In close collaboration with the National Department of Health (NDOH), CDC will provide overall HIV and

AIDS programmatic support to the national and provincial prevention of mother-to-child transmission

(PMTCT) program. In addition, NDOH relies on CDC to implement activities that address NDOH's emerging

priorities, provide financial and technical support quicker than the NDOH systems allow. PEPFAR PMTCT-

specific activities are represented on the NDOH operational plan, and contribute to the overall

implementation of the national PMTCT program.

SUMMARY:

The aim of the "In Support of the NDOH PMTCT" project is to provide technical assistance to the NDOH

and provincial health departments to ensure expansion and strengthening of PMTCT services in all nine

provinces. The major emphasis area is training. Minor emphasis areas include development of

network/linkages/referral systems, policy development, local organization capacity development, quality

assurance, and strategic information. Target populations for these activities include policy makers, National

AIDS Control Program staff, other NDOH staff, other healthcare workers, women, family planning clients,

pregnant women, people living with HIV, HIV-infected pregnant women and their infants.

BACKGROUND:

The goal of the National PMTCT program is to reduce mother-to-child transmission of HIV by improving

access to HIV counseling and testing in antenatal clinics, improving family planning services to HIV-infected

women, and implementing clinical guidelines to reduce transmission during childbirth and labor. In addition,

the National program is responsible for ensuring follow-up of infants born to HIV-infected mothers and

ensuring that these infants are identified early and referred to treatment if necessary. The purpose of this

project is to provide technical assistance to NDOH by funding two program assistants to work within the

NDOH on all aspects of the program. The technical assistance focuses particularly on capacity building of

healthcare workers and community healthcare workers, development and implementation of provincial

PMTCT-specific operational plans, strengthening national and provincial reporting systems, coordinating the

national PMTCT steering committee meeting, developing a monitoring and evaluation system for early

infant diagnosis and strengthening service delivery by implementing systems strengthening activities.

ACTIVITIES AND EXPECTED RESULTS:

ACTIVITY 1: Capacity Building

In FY 2005, PEPFAR and the NDOH finalized the PMTCT and Infant Feeding Curricula and PEPFAR

funding produced a trainers' guide, participants' guide and course directors' guide. In FY 2006, course

directors and trainers were updated on the finalized curriculum and provincial training coordinators were

assisted in developing provincial training plans to implement the curriculum at the provincial level. FY 2007

funding was used to ensure expansion of the PMTCT training throughout the country. Particular support

was given to expand training on PCR implementation and monitoring and evaluation of the PMTCT

program. FY 2007 Plus up funding will be used to align the existing PMTCT and Infant Feeding Curricula

with the important policy shift in the area of PMTCT ARV prophylaxis. As of FY 2008 the national PMTCT

policy will no longer be single dose nevirapine, but the provision of dual therapy to all HIV-infected pregnant

women. It is anticipated that the regimen will be AZT from 24-28 weeks and nevirapine at the onset of labor.

FY 2008 PEPFAR funds will be used to assist the NDOH and provincial DOHs to develop strategies for the

implementation of the new PMTCT policy, the development and printing of the new PMTCT guidelines,

training and updating of all health care workers. Funds will be used to ensure that all healthcare workers

offering antenatal care, postnatal and child health services receive training. These activities will contribute to

the PEPFAR goal of averting seven million new infections, as healthcare workers will be trained to integrate

PMTCT into routine service, and more pregnant women will receive PMTCT services.

ACTIVITY 2: Technical Assistance

In FY 2004 CDC placed a technical advisor at the NDOH to support the PMTCT program. For the last three

years, this advisor has worked closely with the national PMTCT program and the national PMTCT steering

committee to identify gaps and challenges to PMTCT implementation and develop strategies to strengthen

PMTCT implementation. As the PMTCT policy will shift in FY 2008, it is necessary to bring an additional

PMTCT advisor on board to assist the NDOH in the roll-out of the dual therapy PMTCT policy. This will

mean that in FY 2008, CDC will support two PMTCT advisors at the NDOH. The one advisor will focus on

the maternal aspects of the PMTCT program and integration of PMTCT into antenatal care services. This

advisor will be tasked with assisting the NDOH increase PMTCT uptake, develop strategies and provincial

operational plans for the roll-out of dual therapy, providing technical assistance to the provinces to address

health systems challenges in PMTCT implementation. A second advisor will focus on ensuring rollout of

early infant diagnosis, ensuring stronger linkages between PMTCT and treatment, care and support,

addressing infant feeding issues and creating systems to improve follow-up of PMTCT enrolled mothers and

their infants. These advisors will offer technical assistance for the implementation of policy, monitoring and

evaluation and day-to-day programmatic support to the NDOH. The technical advisor will conduct provincial

site visits to assess quality of PMTCT service delivery and will work directly with the provinces to strengthen

and improve existing services.

ACTIVITY 3: Monitoring Early Infant Diagnosis

Using FY 2007 and FY 2008 funding a monitoring and evaluation system for early infant diagnosis is

currently being developed and piloted at the coronation hospital complex in Gauteng province. FY 2008

funding will be used specifically to support the scale-up and rollout of early infant diagnosis services to other

clinics and hospitals in Gauteng province. The monitoring and evaluation system is currently being

developed as no national system to monitor early infant diagnosis exists. The district health information

system (DHIS) which is responsible for the national data set only captures the number of infants tested at

12 months of age. The new system includes monitoring and evaluation training on the national early infant

diagnosis testing protocol implementation, implementation itself and client adherence and follow-up. The

activity is a logical follow-on from the formative/descriptive work conducted in FY 2006, and the results

obtained from the formative work served as the basis for formulating monitoring and evaluation tools (both

quantitative and qualitative, exploring both quality of care and service provision and client adherence and

Activity Narrative: psychosocial impact) that can be used for early infant testing rollout. Expected results include development

of a draft monitoring and evaluation package to be tested in a number of facilities as the early infant testing

training and protocol are progressively rolled out. The draft package will also include an assessment of the

feasibility of implementing the package in different types of health facilities and how it can be adapted to

facilities already offering the service. In addition, while the monitoring and evaluation package will be

thorough and comprehensive, certain components may not be realistic for certain clinical settings.

Therefore, part of the package will explore different levels of monitoring and evaluation (gold, silver, bronze

standard) depending on the clinical environment. This will ensure exploration of quality of care issues in

greater depth. This activity will contribute to PEPFAR goals by facilitating a process where HIV-infected

infants can be identified early and referred to antiretroviral therapy facilities for monitoring and ensuring that

they receive treatment at the appropriate time. In addition, the focus on quality of care will ensure

sustainable implementation of early infant diagnosis.

ACTIVITY 4: Collaboration with Other Donors and Stakeholders

At the request of the NDOH, a stakeholders analysis of PMTCT activities is currently underway. This

analysis will identify and map all existing PMTCT activities taking place around the country. It will facilitate

the identification of gaps in PMTCT service delivery and highlight the different levels of support being given

by various donors and stakeholder to the NDOH PMTCT program. FY 2008 funding will be used to hold a

National PMTCT stakeholders workshop, where the results of this analysis will be presented. The NDOH,

the donors and stakeholders will then decide how to scale up and strengthen PMTCT activities. The

premise behind the stakeholders workshop is to ensure that there is no overlap in activities, all areas of the

country are being provided with support and assistance and that stakeholders and donors are collaborating

in the rollout of PMTCT services. The expected result of this activity will be the development of one national

annual PMTCT operational plan for South Africa. The NDOH, with support from CDC, will take the lead on

this activity.

The "In support of NDOH" activity plays a pivotal role in the implementation of the national PMTCT program

as all activities assist the NDOH and provincial departments of health in the rollout of the New Strategic

Plan (NSP) for HIV and AIDS, and the accelerated prevention strategy. Funding will ensure that the new

PMTCT policy is disseminated throughout the country and that health care workers are trained in

accordance with the NSP. This program will contribute to 2-7-10 goals by ensuring implementation of quality

PMTCT services and by preventing vertical transmission.

SUMMARY:

PEPFAR funds will be used to continue to support the National Department of Health (NDOH) Youth and

HIV directorate. Since FY 2005, PEPFAR funds have been used to place a Youth HIV advisor at the NDOH.

This advisor has provided programmatic support to the NDOH in terms of growing the youth program and

ensuring support for non-governmental organizations (NGOs), faith-based organizations (FBOs), and other

organizations working in the area of youth and HIV. The emphasis will be on human and local organization

capacity development, and training. The target populations will include host country government workers,

implementing organizations and youth between the ages of 10 -18. Activities will also focus on young

adults, between the ages of 18 and 24, especially women. The focus for this group, particularly those

women that are sexually active, will be on the B component of the AB program

BACKGROUND:

Four NGOs will be supported to carry out AB prevention activities for youth through the NDOH cooperative

agreement. The funds requested under this COP entry "In-Support of the NDOH" will continue to support a

youth specialist that provides technical assistance to the NDOH on youth activities including the provision of

technical oversight to the four NGOs. The "In-support of the NDOH" funds are also allotted to small-scale

activities at the request of the NDOH for AB prevention activities.

ACTIVITIES AND EXPECTED RESULTS:

Three activities will be carried out in this Program Area.

ACTIVITY 1: Technical Assistance

FY 2008 funding will ensure continued support for a locally employed staff to provide technical and

programmatic assistance to the NDOH in the area of youth and HIV. The youth advisor will continue to work

closely with NDOH in the design and delivery of their youth interventions. In addition, the youth advisor will

ensure collaboration between youth-based NGOs funded through the CDC-NDOH cooperative agreement.

ACTIVITY 2: Expansion of the Peer Educator Program

Providing coordination and oversight for Rutanang peer education trainings (particularly addressing

abstinence and be faithful, youth-friendly services, HIV prevention initiatives and strategies, male norms and

behavior and violence, cohesion, stigma and discrimination) offered for the NDOH, the South African

Department of Education (DOE), and other South African Government partners in collaboration with

Harvard University.

ACTIVITY 3: Capacity Building

FY 2008 funding will be used to build the capacity of local organizations that are working with Youth.

Capacity building will be achieved through the provision of training on HIV and on the promotion of AB

messages. This will be done in collaboration with the NDOH and DOE and in line with their priorities.

ACTIVITY 4: Families Matter!

FY 2008 funds will be used to begin to adapt and implement the Families Matter! Program (FMP). FMP is

an evidence-based, parent focused intervention designed to promote positive parenting and effective parent

-child communication about sexuality and sexual risk reduction for parents of 9-12 year olds, with the

prospect of expanding to parents of teenagers at a later stage. FMP recognizes that many parents and

guardians may need support to effectively convey values and expectations about sexual behavior and

communicate important HIV, sexually transmitted infection, and pregnancy prevention messages to their

children. The ultimate goal of FMP is to reduce sexual risk behaviors among adolescents, including delayed

onset of sexual debut, by giving parents tools to deliver primary prevention to their children. Families Matter!

is delivered over five consecutive sessions where each lasts for three hours. Each session builds upon the

foundation laid in the previous session. Activities will be implemented in accordance with the NDOH

These activities support the PEPFAR 2-7-10 goals and the USG five-year strategy by ensuring close

collaboration with the NDOH in the area of AB and youth HIV related activities. This support strengthens

NGO and FBO activities and contributes to seven million new infections averted.

SUMMARY:

In close collaboration with the National Department of Health (NDOH), CDC will provide overall HIV and

AIDS programmatic support to the national and provincial Departments of Health. In addition, NDOH relies

on CDC to implement activities that address NDOH's emerging priorities, providing financial and technical

support more quickly than the systems of NDOH allow. PEPFAR other prevention-specific activities are

represented on the NDOH operational plan, and contribute to the overall implementation of the national HIV

and AIDS program. During FY 2007, CDC participated in the development of the Accelerated HIV and AIDS

Prevention Strategy. During this process, a number of activities where identified and prioritized by the

NDOH. These include activities focusing on prevention with positives (PwP); activities targeting parents,

and activities focused around young women between the ages of 20 and 30. The PwP activities will

complement the PwP activities within the CARE portfolio.

BACKGROUND:

The aim of the "In Support of the NDOH other prevention" project is to provide technical assistance to the

NDOH and provincial health departments to ensure expansion of existing prevention efforts in all nine

provinces of South Africa. In addition this project provides ensures technical assistance and implementation

of new and innovative projects in the prevention arena. Two new prevention initiatives will be piloted in

South Africa using FY 2008 PEPFAR funding. These include "Families Matter!" and a clinic-based

prevention with positives initiative. The major emphasis area is training with a particular focus on in-service

training. Other emphasis areas include development of network/linkages/referral systems and local

organization capacity development. Target populations for these activities include healthcare workers,

community-based and non-governmental organization, the general population, including children aged 10-

18 years, youth, parents, people living with HIV (PLHIV) and discordant couples. A particular focus of this

activity is prevention with positives. Addressing prevention with HIV-infected patients is an important part of

a comprehensive prevention strategy. Through healthy living and reduction of risk behaviors, these

prevention interventions can substantially improve quality of life and reduce rates of HIV transmission. The

goal of these interventions is to prevent the spread of HIV to sex partners and infants born to HIV-infected

mothers and protect the health of infected individuals. The rapid scale-up of HIV care and treatment has

created an opportunity to reach many HIV-infected individuals with prevention interventions on a regular

basis.

ACTIVITIES AND EXPECTED RESULTS:

ACTIVITY 1: Capacity Building

FY 2008 funding will be used to building the capacity of local organizations supported by the NDOH that are

working with in the area of other prevention. Capacity building will be achieved through the provision of

training on HIV and on the promotion of prevention messages. This will be done in collaboration with the

NDOH and in line with their priorities. Prevention messages and activities will target the general population

and will focus on reducing concurrent partners, correct and consistent condom use, and behavior change

messaging.

ACTIVITY 2: Families Matter!

FY 2008 PEPFAR funding will be used to begin to adapt and implement the Families Matter! Program

(FMP). FMP is an evidence-based, parent-focused intervention designed to promote positive parenting and

effective parent-child communication about sexuality and sexual risk reduction for parents of 9-12 year olds.

FMP recognizes that many parents and guardians may need support to effectively convey values and

expectations about sexual behavior and communicate important HIV, STD, and pregnancy prevention

messages to their children. The ultimate goal of FMP is to reduce sexual risk behaviors among adolescents,

including delayed onset of sexual debut, by giving parents tools to deliver primary prevention to their

children. Families Matter! is delivered over five consecutive sessions where each lasts for three hours. Each

session builds upon the foundation laid in the previous session. Activities will be implemented in accordance

with the NDOH.

ACTIVITY 3: Prevention with Positives

HIV clinics and hospitals will be supported to adapt and implement a comprehensive package of prevention

interventions for HIV infected individuals in care and treatment settings. Two provinces will be selected to

pilot the intervention, namely Free State and Mpumalanga. The prevention interventions include provider-

and counselor-delivered prevention messages, family planning counseling and services to HIV infected

women and their partners, STI management and treatment, and testing of partners and children.

Specifically, health care providers will be trained to deliver targeted behavioral messages to patients on

disclosure, partner testing, and sexual risk reduction (abstaining or being faithful and using condoms

consistently) during all routine clinic visits. Providers will be trained to deliver family planning counseling and

services (funded through wrap around funds) to HIV infected women and their partners in the HIV clinic

settings and these services will be integrated into the HIV clinic. In addition, providers will be trained to

manage and treat STIs in the HIV care and treatment setting. Lay counselors will be placed in these

settings for more in-depth prevention counseling beyond what health care providers have the time to

address. They will counsel persons living with HIV on several key prevention issues, including sexual risk

reduction, disclosure, adherence, reduction of alcohol consumption, and testing of sex partners and children

in the HIV clinic setting. These interventions will be implemented using the CDC's HIV Prevention in Care

and Treatment Settings Prevention Package, which includes several training packages and job aids. Other

prevention is addressed by all providers in all components of the intervention. Medical providers will

promote consistent condom use with all patients during each clinic visit. Mid-level providers and lay

counselors will routinely recommend consistent condom use through tailored prevention messages. In

addition, condom use is promoted in the Family Planning intervention as a method of dual protection.

Condom use is also promoted as part of STI management as a method for reducing STI transmission and

acquisition. In addition to recommending condoms and providing educational materials on condoms, clinics

will stock an adequate supply of male condoms to distribute to each HIV-infected patient at every clinic visit.

ACTIVITY 4: Women 20-30

Activity Narrative:

FY 2008 funding will be used to work with the NDOH to refine its prevention strategy targeting young

women between the ages of 20-30. Funding will be used to assist the NDOH in integrating HIV prevention

activities within the family planning setting. Activities will be aimed at the Provincial Maternal Child and

Women's Health Coordinators. These provincial coordinators meet quarterly to discuss pertinent issues

affecting women and children in their provinces and develop strategies to address these challenges. FY

2008 funding will be used to facilitate two quarterly meetings that address integration of HIV prevention into

family planning services. At the first quarterly meeting, the facilitator will ensure that an implemental

integration strategy specific to each province is developed. Thereafter, at the subsequent meeting,

provincial coordinators will be required to report on progress, and challenges relating to the integration of

HIV prevention and family planning services.

SUMMARY:

The aim of this project is to provide technical assistance to the National Department of Health (NDOH) and

provincial health departments to ensure expansion and integration of palliative care services within all

palliative care programs, including PEPFAR, in all provinces. Target populations for these activities include

host country government, healthcare workers and community healthcare workers. PEPFAR funds will be

used to employ one full time palliative care technical advisors to be placed at CDC and one full time

palliative care technical advisor in each of the nine provinces to assist with the coordination of palliative care

activities at provincial and district level, enhance capacity of provincial and district staff by providing support

and technical assistance for the implementation of the Basic Care Package at district level in all nine

provinces. The funds will also be used as part of a joint (inter-agency) APS to attract new partners to

implement the Basic Care Package for PLHIV who do not qualify for ARV treatment.

BACKGROUND:

The goal of the National palliative care program is to ensure the universal access to palliative to all PLHIV

and family members especially those who do not qualify for ARV therapy thus establishing a continuum of

care from testing HIV positive to end of life care.

ACTIVITY 1:

The technical advisors at provincial level will be responsible for coordinating the implementation of the Basic

Care Package and the integration of pain assessment and management into HIV care services at district

level. This will ensure consistency and quality across all palliative care services and will build capacity within

the provincial DOH to monitor and support palliative care services. It is expected that these advisors will be

able to support and advocate for supportive palliative care policies at the national level and within the

provinces respectively and ensure that these policies are in line with the South Africa National Strategic

Plan for HIV and AIDS. These coordinators will liaise with provinces and work across all PEPFAR partners

within the provinces to ensure quality palliative care services are rendered according to national and

PEPFAR guidelines. They will also provide technical assistance at provincial level in monitoring and

evaluation of Care programs at district level.

ACTIVITY 2:

Funds will be utilized in the joint agency APS to attract new partners to implement the Basic Care Package

in all nine provinces. USG is seeking partners to implement services in: acceptance of status, disclosure,

screening and treatment of opportunistic infection (cotrimoxazole and INH prophylaxis), nutrition

assessment and counseling, pain and symptom screening and management, knowledge of HIV infection

and disease progression, ART and treatment adherence, TB treatment and adherence and basic hygiene

and safe water. Addressing prevention with HIV-infected individuals is an important part of a comprehensive

care strategy. Through healthy living and reduction of risk behaviors, these prevention with positives

interventions can substantially improve quality of life and reduce rates of HIV transmission. The goal of

these interventions is to prevent the spread of HIV to sex partners and infants born to HIV-infected mothers

and protect the health of infected individuals. The rapid scale-up of HIV care and treatment has created an

opportunity to reach many HIV-infected individuals with prevention with positives interventions on a regular

basis. Emphasis will also be placed on accessing gender equity in care programs. USG is seeking partners

to implement these services in hard to reach rural areas.

The main beneficiaries for this program will be PLHIV who will be encouraged to compete. This program will

contribute to 2-7-10 goals by ensuring the implementation of quality palliative care and increasing access to

palliative care services.

SUMMARY:

Tuberculosis (TB) is the leading cause of death among people living with HIV/AIDS, and addressing TB/HIV

is an important part of meeting the Emergency Plan 2-7-10 goals. CDC/PEPFAR carries out additional

activities to strengthen and enhance TB/HIV activities in support of the South Africa National Department of

Health (NDOH). Activities supported with these funds focus on TB/HIV program and laboratory support.

ACTIVITES AND EXPECTED RESULTS:

ACTIVITY 1: Technical Assistance

CDC staff will provide technical assistance to the NDOH and related organizations regarding TB/HIV

program and laboratory activities. Staff needs consist of one CDC direct-hire, 2 locally-employed staff

(TB/HIV clinical coordinator and TB/HIV monitoring and evaluation advisor), 2 contractors (TBHIV laboratory

officer and TB/HIV laboratory training advisor).

ACTIVITY 2: TB/HIV Surveillance

The ETR.Net is the software application conceived and managed by the NDOH National TB Control

Program (NTCP) and reflects program-defined needs and inputs. This has been developed by

WamTechnology CC, a South African private information technology firm. WamTechnology works with CDC

South Africa and the NTCP to develop software and provide support for the ETR.Net. This software has

been modified to track HIV testing and care services among TB patients. The TB/HIV module will be fully

implemented during FY 2008. Expected results include strengthening of TB/HIV recording and reporting

system to include patient-level data collection on TB/HIV (TB patients counseled and tested for HIV, started

on cotrimoxazole (CTX), referred for HIV care and starting antiretroviral treatment (ART). This will in turn be

used to bolster referral systems between services leading to more comprehensive care for TB/HIV patients.

ACTIVITY 3: MDR/XDR reporting

Funds will be used to improve reporting and surveillance systems for drug-resistant TB cases. In

collaboration with the NDOH, funds will be used to expand the number of users using a web-based system

to improve the management and reporting of MDR and XDR-TB cases, data mining activities, and

surveillance analysis of drug-resistant TB cases. Data linkages with the laboratory information management

systems within the National Health Laboratory Services will be expanded.

ACTIVITY 4: Infection Control

In collaboration with the NDOH, funds will support the implementation of a national TB infection control plan

including a national training agenda, standardized training materials, involvement of other partners

(universities, research centers) to accelerate provision of trainings within South Africa. Expansion of

activities will also support expansion of an infection control warmline and/or technical assistance unit for

ongoing technical assistance requests from provinces and partners.

ACTIVITY 5: TB/HIV Pediatric clinical management

In collaboration and with support from the NDOH, funds will be used to develop a standardized pediatric

TB/HIV clinical management training course materials reflecting SA NDOH and WHO guidelines, initiate

efforts to provide access to training via online services, and to implement a warmline consultation service to

provide pediatric TBHIV clinical management guidance to providers.

ACTIVITY 6: TB/HIV integration

In collaboration with the NDOH, expand implementation of field-based DOT program in 4 districts with high

default rates. Efforts would include treatment monitoring in addition to patient tracking and management

using Community health care workers. Project would be evaluated and compared to other DOT models.

ACTIVITY 7: MDR/TB/HIV clinical management

In collaboration and with support from the NDOH, funds will be used to expand efforts to provide access to

MDR/TB/HIV clinical management training, and continued support for a warmline consultation service to

provide MDR/XDR/TB/HIV clinical management guidance to providers.

ACTIVITY 8: TB/HIV Strategic Plan

Funds will be used to support the implementation and monitoring of the TB/HIV strategic plan for South

Africa PEPFAR partners.

ACTIVITY 9: TB/HIV Laboratory Quality Assurance

In collaboration with the National Health Laboratory System (NHLS) and the National Institute of

Communicable Diseases (NICD), funds will be used to strengthening quality assurance measures among

laboratories and to strengthening existing and initiating new External Quality Assurance (EQA) programs

related to HIV and TB diagnostics. Activities will support measures to strengthen reviews, measuring clinical

performance, reporting indicators, and disseminating performance reviews for action.

ACTIVITY 10: TB/HIV Regional Laboratory Training Center (RLTC)

With the availability of significant HIV and TB technical and scientific resources within South Africa, NICD

and NHLS are both well placed to continue to provide regional laboratory support within Sub-Saharan Africa

in these areas. Funds will be used, in collaboration with NICD and NHLS to expand and strengthen existing

TB and HIV regional support mechanisms and enhance further collaboration with other PEPFAR-funded

countries through the established RLTC. Regional support will include TB and HIV related laboratory

services and training initiatives.

Activity Narrative:

ACTIVITY 11: TB/HIV Laboratory capacity

In collaboration and with support from the NDOH, PDOH, NHLS, and NICD, funds will be used to increase

the national coverage of HIV and TB diagnostics and treatment monitoring capabilities. Efforts will also

include strengthening laboratory reporting systems and specimen transport needs in support of rural clinics

and laboratories. Efforts will focus to address existing gaps in laboratory testing outreach and penetration.

ACTIVITY 12. Laboratory Policy Standards

In collaboration and with support from the NDOH, PDOH, NHLS, NICD, National Institute of Occupational

Health (NIOH), South African National Accreditation System (SANAS), and the Medical Research Council

(MRC), funds will be used to encourage and support the development and implementation of a South

African National Laboratory Strategy Plan. The plan will provide the vehicle for establishing minimum

standards and/or requirements for any laboratory (public/private) that performs tests on human specimens

and certify through issuance of a certificate those laboratories that meet the certificate requirements. Efforts

will also attempt to synchronize infection control standards and policies across all TB/HIV laboratories.

ACTIVITY 13: New TB/HIV Automation and Technologies

In collaboration and with support from the NHLS and NICD through co-funding, funds will be used to assess

existing, validate, and implement new automated laboratory diagnostic equipment and high capacity

instrumentation for TB and HIV. Activities will be carried out to increase laboratory through-put for infant

PCR, viral load, and TB diagnostics to meet increased demand, as well as strengthening NHLS's ability to

improve diagnostic, reporting and surveillance activities in relation to TB and HIV.

Title: Patient Outcomes and Management Practices: A Comparison of Proposed 2006 WHO Guidelines for

the Diagnosis of Smear-Negative Pulmonary Tuberculosis against Current Practice in KwaZulu-Natal, South

Africa

Timeline and money: After appropriate approvals of the evaluation (still ongoing), the evaluation will last

approximately 12 months: one month of staff training; six months of data collection; two months of patient

follow-up for each patient cohort (to occur simultaneously with patient enrollment, when applicable); and

three months of data close-out, analysis and reporting. Total budget: no cost extension.

Local Co-investigator: Dr. Douglas Ross, Edendale Hospital, Pietermaritzburg, KZN, South Africa and Local

in-country implementing partner (to be named)

Project Description: Local implementing partner (to be named), in collaboration with three healthcare

facilities in KwaZulu-Natal Province (Edendale Hospital (Pietermaritzburg), McCord Hospital (Durban) and

St. Mary's Hospital (Mariannhill)), will continue to conduct an observational evaluation to assess the

diagnostic utility of the newly proposed WHO guidelines for the diagnosis of smear-negative TB among

hospitalized, seriously-ill adult TB suspects with HIV infection. Specific patient and clinical management

outcomes among patients managed using the WHO algorithm will be compared to these same outcomes

among hospitalized, seriously-ill TB suspects managed with current practices at each collaborating facility.

Evaluation Question: Through this evaluation the partner will attempt to answer the following study

questions in regards to patients managed using current medical practices vs. the proposed 2006 WHO

algorithm:

1.Is there a significant difference in the proportion of patients surviving to completion (i.e., report of final

results) of diagnostic evaluation?

2.Is there a significant difference in the proportion of patients discharged from the hospital due to medical

improvement at 3 weeks after admission?

3.Is there a significant difference in the proportion of patients for whom the diagnosis of SNPTB agrees with

blood and/or sputum Mycobacterium tuberculosis (MTB) culture results (i.e., algorithm sensitivity and

specificity)?

4.Compared with current practices at each hospital, is the 2006 WHO algorithm more, less, or equally

acceptable to healthcare providers and staff in regards to perceived time, human resource and material

resource requirements (to be assessed via surveys)?

We will conduct an observational evaluation to assess the diagnostic utility of the WHO SNPTB guidelines

proposed in 2006 among hospitalized, seriously-ill adult TB suspects with HIV infection. Seriously-ill HIV

infected TB patients are a medically vulnerable population in whom the timing and sequence of clinical

management decisions are particularly critical to patient survival. Additionally, hospitalized seriously-ill

patients are an accessible group whose clinical management is more easily controllable compared to non-

hospitalized patients. By assessing seriously-ill TB suspects the partner hopes to yield information that will

improve the survival rates of this population.

Programmatic Importance/Anticipated Outcomes: The knowledge generated from this assessment will be

used by the provincial and national TB programs, and potentially by other local organizations, to support

decisions on the implementation of new international recommendations. Hopefully, this knowledge will also

result in increased survival rates among seriously-ill, HIV-infected persons with suspected, and confirmed,

TB.

Methodology: This evaluation will involve seriously-ill adult TB suspects with HIV infection. One cohort will

be patients managed using the proposed WHO algorithm, and the second cohort will be patients managed

with current hospital practices. All study participants will be identified from the inpatient services of the

participating facilities. Healthcare facilities routinely collect standard data about patients. The extent of such

routine data collection varies depending on facility and provider practice. Separate study-specific forms will

be used to collect data about the patient's demographic features, recent clinical history, past medical

history, and specific laboratory and diagnostic test results (e.g., sputum AFB smear, sputum and blood

mycobacterial culture, chest radiograph, CD4 T-lymphocyte cell count) relevant to TB disease and HIV

infection. Data elements will be collected using three, newly-created, study-specific forms that will be

managed by the evaluation's data extractors and project coordinator.

Population of Interest: The partner will enroll study participants who have received a diagnosis of HIV

infection within 60 days of current admission. They will identify study subjects from three hospitals in

KwaZulu-Natal (KZN), a province in the southeastern portion of South Africa that includes the city of

Durban, South Africa's second largest city. In KZN the estimated HIV prevalence in pregnant women was

40.7% in 2004- the highest of all of South Africa's provinces.

Budget Justification: The bulk of the evaluation's cost will be for the requisition of human resource/staffing

and laboratory support. Additional costs will be needed for the use of printing and photocopying services

(for data collection elements) and staff travel, between facilities. Evaluation-specific personnel will be

required to collect data from patient records, as well as to coordinate evaluation procedures from within

South Africa. Budget estimates include salary and transportation support for these staff members. Both

blood and sputum mycobacterial cultures will be obtained as part of this evaluation. Blood mycobacterial

cultures, in particular, require processing at private laboratory facilities, at considerable expense, per

specimen.

Information Dissemination Plan: The evaluation will be conducted with cooperation from the National

Department of Health and the Provincial TB Programme as well as the National Health Laboratory Service.

Results will be disseminated to the selected sites, the province, and the national TB programme via a report

and presentations.

Title: Enhancing Diagnosis of Multidrug-resistant Tuberculosis in HIV-infected Patients

Time and Money: This project was approved in COP07 but has not yet begun. Evaluation sites are still

being chosen. After logistical arrangements have been made and the appropriate protocol clearances have

been obtained, the evaluation is expected to be completed in a 6 month time period. Total estimated

budget: no cost extension

Local Co-investigator: Local in-country implementing partner (To be determined)

Project Description: Study will evaluate the implementation of enhanced diagnostic techniques to diagnose

multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB) in HIV-infected TB patients.

In selected sites in a high-HIV prevalence setting, all HIV-infected and un-infected TB patients will undergo

early culture and drug susceptibility testing (DST) at diagnosis to enable earlier detection of MDR-TB and

XDR-TB in the initiation of anti-tuberculosis therapy. Expands upon TB program policy of performing culture

and DST in patients who are smear-positive after two months of TB treatment, are re-treatment patients, or

are high-risk contacts of other MDR-TB patients.

Evaluation Question: MDR-TB is more difficult and costly to treat, and MDR-TB patients have worse

outcomes than patients with drug-susceptible TB. The association between MDR-TB and HIV is unclear, but

a recent study in KwaZulu-Natal has found a higher prevalence of MDR-TB than previously recognized. In

addition, this study found that all patients enrolled with resistance to isoniazid, rifampin, as well as

kanamycin and ofloxacin (XDR-TB) were HIV-infected. There was significant evidence of nosocomial MDR-

TB transmission occurring in the study site. As HIV-infected individuals often have weakened immunity,

nosocomial transmission of TB is of increased concern for this population. The proposed evaluation intends

to examine the number of MDR-TB cases diagnosed at the start of TB treatment in HIV-infected TB patients

as compared with HIV-uninfected TB patients.

Programmatic Importance/Anticipated Outcomes: Results will be used to describe the rates of MDR-TB and

XDR-TB in selected study sites, implement infection control guidelines in the evaluated facilities, and make

recommendations for diagnosis and treatment of MDR-TB and control of nosocomial transmission of TB

and MDR-TB in high HIV prevalence settings. In addition, the evaluation will strengthen the networks

between the study sites and the laboratory.

Methods: The partner proposes to conduct this evaluation in 2 sites in South Africa. The chosen sites will,

as a prerequisite, be conducting provider-initiated HIV counseling and testing, and as such, most of the

study population will know their HIV status. Sputum samples will be collected from all TB suspects and

newly diagnosed (according to South Africa national guidelines) TB patients from January-March 2008.

Sputum specimens will be cultured and DST against first-line drugs will be performed for all study

participants at diagnosis to determine resistance patterns and the proper treatment regimen. Isolates found

to be resistant to isoniazid and rifampicin will be sent for drug susceptibility testing against second-line

drugs.

For those patients found to have MDR-TB at diagnosis, an individualized treatment regimen will be

designed and best practices for MDR-TB treatment will be followed. In addition, each subsequent sputum

sample for MDR-TB patients will be cultured (every other month as required by WHO guidelines). All lab

services will be performed at an NHLS laboratory. A data abstraction form will be developed to collect

pertinent demographic information and to record laboratory results. In addition, current infection control

practices will be assessed in each site

Population of Interest:

HIV-infected TB suspects and newly diagnosed TB patients

HIV-negative TB suspects and newly diagnosed TB patients

As this project is intended to be a demonstration of the use of enhanced diagnostic techniques to identify

cases of MDR-TB in a high-HIV prevalence setting at the time of TB diagnosis, a sample size will not be

calculated. The partner is applying appropriate diagnostic techniques for diagnosing TB in a population with

a high rate of HIV infection, with the express purpose of MDR-TB case finding. All eligible patients will be

enrolled in the study during the 3-month timeframe.

Information Dissemination Plan: The evaluation will be conducted with cooperation from the National

Department of Health and the Provincial TB Program, as well as NHLS. Results will be disseminated to the

selected sites, the province, and the national TB program via a report and presentations.

Budget: This submission is a no-cost extension of 2007 funds. The total budget is 100,000.

Title: Improved HIV Screening among Pediatric TB Patients (< 18 years old) in Community Health Care

Centers

Time and Money: Initial planning for this COP07 approved project has recently begun. After logistical

arrangements have been made and the appropriate protocol clearances have been obtained, the evaluation

is expected to be completed in a 6 month time period. The proposed start date for project is Jan 2008. Total

estimated budget: no cost extension from COP07

Local Co-investigator: Nulda Beyers, Desmond Tutu TB Research Center, Stellenbosch University, Cape

Town, South Africa

Project Description: Estimates of HIV-1 coinfection among children with TB in Africa vary from 13% to 70%.

Given the high prevalence of HIV in South Africa and the high morbidity and mortality associated with TB

coinfection, earlier identification and treatment of HIV in children with TB will lead to improved outcomes.

This project will evaluate current HIV screening and referral activities in community health care centers

caring for pediatric (<18 yo) TB patients. The partner will assess the proximity, availability, and accessibility

of HIV counseling and testing facilities for pediatric TB patients as well as frequency of counseling and

testing. They will also evaluate perceptions of pediatric patients (as appropriate for age) and their

caregivers/families as well as those of healthcare workers regarding acceptability, availability and interest in

HIV testing.

Evaluation Question: This project will evaluate current HIV screening and referral activities in community

health care centers caring for pediatric (<18 yo) TB patients. The partner will assess and improve the

proximity, availability, and accessibility of HIV counseling and testing facilities for pediatric TB patients as

well as frequency of counseling and testing.

Programmatic Importance/Anticipated Outcomes: This project will result in improved surveillance of HIV

among children with TB and a better understanding of potential barriers and opportunities to identifying HIV

coinfection in children with TB that will inform strategies to improve HIV counseling and testing, treatment,

and care in this vulnerable, often overlooked population.

Methods: Evaluation will include both quantitative and qualitative components. Quantitative components will

include a) analysis of pediatric/adolescent data collected by the Zamstar project - both before

and after implementation of new policy of HIV testing for pediatric TB patients (eg. 4th quarter 2006 and 4th

quarter 2007), and b) folder (medical record) review to determine where HIV testing done.

The qualitative component will include key informant interviews and/or focus groups (parents/caregivers,

adolescents, healthcare workers (eg. nurses, doctors, TB program staff, VCT staff)) at a subset of clinics.

Population of Interest:

Ages included in this study will be less than 18 year old TB patients with analysis/reporting, at a minimum,

done by WHO age categories of 0-4yrs and 5-14yrs plus 15-17yrs. In addition, a sample of healthcare

workers from each clinic will be interviewed.

Information Dissemination Plan: The evaluation will be conducted with cooperation from the National

Department of Health and the Provincial TB Program, as well as Desmond Tutu Research Center. Results

will be disseminated to the selected sites, the province, and the national TB program via a report and

presentations.

Budget: This submission is a no-cost extension of 2007 funds. The total budget is 75,000.

The aim of this project is to provide technical assistance to the National Department of Health (NDOH) and

provincial health departments to ensure expansion and strengthening of CT services in all nine provinces.

Target populations for these activities include host country government, healthcare workers, and community

healthcare workers. PEPFAR funds will be used to employ two full-time CT technical advisors to be placed

at NDOH. The technical advisors will assist with the coordination of CT activities, enhance capacity of

NDOH CT staff by providing support for the NDOH annual CT technical meeting, and to support the

implementation of provider-initiated testing and counseling (PITC) in five public facilities sites per province.

BACKGROUND:

The goal of the National CT program is to ensure the universal access to HIV counseling and testing. The

purpose of this project is to provide technical assistance to NDOH by funding two CT technical advisors to

work within the NDOH on all aspects of the program. Responsibilities of the technical advisors include

focusing particularly on development of national guidelines on PITC and the training of healthcare providers.

The technical advisors will also monitor the implementation of PITC in all provinces. They will also assist in

the development and implementation of quality assurance guidelines around HIV testing.

The project will also support capacity building of healthcare workers and community healthcare workers,

development and implementation of provincial CT specific operational plans, strengthening of national and

provincial reporting systems, coordination of the national CT steering committee meeting, development of a

monitoring and evaluation system for early infant diagnosis and strengthening service delivery through the

implementation of systems strengthening activities.

ACTIVITIES AND EXPECTED RESULTS:

ACTIVITY 1: Technical Assistance to NDOH

Technical assistance to NDOH will be conducted by two technical advisors. Although both will engage with

NDOH regularly, one of the advisors, who will be a locally employed staff person, will work at the National

program. Specific technical assistance to the national CT program will be around capacity building for all

cadres of healthcare workers, monitoring and evaluation, the development of protocols and guidelines, and

the implementation of PITC in all nine provinces.

The responsibility of the technical advisors will include support for the provision of quality HIV testing which

will require (a) the development and implementation of quality assurance guidelines on HIV testing; (b)

standardization of national quality assurance guidelines; and (c) supervision of quality training for all CT

coordinators, laboratory technicians and nurses who conduct HIV testing.

Support will also be provided for the accreditation of non-medical CT facilities according to the NDOH

requirements as well as the revision of all current training materials relating to CT.

In addition, PEPFAR funds will support skills enhancement of current NDOH and provincial staff by

providing support for the national CT technical meeting and attendance of NDOH CT staff at the

International HIV and AIDS meeting.

This program will contribute to 2-7-10 goals by ensuring the implementation of quality CT services and

increasing access to CT services.

SUMMARY:

PEPFAR funding is set aside to support the National Department of Health (NDOH) in the implementation of

the Comprehensive Plan for HIV and AIDS Care, Management and Treatment, by providing financial and

technical assistance to ensure greater access to antiretroviral treatment (ART).

BACKGROUND:

This is an ongoing activity in support of the National Department of Health, and has received PEPFAR

funding since FY 2005. The activities are implemented by CDC staff supporting the National Department of

Health, and will, when necessary, involve contracting out services.

ACTIVITIES AND EXPECTED RESULTS:

ACTIVITY 1: CDC Staff Member Costs

Staff and travel costs for a locally hired CDC staff member to provide support to the National Department of

Health (including the nine provincial health departments) when required in the implementation of the

Comprehensive Plan. This includes site visits to PEPFAR-supported treatment sites, and regular provincial

consultations with PEPFAR partners working within a specific province to ensure coordination and

integration with the South African Government (SAG).

ACTIVITY 2: Meetings with Stakeholders

At least six meetings will be held with external stakeholders, including those organizations supported by

PEPFAR. These meetings are held to discuss new developments in ART, program progress,

implementation challenges, and creating new partnerships. Provincial coordinators for ART programs are

involved in these meetings (national meetings). In addition meetings are held at provincial level to

strengthen coordination at local level by mapping service provision at district level, determine gaps, and

direct support.

ACTIVITY 3: Communication Materials

FY 2008 funds will be used to develop and distribute communication and marketing materials to the nine

provincial management teams and PEPFAR partners relating to ART. This will focus specifically on job aids

to ensure patients are properly managed once they test HIV positive. It also includes the distribution of

technical materials to strengthen the five priority areas: human capacity development; pediatric HIV care

and treatment; scaling up HIV counseling and testing; TB/HIV integration; and initiating ART at primary

health care level.

ACTIVITY 4: Training

FY 2008 PEPFAR funds will be used for training meetings as requested by the National Department of

Health, including training in the integrated management of childhood illnesses (IMCI) with a focus on

pediatric ART.

ACTIVITY 5: Longitudinal Surveillance

FY 2008 funding will be used to support the National Department of Health effort to implement longitudinal

surveillance (in previous COPs referred to as LSTEP). This activity will supplement Department of Health

funding for surveillance. The sample will include both PEPFAR and non-PEPFAR supported sites to ensure

representivity. This will include a retrospective sample cohort of persons on treatment with 6- and 12-month

outcome data, and the ongoing monitoring of those still on therapy (at 6-month intervals), and a prospective

cohort, which will collect information on a sample of people newly initiating ART and tracking the individuals

over a period of time at 6-month intervals.

ACTIVITY 6: Monitoring and Evaluation

PEPFAR funds will be used to provide support to the Department of Health in the design and

implementation of standardized pre-ART and ART registers. This activity will also include the training of

data capturers to strengthen the collection of ART data at facility level.

These activities contribute to the implementation of the 2-7-10 PEPFAR goals by strengthening the capacity

of the National Department of Health and the nine provincial health departments to implement the

Comprehensive Plan, and ensure improved access to treatment.

SUMMARY:

PEPFAR funds will support the National Department of Health (NDOH) to implement M&E activities in HIV

and AIDS programs. The major emphasis area for this program is the development of health management

information systems, with minor emphasis on improving information technology and communication

infrastructure, M&E and reporting, and proposed staff for Strategic Information (SI). Target populations

include South African policy makers, members of the National AIDS Control Programme, and other staff in

the NDOH. Activities described in this COP entry have been requested by the national or provincial

Departments of Health.

BACKGROUND:

The NDOH lacks trained M&E personnel for specialized information gathering and management tasks. Data

on disease surveillance and HIV and AIDS service uptake are often not up to standard or not transmitted in

a timely manner, negatively affecting the NDOH's ability to analyze epidemiological trends effectively. CDC

has provided technical support for M&E since 2003, including developing standard indicators, policies and

guidelines, and training tools. Funds will be used to expand the NDOH's M&E activities, especially its

human capacity development at the national and provincial levels.

ACTIVITIES AND EXPECTED RESULTS:

ACTIVITY 1: Training

Funds will be used to conduct orientation sessions on M&E for HIV and AIDS program staff. The sessions

will focus on new and existing M&E officers, and will inform staff of the importance of M&E in measuring the

effects of the HIV epidemic. Staff will be trained to use the District Health Information System (DHIS), an

electronic database that tracks disease and health indicators, and trained to use relatively more

sophisticated M&E techniques for program planning. HIV and AIDS program staff will be trained in data

management techniques. This activity is ongoing and in the past year has primarily focused on improving

data in the PMTCT program.

ACTIVITY 2: Staff

There are four SI positions included in this COP entry.

(1) An M&E Advisor, who is seconded to the NDOH HIV and AIDS Directorate, will continue to provide

technical assistance to the NDOH and provincial health departments to support data use and analysis

efforts at the NDOH.

(2) An M&E Advisor based at the CDC office will continue to work closely with the NDOH and with PEPFAR

partners, on management information systems, data issues, and activities with the Western Cape

Department of Health.

(3) A Management Information Systems (MIS) specialist, who has recently been hired, will conduct an

assessment of USG-supported MIS.

(4) An M&E Assistant will soon be hired to improve the data analysis of PEPFAR data and assist in

providing feedback to partners and the South African Government (SAG) about PEPFAR activities. The

USG is currently engaging with the provincial departments of health to improve collaboration and

communication about PEPFAR-funded activities. This position will assist in facilitating these activities in the

future.

Additional funds will be used to support SI staff as per recommendations from the Staffing for Results

exercise.

ACTIVITY 3: Support to the SAG

Relations between the United States and South Africa are steadily improving. In an effort to continue to

strengthen this relationship, funds have been budgeted for technical assistance that the national and

provincial Departments of Health frequently request on an ad hoc basis. Examples include technical

assistance to the KwaZulu-Natal Premier's Office for improving data quality and data use in the province

and assistance with conducting a Data Quality Assessment of the TB/HIV data management system in the

NDOH.

ACTIVITY 4: Strengthening Management Information Systems

The South Africa PEPFAR Task Force is prioritizing the harmonization and coordination of MIS within

PEPFAR-supported partners and with the South African Government M&E systems. The USG recognizes

that as PEPFAR programs are scaling up, there is a need for a a more strategic plan for developing and

implementing systems that focus on patient care, community-based care, and managing aggregated data.

The new USG HMIS staff person will develop an investment strategy in MIS and work towards aligning or

improving communication between systems. He will provide support to partners, especially those working in

the public sector, and will provide technical assistance to the NDOH for harmonization of health systems

and to the Department of Social Development on an MIS for orphans and vulnerable children.

Improving the NDOH's ability to collect, process and utilize SI will directly contribute to improvements in HIV

and AIDS service delivery by having the information available for decision-making purposes. These

improvements, in turn, will have a positive impact on South Africa's ability to prevent new infections, care for

patients living with HIV, and to provide treatment for those with AIDS, in support of PEPFAR's goals. These

efforts also support the USG Five-Year Strategy for South Africa by building capacity within the South

African government.