This activity contains one component to provide an additional medical technologist to the diagnostic PCR laboratory at the main Windhoek laboratory of the Namibia Institute of Pathology (NIP). This is a new activity for FY07 in support of early infant diagnosis and relates to MoHSS PMTC_ 7334, CDC lab infrastructure_7358, NIP lab infrastructure_7337.

NIP is responsible at the national level for provision of all HIV-related testing technologies for the public sector. The NIP charges health facilities for tests performed. During FY05, the diagnostic algorithm for pediatric diagnosis using PCR has been developed and the use of dried blood spots (DBS) has been field-tested. During FY06 in collaboration with the Ministry of Health and Social Services (MoHSS) PMTCT program, the diagnostic DNA/PCR has been introduced for symptomatic infants and HIV-exposed infants at six weeks of age. Staff at the lab have been newly trained in PCR, new equipment has been bought, specimens are being processed (at least 1,000 thus far) and the rollout of decentralized training of health workers in the collection of DBS is underway. It is expected that >8,000 diagnostic PCR tests will be performed in FY07 and an additional technologist is needed for the laboratory to have sufficient capacity in response to demand. This person will be supported by the CDC laboratory scientist assigned to the NIP's molecular HIV laboratory.

In FY07, USG will continue to provide technical assistance to the national TB laboratory at the Namibia Institute of Pathology. This activity relates to the International Laboratory Branch Consortium Partners activity (8019) and the CTS Global activity (7323).

In FY06, a comprehensive review of the TB laboratory program was performed including laboratory aspects of the National TB Control Program (NTCP), the laboratories performing TB smear microscopy and culture, and the needs of the NIP for developing a quality assurance program, followed by recommendations towards capacity building and strengthening the national TB laboratory system. Based on the recommendations from the assessment, a team of consultants from the American Society for Microbiology spent 2 months at the NIP TB laboratory consulting on smear-microscopy training, use of liquid media for culture, rapid identification of TB using DNA probes, and optimizing drug susceptibility testing. This support resulted in increased capacity for accurate testing of patient specimens and for performing the National TB Control Program (NTCP) Surveillance Study to determine resistance to anti-tuberculosis drugs in Namibia. This survey will provide the NTCP with information on the burden of resistant TB in the country. Information from this survey will be used to put in place strategies to counter the problem. Furthermore, this information will justify the use of second line drugs by NTCP and support the country's application to the Green Light committee for access to cheaper second line drugs.

The funding for this initiative will allow the NIP to equip the national TB laboratory with instrumentation that provides adequate capacity for optimizing turn-around time and accuracy for liquid culture and drug susceptibility testing. The MGIT 960 instrument will be purchased and installed in the laboratory to replace the current BACTEC 460 radiometric system, and augment the lower-capacity BactAlert instruments. In addition, one of the primary concerns during the laboratory assessment was Biosafety. There is a critical need for adding two other biological safety cabinets (BSC) to the central TB laboratory, and also to provide BSC for peripheral laboratories performing smear microscopy on patient sputum specimens. Currently the central laboratory has only one functioning BSC, resulting in the potential for continual exposure of laboratory staff to infectious TB aerosols. In addition, most of the peripheral laboratories are preparing sputum smears on the open counter, and would benefit greatly from the purchase of smaller bench top BSCs to enclose the infectious material during preparation and drying.

Namibia has the highest rate of tuberculosis in the world and TB currently is the leading cause of death for persons with HIV. In addition to multidrug resistant TB, Namibia is facing the added challenge of identifying and responding to the potential emergence of extreme drug resistant TB, first recognized in neighboring South Africa. This activity has three components:

(1) Upgrades to the Namibia Institute of Pathology tuberculosis laboratory. This component will improve NIP's ability to process a greater volume of testing anticipated from expanded testing for ART clinic patients and other persons identified as being at risk of HIV and/or TB. These upgrades will also minimize the potential for specimen contamination and improve safety for NIP staff. NIP's current TB lab is outdated and cannot accomodate the large volume of TB testing needed (including drug sensitivity testing), newly acquired state-of-the-art TB testing equipment, and the need for on-going training of laboratory technologists.

(2) Recruitment and hiring of a TB QA technologist. This technologist will oversee the ongoing and expanding TB testing activities within Namibia. In addition to an anticipated increase in volume of TB testing among HIV-positive persons and others at risk, TB testing will be decentralized to Walvis Bay and Oshakati, two high prevalence areas respectively located in populated areas in the west and north. By decentralizing testing, results can be returned to the care site in a more timely manner and lessens the likelihood of specimens being lost or contaminated during transport. The QA technologist will oversee the TB testing operations at the central laboratory in Windhoek, as well as playing the lead role in establishing the satellite testing sites in Walvis Bay and Oshakati. This individual will be responsible for monitoring equipment performance, data management, and oversight of medical technologists working in the TB laboratory.

(3) Procurement of TB-related Laboratory Equipment. Two MGIT 960s, state-of-the-art

TB testing equipment, will be purchased for the decentralized NIP TB testing sites in Walvis Bay and Oshakati. Related items, such as reagent and supply cabinets, will also be procured to ensure that these sites are fully equipped to serve as satellite testing sites.

This activity links with all Ministry of Health and Social Services Counseling and Testing activities: Preventing Mother to Child Transmission (7334), Abstinence and Be Faithful (7329), Other Prevention (7333), HIV/TB (7972), Counseling and Testing (7336), and ARV Services (7330). This activity also links with Counseling and Testing activities of inter-faith Intrahealth (7405), Potentia (7343) I-TECH (7351), SMA (7418) and CDC's system strengthening activity (7360).

This activity contains five components which serve as the foundation for the quality assurance provided at the national level to all rapid HIV testing sites in Namibia, including both public and NGO/FBO sectors. This is a new activity for FY07 in support of rapid and extensive expansion of provider-initiated testing as well as existing VCT services

Namibia Institute of Pathology (NIP) is responsible at the national level for provision of all HIV-related testing technologies for the public sector. With respect to rapid HIV testing, the NIP is responsible for validation of any new rapid test technologies before being used in Namibia; making recommendations to the Ministry on the rapid testing algorithm and selection of test kits; training and post-training certification (based on their first 50 samples being also tested by ELISA) of all rapid testers before they can give results; site inspection of all new rapid test sites to ensure that they meet the minimum standards; preparation, distribution, and follow-up analysis of quality controls and proficiency panels that are sent to rapid test sites; analysis of a 5% sample from test sites that is also tested by ELISA and following up any performance issues with the tester; submission of reports on rapid test QA to the CT unit, Directorate of Special Programs, MoHSS.

Rapid HIV testing is still relatively new in Namibia, but has been spearheaded by the NIP in collaboration with the Ministry and CDC. Rapid testing began in New Start VCT Centers in March 2005 followed by Ministry facilities in mid-2005. There are now 41 sites for MoHSS and 24 sites for SMA and partners in operation. From January to July 2006, 169 new testers were trained, including 98 health workers, 30 community counselors, 13 SMA counselors, and 28 community counselors who were retrained after performing sub-optimally on the first training. A total of 88 new rapid testers started their first 50 re-tests, 58 completed them, and 22 were certified during this time period. The number of new MoHSS sites was 29 as well as 5 new New Start sites. A further 66 Ministry and 10 New Start sites were visited to perform sites assessments prior to starting rapid testing. Out of 3189 tests performed as part of the first 50 tests, there were only 3 (0.09%) discrepancies noted in the field, but these were are traced to potential procedural issues. Similar performance was observed for the 10% sample of ongoing testing that has been retested, therefore, NIP has recommended that stable sites move to a 5% sample to lower costs.

Support is needed at the NIP to increase capacity to drive and support rapid testing. This will include:

(1) Funding for preparation of quality controls, proficiency panels, and to cover the costs of the ELISA tests for ongoing sampling of rapid tests performed (2) To increase the number of NIP medical technologists for quality assurance from two just in Windhoek to support the north with one additional technologist in Oshakati and one in Rundu. This will be an increase of two technologists in FY07 for a total of four. (3) Currently NIP has no transport to support the rapid test rollout process. Funding will be included for a vehicle in Windhoek, Oshakati, and Rundu. (4) A modest amount of funding will be included for laboratory equipment related to the quality assurance program.

This activity contains one component to provide an additional medical technologist to perform viral load testing at the main Windhoek laboratory of the Namibia Institute of Pathology (NIP). This is a new activity for FY07 in support of ARV services and relates to other NIP activities in PMTCT (7927), TB/HIV (7971), and Lab Infrastructure (7337), as well as to Basic Care, Ministry of Health and Social Services (7331), and CDC lab infrastructure (7358).

NIP is responsible at the national level for provision of all HIV-related testing technologies for the public sector. The NIP charges health facilities for tests performed. During February 2006, the national ART treatment guidelines were updated to include viral load testing for patients suspected as failing treatment. With the expansion of ARV treated patients in Namibia, viral load testing will become an increasingly critical part of bioclinical monitoring. Future guidelines may expand to more routine measurement of HIV-1 viral load to screen for treatment failure. With help of USG, NIP acquired a state of the art molecular biology lab with viral load testing capacity. Anticipating increasing demand for viral load testing, a dedicated lab technician will be hired and placed at NIP to perform this service. It is expected that >9,000 viral load tests will be performed in FY07 and an additional technologist is needed for the laboratory to have sufficient capacity in response to demand. This person will be supported by the CDC laboratory scientist assigned to the NIP's molecular HIV laboratory.

This activity, which contains 2 components, expands on activities implemented in FY06 and relates to MoHSS C&T(#7336), Potentia C&T(#7343), Potentia ART services(#7339), and TBD lab capacity building for TB, HIV, and malaria(#7358).

NIP is responsible at the national level for provision of all HIV-related testing technologies for the public sector. The NIP charges health facilities for tests performed. The public sector now has approximately 22,000 patients on ART since starting in mid 2003 and is expected to reach 50,000 patients by March 2008. This has placed enormous strain on the laboratory services for routine tests, the results of which are often delayed and of questionable quality, and has impeded the introduction of new and appropriate technologies. Though viral load testing is not a routine test in the Namibia ART program because of its high cost and complexity, it is important for Namibia to support a modest level of viral load testing in order to improve detection of treatment failure and to better monitor program performance and effectiveness at sentinel sites (e.g., using an indicator of the percentage of patients with undetectable viral load levels at 6 months).

(1) The first component of this activity will entail human resources for NIP. There is a severe shortage of qualified medical technologists who can perform newer test methods and ensure that best laboratory practices are followed throughout the NIP. In FY07, funds will provide salary support for 4 medical technologist positions in the central NIP laboratory for infant diagnostic PCR, viral load (used for patient evaluation upon clinical suspicion of ARV treatment failure per MoHSS guidelines), TB, and laboratory quality assurance (QA), and 2 medical technologists at peripheral laboratories in high burden regions to implement laboratory QA, as well as 5 laboratory assistants in the HIV and TB laboratories. The medical technologist positions include: one NIP medical technologist to be continued in the viral load laboratory in Windhoek; a second new technologist recruited in FY06 to work with the USG laboratory scientist to process dried blood spot (DBS) specimens and train health workers in order to increase early access of HIV-infected infants to appropriate care and treatment; continued support for 1 technologist and addition of 3 others (2 at the central lab and 2 at peripheral labs), responsible for building capacity of NIP for laboratory QA, particularly with respect to supporting the nationwide roll-out of rapid HIV testing.

(2) The second component of this activity will go towards the QA program for HIV rapid testing that includes the provision of quality control samples, re-testing of 50 samples after start-up in order for the tester to become "certified", a 5% ELISA re-test of rapid test samples, a proficiency panel (‘blind' samples) and at least 7 site visits per center in the first year. In addition to providing QA for each rapid test site, technologists will also participate in USG-supported training for health workers, lab technicians & community counselors in rapid testing, certification, and support. In FY06, the USG supported the NIP in the provision of QA for rapid HIV testing at 65 testing sites (50 MoHSS sites and all 15 New Start Counseling and Testing centers).

(3) The third component of this activity will involve connection of an additional 10 district laboratories to the national laboratory information system, capacity-building for diagnostic DNA PCR, viral load testing, and the introduction of the BED incidence assay through the purchase of equipment, supplies, and reagents and further improvement of standard operating procedures and protocols for QA. The plus up funds will support: (1) HIV Laboratory Equipment. Funds will be used to upgrade and expand HIV testing equipment at the central NIP laboratory in Windhoek. This need has come about by an increasing need to expand capacity to provide PCR testing, CD4 testing, and testing for opportunistic infections.

(2) HIV QA Medical Technologists. Two QA technologists will be recruited and hired to oversee the ongoing and expanding HIV testing activities within Namibia. These technologists will be critical in ensuring the ongoing roll-out of HIV rapid testing throughout the country, an activity slowed by the difficulties in assessing testing sites and proficiency of community counselors and health care workers to perform rapid testing. These technologists will be expected to travel throughout Namibia to monitor the quality of rapid testing and the safety and appropriateness of space being used to perform rapid testing. Additionally, these QA technologists will monitor routine HIV testing, including assessing equipment performance and proficiency of NIP medical technologists. These two QA technologists will also work in collaboration with the Ministry of Health and Social

Services, CDC, and other appropriate entities to ensure that HIV testing data, including rapid test data, is maintained and disseminated appropriately and in a timely manner.

(3) Development of Laboratory Training Unit. In 2006, NIP hired a training unit coordinator. These funds will be used to register and travel the coordinator to "train the trainer" courses as appropriate. This coursework will serve to develop the capacity of NIP to provide in-house training without having to rely on more costly "twinning" arrangements with laboratories in other countries. Initial courses that would be most appropriate include courses in infection control, quality assurance, data management, and courses specific to the latest HIV and TB testing techniques. (4) Laboratory Training. Funding will be used to support materials, speakers, travel costs for participants, and space rental as appropriate to carry out HIV-related trainings within the NIP Laboratory Training Unit. Initial training will include courses on rapid testing, opportunistic infections, and STIs.

This is a new activity in FY07 and will provide laboratory support for an incidence survey using banked samples from the 2006 national sentinel survey for HIV in pregnant women and is linked to CTS Global (7322), Namibia Institute of Pathology (7323), CDC Central (7359), and Potentia (7338). Funds for this activity will be carried over from leftover lab infrastructure funds from FY06 HIV resistance testing.

Determination of incidence is a critical component of HIV surveillance. Prevalence estimates derived from routine HIV surveillance completed on ante-natal clinic attendees does not discriminate between old and new infections, but incidence testing will inform the government of the regional and demographic groups where new infections are currently the highest or where incidence is increasing. This is critical for making policy decisions including targeting prevention messages and PMTCT.

This activity will support laboratory analysis of HIV+ samples identified and banked in the 2006 HIV sentinel survey to determine which are newly infected (infected within the last 153 days). It will apply an international protocol developed by the CDC which applies a laboratory analysis tool known as the BED assay to identify the samples representing recent infection. It will leverage the presence of a CDC-supported laboratory scientist in place at the Namibia Institute of Pathology (#7323) and a CDC-supported epidemiologist in place at the National AIDS Program (#7322) to complete the laboratory analysis and statistical analysis for the survey.

The laboratory scientist will train local laboratory technicians in completion of the BED assay; the laboratory scientist will then supervise the evaluation of HIV+ samples from the 2006 sentinel survey to identify those that are new (incident). The epidemiologist will train local data analysts in methods used to estimate incidence rates (national and sub-population) from the laboratory data produced. Methods and estimated incidence rates will then be summarized in a report format by the M+E Unit, leveraging USG-supported evaluation personnel.