Detailed Mechanism Funding and Narrative

Years of mechanism: 2008 2009

Details for Mechanism ID: 7316
Country/Region: South Africa
Year: 2009
Main Partner: University of the Witwatersrand
Main Partner Program: Wits Health Consortium, NHLS
Organizational Type: Implementing Agency
Funding Agency: HHS/CDC
Total Funding: $327,036

Funding for Biomedical Prevention: Prevention of Mother to Child Transmission (MTCT): $160,137

ACTIVITY HAS BEEN MODIFIED IN THE FOLLOWING WAYS:

ACTIVITY 1: Technical Assistance and Scale-up of Early Infant Diagnosis

Using FY 2009 funding, The Wits Pediatric HIV Clinics (WPHC) and National Health Laboratory Service

(NHLS) aim to assess the implementation challenges and develop guidelines to scale up early infant

diagnosis for infants born in prevention of mother-to-child transmission (PMTCT) programs. Technical

assistance will be provided to the provinces (and other countries on request) to help escalate the rollout of

early infant diagnosis services. This project was specifically requested by Gauteng's Department of Health

(DOH), with strong support from the National Department of Health and its PMTCT Early Diagnosis

Committee. Technical assistance for the introduction of the new automated Taqman assay to replace the

HIV DNA polymerace chain reaction (PCR) assay will be provided. In particular, monitoring the performance

of this new assay in the field will be done in relation to the new dual therapy PMTCT program; the age of the

infant and the ability to use the assay for viral load monitoring on dried blood spots; monthly PCR test

statistics for monitoring the progress of the program will be provided to HIV program managers in Gauteng

and the monitoring database will be upgraded to a national level (except for KZN data); incorporation of

rapid HIV tests for infants and children; updating of diagnostic algorithms for children in an evidence-based

manner; and establishing a system for feedback from clinics for central monitoring (e.g., service issues,

quality control, etc.). A program that increases peripartum HIV testing of women to improve identification of

HIV-exposed infants is being assessed. All women are offered HIV testing in the peripartum period, newly

diagnosed HIV-infected women's babies are given post-exposure prophylaxis and infants are followed to 6-

weeks of age for PCR testing. Monitoring of the accuracy of the rapid tests supplied by DOH is done using

"Determine" as a gold standard test because health-care worker confidence in these tests that are

frequently changed is low.

ACTIVITY 2: Capacity Building

In FY 2009, WPHC and NHLS will continue to facilitate training clinic health-care workers including nurses,

doctors and lab technician in the area of early infant diagnosis. Training content will be updated as practice

evolves. The training will ensure that infants exposed to HIV accessing immunization clinics at six weeks of

age are offered PCR testing. Training will help facilitate an average increase in test volumes from 3,500 to

4,500 per month in the Johannesburg laboratory. Serum panels from infants and children will be

prospectively stored for testing rapid HIV tests. The latter are currently evaluated only on adult samples.

ACTIVITY 3: Linking the Expanded Program for Immunizations at Primary Health-care Clinics with Early

Infant Diagnosis

In FY 2009, WHPC and NHLS will continue to explore systems to ensure primary health-care clinics (PHC)

clinics act as entry points for HIV-affected children by identifying HIV-infected children (and other family

members) for comprehensive HIV medical care, including referral between PHC and hospital facilities.

-------------------------------------------

SUMMARY:

The Wits Pediatric HIV Clinics (WPHC) and National Health Laboratory Service (NHLS) will use PEPFAR

funds to expand a demonstration project that was implemented with FY 2006 and FY 2007 funding. The

project is aimed at increasing access to early HIV diagnosis for infants, and developing guidelines for rollout

of the project on a national level. This project was specifically requested by the Gauteng provincial

Department of Health (DOH), with strong support from the National Department of Health (NDOH) and its

Prevention of Mother-to-Child Transmission (PMTCT) Early Diagnosis Committee. Local organization

capacity building, in-service training and ongoing operational research validating suitable HIV assays will be

the major emphasis areas for this program, with minor emphasis given to commodity procurement,

development of networks, linkages, and referral systems (especially between immunization clinics, early

infant diagnosis and treatment, care and support),and logistics. The primary target population will include

HIV-exposed infants (birth to five years old) and infants who are not infected, and secondary target

populations include lab workers, doctors, nurses and South African government policy makers.

BACKGROUND:

Early infant diagnosis of HIV is vital for monitoring PMTCT programs and identifying HIV-infected children to

receive care. Diagnosing HIV in children is more complex than in adults because of the interference of

maternal HIV antibodies during infancy and ongoing exposure to the virus during breastfeeding. To date,

HIV diagnostic services for children in low resource settings have been neglected and healthcare workers

are not familiar with its theory or practice. About five million people in the country are HIV-infected and it is

estimated that about 500,000 of these, which include 60,000 children, are in urgent need of antiretroviral

(ARV) therapy. One frequently cited reason for so few children accessing treatment is the fact that

mechanisms to diagnose infants early are not in place. Although NDOH Guidelines have made provisions

for early diagnosis with HIV DNA PCR, in most places this has not yet replaced the previous protocol of

using HIV ELISA tests at 12-months of age. In reality, infants are not followed up either die before

accessing care or only present once they are already ill with their first HIV-related illness. Lack of early

diagnosis for exposed infants and the integration of PMTCT services with services providing ARV drugs

have been identified as keys to improving access to care for HIV-affected children and their families, and

thereby increasing the number of HIV-infected people receiving treatment.

ACTIVITIES AND EXPECTED RESULTS:

ACTIVITY 1: Technical assistance and scale-up of early infant diagnosis

Using FY 2008 funding, this activity aims to assess the implementation challenges and develop guidelines

to scale-up early infant diagnosis for infants born in PMTCT programs. Technical assistance will be

Activity Narrative: provided to the provinces to help facilitate the rollout of early infant diagnosis services. This project was

specifically requested by the Gauteng province DOH, with strong support from NDOH and its PMTCT Early

Diagnosis Committee. Technical assistance will be provided to improve lab infrastructure to conduct early

infant diagnosis and scale up these services around the province. Technical assistance will be provided to

establish dried blood spot testing in all HIV DNA PCR laboratories; to make monthly PCR test statistics

available, e.g., to "Concerned Pediatricians" to monitor progress; to optimize current and new HIV assays

used; to update diagnostic algorithms for children in an evidence-based manner; and to establish a system

for feedback from clinics for central monitoring, e.g., service issues, quality control, etc.

ACTIVITY 2: Capacity Building

In FY 2008, WPHC and NHLS will continue to facilitate training of clinic healthcare workers including

nurses, doctors and lab technician in the area of early infant diagnosis and update training content as

practice evolves. The training will ensure that infants exposed to HIV accessing immunization clinics at six

weeks of age are offered PCR testing. Training will help facilitate an average increase in test volumes from

3,000 to 4,500 per month.

ACTIVITY 3: Linking the expanded program for immunizations (EPI) at primary healthcare clinics (PHC)

with early infant diagnosis.

In FY 2008, WHPC and NHLS will continue to explore systems to ensure PHC clinics act as entry points for

HIV-affected children by identifying HIV-infected children (and other family members) for comprehensive

HIV medical care, including referral between PHC and hospital facilities.

The NHLS early infant diagnosis demonstration project directly contributes to PEPFAR's 2-7-10 goals by

increasing the number of infants accessing treatment in Gauteng, and serving as a platform for expansion

of early infant diagnosis programs throughout the country. These activities support the PEPFAR Five-Year

Strategy for South Africa by supporting government efforts to improve quality of and access to care and

treatment for HIV-infected children.

New/Continuing Activity: Continuing Activity

Continuing Activity: 16023

Continued Associated Activity Information

Activity Activity ID USG Agency Prime Partner Mechanism Mechanism ID Mechanism Planned Funds

System ID System ID

16023 16023.08 HHS/Centers for Wits Health 7316 7316.08 CARE UGM $183,262

Disease Control & Consortium, NHLS

Prevention

Emphasis Areas

Health-related Wraparound Programs

* Child Survival Activities

Human Capacity Development

Public Health Evaluation

Food and Nutrition: Policy, Tools, and Service Delivery

Food and Nutrition: Commodities

Economic Strengthening

Education

Water

Table 3.3.01:

Funding for Laboratory Infrastructure (HLAB): $166,899

ACTIVITY HAS BEEN MODIFIED IN THE FOLLOWING WAYS:

ACTIVITY 1: Technical assistance and scale-up of early infant diagnosis

Using FY 2009 funding, this activity aims to assess the implementation challenges and develop guidelines

to scale up early infant diagnosis for infants born in PMTCT programs. Technical assistance will be provided

to the provinces (& other countries on request) to help escalate the rollout of early infant diagnosis services.

This project was specifically requested by the Gauteng Province DOH, with strong support from NDOH and

its PMTCT Early Diagnosis Committee. Technical assistance for the introduction of the new automated

Taqman assay to replace the HIV DNA polymerase chain reaction (PCR) assay will be provided. In

particular, monitoring the performance of this new assay in the field will be done in relation to the new dual

therapy PMTCT program, the age of the infant and the ability to use the assay for viral load monitoring on

dried blood spots. Monthly PCR test statistics for monitoring the progress of the program will be provided to

HIV program managers in Gauteng & the monitoring database will be upgraded to a national level (except

for KwaZulu-Natal data); incorporation of rapid HIV tests for infants and children; updating of diagnostic

algorithms for children in an evidence-based manner; and establishing a system for feedback from clinics

for central monitoring, e.g., service issues, quality control, etc. A program that increases peripartum HIV

testing of women to improve identification of HIV-exposed infants is being assessed. All women are offered

HIV testing in the peripartum period, newly diagnosed HIV-infected women's babies are given post-

exposure prophylaxis and infants are followed to 6-weeks of age for PCR testing. Monitoring of the

accuracy of the rapid tests supplied by DOH is done using Determine as a gold standard test because

healthcare worker confidence in these tests that are frequently changed is low.

ACTIVITY 2: Capacity Building

In FY 2009, The Wits Paediatric HIV Clinics (WPHC) and National Health Laboratory Service (NHLS) will

continue to facilitate training of clinic healthcare workers including nurses, doctors and lab technicians in the

area of early infant diagnosis and update training content as practice evolves. The training will ensure that

infants exposed to HIV accessing immunization clinics at six weeks of age are offered PCR testing. Training

will help facilitate an average increase in test volumes from 3,500 to 4,500 per month in the Johannesburg

laboratory. Serum panels from infants and children will be prospectively stored for testing of rapid HIV tests

which are currently evaluated only on adult samples.

ACTIVITY 3: Linking the expanded program for immunizations (EPI) at primary healthcare clinics (PHC)

with early infant diagnosis. In FY 2009, WHPC and NHLS will continue to explore systems to ensure PHC

clinics act as entry points for HIV-affected children by identifying HIV-infected children (and other family

members) for comprehensive HIV medical care, including referral between PHC and hospital facilities.

-----------------------

SUMMARY: The Wits Paediatric HIV Clinics (WPHC) & National Health Laboratory Service (NHLS) will use

PEPFAR funds to expand a demonstration project that was implemented with FY 2006 and FY 2007

funding. The project is aimed at increasing access to early HIV diagnosis for infants, and developing

guidelines for rollout of the project on a national level. This project was specifically requested by the

Gauteng provincial Department of Health (DOH), with strong support from the National Department of

Health (NDOH) and its Prevention of Mother-to-ChildTransmission (PMTCT) Early Diagnosis Committee.

Local organization capacity building, in-service training and ongoing operational research validating suitable

HIV assays will be the major emphasis areas for this program, with minor emphasis given to commodity

procurement, development of networks, linkages, and referral systems (especially between immunization

clinics, early infant diagnosis and treatment, care and support),and logistics. The primary target population

will include HIV-exposed infants (birth to five years old) and infants who are not infected, and secondary

target populations include lab workers, doctors, nurses and South African government policy makers.

BACKGROUND:

Early infant diagnosis of HIV is vital for monitoring PMTCT programs and identifying HIV-infected children to

receive care. Diagnosing HIV in children is more complex than in adults because of the interference of

maternal HIV antibodies during infancy and ongoing exposure to the virus during breastfeeding. To date,

HIV diagnostic services for children in low resource settings have been neglected and healthcare workers

are not familiar with its theory or practice. About five million people in the country are HIV-infected and it is

estimated that about 500,000 of these, which include 60,000 children, are in urgent need of antiretroviral

(ARV) therapy. One frequently cited reason for so few children accessing treatment is the fact that

mechanisms to diagnose infants early are not in place. Although NDOH Guidelines have made provisions

for early diagnosis with HIV DNA PCR, in most places this has not yet replaced the previous protocol of

using HIV ELISA tests at 12-months of age. In reality, infants are not followed up and either die before

accessing care or only present once they are already ill with their first HIV-related illness. Lack of early

diagnosis for exposed infants and the integration of PMTCT services with services providing ARV drugs

have been identified as keys to improving access to care for HIV-affected children and their families, and

thereby increasing the number of HIV-infected people receiving treatment.

ACTIVITIES AND EXPECTED RESULTS:

ACTIVITY 1: Technical assistance and scale up of early infant diagnosis

Using FY 2008 funding, this activity aims to assess the implementation challenges and develop guidelines

to scale-up early infant diagnosis for infants born in PMTCT programs. Technical assistance will be

provided to the provinces to help facilitate the rollout of early infant diagnosis services. This project was

specifically requested by the Gauteng province DOH, with strong support from NDOH and its PMTCT Early

Diagnosis Committee. Technical assistance will be provided to improve lab infrastructure to conduct early

infant diagnosis and scale up these services around the province. Technical assistance will be provided to

establish dried blood spot testing in all HIV DNA PCR laboratories; to make monthly PCR test statistics

Activity Narrative: available, e.g., to "Concerned Pediatricians" to monitor progress; to optimize current & new HIV assays

used; to update diagnostic algorithms for children in an evidence-based manner; and to establish a system

for feedback from clinics for central monitoring, e.g., service issues, quality control, etc.

ACTIVITY 2: Capacity Building

In FY 2008, WPHC & NHLS will continue to facilitate training of clinic healthcare workers including nurses,

doctors and lab technician in the area of early infant diagnosis & update training content as practice

evolves. The training will ensure that infants exposed to HIV accessing immunization clinics at 6 weeks of

age are offered PCR testing. Training will help facilitate an average increase in test volumes from 3,000 to

4,500 per month.

ACTIVITY 3: Linking the expanded program for immunizations (EPI) at primary healthcare clinics (PHC)

with early infant diagnosis

In Fy 2008, WHPC & NHLS will continue to explore systems to ensure PHC clinics act as entry points for

HIV-affected children by identifying HIV-infected children (and other family members) for comprehensive

HIV medical care including referral between PHC and hospital facilities.

The NHLS early infant diagnosis demonstration project directly contributes to PEPFAR's 2-7-10 goals by

increasing the number of infants accessing treatment in Gauteng, and serving as a platform for expansion

of early infant diagnosis programs throughout the country. These activities support the PEPFAR Five-Year

Strategy for South Africa by supporting government efforts to improve quality of and access to care and

treatment for HIV-infected children.

New/Continuing Activity: Continuing Activity

Continuing Activity: 16285

Continued Associated Activity Information

Activity Activity ID USG Agency Prime Partner Mechanism Mechanism ID Mechanism Planned Funds

System ID System ID

16285 16285.08 HHS/Centers for Wits Health 7316 7316.08 CARE UGM $191,000

Disease Control & Consortium, NHLS

Prevention

Emphasis Areas

Health-related Wraparound Programs

* Child Survival Activities

Human Capacity Development

Public Health Evaluation

Food and Nutrition: Policy, Tools, and Service Delivery

Food and Nutrition: Commodities

Economic Strengthening

Education

Water

Table 3.3.16: