SUMMARY:

Boston University (BU) will use PEPFAR funds to develop 1) an inventory of PEPFAR-supported palliative care activities in South Africa; 2) a practical framework for categorizing these activities; 3) a model for estimating the demand for and supply of palliative care in a specified geographic area; and 4) recommendations for outcomes evaluation of palliative care activities. This exercise will collaborate with the PEPFAR Palliative Care Technical Working Group to utilize lesson learned from the centrally funded Palliative Care Targeted Evaluation that did not include South Africa. Results will be used to inform program planning by the USG/SA team and South African Government, expand palliative care service delivery in under-served areas, and identify priorities for monitoring and evaluation. 100% of the activities fall under the Targeted Evaluation emphasis area, and the target populations for the activities are people living with HIV and AIDS, HIV and AIDS affected families, caregivers, program managers, policy makers, clinicians, community-based, faith-based, and nongovernmental organizations, and USG staff.

BACKGROUND:

PEPFAR supports a tremendous range of palliative care activities in South Africa. Some palliative care is provided by partners and sub-partners under the Palliative Care program areas; other palliative care is provided by partners in other program areas, such as prevention, counseling and testing, and HIV treatment. Palliative care clinical interventions are focused on the patient (e.g. opportunistic infection treatment and pain management) but extend to behavioral, psychological and social interventions for the patient and the patient's family. Because the PEPFAR definition of palliative care is broad and many partners working in other program areas are also providing palliative care, more information is needed on the range of activities being supported by PEPFAR. In FY 2007, Boston University (BU) will conduct an initial assessment of these activities and develop tools that can be used for ongoing monitoring and evaluation of palliative care in South Africa. This activity will be undertaken in consultation with the National Departments of Health and Social Development, which have also expressed the need for better information about all forms of palliative care provision. It will be implemented in partnership with the Health Economics Research Office (HERO) of the Wits Health Consortium, which is BU's local partner in South Africa.

ACTIVITIES AND EXPECTED RESULTS:

This evaluation will be conducted in four stages.

Stage 1: Inventory of existing activities. In consultation with PEPFAR staff in South Africa, BU will develop a descriptive inventory of a purposive sample of palliative care activities currently supported by PEPFAR, including those under the palliative care program areas and those provided under other program areas. The sample will be selected to represent the range of partner types and palliative care activities within the PEPFAR program in South Africa, with palliative care defined to include, at a minimum, elements of the preventive care package, pain and symptom management and an additional category of service (psychological, spiritual and social) to provide holistic care HIV-infected individuals and their families. Programs that are limited to services for orphans and vulnerable children (OVC) will be excluded from the sample, as a targeted evaluation will be done specifically on the OVC portfolio. Data will be collected through detailed interviews of selected partners and sub-partners. Information will be obtained on specific palliative care services provided; content, location, and duration of services; selection, numbers, and types of beneficiaries; staff and other resources utilized; integration of palliative care services with other activities; and other relevant issues.

Stage 2: Framework for categorizing activities. The inventory developed in Stage 1 will be used to identify models of palliative care service provision. Building on the categories of service delivery used by PEPFAR (clinical and physical care, psychological care, spiritual care, and social care, as well as the preventive care package), models may reflect characteristics of the provider (e.g. clinic or hospital, home-based care organization, hospice, etc.); the beneficiaries (e.g. AIDS patients not on antiretroviral therapy, AIDS patients on ART, etc.); level of care provided (e.g. using the definitions of levels proposed by the African Palliative Care Association); and/or the specific service element (e.g. pain

management, infection prophylaxis, counseling, etc.). The models will be identified in consultation with USG in-country staff, South African government staff, and representatives of partners that participated in Stage 1. To the extent possible, the models will be consistent with existing frameworks for categorizing palliative care, such as the Integrated Home/Community-Based Care models of the Departments of Health and Social Development.

Stage 3: Model of demand for and supply of palliative care. Stages 1 and 2 will provide a comprehensive description of the types of palliative care being provided in South Africa and the quantity of care currently supported by PEPFAR. In Stage 3, existing data on HIV prevalence, household socioeconomic status, disease progression, treatment access, and other topics will be used to make a rough estimate of the number of people in need of different types of palliative care in a specified geographic area (e.g. one province). Information on PEPFAR-supported palliative care providers will then be used to model the numbers and types of activities that will be required to meet these needs.

Stage 4: Recommendations for outcomes evaluations. Stages 1-3 will generate descriptive data about the existing PEPFAR portfolio of palliative care activities and the current level of coverage of palliative care services. Using this information, up to three targeted evaluations will be recommended for FY2008 and/or later years that assess the outcomes of the activities. The recommended outcomes evaluations will focus on the extent to which different palliative care activities are achieving the goal of reducing pain and suffering and improving quality of life and, where relevant, the cost-effectiveness of alternative approaches to reaching this goal.

This activity (Stages 1-4) is expected to result in improved information about palliative care than is currently available to the South African government, PEPFAR, or service providers. It will identify geographic and technical gaps in service delivery, allow better monitoring and evaluation of activities, and assist in estimating overall needs for palliative care. It will also provide baseline information for quantitative outcomes evaluations of palliative care services in the future. All of this will assist the PEPFAR program achieve the goal of reaching 10 million people with care.

SUMMARY:

Boston University (BU) will use FY 2007 funds to 1) expand and extend an ongoing analysis of cost and cost-effectiveness of models of treatment delivery in South Africa; and 2) extend an ongoing analysis of the outcomes and sustainability of treatment for adult patients. Results will be used to inform future planning by the USG PEPFAR Task Force and South African Government and improve treatment delivery. All of the activities fall under the Targeted Evaluation emphasis area, and the target populations for the activities are adults, people living with HIV, policy makers, program managers, clinicians (public and private), organizations (all types), and USG staff.

BACKGROUND:

BU was requested in FY 2005 and FY 2006 to examine cost and cost-effectiveness of alternative models of treatment delivery in use in South Africa. The original methodology considered only the first 12 months following treatment eligibility and included relatively small sample sizes. Initial results have raised new questions requiring larger samples and longer periods of follow-up. In FY 2007, BU will amend the methodology to cover up to the first 36 months on treatment, expand the sample of patients from each site, and analyze new models of treatment delivery initiated after the original sites were selected (e.g. mobile clinics). In addition, with USG support, BU began an evaluation in 2005 of the impact of treatment on South African patients' social and economic welfare, including quality of life, labor productivity, family stability, and other outcomes. In FY 2007, this evaluation will be continued for a third year, allowing examination of longer term outcomes essential to treatment sustainability. Both activities address specific areas of interest of the South African Government and are being undertaken with the approval of relevant local and provincial authorities. Both activities will be conducted in partnership with the Health Economics Research Office (HERO) of the Wits Health Consortium. BU's finding from all phases of the targeted evaluations are being utilized by the USG PEPFAR Task Force and other PEPFAR partners to improve efficiencies within current treatment service delivery models.

ACTIVITIES AND EXPECTED RESULTS:

ACTIVITY 1: Analysis of treatment models and costs

The USG supports a wide range of treatment delivery models in South Africa, including public sector, private sector, and NGO-based programs. In FY 2005 and FY 2006, PEPFAR provided support to BU and HERO for a targeted evaluation of the cost-effectiveness of approximately 10 treatment sites representing various models of delivery, including urban and rural public hospitals, a rural NGO clinic and a rural faith-based clinic, and a private physician-based program. The models and sites have been chosen to represent the most promising or most common approaches to large-scale treatment delivery in urban and rural areas and in the public and private sectors. The analysis relies mainly on retrospective data routinely collected by treatment programs to generate information about which models of treatment delivery are successfully treating the largest number of patients at the lowest cost, which characteristics of delivery systems are most important, and whether patient medical outcomes are affected by the model and cost of treatment delivery. The specific measure of cost-effectiveness being used is "cost per successful patient outcome," with successful outcome defined as an undetectable viral load, incremental increase in CD4 count, and/or absence of serious clinical conditions. Both costs and outcomes are estimated at the 12-month point following medical eligibility for treatment under South African national guidelines.

Initial results of the evaluation have raised a number of additional questions that can only be answered by expanding and extending the activity for a third year (FY 2007). These include the cost per successful outcome in years 2 and 3 following treatment eligibility; costs for subsets of patients, such as those who initiate treatment with very low CD4 counts or who switch to second-line regimens during the first year; and cost-effectiveness of treatment delivery models launched after the original study sites were chosen. In FY 2007, BU will revise its methodology to estimate costs and effectiveness up to 36 months following eligibility, incorporate the larger sample sizes needed to examine subsets of patients, and add additional study sites to the evaluation.

The expected results of this activity are accurate and detailed estimates of the costs of delivering treatment and achieving successful outcomes across a wide range of settings and types of patients. This information will assist the South African Government, PEPFAR, and other funding agencies to estimate future resource needs, increase efficiency among existing providers, and target future investments toward the most cost-effective models of delivery.

ACTIVITY 2: Impact of treatment on patients' welfare

While the medical effectiveness of antiretroviral therapy (ART) in suppressing viral replication and restoring immune function is well established, little is known about the impact of treatment of HIV and AIDS on the economic and social welfare of African patients. In particular, it is not known if treatment will offset the impact of untreated AIDS on labor productivity, family stability, quality of life, and other indicators of social and economic development and treatment sustainability. In FY 2005, BU and HERO launched an evaluation of the economic and social outcomes of treatment for adult South Africans receiving care from three PEPFAR-supported treatment sites. The sites include a large urban public hospital, an informal settlement non-governmental clinic, and a rural faith-based non-governmental clinic. At each site, a random sample of pre-ART patients and patients who had been on ART less than 6 months were enrolled in the study and completed a baseline questionnaire focusing on family stability, ability to work and/or perform other normal activities, quality of life, adherence, costs of obtaining treatment, and sources of income. Follow-up interviews are conducted during regularly scheduled clinic visits at intervals of 3-6 months, depending on the patient's status. Over the course of FY 2005 and FY 2006, 672 ART patients and 446 pre-ART patients were enrolled in the study and completed baseline and follow-up questionnaires. By the end of the FY 2006 funding period, all of these patients will have been followed for a minimum of 1 year, and some for nearly 2 years.

In FY 2007 no new patients will be added, but because the impact of treatment on patients' welfare will change over time, following the current patients for an additional year will generate valuable information about the sustainability of treatment beyond the initial year. Most of the pre-ART patients will have initiated ART by FY 2007, allowing a pre- and post-treatment comparison for this group.

The expected result of this activity is the first empirical information available about the non-clinical outcomes of treatment for South African patients treated through PEPFAR and South African Government treatment initiatives. If patients are shown to be able to resume their normal activities, find and retain jobs, maintain family stability, and improve quality of life, support for long-term provision of treatment and expansion of current programs will be strengthened. Analysis of the characteristics of patients for whom outcomes are less successful will also help improve treatment program design and patient support efforts.

Information coming out of both of these targeted evaluations will be definitive in designing more efficient and effective programs, contributing to the US Mission's ability to reach its 2-7-10 PEPFAR targets.