Replacement Narrative

Evaluation of new CD4 testing technology targeting resource limited settings.??Activity Number from COP

07: 8532)

This project aims evaluate new and simple CD4 counting technologies in field conditions of resource poor

settings. The evaluation of these laboratory technologies will be conducted in two phases: in the first

phase, the work will be performed in the reference laboratory, while in the second phase, the evaluation will

be conducted at a rural laboratory.

Time and money summary: Year of activity 2007; year started 2007 & expected year of completion 2008;

$60,000 proposed in COP 2007; $60,000 requested for 2008. Due to delays in funds getting transferred to

APHL, there has been no money spent to date.

Results yielded by the tested methodologies will be compared to those generated by gold standard flow

cytometry. Specifically, absolute and percentage CD4 counts will be compared. The study will

systematically evaluate new methodologies as soon as these become available. Both phases of the

evaluations will be performed in laboratories linked to HIV clinics that already have cohorts of patients under

follow-up and for whom CD4 counts are requested regularly. Samples from adults and children as well

those from HIV/TB co-infected patients will be evaluated.

Those technologies that prove to be precise and accruate and show optimal operational potential will be

considered for use in rural setting where treatment and care is now becoming availale. Furthermore, the

current protocol as developed can easily be adapted for the evaluation for other new instruments that will

becomome commercially available in the near future.

This activity was conceptualized in FY07 and discussions to refine study design and implementing issues

have taken place. The protocol is currently in the final phase of development and will be vetted through the

appropriate ethical reviews in the US as well as the Mozambican Bioethics Committee in October 2007.

The evaluation phase should start in January 2008 and end by March 2008.

Principal investigator is Ilesh V. Jani, Department of Immunology, Instituto Nacional de Saude (INS -

National Health Institute).

Stakeholders (INS, CDC) will participate in the planning and presenting of the data at meetings and

conferences, as well as disseminating information through routine channels within the USG partners

community and MOH organizational structure.

Study activities and data analysis are expected to be complete by the end of FY08.

Budget Justification for FY08 monies:

Salaries/fringe benefits: 5,000

Equipment: 10,000

Supplies: 15,000

Travel: 10,000

Participant Incentives: 0

Laboratory testing: 20,000

Other: 0

Total: 60,000

Continuing activity: Evaluation of new simple and rapid HIV tests for resource limited settings.

Activity Number from COP 07: 8532

Time and money summary: Year of activity 2007; year started 2007 & expected year of completion 2008;

$59,000 proposed in COP 2007; $59,000 requested for 2008. Due to delays in the transfer of funds to

APHL, no money has been spent to date.

The main objective of the study is to evaluate new simple and rapid HIV tests in field conditions of resource-

poor settings. The network of laboratories, testing centers and point-of-care sites that use rapid HIV tests is

growing at a fast rate. As a consequence, HIV testing is increasingly available in sites with minimal

infrastructure. In this context, it is of paramount importance that a program for the systematic evaluation of

rapid tests be established in order to identify new cost-efficient tests to be considered for the national

algorithms.

The evaluation of these laboratory technologies will be conducted in two phases: in the first phase, the

work will be performed in the reference laboratory while in the second phase, the evaluation will be

conducted at the point-of-care locations or at testing centers. Results produced by the new methodologies

will be compared to those generated by gold standard methods such as Enzyme Immunoassay, Western

Blot and PCR. Both phases of evaluations will be performed in locations that routinely receive specimens

for HIV diagnosis from potentially infected individuals or referrals from voluntary testing.

This project will investigate sensitivity, specificity and operational features of methods under evaluation. It is

anticipated that the evaluations will identify simple and rapid HIV tests that are most cost-efficient than

those currently used in the national algorithm. Those technologies that prove to be sensitive and specific

and show optimal operational characteristics will be considered for use in the national HIV diagnosis

algorithm.

This activity was conceptualized in FY07 and discussions to refine study design and implementing issues

have taken place. The protocol is currently in the final phase of development and will be vetted through the

appropriate ethical reviews in the US as well as the Mozambican Bioethics Committee in November 2007.

The evaluation phase should start in January 2008 and end by May 2008.

The Principal Investigator is Ilesh V. Jani, Department of Immunology, Instituto Nacional de Saude (INS -

National Health Institute).

The results of the evaluations will be described in a report that will be sent to the Ministry of Health, CDC

and all PEPFAR partners. Additionally, stakeholders (INS, CDC) will participate in the planning and

presenting of data at meetings and conferences.

Study activities and data analysis are expected to be complete by the end of FY08.

Budget Justification for FY08 monies:

Salaries/fringe benefits: 7,000

Equipment: 5,000

Supplies: 25,000

Travel: 12,000

Participant Incentives: 0

Laboratory testing: 10,000

Other: 0

Total: 59,000

Continuing activity: The main components of this activity are to support the Mozambique Ministry of Health

(MOH) in its efforts to increase the quality laboratory testing services for HIV/AIDS diagnosis and ARV

treatment by providing technical assistance and support in the following areas:

1. Conduct quality assurance / quality control workshops for supervisors and senior lab technicians to

improve quality of laboratory services. In addition, training tools will be provided for Provincial labs to train

lower level labs. Training will be presented in 4 provinces with 40 people trained and will cover: QA/QC,

preventive maintenance, inventory control, lab process flow, test reporting, and communication. Curriculum

will be modified in consultation with CDC/Mozambique and MOH, and materials translated into Portuguese.

This activity will be coordinated with the Federal University of Rio de Janeiro mentorship program.

2. Evaluate instrument operations at testing sites and develop an assessment tool to evaluate staff

competencies and testing quality at sites after introduction of new technology for CD4, hematology and

biochemistry; assess 10 laboratories.

3. Develop pre-service and in-service laboratory training centers, initial center in Maputo at a Medical

Technology pre-service school to include: training center renovation and equipping.

4: Modify the Laboratory Management Workshop to provide a set of curricula for management and basic

laboratory operations training for laboratory technicians working at the different levels of the health system

(central, provincial and district level). This activity will include translation of all materials, training of trainers

at province level workshops. Curriculum is to be used by provincial laboratories to train district staff. 6

training workshops will be provided in 2008-2009 including development of trainers as co-faculty, with 60

people trained.

5. Develop, in collaboration with MOH, JHPIEGO and CDC, laboratory safety manuals, training materials

and SOPs and a training curriculum for a safety workshop series. In addition conduct site assessments for

safety practices and provide on-going workshops through a train-the-trainer program.

6. Collaborate with Immunology Laboratory at the National Institute of Health (NIH) to perform HIV DNA

PCR for early infant diagnosis; support services for viral load testing; advance the quality of laboratory

testing through EQA programs for HIV rapid tests and CD4 Enumeration; monitor testing quality through

supervision; and develop training programs to improve testing quality.

7. Improve design standards for laboratory facility safety, efficiency and ease of adapting to changing

needs. Coordinate MOH, partner and local professional architect/engineer meetings with US laboratory

design expert institution (CUH2A) to develop standard guidelines for laboratory design. Provide model plans

for different laboratory levels and functions and training for local MOH and engineering staff.

8. Continue implementation of a laboratory information system and paper based strengthening. The

electronic LIS will be installed at 6 Provincial laboratories, training will be provided in basic computer skills

and the use of the LIS. The standard paper based laboratory documentation shall be reviewed and

implemented in 15 District level labs; all standard forms including patient demographics/specimen

acquisition, preventive maintenance, QC, inventory control and test reporting forms developed and

technicians trained in use of forms and registers. In addition, a Wide Area Network (WAN) for provincial

laboratory LIS sites will be implemented.

9. Develop and pilot a model national specimen referral and specimen tracking system in three provinces

(Maputo, Nampula and Zambezia). Approve paper based and electronic specimen acquisition process,

implement forms and LIS where needed, train users and evaluate timeliness of transport systems and

accuracy of specimen tracking. In addition APHL will pilot an electronic test reporting system.

10. Improve capacity of and access to quality TB testing services by providing APHL TB experts as needed

to support the NTP. As requested by CDC/Mozambique, APHL will provide laboratory experts to

supplement partner activities for TB diagnostic mentoring and training in testing such as florescence

microscopy, culture and drug sensitivity testing. In addition provide a 2-3 month mentored advanced training

in TB methods and quality assurance at a US State Public Health Laboratory for 1-2 experienced TB

laboratory technologists.

FY07: This activity is related to activity number 8540, 8546 and 9254 as well as treatment activities: 8545,

8593, 8547 and 9160.

The main components of this activity are to support the Mozambique Ministry of Health (MoH) in its efforts

to provide adequate capacity of quality laboratory testing services for HIV/AIDS diagnosis and ARV

treatment by providing technical assistance and support in the following areas:

1) Rental-Reagent Contracts: Manage reagent rental contracts for instruments and essential laboratory

reagents for CD4, hematology and biochemistry testing for treatment sites at all levels of the MoH

laboratory system (includes all Emergency Plan partner supported laboratories). Plan and implement

transition of reagent rental contracts to the Supply Chain management System (SCMS) efficiently to assure

uninterrupted availability of reagents. This will include providing technical assistance to SCMS to assure

the effectiveness and efficiency of the system for providing essential reagents and instruments to

laboratories to support quality testing at all levels of the health care system.

APHL will also provide specific support for the Military and Police services in Mozambique in collaboration

with the US Department of Defense and procure 2 hematology analyzers and 1 CD4 instrument including

reagents needed for ARV treatment facilities in the Military and police services.

2) Laboratory training centers: Provide technical assistance and coordinate planning, development and

implementation of in-service and pre-service training; integrate training activities with those being

implemented by the Federal university of Rio de Janeiro and other groups for laboratory technician

mentoring program; provide assistance to CDC-Mozambique in identifying laboratory partners (APHL,

American Society of Clinical Pathology-ASCP, American Society for Microbiology-ASM, and Clinical and

Laboratory Standards Institute-CLSI) to provide curriculum development, training center renovation and

equipping and faculty to support laboratory technician training.

3) National Specimen Referral System: Provide technical assistance for the planning and development of a

coordinated national specimen referral and transport system that incorporates existing partner transport

systems, standardizes specimen identification, tracks specimens, provides timely delivery of specimens to

referral laboratory services, and provides access to testing to all levels of the health care system.

4) Rapid testing site deployment. Provide start-up technical assistance to new laboratory sites to assure

Activity Narrative: rapid initiation of quality testing, identify training needs and assure communication link to technical

assistance.

5) Laboratory information system (LIS): Implement the LIS developed in FY06 to all laboratories providing

ARV testing support including purchase of hardware, installation of the LIS, user training, and maintenance,

help desk support and training centers

7) Strategic Planning: Provide technical assistance for development and implementation of strategic and

implementation plans: The strategic plan will be developed for each tier of laboratory and describes minimal

requirements needed to effectively support programs. Support will include provision of technical assistance

to the MoH for the development of a strategic plan that incorporates the national objectives and strategies

and defines what and how activities will be implemented to develop a national laboratory network. Senior

laboratory directors will also work with the MoH to support national planning and implementation activities.

7) QA/QC and Safety Training in lab sites: Provide laboratory management, QA/QC and safety training for

laboratories. Provide training to improve laboratory management skills and practices including laboratory

facility infrastructure improvement and equipment validation, operation and maintenance, supply

management within the laboratory, quality control including SOPs, and safety practices.

8) Support QA centrally: APHL will provide sub grant to the National Institute of Health in the MoH to

support Implementation of Laboratory Quality Assurance through; a) training of six Mozambican technical

staff at the National immunology reference laboratory and HIV serology reference laboratory to oversee and

provide supervision of the CD4 T cell and HIV serology quality assurance programs respectively b)

Procurement and distribution of proficiency panels for the quality assurance programs c) provision of

continuous training of laboratory staff in participating laboratories and d) perform DNA PCR for infant

diagnosis of HIV, conduct viral load testing and resistance monitoring.

9) Lab coordination: Participate in project meetings, provide regular reports and communication and

participate in CDC/GAP Laboratory Consortium. Attend CDC-Mozambique laboratory meetings; participate

in laboratory workgroup conference calls with CDC-Mozambique and CDC/GAP Atlanta; and participate in

laboratory consortium conference calls and meetings. Provide reports of activities as required for the CDC

agreement and frequently to inform CDC and partners of activities.

Continuing activity:

This activity is comprised of a number of subactivities. These include:

1) Procurement of laboratory tests, supplies and equipment for ART resistance monitoring

2) Procurement of tests, medicines, and sample collection and processing supplies and equipment for

Sentinel Surveillance

3) Procurement of laboratory tests, and sample collection and processing supplies and equipment for an

AIDS indicator survey

1) Procurement of laboratory tests, supplies and equipment for ART resistance monitoring $20,000

For ART monitoring one MOH-supported treatment site will be selected to pilot drug resistance monitoring

in a pediatric or adult cohort. Expected sample size is 100 patients, for whom baseline data will be

collected. Routinely-collected blood samples will be used for preparing baseline and 12 month genotyping

and viral load samples. Funds will cover procuring sample collection supplies and equipment. This is

related to activities 12267.08 and 8639.08.

2) Procurement of tests, medicines, and sample collection and processing supplies and equipment for

Sentinel Surveillance $240,000

This activity is associated with Mozambique's SI five year strategy to technically and financially support

surveillance to monitor HIV/AIDS-related illnesses, understand the behaviors that influence transmission,

improve access to and use of care and treatment services, strengthen the effectiveness of program

activities, and ensure a supportive environment for USG efforts. This is related to activities 10211.08 and

8639.08.

The Ministry of Health, in coordination with donor and technical assistant partners, began implementing

routine HIV/AIDS sentinel surveillance among pregnant women in 1998 in 10 sites. In 2007 during the latest

round, sentinel surveillance was conducted at 36 sites throughout the country and dry blood spot (DBS)

technology, BED incidence assays, and threshold ARV resistance monitoring were introduced. Data from

the sentinel surveillance round are used to describe the current burden of disease among pregnant women

and to produce estimates of the burden and impact of HIV/AIDS in the country and to monitor trends in

disease over time. Sentinel surveillance data are the cornerstone of allocating resources in the country as

well and are currently the national source for HIV prevalence estimates. For example, data are used to

determine priority areas for opening new treatment sites and focusing prevention efforts.

Since 2001, CDC has provided complete financial and technical support for sentinel surveillance activities in

Mozambique. In 2008, funds will be used to procure sample collection equipment and supplies, sample

processing equipment and supplies, and test kits necessary to conduct sentinel surveillance.

3) Procurement of laboratory tests, and sample collection and processing supplies and equipment for an

AIDS indicator survey $600,000

The only source of nationally-representative HIV indicator data in Mozambique to date was collected during

the 2003 DHS. In order for the US Census Bureau to be able to estimate the number of infections averted,

a key element of the 2-7-10 goals, a second HIV indicator data point is required by mid 2009. In addition,

as of yet no nationally-representative HIV serosurvey has been performed in Mozambique. While both of

these needs could be met by performing another DHS, due to the recent population census, upcoming

elections, and competing survey priorities the National Statistics Institute (INE) has indicated that they will

not conduct a DHS until 2010. This is related to activity 10211.08. Early funding for this subactivity is being

requested since the procurement must begin by April.