SUMMARY:

Toga Integrated HIV Solutions is a new PEPFAR partner awarded funding in July 2007. The aim of Toga is

to establish a network of HIV monitoring laboratories and associated service access tools to resource

constrained ARV treatment settings. This activity is focused specifically on building treatment and

monitoring capacity by training healthcare professionals in HIV management, as well as providing systems

for the monitoring of patients on antiretroviral therapy.

With FY 2008 funding, Toga will train doctors in the implementation of antiretroviral therapy (ART) (Kimera

course in advanced ART), targeted at clinical support. This program area will emphasize training, with the

target population being health care providers, in particular doctors (private and public). The training will

follow National and PEPFAR guidelines. It is anticipated that this program area will twin with other PEPFAR

partners. In this regard training will be coordinated so as to coincide with Togatainer deployment sites.

Togatainers are movable, prefabricated laboratories, placed in settings that will allow for improved

laboratory monitoring for the initiation and management of patients on ART. The selection of suitable

settings is ongoing and tentative at the time of this submission, as funding has only been awarded in July

2007.

BACKGROUND:

The training activities of Toga, carried out by Kimera Solutions, a sub-program within the Toga umbrella

organization, is an ongoing service and has been honed on the demand for rapid scale-up of clinical

capacity. The course consists of a two-day workshop in conjunction with self-study material. Training

activities will be aimed at senior healthcare professionals in the vicinity of Togatainer deployment sites.

Once sites have been selected doctors will be invited to attend training courses. Continued clinical support

will be provided subsequent to the training. The activities associated with training will be coordinated with

interested health departments. It is anticipated that the training of doctors will enhance access to services

for rural and peri-urban women and children.

ACTIVITIES AND EXPECTED RESULTS:

ACTIVITY 1: Training

The training is targeted at healthcare professionals in the public and private/NGO sector, with the aim to

provide healthcare professionals involved in the rollout of ARV treatment with a more advanced level of

knowledge and insight into the treatment of HIV. The course covers the following dimensions of ART:

starting ART, laboratory monitoring, treatment regimens, ART-associated adverse effects, changing

treatment, adherence, tuberculosis, pregnancy, pediatrics, operational preparation, ART implementation

and treatment success.

ACTIVITY 2: Clinical Support

The training of healthcare professionals is followed in programmatic sequence with clinical support. This

component is of vital importance particularly at the initiation and in the early phases of an ART program

rollout. The clinical support comprises an electronic decision support service, as well as a telephonic

support line run by our clinical consultants. Clinical support is seen as an important educational

reinforcement of the initial training.

ACTIVITY 3: White Rabbit (WR)

Toga will deploy 40 White Rabbit electronic requesting and reporting systems for use in conjunction with the

laboratory service to produce cumulative patient reports on laboratory measurement. The WR system has

been developed by Toga to integrate HIV disease measurement events over time against unique patient

identity. The WR system is currently being deployed at selected PEPFAR partner sites. With direct funding,

deployment will extend to clinics and general practitioners in the vicinity of each Togatainer (within a radius

of approximately 30km to 50 km, depending on the setting). The activity will be coordinated by Toga with

selected Togatainer placement sites, selected clinics and doctor's practices as well as interested local

government structures.

Deployment of the WR electronic requesting and reporting system will entail: (a) A detailed site assessment

to understand the site and patient workflow, including user information, training and technical requirements

as well as existing patient numbering systems. Should a client not have a unique patient numbering system

in place, advice and guidance is provided to establish a Primary Unique Patient Identifier (PUPI); (b)

Provision of computer hardware where none exists or where hardware is of inadequate capacity; (c)

Implementation of the WR system, which includes software and logistics support. The WR electronic

requesting and reporting environment produces historically consolidated laboratory reports, enabling

clinicians and other healthcare workers to assess the patient's laboratory measurement at a glance. The

WR system integrates with the Toga laboratory information management system, allowing near real time

access to patient results. The WR is considered a key enabler of the MeTRo (Measure To Roll Out)

principle as a means of rolling out treatment capacity. In monitoring HIV-infected patients on treatment the

availability of viral load test results at specific sites empowers other cadres of healthcare personnel to make

management decisions. In patients who are well controlled on ARV therapy down referral to peripheral clinic

are facilitated, thus decreasing the load on a central clinic or doctor. Should laboratory results of peripheral

patients suggest up-referral this decision can be made by a nurse, based on a laboratory result. This fulfils

an objective of the WHO down-referral strategy.

These activities support the 2-7-10 PEPFAR targets in South Africa.

SUMMARY:

Toga Integrated HIV Solutions (Toga) is a new PEPFAR partner, awarded funding in July 2007. The project

aims to establish a network of HIV monitoring laboratories and associated services in resource-constrained

antiretroviral treatment (ART) settings.

Toga will use FY 2008 funds to deploy three Togatainer laboratories. These laboratories are mobile,

prefabricated structures, ideally situated near ART clinics. The index unit has been operating in Gugulethu,

Cape Town since March 2004. Three units are being deployed with FY07 funding. Many lessons were

learned, including the importance of having staff that can multi-task, and work with minimum supervision.

Communication technology is important, particularly in rural areas, and Toga has redesigned software and

equipment to allow for light data transfer. Toga has also developed special redundancy technology. Each

Togatainer will serve a sub-network of referrals White Rabbit electronic requesting and reporting systems.

BACKGROUND:

In South Africa, regional centralized laboratories serve the public sector, but these have limited capacity for

specialized testing (e.g. CD4 and viral load). The private sector is served by centralized laboratories in

Johannesburg, Cape Town and Pretoria with Stat-labs proximal to high patient, predominantly urban

settings. The Togatainer addresses the need for peripheral deployment of laboratory services, specifically

HIV treatment monitoring and utilizing a unique set of robust assays.

The Togatainer concept is based on the MeTRo (Measure To Roll Out) principle as a means of rolling out

treatment capacity. The core output of a laboratory is information in the form of patient results. The chronic

disease nature of HIV as well as the efficiencies that are attainable when structuring information

appropriately is central to Toga's contribution. Patient data and results are consolidated in the laboratory

information system to allow for cumulative reporting. This information can be used to down-refer patients in

a structured way, thus relieving pressure on scarce clinical capacity. The general of viral load tests on site

empowers healthcare staff to make appropriate management decisions. On-site viral load tests facilitate the

down-referral of patients to peripheral clinics, thus decreasing the load on central clinics. This fulfils an

objective of the WHO down-referral strategy.

Sustainable strategies must be cost effective. Experience and modeling suggests that the cost of testing

peripherally can be done at a rate that is at least equal to a long distance logistical service structure to a

central facility. However, even a cost per unit comparison may not reflect the real programmatic costs.

Statistical variance on lost specimens/results in a small remote program may appear to have insignificant

impact on patient care, but as programs expand, the impact of such variance will result in increased

demand on other programmatic resources (staff, drugs, logistics), and on healthcare systems. South

Africa's testing capacity (public and private) is estimated at 250,000 to 350,000 patients on treatment, most

of whom are catered for by central facilities. Adding capacity to central facilities is expensive, and invariably

results in increased service failure during renovations. Togatainer's modular approach to capacitating ARV

treatment clinics is sustainable and capable of reaching treatment demands of South Africa. Adequate

laboratory support will protect current first-line regimens by minimizing unnecessary switching to more

costly second-line regimens.

Local and provincial government support will be garnered prior to the implementation of each Togatainer.

Toga will be responsible for the implementation of all Togatainers, though local contractors may be used to

assist with infrastructure development. Sustainability is addressed by employing and training medical

technologists from the communities. As medical technology is the chosen profession of many females these

Togatainers are likely to enhance female careers. The provision of on-site and quality laboratory services

will enhance the standard of care to for rural and peri-urban women and children.

ACTIVITIES AND EXPECTED RESULTS:

ACTIVITY 1: Togatainers

Three Togatainers capable of performing the tests for HIV, CD4 and lymphocyte, syphilis, and HIV disease

monitoring will be deployed. Deployment includes preparing the site and laboratory infrastructure, sourcing

equipment, testing, calibration and implementation. The Togatainers are low maintenance environments,

with a focus on preventative maintenance. A Togatainer supply system has been set up to ensure the timely

replenishment of laboratory reagents and consumables.

Ongoing activities will include training and supervision, as well as structured internal and external quality

assurance programs. The selection of suitable sites is ongoing and tentative at the time of this submission,

as funding has only been awarded in July 2007.

Staff retention may be a challenge. Staff that work in remote rural areas are often the only person in the

laboratory. In addition to the regular monitoring, the program will rotate Togatainer technologists to a Toga

central laboratory for ongoing development and training. Telephonic contact will be made on a regular

basis. Togatainer technologists will report weekly in writing to the Peripheral Laboratory Manager. Computer

access from the central laboratory to the site allows monitoring of turn-around times, workload, output, and

quality. The peripheral manager will visit sites each quarter to evaluate staff performance. Toga will award

bursaries to three final-year medical technology students, offering them the opportunity to work in a training

environment after completion of the academic component of their course. All Toga medical technologists

will receive a five-week training at Toga's training laboratory in Johannesburg.

This training will focus on virology, clinical pathology and infectious diseases. One-on-one courses are

conducted in the laboratory, with a strong focus on practical skills development. The course includes quality

control, workflow management, laboratory information management, materials management, laboratory

administration and reporting of key performance indicators, viral load assay and techniques, CD4 assay and

techniques, chemistry testing, hematology testing and service management.

ACTIVITY 2: Laboratory Monitoring

Activity Narrative: Toga expects to conduct HIV monitoring tests for 2,000 PEPFAR- funded patients at peripheral settings,

and 1,000 non-PEPFAR funded patients by the end of the first year. Additional funding will be solicited from

other NGOs, private companies, and government organizations. These tests include viral load, CD4 count,

full blood count, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and urea & electrolytes

(U&E). Provision has been made for hand-held lactate testing devices.

Toga's White Rabbit electronic requesting and reporting system functions seamlessly with laboratory

operations and is not dependant on uninterrupted internet connectivity. A key advantage of this system is

the reporting of patient measurement in a historically consolidated way. This software caters to specific

treatment needs based on individual treatment program parameters. Secure access is a controlled feature

of the software. The White Rabbit software is a significant improvement on reporting efficiency as it is

updated on a near-real time basis from the laboratory information management system. Data is stored on

two independent SQL servers. Data is not accessible via the internet, thus reducing the risk of fraud and

data corruption. The White Rabbit software is continually enhanced to improve and broaden functionality.

The software ensures unique patient identification and data integrity, which results in improved in patient

management and clinic efficiency and reduced costs.

Data communication technology (GPRS data cards or wireless local area networks) will be used where

possible. The White Rabbit system includes a sample tracking facility. Each specimen container is

robotically pre-labelled with a unique bar code that is electronically associated with each sample collection

event and unique patient identifier. Toga provides on-site training.

South African reporting requires unalterable results. Consequently, results are electronically published as

pathology reports, though data is electronically consolidated to enhance the usability of information. Reports

may be electronically requested as event, graphical or tabular reports. Critical values will be available on the

system as they become reported, supported by telephonic notification to clinical staff. Results are

electronically reported once a pathologist has signed them off.

Toga will continue to work with the South African government to address long-term sustainability. Toga will

engage with other donors, specifically in the private sector, to support Togatainers. Toga will remain

involved in the training and technical support of laboratories, as well as the provision of support systems.

Toga will collaborate with other NGOs and donors to ensure the sustainability of peripheralized laboratories.

The organization currently provides laboratory and programmatic support to private sector organizations

(Anglo Platinum, Anglo Gold, Anglo Coal, Gold Fields) and PEPFAR-funded NGOs (Southern African

Catholic Bishops' Conference, Right to Care, Ndlovu Medical Centre and PHRU).