SUMMARY:

EGPAF will use FY 2008 PEPFAR funds to continue prevention of mother-to-child transmission (PMTCT)

support for its existing partners which include National Department of Heath (NDOH) and provincial DOH

KwaZulu-Natal and Gauteng. The Foundation will expand its geographic coverage during FY 2008 to

include direct support to provincial and district health departments in the Free State and North West

provinces. The key objective is to expand the coverage of PMTCT services, and thus ensure provision of

quality PMTCT services, and increase the uptake of PMTCT services. The primary emphasis area is human

capacity development and expansion of services through training and task-shifting, quality improvement,

development of networks, linkages, referral systems and strengthening M&E and health systems, and

strengthening of local organizations. Primary populations to be targeted include infants, men and women,

pregnant women, HIV-infected pregnant women, people living with HIV (PLHIV), and public and private

healthcare providers.

BACKGROUND:

The long-term goal of the EGPAF Project HEART PMTCT program in South Africa is to decrease

transmission of HIV from mother-to-child. This is to be achieved through an intensive focus on increasing:

the capacity of health facilities to deliver high quality PMTCT services in antenatal care (ANC), including

screening and staging of HIV-infected pregnant women; the uptake of voluntary counseling and testing

(VCT) through the implementation of the opt-out policy; and the referral of eligible HIV-infected pregnant

women to care and treatment.

USG support for the PMTCT program was initiated in 2003. This support was provided to McCord Hospital

in KwaZulu-Natal, Hlabisa sub-district through the Africa Centre in KwaZulu-Natal, mothers to mothers

(m2m) in KwaZulu-Natal and Mpumalanga, and the Johannesburg Metro District through the Perinatal HIV

Research Unit (PHRU) in Gauteng. The Africa Centre, M2M and PHRU programs have been transitioned to

the KwaZulu-Natal Department of Health (KZNDOH) and to direct USAID support, respectively.

McCord Hospital implements best practices for PMTCT through highly active antiretroviral therapy (HAART)

for prevention/treatment, AZT from 28 weeks and nevirapine in labor, nevirapine for pregnant women who

first present in labor, as well as a stat dose of nevirapine and AZT seven days post delivery to the HIV-

exposed infant. This is different from the national protocol. This resulted in a vertical transmission of 4.25%

in 2006. McCord uses a family-centered approach for PMTCT.

New partnerships created at the end of FY 2006 and implemented in FY 2007 include working directly with

the Tshwane-Metsweding Region in Gauteng, and the Free State, North West and KwaZulu-Natal provincial

health departments. To improve quality of PMTCT service delivery, EGPAF will continue to support the

national and provincial Departments of Health by providing technical support, human capacity development,

and infrastructure rehabilitation, where applicable.

Priority areas for the South Africa program that are implemented through the activities include:

(a) Follow-up of HIV-exposed infants and referrals to care and treatment for HIV-infected infants.

(b) Develop referral and integration strategies for fast-tracking pregnant women to treatment services.

(c) Improve partner (i.e., couple) testing and increase male and mothers-in-law involvement in the PMTCT

program.

(d) Work directly with government sites to strengthen PMTCT services.

(e) Strengthen monitoring and evaluation (M&E) activities.

(f) Encourage provider-initiated testing and counseling, counseling for HIV negative to stay negative, repeat

HIV test at 36 weeks

(g) Tuberculosis (TB) screening, identification of eligible pregnant women for HAART and referral to care

and treatment sites.

(h) Integrating PMTCT into existing maternal and child health and family planning services including pap

smears.

(i) Infrastructure rehabilitation, e.g., renovations to existing structures, acquisition of park homes.

(j) Encourage support groups for pregnant women.

(k) Community and facility-based strategies to support infant feeding choices made.

ACTIVITIES AND EXPECTED RESULTS:

ACTIVITY 1: McCord PMTCT Program Activities

(a) Implement the family-centered model encouraging couple counseling, providing partner testing and

testing of other siblings.

(b) Use the both provider-initiated and voluntary "opt-out" approach in the counseling and testing (CT)

program

(c) Provide polymerase chain reaction (PCR) testing at six weeks for early infant diagnosis and thus

improve HIV-exposed infant testing and follow-up.

(d) Strengthen the referral system between PMTCT and the wellness clinic or care and treatment services.

This is achieved by offering routine CD4 testing to HIV-infected pregnant women and HIV-infected infants to

identify those eligible for HAART.

(e) Provide TB screening for HIV-infected pregnant women.

(f) Offer complex ARV regimens depending on the clinical and immunological (CD4) staging.

(g) Provide HIV and AIDS training to local community-based organizations such as churches and youth

organizations to raise community awareness.

(h) Provide cotrimoxazole prophylaxis for mothers and children.

Activity Narrative: ACTIVITY 2: Free State, Gauteng, KwaZulu-Natal and North West Provincial Departments of Health

(a) Conduct needs and site assessments to identify gaps and address the needs of human resources,

infrastructure, training of healthcare workers (HCW), technical support, monitoring and evaluation,

commodity, and ways to strengthen PMTCT services.

(b) Provide training in early infant diagnosis (PCR) to improve follow-up of HIV-exposed infants.

(c) Incorporate CD4 testing of HIV-infected pregnant women and HIV-infected infants in the PMTCT

program, and fast-track those eligible to care and treatment sites or wellness clinics.

(d) Facilitate the provision of antiretroviral treatment for eligible HIV-infected women within the PMTCT

program.

(e) Develop comprehensive referral systems to care and treatment sites.

(f) EGPAF respects Provincial Policy on Nutrition. The nutritional advice is provided through health

education to all pregnant women (HIV-infected or not).

ACTIVITY 3: Support to National PMTCT Staff Capacity and Training; Participate in the National Pediatric

AIDS Working Group

(a) Provide training to the nine provinces on early infant diagnosis, antiretrovirals in pregnancy, clinical and

immunological staging of HIV and AIDS in infants and children, and clinical manifestations of HIV and AIDS

in infants and children.

(b) Place a technical advisor within the National Department of Health.

(c) Participate in the National Pediatric Working Group to discuss and advise policy with regard to pediatric

treatment guidelines and access to pediatric treatment services.

The EGPAF PMTCT activities contribute to the PEPFAR 2-7-10 goals by strengthening PMTCT at the

provincial and national level.

With FY08 reprogramming funding, EGPAF will provide support to the national Department of Health and 3

provinces (KwaZulu-Natal, North West and Free State) in training and mentoring of health workers to

implement the new (2008) PMTCT dual therapy guidelines. Tools to measure compliance to these new

guidelines are being developed and will be rolled out to facilities in the three targeted provinces, and

beyond.

TYPE OF STUDY: New.

TITLE OF STUDY: Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) Antiretroviral Pregnancy Register

- A Multi-Country Surveillance Protocol.

TIME AND MONEY: Part A of the study is expected to begin in September 2007. Rollover into Part B will

occur in April 2008. Inclusion of additional countries into the larger surveillance protocol will begin in

October/November 2007 during the revision of the current protocol. Total project time is five to six years.

Total projected budget for South Africa, with activities set to begin in 2008, is approximately $1 million for

the five-year duration of the project. Funding requested will be $200,000 for each year.

LOCAL CO-INVESTIGATOR: EGPAF anticipates using one to two local clinical investigators, though the

investigators have not yet been confirmed. They will work in collaboration with the other country clinical

investigators as well as with the protocol team leader and principal investigator (PI). It is anticipated that

only one to two sites will be included in this study.

PROJECT DESCRIPTION: Antiretroviral treatment (ART) delays disease progression and consequently

HIV-infected pregnant women are increasingly being treated with highly active antiretroviral therapy

(HAART) for the sake of their health and to reduce vertical transmission. Current guidelines in developed

countries for the management of HIV-infected women include the use of HAART during pregnancy as this

achieves complete plasma viral suppression prior to delivery. Although the use of HAART in pregnancy has

significantly reduced rates of vertical transmission of HIV-1, some questions remain regarding the safety of

these therapies and their potential impact on the uninfected infant. The scientific and medical communities

in the western world in collaboration with drug manufacturers have established an Antiretroviral Pregnancy

Registry (APR). In contrast, in most of the resource-poor countries that carry high burden of disease from

HIV and where antiretroviral products are likely to be used, routine surveillance on birth defects is not

documented. EGPAF is establishing such a registry within its Care and Treatment program. The goal of this

registry is to conduct observational surveillance for HIV-infected pregnant women exposed to antiretroviral

products during the prenatal period to evaluate the outcome of the pregnancy and safety of the products.

EVALUATION QUESTION: There are two evaluation questions. The primary question aims to to determine

the frequency of adverse events including teratogenicity and adverse birth outcomes among infants or

fetuses born to mothers exposed to antiretroviral treatment during pregnancy. The secondary question aims

to (a) differentiate the frequency of adverse events including teratogenicity and adverse birth outcomes

among infants born to mothers exposed to antiretroviral treatment during pregnancy by gestational age at

exposure; and (b) differentiate the distribution of adverse events including teratogenicity and adverse birth

outcomes by various drug regimens used in resource-limited countries.

Endpoints include:

(a) Number of major congenital defects documented at birth and at six months and in any fetus > 20 weeks

gestation born to mothers exposed to combination antiretroviral therapy during pregnancy.

(b) Number of adverse pregnancy outcomes documented in mothers exposed to combination antiretroviral

therapy during pregnancy.

(c) Number of maternal > Grade II toxicity events reported in pregnant women exposed to combination

antiretroviral therapy during pregnancy.

(d) Number of toxicity episodes reported among infants born to mothers exposed to combination

antiretroviral therapy during pregnancy.

PROGRAMMATIC IMPORTANCE/ANTICIPATED OUTCOMES: The purpose of this registry will be to track

the effects of ART medications on pregnancy outcomes, infant and maternal health. Results will be used to

supplement animal and human toxicology studies, in order to promote safe use of ART drugs within the

prenatal period and assist clinicians in caring for their patients. The information acquired may also be made

available to the existing international Antiretroviral Pregnancy Registry (APR).

Methods:

(1) This is an observational surveillance program of pregnant women on ART and follow-up of their infants

to the age of six months to observe for major congenital deformities and serious adverse effects.

(2) Case Report Forms (CRFs) will be designed and provided to the study clinicians for completion. Data

relating to the EGPAF APR will be recorded on the CRFs provided. The CRFs will reflect the latest

observations on the EGPAF APR participants. During monitoring visits, an EGPAF representative will

evaluate them for completeness, validity, legibility and consistency.

(3) No major ethical issues are foreseen. The surveillance program will be conducted in accordance with the

(a) World Medical Association Declaration of Helsinki; and (b) the ICH harmonized tripartite guidelines for

GCP, 1996.

POPULATION OF INTEREST:

(1) Sampling frame: The EGPAF APR will systematically sample and recruit from the women attending the

ART clinic. These women range in age from 15-45 years.

(2) Sample size: An 'intent-to treat analysis' will be conducted for this protocol. This means all subjects who

begin combination ART will be included in the analysis, even if they discontinue therapy for any reason or

are designated as 'lost-to-follow-up'. All statistical tests will be interpreted at the 5% level of significance.

Since Part A is an exploratory phase, the relative frequency of teratogenic effects of the ARVs will be

described and the prevalence of these adverse effects including major congenital defects will be calculated.

Comparisons between the groups on various treatment regimens will also be done in Part A. Adjustments

for multiple comparisons will be done in the first phase e.g. teratogenic effects will be compared to

gestational period at initiation of treatment by regimen. In order to do this, the adverse effects including

teratogenicity will be tabulated per treatment group by type of adverse effect and timing of exposure to

treatment. Special attention will be given to those subjects who have discontinued the pregnancy registry

due to teratogenic effects, a severe adverse event of adverse pregnancy outcome.

INFORMATION DISSEMINATION PLAN: The results of this EGPAF APR will be published in a peer-

reviewed journal. The paper should be submitted for publication within six months of EGPAF APR

completion. Information from this peer-reviewed publication will be subsequently shared with South African

government stakeholders and the pharmacovigilance division of the National Comprehensive Care,

Activity Narrative: Management and Treatment of HIV and AIDS (CCMT) program. The initial manuscript describing the multi-

country results will be created by the principal investigator and distributed to study investigators and site

staff for input and comments. Site specific data can be utilized by local investigators as deemed appropriate

by human subject committees' approvals. A final EGPAF APR report will be prepared in collaboration with

all clinical investigators. This report will be provided to all investigators who contributed to the EGPAF APR

and the Independent Ethics Committee/Institutional Review Board if required. Presentation and publication

of the results of this EGPAF APR will be governed by EGPAF policies.

BUDGET JUSTIFICATION FOR YEAR 1 BUDGET:

The following is based per site:

Salaries/fringe benefits: $87,200

Equipment: $5,700

Supplies: $0

Travel: $0

Participant Incentives: $0

Laboratory testing: $0

Other: $ 7,100

Subtotal: $100,000

Total (for 2 sites): $200,000

SUMMARY:

Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) will use FY 2008 PEPFAR funds to continue palliative

care support for its existing partners in KwaZulu-Natal. The Foundation is also expanding its program

activities to the Free State, North West, and Gauteng provinces. EGPAF aims to improve the quality of life

for people living with HIV (PLHIV) by strengthening care and support services at facility as well as

community level. The primary emphasis areas are human capacity development and expansion of services

through training and task shifting, quality improvement, development of networks, linkages, referral systems

and strengthening local organization, development of infrastructure, development of policies and guidelines,

and health information systems strengthening. Primary populations to be targeted include PLHIV, pregnant

women, OVC, and family members.

BACKGROUND:

The long-term goal of EGPAF care and support program in South Africa is to achieve optimal quality of life

for PLHIV. Ongoing care and support of HIV infected individuals and their families are pivotal to their long-

term wellbeing. Sites supported by EGPAF will expand their activities and partnerships with community-

based leaders and organizations providing care and support to communities thus ensuring sustainable

community-based care and support of HIV infected and their families. Strategies to identify family members

who may or may not be infected and are in need of care and support will be explored. Project Help Expand

Antiretroviral Treatment (HEART) care and support services will expand with increased geographic

coverage during FY 2008. The program will focus on routine screening and treatment of opportunistic

infections (OIs) such as tuberculosis (TB), ongoing adherence counseling and support, general HIV

prevention, prevention with positives, nutrition and infant feeding options support, psychosocial support, as

well as strengthen linkages with home-based care, orphans and vulnerable children (OVC), legal, and social

welfare support systems or organizations. In their regular reporting, sites will be required to demonstrate

functional networks/ linkages with existing governmental and non-governmental support services, especially

(OVC), home-based care services. EGPAF utilizes Project HEART resources to complement those of the

Department of Health (DOH) and private partners, such as faith-based organizations (FBOs) and other non-

governmental organizations(NGOs) providing health care services.

EGPAF will expand/strengthen care and support service delivery through training and task-shifting. A

syndromic approach to the most common adult illnesses including sexually transmitted infections (STIs) and

most opportunistic infections will be emphasized in training. EGPAF will also provide additional health care

providers e.g. nurses, counselors, based on staffing needs. The provision of additional staff ensures that

ongoing clinical monitoring and assessments viz. laboratory tests, nutritional assessment, screening for TB

and, other OIs, cotrimoxazole prophylaxis, are conducted at all times. PLHIV as well as family members will

also be utilized in treatment support to achieve optimal compliance and adherence to ART

The existing sites are:

1. McCord Hospital, Durban

2. Aids Healthcare Foundation (AHF), Umlazi, Durban

3. KwaZulu-Natal Department of Health (KZNDOH), Umgungundlovu District (Edendale and Northdale

Hospitals and their feeder clinics),

4. KZNDOH, Zululand District, Vryheid, Benedictine Hospital and their feeder clinics, as well as eDumbe

Community Health Centre (CHC) and its feeder clinics

New HEART partners include the remaining St Francis, Nkonjeni, Ceza, Itshelejuba, and Thulasizwe TB

Hospitals and their feeder PHC clinics, in the Zululand District in KZN; all five districts in the Free State

Province; two sub-districts in North West Province, as well as Eastern Ekurhuleni sub-district in Ekurhuleni

District and Lesedi sub-district in the Sedibeng District in Gauteng Province.

ACTIVITIES AND EXPECTED RESULTS:

Project HEART aims to improve the quality, availability, and accessibility of care and support services.

Activities undertaken in order to achieve the program objectives include:

1. Conducting site assessments to identify gaps or needs to be addressed to increase the number of

patients on palliative care. This could include minor renovations to address space constraints.

2. Improving the quality of counseling and testing by providing ongoing support to lay counselors and health

care professionals.

3. Assessing quality of the program and supportive supervision to staff.

4. Providing technical assistance to enhance family-centered approach to clinical screening and

opportunistic infection prophylaxis in community settings.

5. Human capacity development through training and task-shifting to improve the quality of palliative care

services. This includes a syndromic approach to the most common adult illnesses including sexually

transmitted infections (STIs) and most opportunistic infections will be emphasized in training. Clear

instructions will be provided according to the DOH guidelines so that health worker knows which patients

can be managed at the first-level facility and which require referral to the district hospital or further

assessment by a more senior clinician. Preparing health workers to treat the common, less severe

opportunistic infections will allow them to stabilize many clinical stage 3 and 4 patients prior to ARV therapy

without referral to hospital. All patients are asked/observed for cough (to improve TB case detection) and

asked about genital ulcers or sore or (in men) a urethral discharge.

These trainings enable HCW to offer appropriate prophylaxis and treatment of opportunistic infections for

adults and children. They will also cover Integrated Management of Childhood Illness (IMCI). Trainings will

also cover appropriate referral to and linkages with provision of antiretroviral therapy for eligible patients,

including both adults and children.

Activity Narrative:

6. Providing M&E support with a focus on strengthening data management systems to enhance routine

program monitoring, improve data quality and facilitate data use.

7. Developing/ strengthening linkages and referral systems with community-based government and non-

government support services namely, home-based care, OVC, social welfare and support groups, or other

primary health care services like PMTCT and TB care.

8. Screening and treatment of opportunistic infections e.g. TB screening, INH and cotrimoxazole

prophylaxis).

9. Nutritional support including infant feeding options support

In FY 2008, the HEART program will increase the percentage of HIV-infected patients with palliative care by

30%. EGPAF plans to embark on a growth strategy - building on the experience and success achieved in

FY 2007. This growth in patient numbers will be achieved through a combination of expanding the efforts of

existing HEART programs, forming alliances with new sub-partners, and supporting the efforts of South

African Government Departments of Health at provincial and district level.

By supporting HIV care and treatment services, EGPAF contributes to the 2-7-10 goals of PEPFAR and the

USG South Africa Five-Year Strategic Plan.

With FY08 reprogramming finds, EGPAF will scale up, raise awareness and champion the need for early

initiation of HAART, especially for those babies that are coming out of the PMTCT program, 50% of whom

should be on HAART by the first birthday; support the implementation of community IMCI; strengthen adult

care at the community level; and create pediatric-friendly family clinics and adolescent services.

SUMMARY:

The Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) will support all of its care and treatment partners

in addressing the barriers to increasing case detection and cure rates in TB co-infected HIV-infected

patients. The program intends to strengthen collaboration between TB control initiatives and HIV and AIDS

programs at EGPAF supported sites in KwaZulu-Natal, Gauteng, Free State and North West. EGPAF

receives both Track 1 and Track 2 (South Africa) PEPFAR funding. The primary emphasis areas for

activities are human capacity development and expansion of services through training and task shifting,

quality improvement, development of networks, linkages, referral systems and strengthening local

organization, development of infrastructure, policy and guidelines, and health information systems

strengthening. Primary populations to be targeted include infants, men and women, both pregnant and not,

people living with HIV (PLHIV), and public and private healthcare providers.

BACKGROUND:

Tuberculosis (TB) poses a serious threat to the public health and economic well-being of South Africans

and in the advent of HIV, affects the most productive segments of the population, as well as

disproportionately affects the poor. The HIV and AIDS epidemic in South Africa has further complicated

control and treatment of TB. Although the South Africa National TB Control Program (NTCP) has made

significant progress over the past several years, it still faces challenges in increasing case detection and

cure rates. Key barriers include a lack of community understanding about the disease, limited access to

services, inadequate provider knowledge and compliance with DOTS, and patient adherence to treatment.

The program's key focus will be at the district, municipal, and community levels. EGPAF will:

1. Assist stakeholders and partners to strengthen local capacity to detect, treat, and prevent TB.

2. Develop community-based strategies to identify potential TB cases and ensure early referrals for

diagnosis and treatment.

3. Assist sites to integrate TB services with HIV and other healthcare services.

4. Support and develop community-based approaches to ensure treatment adherence.

ACTIVITIES AND EXPECTED RESULTS:

EGPAF will strengthen linkages between healthcare centers and community DOT supporters to reduce

treatment interruption rates and improve treatment adherence. EGPAF will establish mechanisms for

collaboration between TB and HIV services by providing counseling and testing within TB services, and

screening HIV-infected individuals for TB.

EGPAF will assist in strengthening the technical capacity at the sites where the comprehensive care

management and treatment programs are being supported. The key activities will involve the integration of

TB services, VCT services, and antiretroviral treatment (ART) services, at primary health care and hospital

level. These activities will be included in the site TB control and evaluation plans.

Mechanisms for integration are:

1. Support the district/site TB/HIV coordinator to expand and improve the referral linkages between TB and

CT.

For all TB patients, provider initiated HIV testing and counseling will be offered and HIV-infected patients

referred to CT. CD4 count and ART initiation will be carried at TB service points where possible.

Cotrimoxazole prophylaxis will also be made available. All HIV-infected patients will be screened for TB,

and referred to TB service points. Where possible, anti-TB treatment will be initiated in CT setting.

2. Assist in the development and implementation plan for TB/HIV at sites at which EGPAF will be providing

comprehensive HIV and AIDS services.

The plan will include human capacity development through training. Health care providers at TB and CT

service points will be trained in both TB and HIV management so that they can provide a comprehensive

package of care. Use of community-based care and support initiatives will be explored to improve

adherence and compliance

3. Assist in developing and strengthening monitoring and evaluation of referral systems for TB/HIV related

activities.

EGPAF promotes the use of referral registers between service points e.g. VCT register reflecting the

service point a patient was referred from e.g. TB, as well as TB and CT registers showing referrals between

the two service points. At TB service points, HIV tests and CD4 counts done are recorded in registers to

facilitate referral. All confirmed TB cases diagnosed at CT service points are recorded in registers and

immediately referred to TB service points. Where possible, electronic TB registers will be maintained

4. For monitoring and evaluation, a core set of indicators, based on national guidelines for monitoring and

evaluation of collaborative TB/HIV activities will be used to measure the success of the program.

EGPAF will support the following activities to reduce the burden of HIV in TB patients (adults and

pediatrics):

1. HIV counseling and testing for all TB cases

2. Increased screening rates of TB for all HIV-infected patients within existing care and treatment sites and

services. Intensified case finding methods include screening for symptoms and signs of TB i.e. cough for

more than 2 or 3 weeks, fever, night sweats, recent weight loss, lymphadenopathy, routine three sputum

Activity Narrative: samples for Acid-Fast Bacilli (AFB), chest x-ray, TB culture may be used to confirm smear-negative

pulmonary TB. When TB diagnosis is confirmed, TB notification is done. All HIV-infected patients with

confirmed TB are referred (referral given) to TB service points for initiation of anti-TB treatment according to

national ARV treatment guidelines. All TB referrals are recorded in the TB registers. In addition to the above

screening methods, primary health care (PHC) facilities are encouraged to use TB Suspect Registers,

which are in the form of a questionnaire, to screen for TB.

3. Provision of cotrimoxazole preventive therapy to TB patients with HIV infection as part of the

comprehensive care and treatment program.

4. Provision of antiretroviral therapy and anti-TB treatment to eligible TB patients with HIV infection, will be

carried out according to national ARV treatment guidelines. Staff will be trained on managing patients co-

infected with HIV and TB.

5. Provision of care and support services to TB patients with HIV infection. All TB patients diagnosed HIV-

infected are provided with cotrimoxazole prophylaxis. Prevention with positives activities are implemented

and nutritional support provided in the form nutritional supplements, education, and food parcels.

6. Provision of isoniazid preventive therapy as part of the package of care for PLHIV when active TB is

excluded. Currently, INH prophylaxis is mainly offered in the clinical setting. In its geographic areas of

support, EGPAF will facilitate the provision of INH prophylaxis under DOT, as well as through home-based

care programs, where possible.

EGPAF will assist the National TB Control Program to strengthen information systems, supervision, and

program management. EGPAF will work with provincial, district, municipal, and community health systems

to build or strengthen capacity to prevent, detect, and treat TB. Human capacity development through

training and task-shifting (e.g. DOT staff giving INH prophylaxis). Mentoring, coaching and preceptorships

will be used to ensure skills transfer in all areas including M&E, which will lead to a more sustainable

program

Emphasis will be put on strengthening linkages with home-based care organizations and community

healthcare workers to identify suspected TB cases, ensure early referrals for diagnosis and treatment, as

well as support treatment adherence through DOT.

By supporting HIV care and treatment services, EGPAF contributes to the 2-7-10 goals of PEPFAR and the

USG South Africa Five-Year Strategic Plan.

With FY08 reprogramming funding, EGPAF will address infection control support (assessment, technical

assistance, training); and pediatric TB (training and mentoring) in the Free State and North West provinces.

SUMMARY:

The Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) will support all of its care and treatment partners

by increasing access to antiretroviral treatment (ART) and care for those that need it. The emphasis areas

for this activity are renovation, human capacity development and strategic information. Primary populations

include infants, men and women, people living with HIV (PLHIV), and public and private healthcare

providers. The geographic focus is on KwaZulu-Natal, Free State, Gauteng and North West.

BACKGROUND:

The long-term goal of the EGPAF care and treatment program in South Africa is to increase life expectancy

among HIV-infected persons. This will be achieved through an intensive focus on increasing access to care

and treatment services as well as the service utilization (demand). To achieve these goals and objectives,

project Help Expand ART (HEART) will expand the geographic coverage of services during FY 2008.

HEART/South Africa is part of a larger worldwide initiative by EGPAF to support care and treatment

services, and receives both Track 1 and in-country PEPFAR funding. The program has maintained a focus

on integrating PMTCT services so as to provide a family-centered model of care that includes access to

treatment for HIV-infected pregnant women, couple counseling, partner testing and screening for TB.

EGPAF utilizes PEPFAR resources to complement activities carried out by the KwaZulu-Natal Department

of Health (KZNDOH) and private partners, such as faith-based organizations (FBOs) and other non-

governmental organizations (NGOs). These resources are utilized to fund staff, infrastructure, drugs,

laboratory testing and provide technical support. EGPAF will identify gaps in the program at the individual

site level and implement activities to address the needs. The intent is to facilitate national and provincial

plans and work together with the government and other partners to ultimately transition programs to South

African government (SAG) support.

EGPAF will provide TA to strengthen quality improvement (QI) by developing or reinforcing Standard

Operating Procedures (SOP) and ensuring mentoring and ongoing supervision. HAART regimens used will

follow national guidelines. Patient monitoring will be based on immunological, clinical and virological

responses to HAART. These responses will be checked against the drug protocols and adherence

guidelines used, to dictate the most appropriate change in treatment regimen.

EGPAF has a partnership with a private NGO, the AIDS Health Care Foundation (AHF); this is a cost-

sharing relationship (drugs and staff) to support the AHF care and treatment program. In addition, McCord

Hospital, a faith-based organization, is a sub-grantee of EGPAF. The EGPAF partnership with the

Department of Health (DOH) includes support for human capacity development, infrastructure rehabilitation

and technical support for sites in KwaZulu-Natal.

The existing sites are:

(1) McCord Hospital, Durban;

(2) AHF (Ithembalabantu Clinic), Umlazi, Durban;

(3) KZNDOH, Pietermaritzburg Up/Down referral program (Edendale Hospital and four referral clinics,

Northdale Hospital and five referral clinics); and

(4) KZNDOH, Vryheid Hospital plus three referral clinics, Benedictine Hospital and three referral clinics, and

Edumbe Community Health Centre (CHC) plus one referral clinic, in Zululand District

The partnership with the Department of Health (DOH) has been expanded to the rest of Zululand district,

the whole Free State province, to Ramotshere Moiloa (Zeerust) and Tswaing (Delareyville) sub-districts in

the North West, and the Eastern Ekurhuleni and Lesedi sub-districts in Gauteng.

ACTIVIES AND EXPECTED RESULTS:

ACTIVITY 1: ARV Drug Procurement

ARV drug procurement will be undertaken for one Track 1 partner (McCord Hospital) and for one in-country

partner, AIDS Health Care Foundation. All DOH sites use the DOH ARV drug procurement systems.

Generic medications purchased comply with the USG PEPFAR Task Force requirement of FDA approval as

well as approval from the Medicines Control Council of South Africa.

ACTIVITY 2: Pharmacy

McCord and AHF are both national DOH accredited ARV sites, and each have a dedicated pharmacist for

the HIV and AIDS treatment program. This has resulted in uninterrupted supply of antiretrovirals and

individualized adherence counseling to the increasing number of patients.

Systems are in place to select, procure, store, track and distribute the drugs privately. Drugs can be

sourced at short notice from private suppliers. McCord Hospital has two purchasing systems currently in

operation. These include:

(1) Rolling Forecast System - GlaxoSmithKline access program drugs, that are purchased monthly

according to a three-month committed, and nine-month open forecast updated monthly. This forecast is

determined by the program batching systems.

(2) Demand Dependant System - 24 hour order to delivery system based on demand and maintained with

minimum and maximum stock levels.

Monitoring of purchases and distribution is done both manually and electronically (Pro-Clin and Trakhealth

Systems) and produce statistical and detailed reports. If stock-outs (less than five days) occur, stock can be

purchased from an alternative source.

As the AHF/Ithembalabantu clinic is a national DOH accredited ARV site, the KZNDOH provides the clinic

with two full-time counselors specializing in counseling and testing. AHF Ithembalabantu clinic has an onsite

pharmacy, and the clinic has the capacity to serve all of its clients pharmacy needs. AHF has developed

Activity Narrative: pharmaceutical and health commodities management systems to ensure a sustainable supply of ARVs and

other relevant supplies.

The clinical and psychosocial support staff at the Ithembalabantu clinic uses a locally developed, highly

effective treatment education and adherence program that has resulted in outstanding, sustained rates of

therapy success. Treatment adherence and education classes, social service support and counseling, as

well as skills development and capacity building classes are all provided onsite. Medication adherence

training and support is given before clients begin ART. Adherence counseling is also monitored by self-

reporting, pill counting, and follow-up with patients, dedicated family members or friends.

The EGPAF drug procurement program contributes to the PEPFAR 2-7-10 goals by ensuring adequate

supply of ARV drugs for patients in treatment.

BACKGROUND:

The long-term goal of the EGPAF care and treatment program in South Africa is to increase life expectancy

amongst HIV-infected persons by increasing access to care and treatment services and service utilization.

Primary emphasis areas are human capacity development and expansion of services through training and

task shifting, local organization capacity building, development of infrastructure, policy and guidelines, and

strategic information. Primary populations to be targeted include infants, men and women, pregnant women,

people living with HIV (PLHIV), and public and private healthcare providers.

Project Help Expand ART (HEART) will expand geographic coverage of services in FY 2008. HEART/South

Africa is part of a larger worldwide initiative by EGPAF to support care and treatment services, and receives

both Track 1 and in-country PEPFAR funding. The program's focus is on integrating PMTCT services to

provide a family-centered model of care that includes access to treatment for HIV-infected pregnant women,

couple counseling, partner testing and screening for TB.

EGPAF utilizes PEPFAR resources to complement those of the KwaZulu-Natal (KZN) Department of Health

(DOH) and private partners, such as faith-based organizations (FBOs) and other non-governmental

organizations (NGOs). These resources fund staff, infrastructure, drugs, laboratory testing and provide

technical support. EGPAF will identify gaps in the program at the site level and implement activities to

address the needs. The intent is to facilitate national and provincial plans and work with the government and

partners to transition programs to South Africa government (SAG) support.

EGPAF has a partnership with a private NGO, the AIDS Health Care Foundation (AHF); this is a cost-

sharing relationship (drugs and staff) to support the AHF care and treatment program. McCord Hospital, a

faith-based organization, is a sub-grantee of EGPAF. The EGPAF partnership with the DOH includes

support for human capacity development, infrastructure rehabilitation and technical support for sites in KZN.

The existing sites are:

(1) McCord Hospital, Durban

(2) AHF (Ithembalabantu Clinic), Umlazi, Durban

(3) KZNDOH, Pietermaritzburg Up/Down-referral program (Edendale Hospital and four referral clinics,

Northdale Hospital and five referral clinics),

(4) KZNDOH, Vryheid Hospital plus three referral clinics, Benedictine Hospital and three referral clinics, and

Edumbe Community Health Centre (CHC) plus one referral clinic, in Zululand District.

This partnership with the DOH will be expanded to the whole Free State province, to Ramotshere Moiloa

(Zeerust) and Tswaing (Delareyville) sub-districts in the North West, to all of the Umgungundlovu and

Zululand districts in KZN, and the Eastern Ekurhuleni and Lesedi sub-districts in Gauteng.

ACTIVITIES AND EXPECTED RESULTS:

ACTIVITY 1: Human Capacity Development

EGPAF will support training of healthcare providers on the following:

1. Screening and treatment of TB/HIV and opportunistic infections, ART in pregnancy, and referral systems

(between PMTCT and ART);

2. Supporting systems to improve access to care and treatment of children (including early infant diagnosis);

3. Capacity building at sites for implementation and management of the comprehensive care, management

and treatment support program;

4. M&E;

5. Project management; and

6. Funding health workers to complete a HIV and AIDS Diploma at the University of KwaZulu-Natal.

In addition EGPAF will provide technical assistance for the creation of outreach programs to build capacity

at primary healthcare (PHC) clinics for downward and upward referral in order to maintain patients on ART,

initiate new patients on therapy, and decongest treatment sites that have reached capacity.

ACTIVITY 2: Down Referral Process

The KwaZulu-Natal Health Department (KZNDOH) started providing comprehensive care and treatment

services to HIV-infected patients in May 2004 at hospital level. PHC clinics will be capacitated so that they

are able to manage stable patients on ART referred down from the hospitals or community health centers

(CHCs), and also up refer those that are eligible for initiation of ART to hospital or CHCs that are ARV

accredited sites.

The KZNDOH aims to make ART accessible to all by expanding and strengthening existing HIV and AIDS

care and treatment service delivery. A number of CHCs have been accredited by the national and provincial

health departments and will initiate ART. The PHC clinics conduct rapid HIV testing, CD4 testing and

provide the first, second and third adherence counseling sessions, which is also done at CHC and hospital

level, and then refer patients to accredited CHCs or hospitals for initiation. The KZNDOH has identified the

Pietermaritzburg and Zululand Districts as areas needing immediate support as they are poorly resourced

with high HIV seroprevalence rates. The KZNDOH has requested that EGPAF support be extended to these

districts. The districts have identified clinics where stable patients on treatment can be referred to continue

ART management.

ACTIVITY 3: Pediatric Care and Treatment

EGPAF's goal is to ensure that 10 percent of all patients on treatment are children, which has not been

achieved in the Zululand district. To strengthen pediatric HIV care and treatment, EGPAF will provide

training on early infant diagnosis, pediatric HIV clinical staging and diagnosis and ART in children, in

addition to provision of staff, strengthening the linkages between PMTCT and care and treatment.

Activity Narrative: The Edendale and Northdale pediatric HIV clinic has the largest cohort of pediatrics in the province on ART.

The hospital down refers stable patients to the care of the PHC clinics to free up space for new pediatric

patients.

EGPAF aims to:

1. Increase the rate of down referral of stable children on ART;

2. Increase the up referral of new eligible children for initiation of therapy; and

3. Improve linkages between PMTCT programs and care and treatment programs.

EGPAF will provide financial and technical support to eight PHC clinics in the catchment area of the

Edendale and Northdale hospital in Pietermaritzburg, thus capacitating them to: (1) receive and manage

transferred stable pediatric patients on ART from the pediatric HIV clinic; and (2) provide screening and

preparation of eligible HIV-infected patients at three PHC facilities for up referral and initiation of ART at

Edendale Hospital Pediatric HIV clinic. The same approach will be applied as we expand to other provinces,

namely Free State, North West and Gauteng Provinces.

ACTIVITY 4: Counseling and Testing (CT)

The focus of this activity will be on strengthening comprehensive HIV and AIDS care and treatment services

using a family-centered approach to increase access to CT, by fast-tracking TB, STI, and family planning

patients to CT; to integrate PMTCT with HIV and AIDS care and treatment; to improve referral of eligible

pregnant mothers, partners, family members, and HIV-infected infants and children to treatment sites; to

screen for opportunistic infections. With this focus, EGPAF will increase pediatric care and treatment,

couple counseling, partner testing, and testing for siblings. For patients who test HIV positive and are not

yet eligible for ART, they will be retained through wellness clinics, support groups, patient tracking, etc. The

overall goal is to expand coverage of HIV and AIDS care and treatment services to reach mothers, partners

and children who would not otherwise have access to these services.

The increase in funding in FY 2008 will be used to expand EGPAF program activities viz. human capacity

development, down-referral process, pediatric care and treatment as well as counseling and testing

activities to the Free State, North West and Gauteng Province. In addition, EGPAF will strengthen M&E

systems at all levels of service delivery.

The activities contribute to the PEPFAR 2-7-10 goals.

With FY 2008 reprogramming funds, EGPAF will provide additional support to the Free State and North

West Department of Health (Bojanala District) to provide integrated HIV, TB, PMTCT and HIV care and

treatment services. This will include a focus on strengthening the down-referral program in both provinces.