MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

LETTER
March 17, 2004
№2510/2334-04-32

In order to inform medical workers and use materials in their work, the Ministry of Health of Russia sends a list of current regulatory and departmental documents, as well as comments on them on issues of providing medical care and social support for HIV-infected women during pregnancy and childbirth, infants with perinatal HIV exposure, HIV-infected children and their families.

At the same time, we ask you to inform the Department of Organization of Medical Assistance to Mothers and Children your proposals for further improvement of the regulatory framework in this area on the following issues:

• legislative and other regulatory documents adopted in your territory on this issue;
• a list of additional issues that require legislative and regulatory decisions at the federal and regional levels (specify separately) on the provision of medical care and social support to HIV-infected mothers and children.

Please send your proposals to the Office by 06/01/04 by fax of the Office 292-07-42 or by fax of the Ministry of Health of Russia 504-44-46, as well as by e-mail: [email protected]

Deputy Minister O. V. Sharapova

Normative legal framework for the prevention and control of HIV/AIDS in terms of prevention of transmission of HIV infection from mother to child, provision of medical care to HIV-infected pregnant women, mothers and children born of HIV-infected mothers

I. Regulatory documents (Federal laws, Decrees and orders of the President of the Russian Federation, orders and orders of the Government of the Russian Federation, orders and instructions of the Ministry of Health of Russia)

Federal Law "On the prevention of the spread in the Russian Federation of a disease caused by the human immunodeficiency virus (HIV infection)" dated March 30, 1995 No. 38-FZ (as amended on July 18, 1996 No. 112-FZ, 07.01.97 No. 8-FZ)

(extracts)

Article 4 State Guarantees (extract)

1. The state guarantees: (extraction)

• the availability of a medical examination to detect HIV infection (hereinafter referred to as medical examination), including anonymous, with preliminary and subsequent counseling and ensuring the safety of such a medical examination, both for the examined and for the person conducting the examination;
• free provision of all types of qualified and specialized medical care to HIV-infected citizens of the Russian Federation, free receipt of medicines for them during outpatient and inpatient treatment, as well as their free travel to and from the place of treatment within the Russian Federation.

2. Implementation of the said guarantees shall be entrusted to the federal executive authorities, executive authorities of the constituent entities of the Russian Federation and local self-government bodies in accordance with their competence.

Article 7. Medical examination (extraction)

3. A medical examination is carried out voluntarily, except for the cases provided for in Article 9 of this Federal Law, when such an examination is mandatory.

5. Medical examination of minors under the age of 14 years and persons recognized in the established manner as incapacitated may be carried out at the request or with the consent of their legal representatives, who have the right to be present during the medical examination.

6. Medical examination of citizens is carried out with preliminary and subsequent counseling on the prevention of HIV infection.

7. In institutions of the state and municipal health care systems, medical examination of citizens of the Russian Federation is carried out free of charge.

Article 9. Mandatory medical examination (extraction)

1. Donors of blood, biological fluids, organs and tissues are subject to mandatory medical examination.

Article 13. The right of an HIV-infected person to receive information about the results of a medical examination.

1. A person who has been diagnosed with HIV infection is notified by an employee of the institution that conducted the medical examination of the results of the examination and the need to take precautions to prevent the spread of HIV infection, about guarantees for the rights and freedoms of HIV-infected people, as well as about criminal liability for endangering or infecting another person.

2. In case of detection of HIV infection in minors under the age of 18, as well as in persons recognized in the prescribed manner as incapacitated, employees of the institutions specified in paragraph 1 of this article notify the parents or other legal representatives of these persons.

3. The procedure for notifying the persons specified in paragraphs one and two of this article about the detection of HIV infection in them is established by the relevant federal executive body.

Article 14. Rights of HIV-infected persons when providing them with medical care

HIV-infected people are provided on a general basis with all types of medical care according to clinical indications, while they enjoy all the rights provided for by the legislation of the Russian Federation on protecting the health of citizens.

Article 17

Dismissal from work, denial of employment, denial of admission to educational institutions and institutions providing medical care, as well as restriction of other rights and legitimate interests of HIV-positive people on the basis of their HIV infection, as well as restriction of housing and other rights and legitimate interests of family members of HIV-infected people, unless otherwise provided by this Federal Law.

Article 18. Rights of parents whose children are HIV-infected, as well as other legal representatives of HIV-infected minors

1. Parents whose children are HIV-infected, as well as other legal representatives of HIV-infected minors have the right to:

• joint stay with children under the age of 15 in a hospital of an institution providing medical care, with the payment of state social insurance benefits during this time;
• free travel of one of the parents or other legal representative of an HIV-infected minor under the age of 16, accompanied by him to the place of treatment and back;
• (currently, these benefits apply to parents until children with disabilities and people with disabilities from childhood reach the age of 18);
• maintaining continuous work experience for one of the parents or other legal representative of an HIV-infected minor under the age of 18 in case of dismissal to care for him and subject to employment before the minor reaches the specified age; the time of caring for an HIV-infected minor is included in the total length of service;
• extraordinary provision of living quarters in the houses of the state, municipal or public housing stock if they need to improve their living conditions and if an HIV-infected minor under the age of 18 lives with them.

2. Laws and other regulatory legal acts of the constituent entities of the Russian Federation may also establish other measures of social protection for HIV-infected people and members of their families.

Article 19. Social protection of HIV-infected minors

HIV-infected minors under the age of 18 are assigned a social pension, allowance and benefits established for disabled children by the legislation of the Russian Federation, and persons caring for HIV-infected minors are paid an allowance for caring for a disabled child in accordance with the procedure established by the legislation of the Russian Federation.

Article 22. Benefits in the field of labor

Employees of enterprises, institutions and organizations of the state and municipal healthcare systems that diagnose and treat HIV-infected people, as well as persons whose work is related to materials containing the human immunodeficiency virus, are paid a bonus to their official salary, reduced working hours and additional leave for work in especially dangerous working conditions. The procedure for granting these benefits is determined by the Government of the Russian Federation.

Comments

The specified law establishes:

• state guarantees: availability of a medical examination to detect HIV infection, free provision of all types of medical care to HIV-infected people and free provision of them medicines, free travel to and from the place of treatment, etc. (art. 4);
• the procedure for medical examination of minors (Article 7 and the procedure for notifying parents or legal representatives of the child to receive information in case of HIV infection in a minor under the age of 18 years (Article 13);
• social protection of HIV-infected people, including minors, and members of their families:
  • providing an HIV-infected minor under the age of 18 with a social pension, allowances and benefits established for disabled children (Article 19);
  • a ban on restricting the rights of HIV-infected people in admission to educational institutions and institutions providing medical care (Article 17);
  • the rights of parents or other legal representatives of HIV-infected children - the preservation of continuous work experience for one of the parents in the case of caring for an HIV-infected minor under the age of 18, free travel of one of the parents when accompanied by an HIV-infected child under the age of 16 treatment (currently up to 18 years), joint stay with children under the age of 15 in a hospital, extraordinary receipt of housing when living in the family of an HIV-infected child under the age of 18 (Article 18), mandatory medical examination for HIV pregnant women as potential donors of blood and biological tissues (placenta) (Article 9.1).

By decrees of the Government of the Russian Federation, federal targeted programs aimed at preventing the spread of HIV in the country were adopted and implemented:

— Federal target program for 1993-1995 to prevent the spread of AIDS in the Russian Federation (AntiAIDS).

In terms of implementing this program, an annual health camp for HIV-infected children was organized on the basis of the Republican Clinical Infectious Diseases Hospital of the Ministry of Health of Russia (St. Petersburg, Ust-Izhora); quarterly provision of social and financial support to families with HIV-infected children was envisaged and carried out.

— The federal target program for the prevention of the spread in the Russian Federation of the disease caused by the human immunodeficiency virus (HIV infection) for 1996-1997 and for the period up to 2000 “Anti-HIV/AIDS”, approved by the Decree of the Government of the Russian Federation of May 1, 1996 No. 540, extended for 2001. It is a logical continuation of the previous program.

- Currently, the Federal Target Program "Prevention and control of diseases of a social nature (2002-2006)" is being implemented, one of the subprograms of which is the subprogram "Urgent measures to prevent the spread in the Russian Federation of a disease caused by the human immunodeficiency virus ("Anti- HIV AIDS")".

The FTP was approved by Decree of the Government of the Russian Federation No. 790 dated November 13, 2001.

69 territories of Russia supported the expediency of the federal targeted program and declared that there were programs in the regions for the prevention of HIV infection (as of the beginning of 2003).

Fundamentals of the legislation of the Russian Federation on the protection of the health of citizens dated July 22, 1993 No. 5487-1 (as amended on March 2, 1998, December 20, 99, December 2, 2000, January 10, 2003, February 27, 2003, June 30, 2003 .)

(extracts)

Article 27. Rights of the disabled

On the social protection of disabled people in the Russian Federation (see Federal Law No. 181-FZ of November 24, 1995).

Disabled people, including disabled children and those disabled since childhood, have the right to medical and social assistance, rehabilitation, provision of medicines, prostheses, prosthetic and orthopedic products, vehicles on preferential terms, as well as to vocational training and retraining.

Disabled persons with disabilities have the right to free medical and social assistance in institutions of the state or municipal health care system, to home care, and in case of inability to meet the basic needs of life, to maintenance in institutions of the social protection system of the population.

The procedure for providing disabled people with medical and social assistance and the list of benefits for them are determined by the legislation of the Russian Federation, the republics within the Russian Federation. State authorities of the autonomous region, autonomous districts, territories, regions, cities of Moscow and St. Petersburg, within their competence, may establish additional benefits for disabled people.

To care for children with disabilities and people with disabilities from childhood until they reach the age of 18, one of the working parents or persons replacing them is provided with four additional paid days off per month, which can be used by one of the named persons or divided by them among themselves in their own way. discretion.

Comments

Given that HIV-infected children are recognized as disabled since childhood, working parents are given four additional paid days off per month to care for them up to the age of 18.

The procedure for providing and paying for additional days off for caring for disabled children was approved by a joint resolution of the Ministry of Labor and Social Development of the Russian Federation and the Social Insurance Fund of the Russian Federation dated April 4, 2000 No. 26/34 “On approval of the clarification “On the procedure for providing and paying additional weekends per month for one of the working parents (guardian, trustee) to care for disabled children”, registered in the Ministry of Justice of Russia on May 29, 2000 No. 2238.

Article 36. Artificial termination of pregnancy (extraction)

Every woman has the right to independently decide the issue of motherhood.

Comments

When pregnancy occurs in an HIV-infected woman, only the pregnant woman (after post-test counseling) decides whether to further prolong the pregnancy or terminate it.

Article 61. Medical secret

Information about the fact of applying for medical assistance, the state of health of a citizen, the diagnosis of his disease and other information obtained during his examination and treatment, constitute a medical secret. The citizen must be confirmed the guarantee of the confidentiality of the information transmitted by him.

It is not allowed to disclose information constituting a medical secret by persons to whom they became known during training, performance of professional, official and other duties, except for the cases established by parts three and four of this article.

With the consent of a citizen or his legal representative, it is allowed to transfer information constituting a medical secret to other citizens, including officials, in the interests of examining and treating a patient, for conducting scientific research, publishing in scientific literature, using this information in the educational process and in other purposes.

Providing information constituting a medical secret without the consent of a citizen or his legal representative is allowed:

1) for the purpose of examination and treatment of a citizen who, due to his condition, is unable to express his will;

2) when there is a threat of the spread of infectious diseases, mass poisoning and injury;

3) at the request of the bodies of inquiry and investigation, the prosecutor and the court in connection with the conduct of an investigation or judicial proceedings;

4) in the case of providing assistance to a minor under the age of 15 to inform his parents or legal representatives;

5) if there are grounds for believing that harm to the health of a citizen was caused as a result of unlawful actions.

Persons who, in accordance with the procedure established by law, were given information constituting a medical secret, along with medical and pharmaceutical workers, taking into account the damage caused to a citizen, bear disciplinary, administrative or criminal liability for disclosure of medical secrets in accordance with the legislation of the Russian Federation, the republics within the Russian Federation.

Comments

According to the resolution of the Social Harmonization Fund of the Russian Federation dated May 17, 1995 No. 25, when issuing documents certifying the temporary disability of citizens and other medical documents, special seals or stamps of the institution, organizations are used without indicating its profile.

Nutrition for children born to HIV-infected mothers is carried out on the general basis for providing nutrition to children under two years of age in accordance with:

• by order of the Ministry of Health of Russia dated September 25, 1992. No. 256 "On urgent measures to improve the situation of children in the Russian Federation" (extract);
• the appendix "List of products and calculation of the approximate need for them in children of the 1st and 2nd years of life" to the specified order defines a list of food products (adapted powdered milk formulas - only for children of the first year of life; dry cereals, milk, kefir, cottage cheese - for children of the first and second year of life) and the need for them per child of the first and second year of life per year (kg, l);
• Decree of the Government of the Russian Federation of August 13, 1997 No. 1005 “On streamlining the free provision of children in the first - second year of life with special dairy products baby food».

“In order to strengthen the targeting of social support for families with children of the first and second years of life, and streamline the free provision of children in the first and second years of life with special dairy products for baby food, the Government of the Russian Federation decides:
The executive authorities of the constituent entities of the Russian Federation should consider the issue of establishing the conditions and procedure for free provision of children in the first and second years of life with special dairy products for baby food, taking into account the average per capita income of a family with children and its compliance with the subsistence minimum established in the territory of the constituent entity of the Russian Federation.

Order of the Ministry of Health of the USSR dated May 14, 1991 No. 134 “On the procedure for assigning and paying benefits for children under the age of 16 infected with the human immunodeficiency virus or AIDS patients”

(extract)

This order of the USSR Ministry of Health announces the Decree of the USSR State Committee for Labor and Social Affairs of December 29, 1990 No. 465 “On the procedure for assigning and paying benefits for children under the age of 16 infected with the immunodeficiency virus or AIDS patients” (the specified resolution of the USSR State Committee for Labor was adopted in accordance with with the Decree of the Council of Ministers of the USSR of September 18, 1990 No. 947 "On measures to ensure the social protection of persons infected with the human immunodeficiency virus or AIDS patients").

In accordance with the Decree of the Council of Ministers of the USSR of September 18, 1990 No. 947, children under the age of 16 infected with the human immunodeficiency virus or suffering from AIDS are provided with a state allowance in the amount of the minimum wage. The appointment and payment of state benefits to these children is carried out in the same manner as the appointment and payment of social pensions for disabled children under the age of 16 in accordance with the USSR law "On pensions for citizens in the USSR."

This allowance is assigned on the basis of a medical report issued by health authorities in the manner established by order of the USSR Ministry of Health of December 14, 1979 No. 1265 for children with disabilities from childhood under the age of 16 years.

ConsultantPlus: note.
Order of the Ministry of Health of the USSR dated 12/14/1979 No. 1265 is not applied on the territory of the Russian Federation in connection with the publication of the Order of the Ministry of Health of the Russian Federation dated 12/23/2002 No. 398.

Order of the Ministry of Health of Russia dated December 28, 1993 No. 302 "On approval of the list of medical indications for artificial termination of pregnancy"

(extract)

Comments:

The fundamentals of legislation on the protection of the health of citizens (Article 36) provide that "Every woman has the right to independently decide on the issue of motherhood."

Artificial termination of pregnancy at the request of a woman (artificial abortion), including those infected with HIV, is carried out up to 12 weeks of pregnancy.

Artificial termination of pregnancy for medical reasons is carried out only with the consent of women.

Order of the Ministry of Health and Medical Industry of Russia dated August 16, 1994 No. 170 "On measures to improve the prevention and treatment of HIV infection in the Russian Federation"

(extract)

Vaccination of children with HIV infection is carried out in accordance with the provisions set out in section 2.3. "Vaccinal prophylaxis in patients with HIV infection" (Appendix 1 to the order of the Ministry of Health and Medical Industry of Russia No. 170 dated September 16, 1994 "Methodological guidelines for the organization of medical and diagnostic care and dispensary observation of patients with HIV infection and AIDS", part 2. "Dispensary observation" , section 2.3.).

Particular attention in this section is given to the issue of vaccination of HIV-infected children.

It is indicated that “Vaccination is carried out under the supervision of pediatricians from the AIDS Control Centers. In the post-vaccination period, the child is patronized on the 3rd-4th and 10-11th days ... "

The main principles of immunization of HIV-infected children are defined (eight principles):

• recommended the maximum possible preservation of the vaccination calendar adopted in our country;
• immunization is carried out depending on the stage of the disease;
• the BCG vaccine is excluded from the vaccination schedule, etc.

Order of the Ministry of Health and Medical Industry of Russia dated September 30, 1995 No. 295 “On the Enactment of the Rules for Mandatory Medical Examination for HIV and the List of Employees of Certain Professions, Industries, Enterprises, Institutions and Organizations Who Undergo Mandatory Medical Examination for HIV”

(extract)

"Pregnant women - in case of sampling of abortion and placental blood for further use as raw materials for the production of immunobiological preparations" are subject to mandatory medical examination for HIV (paragraph 3 of Appendix 3 "List of indications for testing for HIV / AIDS in order to improve the quality of diagnosis of HIV infection ").

Order of the Ministry of Health of Russia dated November 26, 1997 No. 345 “On improving measures to prevent nosocomial infections in obstetric hospitals”

(extract)

The order presents the mode of operation during the delivery of HIV-infected pregnant women and the safety measures for medical personnel when caring for an HIV-infected woman in labor, a puerperal woman and her newborn, as well as in case of emergencies.

Issues of HIV infection in obstetrics are reflected in two appendices to the order:

• in Annex 1 "Instructions for the organization and implementation of preventive and anti-epidemic measures in obstetric hospitals" (paragraphs 2.1., 4.8.4., 4.8.5., 4.8.6., 4.8.7., 4.8.8. - further revised , see order of the Ministry of Health of Russia dated 11/24/98 No. 338, 4.8.9.);
• and in Annex 4 "Instructions for the admission and transfer of pregnant women, women in labor and puerperas to the observational department of an obstetric hospital" (paragraphs 1.3., 1.9.).

Annex 1 to the order "Instructions for the organization and implementation of preventive and anti-epidemic measures in obstetric hospitals" reflects the following positions:

• section 2 "Procedure for hiring". Paragraph 1 states that medical workers entering obstetric hospitals undergo a medical examination by doctors in accordance with the established list of specialists and the necessary examinations, which include a blood test for HIV (hereinafter - twice a year);
• section 4 "Rules for the maintenance of structural units of obstetric hospitals", subsection 4.8. "Observation Department".

The following paragraphs of this subsection state the following:

• paragraph 4.8.4.: “Children with HIV-infected pregnant women in large cities are delivered in a specialized maternity ward. In its absence, pregnant women are sent to a maternity hospital (department) of a general type. Delivery is performed in the observational department in a specially designated ward, where the mother and child stay until discharge. If surgical intervention is necessary, the operating room of the observational department is used.
• clause 4.8.5.: “Anti-epidemic measures in departments (wards) for HIV-infected patients and their newborns should be carried out according to the type of regimen of departments for patients with viral hepatitis with a parenteral transmission mechanism”,
• clause 4.8.6.: “During manipulations (operations) in HIV-infected patients, instruments and other single-use medical devices are used. In their absence, reusable instruments are subject to disinfection according to the regime established for the prevention of parenteral hepatitis, followed by sterilization,
• paragraph 4.8.7.: “Medical personnel who deliver and care for an HIV-infected puerperal woman and a newborn in the postpartum department must observe personal safety measures (work with gloves during all manipulations).

If there are microtraumas on the skin of the hands, before starting work, the medical worker must treat the damaged surface with 70% alcohol or alcohol tincture iodine 5% and “glue” with adhesive tape or some kind of film-forming preparation (three layers of “Lifuzol” or others).

It is necessary to exercise maximum caution when working with piercing, cutting tools, needles. Especially carefully, precautions should be observed if the puerperal clinic has an acute infection, hemoptysis, open forms tuberculosis, acute pneumocystis pneumonia, etc. Sanitary and hygienic measures, current and final disinfection should be carried out especially carefully.

- paragraph 4.8.8. This paragraph indicates the algorithm for carrying out measures aimed at reducing the likelihood of infection of medical personnel in the event of emergencies.

In connection with the release of new regulatory documents of the Ministry of Health of Russia regulating the sanitary and anti-epidemic rules, clause 4.8.8. Order No. 345 was revised and set out in new edition in the order of the Ministry of Health of Russia of November 24, 1998 No. 338 “On amendments and additions to the order of the Ministry of Health of Russia of November 26, 1997 No. 345 “On improving measures to prevent nosocomial infections in obstetric hospitals”

- Clause 4.8.9.: Medical personnel taking childbirth and caring for an HIV-infected puerperal mother and newborn in the postpartum period are entitled to receive bonuses for working in hazardous working conditions for health and life in accordance with existing regulations.

Comments

Thus, in subsection 4.8. The “observational department” of the said Instruction defines positions on compliance with the anti-epidemic regimen when delivering an HIV-infected woman and caring for her in the postpartum period and her newborn, as well as the right to receive allowances for medical personnel for working with an HIV-infected pregnant woman, a woman in labor, a puerperal and newborns.

Annex 4 to the order "Instructions for the admission and transfer of pregnant women, women in childbirth and puerperas to the observational department of an obstetric hospital":

• paragraph 1 defines the indications for hospitalization of pregnant women and women in labor in the observational department of an obstetric hospital.

These include patients with an infectious pathology (clause 1.3.), including those with "infections with a high risk of intrauterine and / or intranatal infection of the fetus and a high epidemiological risk of infection of medical personnel" (HIV infection, syphilis, viral hepatitis B, C , D, gonorrhea), as well as "unexamined and in the absence of medical documentation" (paragraph 1.9.).

Order of the Ministry of Health of Russia dated November 24, 1998 No. 338 “On amendments and additions to the order of the Ministry of Health of Russia dated November 26, 1997 No. 345 “On improving measures to prevent nosocomial infections in obstetric hospitals”

(extract)

The order introduced amendments and additions to the order of the Ministry of Health of Russia dated November 26, 1996 No. 345 (Appendix 1 "Instructions for the organization and implementation of preventive and anti-epidemic measures in obstetric hospitals"), in particular, paragraph 4.8.8 is set out in a new edition. Order No. 345 on the issue of a set of measures in emergency situations:

“The risk of contracting HIV infection arises in emergency situations (cuts and pricks with instruments contaminated with blood and other biological fluids from HIV-infected patients, as well as the ingress of blood and other biological fluids on the mucous membranes of the oropharynx, nose and eyes).

To reduce the likelihood of infection in such cases, it is recommended:

• when preparing for manipulation in a patient with HIV infection, make sure the integrity of the emergency kit;
• perform manipulations in the presence of a second specialist, who, in the event of a rupture of gloves or a cut, can continue its implementation;
• treat the skin of the nail phalanges with iodine before putting on gloves;
• if an infected material gets on the mucous membranes of the oropharynx and nose, they are immediately treated with a 0.05% solution of potassium permanganate, the mouth and throat are rinsed with 70% alcohol or a 0.05% solution of potassium permanganate;
• for the treatment of the mucous membrane of the eyes, a solution of potassium permanganate 1: 10000 is used, the solution is prepared ex tempore, for which it is necessary to have a sample of the drug 100 mg (0.1 g), which is dissolved in 1000 ml (1 liter) of distilled water;
• for injections and cuts, wash gloved hands with running water and soap, remove gloves, squeeze blood out of the wound, wash hands with soap and treat the wound with 5% iodine solution, do not rub;
• in case of accidents, prophylactic administration of thymoside (azidothymidine) 800 mg/day is recommended. within 30 days, the drug should be started no later than 24 hours after the accident;
• laboratory examination of persons in an emergency situation is carried out after 3, 6 and 12 months.

Order of the Ministry of Health of Russia dated April 19, 1999 No. 133 "On the Scientific and Practical Center for the Prevention and Treatment of HIV Infection in Pregnant Women and Children"

The order approved the creation of functional basis scientific and practical Center for the Prevention and Treatment of HIV Infection in Pregnant Women and Children on the basis of the Republican Infectious Diseases Hospital of the Ministry of Health of Russia (St. Petersburg, Ust-Izhora settlement) and regulations on its work.

A medical institution has been identified, which is entrusted with the provision of medical and advisory assistance to HIV-infected pregnant women and children, the training of personnel and scientific and methodological materials on this issue. The functions of scientific management of the work of the Center are assigned to the Department of Infectious Diseases with the course of laboratory diagnostics of AIDS of the St. Petersburg Medical Academy of Postgraduate Education.

Order of the Ministry of Health of Russia dated February 10, 2003 No. 50 "On the improvement of obstetric and gynecological care in outpatient clinics"

The order states the need for joint monitoring of HIV-infected pregnant women by obstetrician-gynecologists and infectious disease specialists. The "Scheme of dynamic monitoring of pregnant women and puerperas" includes a double examination of pregnant women for HIV.

Order of the Ministry of Health of Russia dated June 3, 2003 No. 229 “On the Unified Nomenclature of State and Municipal Healthcare Institutions”, registered with the Ministry of Justice of Russia, registration No. 4828 dated June 25, 2003

(extract)

An annex to the order approved the Unified nomenclature of state and municipal health care institutions, and a specialized Children's Home for HIV-infected children was introduced into the nomenclature of health care institutions.

In accordance with the Unified nomenclature for the section “1. Treatment-and-prophylactic institutions” include:

1.5. Centers including:

• on the prevention and control of AIDS and infectious diseases;
• district for the prevention and control of AIDS and infectious diseases (federal districts);

1.7. Institutions for the protection of motherhood and childhood, which include:

1.7.7. Children's home;

1.7.8. Specialized children's home, including:

• for HIV-infected people.

Children's homes, including those specialized for HIV-infected children, are medical and preventive institutions that are created to provide medical, pedagogical and social assistance to orphans and children left without parental care, they bring up children from birth to 3- x years (in some conditions - up to 4 years).

By order, specialized orphanages for HIV-infected children were included in the Unified Nomenclature of State and Municipal Health Institutions. The need to open these institutions is explained by a significant increase in the number of births by HIV-infected women and the number of abandoned children born by them (75 cases - 2000, 157 cases - 2001, 262 cases - 2002), which annually accounts for 8-10% of the number of children born alive with perinatal HIV contact.

Children's homes for HIV-infected children provide for the stay of HIV-infected children and children born to HIV-infected mothers (children with perinatal HIV contact) until they are removed from dispensary observation due to the absence of clinical manifestations and negative results of laboratory diagnostics.

Order of the Ministry of Health of Russia dated 09.06.2003 No. 235 "On the establishment of the Coordinating Council of the Ministry of Health of Russia for the prevention of mother-to-child transmission of HIV infection in the Russian Federation"

In order to coordinate activities on the prevention of mother-to-child transmission of HIV infection, as well as to increase the efficiency of the implementation of international projects and programs in this area, the Coordinating Council of the Russian Ministry of Health for the prevention of mother-to-child transmission of HIV infection has been established. The composition of the Coordinating Council and the Regulations on the Coordinating Council were approved.

Organizers of healthcare, leading specialists of the country in this field, as well as representatives of international organizations (UNAIDS, UNICEF, UNFPA, WHO, etc.) and funds working in the Russian Federation in the field of HIV/AIDS prevention are involved in the work of the Coordinating Council.

Order of the Ministry of Health of Russia dated 28.01.2004 No. 25 "On introducing additions and changes to the order of the Ministry of Health of Russia dated 09.06.2003 No. 235"

In amendment to the order of the Ministry of Health of Russia dated 09.06.2003 No. 235 "On the establishment of the Coordinating Council of the Ministry of Health of Russia for the prevention of mother-to-child transmission of HIV infection in the Russian Federation."

In order to coordinate work on the HIV/AIDS problem with interested ministries and departments, representatives of the Russian Ministry of Labor and the Russian Ministry of Education have been included in the Coordinating Council of the Russian Ministry of Health.

Order of the Ministry of Health of Russia dated September 16, 2003 No. 442 “On approval of registration forms for registering children born to HIV-infected mothers”

(extract)

The order was issued with the aim of organizing monitoring of children born to HIV-infected mothers, analyzing and assessing the situation of HIV infection among pregnant women and children, and improving the diagnosis and treatment of HIV-infected children.

The annexes to the order approved three accounting forms and instructions for filling them out:

- Notice of a newborn born to an HIV-infected mother (registration form No. 309 / y) (Appendix No. 1 to the order) and Instructions for filling out the registration form No. 309 / y (Appendix No. 2 to the order). The notice provides for and fills in items reflecting the ways of infection of the mother, perinatal prophylaxis during pregnancy and childbirth, the time and method of delivery, etc., which will make it possible to predict the condition of the child and the likelihood of infection by the mother.

The notification is filled out by obstetrician-gynecologists of the healthcare institution where the birth took place, for each child (born alive or dead) born to an HIV-infected mother, and sent to the territorial center for the prevention and control of AIDS within 10 days from the date of birth of the child; then the territorial center sends the information to the Scientific and Practical Center for the Prevention and Treatment of HIV Infection in Pregnant Women and Children of the Russian Ministry of Health.

- Report on the removal from dispensary observation of a child born to an HIV-infected mother (registration form No. 310 / y) (Appendix No. 3 to the order) and Instructions for filling out the registration form No. 310 / y (Appendix No. 4 to the order).

The report is sent by specialists of the territorial centers for the prevention and control of AIDS after the child is removed from dispensary observation due to the absence of clinical symptoms and negative results of laboratory diagnostics.

- Report on the confirmation of the diagnosis in a child born to an HIV-infected mother (registration form No. 311 / y) (Appendix No. 5 to the order) and Instructions for filling out the registration form No. 311 / y (Appendix No. 6 to the order).

The report is sent by specialists of the territorial centers for the prevention and control of AIDS when the diagnosis of HIV infection is confirmed in the child, then every six months.

All information is sent to the Scientific and Practical Center for the Prevention and Treatment of HIV Infection in Pregnant Women and Children of the Ministry of Health of Russia (Republican Clinical Hospital of the Ministry of Health of the Russian Federation, St. Petersburg, Ust-Izhora), where a database will be formed for each child, having perinatal contact for HIV infection, and an HIV-infected child.

The introduction of this order into healthcare practice will ensure monitoring of children born to HIV-infected mothers, and is aimed at the timely adoption of specific organizational and treatment and diagnostic measures.

Order of the Ministry of Health of Russia dated 12/19/2003 No. 606 "On approval of the Instructions for the prevention of mother-to-child transmission of HIV infection and the sample of informed consent for HIV chemoprophylaxis", registered by the Ministry of Justice of Russia on 01/22/2004, registration No. 5468

The order was prepared with the aim of strengthening measures to prevent the transmission of HIV infection from mother to child. The Order approved the “Instructions for Preventing Mother-to-Child Transmission of HIV During Pregnancy, Childbirth and the Newborn Period” (Appendix 1) and the sample “Informed Consent for Chemoprophylaxis of Mother-to-Child Transmission of HIV During Pregnancy, Childbirth and Newborn” (Appendix 2).

The Instructions for Preventing the Transmission of HIV Infection reflect:

• drugs used and possible complications when using them;
• features of dispensary observation and delivery of pregnant women with HIV infection;
• chemoprophylaxis of mother-to-child transmission of HIV during pregnancy (applied regimens, efficacy evaluation, follow-up routine examinations, etc.), and during childbirth, as well as to a newborn child ( optimal time the beginning of chemoprophylaxis, chemoprophylaxis according to epidemiological indications, etc.);
• features of antiretroviral therapy in pregnant women, etc.

Order of the Ministry of Health of Russia dated January 19, 2004 No. 9 “On approval of the temporary registration form No. 313 / y “Notification of the termination of pregnancy in an HIV-infected woman”

The purpose of this order is to organize and conduct monitoring after the completion of pregnancy (delivery, abortion, ectopic pregnancy) in an HIV-infected woman, which will contribute to the analysis and assessment of the situation of the reproductive behavior of HIV-infected women, and is also aimed at developing measures to prevent transmission HIV infection from mother to child. The specified accounting form No. 313-u and instructions for filling it out were put into effect for a period of 1 year from February 1, 2004.

Decree of the Chief State Sanitary Doctor of the Russian Federation dated January 14, 2004 No. 2 "On the activation of measures aimed at counteracting the spread of HIV infection in the Russian Federation"

(extract)

The resolution states that “In the total structure of HIV-infected women, the proportion of women of childbearing age has increased to 35%, more than 6,300 children were born from HIV-infected mothers, of which more than 50% have been in the last two years. At the same time, full-scale medical prevention of HIV transmission from mother to child, as well as social support for families where mother and child are infected with HIV, is carried out in insufficient volume. The issues of organizing the maintenance of "refusal" children born by HIV-infected mothers are being slowly resolved.

It is recommended that the executive authorities of the constituent entities of the Russian Federation and local self-government provide for the allocation of the necessary funds for the purchase of test systems for the diagnosis of HIV infection, consider the issue of allocating funds for antiretroviral therapy to all HIV/AIDS patients who need it from the budgets of various levels, and adopt measures to address issues related to the organization of the maintenance of abandoned children born to HIV-infected mothers.

Needed:

• development of a network of pre-test counseling during examination for HIV infection with the involvement of all medical institutions in this work;
• intensifying educational and informational work in risk groups to promote responsible motherhood, ensuring the involvement of antenatal clinics, narcological dispensaries and centers for hygiene education and upbringing of the population in this work;
• tightening state sanitary and epidemiological supervision over compliance with the sanitary and anti-epidemic regime in maternity hospitals and departments, children's hospitals, orphanages in which there are children born to HIV-infected mothers.

The instruction on the procedure for issuing documents certifying temporary disability of citizens was approved by order of the Ministry of Health and Medical Industry of the Russian Federation dated 10/19/94 No. 206 and the resolution of the Social Insurance Fund of the Russian Federation dated 10/19/1994 No. 21 (as amended on 06/25/1996), registered by the Ministry of Justice of Russia on 28.10.94, registration No. 713 and 09.10.96., registration No. 1174

(extract)

Section 5. "The procedure for issuing a certificate of incapacity for work to care for a sick family member, a healthy child and a disabled child." Clause 5.2.4. of this section, it is stipulated that for children under 15 years of age infected with the human immunodeficiency virus, suffering from severe blood diseases, malignant neoplasms, burns, a disability certificate for caring for a child for the period of inpatient treatment is issued for the entire period of stay in the hospital.

The documents

On the approval of SanPin 3.1.5 2826-10 "Prevention of HIV infection"

On approval of SP 3.1.5.2826-10 "Prevention of HIV infection"

In accordance with the Federal Law of March 30, 1999 No. 52-FZ “On the sanitary and epidemiological well-being of the population” (Collected Legislation of the Russian Federation, 1999, No. 14, Art. 1650; 2002, No. 1 (part 1), Art. 2; 2003, No. 2, article 167; No. 27 (part 1), article 2700; 2004, No. 35, article 3607; 2005, No. 19, article 1752; 2006, No. 1, article 10, No. 52 (Part 1) Article 5498; 2007 No. 1 (Part 1) Article 21; No. 1 (Part 1) Article 29; No. 27, Article 3213; No. 46, Article 5554; No. 49, Article 6070; 2008, No. 24, article 2801; No. 29 (part 1), article 3418; No. 30 (part 2), article 3616; No. 44, article 4984; No. 52 (part 1) , article 6223; 2009, No. 1, article 17; 2010, No. 40, article 4969) and Decree of the Government of the Russian Federation dated July 24, 2000 No. 554 “On approval of the Regulations on the state sanitary and epidemiological service of the Russian Federation and the Regulations on the state sanitary and epidemiological regulation” (Sobraniye zakonodatelstva Rossiyskoy Federatsii, 2000, No. 31, Art. 3295, 2004, No. 8, Art. 663; No. 47, Art. 4666; 2005, No. 39, Art. 3953) in l i yu:

Approve the sanitary and epidemiological rules SP 3.1.5.2826-10 "Prevention of HIV infection" (Appendix).

G.G. Onishchenko

Application

APPROVED
Decree of the Chief State Sanitary Doctor of the Russian Federation
from 11.01. 2011 No. 1

Prevention of HIV infection

Sanitary and epidemiological rules
SP 3.1.5. 2826-10

8.4. Prevention of HIV infection during transfusion of donor blood and its components, organ and tissue transplantation and artificial insemination

8.4.1. Prevention of post-transfusion HIV infection, HIV infection during organ and tissue transplantation and artificial insemination includes measures to ensure safety during the collection, procurement, storage of donated blood and its components, organs and tissues, as well as when using donor materials.

8.4.2. Preparation of donor blood and its components, organs and tissues.

8.4.2.1. Donors of blood, blood components, organs and tissues (including sperm) are allowed to take donor material after studying the documents and the results of a medical examination confirming the possibility of donation and its safety for medical use.

8.4.2.2. When carrying out activities to promote blood plasma donation, it is necessary to provide explanations about the need to re-examine the donor 6 months after donation.

8.4.2.3. The safety of donor blood, its components, donor organs and tissues is confirmed by the negative results of a laboratory study of donor blood samples taken during each collection of donor material for the presence of pathogens of bloodborne infections, including HIV, using immunological and molecular biological methods.

8.4.2.4. The selection of donor blood samples for the determination of markers of bloodborne infections is carried out during the procedure of donating blood and blood components directly from the system with blood (without violating the integrity of the system) or a special satellite container for samples included in this system into vacuum-containing (vacuum-forming) disposable test tubes corresponding to the applied research methods. When collecting organs and tissues (including sperm), the selection of blood samples from donors for the determination of markers of hemotransmissible infections is carried out in parallel with the procedure for collecting donor material (with each donation of donor material).

8.4.2.5. When examining a blood sample of a donor, the presence of antibodies to HIV-1, 2 and the HIV p24 antigen are simultaneously determined. The first immunological study (ELISA) is carried out in a single setting. Upon receipt of a positive result of the analysis, the corresponding study (ELISA) is repeated twice using the reagents used in the first setting. If at least one positive result is obtained during repeated testing for HIV markers, the donor material is disposed of, the sample is sent for a reference study.

8.4.2.6. For re-analysis of seropositive blood samples, it is prohibited to use test systems with lower sensitivity and specificity, as well as test systems or methods of a lower generation than those used in the initial analysis.

8.4.2.7. Molecular biological studies (PCR, NAT) are carried out in addition to mandatory immunological studies (ELISA) for markers of bloodborne infections in accordance with the requirements of regulatory documentation and are of auxiliary importance.

8.4.2.8. The first molecular biological study is carried out in a single setting. Upon receipt of a positive test result, the corresponding study is repeated twice using the reagents used in the first setting. If at least one positive result is obtained during repeated testing, the donor blood sample is recognized as positive, the donor material is disposed of.

8.4.2.9. Health care facilities that procure donated blood and blood components are required to develop a system of good manufacturing practices that guarantee the quality, efficacy and safety of blood components, including the use of modern methods for the detection of HIV-1,2 and viral hepatitis markers and participation in an external quality control system.

8.4.2.10. Donor blood and its components are transferred to medical institutions for transfusion only after a repeated (at least 6 months) examination of the donor for the presence of markers of HIV-1,2 viruses and other bloodborne infections to exclude the possibility of not detecting infection during the seronegative window (quarantine) . Quarantinization of fresh frozen plasma is carried out for a period of at least 180 days from the moment of freezing at a temperature below minus 25°C. Upon expiration of the quarantine period for fresh frozen plasma, a second examination of the donor's health condition and a laboratory study of the donor's blood are carried out in order to exclude the presence of pathogens of bloodborne infections in it.

8.4.2.11. Blood components with a short shelf life (up to 1 month) should be taken from staff (repeated) donors and used within the shelf life. Their safety should be additionally confirmed by PCR and other methods of NAT technology. In this case, blood plasma (serum) from the same and the next donation is used as the object of research.

8.4.2.12. As an additional measure that increases the viral safety of blood and its components without replacing them, it is allowed to use methods of inactivation of pathogenic biological agents.

8.4.2.13. Non-safety or unused donated blood and blood components are isolated and disposed of, including disinfection with disinfectant solutions or the use of physical methods of disinfection using equipment authorized for this purpose in the established manner, as well as disposal of the resulting waste.

8.4.2.14. Data on donors of blood and its components, procedures and operations performed at the stages of procurement, processing, storage of donor blood and its components, as well as on the results of the study of donor blood and its components are recorded on paper and (or) electronic media. Registration data is kept for 30 years and must be subject to regulatory scrutiny.

8.4.3. When a blood donation organization receives information about possible infection recipient of bloodborne infections, it is necessary to identify the donor (donors) from which the infection could have occurred, and take measures to prevent the use of donated blood or its components obtained from this donor (donors).

8.4.3.1. If information is received about the possible infection of the recipient with bloodborne infections, an analysis of previous cases of donations for a period of at least 12 months preceding the last donation is carried out, the documentation is re-analyzed, and the organization that processes the blood (plasma) evaluates the need to recall the manufactured blood products, taking into account type of disease, time interval between donation and blood test and product characteristics.

8.4.4. In the production of blood products, the safety of donated blood in accordance with general principles is confirmed by the negative results of a laboratory study of blood samples of donors taken during each collection of donor material for the presence of pathogens of bloodborne infections, including HIV, using immunological and molecular biological methods.

8.4.4.1. Additionally, when processing plasma to obtain blood products, it is necessary to examine the plasma combined in the technological load for the presence of pathogens of bloodborne infections.

8.4.4.2. At all stages of production, measures should be provided to trace blood plasma donations included in the boiler load, production waste (disposable or transferred to other production facilities) and the finished medicinal product.

8.4.4.3. All plasma rejected during the input control for fractionation is subject to mandatory disposal.

8.4.5. Carrying out transfusions of donor blood and its components, transplantation of organs and tissues and artificial insemination.

8.4.5.1. It is prohibited to transfuse donor blood and its components, transplant organs and tissues and artificial insemination from donors who have not been examined for the presence of pathogens of bloodborne infections, including HIV, using immunological and molecular biological methods.

8.4.5.2. The physician prescribing transfusion of blood products should explain to the patient or his relatives the existence of a potential risk of transmission of viral infections, including HIV, during blood transfusion.

8.4.5.3. All manipulations for the introduction of blood transfusion media and blood products should be carried out in accordance with the instructions for use and other regulatory documents.

8.4.5.4. It is forbidden to administer blood transfusion media and preparations from human blood from one package to more than one patient.

8.4.6. In case of transfusion of donor blood, its components, transplantation of donor organs and tissues from an HIV-infected donor, immediately (but no later than 72 hours after transfusion/transplantation), it is necessary to carry out post-exposure chemoprophylaxis of HIV infection with antiretroviral drugs.

MINISTRY OF HEALTH AND MEDICAL INDUSTRY

RUSSIAN FEDERATION

ORDER

August 16, 1994

ON MEASURES TO IMPROVE PREVENTION AND TREATMENT

HIV INFECTIONS IN THE RUSSIAN FEDERATION

2. Typical regulation on the territorial Center for the Prevention and Control of AIDS (republican - republics within the Russian Federation, regional, regional, city) (Appendix 2).

3. Recommended list of specialists from the divisions of the territorial Center for the Prevention and Control of AIDS (Appendix 3).

4. Regulations on the office of psychosocial counseling and voluntary HIV testing (Appendix 4).

I order:

1. To the Ministers of Health of the republics within the Russian Federation, heads of health authorities of territories, regions, cities of Moscow and St. Petersburg, basins in water transport, in air transport:

1.1. Resume the work of interdepartmental committees (commissions, working groups) for the prevention and control of AIDS of republican and territorial subordination.

1.2. Until 01.10.94. complete the development and approval of regional programs for the prevention of HIV infection.

1.3. Ensure the provision of all types of diagnostic, treatment and diagnostic and advisory assistance to HIV-infected and AIDS patients in accordance with the "Guidelines for the organization of medical and diagnostic care and dispensary monitoring of patients with HIV infection and AIDS" (Appendix 1).

1.4. Make changes to the structure and staffing in accordance with the "Model Regulations on the Territorial Center for the Prevention and Control of AIDS" (Appendices 2 and 3).

1.5. In order to prevent the spread of HIV infection in medical institutions, assign the duties of those responsible for the prevention of HIV infection in healthcare facilities to deputy chief doctors for medical work (for epidemiological issues - if any).

1.6. Prohibit the mandatory examination of contingents of the population that are not provided for by the current "Rules for Medical Examination for the Detection of HIV Infection".

1.7. Introduce the heads of territorial centers for the prevention and control of AIDS into the attestation commissions.

1.8. When attesting for the highest, first and second certification categories of doctors and paramedical personnel of all specialties, check knowledge of HIV infection issues.

1.9. In connection with the recognition of the problem of combating AIDS as a state task, the reorganization of centers for the prevention and control of AIDS, entailing a change in their tasks and functions, should be carried out only in agreement with the Ministry of Health and Medical Industry of Russia.

1.10. AT without fail organize counseling for all persons undergoing testing and, first of all, undergoing voluntary (anonymous) testing in accordance with the "Regulations on the Office of Psychosocial Counseling and Voluntary HIV Testing". (Appendix 4) .

1.11. Strengthen the work on the interaction of the centers with the media, non-governmental organizations, youth and representatives of population groups at high risk of contracting HIV by identifying a group of specialists in the center responsible for this section of work.

1.12. In order to improve the quality of medical care for the population, organize and carry out preventive measures, ensure the implementation of policy documents regulating the diagnosis, treatment, quality control of diagnosis and treatment of HIV infection / AIDS, only approved or agreed by the Ministry of Health and Medical Industry of Russia.

1.13. In order to make fuller and more efficient use of material, technical and human resources, allow the territorial centers for the prevention and control of AIDS to conduct reference diagnostics with the right to establish the final laboratory and clinical diagnosis of HIV infection.

1.14. Prohibit the use for the purposes of diagnosis, prevention and treatment of HIV infection, parenteral hepatitis, opportunistic and other infections of means and methods not permitted by the Russian Ministry of Health.

1.15. To submit information on the implementation of this order to the Ministry of Health and Medical Industry of Russia annually by March 1.

2. Head of the Department of Preventive Medicine (Khalitov R.I.):

2.1. Develop medical and economic standards for the provision of all types of medical care to HIV-infected, AIDS patients and AIDS-associated diseases;

2.2. Bring directive and methodological documents regulating the procedure and safety of providing certain types of medical care and carrying out preventive measures in case of HIV infection/AIDS in line with modern requirements.

2.3. By September 1, 1995, prepare a collection of basic regulatory documents on the prevention of HIV infection/AIDS.

2.4. Organize regular quality control of laboratory diagnostics for HIV infection.

2.5. By November 1, 1994, to develop standard regulations on the structural subdivisions of the territorial center for the prevention and control of AIDS.

3. To the Head of the Department of Medical Informatics and Statistics (Pogorelova E.I.), in order to maximize the preservation of medical secrecy and limit the circle of persons who have access to information about HIV-infected people, prepare and submit proposals to the State Statistics Committee of Russia on changing state statistical reporting forms (f -58).

4. To the head of the Republican Center for Medical Prevention of the Ministry of Health and Medical Industry of Russia (Bogun T.F.), by June 1, 1995, create a bank of information and propaganda materials on HIV/AIDS issues developed by territorial centers for the prevention and control of AIDS.

Control over the implementation of this order shall be entrusted to Deputy Minister A.D. Tsaregorodtsev.

Deputy

Minister of Health

and medical industry

Russian Federation

V.K.AGAPOV

Appendix No. 1

and medical industry

Russian Federation

No. 170 dated August 16, 1994

METHODOLOGICAL INSTRUCTIONS

ON THE ORGANIZATION OF THERAPEUTIC AND DIAGNOSTIC CARE AND

DISPENSARY SUPERVISION FOR PATIENTS WITH HIV AND AIDS

The variety of clinical manifestations of infection caused by the human immunodeficiency virus (HIV), its long course and poor prognosis urgently require the optimization of methods for providing medical care to HIV-infected people in the Russian Federation.

Of particular importance in the organization of medical care for HIV-infected persons is the use of the correct therapeutic tactics, the creation of an adequate psychological atmosphere that supports patients at all stages of treatment, regardless of the stage of the disease. Of exceptional importance for the fate of HIV-infected patients is the rapid introduction into practice of the latest methods of treating the disease.

Despite the fact that AIDS remains a disease that is difficult to treat, it has been proven that timely and systematic treatment with modern drugs and simply taking care of the patient's psychological state can prolong the patient's life by several years and improve his condition.

The purpose of these guidelines is to create a unified system of care for HIV-infected people, based on the observance of continuity and coordination of efforts of specialists working on the development of the latest methods of treating HIV infection and AIDS, and doctors directly providing care to HIV-infected people.

CLINIC DIAGNOSIS AND TREATMENT OF HIV INFECTION

1.1. Etiology, epidemiology, pathogenesis of HIV infection

HIV infection is a disease that develops as a result of many years of persistence in lymphocytes, macrophages and cells of the nervous tissue of the human immunodeficiency virus (HIV) and is characterized by a slowly progressive defect. immune system, which leads to the death of the patient from secondary lesions, described as acquired immunodeficiency syndrome (AIDS), or from subacute encephalitis.

The human immunodeficiency virus belongs to the family of retroviruses. This is an RNA virus containing a reverse transcriptase enzyme, the presence of which allows the synthesis of viral DNA and thereby ensures the integration of the genetic material of the virus and the host cell. Currently, 2 types of the virus are known: HIV-1 and HIV-2; the latter is found mainly in West Africa. The composition of HIV-1 includes the following main proteins and glycoproteins (antigens): structural envelope proteins (env - gp160, gp120, gp41), core (gag - p17, p24, p55), as well as virus enzymes (po1 - p31, p51, p66).

HIV-2 contains: env gp140, gp105, gp36; gag - p16, p25, p56; pol-p68. It is generally accepted that HIV-2 has similar properties, spreads in the same ways as HIV-1 and causes HIV-1-like disease. Probably, the infection caused by HIV-2 has some differences. The most common opinion is that HIV-2 has a lower ability to spread and destroy the immune system more slowly, but scientific developments that illuminate this issue are still not enough.

The source of HIV infection is a person. Almost in all biological fluids infected human body(blood, semen, cerebrospinal fluid, breast milk, vaginal and cervical secret) in various concentrations, viral particles are detected.

HIV can be transmitted through sexual contact, transfusion of infected blood and blood products, use of HIV-contaminated medical equipment, from an infected mother to her child and from an infected child to her mother during breastfeeding, and from an infected mother to her child during pregnancy and childbirth.

HIV predominantly selectively infects cells that have CD4 receptors on which HIV is adsorbed: helper T-lymphocytes, macrophages, B-lymphocytes, neuroglial cells, intestinal mucosal cells, dendritic and some other cells.

Based on a clear relationship between the progression of the disease and a decrease in the number of CD4 lymphocytes in a patient, it is believed that a decrease in the number of these cells is main feature the pathogenesis of the disease. However, the mechanism of this process has not yet been convincingly explained. The function of helper/inducer lymphocytes is also impaired, leading to spontaneous activation of B cells and the development of polyclonal hypergammaglobulinemia due to the production of nonspecific immunoglobulins, and the concentration of circulating immune complexes increases. As a result, resistance to secondary infections and neoplasms is reduced. In addition, due to the direct cytopathic action of the virus or as a result of an indirect action (autoimmune mechanisms), cell damage is possible. nervous system, various cells of the blood system, cardiovascular, musculoskeletal, endocrine and other systems. All this causes a variety of clinical symptoms and multiple organ lesions.

1.2. Laboratory Criteria for Diagnosis

HIV infections

The main method of laboratory diagnosis of HIV infection is the detection of antibodies to the virus using enzyme immunoassay. Antibodies to HIV appear in 90-95% of those infected within 3 months after infection, in 5-9% - after 6 months from the moment of infection and in 0.5-1% - at a later date. Most early term detection of antibodies - 2 weeks from the moment of infection. In the terminal phase of AIDS, the number of antibodies can decrease significantly, up to their complete disappearance. Serological diagnosis of HIV infection at the first stage is based on the detection of the total spectrum of antibodies against HIV antigens using enzyme-linked immunosorbent assay. At the second stage, the method of immune blotting (Western blot) is used to determine antibodies to individual proteins of the virus.

1.2.1. Collection of materials, transportation and storage of blood sera.

Blood is taken from the cubital vein into a clean, dry test tube in the amount of 3-5 ml. Cord blood can be taken from newborns. The resulting material is not recommended to be stored for more than 12 hours at room temperature and more than 1 day in the refrigerator at + 4-8 degrees. C. The upcoming hemolysis may affect the results of the analysis. It is best to remove the serum from the blood immediately after taking the blood. The serum is separated by centrifugation or by tracing the blood along the wall of the test tube with a Pasteur pipette or a glass rod. The separated serum is transferred into a clean (preferably sterile) test tube, bottle or plastic container, and in this form it can be stored for up to 7 days at a temperature of + 4-8 degrees. FROM.

When working, you should follow the safety rules given in the "Instructions on the anti-epidemic regime in AIDS diagnostic laboratories" N 42-28 / 38-90 dated July 5, 1990.

1.2.2. Equipment required for enzyme immunoassay.

To conduct laboratory studies using enzymatic methods, you must have the following equipment:

1. spectrophotometer;

2. tablet washer;

3. thermostat;

4. automatic pipettes;

5. tips for automatic pipettes;

6. centrifuges;

7. refrigerators;

8. test systems.

The load on the ELISA diagnostic team should be up to 400 examinations per shift, provided that they are equipped with modern automatic equipment, and up to 180-200 examinations equipped with domestic routine equipment.

1.2.3. Linked immunosorbent assay.

The principle of enzyme immunoassay is based on the detection of an antigen-antibody complex using an enzyme (peroxidase, alkaline phosphotase, etc.) by changing the color of a specific substrate. The main component of enzyme-linked immunosorbent assays is a polystyrene plate with wells or polystyrene beads on the surface of which an antigen is adsorbed: viral lysate, recombinant proteins or synthetic antigenic determinants. Of all the modifications of solid-phase ELISA for the diagnosis of infection caused by HIV, the most widely used indirect and competitive options.

1.2.3.1. Principles of setting the indirect ELISA method.

Pre-prepared according to the instructions attached to the kit, the test material (serum, plasma) is introduced into the well of the tablet. If required by the technique, the tablet is pre-washed. Several wells of the plate are filled with control sera containing and not containing antibodies to HIV. When working with control sera, it is necessary to strictly follow the instructions for using the diagnostic test system, because the interpretation of the results depends on the optical density values ​​of the control sera. The tablet with the added control sera and test material is incubated under the conditions specified in the instructions supplied with the diagnostic kit. If specific antibodies are present in the serum, they form a complex with the antigen adsorbed on the surface of the wells of the tablet. Antibodies that have not bound to the antigen are removed by washing the plate.

Then, conjugate antibodies against human immunoglobulins labeled with an enzyme (peroxidase, alkaline phosphatase, etc.) are added to all wells of the tablet. Subsequent incubation results in the formation of an antigen-antibody-conjugate complex. Unbound conjugate is removed during plate washing. The most widely used indicator enzyme for ELISA is horseradish peroxidase. The substrate for it is hydrogen peroxide.

This reaction proceeds without visible manifestations. A change in the color of the solution occurs during the oxidation of dyes (orthophenylenediamine or others), which is part of the substrate solution.

The dye from the reduced form passes into the oxidized colored form. Thus, only those wells in which the antigen-antibody-conjugate complex is present are stained. Sometimes staining can be the result of non-specific binding of immunoglobulins to HIV antigens. Accounting for the reaction is carried out on a spectrophotometer (reader) at the wavelength specified in the instructions attached to the diagnostic kit. The wavelength depends on the dye used in the test system.

1.2.3.2. The principle of setting up a competitive ELISA method.

With the competitive ELISA method, the studied sera and conjugate are simultaneously introduced into the wells of the tablet with the applied antigen. conjugate in this case are enzyme-labeled anti-HIV antibodies. During subsequent incubation, the antibodies contained in the serum and the conjugate enter into a competitive interaction with the antigen immobilized on a solid carrier. If the serum contains antibodies, they interact with the antigen, blocking the formation of the antigen-conjugate complex. In the absence of antibodies in serum, the formation of an antigen-conjugate complex occurs. The remaining unbound components are washed off after incubation and the appropriate substrate is added to the system. In the presence of antibodies in the serum, a color reaction does not develop.

Table 1

POSSIBLE ERRORS IN ELISA

	Types Defect	Visible manifestations	Possible causes of the defect
1.	High background	The value of optical plot- in wells with negative pre- raises 0.2 units.	Cooked wrong serum dilution, Conducted incorrectly Tablet cleaning, Cooked incorrectly conjugate, Cooked incorrectly substrate, Poor quality dye Va (dye solution Has a yellow color) Manufacturing defects.
2a.	Weak signal	The value of optical plot- positive con- troll below the minimum optical density values ness specified in the inst- instructions, the value of the optical which density is positive nyh sera do not exceed em 0.4	Failure to comply with the rules of storage Neniya test systems that Leads to violation of Zi antigen with a carrier, Wrong breeding Control and subjects Serum, Wrong breeding And keeping divorced conjugate, Wrong breeding And storage of peroxide water- kinda, Factory marriage during manufacture Test system development.
2b.	Weak signal put- tly- th cont- role	The value of optical plot- positive contact role does not exceed 0.4 units.	wrong breeding and Storage of diluted contacts Roll Serums, Factory marriage during manufacture The preparation of the control serum Rothky.
3.	Missing vie sig- Nala	In wells with a positive con- troll and positive serum rotami did not stain sewing	Conjugate not added Not properly prepared Substrate (not added pe- Hydrogen reoxide), No antigen added to wells In the manufacture of test systems Topics.

When setting up an ELISA, if a positive result is obtained, the analysis is carried out 2 more times (with the same serum). If at least one more positive result is obtained, the serum is sent to the reference laboratory.

1.2.3.3. immune blotting.

Currently, Western blot is the most commonly used method to confirm the specificity of an initial positive result. The principle of the method is to detect antibodies to certain proteins of the virus immobilized on a nitrocellulose membrane. In the human body, antibodies are formed to a number of components of the virus; data on these antigens are given in the table.

table 2

group of proteins	HIV-1	HIV-2
Shell proteins virus (env)	GP 160 cd, 120 cd, 41 cd	GP 140 cd, 105 cd, 36 cd
core proteins (gag)	P 55 cd, 24 cd, 17 cd	P 56 cd, 26 cd, 18 cd
Virus Enzymes (pol)	P 66 cd, 51 cd, 31 cd	P 68 cd

Note: The molecular weight of proteins is expressed in kilodaltons - cd, gp - glycoproteins, p - proteins.

The preparation of nitrocellulose membranes for the test system is carried out as follows. At the first stage, the proteins of the human immunodeficiency virus are separated by molecular weight using polyacrylamide gel electrophoresis. Proteins migrate within the gel layers when an electrical potential is applied: low molecular weight proteins pass through the pores in a polyacrylamide gel more easily than high molecular weight proteins and reach the end of the gel faster. As a result, proteins are separated into separate bands by molecular weight. This is followed by electrophoretic transfer from the polyacrylamide gel to the surface of the nitrocellulose membrane. After that, the membrane is treated with a blocking solution to avoid non-specific binding of blood serum immunoglobulins, then washed, dried and cut into separate strips, which are inserted into the kit. The proteins transferred in this way are detected on a nitrocellulose replica (block) using indirect analysis, namely: serum or plasma is incubated with a blot; if the test material contains antibodies to HIV proteins, they bind to the antigen transferred to the nitrocellulose membrane; after washing, the blot strips are incubated with the conjugate; when an antigen-antibody complex is formed, the conjugate attaches to it, after washing from the conjugate and incubation with the substrate, the staining of those parts of the nirocellulose occurs, where the formation of the antigen-antibody-conjugate complex occurred. The result obtained is compared with the results of testing positive and negative control sera.

The results obtained in immune blotting are interpreted as positive, indeterminate and negative.

IMMUNE BLOTTING

	Name of centers	Positive Result	Doubtful Result	Negative Result
	1. WHO	The combination of los k gp41 and gp120, or GP41 and GP160, or gp120 and gp160	Stripes to others hym antigens HIV	Absence stripes to some to anyone from HIV antigens
	2. Russian Center for Prevention And the fight against AIDS	Stripes though to one of gp41 proteins, gp120, gp160, in conjunction with other polos alone or without them	Stripes to others hym antigens HIV	Absence stripes to some to anyone from HIV antigens

Note: The recommendations of the Russian Center take into account the experience of working with the sera of children from nosocomial foci, in which antibodies to only one of the virus envelope proteins were often detected. Timely diagnosis in such children made it possible to quickly begin anti-epidemic measures and specific therapy.

The issues of standardization and interpretation of the results of immune blotting were considered at the WHO expert meeting in Geneva on April 22-23, 1990.

According to these recommendations, in the presence of a reaction only from envelope proteins (rp160, rp120, rp41) in combination with or without reaction with other proteins, the result is considered doubtful and a second study is recommended using a kit from another series or from another company. If the result remains doubtful after this, observation for 6 months (after 3 months) is recommended. The presence of a positive reaction with p24 may indicate a period of seroconversion. In this case, it is recommended, depending on the clinical and epidemiological data, to repeat the study with a serum sample taken after 2 weeks.

Positive reactions with gag and pol proteins without a reaction with env proteins may reflect early seroconversion, or indicate HIV-2 infection or a non-specific reaction. Individuals with these results after testing for HIV-2 should be retested after 3 months (within 6 months). If, after 6 months, indeterminate results are again obtained (no reaction with HIV-1 and HIV-2 env proteins), and risk factors and clinical symptoms of immunodeficiency are not identified, a non-specific reaction can be concluded. The presence of a non-specific reaction does not give rise to a diagnosis of HIV infection, but donors with such a result should be excluded from donation.

The results of serological studies are used by epidemiologists and practitioners for the early diagnosis of HIV infection, timely identification of the source of infection, the speedy implementation of anti-epidemic measures and the provision of assistance to infected people. A diagnosis cannot be made based on laboratory analysis alone. To make a diagnostic conclusion, it is necessary to take into account the data of the epidemiological history, immunological tests and the results of the clinical examination.

1.3. Clinical classification of HIV infection,

characteristics of the stages of the disease

For the convenience of clinical and dispensary monitoring of HIV-infected persons in the Russian Federation, the most convenient classification of HIV infection by V.I. patient management, indications for prescribing medicines without the use of special laboratory methods, which are expensive and the results of which obtained in different laboratories are often incomparable.

Clinical classification of HIV infection

1. Stage of incubation;

2. Stage of primary manifestations:

A. Acute infection,

B. Asymptomatic infection

B. Persistent generalized lymphadenopathy;

3. Stage of secondary diseases;

A. Weight loss less than 10%, fungal, viral, bacterial lesions of the skin and mucous membranes, herpes zoster, repeated pharyngitis, sinusitis;

B. Weight loss greater than 10%, unexplained diarrhea or fever

more than one month: hairy leukoplakia, pulmonary tuberculosis,

repeated or persistent viral, bacterial, fungal,

protozoan lesions internal organs, repeated or

disseminated herpes zoster, skin lesions,

accompanied by ulceration, repeated or persistent

(lasting at least two months), localized sarcoma

B. Generalized bacterial, viral, fungal,

lymphoid interstitial pneumonitis, esophageal candidiasis,

extrapulmonary tuberculosis, atypical mycobacteriosis, cachexia,

disseminated Kaposi's sarcoma, lesions of the central nervous

systems of various etiologies;

4. Terminal stage

Incubation stage (Stage 1) - from the moment of infection to the appearance of a reaction in the form of clinical manifestations of "acute infection" or the production of antibodies. Its duration is usually from 3 weeks to 3 months, but in isolated cases it can be delayed up to a year. The diagnosis of HIV infection at this stage can be made by detecting the p24 antigen in the patient's blood serum by ELISA or by isolating the human immunodeficiency virus from the blood.

Acute infection (2A) is accompanied by varying degrees of fever, pharyngitis, lymphadenopathy, enlargement of the liver and spleen, stool disorders, unstable and diverse (urticarial, papular, petechial) skin rashes. Possible meningeal phenomena. Acute infection occurs in 50-90% of infected individuals in the first 3 months after infection.

The period of acute infection usually coincides with the period of seroconversion, therefore, when the first clinical symptoms appear in the patient's blood serum, antibodies to HIV proteins and glycoproteins may not be detected. In the stage of acute infection, a transient decrease in the level of CD4-lymphocytes is often noted, which is sometimes accompanied by the development of clinical manifestations of secondary diseases (candidiasis, herpes infection). These manifestations are usually mild, short-term and respond well to therapy.

The duration of clinical manifestations of acute infection varies from several days to several months. However, usually the duration of the acute infection stage is 2-3 weeks, after which the disease progresses to one of the other two phases of the stage of primary manifestations - asymptomatic infection (AI) or persistent generalized lymphadenopathy (PGL). Relapses of clinical manifestations of acute infection are possible. In isolated cases, an acute infection can, bypassing the phases of BI and PGL, pass into the stage of secondary diseases.

The phase of asymptomatic infection (2B) is characterized by the absence of any clinical manifestations of the disease. There may be a moderate increase in lymph nodes. In contrast to the stage of incubation, antibodies to HIV antigens are determined in patients with BI.

A characteristic feature of 2B is persistent generalized lymphadenopathy (enlargement of at least 2 lymph nodes in two different groups, excluding inguinal lymph nodes in adults, to a size of more than 1 cm, in children more than 0.5 cm in diameter, persisting for at least 3 months). PGL can also occur in the late stages of HIV infection, but in stage 2B it is the only clinical manifestation.

Asymptomatic infection and persistent generalized lymphadenopathy develop after the acute infection stage or immediately after the incubation stage. Enlarged lymph nodes may shrink and grow again, so phases 2B and 2C may alternate. In general, the stage of primary manifestations is characterized by a relative balance between the immune response of the body and the action of the virus. Its duration can vary from 2-3 to 10-15 years. During this period, there is a gradual decrease in the level of CD4-lymphocytes, on average at a rate of 50-70 cells per cubic meter. mm per year.

As the disease progresses, patients begin to show clinical symptoms that indicate a deepening of the damage to the immune system, which characterizes the transition of HIV infection to the stage of secondary diseases (Stage 3). Stage 3A usually begins to develop 3-5 years after infection. It is characterized by bacterial, fungal and viral lesions of the mucous membranes and skin, inflammatory diseases upper respiratory tract. At stage 3B (after 5-7 years from the moment of infection), skin lesions are deeper and tend to be protracted. Damage to internal organs develops. In addition, localized Kaposi's sarcoma, mild constitutional symptoms (weight loss, fever), and lesions of the peripheral nervous system may be noted. Stage 3B (after 7-10 years) is characterized by the development of severe, life-threatening secondary diseases, their generalized nature, and CNS damage.

In the terminal stage (Stage 4) of HIV infection, the patient's lesions of organs and systems are irreversible; one disease follows another. Even adequately carried out therapy of secondary diseases is ineffective and the patient dies within a few months.

The given terms of the development of the stages of the disease are averaged. In some cases, the disease develops more rapidly and after 2-3 years passes into the terminal stage.

A frequent cause of deterioration in health and decreased performance in patients with a relatively satisfactory somatic condition in the initial stages of HIV infection can often be asthenic disorders that are by no means directly related to CNS damage directly by HIV itself, but with which patients often turn to doctors.

Factors contributing to the formation of asthenic disorders are experiences associated with informing the patient about the presence of HIV infection, fragile habitual way of life, and worsening social conditions. With the progression of HIV infection, asthenic disorders can also develop against the background of somatic pathology.

1.4. Features of the course of HIV infection in children

Infection of children with HIV can occur from an infected mother during pregnancy, during childbirth and breastfeeding, as well as parenterally through medical and paramedical interventions. The risk of HIV transmission to children born from seropositive mothers varies from 15% to 50%, depending on the stage of HIV infection in the mother, and increases with breastfeeding.

The clinic of HIV infection in children has a number of features:

more often than in adults there are recurrent bacterial infections, as well as interstitial lymphoid pneumonitis and hyperplasia of the pulmonary lymph nodes (up to 40% of cases); very rare Kaposi's sarcoma; the most common clinical signs are encephalopathy and delayed psychomotor and physical development; often there is thrombocytopenia, clinically manifested by hemorrhagic syndrome, which can be the cause of death in children; HIV infection in children is characterized by a more rapid progressive course compared to adults.

Diagnosis of HIV infection in children born to seropositive mothers is difficult. On the one hand, during the first year of life, maternal antibodies circulate in the child's blood serum and, therefore, the detection of antibodies to HIV in children of the first year of life is not a sufficient basis for diagnosing them with HIV infection. On the other hand, since HIV infection in the neonatal period can induce hypo-agammaglobulinemia, the disappearance of antibodies cannot be considered sufficient grounds for withdrawing the diagnosis of HIV infection, and therefore children born from HIV-positive mothers should be observed for at least within 36 months of birth. After that, the question of whether they have HIV infection is decided on the basis of an analysis of a complex of clinical, immunological and serological data.

1.5. Substantiation of the clinical diagnosis

When making a complete clinical diagnosis in a patient with HIV infection, one should first substantiate the diagnosis of HIV infection on the basis of epidemiological, clinical and available laboratory data, then determine the stage of the disease, indicating its characteristic manifestations.

For example:

Based on the epidemiological history (sexual contact with an HIV-infected person), generalized lymphadenopathy, detection of antibodies to HIV proteins (gp 41, 160), HIV infection can be diagnosed. Considering the recurrent herpes zoster noted in the anamnesis, it can be assumed that the patient has a stage of secondary diseases 3B. Based on epidemiological data (sexual contact with an HIV-infected person), generalized lymphadenopathy, detection of antibodies to HIV proteins (gp 41, 160), twice transferred herpes zoster, a diagnosis can be made: HIV infection, stage of secondary diseases (3B).

1.6. Therapy for HIV infection

Basic principles of therapy for patients with HIV infection:

Creation of a protective psychological regime. Timely initiation of etiotropic therapy. Careful selection of medicines with selection necessary minimum. Early diagnosis of secondary diseases and their timely treatment.

At the stage of primary manifestations and during periods of remission at the stage of secondary diseases, prevent or delay the development of life-threatening lesions. At the stage of secondary diseases, especially 3B, 3C, during the period of clinical manifestation, with the help of rational therapy of secondary diseases, keep the patient until the moment when, with the help of specific antiretroviral therapy (AZT), it is possible to achieve a temporary restoration of the body's immune status.

1.6.1. Creation of a protective psychological regimen for HIV-infected people.

The epidemic of the disease caused by HIV has led to the appearance in the public mind of prejudice against infected patients. Infection with HIV in most cases is regarded by society as a natural result of immoral and antisocial behavior. When an infected person appears in his environment, a rejection reaction is observed. Social adaptation of the patient prevents his aggressiveness towards society, the desire to "revenge by spreading AIDS", prevents the temptation to engage in prostitution to compensate for financial losses due to loss of livelihood.

Infection with the human immunodeficiency virus entails serious consequences of an emotional and social nature, changes the habitual behavior of an infected person, affects family relationships and legal status. Adaptation to life in conditions of HIV infection involves a constant struggle with psychotraumatic influences.

As a result, from the moment of suspicion of HIV infection, the patient is subjected to constant psychogenic stress, and therefore it is necessary to take measures to mitigate its medical and social consequences. It is necessary to limit as much as possible the circle of persons who have access to information about the personality of an HIV-infected person and take measures for his social adaptation.

According to socio-psychological indications, it is advisable to hospitalize patients when making a diagnosis of HIV infection. In this case, it is better to send the patient to a large center, where there are trained personnel and an environment of "fellow-in-affairs", which will alleviate the emotional shock from the diagnosis. In most cases, doctors cannot solve the material or personal problems of HIV-infected people, but they can protect them from wrong actions by influencing their mental state.

The most accessible form of psychological assistance is an individual conversation, as well as family psychotherapy. During the conversation, the doctor can use elements of explanatory and rational psychotherapy. Explanatory psychotherapy is effective in cases where the patient readily accepts the doctor's explanations aimed at correcting the patient's incorrect judgments and his assessment of his morbid condition or the situation that caused the mental trauma. In cases where the patient does not agree with the doctor in these matters, rational psychotherapy is used. An essential feature of this method is the impact of logical beliefs. It is advisable to have such a psychotherapeutic effect that could have an activating effect on the patient, give an incentive to activities aimed at finding the best way out of a traumatic situation, preparing him for the inevitable restructuring of a life stereotype, and adapting to a change in life prospects.

In addition to the attending physician, specialists who have undergone special training in counseling on the problem of HIV infection should be involved in the psychosocial adaptation of the patient. Considering that in most cases it is not possible to eliminate the psycho-traumatic factors themselves, this counseling is one of the most important methods for creating a security-psychological regime.

Psychosocial counseling for HIV-infected people is a process aimed at ensuring the prevention of the disease, as well as providing psychological support to those infected. Currently, three main approaches to counseling have been developed: during an emotional crisis (crisis counseling), problem solving and decision making.

Crisis counseling is carried out when the applicant is in a state of emotional crisis.

The task of crisis counseling is to determine the essence of the problem and restore the self-control of the counselee.

The goal of decision consulting is to help you understand the problem and focus on the necessary solutions.

Problem solving counseling is based on empathy and emotional support. The consultant helps to clearly define the problem, identify alternatives actions and make a plan for further behavior of the patient. Thanks to the timely provision of psychological assistance, it is possible to prevent emotional breakdowns and inadequate actions of HIV-infected persons.

1.6.2. Etiotropic therapy.

The basic etiotropic therapy of patients with HIV infection includes antiretroviral therapy (aimed at suppressing HIV replication) and chemoprophylaxis of secondary diseases.

1.6.2.1. Antiviral therapy: the drug for etiotropic therapy of HIV infection approved for clinical use in Russia is Azidothymidine (AZT, AZT), which is produced under the commercial name Thymozid (Association "AZT", Russia) in capsules of 0.1 g and Retrovir, Zidovudine (Wellcome, UK) in capsules of 0.1 g and 0.25 g in the form of a syrup. The drug is administered orally at a daily dose of 0.6 g (children at the rate of 0.01 g/kg) in 3 divided doses. Under conditional HIV lesions nervous system, the dose is doubled. With poor drug tolerance daily dose may be reduced to 0.3 g. Lower doses are not effective. In the form of a syrup, the drug is prescribed to patients who cannot swallow capsules (small children, patients with esophagitis). AZT is given continuously or in courses of at least three months. To avoid the development of anemia and neutropenia, AZT treatment is carried out under the control of a complete blood count, carried out every two weeks in the first two months of treatment and monthly thereafter.

Antiretroviral therapy for HIV infection is prescribed according to clinical indications in stages 2A, 3A, 3B, 3C during the period of clinical activity until the disappearance of clinical symptoms, but not less than for three months.

In the absence of clinical symptoms (i.e., during the period of clinical remission), maintenance antiretroviral therapy is prescribed according to clinical and immunological indications. At the level of CD4<200 она проводится по непрерывной схеме, при CD4<500 но >200 - courses of 3 months with three-month intervals. With an unknown level of CD4 in the stage of primary manifestations (2) and in stage 3A, maintenance therapy is not carried out, in stage 3B it is carried out according to the course and in stage 3B - according to a continuous scheme.

1.6.2.2. Prevention of secondary diseases.

Prevention of secondary diseases in patients with HIV infection is carried out according to epidemiological, clinical and immunological indications.

Prevention of pneumocystis pneumonia

Prevention of pneumocystis pneumonia is carried out in patients with HIV infections with a CD4 lymphocyte level below 200 per cubic meter. mm (primary prevention) and patients who have previously had pneumocystis pneumonia (secondary prevention). With an unknown level of CD4, prevention of pneumocystis pneumonia is carried out in patients in stage 3B during the period of clinical activity in the presence of pulmonary pathology, as well as in all patients in stage 3B. The first line drug is Trimetoprim + Sulfamethoxazole (Biseptol 480 or Septrin Y2B for adults, Biseptol 120, Septrin H4B for children). For primary prevention, it is prescribed for 3 days in a row every week, 1 tablet for adults, children with a dose reduction according to weight.

For secondary prevention within 4 weeks after the end of the course of treatment of an acute process, the drug is taken daily, 1 tablet, then, in the absence of negative clinical and radiological dynamics, they switch to the primary prevention scheme. With signs of activation of pneumocystis infection (the appearance or increase of shortness of breath, increased interstitial changes in the lungs), they switch to a daily intake of the drug. With intolerance to biseptol, Dapsone can be used at 0.05 g per day daily.

Prevention of fungal infections. Fungal lesions, predominantly of candidal etiology, are most common in patients with HIV infection. Primary prevention of fungal infections is carried out when patients with HIV infection are given antibiotic therapy.

The following schemes for chemoprophylaxis of fungal infections in patients with HIV infection are recommended: N 1 Nystatin 2.0 per day daily; N 2 Nystatin 4.0 per day daily (no more than 10 days); N 3 Ketocanazole 0.2 daily; N 4 Flucanozol 0.15 once a week; N 5 Flucanosol 0.05 daily;

Prevention begins with schemes that have a lower number and, in the absence or loss of effect, they move on to the next one. In stages 2A, 2B, 2C, 3A with CD4<200 ИЛИ 3Б и CD4>200 start with scheme N 2. In stages 3B with CD4<200 и в стадиях 3В, 4 - со схемы N 3. При неизвестном уровне CD4 в стадии первичных проявлений (2) профилактику начинают со схемы N 1, в стадии вторичных заболеваний 3А со схемы N 2, в стадии 3Б со схемы N 3, в стадии 3В-4 - со схемы N 5. При применении схемы N 3 следует помнить о гепатотоксичности кетоконазола и нежелательности его сочетания с другими гепатотоксичными препаратами и у больных с поражениями печени. При появлении признаков грибковой инфекции на фоне химиопрофилактики препарат назначают в лечебных дозах.

Prevention of mycobacteriosis.

Primary prevention of tuberculosis is carried out for people with a positive Mantoux test, people who have had contact with patients with open forms of tuberculosis, patients with a CD4 level<200. При уровне CD4>100 or unknown use of isoniazid 0.3 g per day. With CD<100 из-за повышения вероятности развития атипичных микобактериозов - рифампицин по 0,3 г в сутки.

DISPENSARY SUPERVISION

The good organization of medical care for patients with HIV infection is not only one of the main conditions that can significantly increase the duration and improve the quality of their life, but also an important anti-epidemic measure, since the lack of confidence in receiving all the necessary medical care and maintaining medical secrecy will inevitably force the patient to apply for it in emergency situations, hiding your diagnosis, which, if sanitary rules are not followed, can cause nosocomial transmission of the infection.

Outpatient monitoring of patients with HIV infection is carried out by employees of the AIDS centers, and in the absence of an AIDS center in the locality where the patient lives, practical health services are involved in dispensary monitoring (a doctor of the CIZ, in his absence, a local therapist, doctors of infectious diseases departments of hospitals), who should work under the methodological guidance of the AIDS center responsible for the given territory and be trained by the center's staff in the specifics of working with patients with HIV infection.

In settlements where large centers with their own clinical base are located, it is advisable for the doctor to carry out both inpatient and outpatient management of the patient. In all cases, when working with patients with HIV infection, it is necessary to use the principle of a "trusted doctor", in which the patient with all his medical problems turns to a specific doctor, who, if necessary, involves other specialists in working with patients.

When organizing a medical care service for HIV infection, it is necessary to take into account the characteristics of this disease: the duration of the course; extremely difficult prognosis, lack of the possibility of a radical cure; more rapid progression of the disease and a high probability of changes in the patient's psyche, associated with the possibility of damage to the central nervous system and with the influence of stressful influences (social and somatic).

Properly organized dispensary observation should ensure the following tasks:

1. Identification and treatment of the patient's existing or newly emerging diseases that contribute to the faster progression of HIV infection.

2. The earliest possible detection of signs of progression of HIV infection and the timely appointment of specific therapy.

3. Providing a patient with HIV infection with all types of qualified medical care with guaranteed observance of the secrecy of the diagnosis.

2.1. Plan of examination of patients with HIV infection

When a patient is registered, his primary examination is carried out, the purpose of which is to confirm the diagnosis of HIV infection, establish the stage of the disease, identify the patient's secondary and concomitant diseases to determine the tactics of further management.

During the initial examination, in addition to the examination by the attending physician, including the collection of anamnesis and physical examination, a blood test for antibodies to HIV (ELISA, immune blot), a general blood test with the obligatory determination of erythrocytes, platelets, a biochemical blood test (cholesterol, bilirubin, ALT, AST , alkaline phosphatase, LDH, GGT, sublimate and thymol tests, glucose, total protein and protein fractions), urinalysis, immune status (CD4, CD8, CD4 / CD8), skin-allergic test (tuberculin) blood test for RW , HBsAg, antibodies to CMV, Toxoplasma, HSV, P.carinii, examination of feces for worm eggs and protozoa, salmonella culture, chest X-ray, ultrasound of the abdominal cavity and kidneys, EEG, ECG, examination by specialists (dermatologist, gynecologist, neuropathologist, ENT, psychiatrist, ophthalmologist, dentist).

Repeated examinations are carried out when the patient's condition worsens and in a planned manner, depending on the stage of the disease. The purpose of a routine examination is to timely identify the threat of disease progression. Repeated scheduled examinations (with the exception of the immune blot) are carried out at the following times:

TERMS OF REPEAT SCHEDULED SURVEY

PATIENTS WITH HIV

┌─────────────┬──────────────────────────────────────────┐

│ Stage │ Level Intervals │

│ diseases │ CD4 (in weeks) │

│ 2-B, C │ > 500 24 │

│ │ < 500 12 │

│ │ unknown 24 │

├─────────────┼──────────────────────────────────────────┤

│ 3-A, B, C │ > 500 24 │

│ │ < 500 12 │

│ │ unknown 12 │

├─────────────┼──────────────────────────────────────────┤

│ 4 │ Depending on the clinical picture │

└─────────────┴──────────────────────────────────────────┘

Note: If CD4 is detected for the first time<200 (кроме стадии 3В, 4), повторить CD4 через один месяц. В стадии 3В при CD<200 или неизвестном ежемесячно проводят врачебный осмотр. Рентгенографию органов грудной клетки и УЗИ рекомендуется проводить в плановом порядке не чаще 1 раза в 6 месяцев; серологически исследования - 1 раз в 6 месяцев; туберкулиновую пробу - 1 раз в год.

An additional examination is carried out according to clinical and epidemiological indications. In case of emergency treatment, the doctor independently determines the scope of the examination.

2.2. Providing specialized assistance

In areas where there are no patients with HIV infection or their number is so small that it is irrational from an economic point of view and from the point of view of maintaining their qualifications, it is advisable to involve specially trained practical healthcare workers, preferably infectious disease specialists, who could subsequently fully switch to work with patients with HIV infection. It is necessary to determine in advance the hospital where patients can be hospitalized, institutions that will provide them with surgical, gynecological or other specialized care.

2.3. Vaccination in patients with HIV infection

Vaccination is carried out under the supervision of pediatricians from the AIDS Control Centers. In the post-vaccination period, the child is patronized on the 3-4th and 10-11th day. If possible, the child is hospitalized in the post-vaccination period. Before vaccination, it is advisable to prescribe a multivitamin containing vitamin A 1-2 weeks before vaccination.

Basic principles of immunization of HIV-infected children:

Exclusion from the BCG vaccination schedule;

Children with HIV infection at stage 2 B-C, in the absence of other contraindications not related to HIV infection, are vaccinated in accordance with the usual vaccination calendar;

Children with HIV infection at stage 2A are vaccinated no earlier than one month after the disappearance of the clinical symptoms of acute infection;

Children observed during the seroconversion period, in the absence of clinical symptoms of the acute stage of HIV infection, are vaccinated after stabilization of the immune blot parameters;

Children with HIV infection at the stage of secondary diseases 3 A-B are vaccinated during the period of remission of the secondary disease lasting more than 1 month;

Children at stage 3-B, 4 undergo passive immunization according to epidemiological or clinical indications;

Children with thrombocytopenia (platelet count less than 150x10/l), regardless of the stage of HIV infection, are vaccinated no earlier than 1 month after stable normalization of platelet count; after vaccination, after 3-4 weeks, it is advisable to introduce a polyvalent immunoglobulin; according to epidemiological indications, if thrombocytopenia persists, passive immunization is carried out.

It should be emphasized that children with HIV infection lose vaccine-associated antibodies as the disease progresses. Therefore, in case of contact with infectious patients, regardless of the vaccination history, the administration of specific immunoglobulin or appropriate antibacterial drugs is indicated for prophylactic purposes.

In the absence of specific immunopreparations, it is possible to administer polyvalent human immunoglobulin intravenously (at the age of 5 years, 25 ml two days in a row, older children - 50 ml two days in a row).

Vaccination of adult patients with HIV infection is carried out in accordance with the existing vaccination schedule, as well as according to epidemiological indications.

2.4. Indications for hospitalization in specialized

hospitals

Hospitalization of a patient with HIV infection can be carried out according to clinical, epidemiological and socio-psychological indications. Clinical indications - identification of signs of progression of HIV infection - the appearance of secondary or concomitant diseases requiring inpatient treatment, or the need for routine studies that cannot be carried out on an outpatient basis.

Epidemiological: the presence of bleeding in patients or the threat of developing hemoptysis, secondary diseases that can pose a danger to others (open forms of tuberculosis) if it is impossible due to housing or social conditions to observe the epidemic at home. mode.

Social: traumatic situations due to harassment by society, conflicts in the family. Such hospitalization ultimately has clinical (prevention of disease progression under stress, prevention of suicidal attempts) and epidemiological significance.

Inpatient treatment of patients should be carried out in specialized clinics or departments. In their absence, it is better to use infectious diseases hospitals (preferably their box departments), which facilitates the preservation of medical secrecy and protects a patient with HIV infection from contact with infectious patients.

If there is a specialized department, it is better to place patients with HIV infection in small single-double wards. The mode allows walking and going outside the territory of the hospital. Isolation of patients with HIV infection in boxed and semi-boxed departments is necessary only if they have pulmonary hemorrhages and hemoptysis, open forms of tuberculosis, acute course of pneumocystis pneumonia, when they can pose a danger to others, especially to other patients with HIV infection. It is also recommended to isolate patients in the acute period of diseases, in stage 3B and in the terminal stage, which, due to the presence of deep immunodeficiency, can easily be infected with new pathogens. In the light of the available data on the possibility of nosocomial spread among people with immunodeficiency of some pathogens of secondary diseases typical of HIV infection (candida, pneumocystis, etc.), patients with HIV infection and patients suffering from immunodeficiencies of a different nature (immunological hospitals, departments for patients with so-called "AIDS-defining diseases").

2.5. Measures to prevent HIV infection

in medical institutions

HIV infection is an infectious disease with a rather limited number of possible transmission routes, the knowledge of which must be taken into account when working with patients. During a routine physical examination, no additional protective measures are required if there is no damage to the skin of the hands. If there are any, they must be sealed with a plaster. When working with biological substrates of patients with HIV infection or carrying out manipulations, it is necessary to apply measures in accordance with the interim instructive and methodological instructions of the Ministry of Health of the Russian Federation "Organization of measures for the prevention and control of AIDS in the RSFSR" dated 22.08.91.

The most real danger of infection occurs when gloves are torn and punctured, which can lead to contact with contaminated material on the skin, possibly with microtraumas, and especially with pricks and cuts. To reduce the likelihood of infection in such cases, it is recommended:

1. When preparing for manipulation in a patient with HIV infection, make sure the integrity of the emergency kit.

2. Perform manipulations in the presence of a second specialist, who, in the event of a rupture of gloves or a cut, can continue to perform it.

3. Treat the skin of the nail phalanges with iodine before putting on gloves.

4. If contaminated material comes into contact with the skin, treat it with 70% alcohol solution, wash with soap and water and re-disinfect with 70% alcohol solution. If an infectious material gets on the mucous membranes, they are immediately treated with a 0.05% solution of potassium permanganate, the mouth and throat are rinsed with 70% alcohol or a 0.05% solution of potassium permanganate. Don't rub!

For injections and cuts, squeeze blood out of the wound and treat the wound with a 5% iodine solution. Prophylactic thymoside (AZT) 800 mg/day for 30 days is recommended.

STAGES OF MEDICAL CARE FOR PATIENTS WITH HIV

For the successful implementation of consistent and adequate assistance to HIV-infected persons, territorial (Republican, regional, regional, city AIDS centers) on their own or with the involvement of the polyclinic network carry out:

Dispensary observation of patients with HIV infection at the place of residence;

Providing medical and diagnostic assistance in outpatient and inpatient settings;

Organization of the provision of specialized assistance;

Organization of therapy and scheduled examinations in accordance with the recommendations of the Russian Ministry of Health and Medical Industry;

Examination of patients within the framework of the federal program of clinical trials of drugs for the treatment of HIV infection;

Referral to the Russian Scientific and Methodological Center for the Prevention and Control of AIDS (Moscow) and the Republican Center for HIV Infection, AIDS and AIDS-Associated Diseases (St. Petersburg) on ​​a planned basis (according to the scheme or individual recommendations) or according to emergency (clinical) testimony;

Coordination of the activities of medical institutions providing assistance to patients with HIV infection in the territory;

Collection and analysis of information on patients with HIV infection in the territory, submitting it to the Russian Scientific and Methodological Center for the Prevention and Control of AIDS (Moscow) in the prescribed form.

Patients with HIV infection are referred to federal-level clinical sites in the following cases:

1. At the initial diagnosis of HIV infection;

2. For hospitalization with clinically severe acute HIV infection (stage II-A);

3. At stage IIB-IIB at least 1 time in 2 years with a level of CD4-lymphocytes > 500 per 1 cu. mm and at least once a year for CD4<500 в 1 куб. мм;

4. At stage IIIA-IIIB at least 1 time per year with a level of CD4-lymphocytes > 200 per 1 cu. mm and at least once every 6 months - with CD4<200 в 1 куб. мм;

5. At stage IIIB - according to clinical indications;

6. When the disease passes from stage IIIA to IIIB or IIIB to IIIC.

Institutions that are not part of the structure of the centers for the prevention and control of AIDS, including the polyclinic network, by means of the doctors of the CIZ (in their absence, the local therapist) under the methodological guidance of the territorial center for the control of AIDS, carry out:

Dispensary observation of patients with HIV infection at the place of residence,

Providing medical and diagnostic assistance on an outpatient basis,

Organization of emergency specialized assistance,

Referral to the Center for the Prevention and Control of AIDS in a planned manner or on an emergency basis.

To improve follow-up and implement succession, all HIV care providers use the same medical history and complete the HIV Patient Exchange Card in accordance with these guidelines.

Deputy Chief

preventive

M.I.Narkevich

Appendix No. 2

to the order of the Ministry of Health

and medical industry

Russian Federation

No. 170 dated August 16, 1994

TYPICAL POSITION

ABOUT THE TERRITORIAL CENTER FOR AIDS PREVENTION AND CONTROL

(REPUBLICAN - REPUBLIC PART OF THE RUSSIAN FEDERATION,

REGIONAL, REGIONAL, CITY)

Has lost its power. - Order of the Ministry of Health of the Russian Federation of 18.04.1995 N 100.

Appendix No. 3

to the order of the Ministry of Health

and medical industry

Russian Federation

SPECIALISTS OF THE TERRITORIAL CENTER

ON AIDS PREVENTION AND CONTROL

1. Department of medical care:

Infectionist

Therapist

Physician psychotherapist

Dermatovenereologist

Obstetrician-gynecologist

Consultants in other specialties may be involved in the provision of specialized medical care.

2. Laboratory division:

Laboratory doctors

Bacteriologist

Immunologist

3. Department of prevention:

Doctors of various specialties

Specialists with higher non-medical education (journalist, translator, artist, sociologist, cameraman, etc.)

epidemiologist

Doctor disinfectionist

Psychologist

Sexologist

Note:

The heads of the centers can make adjustments to the recommended nomenclature depending on the scope of work and specific conditions on the ground.

Deputy Chief

preventive

medicine of the Ministry of Health and Medical Industry of Russia

M.I.Narkevich

Appendix No. 4

to the order of the Ministry of Health

and medical industry

Russian Federation

No. 170 dated August 16, 1994

POSITION

ABOUT PSYCHOSOCIAL COUNSELING ROOM

AND VOLUNTARY HIV TESTING

1. GENERAL PROVISIONS

A room for psychosocial counseling and voluntary HIV testing is organized at the territorial center for the prevention and control of AIDS or as part of a medical facility at the rate of 1 room per 250,000 people.

Voluntary examination is carried out at the request of the applicant, both officially and anonymously.

The activity of the office is based on psychosocial counseling before blood sampling for research and after receiving the preliminary result of the research.

Counseling is a set of preventive and sanitary-educational work carried out in the form of an interview.

The number of staff, the procedure and mode of operation of the cabinet are determined by the head of the medical facility. The doctor of the office must have special training.

The methodological management of the cabinet's activities is carried out by the territorial center for the prevention and control of AIDS.

2. OBJECTIVES OF THE CABINET

Education of the population on safe sexual behavior in terms of preventing the spread of HIV infection.

Providing psychological support to applicants.

Evaluation of the effectiveness of sanitary and educational measures.

3. FUNCTIONAL RESPONSIBILITIES OF THE OFFICE STAFF

3.1. Conducting pre-test counseling:

Determination of the amount of knowledge of the applicant on HIV and AIDS;

Answer the questions of the applicant, providing information about the test itself;

Discuss the likelihood of obtaining a positive, as well as a negative result, consequences and behavior options for the applicant in each situation;

Evaluation, if possible, of the applicant's ability to maintain composure in the event of a positive result;

Persuading the applicant to reappear for subsequent counseling.

3.2. Conducting post-test counseling in case of a negative test result:

Informing the applicant about the presence of a latent period of infection, as the reason for the need for re-testing after 3 months;

Explanation of precautions against contracting HIV infection and other sexually transmitted diseases.

3.3. Conducting post-test counseling with a positive test result:

Explanation of the importance of retesting and the need to continue the examination to obtain a final negative result in the center for the prevention and control of AIDS;

Determining the emotional reaction of the applicant and assessing the likelihood of self-aggression, if possible, discussing these issues with the patient himself;

Convincing the patient of the need to contact the center for the prevention and control of AIDS.

3.4. Issuance of a registration card for each applicant, which indicates the reason for contacting the office, which group according to infection risk factors the applicant belongs to, the nature of advisory measures and their effectiveness.

3.5. Drawing up a weekly (monthly) and at the end of the year final summary and report on the work carried out, submitting them to the territorial center for the prevention and control of AIDS.

Deputy Chief

preventive

medicine of the Ministry of Health and Medical Industry of Russia