BEHAVIOR WITH A POSITIVE HIV RESULT

BRIEF GUIDELINES

  1. INITIAL HIV TESTING
  2. NEGATIVE RESULT FROM INITIAL HIV TESTING
  3. REACTIVE OR INDEFINITE RESULT FROM INITIAL HIV TEST
  4. CONFIRMATORY TESTING AT THE NATIONAL REFERENCE CONFIRMATORY LABORATORY FOR HIV (NRCL HIV)
  5. TESTING OF A SECOND BLOOD SAMPLE AT THE NATIONAL HIV REFERENCE LABORATORY
  6. ISSUING A PROTOCOL FOR HIV INFECTION AND REFERRING THE INFECTED PERSON FOR THERAPY
  7. HIV TESTING ALGORITHM
  8. FREQUENTLY ASKED QUESTIONS
  9. DURING PREGNANCY
  10. CHILDBIRTH AND HIV TRANSMISSION
  11. AFTER THE BABY IS BORN
  12. GLOSSARY

Primary HIV testing can be performed voluntarily or for various medical reasons.

Its purpose is to determine, if possible, whether a person is infected with HIV due to risky sexual contact, risky injection practices, including drug use, possible infection of a baby by a pregnant woman with HIV during pregnancy, during or after birth, etc. The initial HIV test is performed using a certified test for the detection of specific antibodies/antigens. Any person may undergo multiple initial HIV tests, taking into account the test used and the duration of the so-called window period.

Free primary tests are performed at regional health inspectorates (RHI) and anonymous and free AIDS counselling and testing centres (KABKIS). Primary HIV tests are performed for a fee in independent medical diagnostic laboratories (MDL) or in laboratories within other healthcare facilities.

Primary HIV testing is carried out after informed consent has been given by the patient or their parent/guardian. The test may be carried out without the consent of the person/guardian in urgent and/or life-threatening cases.

When the results of the initial test are negative, it is assumed that the person is not infected with HIV.

Considerations. It should be noted that there is a window period during which markers for HIV infection cannot be detected. This is the time from the day of exposure to the day when the first markers indicating HIV infection appear. Different types of HIV tests have different window periods. Standard 4th generation immunoenzymatic laboratory tests for antibodies and p24 antigen detect HIV about 30 days after infection. Rapid tests have a longer window period, about 3 months. The window period should be carefully discussed with the person being tested to avoid testing too soon after exposure. Sometimes people who have been exposed to risk decide to get tested too soon afterwards. They should be informed about the existence of a “window period” and the need to be tested again after 1-3 months. The markers for identifying HIV, as well as the time of their appearance and intensity, are influenced by various factors, including the use of antiretroviral drugs, immunosuppressants and others.

When the initial test is positive, it is considered reactive and a confirmatory test must be performed. In some cases, the result is indeterminate, i.e. it cannot be definitively determined as negative or positive. This is due to a non-specific reaction, a window period or other factors. The sample that has given a reactive or indeterminate result is sent by the person who took the sample (attending physician, MDL, RZI, KABKIS, medical facility) to the National Reference Confirmatory Laboratory for HIV (NRL for HIV at the National Centre for Infectious and Parasitic Diseases). The sample is accompanied by a standard form in accordance with Regulation 47 on the conditions and procedures for testing, reporting and recording HIV infection.

When the initial test is performed with a rapid peripheral blood test, the medical specialist performing the rapid test (consultant, doctor) that the result is reactive or indeterminate and that an additional confirmatory test must be performed by taking venous blood, which is sent to the National Reference Laboratory for HIV.

If the results of the confirmatory tests at the NRL for HIV are negative, it is assumed that the person is not infected with HIV.

Considerations. A window period is possible and should be taken into account.

When the results of the confirmatory tests at the NRL for HIV on the first blood sample are positive, it is necessary to perform repeat confirmatory tests with a new – second blood sample, taken by a new venipuncture. The HIV NRL sends a request for a second blood sample, which must be taken in three vacuum tubes: one with EDTA anticoagulant (purple cap), one with heparin anticoagulant (green cap) and one with serum clotting activator (yellow or red cap). The request is sent by the HIV NRL to the healthcare facility (HF) that took the first blood sample. If this medical facility cannot locate the person, the request is sent to the Regional Health Inspectorate (RHI) at the place of residence in accordance with Regulation 47 on the conditions and procedures for testing, reporting and recording HIV infection. The sample with heparin anticoagulant (green cap) is intended for the initial determination of the absolute number of CD4 T cells, which is performed at the National Reference Laboratory for Immunology at the National Centre for Infectious and Parasitic Diseases. CD4 gives an idea of the degree of immune deficiency and an indication of the time of infection. It is important for the person to understand that immediate treatment increases the chances of restoring the immune system.  The samples are transported by express courier.

Considerations: To date, HIV infection is considered to be lifelong, and diagnosis must be made with at least two different blood samples to avoid the risk of misidentification during sample collection, labelling, shipping, transport, testing, etc.

The second blood sample is provided by the medical facility, CABKIS or RZI that performed the initial test.

When the results of the confirmatory tests at the HIV NRL are inconclusive, additional confirmatory tests must be performed with new blood samples taken by venipuncture several weeks later, following instructions from the HIV NRL.

Considerations. In some cases, indeterminate results may be obtained from confirmatory tests at the NRL for HIV. Cross-reactions occur in some diseases. During acute HIV infection, some of the markers may not react as expected and the results may be indeterminate.

If the results of the confirmatory tests and the second blood sample are positive, the HIV NCP issues a protocol stating that the person is infected with HIV. In compliance with confidentiality, the protocol is given to the person with HIV and they are referred to medical facilities with specialised departments and sectors for monitoring and treatment of HIV infection (see addresses and contacts below). Depending on the specific case, the protocol may be delivered at the medical facility, the Regional Health Inspectorate, the Centre for Infectious Diseases and Parasitology, or the National HIV Reference Laboratory. In a conversation with the infected person, it should be explained that all Bulgarian citizens, regardless of their health insurance status, are provided with free antiretroviral therapy (ART) as well as virological and immunological tests to monitor the effect of the therapy. Infected persons should understand the necessity and benefits of ART and be referred as quickly as possible to medical facilities for monitoring and treatment of HIV/AIDS. Infected persons are encouraged to inform their partners, who should also be tested for HIV. Particular attention should be paid to pregnant women with confirmed infection due to the very high risk of transmission of the virus in utero, during childbirth and afterwards during breastfeeding.

1.1. Reactive result from primary testing with a rapid test.

Inform the person being tested that the results of rapid tests are not definitive; they may be false positive or indicate a true infection, so a confirmatory test must be performed at an HIV reference laboratory.

Collect venous blood in three vacuum tubes, one with EDTA (purple cap), one with serum clotting activator (yellow or red cap) and one with heparin (green cap). All vacuum tubes should be labelled as the first blood sample and with the patient’s name. Venous blood is collected by a medical professional at the healthcare facility where the rapid test is performed, or at the RZI, or at the NRRL for HIV. The samples are transported quickly by courier to the NRRL for HIV. Minimum accompanying information: full name, personal identification number and address according to the National Population Register, and in the case of anonymous testing – code. Name and telephone number of the doctor sending the sample. If it is not possible to collect venous blood on site, refer the patient to the Regional Health Inspectorate / CABKIS or the National HIV Reference Laboratory.

1.2. Reactive result from primary testing with a laboratory test.

Send the remainder of the sample that showed a reactive result and the accompanying information about the person tested to the National Reference Laboratory for HIV.

If the patient has learned of the reactive result, inform them that the results of the primary tests are not final, they may be false reactive or an indication of an actual infection, so a confirmatory test must be performed at the National Reference Laboratory for HIV. The samples are transported quickly by courier to the HIV NRL. Accompanying information: Full name, personal identification number and address according to the identity card, and in the case of anonymous testing – code. Name and telephone number of the doctor sending the sample.

2. CONFIRMATORY TESTING AT THE NRL FOR HIV OF THE FIRST BLOOD SAMPLE

2.1. If the results from the HIV NRL are negative, it is assumed that the person is not infected with HIV, unless they are in the window period.

2.2. If the results of the HIV NRPL are positive, repeat tests must be performed with a new sample (a second blood sample taken by a new venipuncture). The samples are taken as specified in point 1.1. and all vacuum tubes are labelled as a second blood sample with the patient’s name. Along with the second blood sample, the forms from Regulation 47, uploaded on the NRLP for HIV website, shall be completed. The name and telephone number of the doctor sending the sample shall be included.

3. CONFIRMATORY TESTING OF THE SECOND BLOOD SAMPLE AT THE NRL FOR HIV

3.1. Testing of the second blood sample at the HIV NRL. The second blood sample is taken by the doctor who ordered the first test or as in point 1.1.

3.2. If the results from the HIV NRL are inconclusive, additional tests are performed with new blood samples after a few weeks (as instructed by the HIV NRL).

3.3. If the results of the HIV NRPL and the second sample are positive, a protocol is issued stating that the person is infected with HIV. In compliance with confidentiality, the protocol is given to the person and they are referred for HIV therapy. Explain the benefits of therapy and encourage them to refer their partners for HIV testing.

The human immunodeficiency virus (HIV) causes acquired immunodeficiency syndrome (AIDS). Once HIV enters the body, it attacks the most important cells of the immune system. As the immune system gradually weakens, it becomes unable to protect you from infections and malignant diseases.

HIV is transmitted through contact with bodily fluids of an infected person, such as semen, vaginal fluid, blood or breast milk. There is no risk from shaking hands, hugging, sharing eating utensils or other everyday contact.

There is no risk of transmission when the infected person is receiving treatment and has an undetectable HIV viral load.

An undetectable viral load means that you are not infectious to others.

AIDS (acquired immune deficiency syndrome) is diagnosed when, as a result of HIV infection, symptoms of immune deficiency begin to appear: frequent and prolonged infections caused by unusual microorganisms that are difficult to treat, or the onset of certain malignant diseases. AIDS occurs when the number of affected immune cells becomes too low (usually below 200 CD4 T lymphocytes/μl in peripheral blood).

It can take anywhere from months to 10-15 years for HIV infection to develop into AIDS. This depends on many individual factors. If you do not get tested, you may never know you have HIV until the symptoms of AIDS appear.

There is a modern treatment, antiretroviral therapy (ART), which successfully stops the virus from multiplying and destroying the immune system. HIV infection cannot be completely cured with modern methods. Fortunately, however, ART helps you to be practically healthy and non-infectious to others for a long period of time. The earlier you start treatment, the better your immune system will recover and the longer you will be in good health. Treatment reduces the risk of transmitting the virus to almost zero, including to your baby (if you are pregnant).

Regardless of treatment, it is important to use condoms during sex.

If your partner also has HIV, condoms help protect both of you from other sexually transmitted infections.

During pregnancy, there is a high risk of HIV passing through the placenta and infecting the baby.

During childbirth, especially if it is natural, the baby is at risk of HIV infection through the mother’s blood and other bodily fluids.

HIV can also be transmitted to the baby through breast milk.

You, your obstetrician-gynaecologist and your treating physician should discuss the options for minimising the risk of HIV transmission to your baby. Some of the options are:

  • Treatment of HIV infection during pregnancy.
  • Treatment of HIV infection during childbirth, if necessary
  • Administration of anti-HIV medication to your baby after birth, after consultation with a doctor from one of the five specialised departments or sectors for HIV/AIDS monitoring and treatment in Bulgaria (see contacts below).
  • Caesarean section delivery.
  • Do not breastfeed! Give your baby formula milk.
  • By following these guidelines, 99% of HIV-infected women will not transmit HIV to their babies.

HIV treatment reduces the amount of virus in the body. Treatment during pregnancy has two goals:

  • to protect your own health
  • to minimise the chance of passing HIV to your baby. Different combinations of HIV medicines can be used to suppress the replication of HIV. This is called a ‘drug regimen’.

If you are already taking medication for HIV treatment, you should continue treatment during pregnancy, but only after consulting your doctor at the specialised HIV/AIDS department or unit. Your doctor may recommend a change in your treatment regimen while you are pregnant.

If you have not been taking medication until now, talk to your obstetrician-gynaecologist and contact a specialised department or unit at one of the university hospitals in Sofia, Plovdiv, Stara Zagora, Pleven and Varna to start treatment as soon as possible.

Department for the Treatment of Acquired Immune Deficiency, Clinic for the Treatment of Viral Hepatitis, Intestinal Infections and Acquired Immune Deficiency at SBALIPB “Prof. Ivan Kirov” – Sofia

02 9023732; 02 9023733; 02 9023711

from 8:00 a.m. to 2:00 p.m.

sbalipb@abv.bg

HIV Treatment Unit, Infectious Diseases Clinic, Base II of the University Hospital “St. George” – Plovdiv, 66 Peshersko Shose Blvd. AIDS Office

032/60 27 46; 032/60 27 41;032/60 27 45

unihosp@unihosp.com

HIV Treatment Sector, First Infectious Diseases Clinic, St. Marina University Hospital – Varna. 100 Tsar Osvoboditel Blvd., Varna

052/30-28-51; 052 978 703

office@svetamarina.com

HIV Treatment Unit, Infectious Diseases Clinic, Dr Georgi Stranksy University Hospital – Pleven. 8A Georgi Kochev Blvd. 5800 Pleven

064/ 886100

umbal@umbalpln.com

HIV Treatment Unit, Infectious Diseases Clinic, Prof. Dr Stoyan Kirkovich University Hospital – Stara Zagora. 2 General Stoletov Street

042 698 420; 0887664216; 0887310727

www.umbal-kirkovich.org

It is important to take your prescribed medication exactly as directed. If you do not take it regularly, the virus may become resistant to it. If this happens, the medication will no longer work and there will be a much greater chance of HIV infecting your baby.

Medicines used to treat HIV infection can cause side effects. Common side effects include nausea, diarrhoea, headache and muscle pain. Less common side effects include anaemia, liver damage and bone problems such as osteoporosis. Your doctor can provide you with information about any HIV medication you are taking.

Having HIV means that you can be infected more easily by other causes of infection. To stay as healthy as possible, your prenatal consultations will discuss:

  • the vaccinations you have received
  • the need for tests to monitor liver function
  • the need for tests for other sexually transmitted infections. If you have any, these will also need to be treated.

Your viral load is the amount of HIV you have in your body. A high viral load means a greater risk of passing HIV to your baby and a greater risk of becoming ill. Your viral load should be monitored closely throughout your pregnancy. Keep in mind that even with a low viral load, it is still possible to pass HIV to your baby. However, taking medication reduces this risk.

Having HIV infection does not increase the likelihood of genetic disease in your baby. You can undergo genetic testing just like any other pregnant woman. If you decide to have foetal genetic tests such as amniocentesis or chorionic villus sampling (CVS), the risk of transmitting the virus to your baby during these tests is not increased, provided you follow the treatment regimen prescribed by your doctor.

CAN I GIVE BIRTH NATURALLY?

If your viral load is not high, you can give birth naturally. Discuss the best option for you with your obstetrician-gynaecologist.

Most babies infected with HIV from their mother are infected during birth. During natural birth, the baby is exposed to the mother’s bodily fluids, which contain the virus. Intravenous administration of HIV medication during birth significantly reduces the risk.

If you have a high viral load, your gynaecologist may recommend a caesarean section. A caesarean section reduces the risk of HIV transmission to the baby during birth. In these cases, the procedure is performed shortly before the due date (at 38 weeks of gestation) to reduce the risk of labour starting before the planned surgery.

Caesarean section carries some additional risks if you have HIV infection:

  • You may have a weakened immune system, which means you are at greater risk of infection after surgery.
  • The surgical incision may heal more slowly.
  • Discuss these risks with your gynaecologist, as well as the benefits of a caesarean section for you and your baby.

If you have planned a caesarean section and labour starts early, you should go to the hospital immediately. The decision on how your baby will be born will be based on several factors: how long ago labour started, your viral load, your HIV treatment regimen and your overall health.

If you are infected with HIV, your baby will be tested for HIV several times during the first few months after birth. The test checks whether the virus is present in the baby’s blood.

Your baby should receive liquid medication after birth to further reduce the risk of infection. The first dose is given as soon as possible within 6 to 12 hours after birth. Prophylaxis continues for 4 to 6 weeks.

The most common side effect of this treatment is anaemia. Your baby’s doctor should monitor them for anaemia and treat it if necessary.

Babies diagnosed with HIV infection need specialised care. Your baby’s doctor can tell you more about this.

Staying healthy is the best thing you can do for yourself and your baby. Here are some things you can do to stay healthy:

  • Continue taking your HIV medication. Discuss your treatment with your HIV doctor from the specialised HIV/AIDS treatment department or sector after your baby is born.
  • Take care of your mental health. Giving birth can be a happy time, but it can also be very stressful. You may find it more difficult to take care of yourself after your baby is born. If you are having difficulty taking your medication as directed or simply need help coping with childcare, talk to your partner, family members, friends or obstetrician-gynaecologist.
  • Choose a method of birth control. You can become pregnant 4 weeks after giving birth. It is a good idea to think about methods of contraception to use after your baby is born. It is important to allow enough time between pregnancies. This gives your body a chance to recover.
  • Plan your next pregnancy if you wish. Before you become pregnant again, visit your gynaecologist for a check-up. During this visit, you should discuss the antiretroviral therapy you are taking.

Acquired immunodeficiency syndrome (AIDS): A group of signs and symptoms, usually of severe infections, in people who are carriers of the human immunodeficiency virus (HIV).

Amniocentesis: A procedure in which amniotic fluid and cells are taken from the uterus for testing. The procedure uses a needle to withdraw fluid and cells from the placenta.

Anaemia: Unusually low levels of red blood cells in the bloodstream. Most cases are caused by low iron levels.

Caesarean section: Delivery of the foetus from the uterus through an incision made in the woman’s abdomen.

Chorionic villus sampling (CVS): A procedure in which a small sample of placenta cells is taken for testing.

Human immunodeficiency virus (HIV): A virus that attacks certain cells of the immune system. If left untreated, HIV can cause acquired immunodeficiency syndrome (AIDS).

Immune system: The body’s natural defence system against microorganisms (viruses and bacteria) that cause disease.

Obstetrician-gynaecologist: A doctor with special training and education in women’s health.

Osteoporosis: A condition in which bones become thin and brittle, making them more likely to break.

Placenta: An organ that provides nutrients and removes waste from the foetus.

Pneumonia: An infection of the lungs.

Seminal fluid: Fluid produced by the male sex glands that contains sperm.

Sexually transmitted infections (STIs): Infections that are spread through sexual contact. Infections include chlamydia, gonorrhoea, infections caused by HPV and HSV, syphilis, and HIV infection.

Vaccines: Substances that help the body fight infections. Vaccines are made from very small amounts of harmless microorganisms that cause disease (bacteria, toxins, and viruses).

THE FOLLOWING PEOPLE WORKED ON THE GUIDELINES:

Prof. Maria Nikolova, MD

Head of the National Reference Laboratory for Immunology, NCPH

Assoc. Prof. Ivaylo Alexiev, MD

Head of the National Reference Confirmation Laboratory for HIV, NCPH

Prof. Mariana Stoycheva, MD

Medical University, Plovdiv

Prof. Nina Stoyanova Yancheva-Petrova, MD

Department of Infectious Diseases, Parasitology and Tropical Medicine – Medical University of Sofia;

SBALIPB “Prof. Ivan Kirov”

With the support of:

BULGARIAN SOCIETY OF OBSTETRICS AND GYNAECOLOGY

Dr. Radko Totsov – Chief Coordinator

Prof. Asen Nikolov

Prof. Ivan Kostov

CAPITAL COLLEGE OF THE BULGARIAN MEDICAL ASSOCIATION

Dr Stanimir Kachesmarov OPL – Chief Coordinator

Dr. Asen Medzhidiev

NATIONAL CENTRE FOR INFECTIOUS AND PARASITIC DISEASES

NATIONAL NETWORK OF HEALTH MEDIATORS

Prof. Ivaylo Tarnov Member of the Management Board

MARFARMA SD EOOD

Manager Mag. Pharm. Mariela Marcheva