Detailed Mechanism Funding and Narrative

Years of mechanism: 2007 2008 2009

Details for Mechanism ID: 6134
Country/Region: South Africa
Year: 2009
Main Partner: TogaLabs
Main Partner Program: NA
Organizational Type: Private Contractor
Funding Agency: HHS/CDC
Total Funding: $2,172,108

Funding for Treatment: Adult Treatment (HTXS): $0

NO FY 2009 FUNDING IS REQUESTED FOR THIS ACTIVITY:

This activity was approved in the FY 2008 COP, is funded with FY 2008 PEPFAR funds, and is included

here to provide complete information for reviewers. No FY 2009 funding is requested for this activity.

PEPFAR funds were allocated to ARV Services for Toga Laboratories. However, based on the project's

activities, it became clear that the funding would be more accurately categorized under Laboratory

Infrastructure. Therefore there is no need to continue funding this activity with FY 2009 COP funds.

New/Continuing Activity: Continuing Activity

Continuing Activity: 13841

Continued Associated Activity Information

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

System ID System ID

13841 12329.08 HHS/Centers for Toga Laboratories 6630 6134.08 $218,000

Disease Control &

Prevention

12329 12329.07 HHS/Centers for Toga Laboratories 6134 6134.07 $300,000

Disease Control &

Prevention

Table 3.3.09:

Funding for Laboratory Infrastructure (HLAB): $2,172,108

ACTIVITY HAS BEEN MODIFIED IN THE FOLLOWING WAYS:

It is anticipated that service access will increase the number of patients tested at existing sites from 4000 to

6,500 patients. Three new Togatainer deployment sites have been identified. The implementation will

provide laboratory testing for an additional 2500 patients. The implementation of additional White Rabbit

reporting and requesting systems is anticipated. Thirty healthcare professionals in the vicinity of deployed

Togatainer will be trained in the implementation and management of ARVs. The clinical support service will

be expanded to include these healthcare professionals. The emphasis in FY 2009 expansion activities will

be the strengthening of healthcare systems where little resource exists, contributing to greater uptake of

patients. Alignment will be sought with public partners.

The White Rabbit (WR) deployment has been problematic to date with the current IT system. Therefore, the

WR enhancements of the Toga in-house IT system strengthening will be accelerated during FY 2009. This

is a high priority area.

The development of a clearly defined sustainability plan is a key focus for FY 2009. Part of the roll-out

program is to ensure its sustainability. In support of this process currently, once a site is identified a

feasibility evaluation is performed on the possible support of other stakeholders or partners surrounding the

area. The access to affordable testing allows patients to receive treatment, and the greater the number of

patients served through the container, the greater opportunity exists for sustainability and cost reduction.

The networks with local Department of Health (DOH) as well as voluntary organizations and individual

clinicians will allow for each laboratory to run as business units allowing for surplus funds to be applied to

further the interest of patients and care and enhance sustainability efforts. The Training of Healthcare

workers is not limited to the clinics directly involved with Togatainer but is also open to allow interested

partners to be exposed to advanced training as well as supporting the container as part of a community

project further enhancing sustainability.

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

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.

Activity Narrative: 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

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.

New/Continuing Activity: Continuing Activity

Continuing Activity: 13842

Continued Associated Activity Information

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

System ID System ID

13842 12307.08 HHS/Centers for Toga Laboratories 6630 6134.08 $2,041,000

Disease Control &

Prevention

12307 12307.07 HHS/Centers for Toga Laboratories 6134 6134.07 $1,000,000

Disease Control &

Prevention

Emphasis Areas

Human Capacity Development

Estimated amount of funding that is planned for Human Capacity Development $208,200

Public Health Evaluation

Food and Nutrition: Policy, Tools, and Service Delivery

Food and Nutrition: Commodities

Economic Strengthening

Education

Water

Table 3.3.16:

Cross Cutting Budget Categories and Known Amounts Total: $208,200
Human Resources for Health $208,200