Thông tư 07/2023/TT-BYT hướng dẫn quy trình, phương pháp giám sát dịch tễ học HIV/AIDS và giám sát các bệnh lây truyền qua đường tình dục do Bộ trưởng Bộ Y tế ban hành

CIRCULAR

PROVIDING PROCEDURES AND METHODS FOR EPIDEMIOLOGICAL SURVEILLANCE OF HIV/AIDS AND SEXUALLY TRANSMITTED DISEASES (STDs)

Pursuant to the Law on Prevention and Control of HIV/AIDS dated June 29, 2006; Law on amendments to the Law on Prevention and Control of HIV/AIDS dated November 16, 2020;

Pursuant to Decree No. 95/2022/ND-CP dated November 15, 2022 of the Government on functions, tasks, powers and organizational structure of the Ministry of Health of Vietnam;

At the request of the Director of Vietnam Administration of HIV/AIDS Control (VAAC);

The Minister of Health promulgates a Circular providing procedures and methods for surveillance of hiv/aids epidemiology and sexually transmitted diseases (STDs).

Chapter I

GENERAL PROVISIONS

Article 1. Scope

This Circular providing guidance on procedures and methods for HIV/AIDS epidemiology and STD surveillance.

Article 2. Definitions

For the purposes of this Circular, the terms below shall be construed as follows:

1. “HIV surveillance“ means collection of data on HIV/AIDS epidemiological indicators of groups of  people who are at different risks of getting HIV/AIDS to detect cases of confirmed HIV infection.

2. “HIV/AIDS case surveillance" means ongoing collection and monitoring of data on epidemiological indicators of people having HIV after they have confirmed HIV-positive test results, during the process of HIV/AIDS treatment, until they are dead to have knowledge about directions and results day by day in order to provide such data to serve preparation of plans, suppression and assessment of efficiency of anti-HIV/AIDS measures.

3. “HIV behavioral surveillance survey (BSS)" means collection of information on HIV risk behaviors by putting interview questions to groups of the selected people of targeted HIV surveillance.

4. “Sexually transmitted infections (STD)” means infections caused by bacteria, viruses, fungi, parasites, protozoa or other agents that are transmitted through sexual contact.

5. “STD surveillance“ means collection of information on epidemiological indicators of people who are at different risks of getting STDs after diagnosis.

6. "etiological surveillance of STDs" means periodic and systematic collection of information relating to epidemiological indicators of people who are at different risks of getting STDs on the basis of testing to find out infectious agents that are transmitted through sexual contact.

7. "syndromic surveillance of STDs" means periodic and systematic collection of symptoms and signs after clinical examinations to group them into syndromes of STDs.

8. “Syphilis targeted surveillance” means collection of data on epidemiology and syphilis tests from groups of selected people of HIV surveillance.

Chapter II

METHODS AND PROCEDURES FOR SURVEILLANCE OF HIV/AIDS EPIDEMIOLOGY

Section 1. HIV surveillance

Article 3. Methods for HIV surveillance

1. Methods for HIV surveillance include:

a) Counselling before and after HIV testing;

b) HIV testing;

c) Collection, consolidation of and report on epidemiological indicators of HIV/AIDS.

2. Priority subjects of HIV surveillance include:

a) Drug users;

b) Prostitutes;

c) Homosexual active people;

d) Transgender people;

dd) Spouses and other family members living together with HIV-positve people; spouses of the persons prescribed in Points a, b, c and d of this Clause;

c) Sex partners of HIV-positive people;

g) People infected with STDs;

h) Frequent travelers;

k) Tuberculosis patients;

l) People having clinical symptoms of HIV/AIDS infection;

m) Prisoners, persons held in detention, and persons held in custody at reform schools, compulsory education institutions or rehabilitation centers;

n) Other subjects.

Article 4. HIV testing and counselling process

1. Counselling before and after HIV testing:

a) Counselling before and after HIV testing at healthcare facilities, compulsory education institutions, reform schools, rehabilitation centers, social protection centers, prisons, detention centers and other custody facilities shall be done according to regulations in Circular No. 01/2015/TT-BYT dated February 27, 2015 of the Minister of Health on guidelines on counseling for HIV/AIDS prevention and control at healthcare facilities;

b) Counselling before and after HIV testing in community shall be done according to Decision No. 2673/QD-BYT dated April 27, 2018 of the Minister of Health on promulgation of HIV testing and counseling guidelines in community.

2. HIV testing shall be done according to professional guidelines in Decision No. 2674/QD-BYT dated April 27, 2018 of the Minister of Health on promulgation of the national guidelines for HIV testing.

Article 5. Procedures for collection, consolidation of and report on epidemiological indicators of HIV/AIDS.

1. Epidemiological indicators of HIV/AIDS of the person subject to HIV testing shall be collected, consolidated and reported as follows:

a) HIV screening facility shall collect and transfer information of people who test positive for HIV via a system for management of HIV/AIDS information (hereinafter referred to as “HIV-INFO”) or as a physical document using the form in Appendix 1 enclosed herewith to the facility where the confirmatory HIV testing is performed (hereinafter referred to as “confirmatory HIV testing facility”);

b) The confirmatory HIV testing facility shall receive the electronic document via the HIV-INFO system or printed document from the HIV screening and testing center. In case the person subject to HIV testing directly have test at the confirmatory HIV testing facility, this facility shall collect information as prescribed in Point a Clause 1 of this Article.

2. The update of information, transfer and return of the confirmed positive result shall be done as follows:

a) After the confirmed HIV result is presented, the confirmatory HIV testing facility is responsible for updating the testing result on the HIV-INFO system and transfering an electronic document or physical document on the confirmed positive result to the screening facility or returning the confirmed positive result to the person subject to HIV testing;

b) The HIV screening facility shall receive the confirmed positive result from the confirmatory HIV testing facility and update the confirmed HIV-positive test results (if any) as prescribed in Appendix 1 enclosed herewith and send the updated information to the confirmatory HIV testing facility.

3. The confirmatory HIV testing facility shall prepare a HIV surveillance report prescribed in Appendix 1 enclosed herewith and send the report to the HIV/AIDS surveillance agency prescribed in Article 6 of this Circular.

4. The HIV screening facility and the confirmatory HIV testing facility shall transfer information of the HIV-positive person to the HIV/AIDS treatment facility registered by the HIV-positive person.

Article 6. Procedures for notifying positive HIV test results to agencies and units tasked with HIV/AIDS epidemiological surveillance

1. After the confirmed HIV-positive test result is presented, the confirmatory HIV testing facility shall notify to an agency or unit tasked with HIV/AIDS epidemiological surveillance of a province or district, the National Institute of Hygiene and Epidemiology, the Pasteur Institute in Ho Chi Minh City, the Central Highlands Institute of Hygiene and Epidemiology and Pasteur Institute in Nha Trang (hereinafter referred to as “Institute”) and VAAC (hereinafter referred to as “HIV/AIDS surveillance agencies”) through the HIV-INFO system.

The confirmatory HIV testing facility affiliated to the Ministry or Central authority shall notify the positive HIV test result to the HIV/AIDS surveillance agency of the province where the testing facilty is located.

2. After receiving the notification of positive HIV test result of the confirmatory HIV testing facility, HIV/AIDS surveillance agencies shall manage information of the person having confirmed positive result according to the regulations in Article 8 hereof.

Section 2. HIV/AIDS case surveillance

Article 7. Methods for HIV/AIDS case surveillance

1. Methods for HIV/AIDS case surveillance include:

a) Surveillance of HIV-positive person;

b) Surveillance of treatment status of HIV-positive person;

c) Surveillance of HIV-related deaths.

2. Subjects under HIV/AIDS case surveillance are HIV-positive people.

Article 8. Procedures for managing information of people getting tested for HIV confirmation

1. After receiving information on the HIV-positive person, VAAC shall assign an official to be in charge of HIV/AIDS surveillance (hereinafter referred to as “surveillance official” to:

a) Update information on the HIV-positive person as prescribed in Appendix 1 enclosed herewith on the HIV-INFO system; 

b) Review, compare and certify information on the HIV-positive person on the HIV-INFO system if there is a request;

c) Cooperate with Institutes in organizing HIV surveillance and assess HIV transmission risks when the number of HIV-positive people increases according to the professional guidelines.

2. After receiving information on the HIV-positive person, the Institutes shall assign a surveillance official to:

a) Update, review, compare and certify information of the HIV-positive person according to Point a and Point b Clause 1 of this Article; 

b) Cooperate with VAAC and the provincial HIV/AIDS surveillance agency in organizing HIV surveillance and assess HIV transmission risks when the number of HIV-positive people increases according to the professional guidelines.

3. After receiving information on the HIV-positive person, the provincial HIV/AIDS surveillance agency shall assign a surveillance official to:

a) Update, review, compare and certify information of the HIV-positive person according to Point a and Point b Clause 1 of this Article; 

b) Send a notification of information on the HIV-positive person to the HIV/AIDS surveillance agency of the district where the HIV-positive person is residing or has permanent residence via the HIV-INFO system;

c) Organize HIV surveillance in the district and assess HIV transmission risks when the number of HIV-positive people increases according to the professional guidelines.

4. After receiving information on the HIV-positive person, the district-level HIV/AIDS surveillance agency shall assign a surveillance official to:

a) Update information of the HIV-positive person according to Point a Clause 1 of this Article; 

b) Take charge and cooperate with the Commune-level medical station in reviewing, comparing, certifying and updating information on the HIV-positive person receiving from the provincial HIV/AIDS surveillance agency on the HIV-INFO system;

c) Send a notification of information on the HIV-positive person to medical station of the commune where the HIV-positive person is residing or has permanent residence via the HIV-INFO system;

d) Organize HIV surveillance in the district and assess HIV transmission risks when the number of HIV-positive people increases according to the professional guidelines.

5. After receiving information on the HIV-positive person, the commune-level medical station shall assign a surveillance official to:

a) Review and calibrate information on the HIV-positive person on the HIV-INFO system;

b) Cooperate with the district-level HIV/AIDS surveillance agency in assessing HIV transmission risks when the number of HIV-positive people increases according to the professional guidelines.

Article 9. Procedures for managing information on the HIV-positive person who are undergoing HIV/AIDS treatment

1. After the HIV-positive person sent to a HIV/AIDS treatment facility or in the process of HIV/AIDS treatment, the HIV/AIDS treatment facility shall send information on the HIV/AIDS treatment of the HIV-positive person as prescribed in Appendix 2 enclosed herewith to the HIV/AIDS surveillance agency.

The HIV/AIDS treatment facility affiliated to the Ministry or the central authority shall notify information on the HIV-positive person who is undergoing HIV/AIDS treatment to the HIV/AIDS surveillance agency of the province where headquaters of the HIV/AIDS treatment facility is located.

2. After receiving information on the HIV-positive person who is undergoing HIV/AIDS treatment, the provincial HIV/AIDS surveillance agency shall assign a surveillance official to:

a) Update information on the HIV/AIDS treatment of the HIV-positive person prescribed in Appendix 2 enclosed herewith on the HIV-INFO system;

b) Review and compare information on HIV-positive people who are undergoing HIV/AIDS treatment for the first time with HIV/AIDS treatment data on the HIV-INFO system;

c) Send a notification of list of HIV-positive people who are undergoing HIV/AIDS treatment to the HIV/AIDS surveillance agency of the district where such HIV-positive people are residing or have permanent residence via the HIV-INFO system;

d) Submit a report on the HIV/AIDS treatment of the HIV-positive people to VAAC and local institutes.

3. After receiving information on the HIV/AIDS treatment of the HIV-positive person, the district-level HIV/AIDS surveillance agency shall assign a surveillance official to:

a) Update information on the HIV/AIDS treatment of the HIV-positive person prescribed in Point a Clause 2 of this Article and send a report on the HIV/AIDS treatment of the HIV-positive person to the provincial HIV/AIDS surveillance agency;

b) Notify the list of HIV-positive people who are undergoing HIV/AIDS treatment to the commune-level medical station;

c) Review and compare information on HIV-positive people who are undergoing HIV/AIDS treatment for the first time with HIV/AIDS treatment data on the HIV-INFO system;

4. After receiving information on the HIV-positive person who is undergoing HIV/AIDS treatment, the commune-level medical station shall assign a surveillance official to update information on the HIV-INFO system.

5. After receiving information on the HIV-positive person who is undergoing HIV/AIDS treatment, the local institute shall assign a surveillance official to:

a) Update information on the HIV/AIDS treatment of the HIV-positive person prescribed in Point a Clause 2 of this Article and send a report on the HIV/AIDS treatment of the HIV-positive person to VAAC;

b) Review information on the HIV-positive people who are undergoing HIV/AIDS treatment in the assigned area on the HIV-INFO system;

6. After receiving information on the HIV-positive person who is undergoing HIV/AIDS treatment, VAAC shall assign a surveillance official to:

a) Update information of the HIV/AIDS treatment of the HIV-positive person prescribed in Point a Clause 2 of this Article; 

b) Review and respond information on HIV-positive people who are undergoing HIV/AIDS treatment nationwide on the HIV-INFO system to HIV/AIDS surveillance agencies (if any).

Article 10. Procedures for managing information on HIV-related deaths

1. After receiving information on a dead HIV-positive person in a commune, the commune-level medical station shall cooperate with a judicial official of the commune where the dead HIV-positive person had resided or had permanent residence in collecting and updating information prescribed in Appendix 3 enclosed herewith on the HIV-INFO system or sending them in writing to the district-level HIV/AIDS surveillance agency.

2. After receiving information on a HIV-related death, the district-level medical station shall update information of the HIV-positive person prescribed in Appendix 3 enclosed herewith on the HIV-INFO system.

3. After receiving information on the HIV-related death, the HIV/AIDS surveillance agency at any level shall assign a surveillance official to manage and use information to serve HIV/AIDS epidemiological surveillance according to their fuctions and tasks.

Article 11. Consolidated reports on HIV/AIDS case surveillance data

1. Reporting frequency: quarterly reports and annual reports;

2. Reporting periods:

a) The reporting period of a quarterly report shall be the period from the first day of the quarter to the end of the last day of the same quarter;

b) The reporting period of an annual report shall be the period from the first day of the year to the end of the last day of the same year;

3. Reports shall be sent in person or by email or via the HIV-INFO system. Reports must be signed, sealed and saved according to regulations of law on archives.

4. Contents of a consolidated report on HIV/AIDS case surveillance data include the number of new HIV-positive people and the number of HIV-related deaths using the form prescribed in Appendix 4 enclosed hererwith.

5. Reporting entities and procedures:

a) Commune-level medical stations shall submit their reports as prescribed in Clause 4 of this Article to district-level HIV/AIDS surveillance agencies no later than the 5^th of the next month of the reporting period;

b) The district-level HIV/AIDS surveillance agencies shall consolidate the reports sent by the commune-level medical stations as prescribed in Clause 4 of this Article and send a consolidated report to provincial HIV/AIDS surveillance agencies no later than the 10^th of the next month of the reporting period;

c) The provincial HIV/AIDS surveillance agencies shall consolidate the reports sent from the district-level medical stations as prescribed in Clause 4 to VAAC and Institutes no later than the 15^th of the next month of the reporting period;

d) The Institutes shall consolidate the reports sent from the provincial HIV/AIDS surveillance agencies as prescribed in Clause 4 to VAAC no later than the 20^th of the next month of the reporting period;

Section 3. TARGETED SURVEILLANCE

Article 12. Methods for targeted surveillance

1. Methods for targeted surveillance include:

a) HIV/AIDS targeted surveillance;

b) Syphilis targeted surveillance;

c) HIV behavioral surveillance survey (BSS).

2. Subjects under targeted surveillance include:

a) Men addicted to drug injection;

b) Female prostitutes;

c) Men who have sex with men (MSM);

d) Another group: Based on the risk of HIV transmission of each province to select a group that play a role in increasing HIV transmission in their provinces, the estimated HIV infection rate in this group must be over 1% and continuous surveillance must be ensured according to the frequency specified in Clause 1 Article 14 of this Circular.

Article 13. Procedures for organizing targeted surveillance

1. Provincial HIV/AIDS surveillance agencies shall take charge and cooperate with district-level HIV/AIDS surveillance agencies, commune-level medical stations and organizations and individuals tasked with targeted surveillance in:

a) Conducting surveys, making model frames for targeted surveillance;

b) Accessing, inviting entities under targeted surveillance;

c) Sampling, transporting and testing;

d) Interviewing participants in targeted surveillance according to survey forms;

dd) Clearing, updating, consolidating and analyzing data;

e) Summarizing and reporting targeted surveillance results.

2. VAAC shall take charge and cooperate with Institutes and National Hospital of Dermatology and Venereology in developing and updating guidelines on the process of organizing and carrying out targeted surveillance.

Article 14. Frequency and period of targeted surveillance

1. Targeted surveillance is carried out simultaneously or sequentially according to target groups every two years and not overlapping with each other in the same year.

2. Surveillance period: Starting from June 1 and ending on September 30 of the year in which the surveillance is carried out.

Article 15. Criteria for selecting targeted surveillance sites

1. Targeted surveillance sites shall be selected  as follows:

a) District-level authorities may select to carry out targeted surveillance when there are the largest number of entities specified in Clause 2 Article 12 of this Circular according to the managed or estimated data on entities under targeted surveillance;

b) In a province, no more than 5 districts shall be selected to carry out targeted surveillance.

2. The list of provinces and entities under targeted surveillance shall comply with the guidelines of the Ministry of Health (via VAAC).

Article 16. Selection criteria, sample size and targeted surveillance sample selection methods

1. Criteria for selection of entities under targeted surveillance: people who are full 16 years of age or older, have civil act capacity and meet the following criteria:

a) Drug users who are men having at least one injection of drug within a month before sample collection;

b) Female prostitutes having vaginal or anal sex at least one time within a month prior to sample collection;

c) Men having had anal sex with other men within 12 months prior to sample collection;

d) Other subjects having HIV risk behaviors in the province and currently reside in the province.

2. Targeted surveillance sample size:

a) Men addicted to drug injection: 150-300 samples;

b) Female prostitutes: 150-300 samples;

c) MSM: 150-300 samples;

d) Other subjects who have HIV risk behaviors: 300 samples.

3. The sample selection methods shall follow the professional and technical guidelines of the Ministry of Health (via VAAC).

Article 17. Consolidated reports on targeted surveillance data

1. Reporting frequency shall comply with the regulations in Clause 1 Article 14 hereof.

2. Reporting periods shall comply with the regulations in Clause 2 Article 14 hereof.

3. Reports shall be sent and received in accordance with the regulations in Clause 3 Article 11 hereof.

4. A consolidated report on targeted surveillance data includes areas and entities under targeted surveillance, sample size and results of HIV and syphilis tests, assessment of HIV infection trend and syphilis infection rate, analysis of indicator groups, assessment of implementation and submit petitions using the form specified in Appendix 8 enclosed herewith.

5. Reporting entities and procedures:

a) Provincial HIV/AIDS surveillance agencies shall report targeted surveillance specified in Appendices 5, 6, 7 and 8 enclosed herewith to VAAC, the National Institute of Hygiene and Epidemiology and local institutes where they take charge before October 31 of the year in which the targeted surveillance is carried out;

b) The National Institute of Hygiene and Epidemiology shall consolidate and transfer national targeted surveillance reports specified in Appendices 5, 6, 7 and 8 enclosed herewith to VAAC before November 15 of the year in which the targeted surveillance is carried out;

Chapter III

STD SURVEILLANCE

Article 18. Methods for STD surveillance

1. Methods for STD surveillance include:

a) Etiological and syndromic diagnosis and treatment of STDs;

b) Collection, consolidation of and report on epidemiological indicators of STDs.

2. Entities under STD surveillance are patients diagnosed with STDs.

Article 19. Procedures for collection of information on STD surveillance

1. Healthcare facilities shall diagnose and manage STDs according to regulations of law on medical examination and treatment and collect epidemiological information of people who have STDs as prescribed in Article 20 hereof.

2. After examination and diagnosis results are presented, healthcare facilities shall assign officials who act as focal points to collect data on STDs prescribed in Appendices 9, 10 and 11 enclosed herewith and prepare reports as prescribed in Article 21 and Article 22 hereof.

Article 20. Information on epidemiology of people having STDs to be collected

1. Age, sex, occupation.

2. Information on etiological and syndromic diagnosis of STDs prescribed in Appendices 9 and 10 enclosed herewith.

3. HIV infection status of people infected with STDs;

Article 21. Frequency, ending date of the reporting period and reporting methods

1. Reporting frequency shall be every 6 months.

2. Reporting periods:

a) The first 6-month report shall cover the period from January 01 to the end of June 30;

b) The last 6-month report shall cover the period from July 01 to the end of December 31;

3. Reports shall be sent and received in accordance with the regulations in Clause 3 Article 11 hereof.

Article 22. Procedures for STD surveillance reports

1. Reports of commune-level medical stations:

a) Content of reports: the number of patients who have STDs and have been examined and managed in the last 6 months using the forms prescribed in Appendices 9, 10 and 11 enclosed herewith;

b) Submitting period: The first 6-month report shall be submitted within the period from July 01 to 05 of the reporting year; The last 6-month report shall be submitted within the period from January 01 to 05 of the succeeding year;

c) Units receiving reports: district-level HIV/AIDS surveilance agencies.

2. Reports submitted to district-level authorities include:

a) Contents of reports as prescribed in Point a Clause 1 of this Article;

b) Units submitting reports: commune-level medical stations, district-level healthcare facilities providing STD examination and treatment services and private healthcare facilities in the districts;

c) Submitting period: The first 6-month report shall be submitted within the period from July 01 to 05 of the reporting year; The last 6-month report shall be submitted within the period from January 01 to 05 of the succeeding year;

d) Units receiving and consolidating reports: the district-level HIV/AIDS surveillance agencies.

3. Reports submitted to provincial authorities include:

a) Contents of reports as prescribed in Point a Clause 1 of this Article;

b) Units submitting reports: district-level HIV/AIDS surveillance agencies, provincial healthcare facilities providing STD examination and treatment services, healthcare units affiliated to the Ministry and central authorities located in provinces and other healthcare facilities providing STD examination and treatment services.

c) Submitting period: The first 6-month report shall be submitted within the period from July 06 to 10 of the reporting year; The last 6-month report shall be submitted within the period from January 06 to 10 of the succeeding year;

d) Units receiving and consolidating reports: provincial dermatology and venereology facilities.

4. Reports submitted to central authorities include:

a) Contents of reports as prescribed in Point a Clause 1 of this Article;

b) Unit submitting reports: provincial dermatology and venereology facilities;

c) Submitting period: The first 6-month report shall be submitted within the period from July 11 to 15 of the reporting year; The last 6-month report shall be submitted within the period from January 11 to 15 of the succeeding year;

d) Units receiving and consolidating reports: The National Hospital of Dermatology and Venereology shall consolidate data of the whole country and submit it to VAAC before July 20 of the reporting year and January 20 of the succeeding year.

Chapter IV

IMPLEMENTATION CLAUSES

Article 23. Organizing implementation

1. VAAC shall:

a) Take charge and cooperate with relevant agencies and organizations in guiding, inspecting and summarizing the implementation of this Circular nationwide;

b) Take charge and cooperate with specialized agencies in formulating and updating technical professional guidelines; selecting entities and cities/central-affiliated cities under targeted surveillance; organizing trainings, providing technical supports to units and local authorities; doing researches, assessing HIV/AIDS epidemiological surveillance and STD surveillance methods;

c) Preside over implementation of the HIV-INFO system.

2. Relevant Institutes affiliated to the Ministry of Health and the National Hospital of Dermatology and Venereology shall:

a) Implement this Circular within their scope of professional operation;

b) Provide guidelines and professional technical supports within its management and cooperate in doing researches and assessing HIV/AIDS epidemiological surveillance and STD surveillance methods.

3. Department of Health of provinces and central-affiliated cities shall guide, implement, inspect, assess and summarize the implementation of regulations of this Circular in their provinces.

Article 24. Effect

1. This Circular comes into force from June 01, 2023.

2. Circular No. 09/2012/TT-BYT dated May 24, 2012 of the Minister of Health on issuance of guidelines on HIV/AIDS epidemiological surveillance and STD surveillance shall be invalid from  the day on which this Circular comes into force.

Article 25. Responsibility for implementation

The Director General of VAAC, Chief of the Ministry Office, Chief Inspector of the Ministry, Director Generals Departments and Sub-Departments affiliated to the Ministry of Health, Directors of the Departments of Health of provinces and central-affiliated cities, relevant organizations and individuals are responsible for the implementation of this Circular.

Agencies, organizations and individuals should report difficulties that arise during the period of implementation of this Circular to the Ministry of Health (via VAAC) for consideration and settlement./.