National Guidelines

For
Prevention of Parent-to-Child Transmission (PPTCT)








JUNE 2012











National AIDS Control Organisation, India

With support from

WHO, UNICEF, UNAIDS











Foreword & Acknowledgements







































Xxxx
DG NACO









Contents
Abbreviations ................................................................................................................................. 6
Chapter 1.Introduction ................................................................................................................. 8
Chapter 2. PPTCT Policy, Essential Package and Guiding Principles .................................. 10
2.1 The overall goals of the PPTCT programme .......................................................... 10
Goals of PPTCT programme are: ................................................................................. 10
2.2 The essential package of services under the PPTCT programme ........................... 11
Figure 1: Essential package of PPTCT services ............................................... 11
Figure 2: Components of PPTCT Programme .................................................. 12
2.3 Guiding principles for use of ARV drugs in PPTCT ......................................... 13
Chapter 3. ICTC level roles and responsibilities ...................................................................... 16
3.1 Overview ............................................................................................................ 16
3.2 General Principles .............................................................................................. 16
Chapter 4. PPTCT services under NACP ................................................................................. 18
4.1 Existing facilities ..................................................................................................................... 18
Under the National AIDS Control Programme, various HIV related services are provided through
public and private health providers depending on the programme need and the availability of
health infrastructure, human resource and their expertise ............................................................. 18
Chapter 5. Care and assessment of HIV infected pregnant women ....................................... 21
5.1 Care during the antenatal period ........................................................................ 21
Table 1: Clinical and immunologic evaluation of HIV infected pregnant women
................................................................................................................... 21
5.2 Initial assessment ................................................................................................ 22
5.3 Criteria for ART initiation .................................................................................. 23
5.4 Indications for Co-trimozaxole prophylactic therapy (CPT) in pregnancy ........ 24
Figure 5: Starting co-trimoxazole in pregnancy ............................................... 24
Chapter 6. HIV Infected Pregnant women requiring ART for her own health .................... 25
6.1 HIV Infected Pregnant women newly initiating ART ....................................... 25
6.2 Principles of management .................................................................................. 25
6.2.1For HIV-infected pregnant women who require ART for their own health:
................................................................................................................... 25
6.2.2Choice of ART Regimen for HIV-infected pregnant women ..................... 25
6.2.3Safety of Efavirenz (EFV) in pregnant women ......................................... 26
6.3 ART regimen for pregnant women having prior exposure to NNRTI for PPTCT ....... 26
6.4 Pregnant women already receiving ART ........................................................... 26
6.5 Clinical and laboratory monitoring of pregnant women receiving ART ........... 27
Table 2: Recommended clinical and laboratory follow-up of pregnant women
receiving ART ............................................................................................ 28
6.6 ARV Prophylaxis for Infants born to mothers receiving lifelong ART ............. 29
Table 3: Dose and duration of infant daily NVP prophylaxis ........................... 29
Chapter 7. PPTCT regimen for pregnant women with CD4 > 350 cells/mm
3
....................... 30
7.1 When to start Maternal Triple ARV Prophylaxis : As Early as 14 weeks of
gestation ............................................................................................................. 31
7.2 ARV prophylaxis for pregnant women who have received PPTCT prophylaxis
in the previous pregnancy .................................................................................. 31




Table 4: Triple ARV prophylaxis for pregnant women not needing ART for their
own health ................................................................................................. 32
7.3 Clinical and laboratory monitoring of pregnant women receiving ARV
prophylaxis ......................................................................................................... 32
7.4 ARV prophylaxis for infants born to mothers receiving ARV prophylaxis ........... 32
7.5 Clinical and laboratory monitoring for infants receiving NVP prophylaxis ........... 33
Chapter 8. Interventions for women diagnosed with HIV infection in labour and
postpartum........................................................................................................ 34
8.1 Maternal ARV prophylaxis for women presenting in active labour ..................... 36
Table 5: ARV prophylaxis for pregnant women presenting in active labour with
no prior ARV prophylaxis ......................................................................... 37
8.2 Clinical and immunologic evaluation of HIV infected pregnant women
presenting in active labour ................................................................................. 37
8.3 ARV prophylaxis for infants born to women presenting in active labour ......... 37
8.4 ARV prophylaxis for infants born to women who did not receive any ARV
prophylaxis for PPTCT ...................................................................................... 38
Chapter 9. Special Considerations ............................................................................................. 39
9.1 Pregnant women with active TB ........................................................................ 39
9.2 Pregnant women with HIV-2 infection .............................................................. 39
9.3 Pregnant women with hepatitis B or hepatitis C virus coinfection ........................ 40
Chapter 10. Labour and delivery in the HIV infected pregnant women .............................. 42
10.1 Intrapartum Management ................................................................................... 42
10.2 Intrapartum Antiretroviral Prophylaxis .............................................................. 42
10.3 Special circumstances: Caesarean section .......................................................... 42
10.4 False labour ........................................................................................................... 43
10.5 Safer delivery techniques ................................................................................... 43
Chapter 11. Care during the postnatal period .......................................................................... 45
11.1 The postpartum period ....................................................................................... 45
11.2 Screening for depression postpartum .................................................................... 46
11.3 Counsel and follow-up mother-baby (m-b) pairs after discharge ...................... 47
Chapter 12. Infant feeding practice ........................................................................................... 49
Figure 7: Recommendations for infant feeding in HIV exposed and infected
infants < 6 months of age ......................................................................... 49
Figure 8: AFASS criteria for Exclusive Replacement Feeding ......................... 50
12.1 Principles of infant feeding for HIV infected pregnant women ........................... 50
Chart 2: Exclusive replacement feeding (ERF) ................................................. 53
Chart 3: Antiretroviral prophylaxis for women presenting directly in labour,
immediately postpartum and their infants, including infant feeding options
................................................................................................................... 53
Chapter 13. Care and follow-up of HIV exposed infants..54
13.1 During the first post-delivery visit at 6 weeks/first immunization visit: ............ 54
The activities which will be conducted at each visit are shown below: .............. 55
Table 6 : Activities at each follow up visit for HIV exposed infants and children
< 18 months .............................................................................................. 55
13.2 Confirmation of HIV status in HIV exposed infants should be done at 18
months, regardless of earlier diagnosis .............................................................. 55





Chapter 14. Essential Gynaecologic care for HIV infected pregnant women ........................ 57
14.1 Cervical screening .............................................................................................. 57
14.2 Family planning and birth-spacing ..................................................................... 57
Annex 1: Guidelines for rolling out NACP and NRHM Convergence plan in the
states. No. X-19020/17/2009-NACP(IEC) , 10 August 2010 .................... 60
Annex 2: Dosing schedules for Triple ARV prophylaxis for pregnant women .. 71
Annex 3 : ARV prophylaxis for pregnant women presenting in active labour
with no prior ARV prophylaxis ................................................................. 71
Annex 4: Infant NVP prophylaxis dosing ........................................................... 71
Annex 5: WHO Clinical Staging for adults and adolescents ............................. 72
Annex 6: Grading of selected clinical and laboratory toxicities (Reference:
WHO 2010 Guidelines for ART in adults and adolescents) ..................... 74
Annex 7 : Postpartum depression screening tool the Edinburgh scale .......... 77
Annex 8: Comparing effectiveness of family planning methods ........................ 79
Annex 9: Flowchart on Counselling mothers and their families on infant feeding
options 0-6 months of age......................................................................................80





Abbreviations

3TC Lamivudine
ANC Antenatal Care
AIDS Acquired Immune Deficiency Syndrome
ALT Alanine Aminotransferase
ART Antiretroviral Therapy
ARV Antiretroviral
ARSH Adolescent Reproductive & Sexual Health
AZT Zidovudine
BBA Born Before Arrival (to delivery unit)
CPT Cotrimoxazole Prophylactic Therapy
DBS Dry Blood Spot
DNA Deoxyribonucleic Acid
D4T Stavudine
EBF Exclusive Breastfeeding
EID Early Infant Diagnosis
ERF Exclusive Replacement Feeding
EFV Efavirenz
EPI Expanded Programme on Immunisation
HBV Hepatitis B virus
HCT HIV Counselling and Testing
HCV Hepatitis C virus
HIV Human Immunodeficiency virus
ICF Intensified case finding of TB
ICTC Integrated counseling and testing centres
IMNCI Integrated Management of Childhood and Neonatal Illness
IUD Intrauterine contraceptive Devices
LPV/r Lopinovir/ritonavir
MCH Maternal and Child Health
MTCT Mother-to-Child Transmission of HIV
NACO National AIDS Control Organisation
NRHM National Rural Health Mission
NVP Nevirapine
OIs Opportunistic Infections
PEP Post-Exposure Prophylaxis
PCP Pneumocystis jiroveci Pneumonia
PCR Polymerase Chain Reaction
PPTCT Prevention of Parent-to-Child Transmission of HIV
PP Postpartum
RF Replacement Feeding
RCH Reproductive Child Health
sdNVP Single-Dose Nevirapine
SRH Sexual and Reproductive Health
TB Tuberculosis




TDF Tenofovir
ULN Upper limit of normal
UNAIDS United Nations Programme on HIV/AIDS
UNICEF United Nations Childrens Emergency Fund
VCT Voluntary Counselling and Testing
WBS Whole Blood Sample
WHO World Health Organisation
WBFPT Whole Blood Finger Prick Test



8
Chapter 1. Introduction

There are 2.39 million people living with HIV (PLHIV) according to latest HIV estimations
(2010) and the national adult HIV prevalence is 0.31%. Of these, women constitute 39%
of all PLHIV while 4.4% are children. By Dec2011, 99,000 HIV positive children have
been registered under the antiretroviral therapy (ART) programme, and 28,225 are
receiving free ART. There has been a significant scale up of HIV counseling & testing,
PPTCT and ART services across the country over last five years. Between 2004 and
2011, the number of pregnant women tested annually under the Prevention of Parent-
To-Child Transmission (PPTCT) programme increased from 0.8 million to 6.6 million and
reach of the services has expanded to the rural areas to a large extent. Concurrently,
there has also been a significant decentralization and scale-up of the ART services, with
5,16,412 persons receiving free ART across the country through 355 ART centers and
735 Link-ART centers (LAC) as on December 2011.

Mother-to-child transmission of HIV is a major route of new HIV infections in children.
However, out of an estimated 27 million annual pregnancies in India, only about attend
health services for skilled care during childbirth. Of those who avail health services, 6.6
million pregnant women received HIV counseling and testing in 2010. To enhance this
coverage, in July 2010 a joint directive from the National AIDS Control Programme
(NACP) and the National Rural Health Mission (NRHM) regarding convergence of the
two programme components was issued, explicitly stating that universal HIV screening
should be included as an integrated component of routine ANC check-up. The objective
was to ensure that pregnant women who get diagnosed with HIV would be linked to HIV
services for their own health as well as to ensure prevention of HIV transmission to
newborn babies under the PPTCT programme. Therefore, it has increased and the
numbers of ANCs counseled and tested for HIV until March 2012 has risen to 85,63,104.

In the absence of any intervention, a substantial proportion of children born to women
living with HIV, acquire HIV infection from their mother either during pregnancy, labour
and delivery or through breastfeeding. Without any intervention, the risk of transmission
from HIV infected pregnant women to their children is estimated to be around 20-45%.
Use of antiretroviral (ARV) drugs has been shown to be quite effective in preventing this
transmission.

Use of single dose Nevirapine (sd-NVP) at the onset of labour significantly reduces peri-
partum HIV transmission. However, it is less effective than other available ARV
prophylactic regimens and it does not reduce risk of HIV transmission during the ante-
natal or breastfeeding periods. Further, it also adds to the risk of acquiring drug
resistance to non-nucleoside reverse transcriptase inhibitor (NNRTI).

In the last few years, new evidence on ARV prophylaxis regimens to prevent HIV
transmission from mother-to-child and the optimal timing for ART initiation has been
accumulated which clearly shows that;

Earlier initiation of ART is associated with improved survival and reduced HIV-
related morbidity. In pregnant women, the earlier initiation of ART will not only
benefit maternal health, but will also have a significant impact on mother to child



9
transmission of HIV. Women with more advanced HIV infection (CD4 < 350
cells/mm
3
) account for more than 75% of the HIV transmission to their child.

Longer ARV prophylactic regimen for PPTCT, started earlier during pregnancy
have more benefit in preventing HIV transmission

Extended ARV prophylaxis to mothers and/or infants during the breastfeeding
period will significantly prevent transmission through breastfeeding period.

These updated national guidelines provide a platform to work towards the goal of
significantly reducing mother-to-child transmission, new paediatric HIV infections and
improving HIV-free child survival in India. These recommendations have the potential to
reduce the risk of mother to child transmission to less than 5% in breastfeeding
populations and less than 2% in non-breast feeding populations. The wider
implementation of these guidelines will also help eliminating the goals of new HIV
infections among children





10
Chapter 2. PPTCT Policy, Essential Package and Guiding
Principles

2.1 The overall goals of the PPTCT programme

In line with WHO standards for a comprehensive strategy, the national PPTCT
programme recognizes the 4 elements integral to preventing HIV transmission among
women and children. These include:

Prong 1: Primary prevention of HIV, especially among women of childbearing age
Prong 2: Preventing unintended pregnancies among women living with HIV
Prong 3: Prevent HIV transmission from pregnant women infected with HIV to their child
Prong 4: Provide care, support and treatment to women living with HIV, her children and
family









The national PPTCT programme adopts a public health approach to provide these
services to pregnant women and their children. This approach seeks to ensure equitable
access to high-quality PPTCT services at the population level while taking into account
what is feasible on a large-scale with available health infrastructure, human and financial
resources.

Goals of PPTCT programme are:

Primary prevention of HIV, especially among women in child-bearing age
Integration of PPTCT interventions with general health services such as basic
antenatal care (ANC), sexual reproductive health and family planning, children and
Adolescent Reproductive and Sexual Health (ARSH), TB and STI/RTI services.
Strengthening postnatal care of the HIV-infected mother and her exposed infant
Provide the essential package of PPTCT services (see Figure 1 below)




Prevention of
HIV in women
in child bearing
age

Prevention of
unintended
pregnancies in
HIV
Prevention of
HIV
transmission
from HIV
infected pregnant
women to infants
Provision of care,
treatment and
support to mothers
living with HIV,
their children and
families



11
2.2 The essential package of services under the PPTCT programme

The PPTCT services provide access to all pregnant women for HIV diagnostic,
prevention, care and treatment services. As such, the key goal is to ensure the
integrated delivery of PPTCT services with existing Reproductive & Child Health (RCH)
programme.
Figure 1: Essential package of PPTCT Services






































The Essential package of PPTCT Services includes:

o Routine offer of HIV counseling and testing to all pregnant women attending
antenatal care, with opt out option. (Group / Individual counselling)

o Ensure involvement of spouse and other family members. Move from an ANC
Centric to a Family Centric approach

o Provide appropriate ART or ARV prophylactic regimen to the HIV infected
pregnant women based on the medical assessment, CD4 Count and Clinical
Staging

o Promote institutional deliveries of all HIV infected pregnant women (ANMs /
ASHAs, Community Workers to accompany to institutions; reduction of stigma
and discrimination amongst health care providers through capacity building)

o Provision of care for associated conditions (STI/RTI, TB & Opportunistic Infections
(OIs))

o Provide nutrition counselling and psychosocial support for HIV infected pregnant
women (Linkages with ANM, ASHAs to advise them on the right foods to take and
to go to Anganwadi Centres for nutritional support and Networks of Positive
People for peer counselling and psycho-social support)

o Provide counselling and support for initiation of exclusive breast feeds within an
hour of delivery as the preferred OptionI. Only a small number of babies born to
HIV infected mothers who have serious illness or have died and a few reluctant
mothers (who at their own risk despite counselling not to breast-feed but adopt
exclusive replacement feeding

o Provide antiretroviral prophylaxis to infants

o Integrate follow-up of HIV-exposed infants into routine healthcare services
including immunisation
o Ensure initiation of Co-trimoxazole, Prophylactic Therapy (CPT) and early infant
diagnosis (EID) using HIV-DNA PCR at 6 weeks of age onwards as per the
National EID guidelines



12
Figure 2: Components of PPTCT Programme


HIV Infected Pregnant Women

Antenatal Care (ensure atleast 4 times) Monthly ART/ARV
prophylaxis at ART Centres
Counseling on choices of continuation or medical termination of
pregnancy (MTP) to undertake within the first 3 months of
pregnancy
Screening for TB and other OIs
Screening and treatment for STIs
WHO clinical staging and CD4 testing
Counseling on positive living, safe delivery, birth-planning and
infant feeding options
Referral to ART Center
Couple and safe sex counseling and HIV testing of spouse and
other living children
Family Planning Services
Provide ART or ARV prophylactic regimen based on CD4 count
and / or clinical staging
Infant feeding support through home visits
Psycho-social support through follow-up counseling, home
visits and support groups
Nutrition counseling and linkages to Government/other Nutrition
programmes
Post partum ARV prophylaxis for mother
Offer of HIV Counseling and Testing services to all
pregnant women
HIV Negative Pregnant
Women

Safe sex counseling
Couple counseling
Linkages to family
planning services
Free condoms
Behaviour change
communication for
high risk women and
her partner
Repeat HIV testing,
considering window,
period if spouse is
positive or s/he have
high risk behaviour
Infant feeding and
nutritional counselling

HIV Exposed Infant
Exclusive breast feeds upto 6 months (preferred Option-I
WHO/NACO Guidelines 2010-11) and continued breast feeds
in addition to complement feeds after 6 months upto 1 year for
EID negative babies and upto 2 years for EID positive babies
receiving Paediatric ART
Post partum ARV prophylaxis for infant for 6 weeks
Early infant diagnosis (EID) at 6 weeks of age; repeat testing at
6 months, 12 months & 6 weeks after cessation of breast feeds
Co-trimoxazole prophylaxis from 6 weeks of age
Growth and nutrition monitoring
Immunizations and routine infant care
Gradual weaning after 6 months and introduction of
complementary feeds from 6 months onwards to nutritional
support
HIV care and ART for infants and children diagnosed as HIV
positive
Confirmation of HIV status of all babies at 18 months after
doing 3 Rapid Tests



13
2.3 Guiding principles for use of ARV drugs in PPTCT

The guiding principles for the use of ARV drugs to prevent HIV transmission from
mother-to-child are:

HIV infected pregnant women, in need of ARV drugs for their own health should
receive life-long ART
HIV infected pregnant women, not in need of ART for their own health, should
receive ARV Prophylaxis
The ARV Prophylaxis to be used are effective in reducing vertical HIV
transmission, minimizing side effects for mother and infants and preserving
future treatment options
Post-partum ARV based interventions to mother and/or child are aimed at
improving HIV-free child survival by reducing HIV transmission through breast
feeding
HIV exposed infants should be followed-up and managed as per the National
Guidelines on Care of HIV exposed infants and children

In India, the PPTCT programme has been in place for many years, and the
recommended ARV prophylaxis was a single dose Nevirapine to mother during labour
and to the infant at birth. However, with evolving evidence, the National technical
guidelines have been revised and, it is recommended that:

1. All HIV infected pregnant women needing ART for their own health should
receive complete ART as per the National guidelines.
2. Women not needing ART for their own health should receive ARV prophylaxis
with the more efficacious PPTCT regimen
3. HIV infected pregnant women should preferably be initiated on ART/ARV
Prophylaxis. The treatment remains same irrespective of CD4 count, but CD4
count is essential to determine duration of ART / ARV (life-long ART vs ARV upto
one week after stopping breast feeding)




14


The summary of the technical guidelines and options for the more efficacious
PPTCT regimen is as under:






















*: To Determine ART eligibilitythe treatment will be the same irrespective of CD4
count or clinical stage at baseline. CD4 count is necessary to guide duration (life-long
(ART) or during breastfeeding) of ARVs.
Establish HIV Status of pregnant women
Known HIV infected case
and already receiving ART
HIV test positive HIV test
negative
Continue ART
Initiate ARV (TDF+3TC+EFV) & *determine
ART eligibility after collecting sample for
CD4 ART eligibility
Repeat HIV test (as
per guidelines)
*Eligible for
ART
Not eligible for ART, requires ARV prophylaxis
Preferred
regimen:
TDF+3TC+EFV
TDF+3TC+EFV prophylaxis starting from
14 weeks of gestation (or as early as
possible thereafter) but not before 14 weeks
Continue ART
Continue the same ARV Prophylaxis
Exclusive Breast Feeds or
Exclusive Replacement
Feeding
Mother: Continue ART
Infant: Daily NVP from birth
until 6 weeks of age, then stop
(irrespective of choice of
infant feeding)
Infant on Exclusive
Breastfeeding (EBF)
Mother: Continue same ARV
Prophylaxis until 1 week after
breastfeeding has stopped tail of
TDF+3TC
Infant: Daily Sy. NVP from birth until 6
weeks, then stop
Initiate CPT at 6 weeks
Infant on Exclusive Replacement
Feeding (ERF)
Mother: Stop ARV Prophylaxis after
delivery; provide tail for 7 days
Infant: Daily NVP from birth for 6
weeks, then stop.
Initiate CPT
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15

Care for the HIV-infected mother-baby pair begins on the first contact with health
services during the antenatal period. Establishing a relationship with the HIV infected
pregnant woman is fundamental to providing a continuum of care involving prevention,
care, support, and treatment for the mother and child. This requires the involvement of
the clinical and para - medical team at the health facility the Obstetrician,
Paediatrician, Physician, Medical Officer, Nurse, ANM, ASHAs, Lab Technicians,
Counselors and Outreach Workers. District Positive Networks, Local Community Based
Organizations and Self-Help Groups (SHPs) may help support the HIV infected mother
and her family.





16

Chapter 3. ICTC level roles and responsibilities
KNOW THE HIV STATUS COUNSELLING AND TESTING
3.1 Overview

The first step for all pregnant women attending health services is to know their HIV
status as part of the routine antenatal screening blood tests. As per national directive
jointly issued by both NRHM and NACO
1
(Annex 1)
Four typical scenarios where pregnant women may attend for counseling and testing
services include:
Women attending antenatal clinics
Pregnant spouse of HIV-positive men, or those with high risk behaviours
Pregnant women screened at the sub centre level by ANM (whole blood finger
prick test)
Women arriving directly-in-labour (un-booked cases), who require a HIV
screening

3.2 General Principles

Informed consent as per guidelines is to be taken for all ANCs
Counseling should be done to inform all pregnant women about the antenatal routine
screening tests Haemoglobin (Hb%), Urine albumin/sugar, VDRL/RPR, blood
grouping and typing and HIV and the benefits of testing.
Nurse/counselors may provide information on the antenatal screening
comprehensive package including HIV testing through both individual counseling and
group counseling information sessions.
Pregnant Women who opt-out of HIV testing should be offered repeat counseling to
explore the reasons of this choice, address any misunderstandings and encourage
her to reconsider her decision. These women should be offered routine HIV testing at
each subsequent clinic visit.
Post-test counseling for all pregnant women is very important so as to educate those
with negative tests to remain uninfected; while for those with confirmed HIV positive
tests - further counseling, support and referrals to care & treatment needs to be done
Pregnant women who have been referred by ANM after whole blood screening test
must undergo pre-test counseling and follow the usual HIV testing protocol similar to
the regular antenatal cases at the stand alone ICTCs after confirmatory test
Disclosure of HIV status is to be done only at stand-alone ICTCs after appropriate
confirmatory testing as per laboratory guidelines, and by trained health staff (MO,
nurse or counselor)
All pregnant women referred to other HIV services including ART Center, should be
tracked to ensure they actually reached the services, and have been registered at
the respective centers
Partner/spouse and family (other children) testing of HIV is to be done as per ICTC
guidelines

1
Guidelines for rolling out NACP and NRHM Convergence plan in the state. No X-19020/17/2009-
NACP(IEC) , 10 August 2010



17
Male (husband) involvement in the pregnancy and PPTCT interventions is to be
encouraged e.g. couple counseling for mutual psycho-social support etc.

Figure 3: Counseling and testing all pregnant women in the ante-natal
clinic/ward

Group/individual counselling sessions
Offer HIV test
Agree to test Opt out / Refuse
test
HIV
Negative
HIV
Positive
Repeat
Counseling
Offer HIV test at
each subsequent
visit
Post-test
counseling,
information,
support
Refer to ART center, CD4 test,
TB screening and clinical staging

** Ensure all referred pregnant
women actually reach the ART
center and are started on ARV
prophylaxis / ART without
delay or waiting for CD4 and
other laboratory reports **




18
Chapter 4. PPTCT services under NACP
4.1 Existing facilities
Under the National AIDS Control Programme, various HIV related services are provided
through public and private health providers depending on the programme need and the
availability of health infrastructure, human resource and their expertise

The PPTCT services are provided through the Integrated Counseling and Testing Centres
(ICTCs) which are of the following types:
1. Stand Alone ICTCs: These are HIV counselling and testing facilities supported by
NACP in the form of staff and all the necessary logistic support. These centres
perform confirmatory tests for HIV. Typically these centres are located at Medical
Colleges, District Hospitals, Taluk Hospitals and Community Health Centres
2. Facility ICTCs (FICTCs): These are facilities where the staff (Staff Nurses and
Lab Technicians) from existing health facilities are trained in counselling and
testing, and service delivery is ensured with provision of HIV testing Kits from the
NACP. These centres perform only screening test for HIV using Rapid HIV test kits
and any client testing positive on screening is referred to stand-alone ICTC for
confirmation. Typically these centres are located at PHCs. The private/NGO
facilities also function in this model
3. Screening Centres: These are health facilities where the Auxillary Nurse Midwives
(Now called Jr. Health Assistant (F)) from existing health facilities are trained in
counseling and screening for HIV through whole blood finger prick test. These
centres perform only screening test for HIV through whole blood finger prick test
(WBFPT) and any client testing positive through this screening is referred to Stand-
Alone ICTCs for confirmation. Typically, these centres are located at PHCs and
Sub Centres

The 5 structure of public health system and HIV related services at different levels is
detailed below in Table 0

Levelofhealth
infrastructure
AvailableHIVFacilities AvailableHIVServices
MedicalCollege
StandAloneICTC
ARTCentre
CentreofExcellence(CoE)inHIVcare
CentreofExcellence(CoE)Pediatricin
HIVcare

ICTC,PPTCT,HIVTB,ART(Paed.
ART),OI,STI,EID
DistrictHospital
StandAloneICTC
ARTCentre
LinkARTCentre

ICTC,PPTCT,HIVTB,ART,OI,STI,
EIDservices,Linkagesto
DLNs/DICforpsychosocial
supportandservices



19
Subdistrict/
CommunityHealth
Centre
StandAloneICTC
FacilityICTC
ART/LinkARTCentre

ICTC/HIVScreening,PPTCT,HIV
TB,ART,OI,STI,DIC,EIDServices
PrimaryHealth
Centres/
24x7PHCs
StandAloneICTCs
FacilityICTC
HIVScreening,PPTCT,HIVTB,
STI
SubCentres
ScreeningCentre(WholeBloodFinger
PrickTest)
HIVScreeningTest

4.2. Continuum of care under PPTCT:

With the advent of New PPTCT guidelines that recommend use of the more efficacious
regimes, it is important to consider Prong-3 of National PPTCT programme as a
continuum of interventions rather than a one-time activity. This requires close
co-ordination between various implementing components for PPTCT-ART linkage, Early
Infant Diagnosis (EID), Paediatric ART services

The continuum of care involves the following steps

1. Increasing uptake of PPTCT services by pregnant women
2. Counseling and Testing of pregnant women as an integral part of ANC
Comprehensive Services package
3. Detection of HIV infected pregnant women
4. Linking HIV infected pregnant women with Care, Support and Treatment services
5. Initiating HIV infected pregnant women who require ART for their own health with
CD4<350 and WHO Stage III and IV irrespective of CD4 count on ART as per
guidelines
6. Initiating ARV Prophylaxis for all HIV infected pregnant women after doing CD4
count at the earliest to decide on the duration of treatment, birth planning and
institutional delivery of identified HIV infected pregnant women
7. Screening emergency labour room deliveries (un-booked cases) for HIV. If positive
providing ART (Sd Nevirapine at onset of labour. AZT after checking Hb% and
ensuring Hb > 9gms. + 3CT 12 hourly till 7
th
post-partum day); Sending sample for
CD4 testing and initiating ART as soon as possible if eligible.
8. Linking of HIV infected pregnant women identified through emergency labour room
care services to Care, Support and Treatment services
9. Provision of Syrup Nevirapine for the new born infant from birth till 6 weeks of age.
At the end of 6 weeks CPT should be initiated and baby to be linked to the EID
programme. CPT continued to baby from 6 weeks upto 18 months until the
confirmatory test of the baby is done using all 3 Rapid Tests
10. If the infant is detected positive in EID programme (DBS+WBS), then ensure
initiation of Pediatric ART for the baby through ART centre as per ART guidelines
11. Follow-up of HIV infected mother and baby. Follow-up of HIV infected mother and
baby until breast feeding period is over .After 6 weeks of cessation of breast-feeds
do Rapid test. If positive, do DBS and then WBS. If positive, start Paediatric ART.
12. Confirmation of diagnosis of child through all 3 anti-body tests at ICTCs at 18
months of age
13. No DBS and WBS tests to be done at >18 months or later



20


PRONG 3: CONTINUUM OF CARE FOR HIV INFECTED PREGNANT WOMEN








Antenatal PPTCT
services
Intra-natal PPTCT
services
ARV Prophylaxis
ART >350 CD4
count
Post-natal PPTCT
services
Links with ART services
and CD4 testing
Links with ART services
and CD4 testing
Links with ART services, CD4
testing, EID & pediatric ART
Initiation
Counseling and testing in all phases; encourage institutional deliveries



21
Chapter 5. Care and assessment of HIV infected pregnant women

5.1 Care during the antenatal period

HIV infected pregnant women may present to ICTC and ART centre at various stages of
pregnancy (Table 1). In each case appropriate medical and CD4 assessment should be
performed as soon as possible, baseline medical evaluation and CD4 cell count
assessment should be performed as soon as possible to guide ART or ARV prophylaxis
eligibility:

Pregnant Women who are detected to be HIV-positive during antenatal care should
undergo CD4 test and clinical assessment and should be initiated on ART
(TDF+3TC+EFV). The initiation of ART should not be delayed for want of CD4 test
results
HIV-infected pregnant women who are already registered in the ART center
(irrespective of whether taking ART or not) - need to have a recent CD4 count (if
CD4 Counts was done more than 3 months back) and repeat CD4 test be done as
per ART guidelines.
Pregnant women who are detected to be HIV-positive during active labour should
be initiated on intra-partum ARV prophylaxis and also be referred for confirmation
of HIV status and linked for CD4 count assessment if positive.

Table 1: Clinical and immunologic evaluation of HIV infected pregnant women

Category Initial Clinical and Immunologic Evaluation
Pregnant women detected to be
HIV-infected during routine
antenatal care
Assess WHO clinical stage and plan for CD4 cell
count when client is seen during the post-test
counseling visit and initiate ART/prophylaxis while
awaiting CD4 test results.
Women with known HIV infection
who are already in HIV care
(though not yet on ART) who
become pregnant
CD4 count testing, if last CD4 assessment was 3
months ago to determine ART eligibility
Assess WHO clinical stage
Initiate ART/ARV prophylaxis at 14 weeks or
beyond
Women with known HIV infection
already on ART who become
pregnant
Evaluate current ART regimen, and make
substitutions as necessary (see section 5.3)
Undertake CD4 count testing as per national
guidelines

Pregnant women with unknown
HIV status presenting in active
labour, detected HIV positive
through whole blood finger prick
test
Provide appropriate intra-partum PPTCT
prophylaxis (see section 7.1)
Confirmatory HIV test, as soon as possible and
sample collected and taken for CD4 testing
CD4 count and WHO clinical stage assessment if
HIV infection confirmed
Postpartum women detected to be
HIV positive after delivery of baby
Confirm HIV status



22
(e.g. home delivery) Assess WHO clinical stage and CD4 cell count and
decide on ART
Provide infant with the appropriate infant
prophylaxis, CPT and other requirements as per
guidelines on care of HIV exposed child (see
section 7.4)

HIV infected pregnant women require joint management from both the HIV team (for her
HIV condition) and the Obstetric team (for successful outcome of pregnancy). HIV infected
pregnant women require all components of good antenatal care including iron-folate
supplementation, anaemia management, baseline CD4 count for ART eligibility, provision
of ARV drugs for prophylaxis or treatment, screening of TB, prevention and management
of OIs, STI treatment, improved Obstetric practices especially during labour and delivery,
ARVs during labour and post-delivery, counseling for infant feeding options, postnatal
care, follow-up, family planning and contraception. Postpartum care and follow-up for the
well-being of mother and infant, as well as adherence to the ARV prophylaxis and other
care, to prevent HIV transmission during breastfeeding is important.








5.2 Initial assessment

All HIV infected pregnant women should have the routine ante-natal care for the well-being
of her baby including:

Atleast 4 ANC check-up during pregnancy (registration and 1
st
check-up within 12
weeks, between 14-26 weeks, between 28-32 weeks and between 36-40 weeks)
as per RCH/NACP guidelines
History, physical and abdominal examination
Ante-natal routine blood screening:
o Hb, blood group & Rh typing, urine routine at 1
st
visit; including tests for
syphilis, Hepatitis B and HIV
o Urine routine to be done at all visits, and Hb% to be re-checked at the
3
rd
visit at 28-32 weeks gestation.
2 doses of Tetanus Toxoid (TT) to prevent maternal and newborn tetanus:
o First dose: at ANC registration
o Second dose: 4-6 weeks after the first dose, preferably at least one
month before the expected date of delivery (EDD)
Antenatal drug supplementation:
o IFA tablet (100mg iron + 0.5 mg folic acid) daily for 100 days, after 1
st

trimester to prevent anaemia
o Double the dose if anaemia develops
Counseling on nutrition, rest, warning signs, ART linkages-CD4 testing if HIV
positive and ART/ARV prophylaxis, birth planning, institutional delivery, exclusive
Good antenatal care ensures that pregnancy and delivery:

Is a safe experience for the mother
Builds the foundation for the delivery of a healthy infant.




23
breast-feeding within an hour of delivery , safe sex, HIV-specific advice and
contraception.

From the HIV care aspect for pregnant women, the initial assessment follows standard
adult ART guidelines including:

WHO clinical staging
Clinical screening for TB and STI symptoms:

Screen for TB at each visit: Intensified Case Finding (ICF) as per TB-HIV
guidelines for screening TB in all HIV-infected individuals.
Clinical screening ask for cough (of any duration), cough with
blood in sputum, unexplained fever or weight loss, fatigue, night
sweats, loss of appetite, pleuritic chest pain; lumps/nodes in neck,
armpits, groin, severe back pain (suspect psoas abscess) or
abdominal pain (suspect abdominal lymph nodes enlargement) etc.
The normal weight gain in a normal pregnancy is around 11 kg.
Most of it occurs in the second and third trimester (approximately 5
kg in each trimester), while the first trimester is usually 1-2 kg. A
failure to gain weight should arouse the suspicion for further
evaluation. Weight loss during pregnancy requires detailed
assessment, because it can be a sign of underlying Opportunistic
Infections (OIs) in HIV infected individuals. However, these are
generalized weight gain patterns and should be co-related clinically
and other factors like twin pregnancy, hyperemesis gravidarum
during the first trimester etc.
Screen and treat any STIs: any concurrent STI may increase the risk of HIV
transmission from mother-to-child, and may adversely affect the pregnancy. Treat
STIs according to the national guidelines.
Baseline laboratory investigations as per national adult guidelines
CD4 cell count (baseline)
Women who do not return for results should be actively traced back and
brought to the continuum of care through the help of grass-root level health
functionaries

Initiate adherence counseling, anti-retroviral prophylaxis or treatment and. It is re-

emphasized that the initiation of appropriate prophylaxis or ART for the pregnant
women should not be withheld for want of the above laboratory investigations and
clinical staging Initiate Co-trimozaxole Prophylaxis Therapy (CPT) if CD4 250
cells/mm
3
Nutritional counseling for the mother: good food, rest and exercise
Adherence to iron-folate and vitamin/mineral supplements
Counsel for regular antenatal check-up and institutional delivery
Counsel for exclusive breast-feeding within an hour of delivery
No MIXED FEEDING under any circumstances
5.3 Criteria for ART initiation

Initiation of ART in pregnant women needs to be done quickly and after adequate
treatment preparedness for adherence to maintain her own health and also against HIV
virus transmission to the unborn baby.



24

In HIV infected pregnant women do not delay ART initiation. The eligibility criteria for
initiating ART in positive pregnant women are as below:

Women with CD4 < 350 cell/mm
3
, irrespective of WHO clinical stage Or WHO
Stage 3 or 4 disease, irrespective of CD4 cell count should receive lifelong ART
for their own health and to reduce the likelihood of transmission HIV from mother-
to-child (see Chapter 6)

Women with CD4 > 350 cells/ mm
3
, and WHO clinical stage 1 or 2 should
receive maternal triple ARV prophylaxis to reduce the risk of transmission of HIV
from mother to child (see Chapter 7)


Figure 4: ART eligibility in pregnant women









5.4 Indications for Co-trimozaxole Prophylactic Therapy (CPT) in
pregnancy

The indications for co-trimozaxole initiation in pregnant women follow that for other adults.
Co-trimoxazole prophylaxis prevents Opportunistic Infections (OIs) such as Pneumocystis
jiroveci pneumonia (PCP), toxoplasmosis, diarrhoea as well as bacterial infections.

Figure 5: Starting co-trimoxazole in pregnancy



Initiate lifelong ART in all pregnant women with confirmed HIV infection
who have either
CD4 cell count < 350 cell/mm
3
, irrespective of WHO clinical stage
Or
WHO stage 3 or 4 disease, irrespective of CD4 cell count
Cotrimoxazole should be started if CD4 count is < 250 cells/mm
3
and
continued through pregnancy, delivery and breast-feeding as per
national guidelines
Ensure that pregnant women take their folate supplements regularly




25
Chapter 6. HIV Infected Pregnant women requiring ART for her own
health

HIV infected pregnant women with CD4 cell count <350 cells/mm
3
or those with WHO
Clinical Stage 3 or 4 HIV disease (irrespective of CD4 count) should receive lifelong ART.
This treatment serves two key purposes: 1) improves health and prolongs survival of the
mother and 2) reduces the risk of HIV transmission from mother-to-child during pregnancy,
labour and delivery, and throughout the breastfeeding period.

6.1 HIV Infected Pregnant women newly initiating ART

HIV-infected pregnant women who are found eligible for ART should be referred for
routine baseline ART clinical and laboratory evaluation as per national guidelines for
ART in adults and adolescents. The absence or delay of laboratory investigations
should not prevent the initiation of ART when clinically indicated.


All HIV infected pregnant women should be seen on a priority in the ART
Centre.


6.2 Principles of management
6.2.1 For HIV-infected pregnant women who require ART for their own health:

Start ART as soon as possible and continue ART throughout pregnancy, delivery, and
thereafter
Even if the eligible pregnant women present very late in pregnancy (including those
who present after 36 weeks of gestation) ART should be initiated promptly.

6.2.2 Choice of ART Regimen for HIV-infected pregnant women

There are several regimens recommended for use as first line ART regimens for adults in
India. However, in case of pregnant women requiring ART the recommended first line
regimen is Tenofovir (TDF) (300mgs.) + Lamuvidine (3TC) (300 mgs.) + Efavirenz (EFV)
(600 mgs.)






The recommended first line ART regimen for
HIV infected pregnant women in India is TDF + 3TC + EFV
(If there is no prior exposure to NNRTIs (NVP/EFV))



26
6.2.3 Safety of Efavirenz (EFV) in pregnant women

EFV-based regimen should not be initiated in the first trimester of pregnancy because of
the potential risk of EFV-related teratogenicity. However, EFV can be safely initiated for
women starting ART from the second trimester of pregnancy (14 weeks and beyond). The
national guidelines recommend that ART/ARV prophylaxis for PPTCT should be started
only after 14 weeks of pregnancy.

6.3 ART regimen for pregnant women having prior exposure to NNRTI for PPTCT

A small number of HIV infected pregnant women who require lifelong ART for their own
health have had previous exposure to Sd NVP or EFV for PPTCT prophylaxis in prior
pregnancies, because of the risk of resistance to NNRTI drugs in this population, an
NNRTI-based ART regimen such as TDF/3TC/EFV may not be effective. Thus, these
women will require a protease inhibitor-based ART regimen.

TDF + 3TC + LPV/r (Lopinavir/Ritonavir)

6.4 Pregnant women already receiving ART

Pregnant women who are already receiving ART for their own health, should continue to
receive the same throughout the pregnancy, labour, and post-partum period.

If a pregnancy is recognized during the first trimester in an HIV infected woman
already receiving ART, the regimen should be evaluated for safety to the mother
and foetus.
Pregnant women who are already receiving a NVP-based ART regimen should
continue receiving the ART regimen
Pregnant women who are already receiving EFV-based ART regimen:
o If pregnancy is recognized before 28 days gestation, EFV should be
stopped and substituted with NVP
o If a woman is diagnosed as pregnant after 28 days gestation, EFV should
be continued. There is no indication for abortion/termination of
pregnancy in women exposed to EFV in the first trimester of
pregnancy.

In cases where EFV is substituted with NVP:

Close monitoring for NVP-related symptomatic hepato-toxicity in the first 12 weeks
of therapy is particularly necessary for women who have CD4 cell counts > 250
cells/mm
3
.
When EFV is substituted with NVP, women should immediately commence NVP at
200 mg twice a day. There is no need for a lead-in dose in this case.
In women who cannot tolerate NVP, protease-inhibitor (LPV/r) can be substituted
after expert consultation.




27
6.5 Clinical and laboratory monitoring of pregnant women receiving ART

Clinical and laboratory monitoring of HIV-infected pregnant women on ART should be
done as per national ART guidelines for adults and adolescents.

Key points to note in monitoring ART in pregnant women are:

Look for clinically significant anaemia among HIV-infected pregnant women since
anaemia during pregnancy is common (usually developing around 28-34 weeks of
gestation)
WHO clinical staging will help in monitoring the clinical progress and potential
disease progression
Weight loss is one of the conditions used to determine WHO clinical stage, but can
be difficult to assess in pregnancy. When defining the clinical stage of a pregnant
woman, it is necessary to take into consideration her expected weight gain in
relation to the gestational age of the pregnancy and her potential weight loss from
HIV. (see section 5.2)
ART-related side-effects may overlap with that of common pregnancy conditions
eg. nausea and vomiting. Minor symptoms should be controlled symptomatically
with medicines. Consult the Obstetrician for drugs that are safe for use in
pregnancy
Due to pregnancy-related haemodilution, absolute CD4 cell count decreases
during pregnancy. After delivery, body fluid changes normalize to the non-
pregnant state, and CD4 levels may rise by 50-100 cells/ul. Therefore, a decrease
in absolute CD4 count in a pregnant woman receiving ART in comparison to CD4
values prior to pregnancy may not necessarily indicate immunologic decline and
should be interpreted with caution.

The recommended clinical and laboratory follow-up schedule for pregnant women is
similar to that recommended for non-pregnant adults, and is detailed in Table 2.
Additional assessments of hemoglobin or Liver Function Tests (LFT) should be performed
when warranted by clinical complaints.

HIV care and follow-up of pregnant women should be scheduled to coincide with
their antenatal visits, as far as possible. Document all investigation results in the
RCH (Ante-natal & Child) Card so that the Obstetric team is aware of test results.
Inform patient to ensure that their other health care providers eg. the Obstetric team
is updated on the progress of their HIV care.




28
Table 2: Recommended clinical and laboratory follow-up of pregnant women receiving ART
Assessment Baseline
2
weeks
4
weeks
8
weeks
12
weeks
Every 6
months Comment
Clinical
evaluation

Every month
Adherence
counseling

Every month
Weight

Every month

*Haemoglobin


ALT (LFT)

As and when required
clinically

Urinalysis *
**
**Specifically for TDF-based
regimen. Urinalysis dipsticks
is routinely done in follow up
CD 4 count
Thereafter every 6 months as per guidelines
Blood Sugar*



Blood Urea /
Sr.Creatinine


HBV, HCV
screening

Screening should be
performed in State where
ANCs are being tested
routinely or based on the
risk profile (e.g. IDU
infection through blood
products)
RPR/ VDRL*



* Normally part of standard antenatal routine screening.
A baseline Blood urea and serum creatinine should be undertaken before starting
Tenofovir based regimen, wherever available ( ART/ARV should not be withheld in
pregnant women for want of these baseline investigations, that could be carried over time,
as soon as possible).
Lipid profile and Blood Sugar at every 6 months and one year, if started on LPV/r based
regimen

Table:00. Dosage schedule and associated side-effects with ARV drugs

Name of ARV Dose Side-effects
1 Tenofovir (TDF) 300mg OD Nephrotoxicity, hypophosphetemia
2 Lamivudine (3TC) 300mg OD Very few side effects:



29
Hypersensitivity, rarely Pancreatitis
3 Efavirenz (EFV) 600 mg
Psychiatric problems like hallucinations,
suicidal idiations
4
Lopinavir/Ritonavir
(LPV/r)
400/100 mg BD
Gastro-intestinal disturbance, glucose
intolerance, Lipo-dystrophy and
hyperlipidemia

6.6 ARV Prophylaxis for Infants born to mothers receiving lifelong ART

Infant ARV prophylaxis is required for all infants born to HIV-infected women receiving
ART to further reduce peri-partum and postpartum HIV transmission, in addition to the
protection received from the mother's ART regimen:

Infant ARV prophylaxis provides added protection from early postpartum
transmission, particularly in situations where women started ART late in
pregnancy, have less than optimal adherence to ART and have not achieved full
HIV viral suppression

The infant ARV prophylaxis where mothers are receiving ART is:
o Daily NVP for 6 weeks (i.e., till the first immunization visit for the infant),
regardless of whether the infant is exclusively breastfed or receives
exclusive replacement feeding.
Table 3: Dose and duration of infant daily NVP prophylaxis

Birth Weight NVP daily dose in
milli gram (mg)

NVP daily
dose in milli -
litre (ml.)*

Duration
Birth to 6 weeks:*

Infants with birth weight <
2000 gm




Birth weight 2000 2500
gm

Birth weight more than
2500 gm


2 mg./kg. once
daily. In
consultation with a
pediatrician trained
in HIV care.


10 mg. once daily


15 mg. once daily


0.2 ml./kg.
once daily




1 ml. once a
day

1.5 ml. once a
day

Up to 6 weeks
irrespective of
exclusive
breast feeding
or exclusive
replacement
feeding
* * considering the content of 10 mg. Nevirapine in 1ml. suspension based on WHO
Guidelines





30
Chapter 7. PPTCT regimen for pregnant women with CD4 > 350
cells/mm
3


All HIV-infected pregnant women with CD4 > 350 cells/mm
3
who do not require lifelong
ART for their own health must receive ARV prophylaxis to prevent transmission of HIV to
their infant. The recommended maternal triple ARV prophylaxis regimen is same as
ART regimen i.e. TDF +3TC + EFV. This is the same regimen as the one used to
treat pregnant women who need ART for their own health: TDF + 3TC + EFV. For
high risk pregnancies like PIH, altered renal profile, alternate regimens as per ART
guidelines should be followed.






Figure 6: ARV Prophylaxis for PPTCT




























The recommended regimen for maternal ARV prophylaxis to prevent HIV
transmission from infected mother to child in India is:
TDF + 3TC + EFV
Pregnant Women with CD4>350 cells/mm
3
(i.e. not eligible for ART and requires ARV prophylaxis)
Start from 14 weeks of gestation (or as soon as possible thereafter) but
not before 14 weeks
TDF +3TC +EFV
Continue Regimen
Exclusive Breastfeeding
Mothers: Continue regimen until 1 week after breastfeeding has been
stopped with 7 days tail of TDF +3TC
Infants: Daily NVP from birth for 6 weeks. Then stop
Exclusive Replacement feeding only
Mother: TDF +3TC tail for 7 days after delivery
Infants: Daily NVP from birth for 6 weeks. Then stop P
o
s
t
p
a
r
t
u
m

L
a
b
o
u
r

&

d
e
l
i
v
e
r
y

A
n
t
e
n
a
t
a
l



31
7.1 When to start Maternal Triple ARV Prophylaxis : As Early as 14 weeks
of gestation

Maternal triple ARV prophylaxis should be started as early as 14 weeks of gestation (early
second trimester) or as soon as possible thereafter:

The reason is that HIV viral transmission can occur in utero during the pregnancy
and thus giving ARV drugs earlier during the second trimester reduces the chances
of HIV transmission to the developing foetus.
Women who present very late in pregnancy who do not require ART for their own
health should be started on the same maternal triple ARV prophylaxis as soon as
possible.

7.2 ARV prophylaxis for pregnant women who have received PPTCT
prophylaxis in the previous pregnancy

An increasing number of HIV infected pregnant women who have had previous exposure
to PPTCT prophylaxis are returning for care during their second and third pregnancies. To
prevent this recurrence in them and in other primi-para HIV infected pregnant women a
temporary method of Cu T adoption either PP IUD (Cu-T A-380) to be inserted within 48
hrs of delivery or a regular Cu-T insertion should be undertaken when the baby is brought
at 6 weeks for immunisation, EID and initiation of CPT.

However, PP IUD - Post-partum IUD requires specialised training before the healthcare
personnel undertake the same.

Pregnant women with prior exposure to PPTCT prophylaxis, who do not require ART for
their own health, should receive the recommended maternal triple ARV prophylaxis in this
current pregnancy: TDF+3TC+LPV/r.

Initiation of TDF based triple drug ARV prophylaxis will be done at ART centers, and
hence women should be referred to the nearest ART centre for routine baseline ART
clinical and laboratory evaluation and initiation of ARV prophylaxis. The absence of
laboratory services / laboratory reports should not prevent the initiation of triple ARV
prophylaxis when clinically indicated.


HIV infected pregnant women who have received ARV
Prophylaxis (either Sd NVP ; AZT + 3TC tail for 7 days or
without 7 days tail) during the previous pregnancy, should be
referred to ART Centre for baseline clinical and laboratory
evaluation and receive in the current pregnancy:
TDF + 3TC + LPV/r






32

Table 4: Triple ARV prophylaxis for pregnant women not needing ART for
their own health

Clinical
Scenario
ARV Prophylaxis
and dosing
Antepartum Intra-
partum
Post-partum
1) Pregnant
women
requiring
ARV
prophylaxis







2) Positive
pregnant
women
with prior
exposure
of NNRTI
(NVP/EFV)
TDF 300mg once daily
3TC 300mg once daily
EFV 600mg once daily









TDF 300 mg once
daily + 3 TC 300 mg.
daily + LPV/r 400/100
mg twice daily
Start at 14
weeks or as
soon as
possible
thereafter







Start at 14
weeks or as
soon as
possible
thereafter

Continue
triple ARV
prophylaxis









Continue
triple ARV
prophylaxis

Continue triple
ARV prophylaxis
until 1 week after
all infant
exposure to
breast milk has
ended *
(stop EFV and
continue with 7
more days with
TDF+ 3TC tail)


Continue triple
ARV prophylaxis
until 1 week after
all infant
exposure to
breast milk has
ended *
* Continue the ARV prophylaxis after stopping breast feeding for 7 days
more. Stop EFV and continue TDF + 3TC tail for 7 more days

7.3 Clinical and laboratory monitoring of pregnant women receiving ARV
prophylaxis

This follows standard guidelines for clinical and laboratory monitoring as per national
guidelines for adults and adolescents as outlined in Table 2.

Adherence must be monitored at each visit since effective prevention of mother to child
transmission is dependent on ARV drug adherence of both mothers and infants, during
pregnancy and postpartum especially during the duration of breastfeeding.

7.4 ARV prophylaxis for infants born to mothers receiving ARV prophylaxis

Infants born to women who are receiving maternal triple ARV prophylaxis should receive
six weeks of daily NVP to further reduce the risk of post-partum HIV transmission,
regardless of whether the infant is breastfed or receives replacement feeding:




33
Immediately postpartum, infants should receive the first dose of NVP at birth
(within 6 to 12 hours), or as soon as possible thereafter
All infants must receive atleast 6 weeks of daily NVP until the first visit for
immunization at the health center /follow-up at ICTC
Infants who are Exclusively Breast-Fed:
o Ensure that the mother continues to take and have good adherence to the
ARV Prophylaxis during the whole duration of breast-feeding and for one
week after stopping breast-feeding.
o Infant must receive 6 weeks of daily NVP from birth until the first visit for
immunization at the health center/ICTC
o Thereafter, there is no need to continue infant NVP, but the infant should be
provided Co-trimoxazole Prophylactic Therapy (CPT) upto 18 months and
should be linked for Early infant diagnosis (EID) programme
Infants who are given Exclusively Replacement Feeding:
o Ensure that NO MIXED FEEDING is done to the baby (No breast-feeds and
replacement feeds given to the baby within the first 6 months)
o Mothers can stop regimen after delivery. However, it is important to stop
EFV but continue TDF + 3TC tail for 7 days
o Infant must receive 6 weeks of daily infant NVP Prophylaxis until the first
visit for immunization at the health center/ follow-up at ICTC
o Thereafter, there is no need to continue infant NVP, but the infant should be
provided Co-trimoxazole Prophylactic Therapy (CPT) upto 18 months and
should be linked to Early infant diagnosis (EID) programme

Refer to Chapter 12 on infant feeding practices and the summary PPTCT and infant
feeding charts
7.5 Clinical and laboratory monitoring for infants receiving NVP prophylaxis

No additional laboratory monitoring is required for infants receiving daily NVP
prophylaxis for the duration of 6 weeks or breastfeeding:

Infants should be observed closely during the period of NVP prophylaxis, and
clinical monitoring for rash and signs or symptoms of hepatotoxicity should be
conducted at routinely scheduled clinic visits.
2


Parents and caregivers of infants receiving daily NVP prophylaxis should be
informed about warning signs and symptoms for which they should seek
immediate clinical attention. These include rash, abdominal pain, jaundice and
fever. Physiological jaundice is also not uncommon in new born babies and
referral for expert advice should be solicited in case of any doubt.


2
Note: Data from various studies including the SWEN India trial noted that the risk of hepatotoxicity was
low. Although data are only available for the provision of NVP to breastfed infants up to 6 months, it
is believed that the risk for increased toxicity with 12 months of daily NVP is low since most NVP
toxicity occurs in the first 12 weeks of use. Refer to WHO 2010 Guidelines for PMTCT.



34
Chapter 8. Interventions for women diagnosed with HIV infection in labour
and postpartum

There is a significant group of pregnant women with unknown status presenting directly-in-
labour for delivery. Any pregnant woman who presents in active labour with unknown
status should be offered the routine screening of HIV, with opt-out option as per National
Guidelines. Screening using Whole Blood Finger Prick Test in the delivery/labour ward
should be undertaken.

Pregnant women in labour who are detected to be HIV-infected should:

Receive ARV prophylaxis (TDF+3TC+EFV) for PPTCT as soon as possible to
reduce the risk of intra-partum HIV transmission.
Receive HIV clinical and immunologic assessment to determine ART eligibility and
inform about the duration of infant ARV prophylaxis to reduce the risk of post-
partum HIV transmission.
IN CASE OF A RARE SITUATION WHEN THE 3 DRUGS VIZ., TDF+3TC+EFV
ARE NOT AVAILABLE THE WOMAN SHOULD NOT BE DEPRIVED BUT
SHOULD ATLEAST BE GIVEN ATLEAST THE BENEFIT OF SD NVP.

Clinical staging and CD4 assessment must be done as soon as possible and
ideally before discharge from post-natal ward in hospitals where the ART
center is closeby. If not, a blood sample should be drawn by Lab Technician
of ICTC at the time of confirmation of HIV status the following day of delivery
and take it to the closest ART Centre and s/he should collect the results and
hand it over to the HIV infected mother before discharge. THESE WOMEN
ARE A PRIORITY FOR CLINICAL MANAGEMENT.


WOMEN WHO ARE DIAGNOSED HIV POSITIVE IN LABOUR OR JUST
AFTER DELIVERY HAVE PRIORITY FOR CLINICAL MANAGEMENT AND
CD4 ASSESSMENT IN THE ART CENTRE



35
Protocol PPTCT-3 : Women presenting directly-in-labour
(unbooked case)




























Pregnant women coming directly-in-labour
HIV Positive using Whole Blood Finger Prick testing in labour room /
delivery ward
At onset of labour: Sd Nevirapine once +
AZT (after counselling and ensuring that Hb% >9 gms.) +3TC every 12
hours during labour and delivery
Mother: Continue AZT +3TC for 7 days after delivery
All Infants: Daily
Sy.Nevirapine from birth until 6
weeks (minimum)
See Advisory#

Mother: Assess for ART eligibility
If eligible, start ART
P
o
s
t
-
p
a
r
t
u
m

I
n
t
r
a
-
p
a
r
t
u
m

Next morning:
Counselling and confirmation of test and collection for CD4 testing for ART
eligibility



36






































8.1 Maternal ARV prophylaxis for women presenting in active labour

HIV-infected women in active labour who have not received any prior ARVs should receive
prompt intra-partum ARV prophylaxis. The recommended intrapartum maternal ARV
prophylaxis for PPTCT among women in labour who have not received antenatal ARV
prophylaxis consists of:

sd-NVP at onset of labour, or at presentation if already in active labour
AZT + 3TC during labour and delivery and for 7 days postpartum (Table 5)

Advisory #
All infants born to HIV infected pregnant women who come directly-in-labour
and have not received ART nor ARV prophylaxis during ante-natal period
should receive daily Nevirapine prophylaxis, for a minimum of 6 weeks and
stopped thereafter.

Continuation of infant Nevirapine prophylaxis after 6 weeks depends on whether
mother needs ART for her own health.

Post-partum HIV infected mother assessed for ART eligibility
Mother receives ART for her own
health if CD4 <350 cells/mm
3
Mother receives ARV Prophylaxis
if CD4 >350 cells/mm
3

Exclusive Breast Feeding or
Exclusive Replacement Feeding
infant
Continue infant NVP prophylaxis
until mother has been on a minimum
of 6 weeks of ART, before
prophylaxis may be stopped
Exclusive Breast Feeding infant
Continue infant NVP prophylaxis
till 6 weeks (minimum)
Exclusive Replacement Feeding
infant
Continue infant NVP prophylaxis till
6 weeks, then stop.



37
Table 5: ARV prophylaxis for pregnant women presenting in active labour with no prior ARV
prophylaxis

Maternal Status Intra-partum Post-partum
Presenting in active
labour, no prior ARV
prophylaxis
sd-NVP 200 mg. once at
onset of labour with
AZT 300 mg. (after
counselling and
ensuring that Hb% > 9
gms.) + 3TC 150 mg. at
onset of labour and
every 12 hours until
delivery
AZT 300 mg + 3TC 150 mg twice
daily x 7 days

8.2 Clinical and immunologic evaluation of HIV infected pregnant women
presenting in active labour

Pregnant women who are detected to be HIV-infected by HIV screening Whole Blood
Finger Prick Test during active labour should receive the following:
Confirmation of HIV status in ICTC
Clinical assessment and WHO staging
CD4 count for ART eligibility
Other baseline investigations as per guidelines

All pregnant women with HIV infection should be referred to ART center irrespective of
CD4 count either for ARV prophylaxis or for ART initiation. This is even more important for
women to be referred to the nearest ART centre for detailed assessment and ART /ARV
prophylaxis initiation. There should be no delay in ART / ARV prophylaxis initiation in
these women as prompt ART initiation can help to significantly reduce the risk of HIV
transmission during breastfeeding. The choice of ART regimen for these women is
TDF+3TC+EFV.
8.3 ARV prophylaxis for infants born to women presenting in active labour

All infants born to women who present directly-in-labour and receive intra-partum ARV
prophylaxis should be started on daily NVP prophylaxis at birth and continued for a
minimum of 6 weeks.

If the mother is started on life-long ART for her own health in the post-partum period, infant
NVP prophylaxis can be discontinued after mother has been on a minimum of six
weeks of ART. This is irrespective of infant feeding practices (i.e., Exclusive Breast
Feeding or Exclusive Replacement Feeding).

If the mother does not require ART for her own health and the infant is given Exclusive
Breast Feeds, the mother should be started on maternal triple ARV prophylaxis
(TDF+3TC+EFV) during entire breast feeding period and upto 1 week after cessation of
breast-feeds.



38
If the mother does not require ART for her own health, and the infant is receiving ONLY
Exclusive Replacement Feeding, she should receive six weeks of maternal triple ARV
prophylaxis. Infants should receive daily NVP until 6 weeks of age.
8.4 ARV prophylaxis for infants born to women who did not receive any
ARV prophylaxis for PPTCT

In case of infants who are born to HIV infected mothers who did not receive any antenatal
or peripartum ARV prophylaxis, or in cases where maternal HIV infection is detected after
the birth of the infant (home delivery):

Infants should be started on daily NVP prophylaxis at their first encounter with
health services.
Daily infant NVP prophylaxis can be started even if more than 72 hours have
passed since birth.
Daily infant NVP prophylaxis should continue for 6 weeks, by which time the
mother should be linked to appropriate ART services
In this scenario, mothers should be evaluated for ART eligibility. The duration of daily
infant NVP prophylaxis will depend on whether the mother is initiated on life-long ART and
infant feeding practices (see Chapter 12).

5 Dos for infants at 6 weeks

IT IS IMPORTANT TO DO THE FOLLOWING FOR INFANTS AT 6 WEEKS:

Do re-inforcement for Exclusive Breast Feeding for the first 6 months
(Continuation of breast-feeds with introduction of complementary
feeds thereafter)
Do EID testing
Do Immunisation
Do CPT initiation and continue until baby is 18 months old
Do stop NVP Prophylaxis for baby after 6 weeks



39
Chapter 9. Special Considerations

9.1 Pregnant women with active TB

The risk of active TB is approximately 10 times higher in HIV-infected pregnant women
compared to HIV-uninfected women. Active TB in HIV-infected pregnant women can
contribute to increased risk of maternal mortality, and is also associated with prematurity,
low birth weight, and perinatal tuberculosis. A recent study in India
3
found that maternal
TB increases by 2.5 times the risk of HIV transmission from mother to child.


Intensified Case Finding (ICF) as per national TB-HIV protocols must be instituted
for all HIV infected pregnant women
All HIV-infected pregnant women presenting with a cough, fever, night sweats and
weight loss should be evaluated for TB and started on TB treatment when
indicated.
HIV-infected pregnant women with active tuberculosis should start ART,
irrespective of CD4 cell count.
The tuberculosis treatment should be started first, and followed by ART as soon as
clinically possible.
Drug interactions between rifampicin and some of the antiretroviral drugs, including
NVP, complicate simultaneous treatment of the two diseases. EFV is the preferred
NNRTI for pregnant women, after the first trimester, and hence, can be used in
concurrent TB treatment.
For those HIV/TB co-infected women not able to tolerate EFV, a NVP-based or a
boosted PI regimen can be considered after expert clinical consultation. With the
use of a boosted PI regimen, rifampicin should be substituted with rifabutin.
9.2 Pregnant women with HIV-2 infection

Although the great majority of HIV infections in India are due to HIV-1, there are small foci
of HIV-2 infection as well, primarily in western India. HIV-2 may also progress to AIDS,
although progression is generally much slower. HIV-2 has the same modes of
transmission as HIV-1 but has been shown to be much less transmissible from mother-to-
child (transmission risk 0-4%).

DETECTION OF HIV-2 INFECTION SHOULD BE DONE ACCORDING TO NACOS
TESTING GUIDELINES

NNRTI drugs, such as NVP and EFV, are not effective against HIV-2 infection. Therefore,
for women who are infected with HIV-2 alone and eligible for ART :

Follow standard adult guidelines for HIV-2 treatment which consists of 2NRTI +
LPV/r.

3
Maternal Tuberculosis: A Risk Factor for Mother-to-Child Transmission of Human Immunodeficiency
virus. Gupta A, Bhosale R, Kinikar A, et al for the Six Week Extended-Dose Nevirapine (SWEN) India Study
Team. J ID 2011:203 (1 February)



40

Pregnant women living with HIV-2 infection alone who do not need ART for their own
health (CD4 >350 cells/mm
3
) should:

receive an ARV prophylaxis consisting of TDF/3TC/LPV/r after counselling and
ensuring that Hb% >9 gms. from as early as 14 weeks of pregnancy continued
during labour and delivery 15 mgs. /dose twice daily

This maternal intervention should be coupled with daily AZT to the infant from birth
until 6 weeks of age.

Dose of AZT for babies in mother with HIV-2 level
Birth weight


Infant with birth
weight of
< 2000 gms.

<2500 gms.


2500 gms. and >
AZT daily dosage in
mg.

5mg/dose twice daily



10mg/dose twice daily


15 mgs./dose twice
daily
AZT daily
dosage in ml.

0.5 ml. twice daily



1 ml. twice daily


1.5 ml. twice daily
Duration


6 weeks



6 weeks


6 weeks

(Source: WHO Guidelines)

The risk of mother to child transmission of HIV is considered low in the case of HIV-2
infection. Additionally, there is no evidence to support extended maternal ARV prophylaxis
to reduce mother-to-child transmission in this population. Thus, no other ARV
interventions are recommended for women, or infants born to women with HIV-2 infection
alone

If a pregnant woman is detected to have BOTH HIV-1 and HIV-2 infections, she
should receive PPTCT prophylaxis and treatment interventions recommended for
women with HIV-1 infection

9.3 Pregnant women with Hepatitis B or Hepatitis C virus co-infection

The HIV epidemic in India is driven by injecting drug use in some regions of the Country.
Hepatitis B and Hepatitis C may be a concern in these areas.





41
For women co-infected with HIV and HBV:

If treatment is required for HBV infection
4
, ART should be started irrespective of
the CD4 cell count or the WHO clinical stage:
o The regimen preferred is TDF + 3TC + EFV
o An elevation in liver enzymes following the initiation of ART may occur in
HIV/HBV-co-infected women because of an immune-mediated flare in HBV
disease secondary to immune reconstitution (IRIS) with therapy, particularly
in women with low CD4 cell counts.
o HBV infection may also increase the risk of hepatotoxicity with certain
antiretroviral drugs, specifically NVP and protease inhibitors.
Pregnant women with HIV/HBV coinfection should be counseled about signs and
symptoms of liver toxicity.
For women who do not require HBV treatment, ART or ARV prophylaxis general
recommendation for HIV-infected pregnant women should be followed. It must be
however noted that there is a risk of hepatic flares with the use of maternal triple
ARV prophylaxis when the triple ARVs are stopped after delivery or breastfeeding.
Hence, an experts opinion should be sought in managing these cases.

For women co-infected with HIV and HCV:

No specific changes in treatment are recommended in the adult ART treatment
guidelines
Pregnant women co-infected with HIV and HCV should receive ART or ARV
prophylaxis according to the general recommendations for HIV-infected pregnant
women.
Those women on ART require careful clinical and laboratory monitoring,
irrespective of the ARV prophylaxis.

Co-infection with HIV and HBV or HCV is common among Infecting Drug Users (IDUs).
Hence, all women living with HIV who are recognized to be IDUs should routinely be
offered testing for Hepatitis B and Hepatitis C infections and monitored.


HIV co-infected pregnant women with Hepatitis B or C will be the responsibility of
the health systems






4
Anti-HBV therapy should be considered for all women coinfected with HIV and Hepatitis B virus with any
evidence of liver disease (i.e. elevated transaminase levels, elevated HBV-DNA titres, necro-inflammatory
lesions or fibrosis on liver biopsy).




42
Chapter 10. Labour and delivery in the HIV infected pregnant
women


10.1 Intrapartum Management


The womens serostatus should be recorded in the RCH (Ante-natal card) and maternity
register. Health care workers should check the womans HIV status and details of the use
of ARV drugs during pregnancy. If her HIV status is unknown and she is in the first stage
of labour, offer HIV counselling and testing. If this is not possible, then HIV counselling and
testing should be done as soon as possible after delivery including CD4 count for ART
eligibility.


10.2 Intrapartum Antiretroviral Prophylaxis


For women on lifelong ART, should continue to receive ART as per the usual schedule
including during labour and delivery. She does not require sd-NVP or other additional ARV
dosing.

Women on triple drug ARV prophylaxis should be given TDF+3TC+EFV as per the usual
schedule during labour and delivery.


10.3 Special circumstances: Caesarean section






Caesarean sections are not recommended for prevention of mother-to-child transmission,
particularly where women are taking ART for their own health or have had adequate
duration of ARV prophylaxis for PPTCT.

Use of ARV drugs during Caesarean sections:

For planned (elective) Caesarean sections, antiretroviral prophylaxis should be
given prior to the operation.

Women on lifelong ART should continue their standard ART regimen.


Caesarean section should be performed for obstetric indications only.



43
In case of an emergency Caesarean section in pregnant women who are not on
ART/ARV prophylaxis, ensure that the women receive sd NVP + TDF/3TC
prophylaxis prior to the procedure.

All HIV-infected women who undergo Caesarean section should receive the standard
prophylactic antibiotics. Complications of Caesarean section are higher in women with
HIV, with the most frequently reported complication being postpartum fever.

10.4 False labour

In the case of false labour or mistaken ruptured membranes, for women taking ART or
triple ARV prophylaxis, continue with normal dosing schedule of the combination regimen.

If sd NVP has already been given to a HIV infected pregnant woman who had
false labour pains and did not progress into active labour within 24 hours,
then a second dose of NVP should be repeated again when she goes into
active labour
10.5 Safer delivery techniques

Mother-to-child transmission risk is increased by the prolonged rupture of membranes,
assisted instrumental delivery (vacuum or forceps), invasive foetal monitoring procedures
(scalp/foetal blood monitoring), episiotomy and prematurity. Thus, when delivering HIV-
infected women, observe:

Standard/Universal Precautions
Do NOT rupture membranes artificially (keep membranes intact for as long as
possible)
o The membranes should be left intact as long as possible and artificial
rupture of membranes reserved for cases of foetal distress or delay in
progress of labour.
Minimize vaginal examination and use aseptic techniques
Avoid prolonged rupture of membranes
Avoid invasive procedures like foetal blood sampling, foetal scalp electrodes
Avoid instrumental delivery as much as possible
o unless required in cases of foetal distress or significant maternal fatigue to
shorten labour or the duration of ruptured membranes.
o if indicated, low-cavity outlet forceps is preferable to ventouse, as it is
generally associated with lower rates of foetal trauma than ventouse.
Avoid routine episiotomy as far as possible
Suctioning the newborn with a nasogastric tube should be avoided unless there is
meconium staining of the liquor.


Safer surgical techniques is useful in conducting any operative procedures such as the
Caesarean section, repairing wounds/lacerations etc.




44

Use of dry haemostatic techniques to minimize bleeding; i.e. good observation
and following of surgical fascial planes during dissection, judicious use of
electrocautery during Caesarean section etc.;
During Caesarean section, wherever possible, the membranes are left intact until
the head is delivered through the surgical incision. The cord should be clamped as
early as possible after delivery.;
Use of round-tip blunt needles for Caesarean section
5
;
Do not use fingers to hold the needle;
Use forceps to receive and hold the needle;
Observe good practice when transferring sharps to surgical assistant eg. holding
container for sharps

Disposal of tissue, placenta and other medical/infectious waste material from the delivery
of HIV-infected deliveries follows standard waste disposal management guidelines.




5
Blunt Needles for the Reduction of Needlestick Injuries during Cesarean Delivery: A Randomized
Controlled Trial, SULLIVAN Scott et al Obstetrical & Gynecological Survey 2009, vol. 64, no12, pp. 778-
779



45
Chapter 11. Care during the postnatal period

11.1 The postpartum period

Within an hour of delivery
o Infants born to HIV-infected mothers should receive their NVP prophylaxis
immediately after birth
o Infants after delivery should be put on the mothers abdomen for skin
contact to be established which helps in bonding and maintenance of
babys body temperature as well as helps initiation of breast milk within 1
hour of birth
o Infants should start feeding exclusive breastfeeding or exclusive
replacement feeding. See chapter 12 for updated guidelines on infant
feeding
If the mother has not made a decision about feeding yet, she should be counseled
to give exclusive breast feeds for first 6 months which is the preferred option
(Option I) followed by complementary feeds thereafter.
Counsel and support parent to give infant NVP prophylaxis using the
syringe/dropper provided. Emphasize on washing the equipment with clean boiled
water after every use.


During the post-delivery period, it is important to continue follow-up and support for the
postpartum mother, in light of the fact that this is a stressful period and she has to manage
multiple roles as mother, wife and HIV infected person. Wherever possible, include family
counseling (of husband, in-laws, direct family members) to support care of the HIV
infected mother and HIV exposed infant. Post partum depression & psychosis is common
in HIV-infected women especially post-partum.

Involvement of men (husband/close male family members) is important so that the family
support to the HIV-infected mother and infant is optimal. Husbands support to the mother-
baby pair (m-b pair) should be encouraged, for example, as :
To remind mother to take ART or ARV prophylaxis
Support administration of daily infant NVP prophylaxis medications to the baby
during the exclusive breastfeeding period
Be involved in care and follow-up of the infant including clinic visits and
immunization follow-up; EID and CPT initiation and continuation upto 18 months
Be involved in care of mother for ART center visits
Support exclusive breastfeeding for 6 months minimum and continuation of breast
feeds with weaning foods from 6 months onwards to 1 year in EID negative babies,
and upto 2 years in EID positive babies initiated on Paediatric ART
Insertion of Cu-T (temporary contraceptive method) for HIV infected mother at 6
weeks
Encourage male sterilization in HIV infected father (No Scalpel Vasectomy (NSV)
between 18 months to 2 years when babys survival has been ensured)





46

Postpartum follow-up and care extends beyond the six-week postpartum period and
includes:

assessment of maternal healing after delivery and evaluation for
postpartum infectious complications; and
Continued counselling and information on fertility choices and effective postpartum
Contraceptive methods as well as condom promotion and ensuring Cu-T IUD
adoption and continued motivation for NSV for males at 18 months
Specifically, in HIV infected pregnant women, there should be linking of the baby to
the early Infant Diagnosis (EID) programme and ART programme for mother / child
as indicated

11.2 Screening for depression postpartum

Postnatal blues occur in almost 80% of women, most commonly in the first postnatal
week, and improve afterwards. The postnatal or baby blues refers to a range of feelings
between the third and tenth day after delivery:

The feelings include being tearful, irritable, mood changes, fatigue, anxiety and
feelings of sadness or loneliness
These feelings are thought to be caused by a number of factors, including sudden
changes in hormone levels after childbirth, unexpected discomfort from breast
engorgement and birth pain, adjustment to parenthood and sleep deprivation.
These feelings should disappear after a few days and no specific treatment is
required, apart from recognition, empathy and support from family and friends.

However, in a group of postpartum women, these feelings may persist and become
postpartum depression. Two prospective studies on pregnant women, in the states of Goa
and rural South India, detected depressive disorder in 23% and 16% respectively, with
depression persisting six months after child birth in 11-14% of women.
6
In HIV infected
women, this may be higher.

Postpartum depression may begin at delivery, or a month later; in some women, it may
begin during the first postnatal menstrual period or weaning:

The symptoms include crying, irritability, sleep problems (insomnia or sleeping all
day), eating problems (no appetite or eating all day), persistent feelings of
sadness, lack of desire or inability to care for self or baby, exaggerated concerns
about the baby, and memory loss.
Some women may feel extremely anxious or fearful, sometimes experiencing panic
attacks including palpitations, chest pain, dizziness, cold flushes and shaking.

Postpartum depression should be detected early so that counseling support and other
interventions may be provided. Postpartum depression can interfere with mother-infant
bonding, cause problems with spouse and family or other children; and may affect health

6
Post-partum psychiatric care in India: the need for integration and innovation. Prabha S Chandra. World
Psychiatry. 2004 J une; 3(2): 99100.




47
of the mother. More importantly, postpartum depression may reduce the adherence to
ART or triple ARV prophylaxis especially the infant NVP prophylaxis for the first 6
weeks of life.

Screening for postpartum depression should be done before the mother goes home after
delivery and during follow-up visits. See Annex 8 for the screening tool.
11.3 Counsel and follow-up mother-baby (m-b) pairs after discharge

Counseling on mother issues:

Counsel mothers taking triple drug ARV prophylaxis
o If exclusively breast-fed: for good adherence and to continue the triple ARV
prophylaxis during the duration of breastfeeding and for 1 week after
cessation of BF.
o If given exclusive replacement feeding: the maternal ARV drugs should
have stopped after delivery. Infants should receive 6 weeks of infant NVP
daily.
Counsel mothers taking ART for her own health:
o That ART for her is lifelong
o For good adherence to ART as the ART drugs will reduce the risk of HIV
transmission through breastmilk if breastfeeding.
Counsel mother who came directly-in-labour about the importance to complete
AZT/3TC drugs for 7 days, irrespective of infant feeding practices
o Sd NVP given at the onset of labour pains to the mother aims to reduce the
risk of HIV transmission during the delivery and immediate postpartum
period
o The maternal AZT/3TC tail of 7 days aims to reduce the risk of drug
resistance to the sd-NVP to the mother.
Counsel mother to have adequate rest, nutrition and to take iron-folate during the
lactation period, ensure enough proteins and fluids in the diet
Family support: involve husband and family members to help out with baby care so
that she can rest and recuperate, and to remind her of ART, triple ARV prophylaxis
and infant ARV prophylaxis.
Counsel mother for her post-natal checkup at 6 weeks to coincide with the infants
first immunization visit
Discuss and ensure contraception Cu-T insertion and condom use as dual
protection at subsequent visits
Arrange for the mother on ART to be followed with the ART Center
For women who are not on ART, counsel for regular 6 monthly CD4 count at the
ART Center for assessment for well-being of the immune system, 3 monthly Renal
Function Test (RFT) on counseling for regular and adequate adherence to ARV
prophylaxis during the breast feeding period.
ANM/Nurse/Counselor/ORW will follow-up the mother and baby within a week of
discharge for mothers progress, support infant feeding practice, ensure correct
use of infant NVP prophylaxis at home, general counseling advice and infant
follow-up

Refer to Annex 9: Counseling the HIV infected mother/family for infant feeding options: 0
6 months



48
Counseling for infant issues to the parent/caregivers:

Counsel and reinforce decision on infant feeding practice whether exclusive
breastfeeding or exclusive replacement feeding
All infants (irrespective of maternal ART or ARV prophylaxis in mother) must
receive a minimum of 6 weeks of infant NVP prophylaxis daily until the first visit for
immunization at 6 weeks of age.
o If exclusive replacement feeding is being done, then infant NVP prophylaxis
may be stopped at 6 weeks of age.
o Infants who are diagnosed DNA PCR negative
Should continue breastfeeding and be re-evaluated as per EID
protocol
Stop NVP prophylaxis at 6 weeks for babies given exclusive
replacement feeding
o Infants who are diagnosed DBS positive, are to be referred to the ART
Center for whole blood sample (WBS) collection. If WBS is positive, then
the infant will be initiated on Paediatric ART, irrespective of CD4 Count or
%
o Final confirmation of the HIV should be done at 18 months in ICTCs by
doing all 3 Rapid Tests even if the first rapid test may come negative


5 Dos for infants at 6 weeks

FOR INFANTS AT 6 WEEKS, IT IS IMPORTANT TO DO THE FOLLOWING:

Do re-inforcement for Exclusive Breast Feeding for the first 6 months
(Continuation of breast-feeds with introduction of complementary
feeds thereafter)
Do EID testing
Do Immunisation
Do CPT initiation and continue until baby is 18 months old
Do stop NVP Prophylaxis for baby after 6 weeks



49
Chapter 12. Infant feeding practice

Refer to National Guidelines for Nutrition of HIV affected and infected infants and children,
2011

More than 50% of children under 5 years of age in India have malnutrition. Data from the
2005-06 NFHS-3 showed that overall, 57% of women of childbearing age in India (urban
and rural) have anaemia with 30 % of infants being born underweight. Growth retardation
in young children starts during pregnancy and is irreversible by age of two years if not
corrected. In healthy infants, this could be corrected within six months of exclusive
breastfeeding. But especially in rural areas, where women often go back to the fields a few
days after giving birth, babies diets are often supplemented with cows milk and water,
which exposes them to infection.

The infant feeding guidelines for HIV-exposed and infected infants age 0 to 6 months has
been updated in 2011. After 6 months of age, complementary foods should be introduced
just like for other infants of this age.

Figure 7: Recommendations for infant feeding in HIV exposed and infected infants < 6
months of age


Exclusive breastfeeding is the preferred feeding option for HIV-exposed infants < 6
months of age. However, it is recognized that for some women, breastfeeding may not be
possible - for example in situations of maternal death and severe maternal illness.
Exclusive Replacement Feeding should be done only when AFASS Criteria is fulfilled:
A Affordable
F Feasible
A Acceptable
S Sustainable
S - Safe



The 2011 National Guidelines on Feeding for
HIV-exposed and infected infants < 6 months old recommends:


Exclusive breastfeeding for atleast 6 months
Only in situations where breastfeeding cannot be done (maternal death, severe
maternal illness) or individual mothers choice, then exclusive replacement
feeding may be considered




50
Figure 8: AFASS criteria for Exclusive Replacement Feeding

Mothers known to be HIV-infected if insist on opting for exclusive replacement feeding
which is contrary to the WHO /NACOs guidelines of giving exclusive breastfeeds for first 6
months, are doing so at their own risk. No MIXED FEEDING should be done during the
first 6 months.

When opting for Exclusive Replacement Feeding, they should fulfill the AFASS Criteria
given below:

1. Safe water and sanitation are assured at the household level and in the community,
and can prepare clean feeds
2. The mother, or other caregiver can reliably afford to provide sufficient replacement
feeding (milk), to support normal growth and development of the infant, and can
sustain it un-interruptedly for first 6 months atleast
3. The mother or caregiver can prepare it frequently enough in a clean manner so that it
is safe and carries a low risk of diarrhoea and malnutrition, and
4. The mother or caregiver can, in the first six months exclusively give replacement
feeding, and is feasible
5. The family is supportive of this practice, and accepts it without forcing her to breast-
feed during the first 6 months

12.1 Principles of infant feeding for HIV infected pregnant women

The 10 principles of infant feeding options for HIV infected pregnant women and their
infants are:

1. All HIV infected pregnant women should have PPTCT interventions provided
early in pregnancy as far as possible. The interventions include either maternal or
infant ARV prophylaxis during the duration of breastfeeding.
2. Exclusive breastfeeding is the recommended infant feeding choice in the
first 6 months, irrespective of whether mother or infant is provided with ARV
prophylaxis for the duration of breastfeeding
3. MIXED FEEDING SHOULD NOT BE DONE AT ANY COST WITHIN THE FIRST 6
MONTHS (GIVING breast-feeds and replacement feeds simultaneously first 6
months).



51
4. Only in situations where breastfeeding cannot be done or on individual parents
informed decision, then replacement feeding may be considered only if AFASS
Criteria for exclusive replacement feeding is fulfilled (Figure 8).
5. Exclusive breastfeeding should be done for at least 6 months, after which
complementary feeding should be introduced gradually, irrespective of whether the
infant is diagnosed HIV negative or positive by EID
6. Mother should be receiving ARV prophylaxis or ART during the whole duration of
breastfeeding. ARV prophylaxis should continue for one week after the
breastfeeding has fully stopped.
7. For breastfeeding infants diagnosed HIV negative, breastfeeding should be
continued until 12 months of age irrespective of whether the mother is on ART or ARV
prophylaxis
8. After 6 weeks of stopping breast feeds, repeat EID i.e., Rapid test followed by DBS
(if Rapid Test turns positive) followed by WBS test, WBS positive, Paediatric ART
to be initiated. However, confirmation test for HIV has to be done at 18 months
irrespective of the EID status using 3 Rapid Tests.
9. For breastfeeding infants diagnosed HIV positive, paediatric ART should be started
and breastfeeding should be continued till 2 years of age.
10. Breastfeeding should stop once a nutritionally adequate and safe diet without
breast milk can be provided.
11. Abrupt stopping of breastfeeding should NOT be done. Mothers who decide
to stop breastfeeding should stop gradually over one month.

Refer to Annex 9 for flowchart on counselling mothers and families for infant feeding 0-6
months of age

The summary charts given in the next few pages gives the various action points in the
continuum of the PPTCT activities according to infant feeding practices. Most HIV infected
women should breastfeed their infants, unless there are special situations described
above.

To use the summary charts, start from the left side of the chart and continue towards the
right side. Advice to the mother/child for ART/ARV prophylaxis, when to stop or continue
infant NVP prophylaxis, when to continue or stop breastfeeding etc. is described on the
headings of the charts.



52

** Wherever written HIV positive pregnant women, kindly read it as HIV infected pregnant
*** 6 weeks after cessation of breast-feeds the babys EID should be done (Rapid Test positive, do
All babies detected positive <2years of age are given Paediatric ART irrespective of CD4
Figure 9: Infant feeding summary charts: PPTCT and infant feeding options

Chart 1: Exclusive breast feeding (EBF)
women
DBS; if DBS positive; do WBS; if WBS positive, start Paediatric ART, irrespective of babys CD4
count or %.

count or %





53

Chart 2: Exclusive replacement feeding (ERF)






















* If mother is eligible for ART - do not delay initiation of ART. ART regimen as per National
Guidelines.
If mother is diagnosed HIV infected AFTER DELIVERY, her infant should receive infant NVP
prophylaxis for minimum of 6 weeks
Chart 3: Antiretroviral prophylaxis for women presenting directly-in-labour, immediately postpartum
and their infants, including infant feeding options
W
o
m
e
n

w
i
t
h

u
n
k
n
o
w
n

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a
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s

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e
s
e
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t
i
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g

i
n

l
a
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o
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r

o
r

i
m
m
e
d
i
a
t
e
l
y

p
o
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-
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i
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y

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n
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e
s

H
I
V

s
c
r
e
e
n
i
n
g

ART
eligibility
Mother antiretroviral drug regimens
Infant
feeding
choice
Postpartumassessment of mother
for ART eligibility:
- to bedoneas soon as possible
(samplefor CD4 testing collected
by Lab Technician thefollowing
day during HIV confirmation and
reached to ART Centreand CD4
report handed over to Mother
beforedischarge)
- WHO clinical staging and CD4
count to bedone
Infant NVP:
EID results
Mother
Antenatal
(AN)
During
labour
and
delivery
Post partum(PP)
Givefirst doseof NVP within 6 to 12
hours of delivery and continuefor
minimumof 6 weeks
Unknown
CD4 at
baseline
Women in
direct labour
with infected
HIV using
wholeblood
finger prick
testing
none
sdNVP +
AZT/3TC
(Counsel
& ensure
Hb%
>9gm.
AZT/3TC for 7
days only
EBF
(6
months)
Mother needs ART for her own
health*
After initial 6 weeks, continueinfant
NVP until mother has completed atleast 6
weeks of maternal lifelong ART.
Thereafter, infant NVP can bestopped
EID positive

EID
negative
Mother does not need ART yet
ContinueNVP till 6 weeks; Mother
should havestarted ARV prophylaxis as
per guidelines. Should bestarted on ARV
Prophylaxis and given during the
completebreastfeeding duration and one
week after stopping breast-milk
EID
negative
EID Positive
EBF (6
months)
Irrespectiveof mothers ART
eligibility
Irrespectiveof ART eligibility of mother,
give6 weeks of infant NVP
Irrespective
of EID
results
(whether
negativeor
positive)




54


Chapter 13. Care and follow-up of HIV exposed infants


Any intervention or ARV prophylaxis given to the HIV exposed newborn infant should be
documented in the child health card before discharge. The following should be noted in the card:
Whether the infant had received ARV prophylaxis
What feeding choice the mother has made
Date of next follow-up

13.1 During the first post-delivery visit at 6 weeks/first immunization visit:

All HIV exposed infants must receive at the first immunization visit to ICTC health facility:
o Initiate Co-trimoxazole Prophylactic Therapy (CPT) at 6 weeks of age
o Check adherence of infant NVP prophylaxis for the past 6 weeks
o EID (DNA/PCR) as per National Guidelines
o Decide whether to stop infant NVP prophylaxis or continue as per guidelines (see below)

For exclusively breastfed infants whose mothers are not taking ART or ARV prophylaxis:
o The pattern of feeding, attachment and positioning and the mothers breast condition must
be checked.
o Any infant with problems must have a medical assessment
o Provide monthly supply of infant NVP prophylaxis at ICTC for all HIV exposed babies
o Arrange for monthly follow-up of the infant

For infants on exclusive replacement feeding, check with the parent and family if any problems
so far
Emphasise good hygiene, use of clean boiled water, hand-washing
Any infant with problems must have a medical assessment

NVP infant prophylaxis is to be stopped at 6 weeks in infants:
o Who are on exclusive replacement or formula feeding
o Whose mothers are on lifelong ART
o Whose mothers continue to take triple ARV prophylaxis for the duration of breastfeeding

All infants with HIV DNA PCR positive are to be referred urgently to the ART center as per
guidelines. Confirmation with whole blood sample (WBS) will be done at the ART center.
All infants / children less than 2 years of age with a confirmed whole blood sample (WBS)
positive status at ART centre should be initiated on ART, irrespective of CD4 % at the earliest
All HIV-exposed infants should be followed up monthly in the first year of life and every 3
months thereafter, regardless of the infant feeding method.
Any infant clinically suspected of having HIV should be tested for HIV, regardless of their age
All HIV exposed infants irrespective of prior status, should have the final confirmatory HIV test at
18 months using 3 Rapid Anti-body tests, even if the first rapid test is negative
No DBS / WBS (DNA/PCR) testing to be done at 18 months



55


The activities which will be conducted at each visit are shown below:
Table 6 : Activities at each follow-up visit for HIV exposed infants and children < 18 months

Visit Birth 6
wks
10
wks
14
wks
6
mths
9
mths
12
mths
18
mths
Co-trimoxazole
prophylactic
therapy (CPT)


- Start CPT from 6 weeks (or first immunization visit) for all
HIV-exposed infants and children
- Continue CPT for all babies upto 18 months irrespective of
EID status
Counseling for
Infant feeding

Growth
monitoring

Developmental
assessment

Immunization &
Vitamin A
supplements
BCG
HBV1*
OPV 1
DPT 1
HBV 2*
OPV
2
DPT 2
OPV 3
DPT 3
HBV 3*
Measle
s
+
Vit. A
OPV
DPT
(B)
Vit. A
Clinical
assessment

HIV testing
(-if required)


(DNA/
PCR)


(Rapi
d
Test+
DNA/
PCR)


Rapid
Test+
DNA/
PCR)



All 3
Rapid
Tests
(No
DNA/PCR)

* HBV vaccines as per state approved schedules
Note: 18 months OPV and DPT booster
For any illness educate parents/caregiver to bring infant/child back to ICTC at the earliest

6 weeks after cessation of breastfeeds, HIV testing to be done (Rapid and DNA/PCR, if former is
positive)

13.2 Confirmation of HIV status in HIV exposed infants should be done at 18
months, regardless of earlier diagnosis

All HIV exposed infants and children regardless of HIV status will be followed-up until 18
months of age for care, monitoring and the final confirmatory HIV test at 18 months using 3 HIV
Rapid tests (even if HIV-1 rapid test is negative)

If any HIV exposed infant or child develops clinical signs and symptoms suggestive of HIV
infection, the Medical Officer at health care facility should start immediate treatment for the



56
acute illness, stabilise and refer urgently to ART Centre. HIV testing according to the national
testing algorithm for infants and children < 18 months also has to be done.

Follow-up of HIV infected infants and children started on ART shall be done by ART
centres in collaboration with the Paediatrician at the institution where ART Centre is located.
Infants and children on ART must undergo the confirmatory three antibody test at 18-months of
age in the nearest ICTC, irrespective of the results of the first rapid antibody test.

No DBS & WBS (DNA/PCR) testing to be done at 18 months





57
Chapter 14. Essential Gynaecologic care for HIV infected pregnant
women

During the long term follow-up of HIV infected pregnant women, apart from ART and pre-ART care,
key areas which must be discussed, are:

Cervical screening
Family planning and birth-spacing
Contraception
14.1 Cervical screening

Women infected with HIV are at higher risk of developing cervical dysplasia leading to cervical
cancer. The Human Papillomavirus (HPV) infection is more common in HIV infected pregnant
women, particularly the higher-risk HPV which causes cervical cancer.

In the National ART Guidelines for adults and adolescents, cervical screening eg. Pap smear or
trichloroacetic acid screening of the cervix should be done annually for all HIV infected pregnant
women.

14.2 Family planning and birth-spacing


With ART and PPTCT being increasingly available, HIV infected pregnant women and men are now
living longer and healthier lives and desiring to have children. Accordingly, reproductive plans
including pre-conception counseling, and counseling regarding reversible methods of contraception
should be discussed with HIV infected pregnant women of childbearing age.

Pre-conception counseling for HIV infected pregnant women are similar to non-HIV infected
pregnant women. The goals are to improve the health of the woman before conception and to
identify risk factors for adverse maternal and foetal outcomes. These include:

Safe sex practices
Prevent and manage STI
Reproductive history including numbers of pregnancies and outcomes of pregnancies
Length of relationship with current partner, HIV status of partner and couples sexual history
including condom use and sexual decision-making or control of reproductive choices
Patients and partners reproductive desires and discussion of options
Reduce/avoid risky behaviour eg. smoking, substance abuse
Take folic acid before conception
If woman is on ART, discuss with the ART Medical Officer to revise appropriate ART
Regimen if required eg. EFV change to NVP





58

Family planning counseling
7
information includes:

information about effective contraceptive methods to prevent pregnancy, dual protection; the
effects of progression of HIV disease on the womans health
and the implications for planning a family;
the risk of HIV transmission to an uninfected partner while having unprotected intercourse
(for instance, when trying to become pregnant);
the risk of transmission of HIV to the infant and the risks and benefits of Antiretroviral
prophylaxis in reducing transmission; and
information on the interactions between HIV and pregnancy, including a possible increase
in certain adverse pregnancy outcomes

Contraceptive methods

Most women with asymptomatic HIV and those who are on ART can safely use the available forms
of contraception for preventing unintended pregnancies. However, prevention of cross-transmission
of HIV virus to the partner as well as STI is important and hence dual protection with consistent
condom use is important. Dual protection refers to simultaneous protection against both unplanned
pregnancy and STIs and HIV by using:

Condoms together with another effective method of contraception, including emergency
contraception.

Available forms of contraception for HIV infected pregnant women include:

Hormonal contraception: is safe in women living with HIV. These may be either:
Oral contraceptives
Depot medroxyprogesterone acetate (DMPA)

DMPA is safe to use in women living with HIV as well as those on ART. There is no hormone-drug
interaction with several ARV drugs commonly used such as NVP, EFV and Nelfinavir.

In women living with HIV (whose CD4 is > 350 cells/mm
3
), hormonal contraception is safe.
Adherence to oral contraception needs to be counseled. Dual protection with consistent condom
use is important.

In women taking ART for their own health, they should be assessed for oral contraception use
according to the WHO Medical Eligibility Criteria for Contraceptive Use guidelines
8
. There may be
hormone-drug interactions which need dosing to be adjusted or an alternative contraception to be
used:

Ritonavir:
o Combined oral contraception pills are generally not recommended for women taking
ritonavir-boosted PIs, due to the potentially decreased efficacy of the contraception


7
Sexual and reproductive health of women living with HIV/AIDS Guidelines on care, treatment and support for women
living with HIV/AIDS and their children in resource-constrained settings. WHO/UNFPA 2006.
8
Medical Eligibility Criteria for Contraceptive Use. 4
th
edition. WHO 2009.
http://www.who.int/reproductivehealth/publications/family_planning/en/index.html



59
Nevirapine
o NVP reduces the levels of combined oral contraception (ethinyl estradiol and
norethindrone)
Efavirenz:
o Women taking EFV may be able to take combined oral contraception without loss of
contraceptive efficacy
NRTI such as AZT and TDF:
o Women taking AZT and TDF may take combined oral contraception without loss of
contraceptive efficacy

Lactational Amenorrhoea Method (LAM) does not protect against STI, pregnancy and HIV.
Correct and consistent condom use should be adopted at every sexual encounter.

Male sterilization (NSV): Males should be motivated at every mother-baby pair follow-up to
undergo sterilization. No scalpel Vasectomy (NSV) when the baby attains 18 months/2 years of age
(at 18 months confirmatory test, irrespective of the babys HIV status). However, after NSV
operation, male should continue to use a condom at every sexual encounter.























Intra-Uterine Contraceptive Device (IUCD) is a good contraceptive method for HIV
infected pregnant women. IUCD
9
Copper T380A is recommended by MOHFW as a long term
reversible method of contraception up to 10 years. PP IUD (Cu-T A-380) to be inserted
within 48 hrs of delivery. PP IUD - Post-partum IUD requires specialised training before the
healthcare personnel undertake the same.




9
IUCD Reference manual for Medical Officers 2007. Family Planning Division. MOHFW.

60






Annex 1: Guidelines for rolling out NACP and NRHM Convergence plan in the states.
No. X-19020/17/2009-NACP(IEC) , 10 August 2010
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71



Annex 2: Dosing schedules for Triple ARV prophylaxis for pregnant women

Clinical
Scenario
ARV Prophylaxis
and dosing
Antepartum Intra-partum Post-partum
Pregnant
women
requiring ARV
prophylaxis

TDF 300mg once
daily
3TC 300 mg once
daily
EFV 600mg once
daily
Start at 14 weeks
or as soon as
possible thereafter
Continue triple
ARV
prophylaxis
Continue triple ARV
prophylaxis until 1 week
after all infant exposure
to breast milk has ended

Annex 3 : ARV prophylaxis for pregnant women presenting in active labour with no prior ARV
prophylaxis

Maternal Status Intra-partum Post-partum
Presenting in active
labour, no prior ARV
prophylaxis
sd-NVP 200 mg once at
onset of labour with
AZT (after counselling
and ensuring Hb% of 9
gm) 300 mg + 3TC 150
mg at onset of labour
and every 12 hours until
delivery
AZT 300 mg + 3TC 150 mg twice
daily x 7 days
Annex 4: Infant NVP prophylaxis dosing

Birth Weight NVP daily dose in
milli gram (mg)
NVP daily dose
in milli -litre
(ml.)*
Duration
Birth to 6 weeks:*

Infants with birth weight < 2000
gm



Birth weight 2000 2500 gm

Birth weight more than 2500
gm


2 mg./kg. once daily. In
consultation with a
pediatrician trained in
HIV care.

10 mg. once daily


15 mg. once daily


0.2 ml./kg. once
daily



1 ml. once a day

1.5 ml. once a day







Up to 6 weeks
irrespective of
breast feeding or
replacement
feeding
* * considering the content of 10 mg. Nevirapine in 1ml. suspension based on WHO
Guidelines
* Infants with birth weight < 2000 gm should receive dose of 2 mg./kg. once daily. Consult expert
HIV paediatrician in these cases.
Source: WHO Guidelines



72
Annex 5: WHO Clinical Staging for adults and adolescents





73



74
Annex 6: Grading of selected clinical and laboratory toxicities (Reference: WHO 2010
Guidelines for ART in adults and adolescents)






75








76




77
ANNEX 7 : Postpartum depression screening tool the Edinburgh scale





78






79
Annex 8: Comparing effectiveness of family planning methods

Reference: Reproductive Choices and Family Planning for People Living with HIV
Counselling Tool (http://www.who.int/hiv/pub/toolkits/rhr/en/index.html )









80
Annex 9: Flowchart on Counselling mothers and their families on infant feeding options 0-6 months of age

1. Ask about the mother HIV/ART status, 3. Discuss Exclusive Replacement Feeding (ERF) as a 6. Explain the chosen feeding option 7. Provide follow-up counseling and support at every visit
home & family situation feeding option if mother cannot breastfeed and only if
the 6 criteria for RF are fulfi lled as below Exclusive breastfeeding for 6 months:
EBF means giving only breast milk
and no other liquids or solids, not
even water, with the exception of
medicines.
NO mixed feeding (ie. breastfeeding
and giving other feeds) animal or
formula milk can irritate the lining of
the infant's stomach, causing
inflammation and making it easier for
the HIV virus in breast milk to get into
the babys body
Breastfeeding : Discuss and
demonstrate correct attachment to
nipple and positioning of baby
Discuss prevention and treatment of
cracked nipples: expressed some
breast milk after baby has finished
and rub over nipple
Discuss prevention and treatment of
mastitis: breastfeed frequently and
feed until the breast is empty. Avoid
breast engorgement.
Discuss prevention and treatment of
oral ulcers and oral thrush in infant
Discuss breast and hand hygiene for
mother; and oral hygiene for baby
Exclusive Replacement Feeding for 6
months :
Discuss and demonstrate the amount
to be fed
Tell mother to prepare according to
instructions with scoop (if formula
feeding)
Discuss hygienic preparation of feeds:
Hand washing with soap
Clean utensils and surface
Boiled water
prepare enough for one feed
Throw away leftover feed if baby
does not finish
Do not re-use leftover feeds as it
may lead to food poisoning
About Baby:
Ask about the progress on infant feeding
Ask about babys immunization; cotrimoxazole dosing, EID status;
infant NVP prophylaxis adherence and monthly refill
Ask about babys growth & health, look for signs of illness and
malnutrition
Assess if further action or doctors check is required and advise
Discuss about complementary feeding at 6 months of age, and
whether to continue or stop breastfeeding
For HIV-infected children < 2 years old
Does her family know her HIV status?
Does she know her husbands HIV
status?
Is her husband/family supportive and
willing to help baby care?
Family income per month
Source of drinking water
Type of latrine/toilet used
Can she prepare each feed with boiled
water and clean utensils eg. up to 12-15
times per day in the first 4 months of
babys life
Can she prepare feeds at night?
What is her latest CD4 count and is she
taking ART or PPTCT regimens?
Does she plan to deliver in the health
facility or go back to parents house
somewhere else? (need to plan referral to
other ICTCs)
Advantages:
No risk of HIV transmission
ERF milks can be given by other persons
Disadvantages:
Animal milk is not a complete food for baby
Formula milk is a complete food but is expensive (about
8,000 to 10,000 Rupees for 6 months)
Baby has more risk of infections diarrhoea, respiratory &
ear infections
Careful and hygienic preparation required each time: sterilize
feeding cups, using boiled water and fresh preparation of all
feeds 12-15 times in the first 4 months of babys life
: check that baby is initiated on
ART; encourage breastfeeding to continue till 2 years of age
For breastfeeding infants still on infant NVP daily prophylaxis or
mothers on ART or PPTCT option B:
2. Counsel for breast-feeding
Exclusive breastfeeding is recommended
during the first 6 months of life, as it has
more benefits to baby and mother.
Explain: Breastfeeding is recommended
Advantages:
Complete nutrition for baby for 6 months
Antibodies in breast milk protects against
infections
Babies on breastfeeding do not usually
have health problems like diarrhoea,
pneumonia, ear infections
Always available, free of cost
Most convenient, no need to prepare or
get out of bed at night
Disadvantages:
Breast milk contains HIV virus, however
ART or PPTCT regimens will significantly
prevent the transmission of HIV virus
during breastfeeding
4. Explain the risks of parent-to-child transmission
check babys adherence to daily
NVP; encourage mother to continue breastfeeding till 12 months.
Infants should start complementary feeding at 6 months of age.
Follow IMNCI guidelines for complementary feeding.s
See National guidelines for nutrition for HIV affected and infected
infants and children, NACO 2011.
About mother:
Ask how mother & family is coping with the baby
Ask for mothers mood changes (screen for postpartum
depression)
Family planning / contraception and birth spacing
Give condoms and reinforce consistent condom use
Ask status and progress for pre-ART or ART care
Reinforce adherence to ART or PPTCT regimens
Refer to ART center as appropriate
If mother or baby is taking ART or PPTCT regi men drug
schedules, explain:
That the risk of HIV transmission from mother to child is very
low because the ARV drugs will reduce the numbers of HIV
virus in the breast milk
When mother or baby is taking ARV drugs, less than 5 babies
out of 100 babies may be HIV infected
It is important to take the ARV drugs as prescribed
reinforce adherence to ART or PPTCT regimens.
If mother is not on ART or mother/infant not receiving new
PPTCT regimens (eg. in the dist ricts whi ch are stil l using
sd-NVP during the scale up of new PPTCT guidelines),
explain:
During the first 6 months of life, it is important to keep the
child healthy by good feeding practices
EBF is recommended because breast milk contained
antibodies which protect the babies from infections - unless
ERF can be safely done according to the 6 criteria
ERF must be correctly done otherwise child will not grow well
or may develop malnutrition
Although there is a small risk of transmission of HIV through
breast milk, this must be balanced with the risks of other
health problems (diarrhea, respiratory infections) due to
replacement feeding.
8. Counseling for stopping breastfeeding
5. Help mother and family decide on feeding choice
Clarify questions
Go through points 2 4 again, if necessary
For mother on ART for her own health: continue ART
For infants still on infant NVP prophylaxis or mothers on PPTCT
option B: Continue ARV drugs until 1 week after breastfeeding has
completely stopped.
Do not stop breastfeeding abruptly: gradually cut down the number
of breastfeeding sessions a day according to comfort of mother and
infant over one month
Ensure complementary feeding is nutritionally adequate and safe.
Check for growth and nutritional status of baby
Once breastfeeding is stopped completely , DO NOT put baby back
to breast for any suckling.
Counseling the HIV infected mother and her family for infant feeding options: 0 6 months
BOX : Si x criteria for repl acement feedi ng Support the decision for infant f eedi ng
Breastf eedi ng is recommended as it i s
affordable,
safer with ARV drugs,
feasibl e, and
convenient.
Mothers known to be HIV-infected should give replacement feeding to their infants only when ALL of the following conditions are met:
Saf e water and sanit ation are assured at the household level and in the community, and
The mother, or other caregiver can reli ably aff ord to provide sufficient RF (milk), to support normal growth and development of the infant, and
The mother or caregiver can prepare it frequently enough in a cl ean manner so that it is safe and carries a low risk of diarrhoea and malnutrition, and
The mother or caregiver can, in the first six months exclusively give repl acement f eedi ng, and
The family i s supportive of this practice, and
The mother or caregiver can access health care that offers comprehensive child health services.



81
List of reference doctors for advice on PPTCT and infant feeding and Pediatric Care



Sl.
No.
Name of centre Contact person email mobile Other contact
No.