SUMMARY:

Using FY 2006 and FY 2007 PEPFAR funding, an evaluation of existing program data was conducted to

understand barriers to effective implementation of maternal syphilis screening and treatment in existing

antenatal care (ANC) programs, including links between syphilis and HIV screening. Based on the

evaluation results, a new activity is planned to promote integrated prevention of mother-to-child

transmission (PMTCT) and syphilis screening in government-run primary healthcare facilities providing ANC

services in two provinces, Gauteng and Northern Cape. These provinces were identified in consultation with

the National Department of Health (NDOH). The primary emphasis area addressed by this project is policy

and guidelines. Target populations are pregnant women, HIV-infected pregnant women and healthcare

workers, including nurses, traditional birth attendants and pharmacists, working in antenatal care facilities.

BACKGROUND:

The evaluation described above is expected to be completed in August 2007, with summary results and a

report provided shortly thereafter. FY 2008 funds will be used to implement improved service delivery

activities based on the findings. The activity is planned to be conducted within existing primary care settings

providing ANC to women in their locality, and thus is directly coordinated with and supported by both the

South African national and provincial sexually transmitted infections (STI) program. The prime partner,

CDC's Division of STD Prevention (DSTDP), provides technical expertise and oversight for the project.

DSTDP works directly with the provinces of Northern Cape and Gauteng to conduct activities. DSTDP also

sub-contracts with the National Institute of Communicable Diseases (NICD)/STI Reference Centre (STIRC),

a South African parastatal, for hiring additional staff, laboratory quality assurance testing and other needed

preventive services. Gender issues will be addressed indirectly (e.g., training will cover concerns about

partner violence associated with HIV testing; pregnant women's access to ANC/PMTCT services will be

encouraged and covered in training).

ACTIVITIES AND EXPECTED RESULTS:

ACTIVITY 1: Dissemination of findings from the evaluation

A meeting of local/provincial health departments will be held to review results of the evaluation and develop

a plan of action that (1) integrates HIV testing along with syphilis screening in ANC clinics; (2) integrates

rapid identification and treatment of women who test positive for syphilis and/or HIV through support of lab

capacity; (3) supports pregnant women who are not currently accessing ANC services to do so; and (4)

considers uses of alternative models of integrating service and providing PMTCT. Results will also be

presented at the National PMTCT Steering Committee meeting.

ACTIVITY 2: Setting up a demonstration project

The evaluation that was conducted highlighted a number of challenges to PMTCT implementation. In order

to address these challenges and set up a best practice model for PMTCT implementation in Gauteng

province and the Northern Cape province, two demonstration projects will be implemented. These

demonstration projects will address challenges to implementation. Interventions will be implemented in the

demonstration project to ensure high quality PMTCT services are rendered. Some of the proposed

interventions include opt-out provider initiated counseling and testing, referral networks between PMTCT

and treatment, care and support, dual therapy, mechanisms to follow-up HIV exposed infants in the

community and reduce loss to follow-up and the implementation of a holistic service. The idea is to set up

best practice models in the provinces that can serve as training sites, and a resource to the province for the

implementation of interventions aimed at strengthening PMTCT service delivery.

ACTIVITY 3: Human Capacity Development

Human capacity will be developed through the training course and ongoing support to nurses providing

ANC services for a high quality program. These activities will involve the revision of currently approved

government training curricula (manuals, etc.) and training of primary healthcare nurses providing ANC

services that focus on enhancing antenatal HIV and syphilis testing, treatment and services, and

encouraging access to care for pregnant women. This project aims to improve access and quality of

PMTCT services, to identify HIV-infected or syphilis serology positive pregnant women, and to increase the

number of women receiving treatment for syphilis and antiretroviral (ARV) prophylaxis to prevent STI and

HIV transmission to infants.

By addressing enhanced PMTCT through improving ANC systems for HIV and syphilis screening, it

contributes to the PEPFAR prevention objective of 7 million infections averted. This project contribute to

PEPFAR 2-7-10 goals by improving access to and quality of PMTCT services to identify HIV-infected

pregnant women and increase the number of women receiving ARV prophylaxis to prevent HIV

transmission to infants.

SUMMARY:

Two activities will be implemented with FY 2008 funds. The first is conducting a health promotion campaign

to raise awareness and increase service uptake for sexually transmitted infections (STIs) and HIV care and

treatment among men in townships in Gauteng. The second activity is a continuing activity and involves the

development (using results of 2007 provider survey) and dissemination of training intervention(s) aimed at

improved healthcare provider management of genital ulcer disease (GUD) and other STIs in order to

prevent new HIV infections. Both of these activities will be conducted by the STI Research Centre (STIRC)

in the National Institute for Communicable Diseases (NICD) with the guidance of local Department of Health

officials and CDC staff in South Africa, and in collaboration with local NGOs and CBOs as appropriate. They

will work closely with CDC/Division of STD Prevention staff with prior experience and expertise in this area.

BACKGROUND:

Recently available data indicate that knowledge of STIs including HIV and availability of effective HIV and

STI treatment is low among men living in townships in Gauteng. Additionally, men living in South Africa are

less likely than women to be tested for HIV.

STIs represent episodes of behavioral and biologic risk for HIV, and the STI clinical encounter is a critical

entry point for HIV prevention activities. HIV and other STIs, including GUD (a strong HIV co-factor)

continue to have high prevalence in South Africa despite current prevention efforts. New HIV infections

could be prevented with stronger clinical management of GUD and other STIs, particularly around prompt,

improved case recognition and treatment, HIV testing and provision of other prevention modalities.

STI/GUD management can be strengthened by systematically evaluating health provider barriers and

needs, and providing them improved training and support.

ACTIVITIES AND EXPECTED RESULTS:

ACTIVITY 1: Community Health Promotion

This activity is an adaptation of a proven-effective community health promotion model using lay health

advisors that has been used in other nations with high HIV prevalence. The lay health advisors deliver

HIV/STI education and work with local health clinics to encourage men to use STI clinical services, HIV

testing and treatment. The activity will be conducted in Gauteng province, specifically in townships near

Johannesburg where government provided HIV/STI services are available. The target population is men

living in townships with high HIV prevalence and thus often represents Most At Risk Populations (MARPS)

including people living with HIV and AIDS, partners/clients of commercial sex workers, migrant populations

of all types, and other high risk individuals. Specific activities for which PEPFAR funding will be used are: 1)

Identify key community members who are known and trusted within the community (e.g., lay ministers,

employees of trusted organizations, traditional healers or "lay" healers); 2) Assess the already existing

training curricula in the Province; 3) Adapt an existing HIV/STI training curricula for lay health advisors; 4)

Assess community norms, knowledge and attitudes toward STIs/HIV; 5) Develop appropriate educational

materials (e.g., brochures) about STIs/HIV and ART for dissemination by lay health advisors; 6) Solicit

feedback on educational materials from community members; 7) Translate materials into local languages as

appropriate; 8) Train 30 lay health advisors in STD/HIV awareness and prevention; 9) Collaboration with

local NGOs and CBOS to conduct activities. STIRC will hire needed staff, commodities, and other services

to conduct the activity. The activity is anticipated to contribute directly to PEPFAR 2-7-10 goals in

prevention, by preventing transmission of HIV among infected persons, and preventing acquisition of HIV

among HIV-negative persons.

ACTIVITY 2: Health Care Provider Training in STI Management

To develop new (or as applicable, enhance existing) training and other interventions aimed at improved

provider management of STIs -- particularly GUD -- results from a 2007 health provider survey identifying

knowledge gaps, infrastructure challenges and training needs for STI/GUD care will be used, in consultation

with local and national health officials. Training/dissemination activities will be coordinated with already

existing district, provincial, and national Departments of Health tools and curricula.

Activities include: 1) Reviewing existing local and national STI training programs; identifying gaps and

challenges to quality STI (e.g., GUD) management; 2) Using survey results to build new (or enhance

existing) provider training and educational models using a variety of approaches deemed appropriate by

local and national collaborators, 3) Ensuring integration of HIV testing and preventive services into the STI

clinical encounter, 4) As possible, addressing structural barriers to quality STI/GUD care, 5) Disseminating

provider intervention(s) through direct training of providers (and possibly other approaches).

SUMMARY:

This activity supports screening and testing people living with HIV for sexually transmitted infections (STI),

and help to improve the health of women in prostitution and engaging in transactional sex through cervical

screening. The major emphasis area is policy/guidelines, and implementation of STI screening, with minor

emphasis on needs assessment, and training. Target populations will be people living with HIV and partners

in general population and women in prostitution and engaging in transactional sex.

BACKGROUND:

Both activities are on-going and were funded in FY 2007. STIs are strongly linked to HIV transmission and

can further complicate the clinical care of the HIV-infected patient. South Africa is also experience a rapid

rise in ciprofloxacin resistant gonorrhea and ciprofloxacin, the national first-line therapy, is no longer reliable

as a therapeutic intervention. It is therefore important to test gonococci isolated from HIV-infected patients

for likely ciprofloxacin resistance and ensure appropriate treatment is prescribed. Screening and treating

HIV-infected individuals for STIs identified will result in better palliative care services, will reduce the

likelihood of HIV and STI transmission to their partners and will identify those HIV-infected individuals that

could potentially benefit from additional prevention/risk reduction services, including prevention with

positives services. Currently the South African Government operates all public health clinics, including ARV

sites, using a syndromic management model for STI treatment. Asymptomatic individuals go undetected

and untreated with the syndromic approach, unless such patients present as contacts of other symptomatic

STI-infected patients. Activity 2 is a continuation of the cervical screening service for women in prostitution

and engaging in transactional sex (SWs) who attend a mobile clinic service in the Carletonville area of

Gauteng Province. These women, of whom 65% are HIV seropositive, will be also tested for high risk types

of human papilloma virus (HPV) infection to determine those most at risk of developing cervical cancer. The

prime partner, The Sexually Transmitted Infections Reference Centre (STIRC) carrying out these projects is

part of the South African National Institute for Communicable Diseases (NICD). NICD is organized as a

parastatal, with accountability to the National Department of Heath through a Board of Directors. STIRC will

implement both activities in collaboration with CDC's Division of STD Prevention, an HIV clinic in

Johannesburg and the Mothusimpilo NGO which provides outreach services to SWs.

ACTIVITIES AND EXPECTED RESULTS:

ACTIVITY 1:

Screening and testing for STIs among HIV-infected patients will be carried out in the South African

Government's largest Johannesburg hospital-based ARV site. People living with HIV will be screened for

asymptomatic STIs and tested for pathogenic causes of STI syndromes when present. Since these

activities will take place in a public ARV clinic, medicines needed to treat the STIs diagnosed will be

provided by the South African Government, and not purchased with PEPFAR funds. Those with STIs will be

counseled regarding enhanced risk of HIV transmission in the presence of STIs and will be offered

prevention with positives services. Partner notification and counseling of those infected will result in the

referral of sex partners for STI diagnosis and treatment as well as HIV counseling and testing. Couples

counseling will be encouraged for discordant couples.

ACTIVITY 2:

Women in prostitution and engaging in transactional sex will be tested for HIV infection using rapid tests in

informal settlements by the NGO program. These women will then be screened with cervical Pap smears to

detect either dyskaryosis or cervical cancer as well as undergo HPV screening/typing. Women in

prostitution and engaging in transactional sex with abnormal smears will be referred to gynecologists for

further assessment and treatment.

Total staffing for both activities includes three nurses and three counselors, who will deliver the clinical

service to those with STIs and their partners as well as to women in prostitution and engaging in

transactional sex; two clerks will double-enter data. STI screening results and the importance of the STI-HIV

link will be disseminated through training and building of human capacity of healthcare workers. Treating

STIs will reduce on-going HIV transmission from index HIV clients. Partners in Activity 1 will receive

epidemiological treatment for STIs as contacts and be offered HIV testing. Early treatment of cervical

dysplasia in Activity 2 will prevent cervical cancer in women in prostitution and those engaging in

transactional sex. Activity 2 will involve training in the taking of cervical smears by the NGO project nurses

as well as raise awareness about cervical cancer among women in prostitution and those engaging in

transactional sex . Findings from both activities will be used by STIRC to influence local and national health

policy and guidelines which will enhance sustainability of each activity.

FY 2008 activities will be expanded to include the addition of symptomatic HIV-infected individuals for STI

testing at the HIV clinic in Johannesburg, in addition to the screening of asymptomatic patients. The other

activities remain the same, although approximately 20% more patients and women in prostitution or

engaging in transactional sex will be included in the FY 2008 targets.

These activities contribute to PEPFAR goal of 10 million people in care by improving the palliative care

provided to HIV-infected individuals presenting at ARV sites through the diagnosis and treatment of their

asymptomatic STIs. These activities further contribute to the 2 and 7 portions of the PEPFAR goals through

the referral, testing and treatment of the sex partners of HIV-infected patients and by identifying those HIV-

infected patients that may benefit from further risk reduction and prevention counseling.

SUMMARY:

Activities will be carried out to strengthen the current TB laboratory infrastructure and capacity under the

NHLS with direct support from NICD. With significant increases in MDR and XDR-TB cases within South

Africa, and recognizing the limited laboratory capacity to capture and report cases within NHLS and the

NTP, there is an immediate need to provide increased access of TB culture and referral services,

investigations into creative approaches to increasing laboratory through-put of sputum specimens to meet

increased demand, expansion and refinement of information management and dissemination methods of

TB diagnostic results, as well as strengthening NHLS ability to improve MDR and XDR-TB reporting and

surveillance activities.

BACKGROUND:

NHLS is a public laboratory network that provides services within all 9 provinces. NHLS is composed of

close to 300 laboratories located in both rural and urban settings, and provides diagnostic services to

almost 85 percent of general population. NHLS is a parastatal organization, with NICD residing within the

NHLS organizational structure.

ACTIVITIES AND EXPECTED RESULTS:

ACTIVITY 1: Integrated TB/HIV technologist training program (co support in HLAB)

Funds are requested to respond to technical assistance requests from NHLS to assist in the development of

an integrated TB/HIV technologist training program. It is apparent that many of the rural NHLS laboratory

staffing needs fall short of the human resource requirements needed to maintain and sustain viable HIV and

TB diagnostic services. In light of this shortcoming, NICD/NHLS has proposed an integrated training

program that would encompass the needs of understaffed testing sites. The objectives of the training

curriculum would address technical HIV testing methodologies and practical hands on training to meet the

increased technical demands of HIV testing services, as well as the need to improve TB smear microscopy

and AFB culture techniques. The proposed 1 year training curriculum would include didactic sessions, but

more importantly on-site laboratory practicums. Funding would be used to assist in curriculum development

and technical content review, as well as training implementation and oversight. Efforts will be coordinated

with SA Health Care Professionals Association to ensure course accreditation

ACTIVITY 2: Automated NALC decontamination

With the current number of sputum samples submitted for laboratory smear microscopy and culture already

at an all time high and continuing to increase, it is recognized that one of the most significant rate

determining factors directly impacting laboratory through-put is that of the NALC decontamination process,

a labor intensive processes of sputum concentration and decontamination. In order to streamline this

process and to increase overall laboratory through-put of sputum specimens to meet the increased demand

and lack of available staff to process such specimens, alternate or automated measures should be

investigated. Currently, NICD has vested time in investigating possible automated methods that could

significantly reduce and provide standardized decontamination processes. The currently proposed funds

would be used, in partnership and through co-funding with NHLS, for the development of automated NALC

decontamination instrumentation and technologies.

ACTIVITY 3: Expansion and refinement of information management processes

Information management and dissemination of TB/HIV diagnostic results is a continuing issue that needs to

be addressed. Current laboratory reporting mechanisms, as well as patient enrollment systems into DOTS

treatment programs need IT support and information bridges that currently do not exist. Currently, NICD has

vested time in investigating logistic support mechanism for strengthening the current system. A draft

proposal has been submitted by LTS, an engineering firm within South Africa, to address this problem. The

currently proposed system will utilize biometric enrollment systems as confirmation of patient identification

and incorporates the existing NHLS data warehouse as a source of laboratory information that can be used

to increase the efficacy and use of the existing systems for diagnostic and treatment purposes. CDC

proposes a modular approach to address the overarching system needs. The currently proposed funds

would be used, in partnership and through co-funding with NHLS, for the development of modular logistical

and information management support systems as a means to address the current integration issues

associated with the existing system.

SUMMARY:

This activity supports expansion of routine provider-initiated HIV counseling and testing (CT) through

appropriately augmented CT activities (to be decided) for sexually transmitted infection (STI) patients. The

activity will be conducted in primary care clinics in Gauteng province and, as applicable, other provinces, in

collaboration with local Departments of Health. The prime partner, the STI Research Centre (STIRC) of the

National Institute for Communicable Diseases (NICD) in South Africa will work closely with CDC/Division of

STD Prevention to provide technical expertise and activity oversight, and with CDC staff in South Africa and

local partners to ensure activities are consistent with local and national policies on HIV CT.

ACTIVITIES AND EXPECTED RESULTS:

Target populations are adolescents and young adults (15-24) and older adults (> 24 yrs) with STIs, and will

include other vulnerable groups who come for STI care at primary care clinics (e.g., clients of sex workers

and their partners). Specific ongoing activities on which PEPFAR funds will be used will be decided under

consultation with CDC staff in South Africa. The results of this activity contribute directly to all PEPFAR

goals through prevention of new HIV infections, and identification of new HIV infections through increased

testing -- thus allowing referral to HIV clinical care and (as applicable) HIV treatment.

SUMMARY:

Laboratory infrastructure will be strengthened and enhanced in key areas to provide strategic information,

develop policies and technologies, and improve monitoring of laboratory testing quality that will enhance

access to diagnostic testing and enhance treatment. These activities will also focus on the strengthening of

regional laboratory activities in Southern Africa. Other countries will be contributing their country funds to

leverage services from NICD.

BACKGROUND:

As the burden of TB increases, the need for a National TB Reference Laboratory (NTBRL) becomes

increasingly important. The National Health Laboratory Service (NHLS) is overburdened with routine

diagnostic testing, affecting standards, and turnaround times for specimen processing. The NTBRL will play

a pivotal role in improving routine TB laboratory services and drug-resistance surveillance. As HIV rapid test

use increases, it is critical to ensure quality assurance and quality control (QA/QC) mechanisms and review

of rapid test kits for efficacy. QA mechanisms must be equivalent to those in place in diagnostic labs. The

proposed HIV rapid testing quality management system (QMS) will identify and remedy any deficiencies in

CT centers. A program of technical audits will also provide accurate information regarding compliance with

prescribed practice. There are also quality concerns with routine use of nucleic acid testing including assay

sensitivity and specificity, contamination, clinical significance, variable isolation/amplification procedures,

lack of robustness and standardization, lack of appropriate control material and regulations and policies.

The activity is integrated as part of the program to increase access to CD4, viral load, and PCR testing. The

development of improved practical methods for early infant HIV diagnosis is important for effective

prevention of mother-to-child transmission (PMTCT) interventions and for improved clinical management of

HIV-exposed infants. Expanded scientific and financial management is required given the expanded

activities with and the increasing required reporting.

ACTIVITES AND EXPECTED RESULTS:

ACTIVITY 1:

The National Department of Health (NDOH) is represented on the NHLS board to provide strategic direction

in endeavors of the NTBRL. On an operational level there is frequent contact between the National

Tuberculosis Control Programme (NTCP) as well as the provincial departments. The NTBRL is always

formally represented at quarterly NTP meetings, and meet frequently on an informal basis. The NTCP is

represented at NTBRL meetings and provide direct input into data requirements for reporting and

surveillance purposes. A national drug resistance surveillance (DRS) survey is currently planned for South

Africa; this will be directly funded by the NTP.

The NTBRL will be integrated with NHLS service provision. Construction of a new laboratory began in 2007

for completion in early 2008 (not CDC funded). The NTBRL will (a) develop a quality assurance program for

TB laboratories, including proficiency testing (PT) and a nationwide re-screening program as part of the

NTCP; (b) characterize the mechanisms of drug resistance found in South African isolates; and (c) conduct

laboratory investigations of drug-resistant outbreaks using molecular methods. The NTBRL will enhance the

South African government's ability to respond to the growing TB epidemic among the HIV-infected by

quality assuring routine testing to ensure that TB and MDR-TB cases are properly identified. This will also

ensure that high quality surveillance systems are in place. The NTBRL will work with the Medical Research

Council, WHO, CDC and other partners to implement rapid drug-resistance surveys to help characterize the

extent of drug-resistance including XDR-TB.

ACTIVITY 2:

NICD will continue to evaluate the performance of rapid test kits and testing algorithms in the field and in the

laboratory. In Phase 1, individual rapid test kits - and combinations of kits - are evaluated for sensitivity,

specificity, positive predictive value and negative predictive value. Phase 2 assesses the field performance

of rapid kits to inform scale-up. In FY 2006-07, NICD evaluated 42 rapid HIV test kits, and conducted field

testing of three kits. The initial field trials will focus on the performance of the NDOH's recommended list of

kits (n=5) since this requires testing at least 500 tests/per site (3 sites) and duration of at least 6-8 weeks

per kit. Laboratory-based assessments will include approximately 10 kits annually. Post-marketing

surveillance will also be included as part of the QA procedures. In addition, an assessment and quality

control program will be expanded as part of the national strategy for quality control of HIV testing. Well-

characterized panels will be sent to participating labs on a quarterly basis. The approach has been

successfully tested in participating labs in the national antenatal survey, in 210 NHLS labs and 60 non-

NHLS sites, including non-governmental vaccine sites.

ACTIVITY 3:

A counseling and testing QMS will be further refined first defining aspects required for such a system (i.e.,

proficiency panels, standard operating procedures, safety, piloting ELISA testing from DBS if appropriate)

and then establishing laboratory and training capacity to implement it based on the initial piloting. Expected

outcomes are to train public health sector and NGO counselors that perform rapid HIV testing to implement

quality management of testing. The NICD and CDC have engaged key organizations including the NDOH

and NGOs in the demonstration of the WHO/CDC training curriculum. The curriculum has been revised and

is ready for piloting for 2007 and rollout in 2008.

ACTIVITY 4:

An EQA program will be implemented to monitor lab performance related to the ART program, including

performance of the viral load assay as well as DNA PCR (standard and DBS) important for infant diagnosis.

Currently 11 laboratories perform viral load testing, 5 provide DNA testing for infants and 45 labs are

equipped CD4 testing. The ART program will expand to 16 NHLS laboratories in 2008 for viral load testing

and 11 NHLS laboratories for DNA testing. The CD4 testing sites will expand to 58 sites. The NICD will

monitor HIV testing performance and provide training in the use of EQA/IQC in the management of quality.

Parallel program EQA for CD4 will be assisted though NHLS. The NICD intends to roll out an internal quality

Activity Narrative: control (IQC) program for real time monitoring of viral loads. To help detect weak spots in performance and

improve reliability and confidence when reporting results, an EQA PT and internal quality control (IQC)

program (as part of the QMS) will allow comparison and benchmarking. As a consequence of any negative

PT findings, appropriate education in good lab practice and method utility will be conducted. Refurbishment

of existing structures will be required to house the expanded activities.

ACTIVITY 5:

NICD will provide technical support to CDC to develop expert guidance on simplified early diagnosis tools

and the use of DBS PCR testing. NICD will help develop program guidance, technical support and in-

country and regional evaluations to implement an operational plan to scale up HIV diagnosis in infants.

Progress includes automation for an infant diagnosis program at NHLS. The NICD supports the Lesotho

and Swaziland's Ministries of Health in testing infants and intends to introduce further automation to improve

service delivery. Specific activities include: provide expert lab consultation and participate in a CDC-

organized early diagnosis workgroup; develop simplified laboratory standard operating procedures for

standardized field application in resource-poor settings; test available specimens for test validation and

optimization; provide training to selected labs and PEPFAR partners; and help develop and support a plan

for implementation of improved methods for early diagnosis. By scaling up access to advanced PCR-based

HIV testing assays for infants born to HIV-infected women, the NICD will improve the ability of pediatricians

to assess and prescribe ART to prevent or treat infection in exposed infants.

ACTIVITY 6:

The NICD will expand the grant management administration (size and scope) to ensure that the activities

fulfill PEPFAR objectives and reporting requirements. The management focus will be on financial

management and grant activities for both laboratory infrastructure and strategic information. The staff

complement will include two additional financial assistants to assist in ensuring correct procedures, collating

financial reports and reporting the required mechanisms.

SUMMARY:

The National Institute for Communicable Diseases (NICD) will use PEPFAR funds to (1) enhance existing

national and provincial surveillance by extending sentinel surveillance of opportunistic bacterial and fungal

pathogens in HIV-infected individuals; (2) conduct microbiological, etiological and antimicrobial resistance

surveillance for sexually transmitted infections (STIs) in five population groups in Gauteng; (3) develop a

program to assist national efforts in communicable disease surveillance by providing appropriate training for

epidemiologists and laboratory workers; (4) collect trend data for HIV incidence in the evaluation of the BED

assay and the validation of the assay in general populations; and (5) conduct HIV-1 drug resistance testing

in drug-naive and drug-treated persons.

BACKGROUND:

(1) AIDS-related opportunistic infection (OI) surveillance was initiated with CDC funding by establishing

laboratory-based surveillance for cryptococcosis in Gauteng province in 2002 and enhancing surveillance

for bacterial OI in 2003. FY 2006 funds were used to expand enhanced surveillance for bacterial OI and

cryptococcosis to all nine provinces and to introduce laboratory-based surveillance for pneumocystis carinii

pneumonia (PCP). This system will continue to document the effect that the introduction of antiretroviral

treatment (ART) has on the incidence of opportunistic diseases.

(2) Sexually transmitted infections (STIs) remain a major co-factor in acquiring and transmitting HIV

infection. An ongoing surveillance program for STIs is essential to provide appropriate management

information at all levels of the health service. These data are critical for monitoring the effectiveness of

syndromic management algorithms and for measuring the impact of STI interventions on HIV prevention.

However, syndromic management of STIs does not allow for surveillance of either disease etiology or of

antimicrobial resistance. Rising levels of antimicrobial resistance in gonococci and the high prevalence of

herpes as a cause of genital ulceration are cause for concern and may accelerate HIV transmission.

Microbiological surveillance activities will focus on STI microbiological surveillance in Gauteng. Data from

these projects will inform national and local HIV and STI policy development.

(3) There is an increasing need for public health professionals to receive training in integrated public health

practice. The South African Field Epidemiology and Laboratory Training Program (SAFELTP), modeled on

CDC's Epidemic Intelligence Service, is a training and service program intended to build capacity in applied

epidemiology and public health laboratory practice.

(4) The National Department of Health (NDOH) has set a 50% reduction in new infections by 2011.

Incidence testing is critical for targeted planning and measuring the effect of HIV prevention programs. HIV

incidence measures are required to understand the dynamics of the epidemic and to make decisions about

interventions to prevent infections.

(5) With expanded program to provide treatment there is the concomitant risk of increased circulation and

transmission of drug resistant strains of HIV. Given the limited drug regimens it is important to perform

surveillance to inform on decisions of drug regimen changes at both a local and regional level.

ACTIVITIES AND EXPECTED RESULTS:

ACTIVITY 1: OI Surveillance (GERMS-SA)

Enhanced OI surveillance will be continued by collecting clinical case data at sentinel hospitals, capturing

and analyzing clinical data centrally, and characterizing pathogens with regard to susceptibility,

serotypes/groups, and subspecies. This activity will also focus on training, site visits for feedback to clinical

and laboratory staff, maintaining the national laboratory surveillance network, and conducting annual

meetings for collaborators to discuss results, surveillance objectives, and the inclusion of new

diseases/syndromes as national priorities change.

ACTIVITY 2: STI Microbiological Surveillance

STI surveillance will take place among five groups including township youth, HIV-infected symptomatic

patients, pregnant women living with HIV, STI patients attending private health providers and STI patients

attending public health-care facilities. Youth and STI clinic attendees will be encouraged to test for HIV

using VCT delivered at the same time as STI testing. STIs are strongly linked to HIV transmission and

effective STI management reduces HIV transmission. NICD will implement the project in collaboration with

local health departments (STI medicines), Mothusimpilo, a youth NGO, treatment and antenatal clinics for

people living with HIV, primary healthcare and private practitioner clinics in Johannesburg and Carletonville.

STI screening results will be used to determine prevalence of STIs in each population, to inform STI

syndromic management guidelines through provision of information on syndrome etiology and resistance of

gonorrhea to current first-line antimicrobial therapy. Thirty healthcare workers will be trained on the

importance of STI management to prevent HIV transmission.

ACTIVITY 3: SAFELTP

The NICD will continue to work with the NDOH, the University of Pretoria and the CDC to run the SAFELTP

in South Africa. SAFELTP activities include (a) identifying skills and performance gaps; (b) creating an

action plan for faculty and curriculum development; and (c) training in epidemiology, laboratory, and public

health practice. In FY 2008 the SAFELTP will undertake the following training activities: (a) The 2007

SAFELTP cohort (10 students) will complete their first year of applied field epidemiology training in 2007

and continue with their second year in 2008. NICD will enroll another 10 - 12 students for their first year as

SAFELTP residents in 2008. This is a two-year Masters' of Public Health (MPH) accredited course run in

conjunction with the NDOH, the National Health Laboratory Service (NHLS), NICD and the University of

Pretoria's School of Health Systems and Public Health. At the end of the two years the students will have

produced a portfolio of epidemiological projects including two or more outbreak investigation reports, an

evaluation of a surveillance system, an analysis of an exciting data set and a research report. Field

placements of the residents will be in the provincial Departments of Health and the NHLS. The University

will award them an MPH on satisfactory completion of the course. One hundred and fifty laboratory

Activity Narrative: personnel were trained in a one-day quality assurance (QA) course offered in peripheral venues to promote

quality of hematology and chemistry testing in support of the antiretroviral program. The NICD will monitor

the progress and implementation based on the course work and problem-solving exercises in conjunction

with the NHLS QA. Training segues with the Laboratory Information program. Ten residents, nearing the

end of their first year of SAFELTP residency training, have completed field activities in eight provinces and

will complete their training in 2008. Ten new residents will be enrolled in 2008. A five-day TB course for

provincial TB Coordinators, HIV Coordinators and Laboratory focal persons (n=9) will take place in 2008.

ACTIVITY 4: Incidence Testing

Measuring incidence in cross-sectional population surveys can help avoid the complexities associated with

surveillance systems or with inferring incidence from prevalence. In the context of expanding ART programs

it will become more difficult to interpret HIV prevalence survey data, and more valuable to have HIV

incidence estimates as an additional data source. The BED assay will be used to evaluate HIV-1 serology

positive specimens from the 2005-2007 antenatal care seroprevalence surveys. The total specimen number

will increase to less than 10,000 based on the expanded survey numbers to 1,400 clinic sites. The NICD will

also measure the specificity of the BED, estimate the sensitivity of the BED and determine HIV-1 incidence

in different general populations in collaboration with PEPFAR-funded partners. The assay will be applied to

a large population-based HIV surveillance program conducted by the Africa Centre (a PEPFAR partner

located in KwaZulu-Natal) and the planned Human Sciences Research Council's population survey in 2008.

Additional incidence tests and empirically derived correction factors will be applied to determine the

suitability of the BED assay.

ACTIVITY 5 HIV-1 Drug Resistance

The HIV-1 drug resistance project started in 2003 will continue to monitor for the emergence of drug

resistance in the community (transmitted resistance). This project is based on the WHO Threshold Survey

using samples collected from the NDOH's Annual Antenatal Survey (ANSUR). This is important to

determine the choice of regimen and to identify high levels of resistance for further investigation. Resistance

testing will be performed on patients receiving and failing treatment to determine resistance to current first-

and second-line drug regimens. This forms part of the South African Treatment and Resistance Network

(SATuRN). NICD plans to link with the epidemiology division to study Early Warning Indicators for

resistance at the program level. Other methodologies for resistance surveillance will be evaluated, including

the use of dried blood spots (DBS) for resistance testing and assays for measuring phenotypic drug

resistance.

These NICD's activities contribute to PEPFAR's goals of preventing 7 million new infections and treating 2

million people by improving surveillance and building capacity to inform policy and to facilitate program

management. These activities support the prevention and treatment goals in the USG Strategy for South

Africa.