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Module 3 Specific Interventions to Prevent Motherto-Child Transmission of HIV (PMTCT) Total Time: 265 minutes After completing the module, the participant will be able to: Describe all essential components of antenatal care (ANC) for a woman who is HIV-infected. Explain the role of antiretroviral drugs (ARVs) in preventing mother-to-child transmission of HIV (PMTCT). Describe strategies for reducing the risks of MTCT during labour and delivery. Discuss the management of women during labour and delivery who are of unknown HIV status. Describe immediate postpartum care of women with HIV infection. Explain the need to integrate family planning into community services. Describe guidelines for immediate newborn care. UNIT 1 Implementation of Comprehensive ANC Services Activity/Method Time Interactive lecture 20 minutes Exercise 3.1 Antenatal care: case studies 25 minutes Questions and answers 10 minutes TOTAL UNIT TIME UNIT 2 55 minutes Antiretroviral Prophylaxis and Therapy for PMTCT Activity/Method Time Interactive lecture 20 minutes Exercise 3.2 Nevirapine prophylaxis for PMTCT: case studies 30 minutes Questions and answers 5 minutes TOTAL UNIT TIME 55 minutes UNIT 3 Optimal Management of Women During Labour and Delivery Activity/Method Time Interactive lecture 20 minutes Exercise 3.3 Obstetric practices and HIV: group discussion 25 minutes Exercise 3.4 HIV testing and ARV prophylaxis during labour and delivery: case studies 35 minutes Questions and answers 10 minutes TOTAL UNIT TIME UNIT 4 90 minutes Postpartum Management of Women and Infants Activity/Method Time Interactive lecture 30 minutes Exercise 3.5 Supporting postpartum follow-up: group discussion 25 minutes Questions and answers 10 minutes TOTAL UNIT TIME Trainer Instructions Slides 1-3 Begin by reviewing the module objectives listed above. 3-2 65 minutes Malawi PMTCT Trainer Manual UNIT 1 Implementation of Comprehensive ANC Services Advance Preparation The trainer should become familiar with the appendices and be prepared to integrate the content into the presentation. . Review Exercise 3.1. If necessary, adapt the cases and the names to reflect typical scenarios at the clinics where participants work. The trainer should consider speaking with clinic staff to adapt the cases. Total Time: 55 minutes Trainer Instructions Slides 4-5 Introduce the unit and review objectives. After completing the unit, the participant will be able to: Describe all essential components of antenatal care (ANC) for a woman who is HIV infected. Trainer Instructions Slides 6-7 Begin the discussion of quality reproductive health services and the importance of integrating PMTCT services into antenatal care, using the information below. Make These Points Confidential HIV testing services must be made available to all women. Testing and counselling serve as the gateway to PMTCT interventions. Women who refuse HIV testing should be offered counselling to address their concerns and reservations. If they continue to decline testing, this decision must be respected. They should be informed that if they change their mind, or want to discuss this further, testing and counselling will be available throughout their pregnancy. Antenatal care Antenatal care (ANC) is an essential part of quality reproductive health services and improves the general health and well-being of mothers and their families. Given the rapid spread of HIV infection worldwide, all pregnant women should be considered at risk for acquiring HIV infection. Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT) 3-3 The ANC setting is an important source of health care for women of childbearing age. By integrating PMTCT services into essential ANC services, healthcare programmes can improve care—and pregnancy outcomes—for all their clients. This unit addresses the integration of PMTCT services into ANC for all women, as well as the management of pregnant HIV-infected women and women of unknown HIV status in ANC programmes. Antenatal interventions can reduce the risk of MTCT. Good maternal health care helps women with HIV infection stay healthy longer and care for their children better. When mothers die prematurely, their children face higher rates of illness and death. Components of quality ANC and reproductive health relevant to PMTCT Determining a woman’s HIV status is the first step in providing appropriate treatment, care and support services. Availability of rapid testing allows women to be tested and receive their HIV test results at the first prenatal visit. In the context of PMTCT, components of quality ANC and reproductive health services include (see also Module 2, Unit 4: Role of Maternal and Child Health Services and Reproductive Health Services for the Prevention of HIV Infection in Infants and Young Child): Comprehensive antenatal services Routine HIV testing and counselling Counselling on the use of antiretroviral drugs for PMTCT prophylaxis. If the woman meets eligibility criteria for initiating ARV therapy, she should receive counselling about that as well. Safer infant feeding counselling and support Quality intrapartum care that avoids unnecessary invasive procedures and adheres to infection-prevention practices. Quality postpartum care that includes: Safer infant feeding counselling and support Family planning services Comprehensive follow up care for both the HIV-infected mother and her HIVexposed baby The woman who refuses HIV testing during ANC should be counselled so she has an opportunity to have her reservations about testing addressed. Where available and appropriate, she should also be offered couples counselling. Women of unknown HIV status should be made aware that testing is available at any ANC visit and reminded of the benefits of knowing their HIV status. If they continue to decline testing, this decision must be respected. They should be informed that if they change their mind, or want to discuss this further, testing and counselling will continue to be available throughout their pregnancy. Trainer Instructions Slides 8-10 Discuss routine ANC and ANC for women who are HIV-infected using the following information. 3-4 Malawi PMTCT Trainer Manual Make These Points A comprehensive approach to the care of the woman who is HIV-infected is important for a successful PMTCT services. Screening for, and treatment of, HIV-related conditions and common illnesses can greatly improve the quality of life for pregnant women living with HIV infection. Male involvement in birth preparedness is important, especially for women with HIV, as it provides an opportunity for the male partners to hear about PMTCT and its benefits from the healthcare worker. Integrated essential package for ANC services ANC for women infected with HIV includes the basic services recommended for all pregnant women. However, obstetric and medical care should be expanded to address the specific needs of women infected with HIV. Table 3.1: Integrated essential package for ANC services Integrated essential package for ANC services Schedule of ANC visits Within the first 16 weeks First visit Between 20 and 24 weeks Second visit Between 28 and 32 weeks Third visit From 36 weeks Fourth visit Every pregnant woman should have at least 4 ANC visits. There is no need to increase the number of antenatal visits for HIV-infected women, unless there are complications. However additional counselling time may be required. Determine the following: Client history History of puerperal sepsis, postpartum haemorrhage, infected caesarean section wound, pre-term labour and delivery, and/or history of abortions Past infant-feeding practices; growth and development of the previous child, history of still birth History of HIV Testing and Counselling (HTC, formerly referred to as “VCT”) and ARV therapy History of chronic cough or tuberculosis Drug history, known allergies, and use of traditional medicines such as herbal products. History of present Determine the following: pregnancy History and treatment of STIs for woman and partner History of significant weight loss History of recurrent fever, diarrhoea, and/or cough Enquire about: Social history Death of children in previous two years and cause of death Death of partner and cause of death Nature of relationship with partner, e.g., monogamous, polygamous, casual relationship Perform full physical exam to assess for current signs or symptoms of illness, Physical exam and targeting common symptoms of TB, malaria, anaemia, and sexually transmitted vital signs infections (STIs). Assess for/perform the following: General appearance Height and weight Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT) 3-5 Integrated essential package for ANC services Nutritional status (skin fold measurement) Anaemia (check sclera and nails, auscultate heart) Lymphadenopathy Full breast exam Full gynaecological exam, speculum and bimanual (inspecting for evidence of STIs) Abdominal exam (checking size of uterus, spleen and liver) Intra uterine growth retardation Lung sounds (evidence of TB or other respiratory infections) Avoid any unnecessary assessment that would potentially rupture a woman’s membranes. Request the following lab tests: Haemoglobin to test for anaemia Whole blood rapid test for syphilis HIV testing if patient did not decline testing Urinalysis Others according to history and physical exam findings Diagnose and treat early according to national protocols, refer if necessary Include risk assessment for STIs. Counsel about STIs, their signs and symptoms and how STIs increase the risk of HIV transmission. Educate about how to avoid transmission or re-infection. Treat according to national guidelines or refer Provide prophylaxis based on national protocol. Co-infection with TB is the leading cause of HIV mortality. Prevention and screening If pulmonary TB is suspected, refer for registration in national programme and for sputum collection Malaria is a major cause of maternal and infant morbidity and mortality rates and is linked to increased MTCT (via placental infection). Administer malaria prophylaxis according to national protocol. Immunize according to national guidelines Lab tests STI screening HIV-related conditions Tuberculosis Antimalarials Immunizations ARV prophylaxis and/or therapy: Nutritional assessment, counselling, and support Health Education Counselling on infant feeding 3-6 Determine stage and eligibility for therapy at ARV Clinic Refer to ARV Clinic if eligible according to national guidelines If woman is not eligible for ARV therapy, counsel and educate her about use and benefits of ARV prophylaxis Include iron and folate supplementation according to national guidelines Monitor for anaemia, adequate caloric, and nutrient intake. Counsel about proper diet based on local resources. Consider providing supplements of protein and energy rich food to high risk mothers (primigravida, multiple gestation, grandmultipara, women with anaemia, and those who are malnourished) De-worm according to national guidelines. Provide ongoing education about HIV. Encourage mother to deliver at a health facility Provide infant-feeding counselling and support. Malawi PMTCT Trainer Manual Key support needs of mothers infected with HIV Pregnancy is a time of unique stress, and healthcare workers should consider assessing Living Positively the amount of support a woman is receiving from family and friends. Both mothers who are “Living Positively with HIV” refers HIV-infected and those who are not HIVto living with HIV disease healthily infected need support. However, women with and productively. That is, maintaining HIV infection usually have additional concerns physical, psychological and emotional related to their own health, their child’s health, health. Having dependable sources of and the possibility that their HIV status may be counselling and support to health in disclosed to other people. Providing support to an effort to lead a happier, more mothers who are infected with HIV will lead to fulfilling life. HIV/AIDS is a major more hope and acceptance, essential elements medical condition that must be taken for “living positively” (see box). Referrals for seriously, but it is not necessarily a clients with HIV and their families may include death sentence. the following: Food along with nutritional counselling and supplementation Practical necessities such as clothing and housing Social and psychological support, including counselling as well as peer support such as groups for people living with HIV and groups for mothers. Home care, including referrals to community-based health care (CBHC) and community based distribution (CBD) agents Traditional/herbal healers Orphan care and support Care of children with HIV/AIDS, including growth monitoring Additional information about linkages and referrals can be found in Module 8. Trainer Instructions Slides 11-12 Discuss the prevention of HIV-related conditions as well as other recurrent or chronic infections. Introduce the basic principles of maternal nutrition and the prevention of MTCT. Preventing HIV-related conditions Preventing HIV-related conditions can reduce rates of illness and death among pregnant women who are HIV-infected. It also can reduce the risk of adverse pregnancy outcomes, such as preterm labour and delivery, which can increase the risk of MTCT. All women who are infected with HIV and have HIV-related conditions should be treated according to the treatment guidelines and within the context of the available resources in Malawi. In situations where such services are not available, a woman should be referred for appropriate management of the infections to other centres that have the capability. Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT) 3-7 Women infected with HIV are more susceptible to common infections. Healthcare workers should pay special attention to signs and symptoms of possible HIV-related conditions, and follow guidelines for treatment and prophylaxis of common problems (see Module 7 for additional information). Examples of common conditions that affect HIV-infected women are TB Urinary tract infections Respiratory tract infections Recurrent vaginal candidiasis Malaria Breast conditions Unhealed episiotomies and/or delayed healing of caesarean section wounds Herpes zoster Puerperal sepsis Maternal nutrition and mother-to-child transmission Maternal nutrition during pregnancy and lactation is of considerable importance in preventing mother-to-child transmission of HIV. A well-nourished woman is likely to be in good health. However, nutritional deficiencies, such as iron and Vitamin A deficiency, are associated with an increased risk of mother-to-child transmission of HIV. Maternal malnutrition is also associated with preterm delivery, a factor that significantly increases the risk of HIV infection in the infant. Weight gain during pregnancy is an indicator of the mother’s nutritional status. See Table 3.2 below for recommendations on weight gain in pregnancy. Table 3.2 Recommended weight gain during pregnancy Women’s pre-pregnancy weight Recommended weight gain (kg) Normal 11.5- 18.0 Underweight 12.5-18.0 Overweight 7.0-11.5 See Appendix 3-A for additional information about maternal nutrition in the context of HIV. Trainer Instructions Slide 13 Facilitate Exercise 3.1 to explore community and individual-level challenges to the provision of integrated ANC services in Malawi. Please note that the first case study is used to review all the services required in ANC. Responses listed to case study questions are for illustration and are not the only “correct” answers. Do not provide or read the answers to participants. However, they can be used as prompts to help participants respond to the questions. 3-8 Malawi PMTCT Trainer Manual Exercise 3.1 Antenatal care: case studies Purpose To review ANC management in the context of HIV. Duration 25 minutes Introduction The purpose of this exercise is to review ANC management in the context of HIV. Activities Debriefing Using information in this unit, ask participants—who will remain in the large group for this exercise—to comment on whether these services (i.e. PMTCT services and the services described in “Table 3.1: Integrated essential package for ANC services) are being provided in their clinical settings. Ask participants about any challenges or obstacles they may have experienced in their ANC settings related to providing these services. The Participant Manual includes copies of the ANC case studies. Ask a volunteer to read the narrative section of the first case study. Ask participants for answers to the questions posed in the case study. Repeat these steps for the second case study. Determine whether any participants disagree with the answers offered. Ask whether this case study is similar to cases the participants may have encountered when providing ANC. Write exceptions (i.e., ways in which the participants’ experiences differ from the case studies) on the flipchart. Ask participants to describe a particular case that has challenged them in the ANC clinical setting, and how they resolved the case. Summarize how the local policies are reflected in local practice. Remind participants that the policies serve as practice guidelines. Mention that each case is as unique as the person or circumstances involved. Exercise 3.1 Antenatal care: case studies Case study 1 Nambewe, a 19-year-old single woman, tested HIV-positive at her first antenatal visit. According to the date of her last menstrual period (LMP), she is approximately 34 weeks pregnant with her first child. She received post-test counselling and was encouraged to bring her partner in for testing. According to the above information, what ANC services should Nambewe receive during the course of her care? Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT) 3-9 Case study 2 During her first visit to the antenatal clinic, Thoko found out that she was HIV-positive. When she returned for her second visit, she was “treated badly” by the staff and she left the clinic. Thoko is now 36 weeks pregnant and although this is her third visit, she has only seen the nurse once. She asks about the medicine for her and her baby so that the baby will not get HIV infection. She also tells you that her partner must not find out that she is HIV-infected. What do you tell Thoko? How was Thoko’s care affected as a result of her second visit? What other potential obstacles is Thoko facing at home? What would be your plan of care for Thoko? Exercise 3.1 Antenatal care: case studies, possible case study answers (Please note: answers are not exhaustive and should prompt discussion.) Case study 1 What ANC services should Nambewe receive during the course of her care? Ongoing care includes many of the services listed in Table 3.1, such as assessment of OIs, counselling about infant feeding, and referral for ARV therapy. In addition, it is appropriate to offer HIV testing and counselling for her partner if he comes to clinic with Nambewe. Case study 2 What do you tell Thoko? That you are very glad to see her in the clinic so that she can continue to receive ANC to protect her health and that of her baby. If you think it is appropriate apologize for the “bad treatment” that she received at the previous visit. How was Thoko’s care affected by her second visit? Thoko may not have received all the services she needed at her second visit. Fortunately, she has come back to the clinic for further care—in some cases women may not return. It is important that clients are treated with sensitivity and respect. What other potential obstacles is Thoko facing at home? Because she has not yet disclosed her HIV status, there is a need for secrecy, which in turn creates stress and limits the support Thoko receives for coping with her illness. She will need to consider how to manage ARV prophylaxis at home, issues about infant feeding, contraception, etc. What would be your plan of care for Thoko? Many of the components of care in Table 3.1 are appropriate. At this time, providing patient education about ARV prophylaxis, advising her to try and deliver at a health facility, and providing infant feeding counselling are important. 3-10 Malawi PMTCT Trainer Manual UNIT 2 Antiretroviral Prophylaxis and Therapy for PMTCT Advance Preparation The trainer should become familiar with the Prevention of Mother-to-Child Transmission of HIV in Malawi, Guidelines for Implementers and Handbook for Health Workers, September 2002, and the ARV guidelines for Malawi (2nd edition). Review exercise 3.2. If necessary, adapt the cases and the names so they reflect typical scenarios at clinics where participants work. The trainer may consider speaking with clinic staff in adapting the cases. Total Time: 55 minutes Trainer Instructions Slides 14-15 Introduce the unit and review objectives. After completing the unit, the participant will be able to: Explain the role of antiretroviral drugs (ARVs) in preventing mother-to-child transmission of HIV (PMTCT). Trainer Instructions Slides 16-18 Present the following information, emphasizing the difference between antiretroviral prophylaxis and antiretroviral therapy as indicated in the box on the next page. Make This Point Antiretroviral therapy is different from antiretroviral prophylaxis. The goal of antiretroviral therapy is care of the mother’s HIV infection. ARV therapy improves a woman’s health and reduces viral load, lowering the risk of HIV transmission to the infant. Antiretroviral prophylaxis is the short-term use of antiretroviral drugs solely to reduce MTCT to the baby. ARV prophylaxis does not treat maternal HIV or provide long-term protection for the infant. Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT) 3-11 Antiretroviral (ARV) Therapy and ARV Prophylaxis Antiretroviral drugs are substances that hinder or inhibit the replication and mutation of HIV, resulting in less damage to the immune system by the virus. ARV therapy and prophylaxis reduce the chances of mother-to-child HIV transmission by decreasing viral replication in the mother, lowering the risk of HIV transmission to the infant. Definitions ARV therapy: Long-term use of antiretroviral drugs to treat maternal HIV/AIDS in order to improve health and slow the progression of the disease. ARV therapy also reduces HIV transmission from mother to infant. ARV therapy during pregnancy ARV prophylaxis: Short-term For women diagnosed with HIV during use of antiretroviral drugs to pregnancy and eligible for therapy with reduce HIV transmission from ARVs, referral to the ARV Clinic should mother to infant. ARV be made as soon as possible. ARV prophylaxis does not treat drugs are effective for both managing maternal HIV or provide longHIV infection in the mother and term protection for the infant. preventing MTCT. There are a number of antiretroviral regimens that reduce the risk of MTCT in both pregnant and breastfeeding women. The choice of when to start therapy may be delayed until after the first trimester in order to avoid the side effects of ARV drugs and the risks of taking the drugs during early pregnancy. However, when the woman is severely ill, the benefits of therapy outweigh any potential risk to the foetus. Management of pregnant women receiving ARV therapy Pregnant women receiving ARV therapy require ongoing care and monitoring in both the ANC and ARV Clinics. When coinfection with TB exists, additional drug therapy and clinical management are required. The goal is to minimize side effects, which may occur when ARV drugs are co-administered with TB therapy, and to ensure that the ARV regimen does not contain a drug that interacts with anti-TB medications. Any pregnant woman who is taking ARV therapy should continue therapy as before. The woman taking ARV therapy should not be given NVP at the onset of labour; however, the newborn should be given NVP as a single oral dose 2mg/kg within 72 hours of birth. (See Module 7 and Appendix 3-B for additional information about ARV therapy.) The nationally recommended first-line ARV regimen also can be safely given to women of childbearing age, who are HIV-infected and not pregnant. Trainer Instructions Slide 19-20 Discuss ARV prophylaxis using the following information. 3-12 Malawi PMTCT Trainer Manual Make These Points Antiretroviral prophylaxis alone will not protect breastfeeding infants from the risk of becoming infected with HIV. The recommended ARV prophylaxis regimes are based on both when the mother accesses services as well as the infrastructure and human capacity at the health facility. The AZT prophylaxis regimen can be started in the antenatal period; the NVP prophylaxis is administered in labour. The infant ARV prophylaxis regimen is either NVP alone or a combination of sdNVP and AZT. ARVs should be initiated to the infant as soon as possible after birth or within 72 hours of delivery. Birth preparedness with male involvement especially is important, particularly for women who are HIV positive, for support to adhere to PMTCT interventions (e.g., ARV prophylaxis and safer breastfeeding options). Antiretroviral medications for prophylaxis Since the inception of the PMTCT programme in Malawi in 2001 the predominantly used ARV prophylaxis has been single dose Nevirapine (sd-NVP) for the mother taken at the commencement of true labour and sd-NVP for the infant within 72 hours of delivery. Recently it has been recognized that other regimens given daily during pregnancy and in combination are more effective in reducing MTCT and emergence of resistance. However, these regimens are more difficult to administer where infrastructure/access is an issue. The HIV/AIDS Unit has phased in the more complex but efficacious WHOrecommended regimen at sites with adequate infrastructure and human capacity for its delivery. At the same time, expansion of PMTCT to sites with limited infrastructure will be done using sd-NVP while steps are taken to build their capacity to deliver the recommended combination regimen. The recommended regimens are listed in Appendix 3-C. See Appendix 3-D for information about the studies supporting the recommended ARV prophylaxis regimens used in Malawi. Preventing nevirapine resistance In order to prevent nevirapine resistance, healthcare workers should avoid providing multiple doses of NVP to the mother. If the maternal NVP dose is given during false labour, the dose should not be repeated. The infant should receive the standard dose. Trainer Instructions Slide 21 Facilitate Exercise 3.2 using the case studies provided. Refer participants to Appendix 3C for more information on the PMTCT prophylaxis regimens. Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT) 3-13 Exercise 3.2 Nevirapine prophylaxis for PMTCT: case studies Purpose To help participants understand the use of nevirapine (NVP) for PMTCT. Duration 30 minutes Introduction Many HCWs have been introduced to the use of NVP for prophylaxis in MTCT. Questions often arise regarding the provision of NVP in specific circumstances. Case studies will be used to clarify the policy. Ensure participants have copies of the case studies. Ask for one volunteer to read Case Study 1. Ask the group to answer the question at the end of each case study if they can. Repeat this process for the 3 case studies provided. Encourage participants to ask questions if they do not understand. Remind participants that for women who did not receive AZT while pregnant or are not on ARV therapy, the regimen for PMTCT in Malawi is nevirapine (NVP). Emphasize that the long half-life of NVP, meaning the time required for drug potency to be reduced by half or eliminated from the body, is one of the reasons it is so effective, but that this also makes it easier for resistance to develop. Activities Debriefing Exercise 3.2 Nevirapine prophylaxis for PMTCT: case studies Case study 1 Baby Sibande was born weighing 2.5 kg. According to the ARV regimen used in your setting, what drug or drugs should you give him? What dosage of each drug(s) will you give him? Case study 2 Susan, a traditional birth attendant (TBA) you know from the community tells you that she helped deliver a healthy baby to an HIV-infected mother last week. She asks you whether you can give a medication to prevent HIV-transmission to the newborn. What do you tell her? Case study 3 Mwate has come to your health care facility in labour. You only have NVP available at your clinic. She is given a 200-mg dose of NVP according to the guidelines, but shortly afterwards her contractions stop. Several hours later you check her condition and realize that Mwate was in false labour. What should you do about Mwate being given her NVP prematurely? How does this affect the baby’s dose of NVP ? 3-14 Malawi PMTCT Trainer Manual Exercise 3.2 Nevirapine prophylaxis for PMTCT: case studies , Possible case study answers Case study 1 According to the ARV regimen used in your setting, what drug or drugs should you give him? What dosage of each drug(s) will you give him? The answer depends on the regimen used in your facility (which may be different from other facilities. But chance are the infant should be given either one or both of the following: 1. 2. Single dose NVP (6mg) AZT 4mg/kg twice daily for 7 days (NB: low birth babies <2.5 kg will receive 2mg/kg) Case study 2 Susan, a traditional birth attendant (TBA) you know from the community tells you that she helped deliver a healthy baby to an HIV-infected mother last week. She asks you whether you can give a medication to prevent HIVtransmission to the newborn. What do you tell her? You thank Susan for letting you know that she delivered an HIV-exposed baby. However, a single dose of ARV drugs are only effective in preventing HIV-transmission from mother to child if given within 72-hours after birth. You tell her that in the future you would be very grateful if she could encourage the mother to bring the baby to the healthcare center as soon as possible after birth, but within 72 hours of birth. Encourage Susan to tell the mother to come to the healthcare center for postpartum care as well as ongoing HIV treatment, care and support. Case study 3 What should you do about Mwate being given her NVP prematurely? How does this affect giving the baby’s dose of NVP? Do NOT give a repeat dose of nevirapine when labour is established. As repeat dosing of NVP during labour can cause NVP resistance, compromising her future choices of ARV therapy. You document when you gave the single dose of NVP in her medical chart. Provide infant NVP dose as soon as possible but within 72 hours following birth. Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT) 3-15 UNIT 3 Optimal Management of Women During Labour and Delivery Advance Preparation The trainer should review the guidelines on the management of women during labour, and guidelines on the use of Standard Precautions. Review exercises 3.3 and 3.4. If necessary, adapt the cases and the names so they reflect typical scenarios at local labour and delivery departments. The trainer may want to speak to hospital and clinic staff while adapting the cases. Total Time: 90 minutes Trainer Instructions Slides 22-23 Introduce the unit and review objectives. After completing the unit, the participant will be able to: Describe strategies for reducing the risks of MTCT during labour and delivery. Discuss the management of women during labour and delivery who are of unknown HIV status. Trainer Instructions Slides 24-29 Focus on describing strategies for reducing MTCT risk during labour and delivery, and on the management of women of unknown HIV status during labour and delivery. Ask participants to describe what the standard procedure or what steps are typically taken when a women arrives at their ANC in labour. Make These Points 3-16 Infection prevention with the use of Universal Precautions is especially important during labour and delivery. MTCT of HIV can be reduced during labour and delivery with the use of safer obstetrical practices. The box below summarizes key interventions. The material that follows provides additional information on each of the key interventions. It is important to record all vaginal examinations on the partograph. Performing unnecessary repetitive vaginal exams increases the risk of infection. It is also important to record the administration of nevirapine on the partograph. Malawi PMTCT Trainer Manual Principles of infection prevention should be reviewed with all pregnant women, including those who plan to deliver their babies at home. Care of women during labour and delivery Most HIV infections that are due to MTCT occur during labour and delivery. It has been documented that MTCT of HIV can be reduced by using specific interventions during this time. Interventions to reduce MTCT during labour and delivery Administer ARV therapy or prophylaxis during labour in accordance with guidelines Use Universal Precautions. Minimize vaginal examinations. Avoid prolonged labour. Avoid routine artificial rupture of membranes. Avoid unnecessary trauma during delivery. Avoid routine episiotomy. Minimize the risk of postpartum haemorrhage. Use safe transfusion practices Elective caesarean section is known to reduce MTCT of HIV, but is not a feasible option in Malawi. Always use Universal Precautions when providing patient care. Observe strict aseptic technique throughout the first stage of labour to prevent infections. Wash hands before and after every procedure. Decontaminate the bed, instruments, and linens soon after use. Autoclave all instruments used for delivery. Areas without electricity should utilize high-level disinfection (boiling) following the instructions in the infection prevention guidelines. Use the six swab technique with antiseptic solution for vulval swabbing and vaginal cleansing, e.g. 0.25% chlorhexidine after excluding contraindications. Use protective gear, safely dispose of sharps and contaminated materials, and sterilize equipment. See Module 9 for additional information. Minimize vaginal examinations. Perform vaginal examinations only when absolutely necessary, using appropriate sterile technique. Record all vaginal examinations on the partograph. Avoid prolonged labour. Use the partograph to monitor the progress of labour. Avoid artificial rupture of membranes, unless cervix is at least 6 cm dilated or above. In case of spontaneous rupture of membranes when the mother is not in labour, induce immediately if no contraindications are noted. If in latent phase of labour, augment, if there are no contraindications. If in active phase of labour, aim to deliver within 4 hours. Reinforce pain relief in labour. A woman who is relaxed progresses faster. Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT) 3-17 Avoid unnecessary trauma and invasive procedures during delivery. Avoid unnecessary episiotomy. Avoid unnecessary trauma to the infant e.g., vigorous suctioning of the airway. Minimize the use of vacuum extractors. Prevent genital tract and perineal lacerations. Do not give enemas. Do not shave the vulva. Minimize the risk of postpartum haemorrhage. Carefully manage all stages of labour to prevent infection and to avoid prolonged labour. Actively manage the third stage of labour. Use safe transfusion practices. Minimize blood transfusions. Use only blood screened for HIV, hepatitis B, and syphilis. Trainer Instructions Slide 30 Facilitate Exercise 3.3 using the case studies provided. Responses to case study are for illustration and are not the only “correct” answers. Do not read the answers. However, they can be used to create prompts to help participants to respond to the questions. Exercise 3.3 Obstetric practices and HIV: group discussion Purpose To discuss a scenario that will enable participants to exercise their clinical judgement about safe practices in the labour and delivery setting. 25 minutes Duration Introduction Explain to participants that the case study will help them address questions that may arise when trying to implement safer obstetric practices. Divide participants into three groups. Activities Instruct them to read through the case study together. Tell participants that the groups have 10 minutes to discuss the case study and recommend a course of action. Bring the groups back together and, in the large group, ask each group to provide their recommendation. Determine if all participants agree on the recommendations each group makes. Discuss alternate answers or strategies that may apply. Did they think this case study was appropriate for discussing a labour and delivery scenario? What other issues typically come up during labour and delivery when trying to implement safer obstetric care? 3-18 Malawi PMTCT Trainer Manual Exercise 3.3 Obstetric practices and HIV: group discussion Debriefing Emphasize that each case is individual and that appropriate interventions must be determined by considering the particular circumstances involved and balancing the risks and the benefits of the action. Exercise 3.3 Obstetric practices and HIV: group discussion, case study You are a midwife in a busy labour and delivery ward. Today you are teaching 3 medical or midwifery students. A new patient arrives and states that she has been labouring at home for 5 hours. Her contractions are mild and 8 minutes apart. She tells you that she tested HIV-positive at an ANC clinic. 1. What are your concerns about performing the initial vaginal exam on this patient? You assess the patient and she is dilated to 4-5 cm; foetal heart tones are within normal limits, and the baby’s head is engaged. However, her membranes have not ruptured yet. You are under pressure from your director to attend to the 4 other labouring women in the clinic that evening. 2. Do you rupture her membranes to progress labour? Four hours go by and a nurse comes to tell you that she has ascultated the baby’s decelerating heart beat, which did not correspond to a contraction. Upon inspection of the birth canal, you see that the baby’s head is engaged but that the amniotic sac is still intact. 3. At this point do you rupture her membranes to progress labour? 4. Would you perform an episiotomy now? Exercise 3.3 Obstetric practices and HIV: group discussion, possible case study answers (Please note: answers are not exhaustive and should prompt discussion.) 1. What are your concerns about performing the initial vaginal exam on this patient? As this patient is HIV-infected, you understand that performing vaginal exams on this patient increases the risk of MTCT. Hand washing, using gloves, and avoiding trauma will be critical. While performing the vaginal exam to initially check dilation of the cervix, you are careful to note the exam on the partograph. 2. Do you rupture her membranes to progress labour? No, as long as the patient is progressing along the normal curve and there is no indication that the baby is in distress, you should not rupture her membranes. Rupturing her membranes will increase the risk of an infection ascending into the patient’s womb, and may also unnecessarily expose the infant to fluids and blood infected with HIV. 3. At this point do you rupture her membranes to progress labour? Yes, at this point the baby is in distress and it appears that delivery is imminent. 4. Would you perform an episiotomy now? The choice of whether to perform an episiotomy will depend on the status of the baby and the rate at which this late stage of labour is progressing. (Note: Routine episiotomy should not be performed on HIV-infected women). Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT) 3-19 Trainer Instructions Slides 31-32 Present the national guideline recommendations for caring for a woman with unknown HIV status during labour and delivery. Review the checklist to reinforce key information that healthcare workers should communicate to women of unknown HIV status who present in labour. Note: Labour and delivery is broadly defined as the period between admission and discharge of the patient, and is not just the period while the woman is giving birth. Guidelines on management of HIV testing in labour and delivery in Malawi are currently in development. Women with unknown HIV status All pregnant women should be offered an opportunity to receive HIV testing and counselling as early during the antenatal period as possible, according to the recommendations outlined in Module 6, “Testing and counselling.” In some situations, because of the lack of accessible testing services, or because a woman refuses testing, her HIV status may remain unknown during labour. If a woman presents to the health service at the time of labour without knowing her HIV status, the national guideline recommendations for early and late labour are as follows: Early labour: Provide information on HIV, test unless the client declines, and provide women who test HIV-positive and their infants prophylaxis with nevirapine (NVP) as per national guidelines. Late labour (active phase): Defer testing until after delivery and before discharge. At that time, provide information on HIV infection, test unless the client declines, and, when appropriate, offer NVP prophylaxis for the infant according to national guidelines. Post-test counselling following delivery, with referral for follow-up services, is required for all HIV-positive mothers and their infants. Pre-test information checklist for use in labour and delivery HIV is the virus that causes AIDS. HIV can be transmitted from a mother to her infant during pregnancy, labour and delivery, and breastfeeding. Rapid HIV testing can help determine a client’s HIV status and the need for further interventions and care. A positive rapid HIV test result must be confirmed with a second test. It is strongly recommended that the client know her HIV status in order to protect her baby. Medicines are available to reduce the risk of passing HIV infection from a mother to her baby. All woman will be provided with appropriate labour and delivery care services, regardless of her decision about HIV testing and test results. 3-20 Malawi PMTCT Trainer Manual Women and their infants should not be provided with prophylaxis unless the mother has been tested for HIV infection and found to be HIV- positive. Trainer Instructions Slide 33 Facilitate Exercise 3.4 to review issues connected with and practices for providing ARV prophylaxis in the labour and delivery setting. The responses listed to the case study questions are for illustration and are not the only “correct” answers. Do not provide or read the answers. However, they can be used as prompts to help participants respond to the questions. Exercise 3.4 HIV testing and ARV prophylaxis during labour and delivery: case studies Purpose To help participants understand the use of ARVs for PMTCT. Duration 35 minutes Introduction Using case studies and discussion, this exercise will examine issues connected with and practices for providing ARV prophylaxis. Divide participants into four groups, assigning one case study to each Activities group. Ask each group to select a person to record group answers on a flipchart. Allow 15 minutes for review of each case and recording of answers to the case study questions. Ask each group to present their case study and respond to the questions, using the notes on their flipchart as an outline. Determine if all participants agree on the answers provided. As a group, discuss alternate answers or strategies that may apply. Summarize the knowledge and skills needed to creatively address the Debriefing challenges described in the case studies. Emphasize that each case is as individual as the person or circumstances involved. Exercise 3.4 HIV testing and ARV prophylaxis during labour and delivery: case studies, case studies Case study 1 Doreen has arrived at the hospital to have her baby. She tells you that she has a passport from Lilongwe Central Hospital, but in her rush to get to the hospital, she left her passport at home. You would like to ask Doreen if she has been tested for HIV, but the room is crowded and you do not want to discuss this in front of others. Doreen is in early labour and contractions are now regular. How can you find out whether Doreen has been tested for HIV? Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT) 3-21 If you determine that Doreen was tested and is HIV-infected, what will be your next step? Case study 2 Nabanda gave birth yesterday to a beautiful baby girl at home with a traditional birth attendant (TBA). This was her fourth child and the baby was delivered within an hour of the start of her first contraction. Nabanda never had the opportunity to take the nevirapine tablet that had been given to her at the clinic. When Nabanda asks if she should take the tablet now, what do you tell her? When should her dose of NVP (200 mg) have been taken? What about the nevirapine syrup for the baby — when should she give this to her new daughter? Nabanda asks you “Will my little girl still be protected from HIV?” What will you tell her? Case study 3 Theresa arrives in labour and delivery. She has received no antenatal care and has never been tested for HIV. At this time, she is in advanced labour with contractions about 2 minutes apart. On examination you find she is 7 centimetres dilated. She asks you about HIV testing, and says that she is worried that she could be infected and pass HIV on to her baby. Will you provide HIV testing right now? What can you tell her about protecting her baby after delivery? Case study 4 Supuni arrives at the labour and delivery ward at 40 weeks gestation. She presents you with her ANC passport, which states she is infected with HIV and has been taking d4T/3TC/NVP (Triomune) for one year. She started labour one hour ago and this is her first child. Do you need to test her for HIV? What else do you want to know about this patient? Do you administer short-term prophylaxis to the patient? If so, with which ARV(s)? Do you administer short-term prophylaxis to the infant? What procedures do you want to avoid in the delivery process? What additional counselling does the patient need? Exercise 3.4 HIV testing and ARV prophylaxis during labour and delivery: case studies, possible case study answers (Please note: answers are not exhaustive and should prompt discussion.) Case study 1 How can you find out whether Doreen has been tested for HIV? The answer to this question may depend on clinic policy. Generally, you can simply ask a patient if she was tested for HIV and, if tested, when she was tested; additionally check her record to find see if there is a history of HIV testing. If you determine that Doreen was tested and is HIV-infected, what will be your next step? 3-22 Malawi PMTCT Trainer Manual Exercise 3.4 HIV testing and ARV prophylaxis during labour and delivery: case studies, possible case study answers The important issue here is to establish the client’s HIV serostatus. If Doreen’s status in unknown or cannot be verified, or her test result is not recent, follow the recommendations for women of unknown HIV status outlined above. Once the client’s status is determined, if she is HIV-positive, follow the recommendations for offering prophylaxis. She will also require counselling and follow-up in the postpartum stage. Case study 2 When Nabanda asks if she should take the tablet now, what do you tell her? Explain to Nabanda that taking the tablet now will provide no benefit to her and won’t help to reduce MTCT. When should her dose of NVP (200 mg) have been taken? Nevirapine should be taken at the onset of labour in order to reduce the transmission of HIV to an infant. What about the nevirapine syrup for the baby — when should she give this to her new daughter? NVP syrup can and should be given to her new daughter as soon as possible but within 72 hours of her birth. Nabanda asks you “Will my little girl still be protected from HIV?” What will you tell her? Explain that NVP for the baby will help to reduce MTCT but that there is still a chance that her baby was infected with HIV. Both mother and infant will require follow-up. Case study 3 Will you provide HIV testing right now? Theresa is essentially asking to be tested. If Theresa has had a previous pregnancy, then consider her to be in advanced labour. Briefly discuss HIV, MTCT of HIV, and the testing process and obtain consent for testing. If her results come back before she delivers, provide her with her results and NVP prophylaxis if she is HIV-positive. If she delivers before the results are available and is HIV-positive, she will not receive NVP. In either scenario (i.e. she is HIV-positive and either receives her test result before or after delivery), the baby will be given NVP prophylaxis within 72 hours of birth. What can you tell her about protecting her baby after delivery? Discuss ARV prophylaxis for her (if applicable) and her infant as well as safer infant feeding practices. Also discuss disclosure, partner testing and the importance of practising safer sex. The full post-test counselling and follow-up will be needed after she gives birth. Case study 4 Do you need to test her for HIV? You do not need to administer an HIV test to this patient as her ANC passport indicates that she has been tested and that she is infected. What else do you want to know about this patient? You want to know if Supuni has been taking her drugs as prescribed. Do you administer short-term prophylaxis to the patient? If so, with which ARV(s)? Effective ARV therapy should reduce the mother's viral load so that the virus will not be transmitted to the infant. She does not need additional prophylaxis drugs. She should keep to the same schedule during labour and delivery. Do you administer short-term prophylaxis to the infant? The baby should receive ARV prophylaxis of a single dose of NVP—See Appendix 3-C. You should avoid invasive obstetrical procedures like premature rupture of membranes, episiotomy, and vacuum extraction. You should counsel the patient about the potential for transmission of HIV during breastfeeding. Additional counselling would include information about safer infant feeding options, family planning, and other issues, such as recognition of HIV-related conditions. It is important that she and her infant receive all of the appropriate follow-up care outlined in Module 7 Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT) 3-23 UNIT 4 Postpartum Management of Women and Infants Advance Preparation The trainer should be prepared to discuss contraception options in detail during the presentation. Review and prepare for Exercise 3.5. Review essential newborn care guidelines. Total Time: 65 minutes Trainer Instructions Slides 34-35 Introduce the unit and review objectives. After completing the unit, the participant will be able to: Describe immediate postpartum care of women with HIV infection. Explain the need to integrate family planning into community services. Describe guidelines for immediate newborn care. Trainer Instructions Slides 36-41 Begin by informing participants that this unit will address the immediate postpartum care of women and their babies. Explain that Module 7, Comprehensive Care and Support for Mothers and Families with HIV Infection, will provide additional information on postpartum care, focusing on continuity of treatment, care, and support of women with HIV infection, their infants, and their families. Introduce the topic of quality postpartum care (after delivery, before discharge, and upon discharge). Make These Points 3-24 The infant feeding counselling and support provided in the ANC setting should be reinforced before the mother is discharged from hospital. Before discharge observe the mother feed her infant to ensure she is practising her chosen infant-feeding method correctly. Postpartum care requires the provision of education on many topics. HIV-exposed infants are at risk of health problems that require early intervention. Tell participants that more detail on this will be provided in Module 7. Linkages to community services can help provide continuity of care. Keeping HIV-negative women negative through primary prevention is key to eliminating the risk of MTCT of HIV. Malawi PMTCT Trainer Manual Immediate and subsequent postpartum care of HIV-infected mothers The following is a listing of services that should be offered to HIV-infected women after delivery, before discharge, and upon discharge. Provide Assess Mother Offer education, counselling, and support* Provide referrals for Immediately After Delivery ARV prophylaxis to the infant Before Discharge Personal hygiene Nutritional status Routine Vitamin A and iron supplement to the mother Signs and symptoms of anaemia and infections Signs of uterine involution Breast conditions Urinary tract infections Episiotomies, caesarean section Signs of PID and any other infections Clinical features of HIV or AIDS Possible side effects of ARVs Infant feeding (See Module 4, Infant Feeding in the Context of HIV Infection.) Infant re-hydration in the case of diarrhoea Infant’s umbilicus care Infant hygiene: changing diapers and washing the infant Diet and nutrition, particularly during lactation Recognizing signs and symptoms of: Postpartum infection Anaemia Infant illness Accessing help in the event of postpartum haemorrhage Information on breast and urinary tract infections *It may be necessary to include an adult family member (parent or aunt) when counselling the unmarried client younger than 16 years of age and women with special needs. Grandmothers or other guardians and relatives should be encouraged to attend postpartum counselling sessions. Postpartum haemorrhage Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT) 3-25 Offer education, counselling and support* Link patients to centres that provide the following services Ongoing Postpartum Care Follow-up care: both routine (one-week and six-week visits, then monthly check ups) and as needed Family planning information and services, including information on condom use for dual protection (See below.) *It may be necessary to include an adult family member (parent or aunt) when counselling the unmarried client younger than 16 years of age and women with special needs Postnatal review, including date for one-week and six-week visits Immunizations “Under-five” services Infant-feeding support Sexual and reproductive health care, including family planning Prevention and treatment of HIV-related conditions Prevention and treatment of malaria Nutritional counselling and support Support groups available in the community HIV treatment, care, and support (ARV Clinic), if eligible (see Appendix 3-E and 3-F for adult and child ARV therapy eligibility criteria) Social and psychosocial support Home-based care Services for any other health concern for the mother or her infant All services should be provided according to infection prevention guidelines. Trainer Instructions Slide 42 Explain that one important component of postpartum services is family planning. This will now be reviewed in the context of the HIV in Malawi. Make These Points 3-26 Family planning (FP) is an important public health strategy for PMTCT. Effective contraceptive methods should be explored in the context of an individual’s health and ability to safely implement the method of choice. Condoms are effective for contraceptive as well as primary and secondary prevention of HIV, but whether they are a realistic option depends on a woman’s ability to negotiate condom use with her partner. Malawi PMTCT Trainer Manual Family planning in the context of HIV Family Planning (FP) is part of a comprehensive public health strategy to prevent MTCT. Ideally, this should begin prior to a first pregnancy. A range of family-planning services, when integrated into existing ANC and community health services, can minimize the stigma associated with HIV/AIDS and provide: Individual and couples counselling Continued risk assessment Early diagnosis and treatment of STIs including HIV/AIDS Information about and the skills needed to practise safer sex Access to contraceptives Family Planning methods should be discussed before and soon after delivery with access to the chosen method within 6 weeks after delivery to avoid unintended pregnancy or risk of new infection. Emphasize use of dual protection, i.e. the use of condoms to prevent STDs and unplanned pregnancy. Breastfeeding mothers Combined oral contraceptives, that contain estrogen, can decrease breastmilk production. Progesterone-only contraceptives should be started 6 weeks postpartum or later for the breastfeeding mother. Trainer Instructions Slides 43-44 Use the slides and content below to review care of the HIV-exposed newborn and the importance of routine follow-up for growth and development. This will be discussed in greater detail in Module 7. Make These Points Immediate care of the newborn follows established procedures. When a child is delivered at home, the child and mother should be seen within 72 hours of delivery for assessment, administration of ARV prophylaxis and to support safer infant-feeding. Immediate and subsequent postnatal care of the newborn The immediate care of the newborn exposed to HIV follows standard practice. Regardless of the mother’s HIV status, all infants are kept warm after birth and are handled with gloves until maternal blood and secretions have been washed off. Other practices to ensure infant safety: Clamp cord immediately after birth, and avoid milking the cord. Cover the cord with gloved hand or gauze before cutting to avoid splash of cord blood. Wipe infant’s mouth and nostrils with wet gauze or towel as soon as the head is delivered. Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT) 3-27 Use suction only when meconium-stained liquid is present. Use either mechanical suction at less than 100 mm Hg pressure or bulb suction, rather than mouth-operation suction. Reduce exposure to maternal blood and secretions by wiping the infant dry with a towel. Keep the baby warm – skin to skin contact Determine the mother’s feeding choice: If she is using a breastmilk substitute, place the infant on her body for skin-to-skin contact and provide help with the first feeding. If she is breastfeeding, place the infant on the mother’s breast within 30 minutes of birth. Assess for effective sucking. Assess general condition: Bleeding Presence of infections, especially of the eyes Birth defects / Congenital malformations or abnormalities Calculate APGAR score Administer tetracycline eye ointment according to national guidelines. Avoid invasive resuscitation procedures Observe infection prevention measures Subsequent newborn care for infants exposed to HIV Make assessments and implement preventive measures: Infant feeding – Breastfeeding or replacement feeding Administer antiretroviral drugs within 72 hours as specified in the PMTCT guidelines Immunization according to EPI schedule All infants born to HIV-infected women should receive NVP prophylaxis as soon as possible but within 72 hours of birth. If given after 72 hours of birth, NVP is not effective in preventing MTCT. Infants born at home should be brought into the health facility for prophylaxis within 72 hours of birth. HIV Testing HIV testing is an important component of care for HIV-exposed infants. See Module 6: Testing and Counselling for information on testing of HIV-exposed infants and Module 7: Comprehensive Care and Support for Mothers and Families with HIV Infection, for detailed information on signs and symptoms of HIV infection. Ongoing follow-up and preventive therapies for HIV-exposed infants, such as Cotrimoxazole Preventive Therapy (CPT), will also be discussed in Module 7. Trainer Instructions Provide the following information on linking mother and infant to community services. 3-28 Malawi PMTCT Trainer Manual Linkage of mother and infant to community services The MCH and Reproductive Health services play a key role in linking women with HIV and their families to the continuum of care. These linkages and referrals between ANC and maternity are essential to increase the rates of postpartum follow-up, which are currently very low. Efforts to increase uptake of postpartum care will require a multiagency response: Provide education during ANC on the availability of service that the woman will need after the baby is born (adult and infant and young child services) Implement family-centred care whereby the mother and baby receive their routine follow-up care at the same venue during the same visit See Module 8 for additional information about postpartum follow-up care. Trainer Instructions Slide 45 Facilitate Exercise 3.5 to explore postpartum support strategies for women. Exercise 3.5 Supporting postpartum follow-up: group discussion Purpose To explore strategies to support women during postpartum follow-up. 25 minutes Duration Introduction The purpose of this exercise is to discuss strategies to support women during postpartum follow-up. Ask participants to cite what they believe to be the biggest challenges Activities to postpartum follow-up in their communities. Record answers on a flipchart. Encourage discussion of strategies to increase the uptake of postpartum services for mothers and infants. As examples, suggest the following: Education during the antenatal period about the importance of follow-up and where to go for the postpartum visit Communication between ANC and ARV clinics Communication and referral between maternity units and ARV clinics Schedule the postpartum appointment after delivery or before discharge from the labour and delivery hospital Outreach to post-test counselling support groups Infant-feeding support groups Community agencies for social support Record suggestions on a flipchart. Which of the recorded suggestions are community-specific? Which are useful for encouraging postpartum follow-up for women who deliver at home? Which key community agencies or groups might be able to help bridge the gap between MCH and RH services? Record on flipchart. Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT) 3-29 Exercise 3.5 Supporting postpartum follow-up: group discussion Debriefing Remind participants that postpartum follow-up of HIV-infected women and their infants is part of a comprehensive PMTCT services. Module 7, Comprehensive Care and Support for Mothers and Families with HIV Infection, will examine the linkages to extended community services for HIV-infected women and their families. Trainer Instructions Slides 46-51 Summarize this module by reviewing the key points in the slides and box below. Module 3: Key Points 3-30 The essential package of ANC services includes the basic services recommended for all pregnant women, including HIV testing. However, for women with HIV, obstetric and medical care should be expanded to address the specific needs of women infected with HIV. Nutritional assessment, counselling and support are important not only in the antenatal period when good nutrition plays a role in foetal health and PMTCT, but also in the postpartum period, particularly for the breastfeeding mother and for the HIV-exposed or HIV-infected infant and young child. ARV therapy is the long-term use of antiretroviral drugs to manage maternal HIV and prevent MTCT; ARV prophylaxis is the short-term use of antiretroviral drugs to reduce MTCT of HIV. The HIV/AIDS Unit has phased in the more complex but efficacious WHOrecommended regimen (which include AZT, NVP and, in some instances, 3TC) at sites with adequate infrastructure and human capacity for its delivery. At the same time, expansion of PMTCT to sites with limited infrastructure will be done using single dose Nevirapine (sd-NVP) while steps are taken to build their capacity to deliver the recommended combination regimen. The infant ARV prophylaxis regimen is either AZT alone, NVP alone or a combination of AZT and NVP. ARVs should be initiated to the infant as soon as possible after birth but within 72 hours of delivery. Using safer obstetrical practices can reduce MTCT of HIV in labour and delivery. There are national recommendations for testing of women of unknown HIV status in early labour and soon after delivery. Support for safer infant-feeding practices are a priority in the immediate postpartum period. Establishing linkages for postpartum follow-up of mother and infant can improve uptake of treatment and support services and reduce HIV-related morbidity and mortality. Malawi PMTCT Trainer Manual APPENDIX 3-A Maternal Nutrition in the Context of HIV A well-nourished woman is likely to be in good health. Consequently she is able to look after the family well. When she is pregnant, the outcome of her pregnancy is likely to be favourable and her lactation performance is enhanced. Maternal malnutrition is also associated with preterm delivery, a factor that significantly increases the risk of HIV infection in the infant. Therefore, maternal nutrition during pregnancy and lactation is of considerable importance in preventing mother-to-child transmission of HIV. Promotion of good maternal nutrition The essential components of a good diet are Protein Energy Minerals Micronutrients These nutrient requirements are essential to maintain Basal metabolic rate Physical activity Growth The nutritional requirements differ during various stages of a girl's life. Girl-child: This is a stage of rapid growth and, therefore, the requirements for all nutrients increase. Adolescent: This stage is characterized by a growth spurt and onset of maturation. Nutritional demands are high. Non-pregnant, non-lactating woman: Requirements for iron are ongoing to replace monthly loss during menstruation. Pregnant woman: During a normal pregnancy, a woman gains 10 to 12 kg. This weight includes the baby, placenta, amniotic fluid, and subcutaneous fat. Lactating women: Breastfeeding is a demanding process. Women require the equivalent of a whole extra meal per day to accommodate lactation. If nutritional intake during pregnancy and lactation is inadequate, foetal growth and milk production may be at risk. Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT) 3-31 APPENDIX 3-A Maternal Nutrition in the Context of HIV (continued) Factors affecting maternal nutrition Beliefs and culture Different cultures have different belief systems about foods that pregnant and lactating women should eat. Often, nutritious protein-rich foods are excluded from the diet e.g. eggs. Familiarize yourself with the foods that may be taboo in the community you serve in order to be able to address them during health education and counselling. Heavy workload A women’s heavy workload requires energy and calories. If a woman’s diet is only marginally nutritious, the competing needs of physical work and pregnancy contribute significantly to nutritional depletion and increased risk of delivering a low-birth-weight infant. Alcohol Alcohol intake during pregnancy may lead to higher rates of spontaneous abortion and low-birthweight. Babies may be born with abnormalities of the eyes, nose, heart including growth and mental retardation, also known as foetal alcohol syndrome, Tobacco Smoking doubles the risk of low birthweight including the following serious pregnancy complications. Bleeding during pregnancy (antenatal haemorrhage) Premature rupture of membranes Preterm delivery Indicators of adequate nutrition 3-32 Infant birthweight: Maternal nutrition during pregnancy and lactation is often discussed from the point of view of infant birthweight. Mother’s height and weight: Height is a measure of skeletal growth. Taller women have heavier babies than do shorter women. Short stature is often the result of chronic food shortage during childhood. The likelihood of having a contracted pelvis is greater in short women and with it comes a higher risk of obstructed labour, requiring operative delivery. Body mass index: Body mass index (BMI) is a composite measure of weight and height (BMI=Weight in kilograms divided by height2 in metres). For example, a woman who is 1.6 metres tall and weighs 55 kgs has a BMI of 55 divided by the square of 1.6 that gives BMI of 21.5. BMI is a reasonable indicator of current nutritional status. Women with a BMI less than 18 are classified as being severely energy depleted, 18 to 21 as moderately depleted, while over 21 is considered to be a reflection of adequate nutritional status. BMI changes considerately during pregnancy; however, it is a useful measure of nutritional status during lactation and in the non-pregnant state. Malawi PMTCT Trainer Manual APPENDIX 3-A Maternal Nutrition in the Context of HIV (continued) Mid-upper-arm-circumference: The mid-upper-arm circumference (MUAC) is measured using a non-stretch tape on the left arm. MUAC does not change appreciably during pregnancy. MUAC is a good measure of the body’s muscle mass and therefore a good indicator of body protein. Weight gain during pregnancy: is an indicator of the mother’s nutritional status during pregnancy. The weight gain is due to the products of conception and maternal fat stores. The fat stores laid down during pregnancy are used as a source of energy during periods of rapid foetal growth in late pregnancy and energy for labour and lactation. The table below outlines the distribution of weight gain during pregnancy. Product Weight (kg) Foetus 3.0 Placenta 0.4 Amniotic fluid 0.8 Uterus (weight increase) 1.1 Breast tissue (weight increase) 1.4 Blood volume (weight increase) 1.8 Maternal fat store 1.8-3.6 TOTAL 10-13.9 Recommended weight gain during pregnancy During pregnancy nutritional status can be monitored by the rate of weight gain. In the first trimester a woman should gain 1 to 3 kg. Thereafter the weight gain should be approximately 1 kg a week for the remainder of the pregnancy. A higher weight gain is not normal and is associated with complications such as pre-eclampsia and gestational diabetes. Consequences of micronutrient deficiencies In a Tanzanian study, HIV-infected and HIV-negative women were randomized to receive a multivitamin supplement containing Vitamins B1, B2, B6, niacin, B12, C, and E, folic acid, and iron and folate alone. The micronutrient supplement that included the B Vitamins significantly reduced the incidence of foetal deaths, low birthweight, preterm delivery before 34 weeks and small-for-gestational age babies. The additional benefit for HIV-infected women was reduced transmission in subgroups of women who were nutritionally or immunologically compromised. Overall, women taking multivitamin supplementation had significantly elevated CD4, CD8 and CD3 lymphocyte counts. Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT) 3-33 APPENDIX 3-A Maternal Nutrition in the Context of HIV (continued) Micronutrients deficiencies have a direct impact on the health of pregnant women, including HIV-infected women. Anaemia increases the likelihood that a woman will transmit HIV infection to her infant. Anaemic pregnant women also may require a blood transfusion, thus putting them at risk of HIV infection. The most common nutritional anaemias are deficiencies of iron, folic acid, and vitamin B12. Therefore, preventing anaemia is important for the health of both HIV- and uninfected women. Iron The consequences of iron-deficiency anaemia can be classified into maternal and foetal outcomes. Maternal outcomes include heavy bleeding (haemorrhage) during pregnancy and delivery and puerperal infections. Foetal outcomes include prematurity and low birthweight. Preterm babies are at higher risk of acquiring HIV infection from their mothers. Vitamin intake during pregnancy Adequate vitamin intake during pregnancy of B Vitamins (thiamine, niacin and riboflavin) folic acid, B12, Vitamins C, A, D, E, and K are essential. We will only consider a few selected vitamins in this section. Folic acid Folic acid is essential for synthesizing RNA, an important component of cell cytoplasm, and of DNA, the key component of the cell nucleus. Folic acid is also critical for manufacturing non-essential amino acids. Malaria and sickle-cell anaemia increase a women’s need for folic acid. Vitamin A Vitamin A plays an important role in maintaining the integrity of epithelial surfaces such as the skin and mucus membranes. Vitamin A is essential for normal immune responses. However, not enough is known about vitamin A during pregnancy and it should not be taken in large doses. Maternal supplementation with vitamin A is associated with: Reduced prevalence of anaemia Reduced maternal mortality Increased survival of HIV-infected women and children Vitamin A deficiency is associated with Mother-to-child-transmission of HIV Higher concentrations of HIV-1 virus in breastmilk of immuno-suppressed women. Impaired vision with the earliest symptom being night blindness Increased mortality Supplementing the diet of HIV-negative women with vitamin A reduces mortality. Similarly, Vitamin A supplementation reduces mortality of HIV-negative and HIVnegative children. New research findings now show that high doses of Vitamin A supplementation may increase breastmilk transmission of HIV and therefore low-dose supplementation should be maintained during the period of lactation. 3-34 Malawi PMTCT Trainer Manual APPENDIX 3-A Maternal Nutrition in the Context of HIV (continued) Factors contributing to nutritional impairment in the HIV-infected mother Four factors have been implicated in nutritional impairment in HIV-infected persons. Poor energy intake Some HIV-infected persons are unable to eat adequate amounts of food, and therefore they do not receive the nutrients they require. Several conditions may make it difficult to eat enough: Oral lesions: infection with candida, herpes simplex virus and/or cytomegalovirus Gastric irritation, nausea, or vomiting caused by HIV and its co- morbidities or ARV drugs can lead to a loss of appetite and reduced nutritional intake. Primary anorexia may lead to reduced nutrient intake. Gastrointestinal tract absorption GI tract absorption may be impaired in an HIV-infected person because of primary HIV infection of the epithelium. This can also occur with other pathogens like bacterial, protozoan, fungal and viral agents that affect the gut. Energy use During infection, including HIV infection, the basal metabolic rate increases and a higher caloric intake is needed to sustain normal metabolism. Social and psychosocial status Financial constraints resulting from loss of employment or increased health expenditure limit family resources that are available to ensure a varied and nutritious diet for the sick person and other family members. Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT) 3-35 APPENDIX 3-B Mechanism of Action, Side Effects, and General Management Principles of ARV Therapy Types of anti-retroviral drugs and their mechanism of action There are two major classes of ARVs based on their mechanism of action: Reverse Transcriptase Inhibitors (RTIs) and protease Inhibitors (PIs) Class of ARV RTIs Description These drugs non competitively inhibit the enzyme called reverse transcriptase which enables the HIV genetic material to convert into body genetic material, DNA, by binding to a site distant from the enzyme’s active site Reverse transcriptase inhibitors are further divided into 3 groups Nucleoside reverse transcriptase inhibitors (NsRTIs) Protease Inhibitors (PIs) 3-36 Examples Nucleotide reverse transcriptase inhibitors (NtRTIs) Non –nucleoside reverse transcriptase inhibitors (NNRTIs) Protease is an enzyme of the HIV virus that speeds up the assembly of core viral components (proteins) into independent viruses. Protease inhibitors inhibit the action of this viral enzyme leading to production of immature and non-infectious virus particles. Examples of NsRTIs include: Zidovudine (AZT)(ZDV) Didanosine (ddI) Stavudine (d4T) Lamivudine (3TC) Zalcitibine (ddC) Abacavir (ABC) Example of NtRTIs: Tenofovir (TDF) Examples of NNRTIs include: Nevirapine Delavirdine Efavirenz Examples of PIs include: Saquinavir (SQV) Ritonavir (RTV) Indinavir (IDV) Nelfinavir (NFV) Amprenavir (APV) Malawi PMTCT Trainer Manual APPENDIX 3-B Mechanism of Action, Side Effects and General Management Principles of ARV Therapy (continued) Types of ARV therapy used in Malawi Monotherapy This is the use of one antiretroviral drug. Monotherapy is no longer recommended for use in the treatment of HIV infection. However, a single drug can be used in the prevention of mother-to-child transmission of HIV where zidovudine (AZT) or nevirapine (NVP) are used. Combination therapy Combination therapy is the use of more than one antiretroviral drug. The current standard of care for ARV therapy involves using a combination of three ARV drugs, sometimes referred to highly active antiretroviral therapy (HAART). It has been demonstrated that using ARV drugs in combination with one another is more effective at reducing the viral load and has less of a chance of the HIV virus mutating and developing resistance. The current recommendation in Malawi for first line ARV therapy is the use of a three-drug combination of lamivudine, stavudine and nevirapine, which is also known by the name of its fixed-dose combination, Triomune. Rationale for using ARV therapy for PMTCT It will reduce the number of HIV infected infants and thus also reduce the burden they impact on time commitment, energy, and resource for the caretakers. It will reduce the cost of caring for an HIV positive infant to the health care system and family structure. ARV therapy for PMTCT saves children’s lives. Mechanism of action ARV drugs, in the NRTI class, act by specifically targeting and hindering functions of the enzyme reverse transcriptase. This enzyme is responsible for converting the viral protein (RNA) to the human type of genetic material (DNA). The enzyme helps the HIV virus reproduce itself. The use of these drugs during pregnancy and delivery has been shown to be effective in reducing the transmission of HIV from mother to infant because they reduce the amount of HIV virus in a mother’s body. These drugs are Rapidly absorbed after oral dosing Transferred across the placenta to the infant and are therefore effective in preventing MTCT See Appendix 7-C and 7-D for a listing of side effects and management of some common ARV drugs used in Malawi. Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT) 3-37 APPENDIX 3-B Mechanism of Action, Side Effects and General Management Principles of ARV Therapy (continued) Basic principles for combined ARV therapy during pregnancy ARV therapy should not be withheld during pregnancy unless there are known adverse effects for the mother, foetus or infant, which outweigh the potential benefits. All women should be counselled on the risks and benefits of ARV therapy for the mother, for the HIV-exposed or infected infant. AZT and nevirapine have no known teratogenicity, however, the risk of teratogenicity is known for some of the other ARVs e.g., efavirenz (EFZ) an NNRTI. Efavirenz (EFV) which is used as a substitute for NVP if patients have liver disease according to the national ARV therapy guidelines should not be used by women who may become pregnant because of the risk of birth defects. It can however be used after the first trimester of pregnancy. AZT and d4T should not be given at the same time. If the ARV therapy regimen does not include AZT, this drug should be added or substituted, but it should not be added to d4T. Like most medications, all ARV drugs have side effects which should be managed. For more information on the types of side effects of commonly used ARV drugs in Malawi, see Appendix 7-C. For more information on how to manage common side effects see Appendix 7-D. A full blood count is an important baseline test to perform before starting ARV therapy with AZT. AZT should not be started if a women’s haemoglobin level is below 8.0 g/dl. Where possible liver functions tests (LFTs) may be done as a baseline and repeated as indicated if there are abnormal results or clinical indications. Where available, CD4 cell counts and viral load testing may be done before ARV drugs are administered. These lab measurements can be used to monitor patients every 3 to 4 months when available. 3-38 Malawi PMTCT Trainer Manual APPENDIX 3-C National Antiretroviral (ARV) Regimens for PMTCT Single drug ARV prophylaxis administration during labour and delivery and postpartum PREGNANCY LABOUR POSTPARTUM Infant Mother No ARVs during pregnancy Single dose NVP 200mg at onset of labour1 None 1. Single dose NVP 6mg Combination ARV prophylaxis administration during labour and delivery and postpartum PREGNANCY LABOUR POSTPARTUM Infant Mother 1. AZT 300mg twice a day from 28 weeks gestation to onset of labour2 2. No ARVs during pregnancy 3. Women on ART 4. No ARVs during pregnancy 1 2 1. Single dose NVP 200mg at onset of labour 2. AZT 600mg at onset of labour or 300mg every 3hrs until delivery but not more than 1500mg. 1. Single dose NVP 200mg at onset of labour 2. AZT 600mg at onset of labour or 300mg every 3hrs until delivery but not more than 1500mg. For all women that qualify based on clinical staging and or CD4 and the dosage should continue during labour or just before caesarean section. No ARVs during labour AZT/3TC 300mg twice daily for 7 days 1. 2. 3. AZT 300mg twice daily for 7 days 1. 2. 3. Single dose NVP (6mg) AZT 4mg/kg twice daily for 7 days (NB: low birth babies <2.5 kg will receive 2mg/kg) Babies delivered at home should get AZT within 72 hours from the health facility Single dose NVP (6mg) AZT 4mg/kg twice daily for 7 days (NB: low birth babies <2.5 kg will receive 2mg/kg) Babies delivered at home should get AZT within 72 hours from the health facility Should continue ART postpartum 1. AZT 4mg/kg twice daily for 7 days (NB: low birth babies <2.5 kg will receive 2mg/kg) None 1. 2. Single dose NVP 6mg AZT 4mg/kg twice daily for 4 weeks (NB: low birth babies <2.5 kg will receive 2mg/kg) A single dose NVP regimen is inexpensive and effective. It can be used for women who do not attend ANC clinics and for women who present in early labour. The risk of side effects from NVP is very low when used as a single dose. NVP is not teratogenic, it will not harm a foetus. The AZT regimen can be started as early as 14 weeks if a women presents for ANC care early. Most PMTCT services in Malawi will start the AZT regimen between 34 and 36 weeks. A baseline haemoglobin should exclude anaemia before starting this prophylaxis regimen. The risks of side effects from short term AZT is very low. AZT is not teratogenic, it will not harm a foetus. Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT) 3-39 APPENDIX 3-C National Antiretroviral (ARV) Regimens for PMTCT (continued) General information on ARV drugs used in prophylaxis regimens Zidovudine (ZDV, AZT) Absorbed quickly after being taken by mouth. Prenatal and neonatal exposure to ZDV is generally well tolerated. Nevirapine (NVP) Absorbed quickly after being taken by mouth. Crosses the placenta quickly to protect the infant Long half-life benefits the infant May be taken with or without food Can be given as a single dose for mother and a single dose for the infant if no other ARV drugs are available for PMTCT. See Appendix 7-C for Recommended Food Intake and Side Effects of NVP and AZT. Single-dose nevirapine prophylaxis has the following disadvantages: NVP prophylaxis does not protect the infant against HIV transmission outside of the immediate postpartum period if breastfeeding. HIV may become resistant to nevirapine, when it is used alone as prophylaxis to prevent MTCT. Viral resistance HIV can develop resistance when there are not enough ARV drugs in the body. The virus mutates or changes so that an ARV drugs is no longer effective. This can occur when a person on ARV therapy, particularly if they: Regularly skips doses of their ARV drugs Take another medication that interacts with ARVs by lowering the amount of ARV drugs in the body. Resistance can also develop when a single dose of NVP is given during labour to prevent MTCT. The clinical significance of this under investigation but it appears that when a woman is given single dose NVP to prevent MTCT and is later given a HAART regimen that contains NVP, the regimen may not work to reduce her viral load. However, resistance to NVP has been shown to diminish over time. When a pregnant woman was given single dose NVP to prevent MTCT during a second pregnancy, the drug was still effective in preventing MTCT. Single-dose NVP is still effective in preventing MTCT but its use may decrease the number of drugs available to treat a women’s HIV infection in the future. This is especially important as NVP is used in the first line regimen in Malawi. Preventing nevirapine resistance In order to prevent nevirapine resistance, healthcare workers should avoid providing multiple doses of NVP to the mother unless it is necessary. If the maternal NVP dose is given during false labour, the dose should not be repeated. The infant should receive the standard dose. 3-40 Malawi PMTCT Trainer Manual APPENDIX 3-D Studies Supporting the National ARV Prophylaxis Regimens In support of using the AZT regimen Abstract: Short-course zidovudine for perinatal HIV-1 transmission in Bangkok, Thailand: a randomized controlled trial. Bangkok Collaborative Perinatal HIV Transmission Study Group. Authors: Shaffer N, Chuachoowong R, Mock PA, Bhadrakom C, Siriwasin W, Young NL, Chotpitayasunondh T, Chearskul S, Roongpisuthipong A, Chinayon P, Karon J, Mastro TD, Simonds RJ. BACKGROUND: Many developing countries have not implemented the AIDS Clinical Trials Group 076 zidovudine regimen for prevention of perinatal HIV-1 transmission because of its complexity and cost. We investigated the safety and efficacy of shortcourse oral zidovudine administered during late pregnancy and labour. METHODS: In a randomized, double-blind, placebo-controlled trial, HIV-1-infected pregnant women at two Bangkok hospitals were randomly assigned placebo or one zidovudine 300 mg tablet twice daily from 36 weeks' gestation and every 3 h from onset of labour until delivery. Mothers were given infant formula and asked not to breastfeed. The main endpoint was babies' HIV-1-infection status, tested with HIV-1-DNA PCR at birth, 2 months, and 6 months. We measured maternal plasma viral concentrations by RNA PCR. FINDINGS: Between May, 1996, and December, 1997, 397 women were randomized; 393 gave birth to 395 live-born babies. Median duration of antenatal treatment was 25 days, and median number of doses during labour was three. 99% of women took at least 90% of scheduled antenatal doses. Adverse events were similar in the study groups. Of 392 babies with at least one PCR test, 55 tested positive: 18 in the zidovudine group and 37 in the placebo group. The estimated transmission risks were 9.4% (95% CI 5.2-13.5) on zidovudine and 18.9% (13.2-24.2) on placebo (p=0.006; efficacy 50.1% [15.4-70.6]). Between enrolment and delivery, women in the zidovudine group had a mean decrease in viral load of 0.56 log. About 80% of the treatment effect was explained by lowered maternal viral concentrations at delivery. INTERPRETATION: A short course of twice-daily oral zidovudine was safe and well tolerated and, in the absence of breastfeeding, can lessen the risk for mother-to-child HIV-1 transmission by half. This regimen could prevent many HIV-1 infections during late pregnancy and labour in less-developed countries unable to implement the full 076 regimen. Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT) 3-41 APPENDIX 3-D Studies Supporting the National ARV Prophylaxis Regimens (continued) In support of using single dose NVP regimen Abstract: Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomized trial. Authors: Guay LA, Musoke P, Fleming T, Bagenda D, Allen M, Nakabiito C, Sherman J, Bakaki P, Ducar C, Deseyve M, Emel L, Mirochnick M, Fowler MG, Mofenson L, Miotti P, Dransfield K, Bray D, Mmiro F, Jackson JB. BACKGROUND: The AIDS Clinical Trials Group protocol 076 zidovudine prophylaxis regimen for HIV-1-infected pregnant women and their babies has been associated with a significant decrease in vertical HIV-1 transmission in non-breastfeeding women in developed countries. We compared the safety and efficacy of short-course nevirapine or zidovudine during labour and the first week of life. METHODS: From November, 1997, to April, 1999, we enrolled 626 HIV-1-infected pregnant women at Mulago Hospital in Kampala, Uganda. We randomly assigned mothers nevirapine 200 mg orally at onset of labour and 2 mg/kg to babies within 72 h of birth, or zidovudine 600 mg orally to the mother at onset of labour and 300 mg every 3 h until delivery, and 4 mg/kg orally twice daily to babies for 7 days after birth. We tested babies for HIV-1 infection at birth, 6-8 weeks, and 14-16 weeks by HIV-1 RNA PCR. We assessed HIV-1 transmission and HIV-1-free survival with Kaplan-Meier analysis. FINDINGS: Nearly all babies (98.8%) were breastfed, and 95.6% were still breastfeeding at age 14-16 weeks. The estimated risks of HIV-1 transmission in the zidovudine and nevirapine groups were: 10.4% and 8.2% at birth (p=0.354); 21.3% and 11.9% by age 6-8 weeks (p=0.0027); and 25.1% and 13.1% by age 14-16 weeks (p=0.0006). The efficacy of nevirapine compared with zidovudine was 47% (95% CI 2064) up to age 14-16 weeks. The two regimens were well tolerated and adverse events were similar in the two groups. INTERPRETATION: Nevirapine lowered the risk of HIV-1 transmission during the first 14-16 weeks of life by nearly 50% in a breastfeeding population. This simple and inexpensive regimen could decrease mother-to-child HIV-1 transmission in lessdeveloped countries. 3-42 Malawi PMTCT Trainer Manual APPENDIX 3-E Eligibility for ARV Therapy, Adults (aged 15 years and older) Adult patients will be eligible for ARV therapy if they fulfil condition 1 and 2 PLUS either conditions 3, 4, 5, or 6 (See also national ARV guidelines). Condition 1. Patients are known to be HIV-seropositive Description of Condition 2. Patients understand the implications of ARV therapy 3. Patients are assessed as being in WHO Clinical Stage 3 4. Patients are assessed as being in WHO Clinical Stage 4 5. Patients are assessed as being in WHO Clinical Stage 2 with a total lymphocyte count < 1200/mm3 6. Patients have a CD4 lymphocyte below 250/mm3 Patients must have undergone HIV testing and counselling, and must provide written evidence of a positive HIV-test result from a reputable and quality assured HIV testing and counselling (HTC) site. Patients who provide verbal confirmation only of a positive HIV-test result are not eligible for ARV therapy. Patients must have undergone counselling sessions (group and individual) during which the implications of ARV therapy have been discussed, in particular that ARV therapy requires high adherence and compliance and is a life long commitment. Patients who are ill with an opportunistic infection or HIV-related malignancy should be treated appropriately and stabilized before considering the possible use of ARV therapy. ARV therapy is not an emergency treatment. Patients who have any of the features listed in Stage 3 should receive ARV therapy, but be stabilized before treatment commences. There must be documented written evidence of a history of a) pulmonary tuberculosis within the past year or b) severe bacterial infections. Verbal reports of pulmonary TB or bacterial infections will not be acceptable as evidence for starting ARV therapy. Patients who have any of the features listed in Stage 4 should receive ARV therapy, but be stabilized before treatment commences. A total lymphocyte count < 1200/ mm3 when used in conjunction with clinical staging can guide decision-making about when to start ARV therapy. Any patient who is seropositive and has a CD4 count below 250 is eligible for ARV therapy regardless of WHO staging or symptoms Where CD4 count is not available, clinical symptoms guide when to start ARV therapy. See Module 7, Unit 4 for more information on staging HIV infection in adults. These constitute the medical criteria for adult eligibility to ARV therapy. It is beyond the scope of this document to discuss social criteria for eligibility. Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT) 3-43 APPENDIX 3-F Eligibility for ARV Therapy, Children (aged 14 years or younger) Eligibility for ARV therapy in children over the age of 18 months (See also national ARV guidelines). Children over the age of 18 months will be eligible for ARV therapy if: They are HIV-seropositive and They and/or their caregivers understand the implication of ARV therapy, plus the following conditions shown below: In these situations, the presence of a CD4 lymphocyte count may add WHO Paediatric Clinical assist with decision-making. In children with TB, lymphocytic Stage 4 interstitial pneumonia (LIP), oral hairy leukoplakia, or WHO Paediatric Clinical thrombocytopenia, ARV therapy may be deferred if the CD4 count or Stage 3 CD4 percentage is above the threshold value for starting ARV therapy according to the child’s age. WHO Paediatric Clinical Stage 2 With a total lymphocyte count at or below the threshold value (see the Malawi’s national guidelines on the use of ARV therapy or refer to the WHO recommendations) Children with a CD4 lymphocyte count or CD4 percentage below the threshold value for starting ARV therapy See immunological table on the next page which represents WHO recommendations. Eligibility for ARV therapy in children younger than 18 months of age Where virological confirmation of infection is NOT available: paediatric clients less than 18 months of age should be referred to the ARV Clinic if: A presumptive diagnosis of severe HIV disease requiring ARV therapy is made if the infant is confirmed HIV antibody positive, AND The infant is categorized in WHO Paediatric Clinical Stage 4 (this includes severe malnutrition) OR The infant is symptomatic with two or more of the following conditions: i) oral candidiasis ii) severe pneumonia iii) severe sepsis Other factors which support the diagnosis of severe HIV disease in an HIV-sero-positive infant include: i) recent HIV-related maternal death ii) advanced HIV disease in the mother iii) CD4 < 20% in children 12-18 months, and <25% in children less than 12 months. 3-44 Malawi PMTCT Trainer Manual APPENDIX 3-F Eligibility for ARV Therapy, Children (aged 14 years or younger) (cont’d) WHO recommendations for initiating ARV therapy in infants and children according to age-related immunological measures Age-specific recommendation to initiate ARTb Immunological markera ≤ 11 months 12–35 months 36–59 months ≥ 5 years c CD4 % < 25% < 20% < 15% < 15% < 1500 < 750 < 350 < 200 CD4 countc cells/mm3 cells/mm3 cells/mm3 cells/mm3 To be used only in absence of CD4 assays: < 4000 < 3000 < 2500 < 2000 TLC cells/mm3 cells/mm3 cells/mm3 cells/mm3 Notes: a. Immunological markers supplement clinical staging b. ARV therapy should be initiated by these cut-off levels, regardless of clinical stage; a drop of CD4 or TLC below these levels significantly increases the risk of mortality. c. CD4% is suggested for children less than 5 yrs. Source: WHO. Antiretroviral treatment of HIV infection in infants and children in resource-limited settings, toward universal access: Recommendations for a public health approach 2006 version, available at http://www.who.int/hiv/pub/guidelines/en/ See Module 7, Unit 5 for information on paediatric HIV staging. Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT) 3-45 References Malawi Ministry of Health and Population. 2003. “Prevention of Mother-to-Child Transmission of HIV in Malawi” Handbook for Health Workers. Malawi Ministry of Health and Population. “Infant and Young Child Nutrition Policy and Guidelines, 2005–2010”. WHO. 2005. 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Retrieved August 2006 from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_ uids=10459958 Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT) 3-49