These guidelines were prepared by the Ministry of Health and Social Development Russian Federation in accordance with the terms of the Agreement between the Russian Federation and the International Bank for Reconstruction and Development on a loan to finance the project “Prevention, diagnosis, treatment of tuberculosis and AIDS” N 4687-RU in the framework of the preparation of regulations and methodological documents on diagnostics, treatment, epidemiological and behavioral surveillance of HIV/AIDS and related diseases (Order of the Ministry of Health and Social Development of Russia dated April 1, 2005 N 251 “On the creation of a Working Group for the preparation of normative legal acts and methodological documents on the issues of diagnosis, treatment, epidemiological and behavioral surveillance of HIV/AIDS and related diseases )") with the participation of FGUN TsNIIE, Federal Scientific and Methodological Center for the Prevention and Control of AIDS of Rospotrebnadzor and the Department of Organization of HIV/AIDS Surveillance of the Federal Service for Surveillance in the Sphere of Consumer Rights Protection and Human Welfare (Pokrovsky V.V., Goliusov A. T., Ladnaya N.N., Buravtsova E.V.).

I approve Deputy Minister health and social development Russian Federation R. A. Khalfin August 6, 2007 No. 5950-РХ

Introduction

The total number of people living with HIV in the world at the end of 2006 was 39.5 million according to UNAIDS. From the moment the first case of HIV infection was registered in a resident of the Russian Federation in 1987 until December 31, 2006, 373,718 registered cases of HIV infection in Russian citizens and 8,033 in foreign citizens.

In the context of the worldwide evolving HIV pandemic, every country needs information about national characteristics development of the epidemic. Russia, like other countries, needs data on the incidence and prevalence of HIV infection in vulnerable groups and among the general population, as well as information on changes in these indicators to determine trends in the development of the epidemic. This information is required to determine strategies to counter the HIV epidemic and evaluate the effectiveness of preventive interventions.

The exact number of cases of HIV infection is very difficult to establish, and to date, both HIV and AIDS diagnostics are used for epidemiological purposes around the world and there are vastly different HIV/AIDS surveillance systems. The diagnosis of AIDS was introduced even before the discovery of the pathogen, and therefore has priority in a long tradition. Even in countries with a high level of medicine, surveillance based on the diagnosis of AIDS cannot reflect the real situation with HIV infection due to the presence of a long asymptomatic period of HIV infection (on average 8-10 years) before the development of AIDS.

In 1990, WHO, in addition to registering AIDS cases, proposed taking into account information about HIV prevalence and risk behavior of the population in order to obtain more adequate information about the HIV epidemic, since the registration of AIDS led to a lag of information about the epidemic by several years. IN different countries to assess the prevalence of HIV infection, people are examined with varying regularity different groups population, most often pregnant women, donors and patients of sexually transmitted disease clinics. The tool proposed by WHO and UNAIDS for estimating the number of people living with HIV/AIDS (PLWHA) in individual countries is the use of sentinel surveillance systems and further computer modeling of the epidemic.

Sentinel surveillance studies are recommended to be conducted in populations most affected by HIV infection. Second-generation surveillance proposed by WHO and UNAIDS in 2000 recommended strengthening sentinel surveillance data with behavioral studies in the same populations and data on the prevalence of infections with similar modes of transmission.

With the advent of highly active antiretroviral therapy (HAART) in 1996, registration of cases of HIV infection, active HIV testing of the population and clinical monitoring of those infected for timely initiation of therapy became obviously relevant. The consequence of this was the development of a new WHO strategy, aimed in particular at increasing the availability of HIV testing for the population and increasing the scope of HIV counseling and testing, since knowledge of the status helps to obtain treatment and prevent further spread of HIV. “Third generation surveillance for HIV/AIDS/STIs” was proposed in 2003 jointly by WHO, CDC and UNAIDS. It includes: universal testing-based reporting of HIV/AIDS/STI cases, qualitative and quantitative sentinel and behavioral studies in vulnerable groups, resistance surveillance, surveillance of treatment and disease outcomes, and research on the quality of care and treatment received by PLWHA.

In connection with the initiative to treat a large number of people in need "3 by 2005." acquired especially high value in 2003-2004. surveillance of APT, which was proposed to countries by WHO and UNAIDS in 2004. It is particularly relevant in the context of achieving as close to universal access to treatment as possible by 2010. Recent HIV testing policy documents from WHO, UNAIDS and CDC advocate for maximizing public access to HIV testing. In 1999, the United States set the goal of increasing the availability of HIV testing for the population, and since 2003, one of the main goals of the CDC (USA) policy is to sharply reduce the threshold for the availability of HIV testing. It is now recognized that a key component of controlling the spread of HIV infection is for people to receive information about the diagnosis of HIV infection as early as possible. In 2006, WHO Europe recommended that HIV testing and counseling be initiated by health care providers.

To comply with WHO and UNAIDS guidelines, HIV testing for individuals should be:

• confidential,
• accompanied by pre- and post-test counseling,
• carried out only with informed consent. This means that testing is voluntary and based on full information about HIV testing.

In the Russian Federation, the Ministry of Health has developed and continues to function for about 20 years, since 1987, an original system of epidemiological surveillance of HIV infection, which is characterized by:

• A unified systematic collection of data on all cases of HIV infection, AIDS, HIV examinations, changes in the clinical condition of patients and outcomes of HIV infection in all regions of the Russian Federation.
• Mass testing for HIV and active identification of HIV-infected people with mandatory and voluntary testing of the population.
• Mandatory epidemiological investigation of each case of HIV infection (to identify risk factors for infection and carry out anti-epidemic and preventive measures).

In the Russian Federation there is an AIDS prevention service, which includes: more than 100 territorial centers for the prevention and control of AIDS, 6 regional centers, a federal scientific and methodological center, a federal clinical center, more than 1000 HIV diagnostic laboratories and more than 250 anonymous examination rooms. .

In Russia, already in 1988, 9.5 million people were tested for HIV, in 1989 - 6.5 million; from 1990 to 2006 Mass testing for HIV is carried out in the country; 20-24 million people are tested for HIV antibodies per year. From 1990 to the present, the availability of HIV testing in Russia has been universal for the population. Thus, modern approaches to testing recommended by WHO and UNAIDS and recording cases of HIV infection were adopted in Russia about two decades ago. However, at present, the key task in the field of HIV testing in Russia is to ensure that those tested are provided with counseling in accordance with the provisions of the regulatory documents of the Russian Federation.

In accordance with the Federal Law of March 30, 1995 N 38-FZ “On preventing the spread of the disease caused by the human immunodeficiency virus (HIV infection) in the Russian Federation,” testing should be carried out with pre-test and post-test counseling.

In accordance with the rules for medical examination for HIV from 1995, mandatory testing of two groups of Russian citizens is carried out:

• donors of blood, blood plasma, sperm and any other biological fluids, tissues and organs each time a donation is taken.
• Workers of certain professions upon entry to work and during periodic medical examinations:
  • doctors, paramedical and junior medical staff of institutions who have direct contact with HIV-positive people;
  • doctors, paramedical and junior medical personnel of HIV testing laboratories and laboratory testing for HIV-positive people;
  • employees of research institutions, enterprises (productions) for the production of medical immunobiological preparations and other organizations whose work is related to materials containing HIV.

In this case, testing is a necessary precondition for obtaining a particular benefit, position or service. At the same time, the examination of donors is carried out for the purpose of donation safety, and for workers of certain professions - to ensure insurance against cases of occupational HIV infection.

In all other cases, based on the AIDS Act, testing is carried out voluntarily with the informed consent of the patient. Groups recommended to offer HIV testing include:

• patients with clinical indications (patients with a number of clinical indications indicating the presence of HIV);
• patients with a suspected or confirmed diagnosis:
  • IV drug addiction;
  • STD;
  • diseases that meet the criteria for AIDS;
  • hepatitis B, C, Hbs-antigen carriage;
  • pulmonary and extrapulmonary tuberculosis;
• pregnant women in case of collection of abortion and placental blood for further use;
• persons who have household and medical contacts with AIDS patients or seropositive:
  • persons who have had sexual contact with HIV-infected people or those with STIs;
  • healthcare workers who received microtrauma while performing their professional duties;
  • patients in whose care a health worker was injured.

In accordance with the 1990 guidelines, other standard groups for HIV screening testing that were not included in the 1995 guidelines were:

• homo- and bisexuals,
• persons with promiscuous sexual relations,
• prostitutes,
• persons who have been abroad for more than 1 month,
• blood product recipients,
• military personnel,
• persons in prison
• foreign citizens arriving for a period of more than 3 months.

During the epidemiological investigation, contact persons were tested for HIV if a risk of HIV infection was identified.

In subsequent years, various orders and regulations introduced mandatory HIV testing for several other groups of the population, in 1996 - some groups among those in prison, in 1997 - pregnant women, in 1999 - staff of obstetrics and gynecology departments, in 1998 - entering military universities and military service under contract, in 2003 - persons receiving Russian citizenship.

The WHO-recommended method for diagnosing HIV infection is the detection of antibodies to HIV (AT HIV) using an enzyme-linked immunosorbent assay (ELISA). Other methods, such as detection of antigens (HIV Ags) or combinations of AT + HIV Ags, and HIV genetic material (PCR), can be used as auxiliary in certain cases. Recently, rapid tests for detecting antibodies to HIV have become widespread and are recommended by WHO and UNAIDS for use in certain cases.

Currently in Russia, the standard procedure for laboratory diagnosis of HIV infection is the detection of antibodies to HIV using an enzyme-linked immunosorbent assay, followed by confirmation of their specificity in an immune blotting reaction.

Thus, approaches to HIV testing have changed both in the Russian Federation and in the world, and this instruction revises the existing provisions for conducting medical examinations for HIV in the Russian Federation.

General provisions

This manual replaces and supplements the order of the Ministry of Health and Medical Industry of the Russian Federation N 295 of October 30, 1995 “On the introduction of the rules for conducting mandatory medical examination for HIV and the list of workers in certain professions, industries, enterprises, institutions and organizations that undergo mandatory medical examination for HIV" and the corresponding section of the temporary guidelines "Organization of activities for the prevention and control of AIDS in the RSFSR" of 1990.

Rationale and current situation

The revision of existing documents in this area is caused by the emergence of new scientific data on the development of the HIV epidemic in the Russian Federation, as well as the emergence of new domestic and international approaches to the policy of counseling and testing for HIV, prevention, treatment and care for HIV infection.

Currently, a concentrated epidemic of HIV infection is developing in the Russian Federation; in several of the most HIV-affected areas of the country in recent years, there has been a serious threat of the epidemic moving into a generalized stage. By the end of 2006, 0.5% of Russian adults aged 15 to 49 years were officially registered as HIV-infected. In the age group of 18-24 years, 1% of HIV-infected people were registered in the country. Extrapolation of the number of identified cases to the population of the Russian Federation suggests that at least a million people or 1% of the Russian population aged 15-49 years are infected with HIV, and will die from AIDS within the next 10 years if they do not receive modern treatment. Another negative aspect, aggravating the drama of the situation, is that the intensification of sexual transmission of HIV continues, which accounted for 32% of new cases in Russia in 2006 compared to 6% in 2001. In half of the regions of Russia, sexual transmission of HIV in 2005 became the presenter. In this regard, there is an equalization in the proportion of infected men and women. In 2004 and 2006, women made up 44% of new cases. As a result of HIV infection among women, the number of children they have has increased.

Every year, more than 20 million blood samples of Russians are tested for AT in HIV. However, representatives of vulnerable groups of the population make up only 10% of all those tested, and the number of tested representatives of vulnerable groups decreased in 2002-2004. by 30%. This leads to a distortion of the overall picture of the development of the HIV epidemic in Russia.

It is necessary to optimize the structure of population groups involved in HIV testing, taking into account the most vulnerable groups, and ensure control over the implementation of mandatory counseling when testing for HIV infection.

Currently, there is effective treatment for those infected with HIV and schemes for chemoprophylaxis of vertical transmission of HIV infection, which can significantly reduce the risk of transmission of HIV infection from mother to child. HIV-infected citizens of the Russian Federation are provided with free medications for the treatment of HIV infection in accordance with Federal Law of March 30, 1995 N 38-FZ “On preventing the spread of the disease caused by the human immunodeficiency virus (HIV infection) in the Russian Federation” and Federal Law of August 22, 2004 N 122-FZ “On Amendments to Legislative Acts of the Russian Federation and Recognizing Certain Legislative Acts of the Russian Federation as Invalid.”

In 2006, in Russia there was a real prospect of covering a large number of people in need of APT with treatment. Funds for the treatment of HIV infection in Russia were allocated both within the framework of the Priority National Health Project and within the framework of several international projects, which include two projects under grants provided by the Global Fund to Fight AIDS, Tuberculosis and Malaria, the Loan project World Bank, and other projects.

A guarantee of the state in accordance with Federal Law N 38-FZ, in addition to providing treatment for HIV-infected people, is also the availability of a medical examination to identify HIV infection, including anonymous, with preliminary and subsequent consultation and ensuring the safety of such a medical examination for both the person being examined and and for the person conducting the examination.

Global experience in combating the HIV epidemic has examples of effective prevention programs aimed at reducing behavioral risks among the population. During pre-test and post-test counseling, specialists have a unique opportunity to provide the necessary knowledge on HIV infection to a large number of the country's population and promote behavior change to one that is safe and less dangerous in terms of contracting HIV infection. Pre- and post-test counseling should be tailored to the different populations being tested for HIV and meet the needs of individuals undergoing HIV testing.

Currently, various methods for detecting HIV, HIV antigens and genetic material, as well as methods for detecting antibodies to HIV are used for laboratory diagnosis of HIV infection. All of these techniques have varying effectiveness, require different equipment and different levels personnel training. The most studied and convenient from a practical point of view, as well as the most economical, remains the diagnosis of HIV infection by detecting antibodies to HIV. Enzyme-linked immunosorbent assay (ELISA) provides extensive research, but allows for the possibility of false-positive results, therefore, to make a diagnosis of HIV infection, the specificity of positive results is confirmed using the immunoblotting (IB) method with HIV antigens in the Western Blot modification. However, even with the high sensitivity and specificity of laboratory techniques, the possibility of false-positive and false-negative results remains. False-positive cases include testing of children born to HIV-infected mothers who have maternal antibodies to HIV at birth. False-negative results include cases of testing recently infected people with HIV, seroconverters, who, during the “seronegative window”, in the presence of the human immunodeficiency virus in their blood, have not yet developed antibodies to HIV in sufficient quantities for detection. Specific antibodies to HIV are formed soon after infection, but the exact time of their appearance depends on several factors, including the characteristics of the host and the virus; most often, antibodies to HIV are detected 3 months after infection. Antibodies may be present in the early stages of infection, but their concentration may be below the detection limit of the methods used.

With first-generation tests, antibodies could be detected in most individuals 6 to 12 weeks after infection. Newer generations of tests, including third-generation sandwich antigen tests, can detect antibodies as early as 3-4 weeks after infection. The latest generation of tests, which simultaneously detect antigens and antibodies to HIV, can further increase the analytical sensitivity of the method. The advantages of performing both antibody and antigen testing are justified by the need to identify individuals who have seroconverted not only among blood donors, but also in connection with certain clinical situations. Fourth generation ELISAs, due to their ability to detect p24 antigen, are valuable for detecting infection in the early stages.

The latent period - the "window period" - can be shortened by several days using antigen detection tests, and by several more days by isolating the proviral DNA of the virus. Therefore, the window period may only last 2 to 3 weeks if a comprehensive HIV detection strategy is used. Thus, by combining different methods for detecting HIV, a fairly high diagnostic efficiency is achieved.

In Russia, the standard procedure for laboratory diagnosis of HIV infection is the detection of antibodies to HIV in ELISA with mandatory subsequent confirmation of their specificity in the immune blotting reaction.

Purpose of the instructions

This instruction is intended for specialists from centers for the prevention and control of AIDS, managers and practitioners of state, municipal and private healthcare institutions providing medical care to the population, and wide range specialists dealing with the problem of HIV infection.

This document sets out guidelines for referring the population for HIV counseling and testing, and provides procedures for conducting HIV screening of the population of the Russian Federation. The rules for conducting compulsory medical examination for HIV, given in the appendix to this document, establish a unified procedure for HIV testing of citizens of the Russian Federation, foreign citizens and stateless persons in the Russian Federation to ensure preventive, anti-epidemic measures and timely effective treatment of HIV infection.

This document can be useful for various types of HIV testing, both for mandatory testing, which is carried out for the purposes of donation safety or insurance against cases of occupational HIV infection, and for voluntary testing of the general population and people from vulnerable groups.

Goals and objectives of screening for HIV infection of the population of the Russian Federation

The purpose of testing for HIV infection is to establish the HIV status of patients, as well as serological screening for the presence of antibodies to HIV for surveillance, anti-epidemic and preventive measures.

Determining the fact of HIV infection (and even suspicion of it) leads to important consequences. The success of anti-epidemic measures depends on its timeliness, for example, preventing the transmission of HIV through donated blood or prescribing chemoprophylaxis for the vertical transmission of HIV infection. On the other hand, an incorrect diagnosis of HIV infection can cause severe mental trauma for the patient and those close to him. Determining the clinical diagnosis of HIV infection is carried out mainly with the aim of providing the patient with adequate medical care. Of particular value is counseling the subject on HIV infection issues.

Diagnosis of HIV infection must necessarily be preceded by counseling of the subject, which has both therapeutic, preventive and anti-epidemic significance. Individual counseling is an extremely important element of preventive work with the population. The consultation provides information about HIV infection, modes of transmission and prevention measures, psychologically prepares the patient for a possible message about the diagnosis of HIV infection, helps to improve the subsequent mutual understanding of the patient with medical personnel and, even if the diagnosis of HIV is not confirmed, is important for preventing possible infection or further spread of HIV.

The objectives of testing for HIV infection are:

• early diagnosis of HIV infection cases for timely initiation of treatment and prevention;
• training the population in safe behavior during pre-test and post-test counseling;
• preventing new cases of HIV infection by identifying HIV-infected individuals during testing of donors and pregnant women and taking appropriate measures;
• determination of prevalence and incidence to monitor the epidemic, develop and evaluate the effectiveness of preventive measures.

Serological screening for HIV antibodies can be carried out either as ongoing routine screening of certain population groups or as periodic screening of samples as part of sentinel surveillance. A separate document is devoted to second-generation surveillance studies, including behavioral studies, so unlinked anonymous testing and other testing of sentinel surveillance samples will not be discussed in this guidance. In addition to HIV testing, biological methods for obtaining epidemiological information regarding HIV infection include molecular genetic studies, immunological and microbiological diagnostics of the clinical condition of an HIV-infected person; a description of these methods is also given in other documents.

Voluntary testing is carried out both for the purpose of pre-test and post-test counseling, during which the patient is provided with information about measures to prevent HIV infection, and for the purpose of establishing a diagnosis. Voluntary testing for HIV antibodies is carried out at the initiative of the patient or health care worker, and voluntary confidential testing for HIV antibodies can be carried out. In this case, the identity of the person being tested is known to a limited number of people. There is also voluntary anonymous testing for AT to HIV - in this case, the sample is encoded with a digital code, and there is no personal data of the person being examined. The test taker can anonymously get the result using the code. If desired, the examinee can receive a certificate of HIV testing; the certificate contains the passport data of the examinee if confidential testing was carried out or a digital code if an anonymous examination was carried out.

Principles of HIV testing in Russia:

• Confidentiality of information about HIV antibody testing must be ensured. Personalized information about all persons undergoing or having been tested for HIV must remain confidential. Personalized information about HIV testing can only be provided with the personal consent of the person being tested.
• HIV testing should be carried out after obtaining the informed consent of the person being tested. HIV testing should be done voluntarily, not forced. Before obtaining consent for testing, the subject must be provided with information about the benefits and consequences of HIV testing, the right to refuse HIV testing, subsequent medical services that will be provided if HIV infection is detected, routes of transmission of HIV infection and measures to prevent HIV infection, in particular, for example, about measures to prevent infection of regular or casual sexual partners. Cases of exclusion from this paragraph include testing of donors, workers of certain professions, pregnant women and children born to HIV-infected mothers. The principles of HIV testing for these groups are given in paragraph 3.
• Testing of donors, workers of certain professions and pregnant women and children born to HIV-infected mothers is mandatory. In this case, donor screening is carried out to prevent HIV infection of recipients. Workers in certain professions are examined to ensure insurance against cases of occupational HIV infection. Individuals who do not wish to undergo HIV testing may refuse these activities. Testing pregnant women for HIV is carried out to initiate timely chemoprophylaxis, prevent the transmission of HIV infection from mother to child, and protect the rights of the child. Testing of children born to HIV-infected mothers is carried out to ensure timely diagnosis of HIV infection, to provide them with timely medical care and to protect the rights of a child who is unable to make any decision about HIV testing.
• Consent or refusal to be tested for HIV should not affect the quality of medical care. Informed consent for HIV testing must be obtained in writing. A sample informed consent is provided in the appendix.
• When testing for HIV, it is necessary to provide the opportunity for confidential HIV testing or anonymous testing at the choice of the person being tested. With anonymous testing, the patient receives information about his own HIV status and can decide to go to a medical facility for treatment or use safer behavior in terms of HIV transmission. If the person being examined has no preference, confidential HIV testing is recommended for him to receive adequate medical care in the future.
• Testing must be carried out on the basis of current regulatory documents, in particular the approved “Rules for mandatory medical examination for the detection of human immunodeficiency virus (HIV infection)” and in compliance with the laws of the Russian Federation.
• HIV testing and counseling must be acceptable and tailored to the population, including vulnerable groups. To reach vulnerable groups and offer them HIV testing, it is possible to use not only health facilities, but other points of access to communities and opening hours that are more suitable for vulnerable groups.
• HIV counseling and testing must be guaranteed to provide quality services. For this purpose, external and internal quality control of laboratory tests and counseling on HIV infection is carried out.

The principles of counseling for HIV testing are outlined in the instructions for counseling for HIV infection.

Methods for laboratory diagnosis of HIV infection

The standard method for diagnosing HIV infection in Russia is the determination of antibodies to HIV. To conduct this study, commercial diagnostic kits are used, registered and approved by the Ministry of Health of the Slovak Republic of the Russian Federation for use on the territory of the Russian Federation, which allow the determination of antibodies to HIV-1 and HIV-2 of all known subtypes. The set of antigens in these tests is constantly updated, the sensitivity of the test is more than 99.5%. In the laboratory diagnosis of HIV, the presence of specific antibodies indicates that infection has occurred. The results of the analysis are usually assessed as positive or negative. Although the tests used for screening are extremely sensitive, they lack a sufficient degree of specificity. Reasons for a false-positive result may be the presence in the serum of antibodies to HLA class II autoantigens and other autoantigens, liver disease or recent vaccination, etc. Therefore, sera that are reproducibly positive during screening should be tested using a confirmatory method (immune blot) or a group of confirmatory methods, including immunoblot.

In Russia, for mass screening of the population, the ELISA method is used at the first stage and confirmatory immune blotting is used when a positive result is obtained in the ELISA at the first stage. The results of serological studies are used by epidemiologists and practitioners to diagnose HIV infection, identify the source, routes of transmission of HIV infection and timely implementation of preventive, anti-epidemic measures and assistance to the infected person. The diagnosis of HIV infection cannot be made based on laboratory testing alone. To make a diagnosis of HIV infection, it is necessary to use laboratory, epidemiological and clinical criteria.

Positive HIV test results

The result of HIV testing is considered positive when a positive immunoblotting test is obtained. A confirmed positive result means that the person is infected with HIV. Persons who test positive for HIV using ELISA are barred from donation indefinitely. False positive results are very rare. They may be associated with an error by the health care facility that collected and transported the material for research, or an error by the laboratory. When patients with a positive immunoblot test result are taken to the dispensary, a primary examination is carried out, including blood sampling and testing the sample for AT to HIV in an ELISA to verify the positive results of HIV testing and exclude the possibility of contamination of the sample and a false-positive result. The tactics for testing children for HIV who inevitably have a false positive test result in ELISA and IB in the first months of life are given in the instructions on the vertical transmission of HIV infection.

Negative HIV testing results

The result of HIV testing is considered negative if there are no detected antibodies to HIV in ELISA and IB. A negative result means there is a high probability that the person is not infected with HIV. A person at low risk of HIV infection who tests negative for HIV is told that there is a high probability of not having HIV infection and is not advised to test again in the near future. A person with a recent high risk of HIV infection and a negative HIV test result is told that the HIV test result is negative, but after explaining the existence of a “seronegative window” period, they are advised to retest for HIV after 3 months. A person with a recent high risk of HIV infection and a negative HIV test result in the IB and a positive ELISA test result is informed of a negative HIV test result, but, explaining the existence of a “seronegative window” period, is recommended to undergo repeated HIV testing in 1-3 months . Persons who test positive for HIV using ELISA are barred from donation indefinitely.

Questionable (uncertain) HIV test results

If a questionable result is obtained in the IB, patients are advised to undergo a repeat HIV test to verify the result after 1-3 months and be observed for 6 months. If, during a re-examination after 1 month, a questionable test result is obtained in the IB, it is highly likely that the person is not infected with HIV.

If, after 6 months, indeterminate results are again obtained (no reaction with the HIV-1 and HIV-2 env proteins) and there is no data on the recent risk of HIV infection and clinical symptoms of HIV infection, we can conclude about a nonspecific reaction and give an answer to the subject about the absence of HIV infection. Persons who have a positive HIV test result in ELISA and/or a questionable test result in IB are barred from donation indefinitely.

While the final result of HIV testing is unknown, people with an equivocal result should receive information about the meaning of that result. Recommendations for behavior change should be the same as for people living with HIV.

Until 2007, PCR was not approved in the Russian Federation as a laboratory method for diagnosing HIV infection. At the same time, with a combination of epidemiological, clinical criteria and PCR results, it is possible to draw a conclusion about the presence of HIV infection in individuals with a false-positive, false-negative or questionable result in ELISA and IB. If there are epidemiological criteria indicating a recent risk of HIV infection for patients and at the same time presumably false-positive or false-negative results in ELISA and IB, for example, when examining children born from HIV-infected mothers or patients in the “seronegative window” period, the PCR method is used , in which HIV gene material is detected. When choosing a PCR method, it is also necessary to determine the feasibility of detecting RNA or DNA of the human immunodeficiency virus using various types PCR.

State guarantees when testing for HIV infection in the Russian Federation

This section provides state guarantees regarding HIV testing to obtain easier access to this information and prevent cases of violation of the rights and freedoms of the population. State guarantees are provided in accordance with Federal Law No. 38-FZ, 1995 “On preventing the spread of the disease caused by the human immunodeficiency virus (HIV infection) in the Russian Federation.”

Chapter II. Medical care for HIV-infected people

Article 7. Medical examination [show] .

1. Medical examination is carried out in institutions of the state, municipal or private healthcare system and includes, inter alia, appropriate laboratory research, which is carried out on the basis of a license granted in the manner established by the legislation of the Russian Federation.
2. The issuance of an official document confirming the presence or absence of HIV infection in the person being examined is carried out only by institutions of the state or municipal health care system.
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.
4. A person undergoing a medical examination has the right to have his legal representative present. Registration of a representative office is carried out in the manner established by the civil legislation of the Russian Federation.
5. Medical examination of minors under 14 years of age and persons recognized as established by law 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 consultation on the prevention of HIV infection.
7. In institutions of the state and municipal health care systems, medical examinations of citizens of the Russian Federation are carried out free of charge.

Article 8. Voluntary medical examination [show] .

1. Medical examination in institutions of state, municipal and private health care systems is carried out voluntarily at the request of the person being examined or with his consent, and in the cases specified in paragraph five of Article 7, at the request or with the consent of his legal representative.
2. At the request of the person being examined, a voluntary medical examination may be anonymous.

Article 9. Mandatory medical examination [show] .

1. Donors of blood, biological fluids, organs and tissues are subject to mandatory medical examination.
2. Persons who refuse compulsory medical examination cannot be donors of blood, biological fluids, organs and tissues.
3. Employees of certain professions, industries, enterprises, institutions and organizations, the list of which is approved by the Government of the Russian Federation, undergo a mandatory medical examination to detect HIV infection during mandatory pre-employment and periodic medical examinations.
4. The rules in accordance with which mandatory medical examination of persons is carried out in order to protect public health and prevent the spread of HIV infection are established by the Government of the Russian Federation and are revised by it at least once every five years.
5. The rules for compulsory medical examination of persons in places of deprivation of liberty are established by the Government of the Russian Federation and are revised at least once every five years.

Article 10. Conditions of entry into the Russian Federation for foreign citizens and stateless persons [show] .

1. Diplomatic missions or consular offices of the Russian Federation issue a Russian visa for entry into the Russian Federation to foreign citizens and stateless persons arriving in the Russian Federation for a period of more than three months, subject to their presentation of a certificate of absence of HIV infection, unless otherwise established by international treaties of the Russian Federation. This provision does not apply to employees of diplomatic missions and consular offices of foreign states, employees of international intergovernmental organizations and members of their families (as amended by Federal Law No. 112-FZ of August 12, 1996).
2. The requirements for this certificate are established by the Government of the Russian Federation.

Article 11. Consequences of detection of HIV infection [show] .

1. Citizens of the Russian Federation, if they are diagnosed with HIV infection, cannot be donors of blood, biological fluids, organs and tissues.
2. If HIV infection is detected in foreign citizens and stateless persons located on the territory of the Russian Federation, they are subject to deportation from the Russian Federation in the manner established by the legislation of the Russian Federation.

Article 12. Right to repeated medical examination [show] .

A person who has undergone a medical examination has the right to a second medical examination in the same institution, as well as in another institution of the state, municipal or private health care system of his choice, regardless of the period that has passed since the previous examination.

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

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, of guarantees of respect for the rights and freedoms of HIV-infected people, as well as of criminal liability for HIV infection. at risk of infection or infection of another person.
2. If HIV infection is detected in minors under the age of 18, as well as in persons recognized as legally incompetent, employees of the institutions specified in paragraph one 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 people when providing them with medical care [show] .

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

Article 15. Prevention, diagnosis and treatment of HIV infection [show] .

The relevant federal executive authorities coordinating scientific research ensure the development and implementation of modern methods of prevention, diagnosis and treatment of HIV infection, and also submit for approval by the Government of the Russian Federation a draft federal target program aimed at preventing the spread of HIV infection in the Russian Federation.

Article 16. Responsibilities of administrations of state, municipal and private health care systems when providing medical care to HIV-infected people [show] .

Administrations of state, municipal and private healthcare institutions providing outpatient and inpatient medical care are obliged to create conditions for the implementation of the rights of HIV-infected persons provided for by this Federal Law, as well as to prevent the spread of HIV infection.

Consequences of identifying HIV infection

Chapter III. Social protection of HIV-infected people and members of their families
Article 17. Prohibition on restricting the rights of HIV-infected people [show] .

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

Rules for conducting mandatory medical examination to detect human immunodeficiency virus (HIV infection)

The current Rules establish a unified procedure for mandatory medical examination of citizens of the Russian Federation, foreign citizens and stateless persons in order to prevent the spread of the disease caused by the human immunodeficiency virus (HIV) in the Russian Federation and to ensure timely and effective treatment.

Mandatory and voluntary medical examinations to detect HIV infection are carried out free of charge for persons subject to examination.

Diagnostic drugs for detecting HIV infection are provided to treatment and prevention institutions that carry out such examinations at the expense of federal, regional and municipal budgets.

The need for diagnostic drugs to detect HIV infection is determined on the basis of consolidated applications submitted by the constituent entities of the federation annually to the Federal Service for Surveillance in the Sphere of Consumer Rights Protection and Human Welfare.

The following are subject to mandatory medical examination to detect HIV infection:

• donors of blood, blood plasma, sperm and other biological fluids, tissues and organs - each time donation is taken;
• employees of certain professions, industries, enterprises, institutions and organizations during mandatory pre-employment and periodic medical examinations;
• pregnant women (at the initial visit to a medical institution regarding pregnancy, at 30-34 weeks of pregnancy and if no examination has been previously carried out upon admission for childbirth);
• children born to HIV-infected mothers (at birth, 12 and 18 months);
• foreign citizens and stateless persons, when applying for a citizenship permit or residence permit, or work permit in the Russian Federation;
• persons entering military educational institutions and military service under contract.

A person undergoing a mandatory or voluntary medical examination has the right to have his legal representative present. Registration of a representative office is carried out in the manner established by the civil legislation of the Russian Federation.

Mandatory and voluntary medical examinations to detect HIV infection are carried out in medical institutions of state, municipal and private health care systems that are licensed to conduct such examinations.

Medical institutions conducting medical examinations to detect HIV infection ensure the safety of such examination, both for the person being examined and for the person conducting the examination, in accordance with established regulations and standards.

The methodology and technology for conducting a mandatory medical examination to detect the human immunodeficiency virus are determined by the Ministry of Health and Social Development of the Russian Federation.

Mandatory and voluntary medical examination to detect HIV infection must be carried out with mandatory preliminary and subsequent counseling on the prevention of this disease.

At the request of the person being examined, a voluntary medical examination may be anonymous. With anonymous testing, the patient is assigned a digital code.

The issuance of an official document confirming the presence or absence of HIV infection in the person being examined is carried out only by institutions of the state or municipal health care system. If desired, the examinee can receive a certificate of HIV testing; the certificate contains the passport data of the person examined if confidential testing was carried out or a digital code if an anonymous examination was carried out.

A person who has undergone a mandatory or voluntary medical examination to detect HIV infection is notified by an employee of the institution that conducted the medical examination of its results in the manner established by the Ministry of Health and Social Development of the Russian Federation.

A person who has passed a mandatory or voluntary medical examination has the right to a second medical examination in the same institution, as well as in another institution of the state or municipal health care system of his choice, regardless of the period that has passed since the previous examination.

Medical workers and other persons who, in connection with the performance of official or professional duties, become aware of information about the results of a medical examination to detect HIV infection, are obliged to keep this information confidential.

For the disclosure of information constituting medical confidentiality, persons to whom this information became known in connection with the performance of their official or professional duties are liable in accordance with the legislation of the Russian Federation.

Persons who have been diagnosed with HIV infection are subject to further medical examination in order to establish the stage of the disease and be provided with antiretroviral drugs for the treatment of HIV infection and chemoprophylaxis of vertical transmission of HIV infection.

Antiretroviral drugs for the treatment of HIV infection are provided to medical institutions providing such treatment at the expense of federal and regional budgets.

The need for antiretroviral drugs for the treatment of HIV infection is determined on the basis of consolidated applications submitted annually by constituent entities of the federation to the Federal Service for Surveillance on Consumer Rights Protection and Human Welfare.

Persons who have been diagnosed with HIV infection or who have refused compulsory medical examination are indefinitely barred from donating blood, blood plasma, sperm, or other biological fluids, tissues and organs.

If HIV infection is detected in workers of certain professions, industries, enterprises, institutions and organizations, these workers are subject, in accordance with the legislation of the Russian Federation, to transfer to another job that excludes conditions for the spread of HIV infection.

If an employee refuses to undergo a mandatory medical examination to detect HIV infection without good reason, he or she is subject to disciplinary action in the prescribed manner.

Appendix 2 provides information on the recommended frequency of testing for HIV antibodies various groups population, including those with questionable HIV testing results. Involving the population in HIV testing and testing representatives of these groups must comply with the principles of HIV testing in Russia outlined earlier.

Monitoring and assessing the quality of HIV counseling and testing services provided

External assessment of the quality of laboratory diagnostics is carried out in accordance with the instructions of the Ministry of Health and Social Development.

All laboratory staff must be trained in the diagnosis of HIV infection, external and internal assessment of the quality of laboratory diagnostics. Personnel providing referrals for HIV testing and counseling should also receive appropriate training in Russia's HIV testing and counseling policies.

Monitoring and assessment of the quality of activities to combat AIDS, including this type of activity, is carried out by collecting and analyzing key national indicators of the effectiveness of activities ensuring control over the HIV/AIDS epidemic in the Russian Federation. Such indicators in the field of HIV testing include:

1. The amount of public funds spent on activities aimed at preventing the spread of HIV/AIDS in the Russian Federation - in the HIV testing section.
2. The number of representatives of risk groups who have been tested in the last 12 months and are aware of the test result.
3. Percentage of HIV-infected children born to HIV-infected mothers.
4. HIV prevalence among:
   • injection drug users
   • persons providing sexual services for a fee
   • men having sex with men
   • prisoners.
5. HIV prevalence among pregnant women.

Monitoring and evaluation of the quality of HIV counseling and testing services provided should be carried out on a regular basis in the following areas:

• availability and compliance of the services provided in the institution/organization with the existing charter and license,
• availability of personnel trained in HIV diagnosis and counseling,
• availability of necessary premises, equipment and information materials,
• compliance with the principles of HIV testing in Russia and the instructions of the Ministry of Health and Social Development of the Russian Federation for testing and counseling,
• compliance of the procedures for collection, processing and disposal of biological samples with the instructions of the Ministry of Health of the Slovak Republic of the Russian Federation and the requirements of the sanitary and epidemiological regime,
• availability of written informed consent from patients for HIV testing,
• accessibility of HIV counseling and testing services for the population and adequacy of information materials to target groups,
• coverage of vulnerable groups with HIV testing and counseling,
• maintaining and storing documentation and reporting materials, including security issues,
• availability of adequate funding for this type of activity.

Most of the parameters outlined can be assessed by analyzing documentation; to analyze some parameters, it is advisable to conduct research that includes surveys among population groups.

Data collection, storage and analysis

Data on HIV testing and those tested must be collected in accordance with the forms of registration and reporting documentation approved in the Russian Federation. A set of forms for recording and reporting documentation for HIV testing is presented in the instructions “Statistical forms for recording information about persons tested for HIV antibodies.” Registration forms must be entered into the HIV survey database, where mathematical processing of the results and analysis of the results is carried out. Every month, after reporting forms No. 4 are generated within the time limits approved by orders of the Ministry of Health of the SR RF and Rosstat, this documentation is sent to the Federal Scientific and Methodological AIDS Center. The Federal AIDS Center analyzes information about HIV testing in the Russian Federation and disseminates this information within the time frame and volume approved by orders of the Ministry of Health of the Slovak Republic of the Russian Federation and Rosstat.

Ensuring data quality is an ongoing process and the responsibility of HIV testing managers and staff.

The priorities for storing data are their timely registration, entry into the database, maintaining confidentiality and security of data storage. Forms of registration and reporting of those tested for HIV antibodies are kept securely for 20 years, after which they are destroyed.

Confidentiality

The basic principle of HIV testing is to maintain the confidentiality of information about testing for HIV antibodies. Personal information about all individuals undergoing or who have been tested for HIV must remain confidential. Personalized information about HIV testing can only be provided with the personal consent of the person being tested.

Dissemination of results

The results of HIV testing in Russia are aimed at specialists in the field of combating the HIV epidemic and at the general population. The results are planned to be disseminated in the form of government statistics and scientific articles by all possible means, including publication and presentation of data at meetings at various levels.

Prepared by the Federal Scientific and Methodological Center for the Prevention and Control of AIDS together with the Department of HIV/AIDS Surveillance of the Federal Service for Surveillance in the Sphere of Consumer Rights Protection and Human Welfare based on current regulatory and methodological documents in the field of HIV infection in Russia and WHO publications , UNAIDS, CDC, 2006.

Bibliography [show] .

1. UNAIDS. Development of the AIDS epidemic: December 2006. UNAIDS/06.29R, AIDS epidemic update: December 2006.
2. Global Program on AIDS "Guidelines for Monitoring infection in population", WHO, February 1990.
3. Guidelines for second generation HIV surveillance, 2000 WHO, UNAIDS.
4. Global Health Sector Strategy for HIV/AIDS, 2003-2007. Providing a framework for partnership and action, Geneva, WHO, 2003.
5. The Third generation HIV/AIDS/STI surveillance: a summary presentation of the guidelines, Bilari Camara, 2003.
6. Patient monitoring guidelines for HIV care and antiretroviral therapy(ART) WHO, UNAIDS, 2005.
7. Guidelines for Conducting HIV Sentinel Serosurveys among Pregnant Women and Other Groups WHO, UNAIDS, CDC, December 2003.
8. UNAIDS/WHO Policy Statement on HIV Testing, June 2004.
9. Technical Meeting for the Development of a Framework for Universal Access to HIV/AIDS Prevention, Treatment and Care in the Health Sector, Geneva 18-20 October 2005.
10. Revised Guidelines for HIV Counseling, Testing, and Referral, Technical Expert Panel Review of CDC HIV Counseling, Testing, and Referral Guidelines February 18-19, 1999 Atlanta, Georgia.
11. The PRN Notebook, 2003 March.
12. Guidance on provider-initiated HIV testing and counseling in health-care settings, WHO/UNAIDS, 2006.

Code	Contingents	Duration of observation and frequency of examination	Responsible for consulting, providing recommendations to undergo testing and collecting material
119	Examined according to plan
108	Donors (blood, body fluids, organs and tissues)	Every time you donate blood or any other donation materials	Chief doctors of the SPC, OPK, heads of health care facilities at the place of collection of the material
109	Pregnant	At the initial visit to a medical institution regarding pregnancy, at 30-34 weeks of pregnancy and if a previous examination was not carried out upon admission for childbirth	Chief doctors of health care facilities providing care to pregnant women
115	Medical personnel working with HIV-infected or HIV-infected materials	Once a year during medical examination	Chief doctors of health care facilities
124	Children born to HIV-infected mothers	At birth, 12 and 18 months	Chief doctors of health care facilities providing care to children born from HIV-infected mothers
126	Examined voluntarily with the informed consent of the patient
102	Intravenous drug users, including those with drug addiction or abusing drugs with harmful consequences	Once a year if there is a history of drug use	Chief doctors of drug dispensaries, clinics with drug treatment rooms, heads of institutions and organizations providing assistance to drug users.
103	Men who have sex with men (MSM)	1 time per year	Chief doctors of health care facilities, heads of institutions and organizations providing assistance to MSM
104	Patients with sexually transmitted diseases	At diagnosis or symptoms of an STI and after 6 months	Chief physicians of the Clinical Institution, heads of health care facilities providing assistance to patients with STDs
105	Persons engaged in the provision of commercial sexual services (CSS)	Once every 3 months if there is a practice of providing commercial sexual services	Heads of health care facilities providing assistance to the RAC
106	Persons with a large number of sexual partners	Upon application and after 6 months	Heads of healthcare facilities conducting voluntary HIV testing and providing assistance to the population
111	Persons conscripted for military service, entering service under a contract, applicants to military educational institutions	When conscripted for compulsory military service, entering service under a contract, applicants to military universities	Heads of institutions of the Medical Service of the Moscow Region
112	Persons in prison	Upon initial admission to prison and after 12 months. If the prisoner belongs to one of the groups recommended for testing, in accordance with the indications for this group.	Heads of medical service institutions of the Federal Penitentiary Service
113	Patients with a number of clinical indications indicating the presence of HIV or with a suspected or confirmed diagnosis of an AIDS-defining disease	If there are clinical symptoms of HIV infection or AIDS-defining diseases when seeking medical help	Chief doctors of health care facilities providing medical care to the population
114	Viral hepatitis B, Hbs-antigen carriage, hepatitis C		Chief doctors of health care facilities
116	Pulmonary and extrapulmonary tuberculosis	At diagnosis and after 6 months	Chief doctors of health care facilities
127	Surveyed anonymously		Chief doctors of health care facilities
128	Examined voluntarily at the patient’s initiative (without other reasons for HIV testing)	When contacting for examination	Chief doctors of health care facilities
120	Those examined during an epidemiological investigation	If contact is identified as a result of which HIV infection could occur, 3, 6, 12 months after the last contact
121	Heterosexual partners of people infected with HIV		Chief doctors of AIDS Centers responsible for the problem of HIV/AIDS
122	Homosexual partners of people infected with HIV	The same as for code 120, in the presence of ongoing risky contacts, once a year.	Chief doctors of AIDS Centers responsible for the problem of HIV/AIDS
123	Partners in IV Drug Administration	The same as for code 120, in the presence of ongoing risky contacts, once a year.	Chief doctors of AIDS Centers responsible for the problem of HIV/AIDS
125	In-hospital contact with an HIV-positive person		Chief doctors of AIDS Centers responsible for the problem of HIV/AIDS
127	Recipient of blood, fluids, organs from an HIV-positive donor	If contact is identified, after 3, 6, 12 months. after receiving donor material.	Chief doctors of AIDS Centers responsible for the problem of HIV/AIDS
128	Other contact with someone who is HIV-positive and at risk of contracting HIV	If contact is identified, after 3, 6, 12 months. after contact.	Chief doctors of AIDS Centers responsible for the problem of HIV/AIDS
200	Foreign citizens and stateless persons	When applying for a citizenship permit or residence permit or work permit in the Russian Federation	Heads of Immigration Departments

Frequency of examination of persons undergoing dispensary observation before diagnosis

Appendix No. 2.

Informed consent for HIV testing

I (Last Name, First Name, Patronymic) ______ year of birth, hereby confirm that, based on the information provided to me, freely and without coercion, reporting the consequences of the examination, I decided to undergo testing for HIV antibodies. For this purpose, I agree to take a blood test of approximately 5 ml. During the blood collection process, a single needle stick will usually be necessary. This procedure may involve some discomfort, including possible bruising at the injection site.

I confirm that I have been told why it is important to get tested for HIV, how the test is performed, and the consequences of HIV testing.

I am informed that:

• Testing for HIV can be done at the AIDS Center and other medical institutions; testing, at the voluntary choice of the person being tested, can be voluntary anonymous (when you do not need to provide your name and personal data, and only the person being tested can find out the result by code) or confidential (in this case, testing is carried out using an identification document, and the result will be known to the person being examined and the attending physician). In public medical institutions, HIV testing is provided free of charge.
• The presence of HIV antibodies is evidence of HIV infection. But there is a period of “seronegative window” (the period of time between HIV infection and the appearance of antibodies to HIV, the presence of which can be determined in a laboratory). During this period, the person is already infected and can infect others, but HIV antibodies are not detected in a blood test; this period is usually 3 months.
• Currently in Russia there is free treatment for all those infected with HIV who need it, to receive it you need to contact the territorial AIDS center. Treatment significantly prolongs life and improves quality of life with HIV infection. It is important for HIV-infected pregnant women to contact an AIDS center in time and start taking special medications to prevent infection of the unborn child.
• HIV infection is transmitted in only three ways:
  • during sexual intercourse without a condom;
  • through blood, during medical or non-medical procedures. Most often, infection through this route occurs through the use of unsterile equipment for drug use;
  • from an HIV-infected mother to her child during pregnancy, childbirth and breastfeeding.

HIV infection in everyday life does not occur through shaking hands, using shared utensils, a swimming pool, a toilet, or through insect bites.

You can protect yourself from HIV infection if you do not have dangerous contacts (contacts with blood or genital secretions, breast milk) with people infected with HIV or people with unknown HIV status. Throughout life, depending on personal circumstances and beliefs, in order to avoid contracting AIDS, a person can use different methods of contraception. For example, always use condoms or have only sexual partners who are not infected with HIV. To avoid infection through blood when the integrity of the skin is damaged, you can use only sterile instruments.

HIV testing results are not provided over the phone. They are communicated by the consultant during post-test counseling.

If you have any questions, please contact your regional AIDS center.

1. Developed by the Federal Budgetary Institution “Central Research Institute of Epidemiology” of Rospotrebnadzor (V.V. Belyaeva).

2. Approved and put into effect by the head of the Federal Service for Supervision of Consumer Rights Protection and Human Welfare, Chief State Sanitary Doctor of the Russian Federation G.G. Onishchenko August 20, 2013

3.1.5. EPIDEMIOLOGY. PREVENTION
INFECTIOUS DISEASES. HIV INFECTION

Pre- and post-test counseling
How to prevent HIV transmission

1 area of ​​use

Guidelines are intended for specialists conducting screening of the population for markers of HIV infection, specialists in the field of HIV infection prevention, health care managers, employees of AIDS service organizations, and can also be used in training students of medical educational institutions and in the process of postgraduate education.

2. Basic provisions

2.1. HIV infection is a disease whose spread is associated with human behavior. Therefore, disease prevention is based on changing people's behavior.

2.2. To help change people's behavior towards HIV infection, it is necessary to:

Draw attention to the problem of HIV infection;

Make it meaningful to specific people;

Cause an emotional response to the problem of HIV infection;

Improve knowledge about HIV infection;

Help assess the individual risk of this disease;

Show ways of less dangerous behavior;

Stimulate decision making to change behavior;

Provide support.

2.3. Addressing these challenges requires the introduction of innovative, practical, effective and ethically acceptable testing and counseling (T&C) methods that meet the needs of different target groups and health care settings.

2.4. Testing to detect the presence of antibodies to the immunodeficiency virus in a person’s blood is not in itself a preventive procedure, since it does not lead to changes in behavior that is dangerous in relation to HIV infection.

Pre-test counseling includes:

Infection risk assessment;

Development of an individual plan to reduce this risk;

Obtaining voluntary informed consent for testing;

Support;

Motivation to change behavior;

Formation of trust, subsequent adherence to the system of receiving care, dispensary observation and treatment of the disease occur during pre- and post-test counseling during testing for HIV antibodies.

2.5. Voluntary HIV counseling and testing (VCT) should be standardized and offered to patients in the following situations:

If the patient wishes to receive assistance related to the prevention of HIV transmission or infection;

In the presence of medical indications identified during the examination and treatment of the patient;

To prevent mother-to-child transmission of HIV.

2.6. While the offer of HIV antibody testing should be mandatory in certain circumstances, the testing itself should be carried out only after obtaining the patient's informed consent and in strict confidentiality .

2.7. The procedure for obtaining informed consent will inevitably differ from one health care setting to another, but its basic components remain the same:

Providing the patient with sufficient information about HIV infection;

Their awareness of the positive and negative consequences of determining their HIV status;

His free choice regarding HIV antibody testing.

3. Procedure for HIV testing in the Russian Federation

3.1. Federal Law No. 38-FZ of March 30, 1995 “On preventing the spread in the Russian Federation of the disease caused by the human immunodeficiency virus (HIV infection)” establishes that any citizen of the Russian Federation can be examined for the presence of antibodies to HIV:

Voluntarily (clause 3, article 7 of Law No. 38-FZ);

Free in institutions of state and municipal healthcare systems (clause 7, article 7 of Law No. 38-FZ);

Anonymously if desired (clause 2, article 8 of Law No. 38-FZ);

With preliminary and subsequent consultation on the prevention of HIV infection (clause 6, article 7 of Law No. 38-FZ).

3.2. Examination for HIV infection (including anonymous) is carried out in medical institutions of all forms of ownership with the informed consent of patients in strict confidentiality, and in the case of examination of minors under the age of 14 years - at the request or with the consent of his legal representative (SP 3.1 .5.2826-10, clause 5.5).

3.3. If desired, a person who has passed a medical examination has the right to undergo a second medical examination at any health care institution of his choice, regardless of the period that has passed since the previous examination (Article 12 of Federal Law No. 38-FZ).

3.4. There are categories of people who must undergo mandatory medical examination to identify their antibodies to HIV. In any case, mandatory testing for HIV infection should be carried out with pre- and post-test counseling.

3.5. Citizens of the Russian Federation who refuse compulsory medical examination, or if they are diagnosed with HIV infection, cannot be donors of blood, biological fluids, organs and tissues.

3.6. Testing for HIV antibodies without pre- and post-test counseling has no preventive value. Motivation to change behavior regarding HIV infection occurs during the counseling process.

3.7. If there are medical indications identified during the examination and treatment of the patient, testing for antibodies to HIV has diagnostic value and is necessary for proper treatment of the patient.

3.8. The procedure for counseling and testing for HIV antibodies in the Russian Federation is regulated by a number of regulations and documents, but in practice the provision of counseling is limited for a number of reasons:

As a service, counseling for HIV testing has not yet had a corresponding code in regulatory documents.

Persons obligated by law to provide the service cite a lack of time and skills, and insufficient awareness of the need and procedure for providing the service.

In some cases, counseling is formal in nature.

The service is not monitored.

Monitoring of the quality of counseling during testing for HIV antibodies is not carried out on an ongoing basis.

The quality of counseling during testing for HIV antibodies is studied mainly as part of project activities.

4. Mandatory requirements for the procedure for counseling and testing for HIV antibodies

4.1. The main method of detecting HIV infection is testing for HIV antibodies with mandatory pre- and post-test counseling. The presence of HIV antibodies is evidence of HIV infection. A negative HIV antibody test result does not always mean that a person is not infected, as there is a “seronegative window” period (the time between HIV infection and the appearance of antibodies), which is usually about 3 months.

4.2. Testing and counseling must be voluntary.

4.3. The patient must give informed consent for testing. It means that:

He has been provided with sufficient information;

He understands the positive and negative consequences of determining his HIV status;

He gave his consent in a non-coercive environment.

4.4. When conducting pre-test counseling, it is necessary to fill out an informed consent form for testing for HIV infection in two copies, one form is given to the person being examined, the other is kept in the health care facility (Appendix).

4.5. During pre-test counseling, the patient should be told about the purpose and procedure of testing, as well as about HIV treatment options and the availability of various types of social support.

4.6. The results of HIV testing are communicated to the person being examined by a consultant during post-test counseling.

4.7. If possible, pre- and post-test counseling of the patient is carried out by the same specialist.

4.8. Test results should be reported confidentially and should only be available to health care professionals directly involved in patient care.

4.9. Patients who test positive should receive counseling and referrals to medical and psychosocial services.

4.10. Counseling should be carried out by a trained specialist (preferably an infectious disease specialist, an epidemiologist and a psychologist).

4.11. During confidential testing, personal data on the patient is given without abbreviations (according to the passport or a substitute identification document of the person being examined): full name, full date of birth, citizenship, address of residence, contingent code.

4.12. During anonymous testing (without a passport), only a digital code is indicated, including the serial number of the person being examined, year of birth, place of residence (subject of the Russian Federation). The last name, first name and patronymic of the person being examined are not indicated.

4.13. Study results are not communicated over the phone.

4.14. To attract and retain patients in specialized HIV care programs, creating a psychologically supportive environment is key to success. A trusting atmosphere creates a more sincere and stable relationship between the patient and the doctor; the patient will be inclined to more openly discuss the characteristics of his behavior in connection with HIV infection.

4.15. Exercising psychological pressure, coercion, intimidation, judgment and dismissive attitude should be excluded from the interaction of medical workers with patients, since the use of such techniques is a barrier to receiving medical care.

5. What does counseling and testing for HIV antibodies provide?

5.1. The one who passed the test.

If the result is positive:

Access to necessary medical care (determination of the stage of HIV infection, prescription of ART, prevention of opportunistic diseases, vaccination, testing for other STIs and tuberculosis, other medical procedures);

A conscious opportunity to change your behavior in order to protect other people from infection;

A chance to intelligently replan your life based on new circumstances.

If the result is negative:

Motivation to change behavior to prevent future HIV infection;

Medical care for other medical conditions not related to HIV;

Opportunity to receive counseling on HIV infection and related risk behavior.

5.2. To another person:

If a pregnant woman tests positive for HIV, special preventive measures can reduce the risk of infection for her unborn child. Voluntary testing and counseling of pregnant women makes it possible to promptly offer them the preventive treatment necessary to preserve the health of the unborn child.

5.3. Public health:

HIV antibody testing promotes the safety of blood and organ donations;

Epidemiological data on current risk behaviors related to HIV transmission are needed to develop effective HIV prevention and treatment programs.

5.4. The listed possibilities can only be realized if effective pre- and post-test counseling is carried out.

5.5. Testing for HIV antibodies is not the same as preventing HIV infection. Merely receiving a test result does not guarantee behavior change. The only thing that links testing to a decision to change behavior is quality pre- and post-test counseling.

5.6. Counseling during testing for HIV antibodies is regulated by Russian legislation, and a doctor of any specialty must have the skills of counseling, as well as conduct it before and after testing for HIV.

5.7. It should be generally accepted in clinical practice to obtain the patient's informed consent recorded on a special form.

6. Pre-test counseling when testing for antibodies to HIV as a prevention of HIV transmission

6.1. Pre-test counseling is a confidential dialogue between a client and a health care professional to discuss an HIV antibody test and the possible consequences of knowing one's HIV status. This type of counseling includes:

To make an informed decision about conducting a test;

Refusal to take the test.

6.2. The scope of pre-test counseling is determined by the sanitary rules SP 3.1.5.2826-10 “Prevention of HIV infection”.

6.3. All patients offered testing have the right to refuse testing.

6.4. Anyone who refuses testing should be provided with information about the modes of transmission of HIV, prevention of HIV infection, and also told where they can get additional information about HIV infection if they need such a need in the future.

6.5. Counselors should be able to convey to the patient the basics of HIV testing and:

About the ways of transmission of VRI;

About ways to protect against HIV infection;

About the types of medical and psychosocial care that people infected with HIV can receive.

6.6. Patients must be provided with contact numbers and addresses of relevant medical institutions and psychosocial services.

6.7. It is advisable to conduct group pre-test counseling:

In facilities providing outpatient testing and counseling (for example, voluntary/anonymous HIV testing rooms);

In drug treatment clinics;

In dermatovenerological dispensaries;

In anti-tuberculosis dispensaries;

In antenatal clinics.

6.8. During the conversation before testing for HIV antibodies, both individual and group counseling, it is necessary to cover the following issues:

Behaviors associated with the risk of HIV infection;

Benefits of testing, including the range of care available to people who test positive for HIV;

Routes of HIV transmission, prevention measures; testing procedure;

Possible consequences of finding out your HIV status (for personal life, practical conclusions);

The procedure for obtaining informed consent for testing;

The procedure for issuing test results;

Ways to get further help.

6.9. Pre-test counseling may also include:

Providing condoms;

Referral to harm reduction programs for injection drug users (eg, needle exchange);

Referral to appropriate services (for example, if the patient has a high-risk sexual life, he should be referred to a dermatovenerological dispensary, if the patient has a cough, to an anti-tuberculosis dispensary).

Table 1

Stages of pre-test counseling

Pre-test counseling stage
Introductory
Introduce yourself. Ask how to address the visitor. Discuss privacy
	The physician must explain in detail what information is considered confidential
Determine the presence or absence of risk factors	Find out the following questions: characteristics of the patient’s sexual behavior; frequency of changing sexual partners; using condoms; the presence of HIV infection among the patient’s sexual partners; facts of intravenous drug use by the patient; the presence of persons with homosexual preferences and commercial sex workers among the patient’s sexual partners; previous blood transfusions; use of blood products; organ transplantation, non-sterile penetrating procedures
A. Obtaining and evaluating information
	It is important to assess the counselee's ability to assimilate the information provided. There are cases when the doctor’s words that “HIV infection and AIDS are different things” were taken literally and those being consulted, thinking that they were not at risk of AIDS, showed their intention to return to their previous lifestyle.
Does the patient understand the information provided;
Are you thinking about changing risky behavior?
How he will react in case of a positive test result;	If the counselor has identified risk factors and can expect the test result to be positive, clarifying what the caller thinks about their reaction to a positive or negative test result and who will support them in the event of a positive test result will allow the counselor to effectively deal with the situation of reporting a positive result.
Does he have the opportunity to get the support he needs?
	Ask the question: “What do you know about HIV infection, AIDS?”
B. Providing information
About HIV infection	Identify the patient's beliefs about this disease and discuss misconceptions
About the proposed test	Identify and discuss misconceptions about the planned test. So, stipulate that the presence of antibodies to HIV is proof of the presence of HIV infection, but does not allow us to judge either the timing, sources of infection, or other diseases associated with HIV infection, either in the present or in the future. It is also necessary to tell the patient about the “window” period (the period of time between HIV infection and the appearance of antibodies to it in the blood). During this period, the person is already infected, but blood tests do not detect antibodies to HIV. Explain what needs to be done to avoid acquiring or transmitting HIV during this period (3-6 months from the moment of possible infection): refuse donation; use condoms every time you have sexual intercourse; use disposable syringes and needles when using drugs intravenously and do not share them with others; maintain the sterility of the drug solution and the container from which it is taken
B. Discussion of the likely consequences of testing
Make sure the patient understands what “positive”, “negative”, and “indeterminate” mean in relation to the test result. Discuss the patient's possible reactions to the result (especially positive ones). Assess the possible consequences of testing.
D. Obtaining informed consent for testing
Obtain informed consent for the test. Discuss timing of post-test counseling. Summarize.	Give the patient time to think about the issues raised during the consultation.
	Ask the patient if he agrees to be tested.
	Offer to fill out and sign the informed consent form (Appendix 6) in two copies. Give one copy to the person being examined.

6.10. When conducting individual pre-test counseling, the following algorithm is recommended::

Begin counseling by justifying the importance of discussing issues related to HIV infection. Obtain consent for counseling. Find out what the person being examined knows about HIV infection. Discuss the opportunities that come with knowing your HIV status.

Discuss the issue of confidentiality.

Determine presence or absence risk factors : find out the characteristics of sexual behavior; frequency of changing sexual partners; using condoms; presence of HIV infection among sexual partners; intravenous drug use; the presence of persons with homosexual preferences and commercial sex workers among sexual partners; previous blood transfusions, use of blood products, organ transplants, non-sterile penetrating procedures.

Assess whether the patient understands the information provided, whether he is thinking about changing risky behavior, whether he can get the necessary support, and how he will behave in the event of a positive test result. Identify and discuss misconceptions about HIV infection.

Identify and discuss misconceptions about the planned test. So, stipulate that the presence of antibodies to HIV is evidence of the presence of HIV infection, but does not allow us to judge the timing, sources of infection, or other diseases associated with HIV infection, either in the present or in the future. It is also necessary to explain the existence of a “window” (the period of time between HIV infection and the appearance of antibodies to HIV, the presence of which can be determined in a laboratory). During this period, the person is already infected, but blood tests do not detect antibodies to HIV.

Explain what needs to be done to avoid acquiring or transmitting HIV infection during this period of time (3 - 6 months): refuse donation, use condoms during sexual intercourse. If it is impossible to refuse intravenous drug use, use disposable syringes and needles without sharing them with other users, monitor the sterility of the drug solution and the container from which it is drawn. Refrain from getting tattoos. Make sure the patient understands what it means positive, negative And indeterminate result.

Discuss How will the patient react to the result?(especially positive in the presence of risky behavior). Assess the possible consequences of testing. Assess whether the patient is thinking about changing risky behavior, if it took place.

Emphasize the importance of receiving test results.

Obtain consent to take the test.

Schedule a post-test counseling appointment to communicate your results.

If necessary, re-talk with the patient.

The patient is sent to the AIDS Center for the Prevention and Control of AIDS to establish a final diagnosis and register with a dispensary. The consultant must give the patient the coordinates of the territorial AIDS center, and also make a preliminary agreement with colleagues from the center about the patient’s upcoming visit.

Clinical observation and treatment for HIV infection is carried out on a voluntary basis. Specialists have no other legal ways of motivating subjects to follow recommendations, other than properly conducted counseling..

Thus, counseling during testing for HIV antibodies is not only mandatory, but also an effective way of individual preventive work with people on issues of HIV infection. Many people think about this disease for the first time in relation to themselves, realize the individual level of risk, receive the necessary information, that is, take the first step towards changing behavior.

Skilled counseling helps people cope when they test positive and thus makes a significant contribution to the prevention of suicide and other acts of despair.

8. Monitoring and assessing the quality of testing and consulting

Monitoring and assessing the quality and content of counseling is a necessary condition for ensuring the highest standards of TC. The same is true with regard to monitoring and assessing the quality of testing - laboratory research methods and the provision of consumables.

In relation to individual patients, monitoring and assessing the quality of H&C involves answering the following questions.

8.1. Did you have a conversation with a consultant before testing for HIV antibodies?

8.2. Assessing the quality of pre-test counseling - were the following topics covered?

High-risk behaviors and arguments for HIV testing.

Routes of HIV transmission, prevention measures, testing procedure, the meaning of negative and positive test results, possible consequences of determining HIV status.

Ability to cope with the news of a positive test result.

Possible needs and available sources of support.

Individual risk reduction plan.

Obtaining further medical care.

Referral to certain services if necessary.

Was there enough time to fully understand these issues?

Was informed consent truly given without any coercion?

Has the consultant checked the level of understanding of the information and cleared up any misunderstandings of any facts?

8.3. Did you have a conversation with a consultant after testing for HIV antibodies?

8.4. Assessing the quality of post-test counseling - are the following statements true?

The test result was communicated in simple and understandable language.

The consultant ensured that the patient understood the test result.

The meaning of the test result, the consequences of finding out the HIV status, and the circle of people who are supposed to be informed about the test result were discussed.

The consultant helped me cope with the first emotional reaction to the news of my positive HIV status.

Support options were offered.

Further ways to obtain medical care and support were discussed.

Referrals to certain services were issued (if necessary).

8.5. Satisfaction with testing and counseling.

Is the facility conveniently located?

What was the average wait time?

Did the consultant demonstrate the necessary degree of understanding?

Was further medical care arranged?

List of abbreviations

Bibliography

1. HIV infection and AIDS: national guidelines / Ed. acad. RAMS V.V. Pokrovsky. M.: GEOTAR-Media, 2013. pp. 368 - 378.

2. Belyaeva V.V. et al. Communication and counseling in the field of HIV infection: A manual for health workers. Ed. 2nd. M., 2008. 109 p.

3. Methodological recommendations of the Ministry of Health and Social Development of the Russian Federation dated August 6, 2007 No. 5952-РХ “Conducting pre- and post-test counseling for persons being examined for HIV infection.” M., 2007. 27 p.

4. Resolution of the Chief State Sanitary Doctor of the Russian Federation dated January 11, 2011 No. 1 “On approval of SP 3.1.5.2826-10 “Prevention of HIV infection.”

5. Federal Law of March 30, 1995 No. 38-FZ “On preventing the spread of the disease caused by the human immunodeficiency virus (HIV infection) in the Russian Federation.”

Annex 1

HIV infection- an infectious chronic disease caused by the human immunodeficiency virus (HIV), characterized by a specific lesion of the immune system, leading to its slow destruction until the formation of acquired immune deficiency syndrome (AIDS).

HIV infection is transmitted in only three ways:

◦ through blood during medical or non-medical procedures. Often, infection occurs when several people share the same equipment for drug use (any object or device that gets blood on it); infection is possible when using ready-made drug solutions, which could have previously been infected with HIV;

◦ from an HIV-infected mother to her child during pregnancy, childbirth and breastfeeding.

HIV infection does not occur through everyday contact (shaking hands, using shared dishes, household items, swimming pool, toilet, transport, sharing food), or through insect bites.

How to avoid HIV infection. Throughout life, depending on personal circumstances and beliefs, a person can use different methods of birth control. For example, have only one faithful sexual partner who is not infected with HIV, or always use condoms, and do not use drugs. To prevent infection through blood, you must avoid contact with any tools or materials that may have come into contact with the blood of another person. An HIV-infected pregnant woman can protect her baby from HIV infection by taking special medications during pregnancy and not breastfeeding.

What is the purpose of testing for antibodies to HIV?. Timely diagnosis of HIV infection based on the detection of antibodies and subsequent research data allows timely initiation of the necessary treatment and the adoption of other measures to reduce the negative consequences of HIV infection, for example, to prevent the transmission of HIV to loved ones.

Counseling before the examination (pre-test counseling) testing for HIV antibodies should be provided to everyone so that the person, before the examination, can discuss with a specialist all aspects of this testing, including its possible consequences.

Blood test for antibodies to HIV. One of the most important evidence that a person is infected with HIV is the detection of HIV antibodies in his blood. To do this, 5-10 ml of blood is taken from the patient’s ulnar vein, which is subjected to further examination in medical institutions that have permission (license) for such activities.

The results of a blood test for HIV antibodies can be positive (antibodies to HIV are detected), negative (antibodies to HIV are not detected, the results are “negative”) or indeterminate.

When antibodies to HIV are detected, the person in whom they are detected is considered “HIV-positive” or “HIV-positive” and can infect another person. The detection of antibodies to HIV imposes certain obligations on a person to prevent possible infection of others.

In case of “indeterminate” examination results, the subject is prescribed repeated blood tests for HIV antibodies or other necessary studies. A person with indeterminate test results should also take precautions to prevent infecting others.

If antibodies to HIV are not detected, then the person is probably not infected with HIV. However, there is a “seronegative window” period (the period of time between HIV infection and the appearance of HIV antibodies, which is usually up to 3 months, but can be longer). During this period, the person is already infected and can infect others, but HIV antibodies are not detected in a blood test. Therefore, if there was a risk of HIV infection for less than 3 months before the HIV test, it is recommended to repeat the test after 3 and 6 months.

If antibodies to HIV are detected, the HIV-positive person must be informed about the results of the study, the significance of the results of this study will be explained to him in detail (that is, he Detailed post-test counseling should be provided) and were asked to undergo additional clinical, laboratory and epidemiological examinations to establish a final diagnosis of HIV infection, the stage of the disease and prescribe appropriate treatment.

All necessary studies related to the diagnosis of HIV infection and its treatment are carried out free of charge for citizens of the Russian Federation.

The test for antibodies to HIV can be carried out anonymously (when the subject does not give his real name and the subject can find out the result by code) or confidentially, when the subject provides medical workers with data that allows him to be identified (for example, full name, passport details ), and the medical professionals who conduct the examination undertake to keep the name of the person being examined secret, regardless of the results of the examination.

HIV testing results are not provided over the phone. They are communicated by a specialist during post-test consultation, which is carried out after receiving the results of an examination for HIV antibodies in order to explain them to the person being examined and give recommendations regarding future lifestyle.

If you have questions, please contact the territorial AIDS center at:

If you agree to conduct a confidential examination for HIV antibodies, you must indicate your details here (if you wish to undergo the examination anonymously, leave the following lines blank)

I ______________________________________________________________________ (Full Name) The year of birth, I hereby confirm that, on the basis of the information provided to me, freely and without coercion, while reporting the consequences of the examination, I decided to undergo testing for HIV antibodies. I confirm that I have been told why it is important to get tested for HIV, how the test is performed, and the consequences of HIV testing.

Appendix 2

During the examination, you were found to have antibodies to HIV. We inform you that: The detection of antibodies to HIV is a sign of the presence of HIV infection. People who have antibodies to HIV are called HIV positive. To establish a diagnosis of HIV infection, clarify the stage of the disease, dispensary observation and prescribe treatment, you must immediately contact the territorial center for the prevention and control of AIDS or an authorized doctor of the healthcare facility at ___________________________________________________________________________ Tel. __________________ HIV-positive citizens of the Russian Federation have all rights and freedoms on its territory and perform duties in accordance with the Constitution of the Russian Federation and the legislation of the Russian Federation. Russia has organized free HIV treatment for all Russians in need. To undergo free examination and treatment, you need to contact the address indicated above. Treatment does not cure HIV infection, but it significantly prolongs life, improves its quality, and allows one to maintain working capacity for many years. It is important for HIV-positive pregnant women to contact an AIDS center in time and start taking special medications to prevent infection of the unborn child. HIV infection is transmitted in only three ways: ◦ during sexual intercourse without a condom; ◦ through blood during medical or non-medical procedures. Often, infection occurs when several people share the same equipment for drug use (any object or device that gets blood on it); infection is possible when using ready-made drug solutions, which could have previously contained HIV; ◦ from an HIV-infected mother to her child during pregnancy, childbirth and breastfeeding. HIV infection does not occur through everyday contact (shaking hands, using shared dishes, household items, swimming pool, toilet, transport, sharing food), or through insect bites. In order not to transmit HIV infection to another person, I must/have to take precautions. I was given a recommendation to inform my sexual partners about my HIV infection and to always use condoms. Do not breastfeed your baby. I must/must take measures to ensure that my blood that gets on stabbing and cutting instruments cannot cause infection to other people. HIV-positive people cannot donate blood, biological fluids, organs or tissues. There is criminal liability for knowingly putting another person at risk of contracting HIV infection or infecting another person with HIV infection (Article 122 of the Criminal Code of the Russian Federation). For all questions related to HIV infection, you can contact the territorial center for the prevention and control of AIDS. If the survey was conducted anonymously, then do not indicate your last name, first name, and patronymic. I _______________________________________________________________________ (Full Name) Year of birth, I hereby confirm that I have received information about the detection of antibodies to HIV, guarantees of medical care, respect for the rights and freedoms of HIV-infected people, as well as the need to take precautions to prevent the spread of HIV infection.

^ V. Procedure for testing for HIV infection

5.1. The main method of detecting HIV infection is testing for HIV antibodies with mandatory pre- and post-test counseling. The presence of HIV antibodies is evidence of the presence of HIV infection. A negative HIV antibody test result does not always mean that a person is not infected, since there is a “seronegative window” period (the time between HIV infection and the appearance of antibodies, which is usually about 3 months).

5.2. Testing for HIV infection is carried out voluntarily, except in cases where such testing is mandatory.

The following are subject to mandatory medical examination for HIV infection:

Donors of blood, blood plasma, sperm and other biological fluids, tissues and organs (including sperm), as well as pregnant women in the case of abortive and placental blood collection for the production of biological products each time donation material is taken;

The following employees are subject to mandatory medical examination to detect HIV infection upon entry to work and during periodic medical examinations:

Doctors, paramedical and junior medical staff of centers for the prevention and control of AIDS, health care institutions, specialized departments and structural divisions of health care institutions, engaged in direct examination, diagnosis, treatment, service, as well as conducting forensic medical examinations and other work with infected persons human immunodeficiency virus, having direct contact with them;

Doctors, paramedical and junior medical personnel of laboratories (groups of laboratory personnel) who screen the population for HIV infection and study blood and biological materials obtained from persons infected with the human immunodeficiency virus;

Scientists, specialists, employees and workers of scientific research institutions, enterprises (productions) for the production of medical immunobiological preparations and other organizations whose work is related to materials containing the human immunodeficiency virus.

Medical workers in surgical hospitals (departments) upon entry to work and subsequently once a year;

Persons undergoing military service and entering military educational institutions and military service under conscription and contract, when conscripted for compulsory military service, when entering service under a contract, when entering military universities of ministries and departments that establish restrictions for the admission of persons to service with HIV infection;

Foreign citizens and stateless persons when applying for a citizenship permit or residence permit, or work permit in the Russian Federation, when foreign citizens enter the territory of the Russian Federation for a period of more than 3 months.

5.3. At the request of the person being examined, voluntary HIV testing can be anonymous.

5.4. Health care providers should recommend that individuals at high risk of HIV infection regularly undergo HIV testing for early detection of HIV infection, counseling on HIV infection, and timely initiation of treatment in the event of infection.

5.5. Examination for HIV infection (including anonymous) is carried out in medical institutions of all forms of ownership with the informed consent of the patient in conditions of strict confidentiality, and in the case of examination of minors under the age of 14 years – at the request or with the consent of his legal representative.

5.6. Examination for HIV infection is carried out with mandatory pre- and post-test counseling on HIV prevention issues.

5.7. Consultation should be conducted by a trained specialist (preferably an infectious disease doctor, epidemiologist or psychologist) and include basic provisions regarding HIV testing, possible consequences of testing, determining the presence or absence of individual risk factors, assessing the knowledge of the person being examined on issues of HIV prevention, providing information about the routes of transmission of HIV and methods of protection against HIV infection, types of assistance available for those infected with HIV.

5.8. When conducting pre-test counseling, it is necessary to fill out an informed consent form for HIV testing in two copies, one form is given to the person being examined, the other is kept in the health care facility.

5.9. A referral for an enzyme-linked immunosorbent assay (ELISA) of a blood sample for HIV infection is filled out by all health care organizations, regardless of their legal form and form of ownership.

5.9.1. During confidential testing, personal data on the patient is given without abbreviations (according to the passport or a substitute identification document of the person being examined): full name, full date of birth, citizenship, address of residence, contingent code.

5.9.2. During anonymous testing (without a passport), only a digital code is indicated, including the serial number of the person being examined, year of birth, place of residence (subject of the Russian Federation). The last name, first name and patronymic of the person being examined is not indicated.

5.10. A response about the examination result is issued upon completion of the testing algorithm. The issuance of an official document confirming the presence or absence of HIV infection in the person being examined is carried out only by institutions of the state or municipal health care system.

5.11. The results of HIV testing are communicated to the person being examined by a consultant during post-test counseling; If possible, the same specialist provides pre- and post-test counseling to the patient.

5.11.1. Counseling for any HIV testing result should include a discussion of the meaning of the result obtained, taking into account the risk of HIV infection for the person being tested; an explanation of the routes of HIV transmission and methods of protection against HIV infection for the person being tested; types of care available for those infected with HIV, and recommendations for further testing tactics.

5.11.1.1. Counseling for an indeterminate HIV test result, in addition to a set of standard information, should contain a discussion of the possibility of HIV infection, the need to take precautions to prevent the spread of HIV infection, guarantees of medical care, treatment, and respect for the rights and freedoms of HIV-infected people. The person being tested is sent to the Center for Prevention and Control of AIDS.

5.11.1.2. A person diagnosed with HIV infection is notified by a consultant of the test results. The specialist communicates the positive test result in a clear and concise manner, provides time to absorb this news, and answers the patient’s questions. Explains the need to take precautions to avoid

the spread of HIV infection, guarantees of medical care, treatment, respect for the rights and freedoms of HIV-infected people, as well as criminal liability for putting in danger of infection or infecting another person. The person being tested is sent to the Center for the Prevention and Control of AIDS to establish a diagnosis of HIV infection and provide medical care.

5.11.2. Study results are not communicated over the phone.

5.11.3. The diagnosis of a disease caused by the human immunodeficiency virus is established by a doctor at the Center for the Prevention and Control of AIDS or an authorized physician at a medical facility based on a set of epidemiological data, the results of a clinical examination and laboratory tests. The diagnosis of HIV infection is communicated to the patient by a doctor (preferably an infectious disease specialist, epidemiologist or psychologist) during consultation with the patient at the Center for the Prevention and Control of AIDS or an authorized healthcare facility. The patient is notified in writing about the detection of HIV infection, and he is provided with information on this problem. If HIV is detected in minors under the age of 18, their parents or legal representatives are notified.

^ VI. Organization of dispensary observation of patients with HIV infection

6.1. The goal of clinical monitoring of HIV-infected patients is to increase the duration and maintain the quality of their life. The main objectives are to form adherence to dispensary observation, timely identify their indications for antiretroviral therapy, chemoprophylaxis and treatment of secondary diseases, ensure the provision of timely medical care, including psychological support and treatment of concomitant diseases.

6.2. HIV-infected persons are subject to invitation to initial and periodic examinations, but their right to refuse examination and treatment, as well as the right to be observed in a medical institution of their own choice, expressed in writing, must not be violated.

6.3. Persons with an established diagnosis of HIV infection should be taken for clinical observation for HIV infection. Dispensary observation is carried out by healthcare facilities authorized by an administrative act of the healthcare management body of the constituent entity of the Russian Federation.

Dispensary observation can also be carried out at the Federal State Institution, on the basis of which the federal and district centers for the prevention and control of AIDS operate, and at the Federal State Institution Republican Clinical Infectious Diseases Hospital (St. Petersburg).

6.4. For each case of HIV infection (including when a positive laboratory test result for HIV infection is detected on sectional material), an epidemiological investigation is carried out by specialists from the AIDS center and, if necessary, by specialists from the bodies carrying out state epidemiological surveillance. Based on the results of the epidemiological investigation, a conclusion is given about the causes of the disease, sources of infection, leading routes and factors of transmission of HIV infection that determined the occurrence of the disease. Taking into account this conclusion, a set of preventive and anti-epidemic measures is being developed and implemented, including training of HIV-infected people and contact persons, and the prescription of specific and non-specific prevention means.

6.4.1. If nosocomial infection is suspected, an epidemiological investigation is carried out by specialists from the bodies carrying out state epidemiological surveillance, together with specialists from AIDS Centers and/or specialists from the Federal State Institution, on the basis of which the federal and district centers for the prevention and control of AIDS, the Federal State Institution Republican Clinical Infectious Diseases Hospital (city of Moscow) operate. St. Petersburg), with the involvement of the necessary experts.

For each case of nosocomial infection, a set of preventive and anti-epidemic measures is carried out to localize the outbreak and prevent further spread of the infection, and an “Epidemiological Investigation Report” is drawn up.

6.4.2. Epidemiological investigations into sexual partners and drug-using partners are carried out using the “partner notification” method (if an HIV-infected person is detected, contact persons are identified and they are provided with individual counseling on HIV prevention issues). An HIV-infected person is given the opportunity to either independently inform their partners about the risk of HIV infection and invite them to counseling at the AIDS center, or provide the consultant with contact information about their partners (usually the partner’s name and phone number) for an invitation to counseling. The consultant must strictly follow the principle of anonymity of information and guarantee complete confidentiality to the first and all subsequent participants in the notification.

6.5. Dispensary observation of children is carried out by a pediatrician at the AIDS Center together with a pediatrician from the medical education facility.

6.6. During the appointment, the doctor carries out psychological adaptation of the patient, determines the completeness of the examination and treatment, evaluates and forms adherence to therapy.

6.7. Counseling on HIV infection issues is carried out during each examination of a patient with HIV infection as part of his dispensary observation.

6.7.1. When observing HIV-infected children, persons caring for the child and persons legally responsible for the child are consulted. Child counseling on HIV infection is carried out in accordance with age characteristics.

6.8. During dispensary observation, counseling and routine examinations are carried out before prescribing antiretroviral therapy, and during antiretroviral therapy, in accordance with existing standards, recommendations and protocols. It is necessary to ensure regular screening of HIV-infected people for tuberculosis (at least once every 6 months) and opportunistic infections, as well as prevention of tuberculosis and Pneumocystis pneumonia for all those in need in accordance with the requirements of regulatory documents.

6.9. Treatment of patients with HIV infection is carried out on a voluntary basis and includes the following directions: psychosocial adaptation of the patient, antiretroviral therapy, chemoprophylaxis of secondary diseases, treatment of secondary and concomitant diseases.

6.9.1. Antiretroviral therapy is an etiotropic treatment for HIV infection and is carried out for life. Its appointment and control of effectiveness and safety is carried out by the Center for the Prevention and Control of AIDS of a constituent entity of the Russian Federation. This function can be performed by the Federal State Budgetary Institutions, on the basis of which the federal and district centers for the prevention and control of AIDS operate; Federal State Institution Republican Clinical Infectious Diseases Hospital (St. Petersburg), as well as health care facilities under the methodological guidance of the AIDS Center.

6.9.2. To assess the effectiveness and safety of ART, regular studies of viral load, CD4 lymphocyte levels, clinical and biochemical blood tests, instrumental and clinical studies are carried out as part of clinical observation. The main criterion for the effectiveness of ART is the reduction of the viral load to an undetectable level.

6.9.3. Effective (with the achievement of an undetectable level of viral load) antiretroviral therapy is, among other things, a preventive measure that reduces the risk of the patient as a source of infection.

6.10. When identifying people infected with HIV who are undergoing hospital treatment, it is necessary to ensure that they undergo consultation with an infectious disease specialist at the AIDS Center, laboratory tests necessary to clarify the stage of the disease and decide on the prescription of antiretroviral therapy.

6.11. In order to increase the effectiveness of clinical observation and formation of adherence to antiretroviral therapy, a multiprofessional approach should be used with the involvement of the attending physician, nurse, specialized medical specialists, psychologists, social workers, and trained consultants from among HIV-infected people. The formation of patient adherence to dispensary observation is carried out on the basis of counseling technology within the framework of a patient-centered approach.

^ VII. State sanitary and epidemiological surveillance of HIV infection

7.1. Epidemiological surveillance of HIV infection – This is a system of constant dynamic and multidimensional monitoring of the dynamics and structure of morbidity (infection) of a given infectious disease that occurs in the human population due to the peculiarity of the pathogenic agent (biological factor) that caused the infectious process, and various socio-demographic and behavioral characteristics of people.

7.2. The purpose of state sanitary and epidemiological surveillance of HIV infection is to assess the epidemiological situation, trends in the development of the epidemic process; monitoring the coverage of the population with prevention, clinical observation, treatment and support for HIV infection, the effectiveness of ongoing activities for making management decisions and the development of adequate sanitary and anti-epidemic (preventive) measures aimed at reducing the incidence of HIV infection; prevention of the formation of group diseases of HIV infection, severe forms and deaths.

7.3. State sanitary and epidemiological surveillance of HIV infection is carried out by bodies exercising state sanitary and epidemiological surveillance.

7.4. Identification, recording and registration of HIV-infected patients and HIV examinations are carried out in accordance with established requirements.

7.4.1. Each case of HIV infection (positive immunoblot test result) is subject to registration and registration at the place of detection in the health care facility, regardless of departmental affiliation and form of ownership. Records are kept at the patient’s place of residence to organize dispensary observation and treatment.

7.4.2. Information about a positive result of a blood test for HIV in immune blotting from the reference laboratory is transmitted to the screening laboratory and/or health care facility that sent the material for testing, as well as to the territorial bodies carrying out state sanitary and epidemiological supervision, the Federal Scientific and Methodological Center for Prevention and fight against AIDS. When HIV infection is detected in nonresident residents of the Russian Federation, the information is transmitted to the territorial center for the prevention and control of AIDS at the place of permanent registration of the patient.

7.4.3. Upon receipt of a positive test result for HIV from a donor of blood, organs and tissues, information from the reference laboratory is transmitted within 24 hours by telephone to blood service institutions (blood transfusion stations, blood transfusion departments) and to territorial bodies carrying out state sanitary and epidemiological supervision .

7.4.4. An extraordinary report on each case of HIV infection in treatment and prevention organizations or suspicion of it is transmitted to the bodies exercising state sanitary and epidemiological supervision in a constituent entity of the Russian Federation, to the Federal body exercising sanitary and epidemiological supervision in the Russian Federation and the Federal Scientific and Methodological Center for Prevention and the fight against AIDS.

Upon completion of the epidemiological investigation, the Epidemiological Investigation Report is sent to the Federal Authority for Sanitary and Epidemiological Surveillance in the Russian Federation and the Federal Scientific and Methodological Center for the Prevention and Control of AIDS.

7.4.5. The healthcare facility that has changed or clarified the diagnosis submits a secondary report on the patient with HIV infection to the Federal Scientific and Methodological Center for the Prevention and Control of AIDS and the territorial center for the Prevention and Control of AIDS at the place of permanent registration of the patient, indicating the changed (clarified) diagnosis, date its establishment in the case of:

– establishing the causes of infection of an HIV-infected person,

– making a diagnosis of AIDS,

– establishing the death of an HIV-infected or AIDS patient,

– change of place of residence of the patient,

– removal of the diagnosis of HIV infection,

– conclusions about the presence or absence of HIV infection in a child born to an HIV-infected mother.

7.5. Health care facilities that have laboratories conducting HIV research, regardless of organizational and legal forms, forms of ownership and departmental affiliation, including the Federal State Institution, on the basis of which the federal and district centers for the prevention and control of AIDS, the Federal State Institution "Republican Clinical Infectious Diseases Hospital" operate provide information on the results of a blood test for antibodies to HIV (monthly form No. 4 of the federal state statistical observation) to the center for the prevention and control of AIDS of the constituent entity of the Russian Federation on whose territory HIV testing is carried out.

7.6. Bodies carrying out sanitary and epidemiological supervision in the constituent entities of the Russian Federation, health authorities of the constituent entities of the Russian Federation ensure monitoring and evaluation of the effectiveness of measures for the prevention and treatment of HIV infection in the constituent entities of the Russian Federation in accordance with approved indicators, and send the monitoring results to the Federal authority, carrying out sanitary and epidemiological supervision in accordance with established requirements.

7.7. Providing information about the diagnosis of HIV infection without the consent of a citizen or his legal representative is permitted in cases provided for by the legislation of the Russian Federation:

– for the purpose of examining and treating a citizen who is unable, due to his condition, to express his will;

– when there is a threat of the spread of infectious diseases, mass poisonings and injuries;

– at the request of the bodies of inquiry and investigation, the prosecutor and the court in connection with an investigation or trial;

At the request of military commissariats or military medical services;

– in the case of providing assistance to a minor under the age of 18 to inform his parents or legal representatives;

– if there are grounds to believe that harm to a citizen’s health was caused as a result of illegal actions.

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

^ VIII. Sanitary and anti-epidemic (preventive) measures for HIV infection

Prevention of HIV infection must be carried out comprehensively in relation to the sources of the virus, mechanisms, routes and factors of transmission, as well as susceptible populations, including persons from vulnerable groups of the population.

^ 8.1. Activities in epidemic foci of HIV infection

8.1.1. Activities carried out regarding the source of HIV infection

In relation to the identified source of HIV infection, measures are taken to reduce the likelihood of transmission of the virus:

8.1.1.1. Timely detection and diagnosis of HIV infection.

8.1.1.2. Specific therapy with antiretroviral drugs as prescribed by a doctor (including preventive chemotherapy in pregnant women) reduces the viral load in an HIV-infected person and reduces the risk of transmitting HIV infection.

8.1.1.3. Referring someone infected with HIV for STI testing and treatment reduces the risk of sexual transmission.

8.1.1.4. Referring injection drug users to drug addiction treatment reduces the source of drug-related virus transmission.

8.1.1.5. The ban on entry and deportation of HIV-infected foreign citizens in the manner established by the legislation of the Russian Federation reduces the number of sources of infection in the country.

^ 8.1.2. Measures regarding mechanisms, routes and factors of transmission

8.1.2.1. Disinfection and sterilization of medical instruments and equipment in medical institutions, as well as equipment and instruments in hairdressing salons, beauty salons, piercing and tattoo salons, the use of disposable instruments.

8.1.2.2. Ensuring and monitoring the safety of medical manipulation practices and the use of barrier methods of protection.

8.1.2.3. Examination of blood donors and any other donated materials for the presence of antibodies to HIV at each donation of donated material, quarantine of blood products and rejection of infected donated material. Lifelong exclusion of HIV-infected people and those positive for ELISA during a reference study from donating blood, plasma, organs and tissues.

8.1.2.4. Conducting an epidemiological investigation of HIV infection.

8.1.2.5. Consulting/training of the population – both susceptible populations and sources of infection – safe or less dangerous behavior.

8.1.2.6. Preventive work with vulnerable groups of the population (IDUs, sex workers, MSM, etc.).

8.1.2.7. Preventing the child’s contact with the mother’s biological fluids should be combined with the administration of ARV drugs and is achieved:

– during childbirth during planned cesarean section in HIV-infected women;

– after childbirth by replacing breastfeeding of a child of an HIV-infected mother with artificial feeding.

8.1.2.8. If an HIV-infected woman wishes, she can be provided with assistance to prevent unwanted pregnancy.

^ 8.1.3. Measures for susceptible populations

8.1.3.1. Contact persons for HIV infection are considered to be persons who had the opportunity to become infected based on known mechanisms, routes and factors of transmission of the infectious agent. Establishing the fullest possible circle of people who have had contact with an HIV-infected person makes it possible to inform about methods and means of protection against HIV infection during pre-test counseling and examination for HIV infection.

8.1.3.2. Teaching safe behavior regarding HIV infection is the main measure for preventing HIV infection among contact persons and the population.

8.1.3.3. Carrying out preventive chemoprophylaxis. For emergency prevention of the disease, antiretroviral drugs are prescribed to persons at risk of contracting HIV infection, including: newborns of HIV-infected mothers, health workers and other persons injured while providing care to HIV-infected persons, citizens in respect of whom there is reason to believe the presence of contact resulting in a risk of HIV infection.

^ 8.2. Prevention of hospital-acquired HIV infection

8.2.1. The basis for the prevention of nosocomial HIV infection is compliance with the anti-epidemic regime in medical institutions in accordance with established requirements (SANPIN 2.1.3.2630-10 “Sanitary and epidemiological requirements for organizations engaged in medical activities”, registered with the Ministry of Justice of Russia on August 9, 2010. No. 18094). Preventive measures are carried out on the basis that each patient is regarded as a potential source of blood-borne infections (hepatitis B, C, HIV and others).

8.2.2. Monitoring and assessment of the state of the anti-epidemic regime in healthcare facilities is carried out by bodies exercising state sanitary and epidemiological supervision.

8.2.2.1. In order to prevent nosocomial transmission of HIV infection, it is necessary to ensure:

8.2.2.1.1. Compliance with established requirements for disinfection, pre-sterilization cleaning, sterilization of medical products, as well as for the collection, disinfection, temporary storage and transportation of medical waste generated in medical facilities.

8.2.2.1.2. Equipping with the necessary medical and sanitary equipment, modern atraumatic medical instruments, means of disinfection, sterilization and personal protection (special clothing, gloves, etc.) in accordance with regulatory and methodological documents. Single-use products must be decontaminated/decontaminated after use during manipulations on patients; their reuse is prohibited.

8.2.2.1.3. If a case of nosocomial HIV infection is suspected, a set of preventive and anti-epidemic measures is carried out in health care facilities:

8.2.2.1.4. An unscheduled sanitary and epidemiological investigation is carried out with the aim of identifying the source, transmission factors, establishing a circle of contact persons, both among staff and among patients who were in equal conditions, taking into account the risk of possible infection, and implementing a set of preventive and anti-epidemic measures to prevent infection in conditions LPO.

^ 8.3. Prevention of occupational HIV infection

In order to prevent occupational HIV infection, the following is carried out:

8.3.1. A set of measures to prevent emergency situations when performing various types of work.

8.3.2 Accounting for cases of injuries, microtraumas received by personnel of health care facilities and other organizations during the performance of professional duties, emergency situations involving contact of blood and biological fluids with the skin and mucous membranes.

8.3.3. If an emergency situation occurs at the workplace, a medical worker is obliged to immediately take a set of measures to prevent HIV infection.

8.3.3.1. Actions of a medical worker in an emergency:

– in case of cuts and injections, immediately remove gloves, wash your hands with soap and running water, treat your hands with 70% alcohol, lubricate the wound with a 5% alcohol solution of iodine;

– if blood or other biological fluids come into contact with the skin, the area is treated with 70% alcohol, washed with soap and water and re-treated with 70% alcohol;

– if the patient's blood and other biological fluids come into contact with the mucous membranes of the eyes, nose and mouth: rinse the oral cavity with plenty of water and rinse with a 70% ethyl alcohol solution , the mucous membrane of the nose and eyes is washed generously with water (do not rub);

– if blood or other biological fluids of the patient get on the gown or clothes: remove work clothes and immerse in a disinfectant solution or in a tank for autoclaving;

– Start taking antiretroviral drugs as soon as possible for post-exposure prophylaxis of HIV infection.

8.3.3.2. It is necessary, as soon as possible after contact, to test for HIV and viral hepatitis B and C a person who may be a potential source of infection and the person in contact with him. HIV testing of a potential source of HIV infection and a contact person is carried out using rapid testing for HIV antibodies after an emergency with the obligatory sending of a sample from the same portion of blood for standard HIV testing in an ELISA. Samples of plasma (or serum) from the blood of a person who is a potential source of infection and a contact person are transferred for storage for 12 months to the AIDS center of a constituent entity of the Russian Federation.

The victim and the person who may be a potential source of infection must be asked about the carriage of viral hepatitis, STIs, inflammatory diseases of the genitourinary tract, and other diseases, and counseled regarding less risky behavior. If the source is infected with HIV, find out whether he has received antiretroviral therapy. If the victim – a woman, it is necessary to conduct a pregnancy test and find out if she is breastfeeding a child. In the absence of clarifying data, post-exposure prophylaxis begins immediately; if additional information becomes available, the regimen is adjusted.

8.3.3.3. Carrying out post-exposure prophylaxis of HIV infection with antiretroviral drugs:

8.3.3.3.1. Antiretroviral medications should be started within the first two hours after the accident, but no later than 72 hours.

8.3.3.3.2. The standard regimen for post-exposure prophylaxis of HIV infection is lopinavir/ritonavir + zidovudine/lamivudine. In the absence of these drugs, any other antiretroviral drugs can be used to initiate chemoprophylaxis; If it is not possible to immediately prescribe a full-fledged HAART regimen, one or two available drugs are started. The use of nevirapine and abacavir is possible only in the absence of other drugs. If the only available drug is nevirapine, only one dose of the drug should be prescribed - 0.2 g (repeated administration is unacceptable), then when other drugs are received, full-fledged chemoprophylaxis is prescribed. If chemoprophylaxis is started with abacavir, testing for hypersensitivity reactions to it should be carried out as soon as possible or abacavir should be replaced with another NRTI.

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DECISION of the Chief State Sanitary Doctor of the Russian Federation dated 01/11/2011 1 ON APPROVAL SP 3-1-5-2826-10 PREVENTION... Relevant in 2018

V. Procedure for testing for HIV infection

5.1. The main method of detecting HIV infection is testing for HIV antibodies with mandatory pre- and post-test counseling. The presence of HIV antibodies is evidence of HIV infection. A negative HIV antibody test result does not always mean that a person is not infected, since there is a “seronegative window” period (the time between HIV infection and the appearance of antibodies, which is usually about 3 months).

5.2. Testing for HIV infection is carried out voluntarily, except in cases where such testing is mandatory.

The following are subject to mandatory medical examination for HIV infection:

Donors of blood, blood plasma, sperm and other biological fluids, tissues and organs (including sperm), as well as pregnant women in the case of abortive and placental blood collection for the production of biological products each time donation material is taken.

The following employees are subject to mandatory medical examination to detect HIV infection upon entry to work and during periodic medical examinations:

Doctors, paramedical and junior medical staff of centers for the prevention and control of AIDS, health care institutions, specialized departments and structural divisions of health care institutions, engaged in direct examination, diagnosis, treatment, service, as well as conducting forensic medical examinations and other work with persons infected human immunodeficiency virus, having direct contact with them;

Doctors, paramedical and junior medical personnel of laboratories (groups of laboratory personnel) who screen the population for HIV infection and study blood and biological materials obtained from persons infected with the human immunodeficiency virus;

Scientists, specialists, employees and workers of research institutions, enterprises (productions) for the production of medical immunobiological preparations and other organizations whose work is related to materials containing the human immunodeficiency virus;

Medical workers in surgical hospitals (departments) upon entry to work and subsequently once a year;

Persons undergoing military service and entering military educational institutions and military service under conscription and contract, when conscripted for compulsory military service, when entering service under a contract, when entering military universities of ministries and departments that establish restrictions for the admission of persons to service with HIV infection;

Foreign citizens and stateless persons when applying for a citizenship permit, or a residence permit, or a work permit in the Russian Federation, when foreign citizens enter the territory of the Russian Federation for a period of more than 3 months.

5.3. At the request of the person being examined, voluntary HIV testing can be anonymous.

5.4. Health care providers should recommend that individuals at high risk of HIV infection regularly undergo HIV testing for early detection of HIV infection, counseling on HIV infection, and timely initiation of treatment in the event of infection.

5.5. Examination for HIV infection (including anonymous) is carried out in medical institutions of all forms of ownership with the informed consent of the patient in conditions of strict confidentiality, and in the case of examination of minors under the age of 14 years - at the request or with the consent of his legal representative.

5.6. Testing for HIV infection is carried out with mandatory pre- and post-test counseling on HIV prevention issues.

5.7. Consultation should be conducted by a trained specialist (preferably an infectious disease doctor, epidemiologist or psychologist) and include basic provisions regarding HIV testing, possible consequences of testing, determining the presence or absence of individual risk factors, assessing the knowledge of the person being examined on issues of HIV prevention, providing information about routes of HIV transmission and methods of protection against HIV infection, types of assistance available to those infected with HIV.

5.8. When conducting pre-test counseling, it is necessary to fill out an informed consent form for HIV testing in two copies, one form is given to the person being examined, the other is kept in the health care facility.

5.9. A referral for an enzyme-linked immunosorbent assay (ELISA) of a blood sample for HIV infection is filled out by all health care organizations, regardless of their legal form and form of ownership.

5.9.1. During confidential testing, personal data on the patient is given without abbreviations (according to the passport or a substitute identification document of the person being examined): full name, full date of birth, citizenship, address of residence, contingent code.

5.9.2. During anonymous testing (without a passport), only a digital code is indicated, including the serial number of the person being examined, year of birth, place of residence (subject of the Russian Federation). The last name, first name and patronymic of the person being examined is not indicated.

5.10. A response about the examination result is issued upon completion of the testing algorithm. The issuance of an official document confirming the presence or absence of HIV infection in the person being examined is carried out only by institutions of the state or municipal health care system.

5.11. The results of HIV testing are communicated to the person being examined by a consultant during post-test counseling; If possible, the same specialist provides pre- and post-test counseling to the patient.

5.11.1. Counseling for any HIV test result should include a discussion of the meaning of the result, taking into account the risk of HIV infection for the person being examined; explanation of the routes of transmission of HIV and methods of protection against HIV infection for the person being examined; types of care available for those infected with HIV, and recommendations for further testing tactics.

5.11.1.1. Counseling for an indeterminate HIV test result, in addition to a set of standard information, should contain a discussion of the possibility of HIV infection, the need to take precautions to prevent the spread of HIV infection, guarantees of medical care, treatment, and respect for the rights and freedoms of HIV-infected people. The person being tested is sent to the Center for Prevention and Control of AIDS.

5.11.1.2. A person diagnosed with HIV infection is notified by a consultant of the test results. The specialist communicates the positive test result in a clear and concise manner, provides time to absorb this news, and answers the patient’s questions. Explains the need to take precautions to prevent the spread of HIV infection, guarantees of medical care, treatment, respect for the rights and freedoms of HIV-infected people, as well as criminal liability for putting in danger of infection or infecting another person. The person being tested is sent to the Center for the Prevention and Control of AIDS to establish a diagnosis of HIV infection and provide medical care.

5.11.2. Study results are not communicated over the phone.

5.11.3. The diagnosis of a disease caused by the human immunodeficiency virus is established by a doctor at the Center for the Prevention and Control of AIDS or an authorized physician at a medical facility based on a set of epidemiological data, the results of a clinical examination and laboratory tests. The diagnosis of HIV infection is communicated to the patient by a doctor (preferably an infectious disease specialist, epidemiologist or psychologist) during consultation with the patient at the AIDS Prevention and Control Center or an authorized healthcare facility. The patient is notified in writing about the detection of HIV infection, and he is provided with information on this problem. If HIV is detected in minors under the age of 18, their parents or legal representatives are notified.