Impact of Integrating HIV treatment, care and services in Primary Health Care in Free State, South Africa, P.I. Yassi, A. Co-Investigator Rawat, A.

UBC ETHICS Protocol

1.Purpose

HIV/AIDS is devastating many communities globally, especially in high-prevalence countries such as South Africa. Public sector clinics provide the majority of the health care services to the population and are plagued by chronic underfunding and human resource shortages. In order to improve accessibility to treatment and services for those with HIV/AIDS in South Africa, a national strategy to integrate HIV-related services at primary health care (PHC) facilities was promoted. However, to-date little is known about the impact of the integration of HIV care on primary health care service function, human resources for health (HRH) or patients’ and caregivers’ satisfaction of health care services. This study aims to employ quantitative and qualitative methods to add to the knowledge base and elucidate the impact of integration on the health system in Free State, South Africa.

2.Hypothesis or Aim
The overall aim of the study is to understand the impact of integrating antiretroviral treatment (ART) into public sector PHC clinics in the Free State province from the perspective of PHC clinic function, HRH and patient satisfaction. The hypothesis is that integration is having negative impacts on the health system. The three main objectives of the study are to understand how provision of ART (integration) at PHC clinics impact: 1) services and clinic function; 2) HRH (with an emphasis on workload, morale, stigma, attrition and stress); and 3) patient and caregiver satisfaction of clinic level service provision.

3.Justification for the study

In 2008, approximately 33.4 million people were estimated to be infected with HIV globally, with 2.7 million new cases in 2008 alone1. The emergence of HIV/AIDS filled hospitals in high prevalence countries with few available treatment options. The advent of antiretroviral therapy (ART) transitioned HIV from being a terminal illness into a manageable, chronic condition and dramatically reduced mortality by 90%2. However, rolling out population level programs and caring for large percentages of the population who would now need complex drug regimens and management opportunistic infections within fragile health systems presented itself as another challenge.

Historically, with increased financing through larger global health initiatives a vertical approach was taken in high-prevalence countries resulting in a rapid response to scale up targets with little connection to the health system3. Vertical approaches are defined as those which create “stand-alone”, disease-specific programs aimed at targets for a disease versus general health system strengthening (i.e. horizontal). Lack of sufficient financial resources4 and human resource for health (HRH) constraints are a consistently cited as major barriers for effective HIV service delivery within the public sector 21 22 17.

The debate of whether to focus on disease specific programs versus broader public health approaches is not new4. Much debate currently lies in whether and to what extent scaling up HIV/AIDS programs via a vertical system is helping or harming overall health systems8. Proponents of the vertical approach for HIV/AIDS programming have discussed the resulting increased laboratory functioning, investment towards infrastructure7 and the promotion of primary health care (PHC)5. In many countries significant improvements in maternal health and reproduction related outcomes were noted6 10. Opponents of the vertical approach challenged that inequities were exacerbated between those with HIV/AIDS and those without, while health workers were migrating from their posts to higher paying posts focusing on HIV/AIDS4 11.Those remaining had worse working conditions with an influx of demand for health services, especially in the public sector6. Concerns have been raised that the focus on HIV related services may turn the focus away from other important health priorities12 within a health system.

Health systems, as defined by the WHO, “compris[e] of all the organizations, institutions and resources that are devoted to producing health actions”8. The goal of the health system is “the delivery of effective preventive and curative health services to the full population, equitably and efficiently, while protecting individuals from catastrophic health care costs”8. According to the WHO, HRH are the “most important” health system input. The WHO defines the key elements of a health system to: “improving the health status of individuals, families and communities and providing equitable access to people-centred care.” A key strategy to accomplish this is through a primary health care centered approach.

Primary health care is more broadly defined as “the mobilization of forces in society around an agenda of transformation of health systems that is driven by the social values of equity, solidarity and participation” according to the World Health Report 2008. This is distinctively different from “primary care’ which is specific to aspects of health service provision, an approach characterized with the first contact in a health system, ease of access, care of a broad range of health needs , continuity and the involvement of family and community (as outlined in the Alma Ata Declaration)8. PHC in the context of this study refers to a hybrid of both definitions including elements of health service provision with the long-term transformation of the health system. Integration of disease specific programming into a primary care setting has been viewed as a strategy to improve universal access to ARTs within a health system.

The term “integration” translated into practice produced a kaleidoscope of definitions ranging from integration at the point of delivery, integration of 2 programs (e.g. child immunization program with prevention of maternal to child transmission of HIV or HIV and TB), or integration of governance. A recent definition by Atun et al defines integration as “the extent, pattern, and rate of adoption and eventual assimilation of health interventions into each of the critical functions of a health system”15. In 1996 the WHO promoted integrated services as being linked to the development of district health services and a “one stop shop” for a persons’ health needs including multipurpose staff, clinics across disciplines to strengthen coordination and across all sections of a health system11. In the context of this study integration refers to the provision of services together which were previously separate (i.e. adding services for HIV patients to PHC).

Although integration is appealing and widely promoted312there is little evidence as to the extent to which integration impacts the health system, more specifically primary health care service delivery within a health system. Currently, a lack of common conceptual understanding on elements of integration has been identified16. The following 2 studies highlight some findings from similar settings.

A study in Zambia by Toppet al10 examined the impact of integrating in ART at the PHC level at 2 urban health facilities. Integration in this context referred to the following 3 characteristics: “amalgamation of space and patient flow, standardization of medical records and introduction of routine provider initiated testing and counseling”. Results indicated that integration resulted in increased HIV case finding, reduction in stigma, and increase in patient wait times.

Another study in Rwanda by Price et al9examined integration of HIV clinical services into primary care in 30 PHCs and comparing “pre” and “post” integration with 21 service delivery variables in a retrospective observational design. Findings suggested that HIV-focused care showed positive association with 13 indicators of reproductive service delivery. No declines in delivery of other PHC services were noted and an increased uptake of antenatal care.

Few studies have addressed the impact of ART integration on PHC in a comprehensive approach. There is a current lack of evidence on the outcomes (positive or negative) although many agencies and governments are promoting this strategy. With the need for strong health systems to continue to provide the primary health care needs for the population integration is being promoted as a strategy for enabling access to treatment, care and support for the millions of people who are living with HIV/AIDS. However, the impact it may be having on other aspects of primary care and more broadly the health system, including HRH is unknown. Understanding the current situation is critical to ensure proper attention is given to strengthen the aspects of the health system which may be weakened and continue to uphold the continuum of care necessary to provide universal coverage of health services across the population.

Setting

South Africa has 5.7 million infected1 which equates to almost 12 % of the population. It is an ideal setting for this study for many reasons. South Africa currently has the largest public-sector ART program in the world20.However with a lack of sufficient resources, both human and financial, it is estimated that 2.16 million people will have died from HIV/AIDS between 2007–2011 in South Africa4. Seventy-five to 80% of the South African population is dependent on the health care that is provided at public health care facilities21.

Several challenges have been identified in improving the health of South Africans namely “underdeveloped public health-care delivery system, struggling to overcome poor

administrative management, low morale, lack of funding and brain drain” 22. The importance of strengthening primary care in this context cannot be understated. In a nurse led health system such as South Africa’s structure, the integrated primary health care approach to accessing ART has been seen as the only way for the millions of people who need treatment to access it17. Additionally, with a growing emphasis on the burden of non-communicable diseases (NCDs) and the future impact on health systems23 a balance between treating and preventing communicable diseases and NCDs must occur.

The Free State province with a population of 2.8 million people has an HIV prevalence rate of 18.5% amongst 15 to 49 year olds- the 3rd highest of the nine provinces in the South Africa2 . In 2003 a plan to provide ARVs rollout with universal access was unveiled by the South African National Department of Health with a target of reaching 1.4 million people over the course of the next 5 years. In 2004 ART rollout was expanded in a vertical manner and staff was hired to work specifically with HIV/AIDS patients. This allowed for specialized training of staff which was needed to learn the specialized regimen for ART along with the management of opportunistic infections. In the Free State rollout began with treatment sites as well as initiation and monitoring sites. By mid 2008, 57 ART treatment and assessment sites in clinics and hospitals had been established but this still meant that less than a quarter of the 220 primary care clinics in the province had on-site access to ART. The process to initiate and remain on treatment was cumbersome for the patients and it was noted that these vertical programs were draining staff from other PHC services to handle specialized HIV services. From 2004-2007 the total number of patients accessing was ART in South Africa was approximately 475,000 but still only 30% of those estimated to be in need of ART24.

The National Strategic plan for of 2007-2011 proposed to reach 80% of all South Africans in need of ART with stated goals of having patients commenced on treatment in primary care, but no practical steps were taken to change the initial vertical nature of the rollout. Finally in early 2010, in response to the slow progress towards universal access to ART the South African national department of health announced a plan to place ART within reach of all South Africans who needed it by making it available at every primary care clinic and every hospital and by training professional nurses to prescribe ART in primary care. Ambitious goals were set to complete the implementation of this policy in all primary care clinics by April 2011. In reality the implementation has taken longer. In the Free State province although integration of ART into every primary care clinic began in April 2010 the current plan is that process will be integrated into all 220 primary care clinics by the end of April 2012. This process in the Free State represents a unique opportunity to document the impact of integration of HIV care on existing primary care services24.

4.Objectives

The three main objectives of the study are to understand how provision of ART (integration) at PHC clinics impact: 1) services and clinic function; 2) HRHand 3) patient and caregiver satisfaction of clinic level service provision.

5.Research Method
The research framework is adapted from a “Framework of health system measure for developing countries” conceptualized by Kruk and Freedman25 as found in Appendix 1. The framework used for this project builds upon effectiveness, equity and efficiency. The focus of this study will be on the input of policy (i.e. the policy to integrate HIV services into PHC) and output/process indicators of access to care, quality of care, satisfaction and productivity. The target population will be those accessing primary health care services in the Free State Province, South Africa. Purposive sampling will be used for the selection of 4 clinics. Convenience sampling will be used for identifying patients and caregivers for the surveys. Snowball sampling will be used for identification of key informants. The study will be a longitudinal observational study with a timeframe of 4 years (March 2009 to March 2013). The study design is both a retrospective (March 2009-Feb 2012) and prospective (March 2012-March 2013). The indicators of PHC are especially of interest to determine integration’s impact on PHC. A preliminary list of indicators can be found in Appendix 2 as well as the PHC package for South Africa as outlined by the government.

Six key methods will be used to meet the objectives of the study (Appendix 3). Secondary administrative data will be analyzed for methods i-iv. Four clinics will be identified via stratified purposive sampling techniques and will be determined from key informant interviews for the primary data collection for methods v-viii. Selection criteria include whether or not the clinic is representative of the provincial patient population in terms of age, gender, HIV prevalence and PHC needs. Accessibility and time since integration (if applicable) will also be considered. Clinics given special priority for integration (e.g. the first 47 clinics that were given extra support from the government to integrate) will be excluded. Methods include:

i) 8 indicators of PHC and clinic function-Monthly, per-clinic aggregated data will be obtained from previously and currently collected administrative data from the Department of Health Information System (DHIS) and National Indicator Data Set (NIDS) for approximately 8 indicators of PHC clinic function and service delivery across the public sector clinics. The unit of analysis is the clinic level. Inclusion criteria are all 222 public-sector, PHC clinics in Free State. Hospitals, private or NGO clinics and mobile clinics will be excluded from the analysis. The indicators for clinic function/PHC service delivery (dependent variable) will be based on the domains of primary care are defined by the primary care package from the Government of South Africa as seen in the Appendix 2. Indicator selection will be based on: 1) robustness and 2) whether it is an important component for meeting national/provincial targets. Preference will be given to indicators which are routinely collected from administrative data and where action is taken by a Department of Health (DOH) employee when there is a variation from expected range. Final indicator selection will be based on a subset data analysis for trends, published literature, data consistency/completeness, key informant interviews and its relevance to the research framework.

The quality of data recorded in the DHIS and NDIS will also be compared to hard-copy clinic registers. Spot checks will be conducted at the 4 clinics visited. Indicators deemed as key indicators from the key informant interviews will be examined in terms of whether these data are available in the database and checked for completeness and accuracy. Individual patient files will not be examined but clinic logs will be.

ii) Month/Year of integration - Integration (independent variable) is the defined as the month and year the clinic provides ART and is currently being ascertained by interviews and collated in a spreadsheet by the Free State Department of Health (FSDoH). This variable will be binary. Time will be classified in two terms “pre” ( T1) and “post” (T2) integration (T1 defined as time prior to integration, T0 defined as the month and year integration happened and T2 defined as time after integration).

iii) Health worker per number of patients on ART-a variable will be derived for clinics during “post” integration (T2) to understand how indicators may be influenced as HRH changes per number of patients on ART. This will allow for further analysis for large increases in patient load (not simply integration yes/no) and fluctuations of health workers to ascertain if there is a threshold where clinic function deteriorates based on these factors.

iv) Health worker attrition rates-will be collected from secondary data from the human resource database (a.k.a. PERSAL) per cadre of health worker. Cadres may include professional nurses, nursing students, nursing assistants physicians (if applicable), pharmacists/pharmacy assistants (or those dispensing ARVs and those not), laboratory staff, receptionist/triage nurse/clerks. This will be included as a variable of interest in the model for (i) above.