Ministry of Health NATIONAL PROTOCOL GUIDELINES INTEGRATED PREVENTION OF MOTHER-TO-CHILD TRANSMISSION OF HIV/AIDS NAC

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1 Ministry of Health NATIONAL PROTOCOL GUIDELINES INTEGRATED PREVENTION OF MOTHER-TO-CHILD TRANSMISSION OF HIV/AIDS NAC ZAMBIA 2008

2 FOREWORD PMTCT services are now offered in all the 72 districts in the nine Provinces of Zambia, from the pilot phase seven years ago, the country is in the phase of expansion and as of January,2008 :678 facilities were implementing PMTCT. The programme is currently meeting 39% of the need, which is one of the fastest increasing and comparatively high performance within the region. Expansion and consolidation is ongoing with support from partners, mostly the Global Fund, UN Agencies, UNITAID and PEPFAR and the country is set for higher targets. Mother to child transmission (MTCT) of HIV is by far the largest source of HIV infection in children below the age of 15 years. According to UNAIDS estimates, more than 90% of children who acquire the disease through Mother to child transmission acquire the virus before birth, during birth or through breastfeeding. HIV is the most serious threat to the development agenda in Zambia and the country is one of the most heavily affected countries in the sub-region with the prevalence of 14.3% (DHS 2007) for adults aged 15 to 49 years. Furthermore it is estimated that 1.1million Zambians are infected with HIV of which 130,000 are children. HIV disease progression in children is faster and about 30% of these children need to be on ARVs since they have progressed their HIV status to AIDS. Without any intervention, one third of children born with HIV will die by their first and a half by their second birthday. The prevalence rate of HIV ranges from 25-35% in urban areas and 8-16% in rural areas. Women are disproportionately affected and the prevalence rate among pregnant women in antenatal settings is 16.4% (ZANCSSR 2006). With about 500,000 deliveries every year and an estimated 16% prevalence among pregnant women, Zambia is expected to have around 88,000 HIV positive pregnant women delivering each year and with a transmission rate of 30 to 40% it is expected that 28,000 babies are born HIV positive each year if no interventions are undertaken to prevent mother-to-child transmission of HIV. To achieve the 4th and 5th Millennium Development Goals (MDGs) Zambia a rapid response to scale up PMTCT is needed and this why the Zambia government and cooperating partners have placed HIV as one of the top development agenda. The goal of PMTCT programme in Zambia is to eliminate HIV infection in children and this second edition, PMTCT guidelines have been produced to guide health care workers in the implementation of PMTCT taking into consideration the incorporated new global PMTCT strategy by the Inter-agency Task Team (IATT) as well as the recent World Health Organization (WHO) PMTCT guidelines that promote treatment of pregnant women and prevention of HIV infection in resource limited settings. These guidelines aim for significant improvements in care and delivery needed for pregnant women and their children in the context of PMTCT including increased access to primary prevention and family planning services, greater integration of PMTCT services into antenatal care (ANC) settings, the use of more efficacious regimens to prevent transmission, greater access to highly active antiretroviral treatment (HAART) for mothers eligible for treatment, and greater access on the part of mothers and children to cotrimoxazole prophylaxis to ward off opportunistic infections. In addition, early infant diagnosis (EID) methods that ensure that those children infected despite these interventions have prompt access to HIV care and treatment. This document has been mainly written for use by health care providers at the health facility and district managers for PMTCT programming. Brian Chituwo MP Honourable Minister of Health. 2

3 ACKNOWLEDGEMENTS Dr. V. Mukonka Director Public Health and Research Ministry of Health 3

4 Table of Contents Foreword 2 Acknowledgements 3 Abbreviations 5 Introduction 6 Chapter 1 : Testing and Counselling 8 Chapter 2 : Antenatal Care 12 Chapter 3 : Intrapartum Care 16 Chapter 4 : Immediate Post Natal Care and Neonatal Care 18 Chapter 5: Postnatal Check-up 26 Chapter 6 : Follow-Up Pediatric HIV Care and Long Term support to Mothers 26 Chapter 7 : Care for Health Workers and Community Health Providers 37 Chapter 8 : Monitoring and Evaluation 38 Annex I : Nevirapine Baby Dose Preparation 42 Annex II : Antenatal Care Flowchart with orphan model 43 Annex III : Sources of Iron and other Nutrients and their Absorption 44 Annex IV : Amounts of Foods to Offer for Complimentary Feeding 46 Annex V : Positive Living with PLWHA 47 Annex VI : WHO Staging System for HIV Infection and Disease 49 Annex VII : Clinical Situations and Recommendations 56 Annex VIII : 10 Steps to Successful Breastfeeding 58 References 59 4

5 Abbreviations 3TC ANC ARV AZT BD DHS ELISA HAART HB HIV HMIS IGA INH IU IYCF MNCH MTCT NVP NGO PCP PITC PLHIV PMTCT RPR STI TB TT UNICEF WHO ZBSS ZDV Lamivudine Antenatal care Antiretroviral drugs Zidovudine Bi-daily Demographic and Health Survey Enzyme-Linked Immunosorbent Assay Highly Active Antiretroviral Therapy Haemoglobin Human Immunodeficiency Virus Health Management Information System Income generating activities Isoniazide International Unit Infant and Young Child Feeding Maternal, Neonatal and Child Health Mother to Child Transmission of HIV/AIDS Nevirapine Non Governmental Organisation Pnemocystis Jiroveci Pneumonia Provider Initiated Testing and Counselling People Living with HIV Prevention of Mother-to-Child Transmission Rapid Plasma Reactive - Syphilis test kit Sexually Transmitted Infections Tuberculosis Tetanus toxoid United Nations Children's Fund World Health Organisation Zambia Sexual Behaviour Survey Zidovudine 5

6 Introduction The 2004 Sentinel Surveillance survey indicate that the overall HIV prevalence for pregnant women aged years from the 23 sentinel surveillance sites tracked in 2004 was 18.7%. The mean HIV prevalence at the urban sites was 25% and 11.8% for rural sites. HIV prevalence among year-olds was 11.6% (8.7% for rural sites and 14.6% for urban sites). Without provision of prevention of Mother-to-Child transmission services, an estimated 40,000 out of the 500,000 babies born annually will acquire HIV infection. The implementation of prevention of Mother-to-Child transmission of HIV programmes, has yielded positive results in developed and developing countries. The Zambian programme will have a significant impact on childhood HIV infection and the increasing mortality trends by scaling up prevention of Mother-to-Child transmission of HIV services to all Maternal, Neonatal and Child Health (MNCH) services in the country, with introduction of more efficacious regimens and initiation of testing and counselling by providers. Scaling up includes maintaining ANC utilization above 90 percent, improving acceptance of testing to 70 percent, and acceptance, adherence to ARV therapy by HIV positive women to 75 percent, and improving the number of deliveries attended by a skilled and trained health worker. The goals of the National Prevention of Mother-to-Child Transmission of HIV Strategic Framework are: 1. To contribute to the improvement in child survival and development through reduction of HIV related infant and childhood morbidity and mortality. 2. To contribute to the decrease in maternal mortality through the strengthening of antenatal, delivery and postpartum care services. 3. To contribute to the improvement of the length and quality of life of HIV positive women and their families through the provision of care and support services. The Zambia National prevention of Mother-to-Child transmission of HIV programme uses a fourprong approach in prevention of Mother-to-Child transmission of HIV adopted from WHO recommendations. Major components include primary prevention of HIV among young people, women and men, prevention of unwanted pregnancies among HIV positive women, prevention of HIV transmission from infected mothers to their babies, and care and support to HIV infected families. Expected Outcomes are: Strengthening of primary prevention of HIV and STIs among women of childbearing age and their children. Decreased maternal, infant and under-five morbidity and mortality through improved service delivery of antenatal, delivery and postpartum services. Increased access to contraceptives, double protection, VCT and ARVs. 6

7 Increased access to community based care and support services for those infected or affected by HIV and AIDS. Increased health workers capacity to implement integrated reproductive health, HIV/AIDS prevention and care services. Increased community capacity to prevent and manage HIV/AIDS issues, particularly prevention of Mother-to-Child transmission of HIV. 7

8 CHAPTER ONE Testing and Counselling The first step in the prevention of Mother-to-Child transmission of HIV programme is for all pregnant women to know their HIV status. The Zambia National prevention of Mother-to-Child transmission of HIV Programme uses an opt-out approach. The opt-out approach means that HIV testing is part of the routine laboratory processes undertaken during all pregnancies. (See Annex II: Ante natal Care Flow Chart with Opt out model). Opt-out: HIV test is routinely recommended and provided to each patient. As with any medical procedure, the client may decline to undertake the test The woman does not have to sign a consent form but only needs to be fully informed of the test. It is recommended that, testing and counselling for HIV, is done prior to other antenatal procedures. The blood should be collected at the point of service and results for HIV given the same day. If tests are done in the MNCH 10% of the samples should be sent to the laboratory for quality control and quality assurance on a monthly basis. HIV Counselling People who have been trained in prevention of Mother-to-Child transmission of HIV should offer counselling. However, as prevention of Mother-to-Child transmission of HIV is integrated in MNCH, and services are scaled up countrywide, more people who have been mentored by those trained in prevention of Mother-to-Child transmission of HIV should provide services. Group Health Education, in the context of prevention of Mother-to-Child transmission of HIV also used as group counselling, is the main means of giving information, education and communication in the MNCH. It is meant to be interactive with the clients, to enable clarifying of as many issues and questions as possible. GHE can be conducted by trained counsellors, students, volunteers and other appropriate service providers. Individual pre-test counselling is reserved only for those who have further issues to clarify, or those who have declined the test, in order to probe further the possible reasons for declining the test, offer support and make arrangements for opportunities to test. Clients proceed to have the HIV test done, as well as the syphilis and HB. At the booking visit and subsequent ones, all pregnant women should receive prenatal care and health information that include counselling and testing, and information on Mother-to-Child transmission of HIV, through both group education/discussion sessions as the mainstay of information exchange. 8

9 Pregnant women who tested HIV negative early in pregnancy should be offered an opportunity to re-test later during the third trimester or soon after delivery. Elements in Group Health Education (GHE) 1. HIV transmission and how to prevent it. 2. Mother-to-Child transmission of HIV and programme measures to reduce it. 3. HIV testing process and the fact that an HIV test is an integral part of care for pregnant women, as interventions are available to care for the mother and baby. 4. Importance of encouraging husband/partners to come for counselling and testing. Different culturally appropriate initiatives may be taken in different settings to encourage male partner involvement. 5. Explanation on confidentiality and shared confidentiality. 6. Explanation on the importance of disclosure. 7. A negative result may mean that they are in the window period and will need to be retested after 3 months and information should be provided on how to stay negative. 8. The importance of having HIV negative pregnant women to be re-tested later in the third semester. 9. A positive result means that the mother has HIV and there is a risk that the mother will transmit the virus to her baby either during pregnancy, labour or delivery, however, effective preventive and care interventions are available including ARVs 10. HIV testing for the baby of the HIV positive mother, as well as other members of the family. 11. Information on the anti-retroviral therapy (ART) programme for mothers and children. Provide time to answer questions and clarify any information that the audience may not be clear with. Attention should also be paid to recapping or summarising the prevention of Mother-to-Child transmission of HIV programme and its benefits. Individual pre-test counselling may be reserved for those women who have further questions or are not clear. HIV Testing The women are then individually guided to where their HIV testing and ANC service package will be done, unless she has declined. The person trained in rapid HIV testing takes blood samples and when indicated, could also at the same time perform other tests like RPR, and HB applying National Algorithms for testing. If there is a laboratory and a trained laboratory technician at your station, then use these facilities. If the first rapid test is negative, the woman is considered HIV negative. If the first rapid test is positive, a second rapid test is done using a different test kit. If both tests are positive, the woman is HIV positive. If the first test is positive and the second test is negative, the woman is HIV indeterminate. If her HIV status is indeterminate, and a tie breaker test is not available at 9

10 the facility then a blood sample must be sent to the nearest district laboratory for re-testing. The tie breaker test being used in Zambia is the BioLine test. After the test has been performed, the service provider enters the results in prevention of Mother-to-Child transmission of HIV register and/or the Laboratory HIV Test Register. The register is kept confidential and always remains on site. Test results are given during the post-test counselling session. The major benefit of the rapid test is that it can be done in a short space of time and therefore the woman should go home with her results the same day. Women should not be sent home without their HIV test results. They should receive their HIV test results the same day. HIV Post-test Counselling All women and their partners, regardless of their HIV status should receive post-test counselling in line with the post-test counselling format provided during the counsellor s training. If a woman or her partner tested HIV negative, she should receive post- test counselling on how to maintain the HIV negative status, with a focus on her health, safer sexual practices, and the high risk of transmission to her baby should she become infected during pregnancy or breastfeeding. The window period should be explained once more and she should receive routine antenatal care. It should be emphasized that she will need to be re-tested after 3 months or towards the end of her pregnancy or soon after delivery, depending on which comes first. If a woman or her partner is tested HIV positive, they are informed about prevention of Motherto-Child transmission of HIV and offered an opportunity to join the programme. All HIV positive women and their partners should be clinically tested for CD4 count or clinically staged using the WHO staging criteria and based on eligibility criteria, referred to the ART programme. If the facility is unable to provide this service, they should be referred to the referral facility where they will be clinically assessed for HAART eligibility. Clients who qualify for HAART will be offered all other components of the MTCT programme except the short-course ARVs. All HIV positive women should also receive routine antenatal care. Clients that do not qualify for HAART should be registered in the Pre-ART register, and followed up using national guidelines. Where CD4 Count is not available, the WHO clinical criteria should be used to stage. During post-test counselling and over the next visits, the newly diagnosed HIV positive woman is also provided with: Ongoing counselling which includes: emotional support, assessment of coping, information about existing peer-support groups, appropriate referrals for support and information around positive living (See annex V for more information about positive living). Information about HIV disease, potential health problems and the importance of clinical care for HIV disease 10

11 Information about the ART programme Information about the MTCT Programme and medicines that are offered including potential side effects Counselling about partner identification and disclosure, stigma and discrimination and shared confidentiality. For clients who qualify for prevention of Mother-to-Child transmission of HIV provide anti retroviral drugs as according to the guidelines. All regimens are administered by mouth. Paediatric formulations are used for all infant regimens. Efforts must be made to monitor for side effects and support maternal and infant adherence. Remind the mothers that may deliver at home about ARV doses for herself at the beginning of labour, and for the baby within 72hours of birth, preferably as soon as possible after delivery. Request that she goes to the health facility within 72 hours after delivery for the NVP and AZT syrup baby doses and for immunization. Infant feeding counselling immediately after post test counselling if they can cope otherwise an appointment should be scheduled. All women should receive information about husband/partner testing. HIV results and the post-test counselling session are recorded in the Counselling Register. 11

12 CHAPTER TWO Antenatal care aims at making pregnancy and delivery a safe experience for the mother. It is also intended to build the foundation for the delivery of a healthy baby. Antenatal Care Services Antenatal Care These are meant for all pregnant women who should attend at least four visits of focused antenatal care schedules for: Clinical screening and examination, monitoring of blood pressure, urinalysis, and compulsory weight measurement at every visit. Active detection and effective treatment of STIs (RPR for screening and Benzathine Penicillin as treatment). If RPR is done and found negative in the first trimester, repeat at 36 weeks gestation. The repeat of RPR test could be combined with a repeat HIV testing for women found HIV negative earlier in pregnancy. Prevention, detection and treatment of anaemia should be strengthened in line with Safe Motherhood guidelines. This should include determination of HB at baseline and subsequent visits. Systematic de-worming should also be provided together with Ferrous Sulphate and Folic acid. Intermittent Presumptive Treatment (IPT) with sulphadoxine-pyremethamine for malaria prophylaxis should be given starting in the second trimester. The IPT should be administered at least after every 4 weeks, although it can also be given even after 8 weeks. It should be ensured that, a woman has at least three doses before delivery. However it should be noted that a woman receiving Cotrimoxazole prophylaxis should not receive IPT. Encourage the use of impregnated mosquito nets by ALL pregnant mothers. Multi-vitamin supplementation for the prevention of low birth weight to all antenatal attendees. Counselling about infant feeding options including the health benefits and risks of breastfeeding and replacement feeding. Information about safer sex during pregnancy, breastfeeding, and double protection in the long-term. This should go with promotion and provision of condoms for all couples to use at all times during pregnancy and breastfeeding. Tuberculosis (TB) clinical screening in HIV infected mothers with history taking, examination and sputum smear if indicated. If diagnosed positive, refer for appropriate TB care. 12

13 As soon as the woman reaches 28 weeks of pregnancy, or soon after, provide short-course ZDV therapy. At the first visit after confirming the mother is HIV positive, the woman can be given her single NVP dose to take home so she can take it at the onset of labour. Where blister packs are available she may be given the full course of drugs for her to take during antenatal, labour, delivery and in the postpartum period. How ever it needs to be emphasized that she will need to be seen every four weeks for review. At these visits asses adherence and other issues such as disclosure, side effects and testing of other family members. These visits can also be used to reinforce messages such as infant feeding, family planning, early infant HIV testing and other aspects of continuum of care. She will also be given the babies NVP dose at the 32 visit to be taken soon after birth and she should be advised on safe sex. Between 1 st ANC contact and 28 Weeks Ensure the following are done: 1. HIV, RPR, HB & CD4 tests are done 2. Eligibility for HAART is determined 3. Counselling on ARVs and IYFC is conducted Ensure that counselling on ARV adherence and IYFC is conducted at every visit 28 Weeks 32 Weeks 36 Weeks On-set of labour Administer AZT on-site and dispense for the next 4 weeks Dispense AZT+3TC(for intake during labour) & Nevirapine (for the baby) Check adherence and drug stocks Dispense AZT+3TC At birth Dispense Nevirapine If the woman loses her medication give her a repeat dose but if she takes her NVP too early due to false labour, do not give her a repeat dose. All pregnant women, especially those on the prevention of Mother-to-Child transmission of HIV programme are encouraged to deliver at the health facility. All Pregnant women meeting the criteria for HAART should be treated starting from second trimester. Those on HAART prior to pregnancy should continue through out pregnancy. However, if the regimen contains Efavirenz (EFV), discuss with the mother the possibility of exchanging this drug as it has been associated with teratogenicity. Otherwise the mother is encouraged to continue with the same regimen. If possible the woman should be advised to deliver in a health facility. Where that is not possible the woman should be advised to take the ARVs prescribed but even then the health provider should check the woman s HB before delivery. Based on the individual needs of the mother we need to plan for their care (including frequency of visit) 13

14 Anti-Retroviral Prophylaxis Regimens to Prevent Mother to Child Transmission Course Antenatal Intrapartum Postnatal Recommended for pregnant women presenting at 28 weeks pregnancy or earlier. This is the preferred regimen Mother: ZDV 300mg Twice a day starting at 28 weeks or as soon as possible thereafter Mother: 3TC / ZDV (150/300) start dose of 2 tablets at onset of labour and 1 tablet every 12 hours until delivery. NVP 200mg single-dose at onset of labour. Infant: NVP 2mg/kg oral suspension immediately after birth and ZDV 4mg/kg twice a day for 7 days starting immediately after birth. Mother: 3TC/ ZDV (150/300)1 tablet twice a day for 7 days Regimen for pregnant women who has received less than 4 weeks of AZT or HAART before delivery. Mother: 3TC/ ZDV(150/300) start dose of 2 tablets at onset of labour and 1 tablet every 12 hours until delivery NVP 200mg single-dose at onset of labour. Infant: NVP 2 mg/kg oral suspension immediately after birth and ZDV 4 mg/kg twice a day for 28 days. Mother 3TC/ ZDV (150/300)1 tablet twice a day for 7 days Regimen for mother who has received no ARV prophylaxis. Mother 3TC/ ZDV (150/300)start dose of 2 tablets at onset of labour and 1 tablet every 12 hours until delivery. NVP 200 mg single-dose at onset of labour. Infant: NVP 2 mg/kg as soon as possible after delivery and ZDV 4 mg/kg twice a day for 28 days. Mother 3TC/ ZDV 1 tablet twice a day for 7 days Where combination regimen not available. None Mother: Single-dose NVP 200 mg at onset of labour. Infant: NVP 2mg/kg oral suspension immediately after birth. If the mother did not receive any A R V s f o r prophylaxis and baby is seen soon after delivery. Infant: NVP 2 mg/kg as soon as possible after delivery and ZDV 4 mg/kg twice a day for 28 days. Source: Generic Training Package, Pocket Guide, WHO, 2004 Prophylactic ARVs should be dispensed within MNCH When referred for HAART pregnant women should be given priority for assessment given that there is a limited period within which the opportunity to avert HIV transmission to the unborn baby can be fully utilized. 14

15 Where Combivir is not available, continue with Zidovudine ****** The use of NVP alone is discouraged unless there are no other options.******** 15

16 CHAPTER THREE This involves the modification of midwifery and obstetrical practices for the HIV positive woman to reduce the risk of HIV transmission to the infant. Although elective caesarean section (prior to labour) is of value, it is not practically feasible to be routinely offered in Zambia. However, the following obstetrical practices should be applied to reduce the risk of HIV transmission to the infant: Avoiding episiotomy unless medically indicated. Avoiding routine rupture of membranes unless medically indicated. Avoiding unnecessary suctioning of the neonate as well as other invasive procedures such as intrauterine scalp monitoring. Short Course ARV During Delivery Intrapartum Care NVP 200mg to the mother at onset of labour and single dose 2mg/kg syrup for the baby within 72 hours of birth 3TC/ZDV Start dose of 2 tablets for the mother at onset of labour, 1 tablet every 12 hours until delivery, then 1 tablet twice a day for 7 days and 4mg/kg of ZDV twice a day for 7 days for baby In addition to labour ward routine activities, the following should be observed: Upon admission, the midwife inquires if the woman took the short course ARV at home. If the patient is found to be in labour or to have ruptured membranes but did not take any short course ARV at home, she should be given NVP and 3TC/ZDV dose immediately. If the patient does not have the ARVS given to her previously at the health facility, she must be given doses from the Health centre stocks. NVP should not re-dispensed, when taken in false labour, however if lost or forgotten it can be redispensed. In the case of false labour, if the patient is evaluated before she has taken her Nevirapine, she should be sent home to await more active labour. She should be instructed to continue with AZT and to take her Nevirapine with the onset of stronger and more regular contractions, or upon rupture of membranes. For ruptured membranes, if with fever and/or greater than four hours, give antibiotics. 16

17 If the patient is evaluated after she has taken her Nevirapine and the 600mg ZDV, but found not to be in true labour, and not to have ruptured membranes, she should not be given another dose of NVP, however for ZDV, the patient should take the usual dose of 300mg after 12 hrs, and continue with the twice a day regimen. When labour starts, she should move on to3tc/zdv start dose of 2 tablets then 1 tablet every 12 hours, until delivery. 1. Women can be given NVP at any time during the first stage of labour. It is only too late to give NVP to the woman if the baby s delivery is imminent i.e. if the head is crowning. 2. A woman on HAART should continue the HAART regimen and should not be dispensed ARVs for prevention of Mother-to-Child transmission of HIV Prophylaxis. 3. If a mother knows she is HIV positive at delivery but is not in the prevention of Mother-to-Child transmission of HIV programme, she should be given NVP and 3TC/ZDV as well as NVP and ZDV for the baby as long as she has been counselled about the prevention of Mother-to-Child transmission of HIV programme, including infant feeding practices and the importance of care, follow-up and HIV testing for the baby. For a mother who has not taken ARVs or only receives NVP and 3TC/ZDV during labour or the mother tests positive soon after delivery, the baby should be given: NVP dose immediately after birth AND ZDV 4mg/kg twice daily for 28 days starting immediately after birth If the woman does not know her HIV status and presents in early labour, she should be offered Counselling and Testing and if found positive, spelt out protocol should be followed in giving care. First Stage Strictly keep membranes intact for as long as possible to prolong rupture unless otherwise medically indicated. Use aseptic techniques including vaginal cleansing with 0.5% chlorhexidine with each vaginal examination. Second Stage Avoid invasive procedures i.e. episiotomies and instrumental deliveries unless absolutely necessary. 17

18 CHAPTER FOUR Immediate Post-natal Care and Neonatal Care This refers to the package of services provided to the mother and the infant before they leave the health facility (6 to 48 hours after delivery). The following checklist can serve as a guide to the health care provider to ensure the package of care is complete: ARVs for the postnatal period Revisit time Hb check Next scheduled visit Danger signs that the mother should look out for Look out for opportunistic infections Cotrimoxazole prophylaxis for women with a CD4 count less than 350. The package of care for the Newborn is outlined below: Nevirapine syrup dose: If a baby weighs 2 kg or more (>2000g) = give 0.6 ml (6 mg). If a baby weighs less than 2 kg, dose Nevirapine by baby weigth = > give 0.2 ml/kg (2 mg/kg). ZDV syrup dose: 4 mg/kg twice daily for 7 days. Anti-Retroviral Therapy for the Newborns Nevirapine is given to the baby between 4 and 72 hours after delivery. If the baby vomits the drugs within one hour of taking them, a second dose should be given and the baby observed for another one hour. A third dose should not be given. As earlier stated, if the mother did not take Nevirapine or took her dose of Nevirapine less than two hours prior to delivery, the baby should get the start dose of Nevirapine and the ZDV syrup twice a day for 28 days. If the baby of an HIV positive mother in the prevention of Mother-to-Child transmission of HIV programme is born at home or outside the health facility, and presents to the clinic within 72 hours of delivery, and it is established that the mother took ARVs at the onset of labour, Nevirapine and ZVD should be given to baby as per regular doses for the baby. The mother should also be given ZDV/3TC for 7 days after delivery. This should be noted in all Registers including Under 5 Card. 18

19 If the baby of an HIV positive mother, in the prevention of Mother-to-Child transmission of HIV programme is born at home or outside the health facility, and presents to the clinic within 72 hours of delivery, and you establish that the mother did not take ARVs at the onset of labour, the baby should get the start dose of Nevirapine and the ZDV syrup twice a day for 28 days. This should be noted in the Registers and Under 5 Card. If the baby of an HIV positive mother who is not in the prevention of Mother-to-Child transmission of HIV programme is born at home or outside the health facility, and presents to the clinic within 72 hours of delivery, the baby should get the start dose of Nevirapine and the ZDV syrup twice a day for 28 days. This should be noted in the Registers and Under 5 Card. NOTE: All information on the HIV status and ARVs dispensed as well as follow up should be recorded in Registers and Under 5 Cards. Immunization for the Newborns All babies should receive their routine immunization (OPV0 and BCG) in their first hours of life. OPV0 can be given as suggested, or any time up to 14 th day of birth. Feeding Practices In Zambia, breastfeeding should continue to be protected, promoted and supported. For mothers who are HIV negative, or who are of unknown status, exclusive breastfeeding for 6 months and thereafter continued breastfeeding up to 24 months or beyond with timely, adequate and safe complementary feeding is recommended. All pregnant women should routinely be tested for HIV and all breastfeeding HIV negative women as well as those of unknown status should be encouraged to regularly take an HIV test( during the pregnancy and breast feeding period). Infant Feeding Options (0-6months) when a Mother is HIV Positive There are only two main infant feeding options when the mother is HIV positive. These are: Exclusive breastfeeding This means giving a baby only breast milk, and no other liquids or solids, not even water unless medically indicated. This means that exclusive breastfeeding is recommended for HIV-infected women for the first six months of life unless replacement feeding is acceptable, feasible, affordable, sustainable and safe for them and their infants before that time. Exclusive replacement feeding This is the process of feeding a child who is not breastfeeding with a diet that provides all the nutrients the child needs until the child is fully fed 19

20 on family foods. The infant feeding recommendation in this category is infant formula. Other infant feeding options in special situations include: Heat Treated Expressed Breast milk- This means that a mother expresses breast milk and heats it so that the HIV present in breast milk is destroyed making it safe to feed the infant. This may be used during the transition period from breastfeeding. Heat-treatment reduces the level of some anti-infective components of breast milk. However heat-treated breast milk remains superior to breast-milk substitutes. Wet nursing This refers to breastfeeding by another woman, who is HIV-negative. This may only be considered in special situations such as in case of an orphaned infant and the family can not meet AFASS. The wet nurse should be tested every three months. The wet-nurse will also need to protect herself from HIV infection the entire time that she is breastfeeding. In addition, the wet-nurse should be available to feed the baby on demand, both day and night. She should also receive counselling about how to prevent cracked nipples, breast infections and engorgement. If a baby is already infected with HIV, there may be a very small chance that he can pass the virus to the wet-nurse through breastfeeding. The wet-nurse needs to know about this small risk and avoid breastfeeding while the baby has oral thrush or she has cracked nipples and can express breast milk during this period to give by cup. NOTE: Home modified animal milk is no longer a recommendation. This is in view of not only concerns on the safety of preparation of feeds and storage, but also due to its nutritional inadequacies (micro nutrients and essential fatty acids). Therefore, it is not part of the guidelines. Feeding Options when the Infant is Tested (0-6months) with PCR (Early Infant Diagnosis) What are the recommendations? Breastfeeding mothers of infants and young children who are known to be HIV-infected should be encouraged to continue breastfeeding. If an infant tests HIV negative and is breastfeeding, counsel the mother & reassess AFASS If the infant s HIV status is unknown, encourage mother to use earlier chosen option pending results. Mode of feeding for replacement feeding How should replacement feeding be given to an infant? 20

21 By cup and spoon. Baby should be fed on fresh feed every time. The transition from breastfeeding should be within 2-3 days to 3wks (transition period). Abrupt weaning is not recommended. Feeding of Infants Born to HIV Positive Mothers after 6months What should a breastfeeding mother do after 6months? At six months, if replacement feeding is still not acceptable, feasible, affordable, sustainable and safe, continuation of breastfeeding with additional complementary foods is recommended, while the mother and baby continue to be regularly assessed. All breastfeeding should stop once a nutritionally adequate and safe diet without breast milk can be provided. The transition from breastfeeding should be within 2-3 days to 3wks (transition period). Abrupt weaning is not recommended. The mother s Cd4 count should be assessed every 3months where the service is available so that mothers are initiated on HAART if less than 350. Complementary feeding: This means giving other foods in addition to breastfeeding. This should start after the first 6 completed months (see annex IV for details). Making the Transition from Exclusive Breastfeeding to Exclusive Replacement Feeding While a mother is breastfeeding, teach her baby to drink expressed, unheated, breast milk from a cup. This milk may be heat-treated to destroy the HIV. Once the baby is drinking comfortably, replace one breastfeed with one cup-feed using expressed breast milk. Increase the frequency of cup-feeding every few days and reduce the frequency of breastfeeding. Ask an adult family member to help cup-feed the baby. Stop putting her baby to the breast completely as soon as she and her baby are accustomed to frequent cup-feeding. From this point on, it is best to heat-treat her breast milk. If her baby is only receiving milk, check that he is passing enough urine - at least six wet nappies in every 24-hour period. This means that he is getting enough milk. Gradually replace the expressed breast milk with formula (if below 6months) or whole animal milk if above 6months. If her baby needs to suck, give a clean finger instead of the breast. To avoid breast engorgement (swelling) express a little milk whenever her breasts feel too full. This will help her to feel more comfortable. Use cold compresses to reduce the inflammation. Wear a firm bra to prevent breast discomfort. Do not begin breastfeeding 21

22 again once she has stopped. If she does, she can increase the chances of passing HIV to her baby. If her breasts become engorged, express the milk by hand and discard it. Begin using the family planning method of her choice, if she has not already done so, as soon as she starts reducing breastfeeds. Infant feeding counselling flow charts Counselling for Infant Feeding in Relation to HIV Pregnant or recently-delivered woman in contact with the health services Unknown HIV status Tested negative Tested positive Encourage Testing Counsel on infant feeding; discuss options available Counsel and encourage breastfeeding Infant Feeding Options from 0-6 Months for HIV+ Women Infant feeding options from 0-6 months Exclusive breastfeeding Replacement feeding when AFASS: Infant formula Other breastmilk options: Expression and heat treatment Wet-nursing (breastfeeding by an HIV negative woman) 22

23 1. During the group education, breastfeeding should be promoted while encouraging mothers to test for HIV. Health workers should explain that once a mother has had an HIV test and her result is positive, she should discuss with a health worker on how to feed her baby. 2. Infant feeding options should not be discussed in the group education but rather with an HIV positive mother individually. 3. During the individual counselling for infant feeding the health worker should discuss the benefits and risks of each of the two main options (exclusive breastfeeding and exclusive replacement feeding i.e. is infant formula). It is important to ensure that AFASS is explored so that the client makes an informed decision. If the mother requires more time to make up her mind or consult the spouse, then make an appointment for a later discussion. 4. After the mother has received infant feeding counselling and has decided the feeding method it is important for the health worker to demonstrate how best that method can be practiced. This maybe done during a follow up appointment. Infant Feeding Follow-Up Whatever the feeding decision, health workers should follow-up all HIV-exposed infants, and continue to offer infant feeding counselling and support, particularly at key points when feeding decisions may be reconsidered. Infant feeding counselling, support and follow up should be provided: During pregnancy- First and follow up Antenatal Natal Care visits At Delivery During post natal At 6days, 6weeks and thereafter every month until 24 months of age Health workers should identify and establish community support to refer mothers for follow up. This may be support on psychosocial and/or feeding issues. It is important that mother support groups are strengthened in this regard. Traditional birth Attendants, community Health Workers, Home Based Care Givers are some of the community based agents that can integrate infant feeding support as part of their activities. Feeding the Sick Child Feeding a sick child is critical. HIV positive children are more likely to fall sick frequently. Sick children need to eat small frequent meals to enhance recovery. Breastfed infants and young children should continue breastfeeding during the period of sickness. The IMCI strategy is critical in enhancing optimal feeding for sick children Baby Friendly Hospital Initiative (BFHI) and Compliance to the Marketing of Breastmilk Substitute s Legislation Like all other health facilities providing care for infants and mothers, all prevention of Mother-to- Child transmission of HIV sites should implement the Baby Friendly Hospital Initiative (BFHI). 23

24 The DHMT should ensure that all sites comply with the legislation that regulates the marketing of breast milk substitutes (Food and Drugs Act, Marketing of Breast milk Substitutes, 2006 Legislation). This legislation aims at ensuring that mothers make an informed decision regarding the use of breast milk substitutes rather than on the basis of commercial pressure The revised and expanded BFHI includes the 10 steps to successful breast feeding and 3 additional (Refer to annex VIII): Care for the Mother 1. A high dose of Vitamin A (200, 000 IU) supplementation for the mother after delivery should be given. 2. Promotion and provision of male or female condoms for use irrespective of one s HIV status. 3. Counselling on family planning for HIV positive mothers including use of condoms and risk of pregnancy in non-breastfeeding mothers. 4. Nutrition counselling and support especially for HIV positive mothers. 5. Personal hygiene especially after episiotomy. Role of Traditional Birth Attendant (TBA) TBAs can play an important role in the delivery of quality prevention of Mother-to-Child transmission of HIV services. They can help in referring pregnant women to antenatal care services and contribute to follow-up of women in the community enrolled in the programme. District health teams should therefore organize prevention of Mother-to-Child transmission of HIV training for TBAs to equip them with basic knowledge and skills related to HIV, AIDS and prevention of Mother-to- Child transmission of HIV using the revised Community Lay Counsellor Training Programme of After training, health facility teams should provide support and oversee TBA activities. Trained TBAs can, and are expected to help with the following: Identifying all pregnant women in their catchment areas in the community. Encourage women to deliver in facilities Referring pregnant women to ANC and encouraging counselling and testing for HIV. Perform group education, testing and counselling Packaging and selling of clean delivery kits (CDKs). Reducing stigma associated with HIV and AIDS. Supporting adherence to short-course ARVs and ensure that these are taken at the onset of labour. Ensure that the newborn baby is taken to the health facility for medical assessment, timely administration of short-course ARV syrups for those on the PMTCT programme, and for immunization. 24

25 Encourage Cotrimoxazole initiation and intake Support optimum infant feeding practices Encourage and support women to come back for postnatal check ups and services, especially if a mother is HIV positive. Data entry: The TBAs may be equipped with skills to assist in data entry in registers at the facility as part of the task shifting initiative. They should be also encouraged to record and report using their tools. These may be exercise books or community registers and submitted to their respective support facilities. Health centres need to support the community efforts including the TBAs and facilitate referrals from the community. 25

26 CHAPTER FIVE Post-Natal Check-ups The purpose of this is to ascertain the health status of the mother and the baby. It is also an opportunity to do the following: Initiate family planning Continue with immunisation. Provide nutrition counselling, both for the mother and child Monitoring the baby s growth Starting PCP prophylactic treatment for the baby. At these visits, the following should be emphasised: Double protection using condom and any other family planning method for couples irrespective of their HIV status. Growth monitoring for all infants and nutrition counselling for all mothers. Feeding decisions to be reinforced and supported. Mothers and partners should be referred to a local mother support group. Monitoring of adverse ARV drug reaction both in mothers and babies. Breast conditions should be identified early and treated accordingly. Appointment for HIV testing of the baby. Home Deliveries All women who deliver at home should be encouraged to visit health facilities within 72 hours of delivery by TBAs, other community volunteers and health workers. This is to ensure mothers enrolled onto the programme have access to ARV treatment for their babies, and to access OPV 0 and BCG vaccinations and to go for both postnatal check ups. Birth Attendants have a key role to play by ensuring a clean and safe delivery, as well as timely referral to the nearest health centre. 26

27 CHAPTER SIX Follow-up: Paediatric HIV Care and Long Term Support to Mothers All babies who are born to HIV positive mothers are HIV-exposed. A large component of the paediatric aspect of prevention of Mother-to-Child transmission of HIV is implemented in the underfive clinics during the first 18 months of the baby s life as part of routine care. The paediatric component of MTCT includes: Monitoring adherence to chosen infant feeding practice and provision of necessary support. HIV positive mothers who opted for breastfeeding should be supported during safe transition. Dispensing of Cotrimoxazole to prevent Pneumocystis Jiroveci Pneumonia (PCP) and other opportunistic infections from 6 weeks of age. Frequent clinical visits to monitor for clinical signs of HIV infection and provide routine paediatric care including immunisations. HIV testing and referral to HAART for positive babies. See table below for schedule of HIV testing in babies. HIV positive mothers should also be monitored at all baby contacts including during immunization HIV Testing For babies with access to Infant HIV Diagnosis, do PCR at 6weeks as demonstrated in the flow chart below. For babies with no access to Early Infant HIV Diagnosis, test the baby at 12 months with re-testing of babies at 18 months using rapid antibody tests. It should be noted that for as long as the baby continues to breast feed he/she remains at risk of contracting HIV infection. and clinic visits. Referral mechanisms and procedures for babies and mothers needing additional clinical care should be determined. Mothers should be provided with appropriate patient education materials. An expanded role for trained community counsellors might be considered: community counsellors could provide on-going counselling for mothers, follow-up of defaulters, and sensitization of community to the importance of HIV testing. HIV testing for the brothers and sisters of HIV exposed infants as well as children presenting with clinical signs of HIV infection through the counselling and testing services, may be considered. Partners or husbands of HIV positive women should also be offered HIV testing. 27

28 Pneumocystis Jiroveci (PCP) Prophylaxis with Cotrimoxazole for babies PCP is the leading killer of HIV infected babies. Primary prophylaxis against Pneumocystis Jiroveci should therefore be provided through the use of oral Cotrimoxazole suspension for at least the first year of life. Cotrimoxazole is given to all HIV-exposed babies i.e. all babies born from HIV positive mother s starting at six weeks of life and continues until at least 12 months if the baby still tests HIV positive. Cotrimoxazole can be stopped if the baby tests HIV negative and is not breastfeeding. Cotrimoxazole can also be stopped if the baby is HIV positive but has no symptoms and is doing well at 12 months, or better still, has CD4 25%. (Check WHO recommendation). Cotrimoxazole is continued beyond 12 months if the baby is HIV positive and has symptoms of WHO Stage 2 HIV disease or worse. If Cotrimoxazole has been given for treatment of PCP then it should be given as prophylaxis for life. Cotrimoxazole is dosed by weight, and given daily. The following table demonstrates the once daily Cotrimoxazole dosage. Cotrimoxazole Administration in HIV Exposed infants Weight Daily Dose (100ml) Bottles needed per month < 5kg 5 ml kg 7.5 ml kg 10ml kg 15 ml (1.5 tabs) 2 > 20 kg 20ml (2tabs) 2.5 The following are points to note with Cotrimoxazole administration: Allergic reactions are rare but can present as generalized body rashes. If a rash occurs, refer baby the same day, to an experienced HIV clinician for evaluation and possible switching to Dapsone (2 mg/kg daily). A blistering rash involving skin, mouth, red eyes (if scabies or impetigo are ruled-out), is a medical emergency. Cotrimoxazole is stopped and the baby should immediately be referred to a District or tertiary hospital where switching to Dapsone may be required. 28

29 Medicine is kept in a cool place and refrigerated if possible. Mothers are asked to bring the baby s medicine bottle to each clinic visit so compliance can be assessed. Dispensing of Cotrimoxazole to mothers should be made as easy as possible with consideration being given to fast-tracking the distribution in a well coordinated manner with routine immunization visits, starting at six weeks. Cotrimoxazole administration is documented in the Under-five register and Under-five card. Clinical Evaluation and Follow-Up of Babies All children should be registered at birth, and protected from violence, abuse and neglect. Followups on HIV exposed babies should be frequent. Nurses and other health workers should educate mothers and other care-givers on the importance of the following: Prompt screening and seeking treatment and management of opportunistic infections. Adequate basic hygiene, both personal and environmental. Nutritional education for caretakers and communities. Promotion of the use of Insecticide Treated Nets for children. Parent and community education for prompt treatment of illness as per IMCI guidelines. Community education for integrated approach to Early Childhood Development, which creates a foundation of support for children, their caregivers, and the community MNCH nurses should see babies at one and six weeks and then every four to six weeks, coordinated with the immunisation schedule. The suggested visit schedule for the first 24 months of life is: Weeks: 6, 10 and 14. Months: every month up to 24 months. This schedule can be increased if and when need arises. Adherence to growth monitoring and promotion should be emphasized, in addition to early referral for any growth faltering children born to HIV infected women. Growth faltering is one of the earliest signs of HIV/AIDS infection or tuberculosis. At monitoring visits, the MNCH nurse should assess the following clinical conditions: Growth faltering. Oral thrush or sores and nappy rash. 29

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