Circular No. 32/2013/TT-BYT guiding the management, monitoring, and treatment of people infected with HIV and those exposed to HIV

CIRCULAR

Guidelines for managing and monitoring treatment of HIV-infected individuals and those exposed to HIV

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Pursuant to Decree No. 63/2012/NĐ-CP dated August 31, 2012 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the HIV/AIDS Prevention and Control Department and the Director of the Medical Examination and Treatment Management Department;

The Minister of Health issues this Circular guiding the management and monitoring of treatment for HIV-infected individuals and those exposed to HIV.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

This Circular guides the implementation of management and monitoring of treatment for HIV-infected individuals and those exposed to HIV, including: reception criteria, reception procedures, health status assessment, and management and monitoring of antiretroviral therapy.

Article 2. Principles for managing and monitoring treatment of HIV-infected individuals and those exposed to HIV

1. Ensuring the continuity of treatment for individuals currently receiving antiretroviral therapy.

2. Providing directly to HIV-infected individuals and those exposed to HIV all contents related to their rights and obligations during the management and monitoring of treatment. In cases where the HIV-infected individual is under 16 years old or lacks civil capacity, has no civil capacity, or has civil capacity but is not fully capable, information must be provided to the parents or legal guardians of that person, and such direct provision of information can only be carried out with the written consent of the parents or legal guardians of that person.

3. Preventive treatment for opportunistic infections and antiretroviral therapy must comply with the contents stipulated in Decision No. 3003/QD-BYT dated August 19, 2009 of the Minister of Health on issuing guidelines for diagnosing and treating HIV/AIDS and Decision No. 4139/QD-BYT dated November 2, 2011 of the Minister of Health on amending and supplementing certain contents in the "Guidelines for Diagnosing and Treating HIV/AIDS" issued together with Decision No. 3003/QD-BYT dated August 19, 2009 of the Minister of Health (hereinafter referred to as Guidelines for Diagnosing and Treating HIV/AIDS).

Chapter II

MANAGEMENT AND MONITORING OF TREATMENT FOR HIV-INFECTED INDIVIDUALS AT TREATMENT FACILITIES

Section 1

MANAGEMENT AND MONITORING OF TREATMENT FOR HIV-INFECTED INDIVIDUALS REGISTERING FOR THE FIRST TIME AT TREATMENT FACILITIES

Article 3. Reception Criteria

1. Adults and children aged 18 months and above with a confirmed positive HIV test result.

2. Children under 18 months old with a positive HIV test result using molecular biology techniques.

Article 4. Reception Procedures

1. Counseling according to the provisions stipulated in Circular No. 06/2012/TT-BYT dated April 30, 2012 of the Minister of Health on conditions for establishment and content of activities for organizations providing counseling on HIV/AIDS prevention and control.

2. Based on the level of understanding of HIV-infected individuals regarding contents related to care and treatment of HIV, the following information shall be provided:

a) Benefits of preventing opportunistic infections;

b) Benefits of timely antiretroviral therapy and consequences of delayed or lack of antiretroviral therapy;

c) Role of nutrition and positive living in the health of HIV-infected individuals;

d) Necessity of HIV testing for family members, sexual partners, and those sharing injection equipment with HIV-infected individuals.

3. Establish an outpatient medical record according to the model specified in Appendix No. 01 issued together with this Circular for cases where HIV-infected individuals agree to register for HIV/AIDS care and treatment.

4. Assess the health status of HIV-infected individuals according to the provisions of Article 5 and handle after assessment according to the provisions of Article 6 of this Circular.

Article 5. Assessment of the health status of people living with HIV

1. Collecting history of antiretroviral drug use, information on currently used medications and their side effects; history of prevention of mother-to-child transmission of HIV for pregnant women and children.

2. Determining clinical stage, height, and weight of the patient. For children, additional assessment of mental and physical development should be conducted.

3. Screening for tuberculosis.

4. Diagnosing opportunistic infections and other diseases.

5. Testing: CD4 count, blood formula, liver function, creatinine, HBsAg, anti-HCV, and other necessary tests.

6. Determining immune stage.

7. Determining criteria for antiretroviral therapy.

8. Consulting or referring the patient to other healthcare facilities when necessary.

Article 6. Post-assessment health management

1. For people living with HIV who do not meet the criteria for antiretroviral therapy: managing and monitoring treatment according to the provisions of Article 8 of this Circular.

2. For people living with HIV who meet the criteria for antiretroviral therapy:

a) In cases where people living with HIV have opportunistic infections: immediately treating these infections according to the guidelines for diagnosis and treatment of HIV/AIDS. Subsequently, reassess the health status of the person living with HIV to decide on the application of prophylactic treatment for opportunistic infections with Cotrimoxazole, prevention of tuberculosis with INH, and antiretroviral therapy according to the provisions of Article 9 of this Circular;

b) In cases where people living with HIV do not have opportunistic infections: prophylactically treating opportunistic infections with Cotrimoxazole, preventing tuberculosis with INH, and simultaneously administering antiretroviral therapy according to the provisions of Article 9 of this Circular.

3. Completing the outpatient medical record according to the model prescribed in Appendix No. 01 issued together with this Circular.

4. In cases where the condition of the person living with HIV exceeds the treatment capacity of the facility managing, treating, and caring for people living with HIV and those exposed to HIV (hereinafter referred to as the treatment facility), the patient must be transferred to a healthcare facility with sufficient treatment capacity.

Section 2

MANAGEMENT AND MONITORING OF TREATMENT FOR PEOPLE LIVING WITH HIV BEING MANAGED AT THE TREATMENT FACILITY

Article 7. Management Objectives

People living with HIV who have medical records at the treatment facility.

Article 8. Management and Monitoring of Treatment for People Living with HIV Who Do Not Meet the Criteria for Antiretroviral Therapy

1. Counseling on adherence to prophylaxis for opportunistic infections, prevention of tuberculosis, and the benefits of regular follow-up visits.

2. Assessing the health status of people living with HIV during follow-up visits:

a) For people living with HIV who come for follow-up visits according to scheduled appointments: conducting assessments according to the provisions of Clauses 2, 3, 4, 5, 6, and 7 of Article 5 of this Circular;

b) For people living with HIV who come for follow-up visits due to unusual clinical symptoms: based on the specific disease conditions of the person living with HIV, the treatment facility decides on appropriate measures.

3. Preventive treatment for tuberculosis when the person living with HIV meets the criteria.

4. Treating opportunistic infections and other pathological symptoms (if present).

5. Evaluating the criteria for antiretroviral therapy during all follow-up visits:

a) If the person living with HIV does not meet the criteria for treatment: continue managing and monitoring treatment according to the provisions of this Article;

b) If the person living with HIV meets the criteria for treatment: inform the person living with HIV that they meet the criteria for treatment and implement the provisions of Article 9 of this Circular.

6. Recording complete information about the person living with HIV in the Pre-Antiretroviral Therapy Registration Book according to the model prescribed in Appendix No. 02 issued together with this Circular.

7. Conducting CD4 testing periodically every six months or sooner depending on the specific condition of the patient.

8. Scheduling follow-up visits regularly: every three months.

9. In cases where the condition of the person living with HIV exceeds the treatment capacity of the treatment facility, the patient must be transferred to a healthcare facility with sufficient treatment capacity.

10. Issuing a Transfer Treatment Certificate according to the model prescribed in Appendix No. 03 issued together with this Circular for patients transferring to treatment at another treatment facility.

Article 9. Management and monitoring of treatment for HIV-infected individuals eligible for antiretroviral therapy

1. Treatment process with antiretroviral drugs:

a) Provide information on the antiretroviral drug regimen that the HIV-infected individual will use: drug name, dosage, method of administration, side effects, and management of side effects;

b) Advise on adherence to treatment and the necessity of support for treatment for HIV-infected individuals;

c) Assess the readiness of HIV-infected individuals to undergo antiretroviral therapy;

d) Supply antiretroviral drugs when the HIV-infected individual is ready for antiretroviral therapy and notify the HIV-infected individual about the schedule for drug supply as stipulated in Clause 4 of this Article;

đ) Notify the HIV-infected individual about the follow-up examination schedule:

- For children: Follow-up examinations every 1 to 3 months depending on age and health condition;

- For adults: Follow-up examinations monthly for the first six months after starting antiretroviral therapy, thereafter, based on the level of treatment response and adherence, follow-up examinations may be conducted every six months;

e) In cases where the health condition of the HIV-infected individual exceeds the treatment capacity of the healthcare facility, the patient must be transferred to a healthcare facility with sufficient treatment capacity;

g) Issue a transfer treatment referral form according to the model prescribed in Appendix No. 03 issued together with this Circular for cases where the patient transfers to another treatment facility;

h) Record complete information of the HIV-infected individual in the Antiretroviral Therapy Treatment Log according to the model prescribed in Appendix No. 04 issued together with this Circular.

2. Health status assessment and handling at follow-up examinations:

a) Clinical stage evaluation;

b) CD4 testing periodically every six months or sooner depending on the specific condition of the HIV-infected individual and conducting other follow-up tests as required by the antiretroviral drug regimen being used by the HIV-infected individual;

c) Detect and treat new opportunistic infections;

d) Detect and manage drug side effects;

đ) Evaluate and support adherence to treatment;

e) Screen and detect clinical failure, immunological failure, and risk factors for treatment failure in HIV-infected individuals who have been on first-line antiretroviral therapy for six months or more;

g) Post-examination handling:

- For HIV-infected individuals who respond well to the current antiretroviral drug regimen, continue with that regimen. Specifically for children, adjust the dosage and form of medication according to their weight and age;

- For HIV-infected individuals showing signs of treatment failure with the current regimen, reassess the clinical condition, CD4 test results, level of adherence to treatment, and conduct an HIV-1 viral load test during HIV/AIDS treatment to determine treatment failure and decide on switching to an appropriate regimen;

3. Supply of antiretroviral drugs:

a) For the initial drug supply: Guide HIV-infected individuals on how to use and store the medication, how to identify drug side effects, and manage side effects;

b) For subsequent drug supplies: Before supplying the drugs, assess drug side effects, screen for tuberculosis, and evaluate treatment adherence:

If the HIV-infected individual does not show any abnormal symptoms and has good adherence to treatment, continue supplying the drugs according to the current regimen;

If the HIV-infected individual shows clinical abnormalities or signs of non-adherence to treatment, healthcare staff must refer the HIV-infected individual to the treating physician;

c) Drug supply schedule: Monthly.

Section 3

MANAGEMENT AND MONITORING OF TREATMENT FOR HIV-INFECTED INDIVIDUALS TRANSFERRED FROM OTHER TREATMENT FACILITIES

Article 10. Subjects for Reception

People living with HIV who have registered for management and treatment at another healthcare facility.

Article 11. Reception Procedure

1. Receive the Transfer Treatment Form and send the Treatment Reception Feedback Form according to the model prescribed in Appendix No. 03 issued together with this Circular to the healthcare facility that referred the patient.

2. Complete administrative contents in the Outpatient Medical Record according to the model prescribed in Appendix No. 01 issued together with this Circular.

3. Based on the professional contents in the Transfer Treatment Form, the healthcare facility shall be responsible for implementing:

a) Assessing the health status of people living with HIV according to Articles 2, 3, 4, 5, and 6 of Clause 5 of this Circular or conducting consultations and referring people living with HIV to appropriate healthcare facilities;

b) Implementing management and monitoring of treatment according to the contents prescribed in Article 12 of this Circular.

Article 12. Contents of Management and Monitoring of Treatment for People Living with HIV Transferred from Another Healthcare Facility

1. For people living with HIV who do not meet the criteria for antiretroviral therapy: Implement management and monitoring of treatment according to the contents prescribed in Article 8 of this Circular.

2. For people living with HIV currently receiving antiretroviral therapy: Implement management and monitoring of treatment according to the contents prescribed in Clauses 2, 3, and 4 of Article 9 of this Circular.

Chapter III

MANAGEMENT AND MONITORING OF TREATMENT FOR PEOPLE EXPOSED TO HIV

Article 13. Subjects for Reception

1. Children born to HIV-infected mothers.

2. People exposed to HIV.

Article 14. Reception Procedure

1. For children born to HIV-infected mothers:

a) Advise on the necessity of care and monitoring of treatment for children born to HIV-infected mothers;

b) Complete the Outpatient Medical Record according to the model prescribed in Appendix No. 01 issued together with this Circular for cases where caregivers of children born to HIV-infected mothers agree to register for HIV/AIDS care and treatment for the child;

c) Implement management and monitoring of treatment according to Clause 1 of Article 15 of this Circular.

2. For people exposed to HIV:

a) Advise on the necessity of care and monitoring of post-exposure treatment;

b) Establish an exposure management file including:

- The Outpatient Medical Record according to the model prescribed in Appendix No. 01 issued together with this Circular;

- Copies of tests determining the HIV infection status of the person exposed and the source of exposure (if available);

- Other related documents (if available).

c) Implement management and monitoring of treatment according to Clause 2 of Article 15 of this Circular.

Article 15. Contents of Management and Monitoring of Treatment for People Exposed to HIV

1. For children born to HIV-infected mothers:

a) Assess overall condition, mental and physical development of the child;

b) Provide appropriate nutritional advice;

c) Prevent mother-to-child transmission of HIV using antiretroviral drugs according to the Guidelines for Diagnosis and Treatment of HIV/AIDS;

d) Prophylaxis against opportunistic infections with Cotrimoxazole when the child is 4 to 6 weeks old;

đ) Advise on adherence to treatment, monitoring drug side effects, and how to manage them;

e) Order HIV detection tests according to Decision No. 1053/QĐ-BYT dated April 2, 2010 of the Minister of Health on issuing Guidelines for HIV Detection Tests for Children Under 18 Months Old;

g) Closely monitor clinical progression to detect early signs of HIV infection in all visits;

h) Initiate antiretroviral treatment according to Article 9 of this Circular immediately when the child shows clinical signs of HIV infection or when the child's first molecular biology test result is positive or when the child's confirmatory HIV test is positive;

i) Fully record all information in the HIV Exposure Follow-up Log according to the model prescribed in Appendix No. 05 issued together with this Circular.

2. For people exposed to HIV:

a) Assess the risk of HIV exposure;

b) Determine the HIV status of the source of exposure;

c) Determine the HIV status of the person exposed;

d) Complete the HIV exposure management file;

đ) Post-exposure prophylaxis treatment according to the Guidelines for Diagnosis and Treatment of HIV/AIDS;

e) Fully record all information in the HIV Exposure Follow-up Log according to the model prescribed in Appendix No. 05 issued together with this Circular;

g) Manage and monitor people undergoing post-exposure prophylaxis treatment according to the Guidelines for Diagnosis and Treatment of HIV/AIDS:

- In cases where people exposed to HIV are confirmed to be infected with HIV, implement management and monitoring of treatment according to the provisions in Chapter II of this Circular;

- In cases where people exposed to HIV are confirmed not to be infected with HIV, provide counseling on HIV exposure and prevention of HIV exposure according to Circular No. 06/2012/TT-BYT dated April 30, 2012 of the Minister of Health on conditions for establishment and activities of organizations providing counseling on HIV/AIDS prevention and control.

Chapter IV

IMPLEMENTING PROVISIONS

Article 16. Effective Date

This Circular takes effect from December 15, 2013.

Decision No. 2051/QĐ-BYT dated June 9, 2006 of the Minister of Health on the HIV/AIDS Treatment Process Using Antiretroviral Drugs becomes invalid from the date this Circular takes effect.

Article 17. Reference Provisions

In cases where the referenced documents in this Circular are replaced or amended, apply the replacement or amendment documents.

Article 18. Responsibility for Implementation

1. The Director of the Department of HIV/AIDS Prevention and Control, the Director of the Department of Medical Examination and Treatment, and the Head of the Legal Affairs Department within their respective functions, tasks, and authorities shall be responsible for coordinating with relevant Departments, Bureaus, and General Departments to organize inspections and audits of the implementation of the provisions of this Circular nationwide.

2. The Director of the Provincial Health Department under the central city shall be responsible for organizing inspections and audits of the implementation of the provisions of this Circular within the managed area.

During the implementation process, if there are any difficulties, please promptly reflect them to the Ministry of Health (HIV/AIDS Prevention and Control Department) for study and resolution./.