Outline of the Project

Project's name

The project for Establishment of the "bench-to-bedside" feedback system for sustainable ART and the prevention of new HIV transmission in Vietnam

Project Site

Hanoi

Date of R/D Signed

1st, November, 2018

Term of Cooperation

From 3rd April, 2019 to 2nd April, 2024

Implementing Organization

National Hospital for Tropical Diseases

Background

As of 2018, there are 200,000 to 260,000 people living with HIV (PLHIV) in Vietnam, the 5th largest number in the Asia-Pacific region. In the 5-year health sector development plan 2016-2020, Government of Vietnam (GoV) stressed the importance of improving the quality of prevention, care, and antiretroviral therapy (ART), in order to stop further spread of HIV. So far, Vietnam has received financial support from international organizations, such as, the Global Fund and the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), so that the country could provide antiretroviral (ARV) drugs and various examination free-of-charge to HIV patients. Those support contributed to decreasing the cases of progression to AIDS and related death toll. However, those support started to phase out, as Vietnam has become a middle-income country. Hence, GoV decided to finance ART for HIV patients through national health insurance, at local health facilities. However, those new policy changes could cause more financial burden on patients, and health workers at local health facilities have not been equipped with enough knowledge on HIV diagnosis and treatment. If appropriate regimen are not provided to patients, it would cause decrease of ART adherence or ART failure, as well as a spread of drug-resistant mutations, which leads to increase in new HIV infection.

WHO guideline (2015) recommended the Pre-Exposure Prophylaxis (PrEP) for high-risk groups and PrEP was adopted in Vietnam HIV treatment guideline in 2017. Now, some organizations like USAID are piloting PrEP in some localities to accumulate the evidence. It is expected that PrEP will be further promoted as effective prevention measure, while it is important to make sure that spread of drug-resistant virus is prevented to ensure the success of PrEP. In addition, by analyzing protective immune responses against HIV in HIV high-risk groups, it would provide necessary information to develop HIV vaccine in the future.

With such background, JICA project was launched to establish monitoring system to constantly monitor the progress of ART at local health facilities in North Vietnam, including Hanoi with many PLHIV, to examine effectiveness of PrEP to prevent new infections, as well as to conduct immunological analysis on HIV high-risk groups.

Project Purpose

The ART monitoring system is established in targeted areas, effectiveness of PrEP is verified and policy recommendation is developed.

Output

1. An effective ART monitoring system is established at target health facilities in Northern Vietnam.
2. Causes of PrEP failure are analyzed.
3. HIV-1 protective immune responses are analyzed in individuals exposed to HIV but not infected with the viruses.

Project Activities

1-1	To recruit 1300 HIV+ patients on ART (1,000 at NHTD and 300 at local health facilities) by 2021 and additional 700 HIV+ patients from other local health facilities by 2023.
1-2	To develop a network system that connects the central hospital (NHTD) and local health facilities using health information technology to establish the HIV patient cohort on ART.
1-3	To develop blood sample collection/transportation system from local health facilities to the central hospital (NHTD) to examine HIV viral load.
1-4	To train Vietnamese staffs in NHTD to strengthen basic clinical laboratory techniques including viral load testing and drug resistant testing.
1-5	To monitor results of drug resistance test jointly by lab experts, to assure the quality.
1-6	To implement viral load and drug resistance monitoring in HIV patient cohort on ART.
1-7	To recruit a total of 150 newly identified HIV patients annually local health facilities.
1-8	To examine prior drug resistance in newly identified HIV patients at local health facilities every year.
1-9	To monitor treatment retention and associated factors in HIV patients on ART.
2-1	To follow maximum 800 PrEP users in Hanoi Medical University (HMU)-PrEP program and receive reports on PrEP failure at least once a month.
2-2	To examine plasma TDF concentration in 200 out of 800 PrEP users every 3 months.
2-3	To examine drug resistance for HIV seroconverted PrEP users.
3-1	To recruit individuals who are exposed to HIV but not infected with the viruses from the HMU-MSM cohort.
3-2	To train Vietnamese staffs in NHTD who join the immunological and molecular analysis.
3-3	To detect T cell responses to HIV-1 overlapping peptides in PBMCs from individuals exposed to HIV-1 but not infected with the viruses.
3-4	To identify HIV-1 epitopes recognized by the T cells and characterization of the T cells.

Inputs

Japanese side

1. Dispatch of Experts (Chief Advisor, Project Coordinator, ART Monitoring system, Other experts on HIV Clinical Management (ART/PrEP), HIV-1 Sequence Analysis and Immunological Analysis)
2. Equipment: Laboratory Equipment
3. Training in Japan: Sequence Analysis, Immunological Analysis
4. Local Cost: Running expenses necessary for implementation of the project activities other than that are borne by the Vietnamese side.

Vietnam side

1. Assignment of Counterpart personnel
2. Office space and laboratory space
3. Existing equipment
4. Running costs for research activities