale and staff motivation, insufficient management, an imbalance between urban and rural workforces, and strains on human resources caused by infrastructure changes and new, unfamiliar practices and technologies (see Table 5-1). The burden of HIV/AIDS, which amounts to nearly one-fifth of the disease burden in sub-Saharan Africa, has not only dramatically increased the patient volume and associated workforce needs, but also led to the death of many health workers. According to one report, AIDS-related mortality accounts for 19 to 53 percent of all deaths among government staff, including public-sector health workers, in most African countries (USAID, 2003). Moreover, the number of hours or days of work lost due to AIDS-related illness can be substantial, further reducing actual workforce capacity. Unfortunately, quantitative data and objective analyses of the situation are scarce. Most available data come from only three countries (Malawi, Zambia, and Zimbabwe), although these are by no means the only countries facing this critical problem. The lack of data is due in large part to a generally nonexistent personnel information system, which itself is indicative of how seriously neglected the issue is. The human resource crisis in the health sectors of resource-constrained settings reflects the underlying crisis in tertiary education throughout the developing world, particularly in sub-Saharan Africa. The quality of such education tends to be low; access is limited; and as most health professional training is conducted under the auspices of national governments (through their ministries of health), there is not enough public money available to fund the numbers and types of formal preservice training programs that are needed (an issue discussed further below). In short, the production of new workers has not kept pace with the growing demand for greater workforce capacity. A recent report indicates that when countries do receive aid to build schools and training hostels, they often do not receive the funds needed to support the organizational programs those facilities house. Malawi, for example, has reportedly closed medical and nursing schools during midterm because of a lack of funds to support faculty and student services. Between 1996 and 1999, two of Zambia’s public universities reportedly only received 45 percent of expected funds from the treasury (USAID, 2003). Over the last decade, the underfunding of preservice training for nurses, physicians, and other medical and allied professionals has contributed to a generally limited teaching capacity, significant curriculum gaps, and greater difficulty in enforcing qualification and practice standards. Graduates often are not well prepared to work in the field or at the front lines of public health services. Box 5-1 describes one intiative aimed at addressing this

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Scaling Up Treatment for the Global AIDS Pandemic: Challenges and Opportunities TABLE 5-1 African Countries by Health Care Worker/Population Ratios, late 1990s Population per Doctor Countries 1 per 30,000 or more Burkina Faso, Central African Republic, Chad, Eritrea, Ethiopia, Gambia, Malawi, Mozambique, Niger, and Tanzania (10) 1 per 20,000 Angola, Benin, Comoros, D.R. Congo, Lesotho, Mali, Rwanda, Sierra Leone, Somalia, Togo, Uganda, and Zambia (12) 1 per 10,000 Burundi, Cameroon, Cote d’Ivoire, Djibouti, Ghana, Madagascar, Senegal, Sudan, and Swaziland (9) 1 per 5,000 Botswana, Cape Verde, D.R. Congo, Equitorial Guinea, Gabon, Guinea, Guinea-Bissau, Kenya, Mauritania, Mauritius, Namibia, Nigeria, Sao Tome and Principe, Seychelles, South Africa, Swaziland, and Zimbabwe (16) Population per Nurse Countries 1 per 10,000 or more Central African Republic, Gambia, and Mali (3) 1 per 5,000 Benin, Burkina Faso, Chad, Eritrea, Madagascar, Niger, Senegal, Togo, and Uganda (9) 1 per 2,000 Cape Verde, Comoros, Cote d’Ivoire, D.R. Congo, Equitorial Guinea, Ghana, Guinea, Lesotho, Sierra Leone, and Sudan (10) 1 per 1,000 Angola, Botswana, Djibouti, D.R. Congo, Guinea-Bissau, Kenya, Mauritania, Mauritius, Namibia, Nigeria, Sao Tome and Principe, Seychelles, South Africa, Tanzania, Zambia, and Zimbabwe (16) Population per Midwife Countries 1 per 20,000 Angola, Burkina Faso, Central African Republic, Chad, Equitorial Guinea, Eritrea, Guinea, Mali, Niger, and Sierra Leone (10) 1 per 10,000 Benin, Gambia, Madagascar, Mauritania, Senegal, and Togo (6) 1 per 5,000 Comoros, Congo, Cote d’Ivoire, Guinea-Bissau, and Uganda (5) 1 per 2,000 Ghana, Lesotho, Namibia, Nigeria, Sao Tome and Principe, Seychelles, Tanzania, and Zimbabwe (8) Overall, the population per doctor in the developing world is 1:1,400; in industrialized nations, it is 1 per 300. Population per nurse in the developing world is 1:1,700; in the industrialized world, it is 1 per 170.   SOURCE: USAID, 2003.

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Scaling Up Treatment for the Global AIDS Pandemic: Challenges and Opportunities BOX 5-1 The International Training and Education Center on HIV The U.S. Health Resources and Services Administration and the Centers for Disease Control and Prevention established the International Training and Education Center on HIV (I-TECH) in 2002 to address human capacity development for care and treatment in the countries hardest hit by the AIDS epidemic. One goal of I-TECH is to support health care worker training programs that are locally determined and self-sustaining. Together with its domestic and international partners, I-TECH conducts needs assessments in high-priority areas; develops standards for education, training, and evaluation; disseminates best practices in human capacity development; assists local partners with training; and hosts study and exchange visits. I-TECH uses experienced clinicians, trainers, and program planners for a host of activities, including the following: Needs and capacity assessment Identifying local service and training resources and needs Clinical care and treatment Developing local capacity Developing protocols Providing technical assistance Providing clinical education Training and instructional design Training trainers Writing or adapting curricula for country-specific applications Producing multimedia curriculum components to enhance training and provide programming for distance-learning systems Monitoring and evaluation Evaluating training plans Analyzing costs/benefits Translating standards of care into indicators Organizational development Assisting with recommendations Assisting with short- and long-term strategic planning Assisting with national tuberculosis (TB)/AIDS program development I-TECH currently works with the CDC Global AIDS Program and its collaborators in the Caribbean region, as well as in additional countries including Botswana, Ethiopia, India, Malawi, Namibia, South Africa, Thailand, and Zimbabwe. SOURCE: International Training and Education Center on HIV, 2004. need, while Box 5-2 reviews how the factors discussed above affect the potential role of nurse-based care. To aid in the effort to bolster human resource capacity in resourceconstrained settings, multinational participation is encouraged. Although partnerships between institutions in the developed and developing worlds

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Scaling Up Treatment for the Global AIDS Pandemic: Challenges and Opportunities BOX 5-2 Nurse-Based Care It is estimated that some two-thirds of the burden of care for HIV/AIDS in Africa could potentially be addressed by community health nurses. The Médecins sans Frontières (MSF) program in Khayelitsha, South Africa, is a good example of a successful heavily nurse-based prevention and ART program. (For more detail on this program, see Chapter 2.) Each clinic team consists of one physician, two nurses, and two counselors. Although the physician plays a more prominent role initially, the nurses are becoming increasingly responsible for patient follow-up visits to the clinics (every 1 to 2 months), particularly as the number of people being treated increases. As of December 2003, there were 750 patients receiving ARVs through MSF; an additional 550 are expected to become part of the program this year. Another South African MSF program in Lusikisiki, which was initiated in January 2003 and aims to have 400 people on ART by December 2004, is operated entirely by nurses, counselors, and volunteers. Prior to MSF’s arrival, none of the country’s 12 rural nurse-run clinics had been visited by a physician in 5 years. Now doctors are responsible for training the nurses in ART, as well as OI therapy, prevention of mother-to-child transmission (PMTCT), and VCT, and for supervising newly trained nurses for 1 to 3 weeks before they work by themselves. Thereafter, doctors rotate through the clinics fortnightly. Yet despite this potential for nurse-based care to play a key role in ART scale-up, there are serious nursing shortages and problems with nurse training. Providers must be able to determine when to start, stop, or switch therapy; to explain the often complex dosing regimens and the side effects that may result; and to manage appropriate and adequate monitoring to slow the emergence of multidrug resistance. Knowledge and training for ARV providers are particularly important in settings not well equipped with sophisticated laboratory and monitoring equipment and resources. Although adherence and treatment success are possible based on clinical criteria alone, this is true only if health care providers are knowledgeable and capable with regard to monitoring and evaluating patient response to treatment in the absence of laboratory monitoring. There is an urgent need for an objective evaluation of the extent to which nurse-based care can fill the gaps in human resource capacity. will undoubtedly play a significant role in training, mentoring, and transferring knowledge, the value and usefulness of south–south partnerships should also be recognized. Recommendation 5-1. Efforts should be made to augment mechanisms that can be used to mobilize larger numbers of trained professionals from resource-rich countries with extensive and relevant expertise to provide technical assistance and training to countries in need. Such an HIV/AIDS corps would serve to strengthen long-term ties among health professionals working to fight HIV/AIDS in all countries. A variety of

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Scaling Up Treatment for the Global AIDS Pandemic: Challenges and Opportunities innovative governmental and private-sector mechanisms should be designed and expanded to bring qualified volunteer medical professionals into both urban and rural areas to support prevention, care, and training programs relevant to ART scale-up. The required expertise and skills and the areas for placement in country should be determined by local programs. Recommendation 5-2. Donors and organizations with relevant expertise (e.g., academia, industry, public health agencies, nongovernmental organizations) should support active partnerships among all institutions possessing such expertise and those seeking to acquire the benefits of training; mentoring; and the transfer of antiretroviral therapy– related medical, technical, and managerial knowledge and skills. Partnerships among medical institutions within and across national borders should be encouraged by donors and governmental authorities. These twinning relationships should support the transfer of appropriate technology; expertise in medicine, monitoring and evaluation, and applied and operations research; and lessons learned. Physical and electronic means should be used to provide ongoing support for these partnerships. Recommendation 5-3. Expertise within the AIDS Education and Training Center networks sponsored by the U.S. government and similar initiatives by other countries should be utilized to support the development of effective training programs in HIV care in order to prepare local physicians, nurses, community health workers, laboratory professionals, pharmacists, and logisticians in heavily HIV-afflicted countries facing severe human resource shortages. DEVELOPING A SUSTAINABLE WORKFORCE The Brain Drain The brain drain (i.e., the departure of trained and educated individuals from one place to another) has had severe impacts on the health care sector of developing countries. Higher wages, better living conditions, and increased chances for career advancement are a few of the main reasons that health care workers are leaving their native countries (Dovlo, 2003; Padarath et al., 2003). The brain drain can occur domestically or internationally, with effects being felt at either the regional or national level. Not only are there not enough trained health care workers in most resourceconstrained settings, but the numbers are rapidly declining. As noted above, well-trained workers are leaving in search of better-paying jobs, both locally and abroad and in both the private and nongovernmental organiza-

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Scaling Up Treatment for the Global AIDS Pandemic: Challenges and Opportunities tion (NGO) sectors, thus creating an even greater need for more trained personnel in the most resource-constrained settings (see Box 5-3). According to a recent USAID-sponsored report, data from Ghana, Zambia, and Zimbabwe show that annual losses from the public health sector range from 15 to 40 percent (USAID, 2003). These losses are due to emigration (in search of better-paying jobs), shifts from the public to the private sector, deaths from HIV/AIDS, and early retirement. The situation varies regionally and even within single countries, as the distribution of health workers is heavily skewed toward urban areas (see below). An even greater problem may be the loss of African-trained (and -financed) workers to industrial countries, where shortages of health-sector workers, particularly nurses, appear to be fueling the demand (Bundred and Levitt, 2000; Pang et al., 2002). Although the loss of nurses and physicians may be the most obvious and commonly cited aspect of the human resource crisis in Africa and in the developing world generally, some experts argue that the loss of pharmacists is an even greater problem (Katerere and Matowe, 2003). Pharmacies are commonly considered the “poor man’s clinic” because they offer free consultations and are usually more accessible than primary health care facilities. As indicated in the previous chapter, pharmacist-led counseling is one of the few adherence interventions that are actually evidence-based. Thus the loss of pharmacists not only forces the closure of pharmacies, thereby reducing the accessibility of ARVs, but also comes at a time when the management and counseling skills of pharmacists are desperately needed to ensure the rational use of ARVs. For example, the South African Pharmacy Council recently reported that 600 registered pharmacists emigrated in 2001 alone (Katerere and Matowe, 2003). This is alarming, as only 1,000 students graduate from South African pharmacy schools each year. Also in 2001, more than 60 pharmacists left Zimbabwe—an even more alarming statistic as that country produces only 40 pharmacists a year. Not only are practicing pharmacists and pharmacy school graduates emigrating, but so, too, are pharmacy school academic staff. According to one anecdotal report, many nonpharmacy graduates are teaching courses in South African pharmacy schools, and almost all of the academic staff of the University of Zimbabwe department of pharmacy have emigrated. As most African governments already allocate 50 to 70 percent of their overall public health expenditures to salaries and wages, there is little money left over to address the problematic salary differences between local civil service and private, NGO, or foreign employment opportunities for physicians and other highly trained workers (Over, 2004; USAID, 2003). The pandemic of HIV/AIDS in developing countries has placed enormous strain

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Scaling Up Treatment for the Global AIDS Pandemic: Challenges and Opportunities BOX 5-3 The Brain Drain: Facts and Figures According to a USAID-sponsored report on the human resource crisis in Africa’s health sector (USAID, 2003), only 360 of the 1,200 doctors trained in Zimbabwe during the 1990s continue to practice within the country. A July 2003 article in Lancet (de Castella, 2003) reports that this country’s brain drain is particularly prevalent among doctors and anesthetists, who flee the country for the United Kingdom, New Zealand, and South Africa. A recent survey found that two-thirds of University of Zimbabwe medical students intended to leave the country after graduating, and one of the country’s major 1,000-bed hospitals lacks even a single qualified pharmacist. As the author of the Lancet article writes (p. 46), “If HIV/AIDS is the deadly cancer gnawing away at a population, then the brain drain is the medical profession’s own wasting disease—with particular specialists like pharmacists in very short supply, and an average vacancy rate of 24 percent across the medical spectrum.” The grounds for this exodus can be found in the current working conditions for members of the health professions. The monthly salary for a senior house officer working a 70- to 80-hour week, for example, is the equivalent of US$187, leading most to supplement their public-sector employment with private work. Many doctors report shortages of even basic drugs and medical supplies, such as needles and suture materials. Patients must pay out of pocket for some services, often forcing providers to withhold treatment until at least some level of payment has been provided. In addition to the demoralizing effects of working for so little money and with so few resources, there is the perceived threat of becoming infected oneself with HIV, as is believed to have happened to two doctors through needle-stick accidents at the university’s medical school. In an attempt to address medical staff shortages, the Ministry of Health recently ordered a two-fold increase in the number of medical students in training at the University of Zimbabwe. However, no corresponding increase was made in the size of the teaching staff. The situation in Zimbabwe is paralleled to varying degrees elsewhere on the continent. In other African nations, the USAID-sponsored report finds that: In Zambia, only 50 of the 600 doctors trained locally since independence have remained in the country. In Kenya, 100 advertised vacancies for physicians in 2001 brought applications from only 8 individuals. In Ghana, 328 nurses are recorded to have been lost in 1999, roughly equivalent to the country’s annual output of nurses. Estimated losses for the year 2000 totaled 600. Even for earlier periods, another study found that 61 percent of the graduates of one of Ghana’s medical schools left the country between 1986 and 1995 (Dovlo, 2003). As a result of these losses, many African countries are now actively trying to recruit health professionals through advertisements in foreign publications. This is a crisis that, at the very least, deserves further objective assessment so that the scope and urgency of local needs can be identified and addressed.

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Scaling Up Treatment for the Global AIDS Pandemic: Challenges and Opportunities on health care systems that are already severely underfunded; the brain drain is only worsening the problem. Urban–Rural Imbalance The well-known health care disparities between the “urban poor” and the “rural poorer” that exist throughout the developing world are pronounced in sub-Saharan Africa. These disparities are due in part to a within-country brain drain. Most doctors and nurses are trained to work in hospitals (as opposed to rural clinics) and often find urban areas much more desirable than rural. Urban settings provide physicians with greater camaraderie, increased chances for promotion, and better living conditions (e.g., schools, housing, technology) than are available in rural areas (USAID, 2003). Also, many physicians moonlight from their low-paying daytime jobs with more lucrative private-practice appointments with those patients who are able to pay. This type of work is often easier to find in more heavily populated urban areas (USAID, 2003). Finally, as discussed above, the AIDS pandemic further infiltrates societies, health care workers themselves are often infected, and prefer to remain close to urban hospitals for their own treatment. According to data from Malawi, Zambia, and Zimbabwe, in the late 1990s there were 2 to 10 times more professional health workers in central and provincial hospitals than in rural health centers (USAID, 2003). According to the Ghana Ministry of Health, in 2000 there were nearly 11 times as many doctors and more than 12 times as many nurses working in Greater Accra than in the Upper Western Region, even though there are more than 5 times as many people living in the latter (Ghana Ministry of Health, 2000). Addressing such dramatic imbalances will not be an easy task, as urban settings are generally much more profitable, both salarywise and professionally, for practitioners. According to a survey conducted among government-employed Portuguese-speaking African doctors, their median monthly salary is equivalent to what they would earn from just 7 hours of private practice (Ferrinho et al., 1998). Thus it is clear that ART scale-up programs targeting rural areas will need to allocate funds specifically to ensure the availability of the necessary health care personnel. The need for rural service programs and incentives for health care workers to relocate or remain in traditionally underserved rural areas needs to be further evaluated and appropriately addressed. In the developed world, various incentive programs are employed to maintain physician presence in rural areas. Some state-funded U.S. medical schools offer significant financial relief in the form of tuition benefits in exchange for the student’s future service in a rural part of the state. The

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Scaling Up Treatment for the Global AIDS Pandemic: Challenges and Opportunities certain projects, efforts, or decisions); issues related to commodities (e.g., how decisions impact the availability of certain commodities); the provision of services and coverage; the quality of service delivery; operations research (e.g., how scale-up impacts operations research, whether enough funds have been directed toward such research, how results of the research are being fed back into systems); behavioral components (e.g., adherence); biological and epidemiological components (e.g., prevalence, incidence); and policy. Much of the data needed to monitor these components of scale-up are generally not available or of poor quality in most settings. Where they are generated, few such data are actually used by program managers. Related to these concerns is the current lack of effective mechanisms to rapidly apply the lessons learned from M&E to improve the quality of care and the effectiveness of clinical and procedural management and training programs within scale-up efforts. Information platforms that can be used to identify initial data and information needs, along with methods for effectively assessing and implementing improvements, have not been widely incorporated into developing-country settings. One such method that might be considered is the Breakthrough Series system for learning and improvement developed by the Institute for Healthcare Improvement (IHI) (2003)—a collaborative learning model that incorporates multiple sites (e.g., regional hospitals, primary health care centers, rural clinics) in the study, testing, and implementation of best-practice knowledge to produce rapid improvement in health care delivery or management systems. As noted earlier, effective ART scale-up in resource-constrained settings will have to rely heavily on a learning-by-doing approach. These programs must also ensure that they “do what they learn” (Massoud, 2004). (See Box 5-10 for further information on the IHI model.) To address multiple challenges, M&E information systems should (Delay, 2004): Complement existing information systems. Utilize simplified, harmonized, and prioritized data and data collection techniques. Contribute to the improvement of patient management (in addition to providing useful information to the donor). Build local capacity and incentives to collect, interpret, and disseminate the data in an appropriate form. Support a culture of strategic information sharing (e.g., with respect to translating knowledge). Protect the confidentiality of all health information. Maintain individual patient records using unique patient identifiers. Involve people living with HIV/AIDS.

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Scaling Up Treatment for the Global AIDS Pandemic: Challenges and Opportunities BOX 5-10 The Institute for Healthcare Improvement Model for Improvement IHI’s Model for Improvement requires collaborative teams to ask three fundamental questions: (1) What are we trying to accomplish? (Aim), (2) How will we know that a change is an improvement? (Measures), (3) What changes can we make that will result in improvement? (Changes) (Langley et al., 1996; WHO, 2004b). By addressing these questions, teams establish which specific outcomes they are trying to effect, identify appropriate measures to track their success, and determine key changes they will implement for testing (Plan). Key changes are then tested in a cyclical fashion that recognizes cultural and organizational characteristics. Change is implemented, and progress, problems, and unanticipated outcomes are documented (Do). The collaborative site teams complete data analysis and comparison of outcomes and initial objectives (Study). (See the figure below.) SOURCE: WHO, 2004b. Collect information from all providers of ART, including public, private, NGO, workplace, and other sites. Ensure that the data gathering and analysis methodologies used are flexible, adaptable, and acceptable. It is essential to select good indicators for use in M&E—data that are

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Scaling Up Treatment for the Global AIDS Pandemic: Challenges and Opportunities Decisions are then made regarding how to implement and refine successful changes and abandon unsuccessful efforts (Act). Critical to this collaborative improvement approach is that participating health care teams contribute to adapting the new approaches for care. Real-time interactive operations research is designed to capture local knowledge and experience by making health care teams active partners in the refinement and improvement of care process. (See the figure below.) SOURCE: WHO, 2004b. relevant, easy to collect, and easy to interpret and that reflect changes that are easy to track over time and can be quantified. Measures should reflect both quantitative and qualitative aspects of programmatic management and patient-level quality of care. A number of core ART evaluation indicators have been identified that, if measured every year or two, would probably be sufficient for donor-related evaluation purposes (see Box 5-11).

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Scaling Up Treatment for the Global AIDS Pandemic: Challenges and Opportunities That having been said, depending on the specific scale-up objectives, even these core indicators may not be sufficient for all donors. The fact that different donors may have differing objectives, and thus differing M&E requirements, raises important concerns about the impact of the resulting lack of standardized metrics and harmonization of M&E procedures. The more donors have a presence in a country, the higher will be the potential transaction costs involved with M&E and the higher the burden on resource-strapped host country programs. WHO’s Health Metrics Network, supported by the Gates Foundation, was developed in recognition of the fact that most developing countries are overwhelmed by reporting requirements. For example, the Tanzanian Ministry of Health once filed 5,000 pages of reports, including different sets of measurements for different donors in the same areas. WHO was asked by donors to serve as a secretariat and develop a single set of measurements such that satisfying the criteria of the Health Metrics Network would meet the requirements of multiple organizations (Kim, 2004) (see Box 5-12 for some recommended M&E outcome indicators). The standardization and harmonization of foreign-donor M&E efforts is only one of several political challenges to collecting, analyzing, and interpreting accurate data and unbiased results: Because of widespread denial of the severity of the HIV/AIDS pandemic, data may be suppressed. The needs of funding agencies often conflict with those of program managers (e.g., the former may be interested in outcomes to which the latter does not give priority or vice versa). Collecting data on marginalized or illegal populations is difficult. There may be resistance to tracking resources, as doing so may expose corruption and inequitable distribution. Service delivery statistics are often perceived by staff as punitive. The selective use of evaluation data may skew M&E efforts and bias analyses. Performance-based disbursement policies can have a dramatic effect on data collection, analysis, and accuracy. Another important challenge to M&E of ART scale-up will be monitoring long-term sustainability and impact. Tracking resources, including the cost per unit service and cost per commodity, will become more difficult as the number of people being treated increases. The same is true for tracking and monitoring staffing patterns (whether human resource capacity is really increasing, or ART scale-up is diverting staff from malaria control, childhood immunization, and other programs). Measures of logistics capacity, overall public health capacity, ARV resistance patterns, sur-

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Scaling Up Treatment for the Global AIDS Pandemic: Challenges and Opportunities BOX 5-11 Program Process Indicators for Monitoring and Evaluation Community Level Number of primary health care clinics that have assessed community capacity Number of districts with community training plans Number of community persons trained to provide ART ART Site Level Number of sites with providers trained to provide ART Number of HIV tests conducted Number of positive HIV results Number of test results received by clients Number of HIV patients assessed for care Number of HIV patients beginning care Number of patients on ART at the beginning of a specified time period Number of patients discontinuing ART during a specified time period Number of patients referred to a higher care level for management of ART or second-line treatment District/Region Level Number of districts with evidence of HIV prevalence Number of districts with data for 2-year mortality Number of districts with a designated person(s) for data analysis and interpretation Proportion of providers reporting data to district Number of reports given by district to providers, stakeholders, communities, etc. Central/National Level Presence of a strategic information system Presence of standardized data collection forms Number of data collection forms disseminated to providers Percent of patients assessed and prescribed ART who receive medications within 1 month Percent of central, district, and dispensing site drug storage locations whose stock cards for ARVs are up to date and accurate Percent of central, district, and dispensing site drug storage locations that experience ARV stock-out SOURCE: Delay, 2004. vival patterns, infection incidence, and economic productivity (i.e., whether the economic impact of HIV/AIDS is really changing over time) will also pose increasing challenges. Assuming that incidence is cut by half to 2.5 million cases per year and assuming that the goal will continue to be to treat only half of all clinically eligible HIV-infected individuals, the target will be

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Scaling Up Treatment for the Global AIDS Pandemic: Challenges and Opportunities BOX 5-12 Recommendations for Monitoring and Evaluation Outcome Indicators Number of persons screened under voluntary counseling and testing programs Gender and age of persons screened and testing positive Number of persons testing positive for HIV Number of persons qualified for therapy Number of persons initiating therapy Date of therapy initiation Regimen used Number of persons receiving prevention counseling Number of persons hospitalized while on ART Indication of change in high-risk behaviors after therapy initiation Number of persons discontinuing therapy Reasons for discontinuation of therapy Patient preference Drugs not available Lost to follow-up Failed therapy Drug toxicity Death Reasons for persons remaining on therapy Number of persons continuing therapy despite clinical, immunologic, virologic failure Number of persons switched to a subsequent regimen Opportunistic infections (e.g., tuberculosis, cryptococcal meningitis) to treat 6 to 9 million people by 2010. A global program of that magnitude will require extraordinary M&E efforts. Finally, programs should be monitored at optimum frequency, which may differ for different types of interventions. And a mechanism for regular international communication of M&E results, inspired by the regular international rounds conducted during the SARS crisis, needs to be established. Box 5-13 summarizes some important features of M&E for ART scale-up. Measuring Success What defines programmatic success for ART? The number of drugs distributed is not the best measure, as the numerous problems elucidated earlier attest. There are too many things that can go wrong during the drug

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Scaling Up Treatment for the Global AIDS Pandemic: Challenges and Opportunities BOX 5-13 Important Features of Monitoring and Evaluation for ART Scale-up Complement existing information systems. Prioritize, simplify, and standardize data collection. Develop incentives to collect data. Build local capacity to collect, interpret, and disseminate data. Support a culture of information sharing. Protect the confidentiality of health information. Maintain individual patient records with unique patient identifiers. Involve people living with HIV/AIDS in M&E activities. Collect data from all sites providing ART (e.g., public, private, workplace, NGOs). SOURCE: Delay, 2004. delivery process and far too few management information systems in place to track drug delivery in a way that would provide meaningful information on the number of drugs distributed. Nor is measuring the number of people treated necessarily the best way to monitor progress, as both the individual clinical benefit (reduced toxicity and mortality) and population-level benefit (decreased morbidity and mortality) of therapy depend on adherence and the success of chosen adherence interventions. A definition of treatment success needs to be formulated, with an awareness that it will likely change over time. It must also be realized that success can be defined from several different vantage points, including the patient, physician, community health system, nation, and donor agency. What many U.S. clinicians considered successful a decade ago would not be considered successful today. Just 6 years ago, success was declared if 50 percent of ARV-treated patients showed complete viral suppression at the end of the first year or 18 months of treatment. Now, clinicians strive for 85 or 90 or even 95 percent as a sign of success. It is critical for ART scale-up programs in resource-constrained settings to strive for a very high—for example, 90 percent—success rate for initial regimens and that treatment regimens and care delivery systems be planned accordingly. Some experts argue that it is not fair to set the bar higher than it has been set in the United States or other resource-rich countries. If this is not done, however, the long-term sustainability of donor support in combination with the durability of inexpensive drug regimens will be at serious risk. Most resource-constrained countries simply cannot afford the flexibility in treatment regimen—in terms of both drug cost and the necessary expertise and

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Scaling Up Treatment for the Global AIDS Pandemic: Challenges and Opportunities human resource capacity—required to individualize treatment when complications arise, as can the United States and other resource-rich countries (Redfield, 2004). Within 10 years, ART scale-up will have evolved into a US$30–100 billion annual effort, demanding an enormous amount of program success to meet donor goals. In the rush to achieve a quick fix, initial expectations should not be set too low such that they compromise the long-term sustainability of ART scale-up. At the same time, there can be no delay in responding to the ethical imperative to act now. Recommendation 5-9. Monitoring and evaluation measures and requirements, as directed by various donors and other stakeholders, should be harmonized across programs to minimize time-consuming inefficiencies in data collection and program management. Additional efficiencies would be achieved if these efforts were coordinated by a single national ministry or agency. Donors should avoid attempting to ascribe results solely to individual funding sources in order to minimize the in-country confusion and inefficiency created by mandates to conduct multiple, uncoordinated monitoring and evaluation efforts in the midst of rapid scale-up. REFERENCES Attawell K, Mundy J. 2003. Provision of Antiretroviral Therapy in Resource-Limited Settings: A Review of Experience up to August 2003. London: DFID Health Systems Resource Centre. Brugha R. 2003. Antiretroviral treatment in developing countries: The peril of neglecting private providers. British Medical Journal 326:1382–1384. Bundred P, Levitt C. 2000. Medical migration: Who are the real losers? Lancet 356:245–246. Caminero JA. 2003. Is the DOTS strategy sufficient to achieve tuberculosis control in low-and middle-income countries? 2. Need for interventions among private physicians, medical specialists and scientific societies. International Journal of Tuberculosis and Lung Disease 7(7):623–630. Campaign for Access to Essential Medicines. 2004. Surmounting Challenges: Procurement of Antiretroviral Medicines in Low- and Middle-Income Countries. [Online]. Available: http://www.accessmed-msf.org/prod/publications.asp?scntid=201120031530452&contenttype=PARA& [accessed January 5, 2004]. Chandani Y. 2004 (January 28). Distribution of ARVs: Issues of Security, Logistics, and Quality. Paper presented at the Institute of Medicine Workshop on Antiretroviral Scale-up in Resource Constrained Settings, Washington, DC. Institute of Medicine Committee on Antiretroviral Drug Use in Resource-Constrained Settings. de Castella T. 2003. Health workers struggle to provide care in Zimbabwe. Lancet 362(9377): 46–47. Delay P. 2004 (January 28). Monitoring and Evaluation for ARV Programs in Resource Poor Settings. Paper presented at the Institute of Medicine Workshop on Antiretroviral Scale-up in Resource Constrained Settings, Washington, DC. Institute of Medicine Committee on Antiretroviral Drug Use in Resource-Constrained Settings.

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