Quyết định 5292/QĐ-BYT 2017 Kế hoạch thí điểm phương pháp xác định nhiễm mới HIV

THE MINISTRY OF HEALTH

Decision No.5292/QD-BYT dated November 24, 2017 of the Ministry of Health on promulgating the pilot plan for assays to estimate HIV incidence in certain provinces and cities in Vietnam

Pursuant to the Government s Decree No. 75/2017/ND-CP dated June 20, 2017 on functions, tasks, power and organizational structure of the Ministry of Health;

At the request of Director of Vietnam Administration of HIV/AIDS Control,

DECIDES:

Article 1.To issue a pilot plan for assays to estimate HIV incidence in certain provinces and cities in Vietnam together with this document.

Article 2.This Decision takes effect on the signing date.

Article 3.TheChief of the Ministry Office, Directors, Directors General; heads of units affiliated to the Ministry of Health; Directors of Departments of Health of Hanoi, Ho Chi Minh City, Thanh Hoa, Nghe An, Dien Bien, Son La; and heads of relevant units shall implement this document./.

For the Minister

The Deputy Minister

Nguyen Thanh Long

PILOT PLAN

FOR ASSAYS TO ESTIMATE HIV INCIDENCE IN CERTAIN PROVINCES AND CITIES IN VIETNAM
(Issued together with Decision No. 5292/QD-BYT dated November 24, 2017 of the Minister of Health)

Part I

BASES FOR ESTABLISHMENT OF MODEL

I. Development of HIV/AIDS pandemic, HIV surveillance and testing in Vietnam

By the end of 2016, 215,621 people have infected with HIV, 88,668 people have infected with HIV integrated with AIDS and 90,181 people have died of HIV. However, in the number of reported cases of HIV infection, there are still significant unfounded or death cases, approximately accounting for 80% of the cases in the report. Among those who have infected with HIV in 2016, women accounted for 31.1%, men accounted for 68.9%, sexually transmitted infections accounted for 54.2%, blood transmission accounted for 32.8%, mother-to-child transmission accounted for 2.3%, and others accounted for 10.7%. Recently, HIV risk factors in the population of people who inject drugs are restricted, strong interventions like methadone treatment and other harm reduction interventions have reduced the HIV transmission within the population of people who inject drugs. However, the HIV transmission among people who inject drugs and their wives or sexual partners is still a cause of HIV transmission in Vietnam. In addition, the homosexual contact population and transgender women population shows increased signs in HIV infections.

Sentinel surveillance has been conducted in Vietnam since 2000 in 20 provinces and cities (hereinafter referred to as provinces) on people who inject drugs, sex workers and homosexual contact populations. The strategy II has been used with 2 test kits with different principles and preparation of antigens, and only HIV prevalence in key risk populations has been possibly estimated. Currently, HIV sentinel surveillance plus behavior component (HSS+) has been held in 20 provinces and plus active surveillance that gives testing results to patients in 20 provinces. Active surveillance has been early carried out since 1986 in 63 provinces. The Strategy III has been used with 3 test kits with different principle and preparation of antigens to estimate HIV infections. Nevertheless, the active surveillance and sentinel surveillance only use test kits that could detect antibodies but not HIV incidence in Vietnam.

HIV testing algorithms have been studied and developed since 2011 and recommended with 12 test kits of rapid tests, rapid tests and ELISAs, and particle agglutination tests since 2014 and updated in 2015. However, these algorithms cannot determine the HIV incidence in patients infected with HIV.

The HIV incidence in Vietnam has just been estimated using cohort studies so far; no assay is used to estimate HIV incidence on a trial basis.The HIV incidence is considered crucial and preferred to determine preventive treatments as deemed appropriate; detect variations and trends of patterns of HIV infection; propose effective interventions in key risk populations; and verify if these interventions are effective.

II. Assays to estimate HIV incidence

1. The BED capture enzyme immunoassay (BED-CEIA)

BED-CEIA is a test that determines the stage of HIV infection of a person by identifying the presence of certain biomarkers in his/her serum or plasma. BED-CEIA uses a 3-branched specific peptide containing the gp41 sequences from HIV-1 subtypes. The peptide for subtypes is thereafter used to measure the increasing proportion of anti-HIV-1 specific IgG to total IgG after seroconversion. The increasing proportion of anti-HIV-1 specific IgG to total IgG by progression of HIV stage entitles the estimation of stage of HIV infection.

However, in cross-sectional studies, BED-CEIA reveals its weakness in high estimates of HIV-1 incidence due to misclassifying certain prevalence cases (prevalence means infection ≥ 1 year) as incidence cases. The prevalence misclassified as incidence is called false recent rate (FRR). FRR has been applied to BED-CEIA in Vietnam since 2012.

2. rIDR-M Limiting Antigen Avidity Enzyme Immunoassay (LAg-Avidity)

LAg-Avidity is an avidity-based assay developed by the CDC of USA. This assay uses a recombinant protein for multiple subtypes (rIDR-M) that covered 3 sequences from the immunodominant region (rIDR) of gp41 from all major subtypes and recombinants of HIV-1 from A to E (group M). Recent researches show that this new assay entitles the distinction between incidence and prevalence.  

An important parameter in Lag-Avidity is mean value of incidence time is checked in certain subtypes of HIV-1, initial data of the research shows that there is no difference in incidence time due to subtype HIV-1. The research findings show that this assay has the same response of all major HIV-1 subtypesin the world.

FRR has been verified in Lag avidity in Vietnam since 2012

3. Rapid HIV-1 incidence-prevalence (I-P) test (Rapid I-P test)

Asanté™ HIV-1 Rapid Recency™ Assay is a rapid blood test version in the same manner with Sedia™ HIV-1 LAg-Avidity EIA that estimates HIV infection or stages of HIV infection (under 6 months or above 6 months). Up to now, Asanté™ HIV-1 Rapid Recency™ Assay has been used in USA in study programs and sentinel surveillance.

With the assistance of PEPFAR, Asanté™ HIV-1 Rapid Recency™ Assay has been used for diagnosis procedures in 10 countries in Africa to estimate incidence of pregnant woman under 25 years of age at all HIV/AIDS health facilities funded by PEPFAR with the purpose of including the HIV incidence estimate in the regular pregnancy-testing program.

The Asanté ™ Rapid HIV-1 Assay was developed in 2016. This test gives short-term results within 20 to 45 minutes. This test may distinguish between recent HIV infection (within 6 months) and long-term HIV infection. According to the immunoassay in the same manner with Lag-avidity, HIV Asanté™ Rapid HIV-1 assay uses recombinant antigen HIV-1 (rIDR-M) for incidence region and gp41 and gp36 antigen for prevalence region.

Interpretation of results: A sample is negative when only the control line appears on the test strip. A sample is considered a recent infection when the incidence line is visible, but the prevalence line is not visible.  A sample is considered a long-term infection (longer than 6 months) when both incidence line and prevalence line are visible.

Assays to estimate HIV incidence contribute to decreased transmission of HIV in key risk populations. The initiation of these assays in sentinel surveillance helps to estimate the trend of HIV incidence in Vietnam.

III. Bases for plan

- National HIV/AIDS control strategy by 2020, with a vision to 2030

- Scheme for surveillance of HIV/AIDS epidemiology, monitoring and evaluation of HIV/AIDS control programs with the purposes of: Enhancing the testing network to ensure the surveillance, prevention, diagnosis, and treatment in an accurate and timely manner.

- The Government s Decree No. 75/2016/ND-CP dated July 1, 2016 on conditions for HIV testing.

- Circular No. 09/2012/TT-BYT dated May 24, 2012 on guidelines for surveillance of HIV/AIDS epidemiology and surveillance of sexually transmitted diseases.

Part II

MAIN CONTENTS

I. Objectives:

1. General objectives: Study the application of HIV incidence test kits in Vietnam.

2. Specific objectives:  

- Evaluate characteristics of HIV incidence test kits in the pilot stage in certain provinces of Vietnam.

- Identify HIV incidence rates in groups of HIV-positive people in 6 provinces.

- Identify HIV incidence rates in groups of HIV-sentinel surveillance in Vietnam.

- Verify if HIV incidence assays initiated on a trial basis in the system of surveillance of HIV epidemiology in Vietnam is feasible.

II. Time for performance:2017-2019

II. Administrative division for trial performance:6 provinces below: Hanoi, Ho Chi Minh City, Thanh Hoa, Nghe An, Dien Bien, Son La.

III. Expected indicators:

- Sensitivity and specificity of test kits equivalent to HIV strains in Vietnam.

- HIV incidence rates among group of HIV surveillance.

- Feasibility rates in terms of provision, storage, use, and costs.

- The consent of research participants.

IV. Activities

1. Evaluate the characteristics of test kits at HIV national reference laboratory (identify the sensitivity and specificity).

- Formulate process and outline of evaluating quality of test kits.

- Use the source of samples kept at National Institute for Hygiene and Epidemiology and Pasteur Institute in Ho Chi Minh City to evaluate the sensitivity, specificity and incidence detection of test kits.

- Evaluate capacity of HIV incidence test kits on remaining HIV samples, status of which are known, from the study of evaluating national HIV testing algorithms.

- Sample size: 20 seroconversion samples intended for identifying the sensitivity and specificity in patients infected with HIV recently; 200 HIV positive samples; and 200 HIV negative samples.

- HIV positive and negative samples are chosen to evaluate the quality of assays as recommended by WHO (CDC/WHO 2002). Referring to the recommendation, the sample size is calculated with the hypothese that the sensitivity and specificity is 98% to get the confidence interval of 95% and fluctuation of ± 2%. In this research, the characteristics of the serum/plasma sample have been known from the previous studies, namely studies to evaluate Lag, BED, or algorithm.

- Collect and analyze test kit quality evaluation report.

- Publish the test kit quality evaluation report at the HIV national reference laboratory.

2. Estimate HIV incidence rates in groups of HIV-positive people in 6 provinces: Hanoi, Ho Chi Minh City, Dien Bien, Son La, Thanh Hoa and Nghe An.

- Formulate and approve the scientific research outline determining the incidence distribution among HIV-positive people.

- Initiate methods to determine distribution of HIV incidence on a trial basis among HIV-positive people in 6 provinces:

√ Rules:  The sample which is known positive with HIV by the third algorithm will be thereafter checked by the fourth algorithm to determine whether it is recent infection (within 6 months) or long-term infection.

√ Provide training in procedures for taking samples, testing, counseling, and reporting data for respective health workers in charge working for research participants;

√ Aggregate and analyze data of HIV incidence to give new and effective interventions to access key risk populations, in particular: providing patients with antiretroviral (ARV) care and treatment as soon as practicable after detection, giving tests to sexual partners, giving PrEP (Pre-exposure prophylaxis) to opposite-sex partners.

√ Report and analyze data in the pilot stage in 6 provinces to determine the feasibility of HIV incidence assays in diagnosis of HIV infection.

- Hold a seminar to publish research findings in the pilot stage.

3. Determine HIV incidence test kits in the sentinel surveillance program in 20 provinces participating in HSS/HSS+.

- Formulate and approve the scientific research outline determining the incidence sentinel surveillance groups in 20 provinces.

- Formulate the initiation process.

- Initiate HIV incidence assays in sentinel surveillance groups in 20 provinces;

√ Provide training for health workers participating in the sentinel surveillance program in terms of implementation and explanation for HIV testing results using the HIV incidence assays.

√ Supervise and provide technical assistance for HIV incidence assays in sentinel surveillance HSS/HSS+.

√ Report and analyze data in the technical stage in the sentinel surveillance to determine the feasibility when applying the HIV incidence assays in regular surveillance.

- Hold a seminar to publish research findings in the pilot stage.

4. Verify if HIV incidence test kits used in the system of surveillance of HIV epidemiology in Vietnam are feasible.

5. Apply the HIV incidence results in the preventive, surveillance, and evaluation program.

- Analyze characteristics in terms of anthropology, geography, society and risks of HIV incidence cases.

- Identify priority interventions, including priority and specific objectives focusing on preventive messages, testing services and access.

V. Action plan

VI. Funding

Use legitimate funding from:

- Population health target program budget.

- Budget appropriated by PEPFAR via VAAC – US.CDC projects and cooperation between relevant units.

- Other lawful budgets.

Part III.

IMPLEMENTATION

1. Vietnam Administration of HIV/AIDS Control shall:

a) Manage and regulate the initiation of assays to estimate HIV incidence on a trial basis in certain provinces in Vietnam.

b) Aggregate, analyze, report and publish research findings.

c) Apply research findings to draw up guidelines for surveillance and prevention of HIV transmission in Vietnam.

2. National Institute for Hygiene and Epidemiology cooperates with Pasteur Institute in Ho Chi Minh City, Pasteur Institute in Nha Trang, Central Highland Institute of Hygiene and Epidemiology shall:

a) Initiate the research evaluating quality of assays to estimate HIV incidence.

b) Formulate procedures, training, and provide the technical assistance for provinces included in the pilot plan.

c) Report research data to Vietnam Administration of HIV/AIDS Control affiliated to the Ministry of Health.

3. Departments of Health of provinces shall:

a. Direct HIV/AIDS control standing units and relevant units to implement these researches.

b. Inspect if trial implementation of HIV incidence assays ensures quality accuracy, and promptness.

4. HIV/AIDS control standing units of provinces shall carry out researches and report results thereof to Vietnam Administration of HIV/AIDS Control affiliated to the Ministry of Health./.