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

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.

SUMMARY:

The Wits Pediatric HIV Clinics (WPHC) and the 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 aims 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

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 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. The Gauteng DOH, with

strong support from NDOH and its PMTCT Early Diagnosis Committee specifically requested this project.

Technical assistance will be provided to improve laboratory 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 laboratory technicians in the area of early infant diagnosis, and training content will be

updated as practice evolves. The training will ensure that HIV-exposed infants that access 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 with

Early Infant Diagnosis

In FY 2008, WHPC and NHLS will continue to explore systems to ensure primary health 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.

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.