The Practicalities of Using Nevirapine for PMTCT in Under-Resourced Settings ppt

Prepared for the Eastern Cape Department of Health by a research consortium comprising
the Social Aspects of HIV/AIDS and Health Research Programme of the Human Sciences
Research Council, and the University of Limpopo, Medunsa Campus
Published by HSRC Press
Private Bag X9182, Cape Town, 8000, South Africa
www.hsrcpress.ac.za
© 2005 Human Sciences Research Council
First published 2005
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List of tables and figures iv
Foreword v
Acknowledgements vi
Abbreviations and acronyms vii
1. Background 1
2. Introduction 4
3. The aim of this intervention study 7
4. Rationale for designing the Nevirapine Unit
Dose Pack 8
5. Nevirapine dosing per National Protocol 9
6. Preparation and distribution of mother and
child Nevirapine Pack 10
7. Healthcare worker training 11
8. The role of the pharmacist 12
9 Results: healthcare workers' experiences and
perceptions about the Nevirapine pack 13
10. Discussion 14
11. Recommendations 15
12. Conclusion 16
Appendix 17

References 19

CONTENTS
iv
©HSRC 2005
Tables
Table 1.1: Access to healthcare facility for pregnant women in the Flagstaff district,
Eastern Cape 2
Table 1.2: Place where pregnant mothers delivered their last baby in the Flagstaff district,
Eastern Cape 2
Table 5.1: Nevirapine Protocol in the Eastern Cape (per National Protocol) 9
Figures
Figure 6.1: NVP pack label 10
LIST OF TABLES AND FIGURES
v
©HSRC 2005
South Africa’s response to HIV and AIDS has evolved significantly over the last five years.
This has culminated in the implementation of programmes such as the Prevention of
Mother-to-Child Transmission (PMTCT) that mitigate the impact of HIV to women and
their children. As a result, this has led to much excitement, innovation, achievements,
opportunities and challenges for the Department of Health.
First, I would like to extend words of appreciation to the Human Sciences Research
Council and the University of Limpopo (Medunsa campus) for the commitment and
assistance in implementing the PMTCT programme in the Flagstaff (Qaukeni) area, and
also acknowledge the efforts of the staff working in the rural health facilities in the same
area.
Words of gratitude are also due to Dr Olive Shisana, Dr Henry Fomundam, Dr Thabang
Mosala and Prof. Karl Peltzer for leading this effort in assisting and supporting the rural
women in Flagstaff to access single-dose Nevirapine for PMTCT.
I trust that the lessons learned from this study will be shared nationally and

internationally by all concerned, and will improve services for HIV-infected pregnant
women in rural and under-resourced communities.
Ms Nomalanga Makwedini
Director HIV/AIDS & STIs
Eastern Cape Department of Health
FOREWORD
vi
©HSRC 2005
The research consortium would like to thank the Ford Foundation for financial assistance
and the healthcare workers (HCW) for making sure that this pilot project was successful.
Our special gratitude goes to the Department of Health in the Eastern Cape for providing
the infrastructure: facilities, provision of Nevirapine, as well as the distribution and stock
control of the Nevirapine pack.
ACKNOWLEDGEMENTS
vii
©HSRC 2005
AIDS Acquired Immunodeficiency Syndrome
ANC Antenatal clinics
ARV Antiretrovirals
AZT/ZDV Zidovudine
FDA Food and Drug Administration
HCW Healthcare workers
HIVNET 012 HIV Network Prevention Study 012
HSRC Human Sciences Research Council
HST Health Systems Trust
MCC Medicines Control Council
MTCT Mother-to-Child Transmission
NIH National Institutes of Health
NNRTI Non-nucleoside reverse transcriptase inhibitor
NVP Nevirapine

PACTG Paediatric AIDS Clinical Trials Group
PMTCT Prevention of Mother-to-Child Transmission
SAINT South African Intra-partum Nevirapine Trial
TAC Treatment Action Campaign
TBA Traditional birth attendant
3TC Lamivudine
ABBREVIATIONS AND ACRONYMS

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1. Background
In 2001, the South African government developed a Nevirapine (NVP) protocol to be
implemented in 18 selected pilot sites (two per province), for the Prevention of Mother-
To-Child Transmission of HIV (PMTCT) programme. The Medicines Control Council
(MCC) had approved NVP for the reduction of vertical transmission of HIV from mother
to child. Zidovudine (AZT) protocol at that time had been approved by the Food and
Drug Administration (FDA) and was being used by several developed countries. This
proved to be challenging, particularly for developing countries, because of the duration
of treatment and infusion of the injectable form of AZT during labour and delivery. In the
Eastern Cape Province, two clinics were selected: the urban Cecilia Makiwane and the
rural Umzimkhulu Clinics, as pilot sites to implement the PMTCT programme following
the NVP protocol.
In the landmark case between the South African National Department of Health and the
Treatment Action Campaign (TAC), the court ruled that the government should provide
Nevirapine to HIV-positive pregnant mothers beyond the pilot sites. The South African
Cabinet then decided to extend the programme, to prevent transmission of HIV from
mother to child in all health facilities that had an appropriate infrastructure. The treatment
was provided to all who needed it beyond the current experimental (pilot) sites. It
was therefore crucial for the Human Sciences Research Council (HSRC) to study the
obstacles to effective implementation of this intervention and suggest ways of removing

these barriers. The HSRC has been conducting research in the area of PMTCT in three
provinces: Western Cape, Eastern Cape and Gauteng. The research began in January 2000,
and some of its findings have been used to amend or modify the PMTCT approach in
several clinical settings.
In the Eastern Cape the study was conducted in region E, Qaukeni District. The
communities in region E are rated among the most economically disadvantaged, with
relatively poor access to services and less than 50 per cent having access to basic water
supply and sanitation. Many derive their household income from the migrant labour
and pension grant systems, and there is a high rate of unemployment (48.5 per cent).
The predominant housing type is a traditional mud-and-stick hut, with people living in
dispersed homesteads. It has a population density of 39 persons per square kilometre,
far below that of Gauteng (385 per square kilometre) and KwaZulu-Natal (100 per square
kilometre). The poverty rate (percentage of population in poverty) is 63.3 per cent, the
second highest in the country. The Human Development Index for the Eastern Cape
was 0.51 in 1999. This is far lower than the rest of South Africa, with the exception of
the Limpopo Province (Mahlalela, Rohde, Meidany, Hutchinson & Bennett 2001:3–5; RSA
National Treasury 2001:2–3). In the study area, two hospitals, Holy Cross and St Elizabeth,
render maternal health services. They have five fixed clinics and a few mobile points.
1.1 HIV prevalence in the Eastern Cape Province
Data from the annual antenatal survey conducted by the Health Department, show high
levels of infection among pregnant women attending antenatal clinics (ANC) in the
Eastern Cape, and especially in region E where this study was being conducted.
The overall HIV prevalence among antenatal care attendees for the Eastern Cape, had
risen from 21.5 per cent in 1998 to 22.0 per cent in 1999 and 24.0 per cent in 2000 to
The Practicalities of Using Nevirapine for PMTCT in Under-resourced Settings
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27.1 per cent in 2003 (Department of Health 2004). These figures are important for this
study since they provide an indication of the number of women who need PMTCT
services. Region E has the highest levels of infection in the Eastern Cape, and the

prevalence of HIV infection is increasing by more than one per cent annually.
In an HSRC baseline study in the Qaukeni district, data was collected on 1 534 pregnant
women recruited at initial ANC visits in five PMTCT clinics (n=936), and 598 women from
the community around the five clinics prior to ANC in the Flagstaff region (Peltzer et al.,
2004). The study found the following:
1) Access to healthcare for pregnant women in most healthcare facilities was restricted
by distance. Only one in ten women was able to access hospital services within 30
minutes from where they lived. Clinics were slightly more accessible than hospitals.
More than one in five women were able to access clinics services within 30 minutes
from their homes. However, two-thirds of the pregnant women took more than one
hour to get to the nearest hospital, and almost one-third spent more than an hour
getting to the nearest clinic (see Table 1.1).
2) Further evidence of lack of access to health services was that 42 per cent of those
women who had delivered before (n=995) delivered at home (see Table 1.2), and
that one in four women delivered at home without the services of a healthcare
provider or a traditional birth attendant (TBA).
Table 1.1: Access to healthcare facility for pregnant women in the Flagstaff district, Eastern Cape
Time spent to get to nearest hospital Number of pregnant women Percentage
30 minutes and less 156 10.1
> 30 minutes to 1 hour 370 24.1
> 1 hour to 2 hour 295 19.2
>2 hour 653 42.6
Total 1 474 100.0
Time spent to get to nearest clinic
30 minutes and less 367 23.9
> 30 minutes to 1 hour 624 40.7
> 1 hour to 2 hour 194 12.6
> 2 hour 273 17.8
Total 1 458 100.0
Some of the findings of this study show that almost 60 per cent of the women deliver in

the hospital, but it is of concern when more than 35 per cent of the women deliver at
home, as shown in Table 1.2. The majority of the women live far away from the hospital,
which is the only place where child delivery routinely takes place with a full PMTCT
programme in place. Most of the clinics do not have delivery services.
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©HSRC 2005
Table 1.2: Place where pregnant mothers delivered their last baby in the Flagstaff district, Eastern
Cape
Place of delivery Number of women who delivered there (N=995); N (%)
Hospital 548 (57.4)
Clinic 7 (0.7)
Home, without
TBA
246 (25.8)
Home, with TBA 145 (16.1)
It was thus very obvious that women who delivered at home could not benefit from the
full administration of NVP to the pregnant woman in labour and the newborn infant.
The HSRC study identified gaps, which included the major obstacle of dispensing and
administering NVP, particularly to newborns in rural settings. The HSRC research team
designed an intervention measure (the Nevirapine pack) to improve NVP dispensing
and administration within the required timeframe, thereby complying with the stipulated
national protocol.
Background
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©HSRC 2005
2. Introduction
This intervention study was primarily focused on the implementation of NVP use in a
rural setting according to the approved South African National Protocol. The use of NVP
for preventing vertical transmission of HIV from the pregnant mother to child during
labour and at birth (PMTCT), particularly in developing countries, is quite common. It is

most often used as monotherapy, though in some settings and countries, combinations
of anti-retrovirals (ARVs) are increasingly being used. The finding that NVP reduced
mother-to-child transmission (MTCT) of HIV by about 50 per cent in resource-constrained
settings, at the cost of one pill to the mother and one dose of NVP syrup to the infant,
was potentially one of the most hopeful discoveries in children and HIV research in the
last decade (Nielson, 2004).

HIV can be transmitted from the infected mother to her
child during pregnancy, labour and delivery, or through breastfeeding. In the absence of
breastfeeding, most infections occur during labour and delivery. It has been reported that
transmission rates ranged from 13 to 32 per cent in industrialised countries and from 25
to 48 per cent in developing countries (World Health Organisation, 2001). Recent reports
from the Centre for Disease Control however, show rates to be as low as three per cent
in industrialised countries.
The use of antiretroviral drugs during pregnancy and delivery has been shown to be
effective in reducing the transmission of HIV from mothers to infants. These regimens
reduce the risk of MTCT by decreasing viral replication in the mother and through
prophylaxis of the infant during and after exposure to the virus. Remarkable reductions
in paediatric HIV infection rates have been observed in industrialised countries since
1994, when the Paediatric AIDS Clinical Trials Group (PACTG) Protocol 076 showed that
administration of Zidovudine to women from the 14
th
week of pregnancy and during
labour, and to the newborn, decreased the risk of MTCT by nearly 70 per cent, in the
absence of breastfeeding. Other clinical trials have shown that short-course antiretroviral
regimens using either the combination Zidovudine and Lamivudine, or Nevirapine alone,
also substantially decreased the risk of HIV transmission.
After the results of the HIV Network Prevention Study 012 (HIVNET 012), carried out in
Uganda, had shown a 47 per cent decrease in MTCT, using only one dose of 200mg NVP
to the mother during labour and a 2mg per kg dose to the baby within 72 hours of birth,

NVP was acclaimed as the most cost-effective PMTCT intervention in developing countries
or in resource-limited areas.
Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that binds directly
to HIV-1 reverse transcriptase, slowing the rate of viral DNA synthesis and thereby
inhibiting viral replication. Nevirapine is rapidly absorbed when given orally to adults,
and has a long elimination half-life (t
1/2
) of approximately 40 hours. Nevirapine crosses
the placenta efficiently after a single oral 200 mg dose to the mother at the onset of
labour. In infants, median (t
1/2
) ranges from 45 to 72 hours for elimination of the maternal
Nevirapine, and from 37 to 46 hours for the elimination of a single 2mg per kg neonatal
dose.
There has however been a lot of scientific debate on the role of NVP prophylaxis,
its efficacy, its safety and most importantly, on the issue of resistance. Concerns have
been expressed that there may be a risk of selecting HIV-1 strains that are resistant to
NVP in infected mothers or infants who have received one or two doses of the drug.

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©HSRC 2005
Research questions regarding the interface of prevention of peri-natal HIV transmission,
antiretroviral drug resistance, and antiretroviral treatment differ between resource-rich
and resource-limited settings. In resource-rich settings, a critical question is whether
antiretroviral resistance among treatment-experienced pregnant women and increasing
rates of resistance among antiretroviral-naive pregnant women, will result in higher rates
of peri-natal transmission, reversing the currently successful peri-natal HIV prevention
efforts. In resource-limited settings, where antiretroviral therapy may become more
available in the near future, critical questions revolve around whether widespread use of
antiretrovirals such as NVP, ZDV, and Lamivudine (3TC) for PMTCT will lead to increased

risk of treatment failure among women and infants who become infected despite
prophylaxis, both of whom may later require antiretroviral drugs for their own healthcare.
The lack of data to address these questions has contributed to increased tension between
treatment and peri-natal prevention advocates (Fowler et al., 2003).
2.1 NVP registration and use for PMTCT in South Africa
The MCC is a statutory body that was established in terms of the Medicines and Related
Substances Control Act 101 of 1965, to oversee the regulation of medicines in South
Africa. The MCC was appointed by the Minister of Health and its main purpose is to
safeguard and protect the public through ensuring that all medicines that are sold and
used in South Africa are safe, therapeutically effective and consistently meet acceptable
standards of quality.
In April 2001, the MCC gave conditional approval status to the use of NVP as
monotherapy for the reduction of MTCT of HIV. The conditional status made it incumbent
upon Boeringer-Ingelheim, the manufacturer of the product (the applicant), to monitor
and report on safety, resistance and efficacy. Nevirapine monotherapy was subsequently
launched in 18 pilot sites in the country, two per province (one rural and one urban).
In a case that was brought by the TAC against the government in April 2002 however,
the Pretoria High Court ordered that the use of NVP monotherapy was to be expanded
beyond the 18 pilot sites and be made available countrywide. A clinical trial to determine
the efficacy of oral AZT and oral NVP for prevention of vertical transmission of HIV-1
infection in pregnant Ugandan women and their neonates (HIVNET 012), was sponsored
by NIH and conducted by investigators from Johns Hopkins University in the USA and
Makerere University in Uganda. The results provided the basis for MCC’s approval of
NVP for that indication. Prior to this study, the FDA and the MCC had already approved
the use of NVP in combination with other ARVs for the treatment of HIV infection in
adults and children. The study was started in 1997 and completed in 1999, with the
results, published in
Lancet, concluding that NVP significantly reduced the risk of HIV
transmission from mother to child. Following the use of NVP in South Africa, there were
concerns, discussions and debates by the MCC and scientists on the degree of its efficacy

and the clinical significance of resistance. This debate was aggravated by the withdrawal
(by the applicant) of a NVP application to the FDA in March 2002, due to non-conformity
with FDA regulatory requirements in the collection of primary data during the conduct
of the study. The MCC engaged the applicant and national and international scientists on
the issue of efficacy and resistance in particular, for over a year. In July 2004 the MCC
concluded that ’the risk-benefit profile of NVP monotherapy has changed and therefore
no longer recommends its use for prevention of MTCT of HIV’. It was further stated that
’council decision applies to all monotherapy interventions when used to reduce the risk
of transmission of HIV from mother to child during labour. Council is of the view that
combination therapy should be considered for this indication’.
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©HSRC 2005
International organisations including the World Health Organisation had established the
costs, feasibility and practicality of the AZT protocol in reducing vertical transmission of
HIV from mother to child, and thus urged governments of developing countries to use
NVP instead for this purpose. NVP was recommended as a cost-effective, convenient
intervention.
The Health Systems Trust (HST) published interim findings of lessons and recommendations
from its study on the 18 national PMTCT pilot sites (McCoy, 2002). It concluded that many
of the difficulties and constraints to full and effective implementation were identified as
being systemic in nature, and related to the poor functioning of the healthcare system
in general. The report highlighted challenges regarding human resources, management
and physical infrastructure. They found tremendous differences in implementation
and uptake rates between provinces and sites, and concluded that at the core of these
differences were the large inequities in healthcare infrastructure within the country.
Other findings include the fact that up to as many as 15 per cent of pregnant women
currently had access to PMTCT services; that 51 per cent of the pregnant women in the
national pilot sites agreed to be tested; and that of those tested 30 per cent were HIV-
positive. Furthermore, less than one-third of the number of HIV-positive pregnant women
identified in the national PMTCT sites had delivered with the administration of NVP to

both mother and baby. The HST study concluded that the provision of PMTCT could act
as a catalyst for the improvement of the healthcare system.
The Practicalities of Using Nevirapine for PMTCT in Under-resourced Settings
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©HSRC 2005
3. The aim of this intervention study
The overall purpose of this intervention was to focus on the implementation of the
PMTCT protocol. A particular area of concern was to ensure that pregnant women and
their babies adhered to the NVP administration within the time frame of a dose to the
mother during labour and a dose to the baby within 72 hours of birth.
Specific aims were to:
• Design a user-friendly NVP (mother-infant pair) pack;
• Evaluate the feasibility of dispensing the pack and successful administration of NVP
using the pack; and
• Evaluate acceptability by healthcare staff (nurses) and patients.
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©HSRC 2005
4. Rationale for designing the
Nevirapine Unit Dose Pack
In South Africa, the experience of dispensing and administering NVP has produced
enormous challenges, especially in the rural areas. These challenges relate particularly
to patients living far from hospitals and clinics that have drug storage, dispensing and
administration resources, as well as the problematic shortage of pharmacists and nurses
to accurately dispense the required dose, and carry out monitoring. The NVP suspension
given to babies is currently only available in a 200ml bottle. This makes accurate
measuring and withdrawing of the very small dose of 0.6ml or the equivalent of 2mg per
kg for each baby very challenging, as it would require approximately 333 withdrawals to
finish the entire contents of the 200ml bottle. This in turn, might also compromise aseptic
techniques. Pregnant women are normally supposed to be given a Nevirapine tablet at
28 weeks of gestation per protocol. In some cases however, it is given during the first

antenatal visit for fear that it may be the only visit prior to delivery. Dispensing of NVP
early as a single tablet increases the chances of the tablet being lost. Due to distances
from clinics or hospitals, and also the often hilly terrain, as well as other socio-economic
factors, some women are forced to have their babies at home. In such rural areas delivery
of babies by TBAs is a long-standing tradition. A significant number of these cases are
unable to take their babies back to the delivery centre for the baby dose, which needs to
be given within the stipulated 72 hours. Furthermore, in some cases, for cultural reasons,
babies can only be taken out of the house after a certain period (<10days), which
is much longer than the stipulated 72 hours after birth. NVP is available as a 200mg
tablet in bottles of 60 tablets. It is also available as 200ml bottles of a white-to-off-white
suspension containing 50 mg of the drug in each 5 ml (one teaspoon).
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©HSRC 2005
5. NVP dosing per National Protocol
Following the HIVNET 012 study in Uganda, the adopted and approved dose in South
African public health facilities is one 200mg tablet of NVP as a single dose given to the
mother at the onset of labour and a single dose of 2mg/kg of the suspension given to the
child within 72 hours of birth. The instructions for administration are presented in Table
5.1 as well as in Figure 6.1. However, the South African Intra-partum NVP Trial (SAINT)
used 0.6ml for the babies.
Table 5.1: NVP Protocol in the Eastern Cape (per National Protocol)
Drug Intrapartum Postpartum
NVP One dose of 200mg at onset
of labour
NEVER REPEAT THE DOSE
Baby below 1.5 kg : NVP should
not be given
Baby above1.5 kg but below 2.5
kg: 2 mg/kg
Baby above 2.5 kg: 6 mg stat

within 72 hours
NEVER REPEAT THE DOSE
NVP = 50mg = 5ml
a) If the woman has not delivered in 24 hours the dose of NVP is never repeated.
b) If she delivers within two hours then the baby is given NVP immediately.
c) If the woman is going for an elective Caesarean section, NVP should be given six
hours before.
d) If the woman needs an urgent Caesarean section
, she must be given NVP only if the
provider thinks that the time until the baby is delivered is going to be more than
one hour,
in which case the baby can be given a dose at delivery.
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©HSRC 2005
6. Preparation and distribution of
mother and child NVP pack
The pack is a dispensing bag that contains a 200mg NVP tablet in a blister form for the
mother and an oral syringe containing the baby dose. Figure 6.1 shows the labelling of
the NVP pack.
Figure 6.1: NVP pack label
On one side of the dispensing bag is the name of the healthcare facility (HCF), the batch
number of the NVP tablet and the syrup, the expiry date and space for the pregnant
woman’s name. This side of the bag also includes a picture depicting the pregnant
woman taking the tablet, and the mother giving the baby dose, to avoid any confusion.
The other side of the bag includes counselling tips for the nurse to convey to the
pregnant woman and/or a medication advocate who could be a TBA.
A qualified pharmacist is the only person permitted to prepare the unit doses (drawing
up 0.6ml accurately per syringe) for the baby. Both the NVP tablet and the suspension
unit doses are prepared from a stock that has a minimum of one year’s expiration.
However the contents of the bag are given a shorter shelf-life with the goal of ensuring

that it is used within 4–8 weeks, as stability of the baby dose in a luer lock baby syringe
has not yet been established.
All clinics were evaluated to determine the adequacy of storage space, and the availability
of a sister to dispense according to protocol, including conducting patient counselling
on drug administration. NVP packs were dispensed only to mothers in their last trimester
(28 weeks gestation period). Following the design of the NVP pack, all clinics could
now carry the NVP pack, making it feasible for pregnant women to schedule a trip to
the nearest clinic during their last trimester. Deliveries take place mostly at the main area
hospital (Holycross Hospital), rather than at the feeder clinics.
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©HSRC 2005
7. Healthcare worker training
The clinics were supplied with oral syringes and the bag packs labelled in English
and the local language. NVP tablets and the suspension solution were supplied by the
Department of Health. Posters on PMTCT depicting NVP administration were displayed
visibly in the waiting area of each healthcare facility.
All nurses from the hospitals and clinics participating in the PMTCT programme were
trained on the dispensing of the packs and patient adherence by the pharmacist and the
research team. The training was designed to enable the pregnant woman to administer
the pack to herself and the baby in case she delivered at home. Nurses were also trained
on ordering and maintaining adequate packs, as well as checking expiry dates. Nurses
were trained to deal with problems arising from administration of the drug, so that if a
baby or mother vomited immediately after receiving the dose, nurses were to administer
a second dose. In the case of multiple births, the mother needed to make an effort to
get additional dose(s) within 72 hours, through the community health worker or TBA.
Nurses also counselled mothers on bringing the baby to the clinic if born under unusual
circumstances (for example prematurely), so that the baby could be evaluated prior
to giving the baby dose. Women who were given NVP packs were advised to bring
them along when coming to the clinic or hospital for delivery. Nurses were trained
to document any side effects reported by their patients such as rash, nausea and/or

vomiting.
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©HSRC 2005
8. The role of the pharmacist
Due to staff shortages, there was only one qualified pharmacist for the entire district who
had the monumental task of supervising all pharmaceutical care services in the public
health facilities. The pharmacist participated in the initial briefing and training by the
HSRC research team, on the concept of the NVP unit dose and dispensing procedures.
The pharmacist quickly embraced the concept, as it was cost-effective, timesaving and
very practical. The pharmacist was therefore responsible for accurately drawing the unit
doses and labelling them properly with the batch number and expiry date. In addition
to this, the pharmacist was to ensure availability of NVP stock (tablets and syrup), to
evaluate the clinics and hospitals for proper storage of the stock, to train new staff
(nurses and pharmacist assistants) hired in any of the facilities, to distribute the posters in
the various facilities and to check on usage patterns and expiry dates.
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©HSRC 2005
9. Results: healthcare workers’
experiences and perceptions about
the NVP pack
The researchers further designed a self-administered questionnaire (Appendix A) targeting
professional nurses (n=10) and the pharmacist (n=1) in the health facilities, in order to
elicit their experiences and perceptions of using and supervising the administration of
the NVP pack. Almost 80 per cent of the healthcare workers (HCW) had formal training
on how to administer the NVP pack (only two of the nine HCW interviewed were not
trained), with 90.9 per cent being trained in the PMTCT course (only one of the ten
HCW interviewed was not trained). All healthcare facilities had NVP in stock, and the
pharmacist when needed supplied additional stock. The average presentation gestation
period when the nurses gave mothers the pack, ranged from any stage during the first
visit at 20 weeks (in case the woman did not come back, fearing repercussions now

that the nurses were aware of her HIV status, or for other reasons), to 33 weeks. Many
young women present themselves to the antenatal clinics for the first time during the last
trimester for various reasons, including late awareness of pregnancy.
All healthcare workers were familiar with the local language used by the pregnant
mothers, which made it easy to give instructions on how the pack should be
administered. All healthcare facilities kept the NVP packs under proper storage as
stipulated, by using the NVP register. All HCWs interviewed felt that the NVP pack
intervention should be continued, due to the ease with which they could dispense the
packs and counsel patients on NVP administration, as well as the convenience of storage
by the patient, the easy-to-follow instructions for both the patient and the TBA, and the
higher self-administration rates, which meant that more mothers were successfully being
reached for PMTCT.
The results on perceptions and use of the NVP pack also indicated a high compliance
at the healthcare facilities with storage of the drug, tracking stock in a register, and
regularly checking on the expiry date. All the nurses felt that the pack was ideal for rural
settings, where nurses cannot control the fact that most women deliver at home because
of the distances they have to travel to reach the nearest healthcare facility and often
also because of the cultural influence of using TBAs or family member assistance during
delivery. The NVP pack could now be dispensed at all clinics doing antenatal care rather
than only at facilities where delivery takes place, as was previously the case (most clinics
do not have delivery services capability). Dispensing the NVP packs at all the clinics also
ensured easier access for more patients due to increased proximity. They felt that with the
introduction of the pack, the mother was able to administer the syrup to the baby within
72 hours after birth, even if her culture forbade her to leave the house until ten days
after the child was born. So far, there has been one documented case of suspected NVP
side effect (vomiting and rash) out of the 385 packs given to pregnant women since the
inception of this intervention in August 2003.
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©HSRC 2005
10. Discussion

This HSRC study was started before the government’s national comprehensive treatment
plan was launched in November 2003, and the MCC’s decision to no longer support the
use of NVP monotherapy for PMTCT in July 2004. The unit dose pack designed in this
study was well received by the nurses for its ease of dispensing; and by the patients for
the ease of storage and particularly the fact that it could be administered to babies who
were delivered at home by TBAs. A particularly short expiry date period was given to
the NVP unit dose in the baby syringe, due to lack of stability studies. The study showed
clearly that the rural/urban divide in the South African healthcare system needs to be
addressed quickly. The use of NVP, which was widely proclaimed as the most practical
intervention (one dose to the mother in labour and one dose to the baby) in developing
countries, has proven the contrary in rural settings with infrastructural and human
resources constraints.
The relevance of this study has become more important after the MCC’s pronouncements
about not supporting the NVP monotherapy for PMTCT. Combination therapy for
PMTCT is known to be more efficacious and to decrease resistance, but may also
pose an even bigger concern with regard to dispensing, administering and adhering
to multiple doses. This makes an even bigger case for designing a PMTCT medication
pack with proper instructions, pictograms and for effective training of the TBAs. The
national treatment guidelines require that patients who have recently received NVP in the
PMTCT programme should not be started on a NVP-containing regimen due to possible
resistance.
It is not unusual for a government programme to differ from its drug regulatory authority,
or in some cases partially implementing or modifying decisions to meet the needs or
demands of a public health programme. The drug regulatory authority’s mandate is to
ensure that drugs used in the country are of good quality, safe and efficacious. The
setback for the government was that there was no system in place to monitor and report
on efficacy (how many children were born and stayed negative) and resistance in the
18 pilot sites. The HIV and AIDS Directorate of the National Department of Health is
currently consulting scientists and public health practitioners on how best to address
the issue of NVP

vs. combination therapy for PMTCT. The adoption and implementation
of the national comprehensive treatment plan ensures that several antiretroviral drugs
will be available in the public sector and are on the Essential Drug List. This makes a
combination therapy for PMTCT very feasible. With the availability of ARVs in the public
sector, the uptake of pregnant women in the antenatal clinics is expected to increase
tremendously. Pregnant women with a CD4 count <more than 200 can now be started on
triple therapy and those with a CD4 count of >200 will only receive therapy for PMTCT.
Currently, NVP monotherapy for PMTCT is still being used in the public sector.
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11. Recommendations
Irrespective of the regimen used, the following recommendations will help to ensure
increased PMTCT uptake, proper dispensing and administration of ARV prophylaxis,
compliance with the national PMTCT guidelines and increased patient outcomes:
• The Department of Health needs to design or create a medication pack specifically
for PMTCT.
• In case government decides to introduce dual or triple therapy, the pack should
contain enough ARVs for the duration of treatment.
• The Department of Health should request or support efforts to make available pre-
measured baby-doses (unit doses) of NVP, irrespective of its use as monotherapy or
combination therapy for PMTCT.
• The patient information leaflet should be in various languages, and include
pictograms in the pack.
• Since TBAs continue to carry out delivery in rural areas, the Department of Health
should train TBAs on PMTCT and ARV administration.
• The Department of Health should train more nurses and pharmacy assistants on how
to monitor and report on the programme, in order to sustain the programme.
• Government should ensure availability of transportation, particularly in rural areas
where many patients live far away from clinics or hospitals.
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12. Conclusion
Healthcare facilities serving rural areas have not entirely benefited from the ‘simple’ NVP
monotherapy intervention, mostly due to logistical problems. This pilot project using the
NVP pack has proved that women who have problems in accessing the health facilities
are able to administer the drug at home and thus comply with PMTCT protocols. This
intervention should therefore be scaled up nationally, to reach all women facing the same
predicament.
The national comprehensive treatment programme has increased patient awareness of
PMTCT, availability of treatment for mother and child, hope for a better quality of life
and definitely patient uptake of PMTCT interventions, particularly at antenatal clinics. The
MCC’s decision not to support the use of monotherapy of NVP for PMTCT has caused
a stir and confusion among healthcare providers and patients alike. The Directorate of
HIV and AIDS in the National Department of Health therefore, urgently needs to make
a decision on the best therapy for PMTCT, and to engage drug manufacturers or use
alternative approaches for easy packing and dispensing
. Crucial issues that must be borne
in mind include the necessity of developing PMTCT doses that can be self-administered,
the need to train TBAs, the need for increased healthcare staff in rural areas and the need
to provide transportation.
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How Practical is the Use of NVP for Reducing HIV Transmission from
Mother to Child (PMTCT) in a Rural Under-resourced Setting?
The Case of Qaukeni district in the Eastern Cape Province, South
Africa
Photo Credit: Hugh Rigby/JHUCCP
QUESTIONNAIRE FOR HEALTHCARE PROVIDERS
BY
APPENDIX