This is a new activity.

The Pasteur Institute (PI) was founded in Ho Chi Minh City, Vietnam in 1891 with Dr. Albert Calmette as its

director; it was the first Pasteur facility to be established outside of France. Over the years, it took on the

role of managing hygiene and disease epidemics in southern Vietnam. Today, PI serves as a regional

institute (covering 20 provinces in southern Vietnam) for preventive medicine. Major activities include

research and training for microbiology, immunology, and epidemiology, along with control of infectious

diseases. PI also maintains laboratories, which support the health care programs within Ho Chi Minh City

(HCMC).

In the area of HIV/AIDS, PI has two units that support control and prevention efforts in the south of Vietnam.

The first of these is the Public Health Department responsible for monitoring and evaluating HIV

surveillance (sentinel and high-risk populations) and case reporting. PI's laboratory and analysis department

supports national HIV surveillance activities with laboratory testing, staff trainings, and quality control and

quality assurance (QC/QA). Clinical testing laboratories support HIV diagnosis and care and treatment

monitoring for patients. They also provide PCR-based testing for viral load, early infant diagnosis, and

genotyping for drug resistance.

The Pasteur Institute has a history of working with PEPFAR through the existing HCMC Provincial AIDS

Committee (HCMC PAC) MOU. Vietnam's Ministry of Health (MOH), however, recently designated PI as

one of two national reference laboratories for HIV diagnosis, drug resistance, and surveillance for the

southern region of Vietnam. (The National Institute of Hygiene and Epidemiology (NIHE) is currently

responsible for the north.) For this reason, in FY09, PI will become a new PEPFAR partner, independent of

HCMC PAC. The Pasteur Institute will also support HIV drug resistance monitoring and threshold surveys,

QA/QC programs (including test kit evaluation), and early infant diagnosis (EID).

Related to PI's new role as a regional reference lab, PEPFAR will support training, upgrading of essential

equipment and participation in international external quality assessment (EQA) programs. Training will focus

on good laboratory practices and quality management systems as outlined in ISO 15189 standards for

medical laboratories. PEPFAR will provide PI with technical assistance so they can become a WHO-

accredited HIV sequencing lab.

The Pasteur Institute has been tasked by MOH's Vietnam Administration for HIV/AIDS Control (VAAC) to

participate in the development of a strategy to follow-up HIV drug resistance (DR) in patients receiving first-

line antiretroviral drugs in Vietnam and monitoring the spread of DR HIV in the community. In previous

years, PEPFAR allocated funds to monitor patients on antiretroviral therapy (ART) in PEPFAR-supported

outpatient clinics. In FY09, PI will begin to implement HIV drug resistance patient monitoring among patients

receiving antiretroviral treatment in the southern provinces with funds from the host government and

PEPFAR. The Vietnam National Technical Working Group for HIV DR has adopted the WHO/CDC HIV drug

resistance monitoring protocol. PI is a key participant of the national technical working group and receives

close technical assistance from CDC and the World Health Organization. PEPFAR will also provide support

for monitoring HIV DR in newly infected patients through support of threshold monitoring sites throughout

Vietnam.

Currently PI conducts HIV DR testing using plasma samples but due to logistical difficulties is only able to

test specimens from Ho Chi Minh City (and provinces within one hour's drive). PEPFAR will seek technical

assistance from the CDC International Laboratory Branch to allow PI to evaluate HIV DR testing from dried

blood spots (DBS). If successful, this will allow for the collection, storage, and transportation of specimens

from more remote provinces.

HIV diagnostic testing in Vietnam is not standardized or systematic. To address this issue, the Ministry of

Health has tasked both PI and NIHE to work together to evaluate HIV rapid tests and EIA products for the

development of a diagnostic algorithm(s) for use by laboratories at all healthcare levels. In FY08, PEPFAR

supported NIHE and MOH to evaluate the rapid test kit and develop a testing algorithm. In FY09, PEPFAR

will also support PI to participate in the evaluation of HIV test kits (EIA) by providing technical assistance,

training for laboratory technicians and diagnostic reagents selected for evaluation. PEPFAR will also assist

in the creation of a national standard panel through identification of local specimens or procurement of

commercially available serology panels.

Vietnam currently has limited capacity for diagnosis of HIV infection in children under 18-months old. This is

the first critical step in the delivery of appropriate care and treatment for infected children. In FY09, PEPFAR

will support the implementation of a national EID program through training (sample collection and laboratory

testing) and development of a QA program. Dried blood spots (DBS) collection will be used to expand

testing beyond urban settings. PI will be a part of a network of DNA PCR testing labs. Test kits (Roche

Amplicor 1.5) and DBS collection supplies will be supplied by the Clinton HIV/AID Initiative.

New/Continuing Activity: New Activity

Continuing Activity:

Emphasis Areas

Human Capacity Development

Estimated amount of funding that is planned for Human Capacity Development $65,000

Public Health Evaluation

Food and Nutrition: Policy, Tools, and Service Delivery

Food and Nutrition: Commodities

Economic Strengthening

Education

Water

Program Budget Code: 17 - HVSI Strategic Information

Total Planned Funding for Program Budget Code: $7,279,311

Total Planned Funding for Program Budget Code: $0

Program Area Narrative:

As PEPFAR/Vietnam moves into the second five year phase of PEPFAR and responds to the technical assistance reviews and

recommendations of OGAC and agency headquarters Strategic Information (SI) technical experts, SI activities will focus on the

development of a culture of data use where the National HIV prevention, care, and treatment program in Vietnam becomes

increasingly evidence-based, cost-effective, efficient and sustainable across donors, implementers and program areas. All

planned activities will be integrated with the Government of Vietnam's (GVN) National Strategy on HIV/AIDS Prevention and

Control and its nine programs of action (see uploaded map of SI activities). By working as a single USG team across program

areas and technical assistance partners, the Vietnam SI Team will partner with the GVN, other implementing partners, donors and

the UN to build capacity for all stakeholders to "know their epidemic" and "know their results." SI will continue to work with national

technical working groups (TWGs) to continue to build upon the groundwork of the first five years of PEPFAR SI activities in

Vietnam.

The PEPFAR/Vietnam SI team is an interagency TWG with approved staffing for a U.S. direct-hire team lead, two contractors and

seven locally employed staff (LES). The SI team lead currently serves as the SI liaison. At the time of COP submission, five of the

nine LES positions were vacant. An eighth LES is proposed in COP09 to be hired by DOD to focus on their programs. An

international direct hire M&E Officer will be contracted by USAID to build M&E capacity. SI team members work across agencies,

partners, program areas and SI domains, but are assigned either primary or secondary roles in each of these areas prioritized by

their agency's requirements (see uploaded SI Team Roles document).

The SI Team is responsible for providing tools and guidance to the GVN and other partners for the PEPFAR Annual Program

Results (APR) and Semi-annual Program Results (SAPR) reports. Team members then work directly with assigned partners to

provide technical assistance (TA) on indicator definitions, achievement double-counting, and data quality issues. Once these data

are compiled for all partners, the SI team works with other in-country TWGs to resolve completeness and quality issues and to

eliminate duplicate counting for final program area numbers. Final compiled APR and SAPR data tables are provided to TWGs

and partners. Data quality management is ongoing with supervision provided throughout the year where verification and

reproducibility of reported results are explored. These data are combined with previous target data and provided to TWGs to help

set program area targets for COP planning.

As the SI Team expands, so does its participation on other TWGs and direct support to the GVN and indigenous and international

NGO partners. Beginning in 2007, additional SI staffing resulted in better representation across program area TWGs and allowed

for partner-by-partner review of APR reported data. Data quality checks of national level data have only been possible for

surveillance and survey data to date, although SCMS data systems do allow for some verification of ART numbers. In 2007,

partners also began to share some of their data quality assurance and data quality improvement tools. 2008 and 2009 will see an

expansion of these activities including south to south activities following on discussions started at the regional SI meeting held in

Hanoi in September 2008. The SI team has also invited partners to join in on a broader PEPFAR SI team where tools and

resources can be shared to face the challenges of building the culture of data use described earlier.

Fiscal Year 2009 (FY09) funding will continue support for many FY08 activities while emphasizing the need to build capacity

within the GVN to implement sustainable quality programs based on data. In FY09, PEPFAR will fund activities that support both

national and international technical assistance partners, UN agencies, and implementing partners to help build capacity aligned

with GVN strategies and policies to ensure ownership and sustainability of programs. The first challenge to building a culture of

data use is filling the gaps of missing data and improving the quality of available data. Across all program areas and all funding

streams, there are significant gaps in information related to the epidemic and the response. Because the epidemic in Vietnam is

driven by injection drug use which characterizes all or a portion of all most at risk populations (MARPs), including networks of

injecting drug users (IDU), commercial sex workers (CSW), clients of CSW, and men who have sex with men (MSM), general

population surveys previously conducted, such as the Demographic Health Survey (DHS, 1997, 2002) and AIDS Indicator Survey

(AIS 2005), are of limited utility and frequently misrepresent the epidemic by portraying a picture of limited to no risk. There is no

reliable data on other substance abuse, such as alcohol, which contributes to higher risk behaviors. While sentinel surveillance is

well established and focused on MARPs, better MARP size estimates is a prioritized activity across multiple SI partners in 2009.

Enumeration of MARPs will be prioritized into two activities. A national MARP size estimation will be conducted beginning in

PEPFAR focus provinces while partners will continue to map MARP hot-spots and estimate the size of those populations they are

currently trying to reach. These data will be combined with data regarding catchment and coverage of programs to better plan the

expansion of existing programs and targeting of currently unreached populations.

One of the best sources of information on population behaviors and opportunities for intervention in Vietnam is the integrated

behavioral and biological surveillance (IBBS) planned for a second round in all focus provinces and considered for additional

program expansion provinces. IBBS is an invaluable source of information on populations currently within reach of existing

programs. These data will be combined with size estimation data to plan the expansion of relevant prevention programs in current

and under-served MARPs. In 2009, current IBBS activities will continue and a similar survey is planned for military recruits to

determine risk behaviors and to better plan future programming. To better monitor HIV transmission and assess prevention

program impact in Vietnam, various incidence assays will be considered. First, the BED Assay will be validated with the

appropriate correction factor for Vietnam identified using COP 2008 funds. In 2009, the team plans to use incidence assays to test

samples collected through the IBBS to better understand incidence in Vietnam. HIV drug resistance will also be monitored through

the implementation of both national monitoring systems and WHO monitoring on treatment protocols.

PEPFAR will continue to support the GVN to have better and more comprehensive epidemiologic data in the long-term while

focusing on data use and dissemination of currently available data in the short term. While no official HIV surveillance report has

been released by MOH, these data are routinely cited in national and program area specific reports as underlying epidemiologic

data for HIV in Vietnam. Sentinel surveillance systems have been routinely evaluated and incidence and HIVDR surveillance

systems will require evaluation as well. With substantial epidemiologic data available in 2009, a multi-partner data triangulation

exercise led by MOH will be undertaken to assess the impact of widely implemented HIV/AIDS interventions. Conclusions drawn

will aid the GVN in establishing priorities and objectives for the next phase of the National Strategy on HIV/AIDS.

Data from routine service delivery of prevention and care programs is limited across program areas and donors. Although national

forms exist for most program areas, information systems, paper or electronic, are not well organized or implemented. Starting in

2008 and continuing in 2009, PEPFAR will focus on better information for continuous improvement of quality of services delivered

and better information for program management and planning. Priority program areas will include better information for

commodities management, facility-based client services and community-based services around prevention, methadone programs,

adult and pediatric ART, HIV/TB care, PMTCT, OVC services, and HIV basic care.

To date, PEPFAR has focused on achievement data to ensure that programs were scaling up at a rate commensurate to the

funding levels. While multiple evaluation activities have resulted in program improvement (peer education, out-patient clinic, and

quality of life surveys for ART patients), more data are required to better focus resources and program strategies. Basic M&E

activities planned in 2008 and 2009 will be directed at both the national and implementing partner level and disseminated widely.

Another challenge is the development of a national health management information system (HMIS) that ensures the ongoing

collection and availability of quality information on the epidemic, implemented programs, and their impact. Through a national

HMIS TWG, PEPFAR will support the inclusion of other health sectors and a broader base of GVN agency participation in the

development of a national HMIS strategy. Because of the strong central government in Vietnam, every program is connected to a

government agency, resulting in an opportunity to develop a national strategy that can lead to a national HMIS centered in and

fully owned by the GVN. Systems need to be developed for program service delivery in both facility and community-based settings

and program management at sub-national, donor, and national levels based on standards to ensure harmonized information and

interoperable systems. Other data sources including surveillance, surveys, and population and vital statistics will need to be

incorporated to make a complete HMIS. Currently the only component of an HMIS strategy in place in Vietnam for HIV is the basic

design of the national HIV reporting system under the National M&E Framework and the MOH's official decree of program

reporting requirements for the National HIV Program (Decision 28).

The current USG strategy for supporting investment into an HMIS is a two-pronged approach centered in the GVN-led national

TWGs with close partnerships with UN agencies. The top down approach is advocacy and TA provided in conjunction with WHO

for information systems standards to promote system interoperability and with UNAIDS for harmonization of HIV indicators and

program reporting. The second approach will be the simultaneous development and expansion of service delivery and program

management information systems based on agreed upon harmonized data structures and systems standards. This will be a pilot

approach starting at district level community and facility-based programs with a focus on PEPFAR and GVN priority provinces.

COP08 and COP09 funds will be used in the next 2 years to continue both approaches towards HMIS development.

The Director of VAAC has agreed to the formation of a national HMIS TWG that will coordinate with national M&E TWG to

harmonize data and develop standards across donors and programs reporting into Decision 28 and establish a single national

HMIS. While the development of a national HMIS is ongoing, PEPFAR will continue to maintain data on its program using a

combination of Microsoft SQL Server, Access, and Excel. USG-funded PEPFAR partner systems will be required to adhere to all

standards and protocols developed in support of an HMIS. Meanwhile, further development and piloting of systems by program

area will continue with assessments of potential systems for consideration as a source for proposed standards. One-time

available funding from FY08 yellow-lighted DOD activities and drug cost savings will be used to accelerate the HMIS activities by

supporting advocacy meetings, data harmonization, standards development and software functional specifications development

for priority program areas including methadone, ART, TB/HIV, PMTCT, OVC, and community-based care and prevention.

Finally, the greatest challenge will be developing sustainable capacity to maintain a culture of data use where programs continue

to be dynamic as the epidemic shifts, programs change their scope, and the science of prevention, care, treatment, and SI evolve.

COP09 SI activities will continue to expand the pool of technical assistance resources by supporting implementing and TA

partners to provide support across all program areas in Vietnam. The SI Team will work with OGAC and international and regional

TA partners to provide coordinated, continuous, and focused technical support in program monitoring, evaluation, surveillance,

and HMIS. This pool of consistent technical assistance will be critical to ensure that capacity is developed over time in Vietnam

and gradually shifted to Vietnamese government and technical institutions for further support and training activities.

While the GVN has a strategy for hiring and training staff to focus on SI, PEPFAR will need to work closely with the government to

ensure that TA and resources are maximized for sustainable capacity development. "to be determined" (TBD) agency and partner

allocation of a portion of SI funds will allow for competitive local contracting of training and software development services and the

redirection of funds to partners that demonstrate the greatest ability to move sustainable and capacity building SI activities forward

quickly. It will be critical that capacity building, systems strengthening and training activities are planned and coordinated across

program areas, implementing partners and donors. Health System 20/20 health system assessments and Capacity Project

workforce assessment will help to inform how these various activities might best be integrated to maximum impact. Working with

multiple GVN ministries engaged in services to MARPS, national training institutions and a range of civil society partners will be

critical to a comprehensive SI and broader HSS strategy. This will include a strategy to closely integrate HSS activities with on-

going program TA and support to develop an integrated pre-service and in-service training plan for the development and

maintenance of a well-qualified public health workforce. By partnering with GVN for each area of SI and coordinating the planning

and implementation of these activities through in-country TWGs, PEPFAR SI activities can be transitioned to full GVN support and

implementation. As Vietnam moves into middle-income status, it will be well positioned by a USG inter-agency collaborative effort

to continue to plan and implement HIV programming that is guided by quality strategic information.

Table 3.3.17: