This is a continuing activity from FY07.

In keeping with Vietnam's National HIV/AIDS Strategy and PEPFAR 5-year Strategy, PEPFAR in FY08 will

fund the National Institute of Hygiene and Epidemiology (NIHE) for various ongoing activities to:

disseminate the algorithm for HIV diagnosis using rapid test kits; monitor patients on antiretrovirals for HIV

drug resistance in out-patient clinics in provinces with high prevalence; expand infant diagnosis for HIV to all

provinces offering PMTCT nationally; train 70 laboratory technicians in Quality Assurance (QA) with a focus

on laboratory equipment preventive maintenance in 35 southern and central provinces; and provide

oversight to the national External Quality Assessment (EQA) program in the diagnostic laboratory network.

Vietnam's Ministry of Health (MOH) recently designated NIHE as the national reference laboratory for HIV

prevention and surveillance, enabling NIHE to continue being a key PEPFAR partner. NIHE will work under

the leadership of MOH/Vietnam Administration for HIV/AIDS Control (VAAC) to develop the five-year

national strategic plan for the diagnostic laboratory networks (as described in the Laboratory Infrastructure

section in partnership with the Association of Public Health Laboratories and VAAC.)

In June 2006, NIHE and PEPFAR conducted a survey of 100 laboratories in 64 provinces to understand the

testing, staffing, quality assurance, and quality control and equipment needs and current practices in

Vietnam. Results from the survey revealed issues with quality assurance measures as well as a lack of

standard testing algorithms for rapid testing. Since MOH does not recommend using rapid tests alone for

diagnosis and surveillance, these tests are used as part of a confirmatory testing algorithm (WHO strategy

III) in combination with other tests such as ELISA and Particle Agglutination. Only three out of the 12 rapid

test kits approved by MOH have undergone evaluation for strains prevalent in Vietnam and whose

sensitivity and specificity are published. The ELISA technique recommended by MOH to confirm HIV results

is used by 42 laboratories in 52 provinces. Recently MOH has ordered that all HIV screening laboratories in

64 provinces under the Preventive Medicine Centers (PMC) system should be physically moved or

reestablished under a different department under VAAC and called Provincial AIDS Centres (PAC).

PEPFAR will assess the capacity of provincial laboratories under both PAC and PMC systems to determine

the most appropriate means to provide support.

In FY06, PEPFAR funded NIHE for developing a testing algorithm, which is expected to be highly sensitive,

highly specific, cost-effective, and appropriate for use in the resource-limited settings of Vietnam. In FY07,

PEPFAR supported field testing the proposed algorithm in a controlled field environment in four high and

low prevalence prevalence settings. In FY08, with approval from MOH, results of the rapid test kit analysis

and recommendations to use the test kits under controlled and field conditions will be used to jointly

implement training to roll out the HIV rapid testing training package for voluntary counseling and testing and

surveillance sites.

HIV Drug Resistance: In FY05, PEPFAR funded NIHE indirectly through another MOH partner, LIFE GAP,

to procure a Trugene analyzer for analyzing resistance to antiretrovirals and to implement the HIV Drug

Resistance (HIVDR) Threshold Survey in Hanoi. In keeping with PEPFAR's policy of promoting

sustainability and systems strengthening, two staff from NIHE were trained at the laboratory at CDC

Thailand. In FY06, PEPFAR supported the same survey for HCMC, which is about to commence.

HIVDR patient monitoring: In FY07, PEPFAR allocated funds to monitor patients on antiretrovirals in

PEPFAR-supported outpatient clinics in high prevalence regions in six provinces. In FY08, PEPFAR will

support the expansion of HIVDR patient monitoring survey into its second year

PMTCT: With the prevention of mother-to-child transmission being a major component of the Emergency

Plan, PEPFAR is advocating for approval from MOH to use the Roche Amplicor DNA PCR 1.5 as an early

infant diagnosis (EID) test for HIV. In anticipation of this approval, NIHE has been designated as the prime

partner to coordinate activities nationally via the three regional reference labs. Whole blood samples will be

collected using dried blood spots from infants born to HIV-positive mothers at PEPFAR-supported clinics.

PEPFAR will collaborate with CHAI, which will provide kits and CDC will support all other costs for providing

services, training, and technical assistance in these PMTCT sites.

QA: In FY06, PEPFAR supported training laboratory technicians in QA with special emphasis on preventive

maintenance in 20 northern provinces. NIHE has funds to train 70 laboratory technicians for similar

objectives in 35 southern and central provinces in FY07. Vendors of laboratory equipment were invited to

demonstrate preventive maintenance on various equipment and train laboratory technicians on their

equipment. In FY08, PEPFAR will fund training for QA to provincial laboratories after assessment of

laboratory capacity in both the PAC and PMC system; provide funds to NIHE for service contracts for bio-

safety hoods and pipettes; contract for two new laboratory technicians to provide oversight for the national

Quality Assurance program through site visits and data analyses. NIHE will collaborate with other partners

to develop standard operating procedures for laboratories at the national, regional and provincial level for

quality assurance and bio-safety (as described in Laboratory Infrastructure section in partnership with the

Association of Public Health Laboratories and VAAC).

This is a continuing activity from FY07. The narrative below is unchanged from FY07. Major changes to this

activity since FY07 approval are:

• With technical assistance (TA) from Family Health International (FHI) and the PEPFAR prevention and

strategic information (SI) teams, Vietnam's National Institute of Hygiene and Epidemiology (NIHE) will

determine appropriate methodologies and implement data collection activities to improve epidemiologic data

on drug users to measure incidence and prevalence, assess risk factors for HIV infection and exposures to

interventions, and evaluate the effectiveness of interventions in preventing the spread of HIV. In addition,

the evaluation will incorporate BED capture enzyme immunoassay validation. Results of the data collection

will be used for prevention program planning and improvement and policy development, and the adjustment

factor derived from the BED assay validation will be applied to sentinel surveillance specimens to obtain

incidence trend data in Vietnam.

• NIHE will obtain population size estimates as needed for program coverage assessment and planning.

NIHE, in technical consultation with FHI and PEPFAR, is currently piloting and applying a variety of

methodologies to obtain size estimates of injecting drug user (IDU), commercial sex worker (CSW) and men

who have sex with men (MSM) populations in the PEPFAR focus provinces. In FY08, NIHE will support

program areas needing population size estimates, to potentially include OVC and most-at-risk populations

in non-focus provinces where substantial prevention interventions are planned.

FY07 Activity Narrative:

NIHE heads Vietnam's HIV/AIDS surveillance subcommittee and has contributed to the national strategy by

conducting surveillance and population-based surveys. In FY07, NIHE will focus on strengthening the

national sentinel surveillance system and conducting surveillance among clients of CSW for behavioral data

and among ART patients for drug resistance. The details and estimated costs of proposed activities are as

follows: 1. Sentinel Surveillance - $160,000. NIHE will implement national sentinel surveillance among 6

target populations: IDU, CSW, pregnant women, TB patients, STI patients, and military recruits in 40

provinces. In FY06, with TA from USG to strengthen the national HIV sentinel surveillance system, NIHE is

conducting a pilot project to improve sampling and data quality among IDU and CSW using respondent

driven sampling (RDS). If the Ministry of Health/Vietnam Administration for HIV/AIDS Control (MOH/VAAC)

adopts the RDS methodology as standard protocol for national HIV sentinel surveillance, FY07 funds will be

used to implement RDS among IDU and CSW. Otherwise, funds will be used to improve provincial capacity

for implementing the existing convenient sampling, strengthening national capacity for supervision and

conducting data quality oversight. Funds will also be used to strengthen facility-based sampling of pregnant

women and TB and STI patients. 2. Behavioral Surveillance of CSW Clients - $50,000. Limited information

is available for prevention programs seeking to reach clients of commercial sex workers. NIHE will conduct

a special survey to obtain behavioral risk information on clients of sex workers in 2 provinces that will assist

the MOH to tailor prevention programs to appropriately address risk behavior of clients and the resulting risk

to sex partners. 3. Drug Resistance Surveillance - $100,000. To help ensure quality care and treatment

services, HIV drug resistance genotyping will be completed for patients on ART at 2 sites. Patients enrolled

in enhanced patient monitoring will be tested in order to determine underlying factors for drug resistance.

Enhanced patient monitoring applies longitudinal surveillance to monitor outcomes which could link HIV

drug resistance to factors such as risk behaviors and regimen adherence and change. 4. Technical Support

for National Monitoring and Evaluation Activities - $0. NIHE will continue to support VAAC in

operationalizing the national M&E framework using the previous fiscal year funds. In collaboration with the

M&E unit in VAAC, NIHE has established a set of national core indicators and is establishing surveillance

and M&E units located at the central, regional, and provincial level. NIHE will provide on-going M&E training

and technical assistance to provinces in FY 2007. This activity will support the provision of TA to NIHE and

40 surveillance sites and training for 82 implementing staff. Additional funds ($150,000) will allow rapid

procurement of test kids for IBBS in 3 additional provinces. There is currently no funding for IBBS in NIHE's

budget.