ASSESSMENT OF THE EFFECTS OF PREVENTION OF MOTHER TO CHILD TRANSMISSION OF HIV (PMTCT) PROGRAMME ON MATERNAL AND CHILD HEALTH AT NNAMDI AZIKIWE UNIVERSITY TEACHING HOSPITAL (NAUTH) NNEWI

CHAPTER ONE

INTRODUCTION

Acquired immuno-deficiency syndrome (AIDS) is a disease condition caused by infection of the human body by a retrovirus called the human immunodeficiency virus (HIV) ¹. On entry into the body, the virus invades the Cluster differentiation 4 (CD₄) cells in which it replicates. Its successful multiplication leads to the destruction of the CD₄ cells. Thus, the CD₄ cells count reduces as the viral load increases.

The CD₄ cells are responsible for the protection of the human body against numerous pathogenic organisms with which it comes into contact in day to day living. Depletion of the CD₄ cells leads to immune deficiency state and an increased likelihood of the body being invaded by opportunistic organisms. These organisms, which are ordinarily harmless to the human body, then become pathogenic and cause what is known as opportunistic infections ². It is the opportunistic infections that persistently reduce the quality of life of the individual and eventually result in death if treatment is not promptly and adequately provided. Highly Active Antiretroviral Therapy (HAART), when promptly and adequately

provided and taken, reduces HIV morbidity and mortality ^{3, 4}. 

Magnitude of the Problem of HIV/AIDS  

The HIV and AIDS pandemic is one of the most serious health crises in the world today. By the end of 2008, AIDS and AIDSrelated illnesses had killed more than 25 million  people (2 million in 2008 alone including 280,000 children under 15 years) and an estimated 35.8million people were living with HIV, out of which 15.7 and 2.1million were women and children under 15 years respectively⁵. Sub-Saharan Africa has continued to bear the greatest burden of the HIV and AIDS epidemic, with approximately 67% of the total number of people living with HIV, 68% of the new infections and 72% of AIDS-related deaths in 2008. Over the decades, the epidemic, once dominated by infected males has become progressively feminized and in sub-Saharan Africa approximately 60% of

adults living with the HIV are women^6,7,8. 

Over 90% of infection in children is acquired through motherto-child transmission (MTCT) and as more women contract the virus, the number of children infected also increases⁹. Estimate of the Global HIV pandemic demonstrated that in sub-Saharan Africa, more than 1200 children become infected with HIV each day⁵. In 2008 alone an estimated 2.1 million children were living with HIV and up to 430,000 were newly infected worldwide, with sub-Saharan Africa accounting for about 90% of both of these figures⁵.

Nigeria, with a population of 140 million¹⁰, is the most populous country in Africa and was ranked 2nd worst affected by HIV/AIDS in the world in 2008 after South Africa⁵. Since the first case of HIV/AIDS in Nigeria was reported in 1986 involving a 13 year old girl who died of the disease¹¹, there has been progressive increase in the total number of people living with HIV/AIDS (PLWHA). The national prevalence rose from 1.8% in 1991 to 5.8% in 2001 but declined to 5% in 2003 and 4.4% in 2005 before rising again to 4.6% in 2008 with prevalence in Anambra State determined to be 5.6%¹². 

The HIV prevalence rate is higher in the urban (5.4%) than rural areas (3.4%). Among young persons, the highest prevalence rate of 5.6% is in the age group 25 to 29 years¹³. The average number of adults living with HIV was 3,500,000 in 2005 at a time when number of women (15-49 years old) living with HIV was 1,900,000, giving a female: male ratio of

1.2:1. Heterosexual transmission accounts for nearly 80% to 95% of all infections¹⁴.  About 10% of HIV infections are transmitted by MTCT, while another 10% is transmitted by the use of unsterilized needles and surgical implements, infected blood and blood products¹⁵. 

Mother-to-Child Transmission of HIV

Over 90% of HIV infections in children less than 15 years are due to MTCT. In the absence of interventions, between 15% and 45% of infants born to HIV-infected mothers acquire the infection during pregnancy, delivery or through breastfeeding¹⁶. The burden of MTCT of HIV is higher in sub-

Saharan Africa than the rest of the world, because of higher levels of hetero-sexual transmission, high female to male ratio, high total fertility rate (TFR) and high rate of breastfeeding^17,18. Transmission of HIV in children has become a critical health problem undermining the positive impact of child survival strategies in the African continent^19,20. 

 Estimated magnitude of MTCT in Nigeria

Population	140 million
Birth rate per annum	42/ 1000
Birth per annum	5,900,000
HIV prevalence in ANC women Total number of  infants born to HIV infected women exposed to the	4.4%

260,000

risk of MTCT assuming no multiple pregnancy

Number of HIV positive infants per

65,000 to 117,500

annum

 Source: FMOH. National Guidelines on Prevention of Motherto-Child Transmission of HIV, July 2007.

Risk Factors for MTCT of HIV

Factors associated with increased risk of MTCT of HIV

Factors strongly associated with MTCT of HIV include viral characteristics and high viral load; maternal advanced disease, immune deficiency and HIV infection acquired during

pregnancy or breastfeeding^21,22, obstetric practices like vaginal delivery²³, rupture of membranes for more than 4 hours before delivery²⁴; prematurity of the infant; and feeding factors like prolonged breastfeeding, mixed feeding and breast diseases like abscess, mastitis and cracked nipples during breastfeeding²⁵.

Other factors associated with MTCT of HIV but with limited evidence include viral resistance; maternal vitamin A deficiency, anaemia, Chorioamnionitis, sexually transmitted diseases, frequent unprotected sex, multiple sexual partners, smoking and intravenous drug abuse; obstetric practices like invasive or traumatic procedures, instrumental deliveries, amniocentesis, episiotomy, external cephalic version and intrapartum haemorrhage; and foetal or infant lesions of the skin or mucous membranes and genetic factors.

Prevention of Mother-to-Child Transmission of HIV One of the goals of the June 2001 Declaration of Commitment of the United Nations General Assembly Special Session on HIV/AIDS (UNGASS)²⁶ is to reduce the proportion of infants infected with HIV by 20% by 2005 and 50% by 2010. The Nigeria national goal for PMTCT as contained in the 2003

AIDS Policy is to reduce the transmission of the HIV through MTCT by 50% by the year 2010 and to increase access to quality voluntary confidential counseling and testing services

by 50% by the same year. To achieve this goal, a comprehensive strategy to prevent HIV infection among infants and young children has been developed, which promotes implementation in an integrated manner within the health care delivery system. 

The NAUTH PMTCT programme started in 2003 as a national programme implemented by the Federal Government of Nigeria with NAUTH as one of the pilot sites. The NAUTH programme was taken over by the Institute of Human

Virology Nigeria (IHVN) in 2005. NAUTH has 7 satellite sites, including 3 private hospitals, for the PMTCT programme which is implemented according to the National Guidelines on Prevention of Mother-to-Child Transmission of HIV¹⁵.  

The PMTCT interventions consist of four strategic approaches which include: 

1. Primary prevention of HIV infection in women of reproductive age group and their partners  

This involves provision of early diagnosis and treatment of STIs, making HIV testing and counseling widely available and provision of suitable counseling for women who are HIV negative.

  

2. Prevention of unintended pregnancies among HIV positive women

The responsibility of the government and health services is to provide HIV positive women and their partners with comprehensive information and education about the risks associated with child bearing as part of routine public information about HIV and AIDS, to ensure that HIV positive women and their partners have real choices of action, and to respect and support the decisions they reach¹⁵. This means: providing good quality, user-friendly, and easily accessible family planning services so that HIV positive women can avoid pregnancy if they choose, promoting condom use, either alone or combined with a more effective method of contraception (dual method) for dual protection from HIV and other STIs and from unplanned pregnancies as an effective strategy to prevent HIV transmission, integrating dual protection messages into family planning counseling services and offering contraception to replace the birth spacing effect of exclusive breastfeeding in women who chose replacement feeding because of their HIV status.

3. Antenatal Care for HIV Positive Women

Specific Modification of Obstetric Care for HIV Positive

Women

Health workers in the antenatal clinic are able to identify women who have tested positive in order to treat them appropriately. This is done in a way that respects the privacy and rights of the HIV positive woman. As part of the initial counseling, women are told why it is important that health workers know their HIV status. NAUTH has a way of making this available in the notes, without making it accessible to the public, visitors or others. When a woman is known to be HIV positive or is diagnosed as HIV positive during pregnancy, her obstetric and medical care are strengthened and modified. Post test counseling for HIV positive pregnant women is conducted appropriately.

All HIV positive women are given optimal health care to ensure their safe delivery. Additional visits are not required for obstetric reasons, although she may need to attend for further counseling sessions. To minimize the likelihood of MTCT of HIV, care is taken to avoid invasive procedures such as chronic villous sampling, amniocentesis or cordocentesis and external cephalic version (ECV) which may carry a risk of HIV transmission to the foetus. Care is individualized in special circumstances such as premature rupture of membrane (preterm and term) and ante-partum haemorrhage. Proper and consistent use of the partograph in monitoring progress of labour improves the management of labour and also reduces the risk of prolonged labour in all women.  Because rupture of membranes of more than four (4) hours duration is associated with an increased risk of HIV transmission, ARM is reserved for those with foetal distress or abnormal progress and is only done if cervical dilatation is 7 cm or more. Forceps and vacuum delivery is avoided as they have been shown to be associated with increased risk of MTCT. Vaginal cleansing with chlorhexidine (0.25% solution) helps to reduce the risk of puerperal and neonatal sepsis including HIV transmission where membranes are ruptured for more than 4 hours. After every vaginal examination, the birth canal is wiped with gauze or cotton wool, soaked in chlorhexidine solution and the number of vaginal examinations is kept to a minimum.

Episiotomies are used only for specific obstetric indications. 

4.Prevention of HIV transmission from HIV infected mothers to their unborn babies and

infants. 

The Use of Antiretroviral Drugs in PMTCT of HIV

In addition to the normal criteria for initiation of antiretroviral

therapy (ART) in adults infected with HIV, pregnancy constitutes another indication for ART or prophylaxis. Treatment is indicated as per the WHO clinical staging and eligibility criteria. When the HIV-positive mother does not meet the criteria for treatment then prophylaxis is offered. In HIV infected adult population, ART is initiated based on any of the following criteria if CD4 cell count is available:

1.    WHO Stage IV disease irrespective of CD4 cell count

2.    WHO Stage III disease with CD4 cell count 3

3.    WHO Stage I or II disease with CD4 cell count ≤ 200 cells/mm³

However, pregnancy in the HIV-seropositive woman is an indication for prophylactic ART irrespective of CD4 count, viral

load or clinical stage of the disease. The time of commencement and choice of ART in HIV-seropositive pregnant woman depends on the clinical setting. Where necessary, ART is provided in consultation with an

experienced physician.

Pre-treatment evaluation:

This includes complete history and physical examination, checking laboratory parameters (FBC/ESR, FBS, LFT, E&U, Serum lipids and CD4 count), WHO clinical and immunological staging of the client, ensuring availability of supportive measures (nutritional and psychosocial) and developing patient-specific adherence strategy.

For ARV prophylaxis

All patients placed on ART are monitored clinically, biochemically and immunologically. The regimens stated below in different clinical settings are based on the 2007

National Guidelines on Prevention of Mother-to-Child Transmission of HIV¹⁵ which was still in use during this study.

ART prophylaxis in different clinical settings

Clinical Setting I

For pregnant woman who is HAART eligible, but not

currently on ART, initiation of ART is delayed until after the first trimester, unless benefits outweigh risks. ZDV is included in the regimen unless the haemoglobin level is less than

8g/dL. ZDV, 3TC and NVP are given if CD₄ count is less than 250 cells/mm³. If CD₄ count is more than 250 cells/mm³, NVP is avoided or if used, hepatotoxicity is monitored closely. NVP is stopped for women commenced on HAART – (ZVD, 3TC and NVP) before they became pregnant and found to react to NVP in first trimester pregnancy but EFV + ZDV + 3TC can be given in the second and third trimesters.

Infant

Single-dose NVP is given as soon as possible after birth preferably within 72 hours because NVP given to the HIVexposed infant has been shown to prevent perinatal HIV transmission to the infant²⁷. ZDV is also given for 6 weeks. ZDV is avoided if haemoglobin is less than 8g/dl for the adult and less than 10 g/dl for the infant.  

Clinical Setting II

Pregnant HIV-seropositive women who do not meet the criteria for ART are given ZDV ante-partum from week 28²⁸ or ZDV+ 3TC  from week 34-36²⁹.

Intra-partum: Single-dose NVP (sdNVP) + ZDV + 3TC is

given at onset of labour

Post-partum: ZDV + 3TC are given for 7 days. ZDV is

avoided if haemoglobin is less than 8g/dl.

For the exposed Infant, prophylaxis is as in Clinical Setting I.

Clinical Setting III

Mother receiving HAART at the time of current pregnancy

HIV infected women receiving HAART in whom pregnancy is identified are allowed to continue therapy. Zidovudine is always a component of the regimen unless haemoglobin is

less than 8 g/dl. Efavirenz is avoided in the first trimester.

Infant

For the exposed Infant, prophylaxis is as in Clinical Setting I.

Clinical Setting IV

For HIV sero-positive women who are diagnosed or seen for the first time in labour sdNVP + ZDV + 3TC is given at onset of labour then ZDV + 3TC is given post-partum for 7 days. Thereafter the women are referred to the Adult ARV Unit for evaluation for their and follow-up.

For the exposed Infant, prophylaxis is as in Clinical Setting I.

Clinical Setting V

HIV-seropositive mother who presents after delivery is assessed for eligibility for HAART for her disease, following the

2007 Guideline. For the exposed Infant, prophylaxis is as in Clinical Setting I but if more than 72 hours after birth, NVP is withheld and is given ZDV for 6 weeks.

Clinical Setting VI

For pregnant HIV-seropositive patients who are co-infected with tuberculosis and have active tuberculosis, TB is treated first while ARV is delayed till second trimester if possible when she is started on EFV + ZDV + 3TC and Rifampin is changed to low dose Rifabutin. ZDV is avoided if haemoglobin is less than 8 g/dl. For the exposed Infant, prophylaxis is as in

Clinical Setting I.

Intra-partum care:

The HIV positive women are not isolated or treated differently from other women in labour. The health care providers take supportive measures and show empathy and caring attitudes necessary to boost the morale of the clients. Universal safety precautions are observed by the health workers on all women in labour irrespective of their HIV status.

Rapid HIV testing and counseling in Labour

The HIV statuses of all women who are admitted to the labour ward are verified by checking on the Mother’s records and/or by asking the mother whether she has been tested for HIV infection. Those who are unaware of their HIV status and are in labour are offered rapid counseling and testing for HIV in the labour ward. 

Specific Management of HIV Positive Pregnant Women in labour

Prophylactic antiretroviral therapy is offered all HIV positive pregnant women accessing the NAUTH PMTCT services. 

Mode of delivery

Vaginal delivery

This is offered to HIV positive women where there is no contraindication and especially those who have assessed ARV therapy in the antenatal period and whose maternal viral load may be considered to be low.

(a) Management of labour

Labour management follows normal obstetric guidelines³⁰. HIV positive women are not isolated, but staff use universal safety precautions with all patients. Analgesia is given in labour if required.

(b) Support during labour

Emotional support during labour is important for all women, and may be even more necessary for an HIV-infected woman who is concerned about her condition and the risk of transmission to the child. This may be made worse by her fear of stigmatization and discrimination by medical staff, or because she has not disclosed her status to her partner or family members. Whenever possible, during labour, HIV positive women are given the option to have a companion of their choice who knows their HIV status and can provide supportive companionship. Where this is not possible labour ward staff should be sensitive to the fears and concerns of the HIV positive mother about her infection, and how much she had told any of her companions.

(c) Induction of labour

As prolonged rupture of membranes is associated with increased risk of MTCT, careful assessment of the need for, and the desirability of, caesarean section (C/S) rather than induction is made. Labour may be induced by one or a combination of the following: artificial rupture of membrane (ARM), oxytocin therapy, and prostaglandins. Where induction of labour is chosen, membranes are left intact for as long as possible. Oxytocin is not used with intact membranes. 

(d) Conduct of Delivery

Delivery is conducted using standard practice and aseptic technique while avoiding unnecessary trauma or prolongation of the second stage.

Interventions for safe vaginal delivery

The steps include: performing vaginal cleansing with warm 0.25% chlorhexidine to prevent genital infections; avoiding frequent vaginal examinations, episiotomies unless absolutely necessary, instrumental delivery unless absolutely necessary; clamping the cord immediately after baby is delivered and avoid milking the cord; and cutting cord under cover of a lightly wrapped gauze swab to avoid blood spurting.

Care of the baby at delivery: 

The measures taken include wiping the baby’s mouth and nostrils with gauze at delivery of the head, handling all babies with surgical gloves regardless of HIV status of mother until maternal blood and secretions are washed off, keeping all babies warm after delivery irrespective of their HIV status, baby is washed with warm chlorhexidine solution and wiped dry with a towel or surgical cloth to remove maternal body fluids immediately after birth. Where suctioning is indicated, mechanical suction unit (at a pressure below 100mmHg) or bulb suction is used. Mouth operated suction is avoided.

Determining mother’s infant feeding choice

If the mother has decided to breastfeed, she is helped to attach and position the baby to her breast and if the mother has decided not to breastfeed, the baby is placed on the mother’s body for skin-to-skin contact.

Caesarean Section (C/S)

HIV infection on its own is not an absolute indication for a caesarean section. Available evidence shows that elective C/S on women on HAART with low viral load (

Activities for optimal obstetric practices

All concerned health workers have been trained in safe delivery techniques and life-saving skills for mothers and infants and provisions have been made for safe delivery kits and essential obstetric drugs, safe delivery infrastructure with a water source, good drainage, electricity, delivery beds covered with waterproof materials, antiseptics, gloves, and other materials required for a hygienic delivery environment. Safe blood supply is assured and education about the

importance of antenatal care and deliveries is regularly carried out.

Post-Partum Care

Immediate Post-Partum care

The post-partum period in the health facility offers an opportunity to educate all patients about HIV, to provide counseling and testing if this was not carried out previously, and to reinforce the education provided during the antenatal period. This is done in a private place so that the discussion can be confidential. Both HIV infected and uninfected mothers receive this education and counseling before discharge. Emphasis is also made on the importance of routine immunization and the need for good hygiene to prevent

infection.

For HIV-negative mothers, breastfeeding is reinforced and supported, sexual activity in the postpartum period and protection against HIV infection are discussed, couple or partner testing and Counseling is done. Appropriate family planning methods where appropriate are offered, education on, and reinforcement of infant care is carried out, mother care sessions on education and counseling, delivery and postnatal exam are completed and post-natal visit is scheduled.

For HIV-positive mothers, infant feeding choices are reviewed and supported, discussions are carried out on couple or partner testing and Counseling, sexual activity in the postpartum period and protection of partners against HIV infection. Appropriate family planning methods are offered where appropriate, infant antiretroviral drugs are provided, infant care is taught and reinforced, adherence counseling is provided for women that need to continue on ARV while ARV is discontinued according to the guideline. Infection prevention and prompt medical attention are discussed. Mother-care sessions, education and counseling, delivery and postnatal examination are completed. The importance of early infant diagnosis is discussed while post-natal visit is scheduled.

For mothers whose HIV status is unknown, counseling

and testing is provided in labour or as soon as possible after birth, instructions for immediate post exposure prophylaxis with an appropriate ARV regimen for infants of mothers who are HIV positive are followed while education and counseling as for HIV-positive mothers are completed before discharge.

In the immediate Post partum period routine physical examination is performed with particular emphasis on the vital signs, detection of anaemia, breast examination, abdominal examination and perineal and lochia examination. HIVinfected women are more prone to post-natal infections including urinary tract infections, chest infections (e.g. pneumonia), infected episiotomy, post-partum sepsis and caesarean section wound sepsis. Health workers are aware of this and they observe for signs of infection.

For HIV positive mothers the following are also

essential:

Breast care

A woman who is not breastfeeding should use a firm brassier to limit milk production and support the breast. Bromocriptine therapy to limit milk production is given when necessary in some cases especially for mothers who chose not to

breastfeed.

For a breast feeding woman, cracked nipples, mastitis and breast abscess increase the risk of breast milk transmission of HIV¹⁷. Cracked nipples are often caused by poor attachment of the baby’s mouth on the breast, candida infection, frequent washing of the nipples, and application of abrasive creams and lotions.

Measures for prevention of cracked nipples include making sure that there is good breastfeeding technique with the baby latching on the areola and the nipple, prompt treatment of vaginal thrush or infant oral thrush, the mother washing her breast once a day and avoid use of creams and lotions on the nipples. The mothers are shown how to put a finger on the baby’s mouth to remove a baby from the breast without traumatizing their nipples. A mother is instructed to smear her nipples with breast milk after feeds and air-dry her breasts. Women are encouraged to seek health care promptly if they have nipple discomfort when they are breastfeeding. They are reminded that babies should not be fed on a breast with mastitis or breast abscess.

For care of the perineum, measures include emphasis on good perineal hygiene and proper handling of body fluids, avoiding contaminating the baby with body fluids or bedding soiled with lochia, discouraging bed sharing in hospital and Sitz bath: In the past sitz baths were encouraged for the management of episiotomies³⁰. Local experience is that it is difficult to keep the basins clean and they become a source of contamination. The mothers are taught to clean with a clean cloth soaked in warm saline.

Family planning

Appropriate family planning methods are discussed during antenatal period and again before discharge home. In our area where prolonged exclusive breastfeeding is the norm, some women may rely on lactational amenorrhoea (LAM) as a contraceptive method, and this will be lost with changes in infant feeding. Some women may have a period of abstinence after the birth of the child, and may not wish to start contraceptive use before this. They are given information about how and where to obtain contraception when they wish

it. 

Some artificial family planning methods are:

1. Hormonal

The options include combined oral contraceptive pills, progestogen-only pills, injectable progestogen (DMPA or noristerate/NET-EN) and progestogen implants (such as Implanon or Uniplant/Norplant) but it should be borne in mind that these do not protect against HIV and AIDS.

2. Barrier methods

The methods include female condoms, male condoms, diaphragms, used with spermicides. These can provide contraception and protect against HIV and AIDS

3. Intra-uterine contraceptive devices (IUCD or

IUD)

4. Sterilisation:

This is suitable for HIV positive women and their partners who do not wish to have more children.

5. Emergency contraception

This is especially important where barrier methods are being used as the primary contraceptive method and women should be told about the possibility of using emergency contraception if the condom breaks or slips.

Cervical Screening

HIV-positive women have a higher risk of cervical dysplasia and malignancy³¹. Therefore, they should have a cervical smear, if possible at a postnatal check-up and at least once annually. In women with CD4 counts below 200cells/µl or who have symptoms of AIDS, a six-monthly smear is advised.

Follow up

The follow up schedule for mother- infant pair is at 2, 4 and 6 weeks after delivery. Post natal follow-up is provided as a comprehensive package by the child welfare provider, paediatrician, adult HIV physician and family planning provider. The postnatal period is the beginning of the ongoing care and support for women with HIV infection, especially where the diagnosis was first made during pregnancy. Dried blood spot (DBS) polymerase chain reaction (PCR) provides a feasible method to assess PMTCT programs and identify HIVinfected children and this is done at 6 weeks post-partum visit³². Advice on the need for prophylactic treatment for Pneumocystis Jerovecii pneumonia (PJP) and tuberculosis is given if indicated by the clinical stage of the disease. The woman is linked to a community based support group for ongoing counseling and other support services.

Referral after postnatal care

All HIV infected women are referred to the adult ART Clinic after postnatal visit.

Post Abortion Care

HIV positive women are more likely to have spontaneous abortions. In some cases, the HIV status of the woman is not known. Health workers are aware of the possibility of HIV and look for clinical signs and symptoms related to HIV. Where the woman is known to be HIV-positive, prophylactic antibiotics are given after uterine evacuation and ensure that there is family planning counseling available and the provision of a method as required, as well as access to HIV counseling. They are counseled about possible problems, such as infection or bleeding, which may occur after the procedure

Rationale for the study

The overall purpose of the assessment is to inform future programming in order to build on the programme’s successes and remedy its failures. Understanding the effectiveness of the PMTCT programme is crucial for sustenance and scale-up. The success of a PMTCT programme in reducing seroconversion among exposed newborn infants is determined by many factors, including the administration of ARVs (Nevirapine or Zidovudine [AZT], or HAART) to both HIV-positive mothers and their newborns; infant feeding practices; access to and use of well-baby care; and the health system’s ability to provide care, including counseling and support to both the HIV-positive mother and her exposed newborn. Prior to the assessment, very little is known about the impact of PMTCT interventions in NAUTH, Nnewi, Anambra State, Nigeria.