Evths - Naco 2023

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Contents

1. Foreword I & II v & vi

2. Preface vii

3. Message viii

4. Acknowledgement ix

5. List of abbreviations xi

Chapter 1 Introduction and background 1

Chapter 2 Primary prevention, family planning and 7


pre-conception care

Chapter 3 HIV and Syphilis screening and diagnosis during 10


pregnancy and Direct-in labour

Chapter 4 Care of pregnant and breastfeeding women 17

Chapter 5 Care of exposed infants 22

Chapter 6 Data management 27

Chapter 7 Commodity management 31

Chapter 8 District/Cluster EVTHS intensification plan 34

Chapter 9 Human resource management 40

Chapter 10 Training and capacity building 51

Annexures - I 55
HIV-1 Viral Load Sample Collection, Processing, Storage,
Packaging and Transportation at Linked ARTC/ICTC for
Pregnant Women

Annexures - II 57
Sample Packaging and Transportation Requirements

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note iii


List of Tables:
Table No. Name of Table Page No.
1.1. Maternal, obstetrical, and infant factors that increase the risk 5
of HIV transmission.
1.2. Estimated Adverse Birth Outcomes of Syphilis in 6
Pregnancy (India, 2012)
3.1. Referrals & Linkages 13
5.1. Role & Responsibilities of HCW 25
6.1. Line-list Details for HIV (Pregnant Women & exposed infants) 27
6.2. Line-list Details for Syphilis (Pregnant Women & exposed 28
infants)
6.3. Key Indicators for Monitoring of EVTHS Programme 28
7.1. Commodity and Logistics 33
10.1. Proposed Training at National and State Level for EVTHS 51
Implementation
10.2. Frequency of Virtual Review Meetings during the 52
Implementation Phase
10.3. Frequency & Reporting During the Implementation Phase 54

List of Figures:
Figure No. Name of Figure Page No.
3.1. Screening of HIV and Syphilis using Dual RDT at screening 12
sites
3.2. HIV testing algorithm at confirmatory sites 14
3.3. Screening and Management of Syphilis in Pregnancy 15
4.1. Cascade of Services for pregnant women living with HIV 18
4.2. Cascade of Services for Pregnant Women for Syphilis 20
(screening with Dual RDT)
4.3. Cascade of Services for Pregnant Women for Syphilis 20
(screening with RPR/VDRL)
5.1. Cascade of Care Services for HIV Exposed Infants 23
5.2. Care Cascade for Management of Syphilis-exposed Infants 25
At-birth
10.1. Supportive Supervision Framework of EVTHS 53

iv Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


List of Acronyms and Abbreviations
AAP Annual Action Plan
ANC Ante-natal Care
ANM Auxiliary Nurse Midwife
ANMOL ANM Online
ART Antiretroviral Therapy
ARTC Anti-Retroviral Therapy Centre
ARV Antiretroviral
ASHA Accredited Social Health Activist
BRICS Brazil, Russia, India, China & South Africa
BPG Benzathine Penicillin G
BSD Basic Service Division
CD4 Cluster of Differentiation 4
CHC Community Health Centre
CMHO Chief Medical and Health Officer
CPT Cotrimoxazole Preventive Therapy
CSC Care and Support Centre
CST Care, Support and Treatment
DAPCU District AIDS Prevention and Control Unit
DBS Dried Blood Spot
DIL Direct-In-Labor
DISHA District Integrated Strategy for HIV/AIDS
DLN District Leprosy Officer
DMC Designated Microscopy Centre
DNO DAPCU Nodal Officer
DPMU District Programme Management Unit
DSRC Designated Sexually Transmitted Disease/Reproductive Tract Infection
Centre
EID Early Infant Diagnosis
EPI Expanded Programme on Immunization
EVTHS Elimination of Vertical Transmission of HIV and Syphilis
FOGSI Federation of Obstetric and Gynecological Societies of India
FRU First Referral Unit
HCTS HIV Counseling and Testing Services
HEI HIV Exposed Infant
HIV Human Immunodeficiency Virus

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note xi


AIDS Acquired Immune Deficiency Syndrome.
HMIS Health Management Information System
IAP Indian Academy of Pediatrics
IEC Information, education, and communication
IIMS Integrated Information Management System
ILFS Integrated Life Skills
IM Intramuscular
IMA Indian Medical Association
LAC Link ART Centre
LBW Low Birth Weight
LMP Last Menstrual Period
LR Labour Room
LT Laboratory Technician
M&E Monitoring and Evaluation
MCP Maternal and Child Protection
MH Maternal Health
MLL Master List of Clients Living with HIV
MO Medical Officer
MoHFW Ministry of Health and Family Welfare
NACO National AIDS Control Organization
NACP National AIDS & STD Control Programme
NCD Non-communicable Disease
NHM National Health Mission
NICU Neonatal Intensive Care Unit
NTEP National Tuberculosis Elimination Programme
OI Opportunistic Infection
pCoE Pediatric Center of Excellence
PD Project Director
Pediatric A Medical Facility specialized for treating infants & children
Treatment
Facility
PHC Primary Health Centre
PIP Programme Implementation Plan
PLHIV People Living with HIV
PMTCT Prevention of Mother-to-Child Transmission
PoC Point of Care
PPE Personal Protective Equipment
RCH Reproductive and Child Health

xii Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


RDT Rapid Diagnostic Test
RMNCA+ Reproductive, Maternal, Newborn, Child and Adolescent Health
RNA Ribonucleic Acid
RPR Rapid Plasma Reagin
RTI Reproductive Tract Infection
SACEP State AIDS Clinical Experts Panel
SACS State AIDS Control Society
SA-ICTC Stand-Alone Integrated Counselling and Testing Centre
SEI Syphilis Exposed Infant
SHS State Health Society
SI Strategic Information
SNCU Special Newborn Care Unit
SPMU State Programme Management Unit
SRH Sexual and Reproductive Health
SSV Supportive Supervision Visits
STI Sexually Transmitted Infection
Syphilis A Sexually Transmitted Infection Caused by the Bacterium Treponema
Pallidum
T. pallidum Treponema pallidum
TB Tuberculosis
TPHA Treponema Pallidum Hemagglutination Assay
VDRL Venereal Disease Research Laboratory
VHSND Village Health, Sanitation, and Nutrition Day
VL Viral Load
WHO World Health Organization
WLHIV Women Living with HIV

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note xiii


Purpose of This Guidance Document
This guidance document is a comprehensive resource for the successful implementation
of the first phase of the Elimination of vertical transmission of HIV & Syphilis (EVTHS)
services under NACP V. It provides a standardized approach to implement clear and
concise instructions, comprehensive indicators, and guidance on resource management,
reporting and documentation, and capacity building. By following the guidance provided
in the document, healthcare providers can effectively prevent vertical transmission of
HIV and Syphilis and improve the health outcomes of mothers and their infants.

Following are the key contents of this guidance document: -

1. Standardized Implementation: The guidance document provides a standardized


approach to implementing the EVTHS services across high priority EVTHS states in
India. This ensures consistency and quality of care provided to pregnant women and
exposed infants, leading to better health outcomes for mothers and infants.
2. Step-by-Step Approach: The guidance document provides a step-by-step approach
to implementing the EVTHS services based on revised EVTHS Guidelines 2022, from
the strategic, technical, and operational aspect including planning, monitoring
and evaluation. This ensures that all essential components of the programme are
included and implemented effectively.
3. Clear and Concise Instructions: The guidance document provides clear and concise
instructions for implementing the core interventions to prevent vertical transmission
of HIV and Syphilis. This includes guidance on antenatal care, testing and treatment,
and infant feeding and care.
4. Comprehensive Indicators: The guidance document includes a set of comprehensive
indicators to monitor and evaluate the EVTHS programme implementation and
effectiveness. This helps to identify gaps and areas for improvement, ensuring that
the programme is effective in reducing the number of new infections.
5. Resource Management: The guidance document provides guidance on resource
management, including human resources. This ensures that resources are allocated
effectively and efficiently to achieve the objectives to achieve EVTHS.
6. Reporting and Documentation: The guidance document provides guidance on
reporting and documentation, ensuring that data is collected and analyzed to inform
decision-making and in the program.
7. Capacity Building: The guidance document provides guidance on capacity building,
ensuring that healthcare providers are equipped with the knowledge and skills
to effectively implement the EVTHS services. This includes training in testing and
treatment, as well as communication and counseling skills.

xiv Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


Chapter Introduction

1 and Background

Introduction
The term “vertical transmission” refers to the spread of infection from mother to child,
which can take place during pregnancy (in utero), during labour and delivery (perinatal),
or postpartum through breastfeeding. In recent years, substantial efforts have been
made to prevent vertical transmission of HIV and Syphilis in pregnant women.

India has been making significant efforts and demonstrating strong commitment
towards eliminating vertical transmission of HIV and Syphilis. The country has taken a
multi-pronged approach that includes prevention, testing, treatment, and community
engagement. The National AIDS & STD Control Programme (NACP) is a flagship
programme of the Government of India that focuses on preventing and controlling HIV/
AIDS & Syphilis in the country. The programme has made significant progress in reducing
the spread of HIV and increasing access to antiretroviral therapy for people living with
HIV. India has also been implementing a programme to eliminate mother-to-child
transmission of HIV and Syphilis. This programme includes providing antiretroviral therapy
to HIV-positive pregnant women, testing for Syphilis, and providing treatment for those
who test positive. India has also been working on reducing stigma and discrimination
towards people living with HIV, which has been a major barrier to accessing healthcare
services. In addition, India has been engaging with communities and key populations,
such as men who have sex with men, transgender people, and sex workers, to increase
awareness, provide support, and encourage testing and treatment. Overall, India’s efforts
and commitment towards HIV and Syphilis elimination have been remarkable and have
contributed significantly to reducing the burden of these diseases in the country.

Several countries are now poised to eliminate vertical transmission of both these
diseases. Cuba was the first country to be validated for successful elimination of vertical
transmission of HIV and Syphilis in 2015. As of November 2021, globally, fifteen countries
and territories have been validated for elimination of vertical transmission of HIV and
Syphilis and one country has been certified on the silver tier, in the path to elimination.
In South-East Asian Region, three countries have been validated for having achieved
elimination of vertical transmission of HIV and Syphilis (EVTHS), Thailand in 2016, Maldives
and Sri Lanka in 2019. The momentum created by this process has galvanized many more
countries globally, including India, to strengthen their programmatic performance and
work towards elimination of vertical transmission of HIV and syphilis (EVTHS).

India has made a commitment to end the AIDS epidemic as a public health threat by
2030 in accordance with the Sustainable Development Goals (SDG). This commitment
was reiterated by the Government of India at various international forums, such as the

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note 1


United Nations General Assembly and BRICS. In India, the Prevention of Parent to Child
Transmission of HIV/AIDS (PPTCT) programme was launched under the second phase
of the National AIDS Control Programme (NACP) of the Government of India in the year
2002. Since then, eliminating vertical transmission of HIV and Syphilis remains one of
the key objectives under NACP. Initially, the aim was to attain the elimination of vertical
transmission of HIV by 2015, which was subsequently shifted to 2020.

The global 95-95-95 targets for EVTHS of HIV are a set of goals established by the Joint
United Nations Programme on HIV/AIDS (UNAIDS) in 2016. The targets aim to achieve
a significant reduction in new HIV infections among children and improve the health
outcomes of mothers living with HIV. The 95-95-95 targets refer to three key goals: By
2030, 95% of all pregnant women living with HIV should know their status. By 2030,
95% of all pregnant women diagnosed with HIV should receive sustained antiretroviral
therapy (ART). By 2030, 95% of all infants born to women living with HIV should have an
HIV-negative status.

India has programmatically moved towards achieving the global 95:95:95 targets by
2025. These targets aim to ensure that 95% of all pregnant women diagnosed with HIV
are aware of their status, 95% of pregnant women diagnosed with HIV are on treatment,
and 95% of all infants born to women living with HIV have HIV-negative status. However,
achieving these targets requires sustained commitment and action to address the scale
of challenges ahead.

The progress in EVTHS interventions has also been significant; while the registration of
pregnant women in ante-natal care (ANC) services was 95% in 2021-22, the HIV testing
reported in pregnant women for HIV was 84% and for Syphilis was 57%. ART coverage
in pregnant mothers with HIV infection was 64% against a target of 95%. Adequate
treatment coverage in pregnant women seropositive for Syphilis was 78% against a target
of 95%. As the new HIV infection declined significantly, the pediatric case rate declined
below the target level of <50 per 100,000 live births, but the mother to child transmission
rate continued to be high (24%) given the progress on testing and treatment coverage.

Problem Statement
The HIV/AIDS epidemic in India is the second largest in the world with approximately
2.4 million people living with the virus. The government’s response to this epidemic
has been through the National AIDS Control Programme (NACP) since 1992, which has
been successful in preventing new HIV infections and reducing AIDS-related mortality.
However, certain areas, such as the elimination of vertical transmission of HIV and
Syphilis, require more attention and prioritization.

The World Health Organization (WHO) has identified HIV and Syphilis as two perinatally
acquired infections targeted for elimination globally. While the overall response to the
HIV/AIDS epidemic is on track, specific implementation domains require prioritization to
accelerate progress towards the attainment of the 2030 goal.

2 Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


Under the second phase of the National AIDS Control Programme (NACP) in 2002, the
Government of India launched interventions to prevent the vertical transmission of HIV,
which has remained a key objective of the programme. The initial goal was to achieve
elimination of vertical transmission by 2015, which was later revised to 2020. The four-
pronged strategy for HIV prevention includes primary prevention, preventing unintended
pregnancies, preventing vertical transmission, and providing care, support, and treatment
for women living with HIV and their children. The strategies for Syphilis elimination require
sustained commitment and advocacy, improved access to reproductive, maternal,
newborn, child health, and adolescent services, including screening of pregnant women,
treating Syphilis-positive women, their partners, and newborn infants, and strengthening
surveillance, monitoring, and evaluation. Although there has been significant progress
on eliminating the vertical transmission of HIV and Syphilis, more work needs to be done
to achieve the World Health Organization’s targets for elimination. While the registration
of pregnant women for ante-natal care services is high, between 92-97%, the progress on
HIV and Syphilis testing and treatment has been slower, with HIV testing and treatment
coverage never exceeding 82%. Syphilis testing coverage among pregnant women is
reported to be much lower than HIV testing. Although the number of new pediatric
HIV cases has declined significantly, falling below the target level of <50 per 100,000 live
births, the mother-to-child transmission rate remains high at 24%, indicating a need to
improve testing and treatment coverage. Almost 8% of the estimated new HIV infections
in India in 2021 were contributed by mother-to-child transmission.

To speed up the progress towards eliminating vertical transmission of HIV and Syphilis,
the fifth phase of the NACP programme set a goal of achieving this by 2025. This is
a significant move, as the programme is already ahead of the curve in terms of viral
load suppression, reflecting the country’s strong commitment to making progress. By
including this goal in high-level strategies and documents, the country is signaling
its determination to achieve this objective and providing a strong incentive for action.
The next step would be to develop strategic pathways that guide the actions needed
to achieve these targets and achieve WHO validation status of HIV/AIDS & Syphilis
elimination status.

Rationale for the State Selection


In the first Phase, the EVTHS programme will be rolled out and implemented in 7 high
priority EVTHS States of India. The rationale behind selecting these seven states for the
implementation of Elimination of Vertical Transmission of HIV & Syphilis (EVTHS) in phase
1 was based on several factors such as:

„ High prevalence of HIV and Syphilis: These states have a higher prevalence of HIV
and Syphilis among pregnant women and the general population, which makes
them more susceptible to the spread of the infection.
„ High population density: Most of these states have a high population density, which
increases the risk of transmission of HIV and Syphilis among pregnant women and
their newborns.

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note 3


„ High number of pregnant women: These states cover more than 50% of EVTHS need
making them an ideal target for the implementation of EVTHS programmes.
„ These states also provide adequate geographical representation from the country.

Overall, the selection of these seven states have been based on a combination of the
above factors and the need to target areas where the burden of HIV and Syphilis is the
highest to achieve the maximum impact of the programme.

Background of HIV and Syphilis


Human Immunodeficiency Virus (HIV)
Human immunodeficiency virus (HIV) is a retrovirus which carries their genetic
information in the form of RNA. Once HIV is acquired, people carry it for the rest of their
lives. HIV explicitly targets CD4 cells (also known as T lymphocyte cells), which aid in the
immune system’s ability to fight off infections. In newborns and young children, the HIV
disease advances quite aggressively. In the absence of proper care and treatment, over
half of children under the age of two who are affected with HIV will die by the time they
turn two years old. The body’s immune processes are restored by antiretroviral therapy
(ART), resulting in a long-lasting reduction in the HIV viral load. The reduction in viral
load causes reduced HIV transmission risk and fewer new HIV infections. To enhance the
health of those living with HIV and to stop vertical transmission of the virus, early access
to antiretroviral therapy (ART) and adherence to lifelong treatment are essential.

Syphilis
Syphilis is a sexually transmitted infection caused by a bacterial spirochete Treponema
pallidum. This infection may progress to chronic infection with various adverse systemic
outcomes if not treated early. Syphilis has three stages:

„ Primary Syphilis: The primary stage starts after 21 days (10-90 days) following Syphilis
infection. The infected person may present with a painless ulcer lasting up to 2 to 6
weeks.
„ Secondary Syphilis: The secondary stage is characterized by developing skin rashes
over the body, often associated with fever and muscle pain. The stage lasts for 2-6
weeks. A latent stage is mostly asymptomatic and may last for up to a few years. The
spirochetes may circulate in blood during this phase leading to infection of all the
organs in the body.
„ Tertiary Syphilis: The stage occurs after several years of infection and can be
manifested as neurosyphilis (when the brain/spinal cord is affected), cardiovascular
Syphilis (when the heart and aorta are affected), or late benign Syphilis (when the
skin is primarily involved). The complications can be developed in 40% of people with
the latent infection without treatment.

An infected pregnant woman’s blood contains the infectious agent (T. pallidum), which
can be passed to the fetus vertically and may cause several unfavorable birth outcomes.

4 Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


Early fetal loss, stillbirths, neonatal mortality, low birth weight, preterm, and infection
transmission to newborns are only a few of the adverse birth outcomes the infection is
linked to (also known as congenital Syphilis). Congenital Syphilis is a dangerous condition
that can be avoided by screening all pregnant women effectively and treating infected
pregnant women appropriately. Even one dose of injection Benzathine Penicillin G (BPG)
is sufficient to prevent infection to the fetus, regardless of the mother’s stage of Syphilis,
as Syphilis is curable with suitable therapy.

Risk Factors Associated with Increase in Vertical


Transmission of HIV and Syphilis
Risk of HIV transmission:
Vertical transmission is an important transmission route for new HIV infections in
children. Around 4% of HIV infections in India result from vertical transmission. However,
the risk factors for vertical HIV transmission to the unborn child vary. These could include
newborn risk factors, infant feeding risk factors, or maternal and obstetrical risk factors
as depicted in Table 1.1.

Table 1.1. Maternal, obstetrical, and infant factors that increase the risk of HIV
transmission.

Maternal Factors Obstetrical factors Infant factors


„ Recent HIV infection in „ Uterine manipulations „ Immature Immune
mother (external cephalic System
„ High viral load and advanced version) „ Preterm baby
HIV disease „ Prolonged rupture of „ Low birth weight
„ Resistant strains the membranes (>4 (<2.5kg)
hours)
„ Advanced clinical stage „ First infant of
„ Placental abruption, multiple births
„ Concurrent STI
chorio-amnionitis
„ Viral, bacterial, and parasitic „ Immature Gastro-
„ Intrapartum Intestinal tract
(esp. malaria) placental
hemorrhage
infection „ Mouth sores or an
„ Invasive delivery inflamed GI tract in
„ Malnourishment
techniques: baby
„ Conditions of breasts (sore
episiotomies, forceps,
nipple, breast abscess, „ Mixed feeding:
use of metal cups for
mastitis etc.) Breast milk along
vacuum delivery
with other feeds
„ Mother acquired HIV
„ Invasive fetal
infection during pregnancy or
monitoring
breastfeeding

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note 5


Risk of transmission of Syphilis and impact of maternal
Syphilis on pregnancy outcome
The risk of transmission of syphilis to sexual partners and fetus is most significant during
the first two years following infection and steadily declines. However, there are still some
chances of transferring the infection to the fetus even after two years. Most women
with an untreated infection in its early stages (less than a year old) will transmit it to the
fetus. The transmission can happen as early as the ninth week of pregnancy, although it
typically happens between the 16th and the 28th week. In the early stages of a woman’s
infection, the likelihood of transmission from mother to the child might reach up to 80%.

The exact incidence of congenital Syphilis in India is not known due to the absence of
active surveillance, or any specific programme focused on investigating infants born to
Syphilis reactive mothers.

The estimated number of newborns with clinical evidence of Syphilis due to mother-
to-child transmission was 16,324 in 2012. The estimates were calculated using WHO tool
for estimation of maternal Syphilis and its adverse outcomes. The estimations were
based upon the sero-reactivity of Syphilis as per HSS 2010-11 for ANC attendees and the
proportion of pregnant women accessing ANC services as per HMIS 2010 -11 out of the
estimated 29,681,000 pregnancies. The estimated adverse birth outcomes are mentioned
in Table 1.2.

Table 1.2. Estimated Adverse Birth Outcomes of Syphilis in Pregnancy (India, 2012)

Outcome Estimated number in India (2012)


Early fetal loss/still births 21,488
Neonatal deaths 9,213
Prematurity/LBW babies 6,161
Clinical evidence of Syphilis in newborns 16,324
Any adverse outcomes 53,187

6 Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


Chapter Primary Prevention,

2 Family Planning and


Pre-conception Care

Primary Prevention
This includes a mix of commodity services (like differential HIV testing, STI screening),
non-commodity services (like counselling and risk reduction) and referral services
to engage women who are ‘at-risk’ of acquiring HIV/Syphilis to ensure that they stay
negative and healthy.

Who is responsible: SACS at state level, DISHA at district level in coordination with
RMNCHA+

Activities:
IEC:
1. Focused and customized IEC material (pamphlets, posters, audio-visual, social media
messages, etc.) on prevention of HIV and Syphilis in regional/local languages.
2. IEC campaigns on EVTHS should be rolled out in mission mode at least once a year.
3. EVTHS week may be celebrated to generate awareness with focus on priority districts.

Training:
1. Training of schoolteachers on prevention of HIV and STIs facilitated through Health
and Wellness Ambassadors under the School Health and Wellness Program.
2. Adolescent Education Programmes and Red Ribbon Clubs to engage with the youth.

Counseling:
1. Inform, educate, and counsel adolescents on adolescent health issues and refer
clients to health facilities, or HCTS confirmatory facilities, de-addiction centres, Non-
communicable Diseases’ clinics, etc.
2. Counsellor at ART centre counsels the adolescents living with HIV for safer sex
practices, positive and healthy living, and prevention of transmission of HIV/Syphilis.
3. Counsellor provides counselling services to high-risk population regarding safer sex
practices, behavior change and condom promotion for reduction of STI/RTIs.
4. Women in the reproductive age group should be encouraged to establish and
maintain routine gynecological care, nutritional care, and management of NCD’s
through regular visits to health facilities.

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note 7


Family Development Groups (FDG):
1. Services targeted towards counselling all women in the reproductive age group on
nutrition, food fortification, importance of micronutrients etc. in VHSND programs.

Family Planning Services for PLHIV


Ensuring that people living with HIV have access to stigma-free family planning services
to prevent unintended pregnancies.

Who is responsible: ART centre (Counsellors and ART MO)

Activities:
IEC:
1. Prepare line list of eligible PLHIV in reproductive age group based on IIMS.
2. Counseling:
y Counseling on family planning during follow up at ARTC and document in white
card’s ‘SRH section.’
y Counseling on pregnancy planning if desire pregnancy and provide preconception
care.

FDG:
1. Assessment of requirement and linkages to family planning centre for further services

Preconception Care
Preconception care to be provided to all WLHIV who desire pregnancy as well as negative
partner of HIV positive male who desire pregnancy. The viral suppression of the HIV-
infected partner before pregnancy is a key factor in addition to optimal health condition.

Who is responsible: ART centres

Activities:
IEC:
1. Prepare line list of the couple where one or both partners are infected with HIV and
desire to have a child.

Training Counseling:
1. Ensure viral load suppression before planning pregnancies and optimal ART
adherence.

8 Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


2. Ensure optimal health of the couple. Anemia and malnutrition may be treated by
ART medical officer as PLHIV nutritional requirements and drug-induced anemia
needs special care.
3. Screening and management of STI/RTI of both the partners.

FDG:
1. Link to maternal health services for preconception care.

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note 9


Chapter HIV and Syphilis

3 Screening & Diagnosis


During Pregnancy &
Labour

HIV and Syphilis Screening During Pregnancy


The screening of HIV & Syphilis during pregnancy should be done using HIV & Syphilis
dual rapid diagnostic testing (Dual RDT) kits. However, when Dual RDT is not available
separate PoC test kits for HIV and Rapid Plasma Reagin (RPR) or Venereal disease research
laboratory (VDRL) test for Syphilis may be used.

Who is responsible: Facilities providing ANC services such as VHSND/HWC and labour
rooms with support from nearest HCTS confirmatory facilities.

Activities:
A) Screening of HIV and Syphilis
„ Screen all pregnant women for HIV & Syphilis in the first trimester preferably at the
first ANC visit.
„ Provide pre-counseling, collect consent and post-test counseling for HIV testing as
per guideline.
„ If pregnant women are ‘at-risk’ of HIV/Syphilis infection, the screening should be
repeated in third trimester and at-labour.
In the context of Elimination of Vertical transmission of HIV & Syphilis (EVTHS) under
the National AIDS Control Programme (NACP) in India, «at-risk women» include the
following:- Adolescent Girls and Young Women with high-risk behaviour; Women
from high-risk groups such as female sex workers (FSW), Female Injecting Drug Users
(FIDU); Women with multiple sexual partners or unstable housing/ homelessness or
history of transactional sex, drug use, chemsex, domestic violence, current or past
history of STI/RTI; Female spouse/partners of high-risk groups, bridge populations and
HIV infected males; Walk-in clients with self-perceived risk who screened negative
for HIV/Syphilis; Pregnant women with high-risk behaviour who screened negative
for HIV/Syphilis; Women meeting any of the above criteria and identified through
virtual interventions.
If serologically non-reactive for Syphilis during pregnancy, the screening should
also be repeated among pregnant women who live in areas with high prevalence of
Syphilis among pregnant women (>1% sero-positivity) and for women who are at-risk

10 Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


for acquisition of Syphilis during pregnancy in the third trimester (may be around
32nd-36th week). Additional criteria for repeat testing for Syphilis are:
y Pregnant women with a history of repeated abortions, stillbirths, or past history
of delivery of premature babies or neonatal deaths.
y Testing at the time of delivery in cases where the partner was not tested/managed.
„ All pregnant women with unknown HIV/Syphilis status must be screened in the
labor room by labour room nurse, and appropriate linkages must be established for
subsequent care and treatment.
„ Ensure availability of HIV & Syphilis screening kits at facilities providing ANC services
such as VHND/ HWC/ PHC/ CHC/ FRU and labour room. Maintaining cold chain
throughout supply.
„ Reporting of HIV/Syphilis screening in HMIS/RCH portal-ANMOL/IIMS. This will be
ensured by nurses and data entry operators, who so ever is available and is in charge
for the job profile.

B) Linkages of HIV reactive cases. (By ANM/Nurses)


„ If any pregnant woman is found screened reactive for HIV, then the ANM should
write on the MCP card “Referred to SA-ICTC” and refer the pregnant woman to SA-
ICTC. She must also share details with the linked In-charge PHC MO. This will ensure
proper management of the pregnant women’s HIV infection and reducing the risk of
vertical transmission. This may also facilitate timely initiation of antiretroviral therapy
(ART) for the woman to improve her own health and reduce the risk of transmission
to the infant.
„ If confirmed positive for HIV, then ensure linkage to nearest ART Centre. This may
be ensured by ANM caring for the pregnant women or by the counsellor of the
confirmatory facility (Ref Figure 3.1 & 3.2 & Table 3.1).

C) Linkages of Syphilis reactive cases.


„ If any pregnant woman is found reactive for Syphilis, then the ANM should write on
the MCP card for the pregnant woman “Reactive for Syphilis” and refer the pregnant
woman to nearest PHC. She must also share details with the linked In-charge PHC
MO.
„ Ensure at-least one dose of injection benzathine penicillin to all the pregnant women
screened reactive for Syphilis at the nearest treatment facility (including DSRC).
„ Link all screened Syphilis reactive pregnant women to confirmatory sites for
confirmation. All women screened reactive with RPR/VDRL should be provided with
complete treatment with 3 doses of injection benzathine penicillin at the nearest
treatment facility (including DSRC) (Ref Figure 3.1 & 3.3 & Table 3.1).

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note 11


D) Follow up of all Reactive cases (HIV/Syphilis)
„ All pregnant women referred to other HIV services including ART Centre, should be
tracked to ensure that they actually avail the services, and have been registered at
the respective Centres.
„ All the pregnant women screened reactive for Syphilis should be followed for
complete treatment. The treatment response should be monitored after 3 months/
3rd trimester/ at-labour (whichever is earlier) of completion of treatment at DSRC/
treatment facility.

Data Confidentiality:
The HIV and AIDS (Prevention & Control) Act, 2017, Chapter V, Clause 11 Confidentiality
of Data clearly mentions “Every establishment keeping the records of HIV-related
information of protected persons shall adopt data protection measures in accordance
with the guidelines to ensure that such information is protected from disclosure.”

Explanation. — For the purpose of this section, data protection measures shall include
procedures for protecting information from disclosure, procedures for accessing
information, provision for security systems to protect the information stored in any form
and mechanisms to ensure accountability and liability of persons in the establishment.

Ref:

i) Data Protection Guideline of National AIDS & STI Control Programme.


ii) Standard Operation Procedures for HIV & Syphilis Screening at VHSND, MH division,
MoHFW

Figure 3.1. Screening of HIV and Syphilis using Dual RDT at screening sites.

12 Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


Table 3.1. Referrals & Linkages

No. Result of Screening Referral Action


HIV Syphilis
1 Reactive Reactive Refer to SA-ICTC (HIV reactive cases)
Refer to MO-PHC/CHC or DSRC (Syphilis
reactive cases)
2 Reactive Non-Reactive Refer to SA-ICTC and ensure institutional
delivery
3 Non-Reactive Reactive Refer to MO-PHC/CHC or DSRC and ensure
institutional delivery
4 Non-Reactive Non-Reactive No referral required  re-testing of at-risk
women

(Ref: Standard Operation Procedures for HIV & Syphilis Screening at VHSND, MH
division, MoHFW)

Confirmation of HIV diagnosis:


Who is responsible: HCTS confirmatory facilities (Counsellor)

Activities:
„ All reactive cases need to be referred for confirmation at HCTS confirmatory facility
immediately preferably within one working day.
„ All reactive cases referred from screening sites should be fast tracked for HIV
confirmation testing.
„ At confirmatory facility, three test kits of different principles to be positive in sequence
before a diagnosis of HIV can be established (Fig. 3.2).
„ The pregnant women diagnosed as HIV positive, should be linked to ART centre
immediately preferably within one working day.
„ Recording of details of HIV testing in IIMS.

For more details on HIV testing and diagnosis, refer to the National HIV Counselling and
Testing Services (HCTS) Guidelines,2016.

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note 13


Figure 3.2. HIV testing algorithm at confirmatory sites

Confirmation of Syphilis diagnosis:


Who is responsible: DSRC or health facility with RPR/VDRL testing

Activities:
„ The pregnant women screened reactive for Syphilis (either through Dual RDT at
screening sites or RPR at confirmatory sites) will be provided with first on-spot dose
of injection benzathine penicillin G (BPG) at the nearest treatment facility (with
availability of BPG e.g., DSRC) without waiting for the confirmation. .
„ The second test for confirmation will be RPR/VDRL (wherein the screening test was
a PoC treponemal test or dual RDT kit) or TPHA, if available (when the screening
test was RPR/ VDRL). The availability of confirmatory testing will not be a criterion to
provide on-spot dose of BPG.
„ When facility for RPR/VDRL testing not available, pregnant woman may be referred
to nearest SA-ICTC or DSRC.
„ The details of screening and management of Syphilis in pregnancy are mentioned
in Figure 3.3.

14 Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


Figure 3.3. Screening and Management of Syphilis in Pregnancy

Index Testing HIV and Syphilis


Index testing for HIV:
Index testing for HIV is an important component of the EVTHS programme. In the
context of EVTHS, index testing involves identifying and testing sexual and/or drug-
using partners of pregnant women who are HIV-positive. The purpose of index testing

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note 15


in EVTHS is to identify and diagnose new HIV infections among partners of pregnant
women living with HIV, and to link them to appropriate prevention, care, and treatment
services.

When a pregnant woman is diagnosed with HIV, she is encouraged to disclose her status
to her sexual partner(s) and encourage them to get tested. If the partner is willing to get
tested, healthcare providers can use the information provided by the pregnant woman
to locate the partner(s) and offer them HIV testing and counseling. This approach helps
to identify new HIV infections and link partners to care and treatment services, including
antiretroviral therapy (ART) to reduce the risk of HIV transmission.

Who is responsible: Counsellor at HCTS confirmatory facility & ARTC

Activities:
1. Family testing
„ Spouse with unknown status
„ All biological children (age based on latest HIV testing guidelines of NACO) if the:
y Mother is HIV infected OR
y Father is HIV infected AND reports the child’s mother is HIV infected, deceased,
or having an unknown HIV status.
y Biological siblings and parents (if the index case is a child of less than 19 years)
2. Partner testing for all sexual or injecting drug using partners from the past year,
irrespective of consistent condom use/clean needle use.

Any person who has tested HIV positive must be linked with the ARTC for ART initiation
as soon as possible. Spouse/partner who is tested negative should be followed up further
as per the National Guidelines for HIV testing.

Partner Testing in Syphilis


Who is responsible: DSRC or health facility with RPR/ VDRL

Activities:
„ Partners of pregnant women who are screened reactive for Syphilis should be
evaluated clinically and serologically for confirmation, to be treated according to the
stage of infection to prevent re-infection to the pregnant women.
„ The dual RDT kits can be used for screening of spouses and partners of HIV and/or
Syphilis sero-reactive pregnant women.

16 Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


Chapter Care for Pregnant &

4 Breastfeeding Women
Infected with HIV
and/or Syphilis

Care of Pregnant and Breastfeeding WLHIV


Following screening and diagnosis of pregnant women living with HIV as discussed in
Chapter 3, optimal HIV care, support and treatment needs to be ensured. This needs to
be extended not just to the HIV infected women but also to their children and family.
This includes appropriate stigma-free management during pregnancy and delivery,
treatment support, breastfeeding counselling, immunization of the infant, and linkages
to appropriate health facilities for care of HIV-exposed infants for Early Infant Diagnosis
(EID).

Pregnant Woman Living with HIV or HIV/Syphilis


Co-infection
Who is responsible: ART Centre & DSRC

Activities:
1. For newly identified HIV positive women, rapid ART initiation preferably on same day,
ensuring all the necessary investigations as per ART guidelines.
2. Ensuring optimal health of pregnant women includes routine treatment monitoring
for both newly diagnosed and previously known HIV-positive pregnant and
breastfeeding women, as per the updated ART guidelines. This includes monitoring
of ART adherence, laboratory results, and clinical status. By monitoring these
parameters, healthcare providers can ensure that pregnant women are receiving
appropriate care and treatment to manage their HIV infection and reduce the risk of
transmission to their infants.
3. When pregnant women are provided refill at link ART Centre or through proxy pill
pick up, ensure optimal ART adherence through telephonic counseling or through in
person outreach session.
4. Viral load testing at 32-36 weeks of pregnancy
5. ARV prophylaxis prescription for HIV exposed infant based on maternal viral load
result by ART Medical officer.
6. Infant feeding counseling to be provided by the counselor to support the family in
making the choice between infant feeding options as per the guidelines.

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note 17


7. Birth planning in discussion with pregnant women and her family and pre-
sensitization of selected ANC clinics/delivery sites for stigma free respectful maternal
care.
8. If pregnant women are co-infected with Syphilis, ensure referral to DSRC for
management as per protocol in the Draft National EVTHS Guidelines.
9. The Syphilis co-infected pregnant women should be managed as per the updated
guidelines
(Note: When pregnant women cannot reach ART centre, the care can be provided at
Linked ART Centre under supervision of ART MO. In few cases when pregnant women
cannot reach to Link ART centre, ART MO may coordinate with the nearest health facility
preferably with trained MO or through teleconsultation for providing essential HIV care.
Similarly, viral load sample can be collected to nearest HCTS. Please refer Annexure I for
collecting VL sample at HCTS confirmatory facility.). The Cascade of Services for pregnant
women living with HIV is discussed in Figure 4.1.

Figure 4.1. Cascade of Services for pregnant women living with HIV

18 Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


Syphilis Infected Pregnant Women
Who is responsible: ANM at health facility providing ANC and DSRC counselor

Activities:
1. Link to nearest health facility for first dose of BPG administration.
2. Ensure complete treatment (a total of 3 doses of BPG) for all pregnant women
screened reactive with RPR/VDRL test.
3. Birth planning and pre-sensitization of delivery sites for care during labour and
referral to Special Newborn Care Unit (SNCU)/Neonatal Intensive Care Unit (NICU)/
Pediatric treatment facility at Medical College/ District Hospital/ Sub-district Hospital
for management of exposed infants.
4. Repeat serological titers preferably at least after 12 weeks of treatment/ 32nd week of
pregnancy/ at the time of labour (whichever is earlier).
5. If the titer values persist at the same level or increases after 12 weeks, treatment
failure or re-infection can be suspected, and complete treatment should be given
again according to the treatment protocol.
6. The pregnant women with HIV & Syphilis co-infection will be managed as per the
draft National Guidelines.
7. The NACP counselor will be responsible for adequate follow-up for complete
treatment, treatment monitoring and institutional delivery. He/she will also ensure
compulsory follow-up of Syphilis-exposed neonate at birth, 14 weeks, and 6 months.

The cascade of services at screening sites are mentioned in figure 4.2 & 4.3.

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note 19


Figure 4.2. Cascade of Services for Pregnant Women for Syphilis
(screening with Dual RDT)

Figure 4.3. Cascade of Services for Pregnant Women for Syphilis


(screening with RPR/VDRL)

20 Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


Care and Assessment of Pregnant Women Presenting
Directly in Labour with Unknown HIV/Syphilis Status or
at-risk pregnant women
Who is responsible: Labour room (Nurses)

Activities:
„ Labour room nurse will offer bedside counselling and HIV screening tests for those
women reporting with unknown HIV status.
„ With consent, HIV screening is to be done using the Point-of-care (POC) test - ‘Whole
Blood Finger Prick Test’ or Dual RDT kits in the delivery room or labour ward.
„ If reactive for HIV, the medical officer in charge of the labour room is responsible for
ensuring referral of the mother to HCTS for HIV confirmation and ART linkage.
„ Labour room nurse informs the HCTS confirmatory site counsellor for further
confirmation of HIV status as per guidelines.
„ If HIV-positive status is confirmed at HCTS confirmatory site, rapid ART initiation as
per guidelines.
„ LR Medical Officer will prescribe dual prophylaxis to the infant if the mother is reactive.
The prophylaxis is to be continued until the HIV status of the mother is confirmed. If
the mother is Positive, the prophylaxis will continue as per protocol and if negative,
the prophylaxis can be discontinued.
„ The following pregnant women coming directly in-labour (DIL) should be screened
for Syphilis:
y No history of ANC visits
y No documentation of Syphilis screening during pregnancy
y At-risk pregnant women
„ These direct-in-labour cases can be screened for Syphilis as per the availability of
screening kits – RPR/VDRL or Dual RDT kits.
„ If screened reactive, the woman should receive complete treatment as per the stage
of Syphilis after delivery. The first dose of injection BPG may be administered during
the hospital stay. If BPG is not available, the pregnant women may be referred to the
DSRC for further management. This will not be beneficial to the infant; however, it
will ensure initiation of treatment to the mother.

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note 21


Chapter Care of HIV & Syphilis

5 Exposed Infants

HIV Exposed Infants


The term ‘HIV-exposed infants/children’ is used to describe infants or children born to
mothers infected with HIV, until it can be determined whether or not they themselves have
acquired the virus. Regardless of their HIV status, HIV-exposed infants are at a heightened
risk of malnutrition, growth failure, developmental delays, and repeated morbidity from
infectious diseases caused by both common and uncommon pathogens. Therefore, it
is important to provide appropriate care and support for these infants to ensure their
optimal health and development. Exposed infants who themselves acquire HIV infection
are even more vulnerable to repeated infections, malnutrition and developmental delay.
HIV disease progresses very rapidly in young children, especially in the first few months
of life, often leading to death. Thus, it is very important to follow all HIV-exposed infants
with a structured plan to minimize risk of HIV transmission, ensure timely detection and
management of HIV infection, early detection of OIs, and to give optimal comprehensive
care to improve their overall outcome. (Source: Section-3.1, National Guidelines on HIV
Care and Treatment, 2021)

Who is responsible: ART centre and labour room

Activities:
„ Provide immediate care at birth as per guidelines.
„ At birth, provide ARV prophylaxis preferably within one hour based on the prescription
of ART medical officer.
„ For infants whose mothers are identified during labour (DIL), the labour room nurse
will coordinate with the nearest HCTS counselor. The HCTS counselor will mobilize
ARV prophylaxis to the labour room to ensure administration of ARV prophylaxis to
the infant within 72 hours of delivery.
„ Start Infant feeding based on the counseling provided during the ANC period.
„ For infants whose mothers are identified during labour (DIL), may be counseled for
infant feeding options by the labour room nurse and start infant feeding accordingly.
„ Monitoring of ARV prophylaxis for adherence.
„ Initiation of CPT at 6 weeks and adherence monitoring.
„ Follow up of exposed infants at ARTC for growth and development monitoring and
clinical assessment as per the guidelines at 6 weeks, 6 months, 12 months and 18
months. EID at collocated HCTS confirmatory sites.

22 Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


„ Additional monitoring of growth and development at 10 weeks, 14 weeks, 9 months and
15 months as per the ART guidelines at health facilities preferably with pediatricians
„ Initiate ART if exposed infants found HIV positive at any time.
„ Final diagnosis at 18 months or after 3 months of cessation of breastfeeding whichever
is later. Regular follow up of infants till final diagnosis.
„ Refer infant for Syphilis care if mother is co-infected with Syphilis.

(Note: When the baby cannot reach ART centre, the care can be provided at Linked ART
Centre under supervision of ART MO. In few cases when the baby cannot reach to Linked
ART centre, ART MO may coordinate with nearest health facility preferably with trained
MO or through teleconsultation for providing essential HIV care)

Figure 5.1 Cascade of Care Services for HIV Exposed Infants

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note 23


Syphilis Exposed infants
The infection is associated with various adverse birth outcomes including early fetal loss,
still births, neonatal deaths, low birth weight, prematurity, and transmission of infection
to infant (also known as congenital Syphilis). The term ‘Syphilis exposed infants’ in
this document is used to refer to infants born to mothers infected with Syphilis, until
congenital Syphilis infection can be reliably excluded or confirmed.

Congenital Syphilis is a severe, yet preventable disease that can be proactively eliminated
by implementing effective screening programmes for all pregnant women to detect
Syphilis infection and providing timely treatment to those who test positive. This includes
treating their partners and newborns to prevent transmission of the infection. By taking
these steps, healthcare providers can significantly reduce the risk of congenital Syphilis
and prevent the serious health consequences associated with the disease.

Who is responsible: DSRC, SNCU/NICU/Pediatric Treatment Facility

Activities:
„ Blood sample collection of mother and baby at the time of delivery as per guidelines.
„ Treatment of infants at birth at Special Newborn Care Unit (SNCU)/ Neonatal Intensive
Care Unit (NICU)/ Pediatric treatment facility at Medical College/ District Hospital/
Sub-district Hospital as per the National EVTHS guidelines.
„ Follow up of exposed infant at 14 weeks and 6 months for monitoring at health
facilities having pediatrician for follow-up.
„ Further follow up beyond 6 months, in case of treatment failure as mentioned in
National Guidelines.

(Note: Clinically difficult cases for both HIV or Syphilis exposed infants may be referred to
SACEP or pCoE on case-to-case basis through teleconsultation)

The care cascade of syphilis exposed infants is mentioned Figure 5.2 and roles &
responsibilities of HCW workers is mentioned in Table 5.1

24 Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


Figure 5.2 Care Cascade for Management of Syphilis-exposed Infants At-birth

Table 5.1 Role & Responsibilities of HCW


A. For HIV

Roles Primary Provider Alternative Provider


Counselling regarding Counsellor at ART Centre Direct in Labour
feeding practices presentation – Labour
room MO
Feeding initiation for infant Labour Room Nurse Labour Room Nurse based
based on feeding plan on feeding plan jointly
documented by ART decided by mother and
Counsellor labour room MO

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note 25


Roles Primary Provider Alternative Provider
ARV prophylaxis initiation Labour Room nurse Labour room MO based on
based on ART MO guidance chart for Direct in
prescriptions Labour presentations. ART
(ART Centre/HCTS Centre/HCTS counsellor to
counsellor to provide ARV provide ARV prophylaxis
prophylaxis drugs) drugs
ARV Prophylaxis Adherence Counsellor at ART Centre HCTS Counsellor
EID (6 weeks 6 months, 12 LT at co-located HCTS LT at any other nearest
months) Confirmatory Facility LAC/HCTS confirmatory
site preferred by mother in
discussion with ART MO
CPT initiation ART Centre MO/Nurse
Growth Monitoring of infant ART Centre Nurse Health Facility Nurse/MO
Immunization Health Facility Nurse/MO
Clinical follow-up at 6, MO at ART Centre Health Facility MO
10, 14 weeks, 6,9,12,15,18
months or till 3 months after
breastfeeding is stopped
ART Initiation for newly MO at ART Centre
diagnosed HIV positive
infants and children
Final testing at 18 months LT at co-located HCTS LT at any other nearest
or 3 months after stopping Confirmatory Facility LAC/HCTS confirmatory
breast feeding, whichever is site preferred by mother in
later discussion with ART MO

B. Syphilis

Roles Primary Provider Alternative Provider


Management of SEI at birth Pediatrician at SNCU NICU/Pediatric treatment
facility
1st Follow-up (14 weeks) FRU/Pediatric treatment -
facility
2nd Follow-up (6 months) FRU/Pediatric treatment
facility
Growth monitoring of infant FRU/Pediatric treatment Health Facility Nurse/MO
facility
Immunization FRU/Pediatric treatment
facility
Responsibility of follow-up Counsellor at DSRC Counsellor at
visits Confirmatory site

26 Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


Chapter Data

6 Management

This section presents the details to be captured for line-listing for HIV & Syphilis
components of EVTHS and key indicators for monitoring the programme (Table 6.1 – 6.3)

Table 6.1 Line-list Details for HIV (Pregnant Women & exposed infants)

S. No Variable/details Data Source Person responsible


(Pregnant Women)
1 HIV screening numbers HMIS/IIMS/ RCH ANM/data entry
portal operator at health
facility
2 Basic demographic details IIMS HCTS counsellor
3 HIV test and counselling details, IIMS Counsellor at HCTS
index testing confirmatory facilities
4 Obstetric Details (LMP Months of IIMS Counsellor at HCTS
pregnancy completed-in months, facilities/ART centre
Expected date of delivery, gravida)
5 Para, Birth planning, Pregnancy IIMS Counsellor at ART
outcome, mode of delivery, place centre
of delivery, Family Planning
counselling, Infant feeding option
selected, VL test details at 32-
36 weeks, next VL Date, ART
adherence
6 ART related details like regimen, lab
investigations, OIs, co-infections,
S. No Variable/details (HES) Data Source Person responsible
1 Basic demographic details IIMS HCTS counsellor
2 EID test related details- 10 drops IIMS Counsellor at HCTS
down options for type of test
3 ARV prophylaxis, CPT prophylaxis IIMS Counsellor at HCTS
facilities/ART centre
4 Growth & Development, clinical IIMS Counsellor at HCTS
assessment and birth weight, facilities/ART centre
current feeding practices at each
EID interval, ARV start and stop
date

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note 27


Table 6.2 Line-list Details for Syphilis (Pregnant Women & exposed infants)

S. No Variable/details Data Source Person responsible


1. Screening of Pregnant Women for HMIS/ IIMS/ RCH ANM/data entry
Syphilis portal operator at health
facility
1 Basic demographic details IIMS Counsellor at DSRC/
HCTS
2 Confirmatory testing for Syphilis IIMS Counsellor at HCTS
5 Obstetric Details (LMP Months of IIMS Counsellor at HCTS
pregnancy completed-in months,
Expected date of delivery, gravida,
Para, Birth planning, family
planning) for Syphilis infected
pregnant women
4 Spouse testing for Syphilis IIMS Counsellor at HCTS
3 Treatment for Syphilis IIMS Counsellor at DSRC
S. No Variable/details Data Source Person responsible
1 Basic demographic details IIMS Data Entry Operator
2 Diagnosis, prophylactic and IIMS Data Entry Operator
curative treatment for congenital
Syphilis

The details of the key indicators which will be used to monitor the progress of the EVTHS
programme are mentioned in Table 6.3.

Table 6.3 Key Indicators for Monitoring of EVTHS Programme

S. Indicator Data Person responsible


No. Source
1. Number of pregnant women HMIS ANM/LT
registered
2. Number of pregnant women HMIS ANM/LT
screened for HIV
3.a. Number/percentage of newly IIMS Counselor LT
identified pregnant women
confirmed as HIV positive
3.b. Number/ percentage of Women IIMS Counselor LT
living with HIV(WLHIV) reported
pregnant at ARTC (known positive)

28 Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


S. Indicator Data Person responsible
No. Source
4. No. of HIV positive women started IIMS Patient care related indicators –
ART or already on ART NACP Counselor/ART MO
Lab related indicators (CD4, VL)
– ART LT, Confirmatory facility LT,
Lab LT
5. Unmet need of Women Living with IIMS All related indicators will be filled
HIV (childbearing age group) for by the facility (ARTC/LAC) where
family planning services services provided
6. No. of HIV positive pregnant IIMS All related indicators will be filled
women linked with Family by the facility (ARTC/LAC) where
planning services/birth planning services provided
7. No. of pregnant women IIMS Patient care related indicators –
undergone VL between 32-36 NACP Counselor/ART MO
weeks Lab related indicators (CD4, VL)
– ART LT, Confirmatory facility LT,
Lab LT
8. No. of live births reported IIMS All related indicators will be filled
by the facility (ARTC/LAC) where
services provided
9. No. of infants on Exclusive IIMS All related indicators will be filled
breastfeeding by the facility (ARTC/LAC) where
services provided
10. No. of infants on Exclusive IIMS All related indicators will be filled
replacement feeding by the facility (ARTC/LAC) where
services provided
11. Total No. of HIV exposed infants IIMS All related indicators will be filled
provided ARV prophylaxis by the facility (ARTC/LAC) where
services provided
12. Out of the above, No. of HIV IIMS All related indicators will be filled
exposed infants provided dual ARV by the facility (ARTC/LAC) where
prophylaxis services provided
13. No. of HIV Exposed Infant (HEI) IIMS All related indicators will be filled
initiated on CPT prophylaxis by the facility (ARTC/LAC) where
services provided
14. No. of HIV Exposed Infant (HEI) IIMS All related indicators will be filled
undergone for EID testing at age of by the facility (ARTC/LAC) where
< 2 months (6 week to 2 months) services provided
15. No. of infants undergone EID at 6 IIMS All related indicators will be filled
months by the facility (ARTC/LAC) where
services provided

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note 29


S. Indicator Data Person responsible
No. Source
16. No. of infants undergone EID at 12 IIMS All related indicators will be filled
months by the facility (ARTC/LAC) where
services provided
17. No. of infants undergone EID at 18 IIMS All related indicators will be filled
months by the facility (ARTC/LAC) where
services provided
18. No. of HIV exposed infants who are IIMS All related indicators will be filled
confirmed as HIV positive. by the facility (ARTC/LAC) where
services provided
19. No. of HIV positive babies who are IIMS All related indicators will be filled
on ART by the facility (ARTC/LAC) where
services provided
20. No. of HIV positive babies reported IIMS All related indicators will be filled
as general clients by the facility (ARTC/LAC) where
services provided
21. Number of pregnant/ Direct-In- HMIS/ All related indicators will be filled
Labor (DIL)women screened/ IIMS at the screening sites (Labour
tested (with VDRL/ RPR/ TPHA/ Room Register & facility-specific
RDT/ PoC) for Syphilis respective mechanism for HMIS
reporting to be followed)
22. Number of pregnant/DIL women HMIS/ ANM/Data entry operator
found seropositive for Syphilis by IIMS (Labour Room Register & facility-
VDRL/ RPR/ TPHA/ RDT/ PoC test specific respective mechanism
for HMIS reporting to be
followed)
23. Number of pregnant/DIL women HMIS/ DSRC Counsellor
infected with Syphilis and IIMS
given treatment with injection
Benzathine Penicillin (IM)
24. Number of live births reported HMIS/ Labour Room/ DSRC Counsellor
among Syphilis IIMS
seropositive pregnant women
25. Out of above, Syphilis exposed HMIS/ SNCU
babies who IIMS
received treatment (prophylactic/
curative)
26. Out of above, babies with HMIS/ SNCU
congenital Syphilis IIMS
27. Number of still-births reported HMIS/ Labour Room/DSRC Counsellor
IIMS

30 Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


Chapter Supply Chain

7 Management

The supply chain is a critical component of the EVTHS programme, as it is essential for
the delivery of medical interventions and care to HIV-positive mothers and their children.
The following is to be ensured for successful implementation of EVTHS programme:

Antiretroviral Medications: These are drugs that are used to treat HIV and prevent
mother-to-child transmission of the virus. These medications include antiretroviral
therapy (ART) for the mother, as well as prophylactic treatment for the infant.

Rapid HIV & Syphilis Test Kits: These are diagnostic tests that are used to diagnose
HIV & Syphilis infection quickly and accurately in pregnant women, allowing for timely
initiation of treatment and care.

Laboratory Supplies: Various laboratory supplies are required for testing and monitoring
HIV-positive mothers and their children, including viral load testing, CD4 cell counts, and
other laboratory tests.

Personal Protective Equipment (PPE): Health workers who provide care to HIV-positive
mothers and their children require appropriate PPE to protect themselves from the
transmission of the virus.

The procurement and distribution of commodities for the Elimination of Vertical


Transmission of HIV (EVTHS) programme involves various components at different levels
of the healthcare system:

At NACO level:

„ Central procurement of dual testing kits, RPR kits and injection BPG.

At SACS level:

„ Procurement of ARV prophylaxis drugs (Syp.Nevirapine and Syp.Zidovudine) and


DBS commodities based on estimated requirements.
„ Making appropriate budgetary provisions in the Annual Action Plan (AAP) based on
the estimated forecasts.
„ Coordinating with NACO/State NHM for procurement of dual testing kits.

At Regional Warehouse level:

„ Storage and distribution of commodities to facilities based on their requirements.

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note 31


At facility level:

„ Ensuring availability of necessary commodities for the screening kits for HIV
and Syphilis and treatment of HIV-positive mothers and their children, including
antiretroviral medications, rapid HIV test kits, laboratory supplies, and personal
protective equipment (PPE).
„ Monitoring and reporting of commodity usage to higher levels of the healthcare
system.

It is to be noted that, the availability of necessary HIV and Syphilis diagnostic test kits
and ARV drugs play a critical role in the EVTHS programme. The availability and effective
distribution of these commodities are essential for the success of the programme in
reducing and ultimately eliminating vertical transmission of HIV and Syphilis.

Procurement of ARV prophylaxis drugs (Syp. Nevirapine and Syp.Zidovudine) and DBS
commodities will be done by respective SACS based on the estimated requirement.

SACS will make appropriate budgetary provisions in the Annual Action Plan (AAP) based
on the estimated forecasts (Refer to Guidelines by SCM, NACO). When Zidovudine syrup is
not available, syrup Lopinavir/ritonavir should be used after 14 days of birth. Procurement
of Syp. Lopinavir/ritonavir should be done locally as per need. The distribution of ARV
prophylaxis drugs and DBS commodities will be state-specific. Based on the specific
requirements of the State, SACS may choose to keep the supplies at DAPCU or at the
facility-level. If the commodities are placed at DAPCU, decisions about further distribution
to the facilities shall be taken based on the facility-level requirement. Procurement of
dual testing kits is done centrally by NACO and at State level by State NHM. SACS shall
coordinate with NACO/State NHM for procurement.

32 Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


Commodity Stocking and Logistics
Table 7.1. Commodity and Logistics

S.No. Item Storage Procurement and Supply


Chain management
1 HIV/Syphilis dual RDT Cold chain For screening facility:
RPR/VDRL „ NHM through PIP budget
HIV test kit wherever possible,
„ NACO
For confirmatory facility:
„ NACO
2 Adult ART Regimens Cool dry place SACS to ART centre to LAC
3. Nevirapine Syrup, Cool dry place SACS
Zidovudine Syrup,
LPV/Rt Syrup
4. Injection Benzathine Cool dry place/ SACS to DAPCU to Treatment
Penicillin Room temperature facilities
5. Pediatric Formulation of Refrigerate Under NHM through
Penicillin between 2 to 8 essential medicine
degrees Celsius, do procurement
not freeze
6. DBS collection test kits Cool dry place SACS
and DBS commodities
7. EID test kits Cold chain NACO

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note 33


Chapter District/Cluster

8 EVTHS Intensification
Plan

A district/cluster intensification plan for EVTHS would be a comprehensive and tailored


approach to improve EVTHS services within a specific geographic area, such as a district
or cluster.

Step-by-step approach for the district/cluster implementation plan for EVTHS:

1. Identify the Target district: Determine which district or cluster the implementation
plan will focus on.
2. Conduct a Baseline Assessment: Assess the current state of EVTHS services in the
target district/cluster. This may involve gathering data on the number of pregnant
women living with HIV, the current coverage of antiretroviral therapy (ART) for
pregnant women, and the number of infants receiving early infant diagnosis (EID)
services. This data will serve as the baseline for measuring progress during the
implementation plan.
3. Develop a District Intensification Plan: Develop a comprehensive district/cluster
intensification plan based on the key components. This plan should be tailored to
the specific needs of the target district/cluster and include specific strategies and
interventions for achieving each component.
4. Mobilize Resources: Identify and mobilize the necessary resources for implementing
the district/cluster intensification plan. This may involve securing funding, staffing,
and supplies such as antiretroviral drugs and testing kits.
5. Strengthen the Health System: Strengthen the health system’s capacity to identify
and track pregnant women living with HIV and/or infected with Syphilis. This may
involve training health workers on HIV testing and counselling and ensuring that
all HIV-positive pregnant women are enrolled in HIV care and treatment services.
This may also involve training on Syphilis screening, counselling, and management
in pregnancy.
6. Scale Up ART for Pregnant Women: Prioritize ensuring that all pregnant women
living with HIV are provided with ART and are adhering to their treatment regimen.
This may involve increasing the availability of ART drugs and providing additional
support to pregnant women to help them adhere to their treatment.
7. Strengthen Early Infant Diagnosis and Linkage to Care: Strengthen laboratory systems
and procedures for early infant diagnosis and ensure that HIV-positive infants are
linked to appropriate care and treatment services. This may involve training health
workers on EID procedures and ensuring that laboratory equipment is available

34 Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


and functioning properly. Strengthen referrals and linkages of all SEI to respective
treatment facilities for further management and follow-up.
8. Engage and Mobilize the Community: Work closely with community leaders, local
organizations, and community health workers to increase awareness about EVTHS
services, improve uptake of these services, and reduce stigma and discrimination
towards people living with HIV.
9. Establish Monitoring and Evaluation Systems: Establish robust monitoring and
evaluation systems to track progress, identify areas for improvement, and make
adjustments as necessary. This may involve developing data collection tools, training
staff on data collection and analysis, and regularly reviewing and analyzing data.
10. Data Triangulation: Collect additional data to triangulate or validate the baseline data.
Use multiple data sources to verify the accuracy of the baseline data and confirm the
effectiveness of the implementation plan. Analyze the triangulated data to identify
any areas of success or areas that may need further attention.

The following activities will be covered under district/cluster intensification plan:

„ Rapid assessment at every three months


y Geographical and epidemiological backward blocks
y Assessment of health facility utilization and outreach services
„ Development of BLOCK specific plan
y Health system strengthening
y Need based capacity building
y Resource pooling from partner agencies if needed
y Seeking support from IAP and FOGSI
y Supply chain management
„ Focus on improving demand for services
y Behaviour change communication
y IEC at ARTC, ANC clinics and labour room
„ Mass media approach
„ Engagement of community champions
„ Field data validation through regular supportive supervision visits (SSV) to blocks
„ Optimization of monitoring mechanism by using existing review meetings at block
and district level

Engagement of Community Champions and mobilizers


Community engagement is a crucial component for the implementation of EVTHS
intervention. Engaging community champions, who are individuals or groups within the
community that have a vested interest in the health and well-being of mothers and their
children, can be particularly effective in promoting EVTHS programme.

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note 35


Community mobilizers can include traditional birth attendants, religious leaders, women’s
groups, community health workers, and other influential members of the community.
They are often trusted sources of information and can help to promote EVTHS through a
variety of activities, such as:

„ Advocacy and Awareness-raising: Community champions and mobilizers can help


raise awareness of EVTHS among their peers and other members of the community.
They can help to dispel myths and misconceptions about HIV/AIDS and Syphilis and
promote the benefits of antenatal care, HIV & Syphilis testing, and treatment.
„ Peer Education and Counselling: Community champions and mobilizers can provide
peer education and counselling to pregnant women and new mothers. They can
encourage women to get tested for HIV & Syphilis, adhere to treatment, and practice
safe infant feeding practices.
„ Mobilizing Community Support: Community champions and mobilizers can mobilize
support from the community to help ensure that pregnant women and new mothers
have access to the services they need. They can help to identify barriers to accessing
services and advocate for solutions.
„ Strengthening Community Systems: Community champions and mobilizers can
help to strengthen the community’s system for health by working with health care
providers to ensure that services are accessible and of high quality.
„ Monitoring and Evaluation: Community champions and mobilizers can help to
monitor and evaluate EVTHS programmes by collecting data on uptake of services,
identifying gaps in service provision, and suggesting ways to improve the programme.

„ In conclusion, community champions and mobilizers are essential in promoting


EVTHS by providing a link between communities and the health system. Their
involvement can increase community participation and ownership, improve the
quality of care, and lead to better health outcomes for mothers and their children.
Therefore, it is crucial to involve community in EVTHS programme to ensure their
success.

Field Data Validation Through Regular Supportive


Supervision Visits (SSV)
Field data validation through regular supportive supervision visits (SSV) is a critical
component of the EVTHS services. It involves visits to healthcare facilities at the block
level to verify and validate data related to EVTHS programme implementation.

The primary purpose of field data validation through SSV is to ensure that the data
collected and reported by healthcare facilities is accurate and reliable. It also serves as
an opportunity to provide support and guidance to healthcare workers, identify gaps in
service provision, and develop solutions to address these gaps.

36 Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


The process of field data validation through SSV typically involves the following steps:

1. Planning and Preparation: A schedule is developed for the SSV visits to blocks. A team
of supervisors is identified and trained on the data validation process. The team also
reviews data from previous visits to identify trends and areas of concern.
2. Conducting the Visit: During the visit, the team assesses the healthcare facility’s EVTHS
programme, including reviewing data on antenatal care, HIV testing, treatment, and
infant feeding practices. The team also reviews patient records to verify data accuracy.
3. Providing Feedback: The team provides feedback to healthcare workers on the
findings of the assessment, identifies areas of strength and weakness, and develops
an action plan to address any gaps.
4. Follow-up: The team follows up on the action plan to ensure that solutions are
implemented, and the identified gaps are addressed. They also schedule the next
SSV visit.
5. Documentation: All findings, feedback, and action plans are documented and
reported to the district and state-level EVTHS programme managers.

The benefits of field data validation through SSV include improved data quality, increased
accountability, and enhanced program performance. By ensuring that the data collected
accurately reflects the reality on the ground, healthcare workers and programme
managers can make more informed decisions and allocate resources more effectively.
Field data validation through regular supportive supervision visits to blocks is a critical
component of the EVTHS programme. It ensures that data is accurate and reliable and
helps identify areas for improvement in the programme. By providing feedback and
support to the healthcare workers, the SSV process can contribute to better health
outcomes for mothers and their children.

Optimization of Monitoring Mechanism by Using


Existing Review Meetings at Block and District Level
The optimization of monitoring mechanisms by using existing review meetings at block
and district levels is a critical component of the EVTHS programme. This approach
involves leveraging existing platforms for monitoring and evaluation to ensure that
EVTHS programme performance is tracked effectively.

The primary purpose of optimizing monitoring mechanisms through existing review


meetings is to streamline monitoring and evaluation processes, reduce duplication of
efforts, and ensure that programme performance is regularly assessed. It also provides
an opportunity for stakeholders to review data and identify areas for improvement in the
EVTHS programme.

The process of optimizing monitoring mechanisms through existing review meetings


typically involves the following steps:

1. Planning and Preparation: A schedule is developed for existing review meetings at


the block and district level. The EVTHS program team provides inputs to the agenda

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note 37


of the meetings. The team also reviews data from previous meetings to identify
trends and areas of concern.
2. Conducting the Review Meeting: During the meeting, stakeholders review data
related to the EVTHS programme, including data on antenatal care, HIV/Syphilis
testing, treatment, and infant feeding practices. The team also reviews patient
records to identify any gaps in service provision.
3. Providing Feedback: The team provides feedback on the findings of the review
meeting, identifies areas of strength and weakness, and develops an action plan to
address any gaps.
4. Follow-up: The team follows up on the action plan to ensure that solutions are
implemented, and the identified gaps are addressed. They also schedule the next
review meeting.
5. Documentation: All findings, feedback, and action plans are documented and
reported to the district and state-level EVTHS programme managers.

The benefits of optimizing monitoring mechanisms through existing review meetings


include reduced costs, improved data quality, increased accountability, and enhanced
program performance. By leveraging existing platforms for monitoring and evaluation,
healthcare workers and program managers can make more informed decisions and
allocate resources more effectively.

The optimization of monitoring mechanisms by using existing review meetings at the


block and district level is a critical component of the EVTHS programme. It ensures that
program performance is regularly assessed, and feedback is provided to healthcare
workers and program managers. By streamlining monitoring and evaluation processes,
this approach can contribute to better health outcomes for mothers and their children.

Partner Support for Intensification


„ Full spectrum of NACP and RMNCA+ interventions to be addressed.
„ Harmonized managerial and technical support extending beyond thematic/
organization experts.
„ Coordination with SPMUs, DPMUs and field functionaries by SACS and DISHA.
„ Differential district planning based on gap analysis.
„ Innovation in service delivery mechanism to customize health services in line with
geographical, infrastructural, and economical variations.

Monitoring Progress on EVTHS using Score card


„ Tracker to measure state progress every month. Tracker will include.
y Training of NACP and Non NACP staff
y Preparation of district specific plan based on program need.
y Progress on ANC screening HIV and Syphilis

38 Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


y Progress in reporting in data portal: HMIS/RCH portal-ANMOL/IIMS
y Progress on holistic care provided at ART centre and DSRC for positive pregnant
and breastfeeding women and exposed infants.
„ Score card on 84 indicators at state level and 29 indicators at district level for detailed
assessment every quarter.
„ Sharing progress on the composite index and score card to SHS, NACO and NHM
every quarter.
„ District score card and composite index will be presented during District EVTHS
meetings.

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note 39


Chapter Human Resource

9 Management

Role and Responsibility of Functionaries


Nodal officer EVTHS – NACO
„ Overall responsibility for implementation of the EVTHS strategies across NACP
facilities including prevention sites.
„ Facilitate establishment of National EVTHS programme implementation committee.
„ Facilitate regular meetings of the implementation committee for programme review
and policy decisions.
„ Development of policies for smooth implementation of the EVTHS strategies based
on feedback by experts and field staff.
„ Ensure that the EVTHS Guidelines are followed across all NACP facilities.
„ Co-ordination and advocacy with other nodal officers of NHM to ensure joint
ownership of the programme.
„ Timely review of the National EVTHS programme implementation committee.
„ Overall responsibility of screening of pregnant women for HIV and Syphilis and
linkages to the confirmatory facilities.
„ Participate in joint meetings with NACO for programme review and policy decisions.
„ Timely review of national data on key Maternal and Child health indicators and
provide solutions to reduce programmatic gaps.
„ Contribute to the development of policies and guidelines for smooth implementation
of the EVTHS strategies based on feedback by experts and field staff.
„ Regular visits to the NHM health facilities to supervise and mentor the field staff.
„ Analysis of data on key EVTHS indicators and provide solutions to reduce programmatic
gaps.

Project Director State AIDS Control Society (SACS)


„ Facilitate development of state micro-plan for implementation of EVTHS programme.
„ Facilitate establishment of Joint State EVTHS programme implementation
committee.
„ Facilitate regular meetings of the implementation committee for programme review
and policy decisions.

40 Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


„ Facilitate formation of the Joint District EVTHS implementation committee and Case
Management Team in all districts of the state.
„ Facilitate measures to ensure ownership of the programme at district level by District
Health & Family Welfare Officer, CMHO, Civil Surgeon, District RCH officer etc.
„ Advocacy with Principal Secretary, Health & Family Welfare and MD NHM to ensure
ownership of EVTHS programme by Director, Health & Family Welfare Services, state
RCH officer.
„ Advocacy with Secretary Medical Education to ensure adherence to National
programme guidelines so as to minimize linkage loss in medical college hospitals.
„ Facilitate joint review meetings of NACP-NHM and Medical Education programme
managers at regular intervals.
„ Facilitate involvement of professional organizations like FOGSI, IAP, IMA etc to ensure
systematic involvement of private sector.
„ Provide overall leadership of programme in the State with regular monitoring of
progress.

Nodal Officer for EVTHS in SACS


„ Ensure availability of EVTHS services as per national guidelines, in the state, including
prevention and family planning services.
„ Ensure close coordination between the Basic Services, STI and Care and Support &
Treatment division at state and district level for implementation of EVTHS guidelines.
„ Establish close liaison with State RCH officers and other key stakeholders in NHM.
„ Establish close liaison with state level office bearers of professional organizations like
FOGSI for systemic involvement of private nursing homes.
„ Facilitate formation of the Joint District EVTHS implementation committee and Case
Management Team in all districts of the state.
„ Ensure regular meetings of Joint District EVTHS implementation committee through
supportive supervision and monitoring.
„ Establish mechanisms for monitoring progress in linking up of HIV or Syphilis
infected pregnant women to EVTHS services e.g., use of google doc, for tracking and
monitoring at state level.
„ Coordinate with RMNCHA+ officer to ensure all health facilities providing ANC services
are providing HIV and Syphilis screening.
„ Ensure mechanisms for quick linkages of screened HIV positive pregnant women to
confirmatory facilities for confirmation, to ARTCs for life-long ART and EID services
for HIV exposed babies.
„ Ensure mechanisms for quick linkage of screened Syphilis sero-reactive pregnant
women to confirmatory facilities for confirmation and adequate management.
„ Monitoring the compliance of EVTHS guidelines through regular follow-up visits by
NACP outreach workers and other health system human resources.

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note 41


„ Identify and train health facility pediatrician/medical officer for care of HIV exposed
infants, if the district does not have ART centre /LAC, or when ART centres/LAC are
too far.
„ Identify and train health facility pediatrician/medical officer for care of Syphilis-
exposed infants.
„ Training of pediatricians/medical officers of LAC/DSRC for care of Syphilis exposed
infants.
„ Capacity building of health care workers facilitating EVTHS services at NACP sites.
„ Supervise Private Sector Engagement: Sensitization of Professional Medical
Associations (PMA) such FOGSI, IMA, IAP, on EVTHS guidelines.
„ Training and sensitization of private practitioners through PMA on EVTHS guidelines.
„ Reporting from the private sector in the relevant portal/ format.

State RMNCH+ Officer


„ Facilitate ownership of the HIV and Syphilis screening for pregnant women and
linkages by the District Health & Family Welfare Officers (CMHO, Civil surgeon).
„ Facilitate ownership of EVTHS activities by PHC medical officers and their field staff.
„ Establishment of screening facilities at all high delivery points in the form of Facility
integrated - HCTS screening facilities and sub-centre level screening using Dual RDT
(PoC for Syphilis / HIV, in absence of Dual RDT).
„ Ensure availability of EVTHS services at all high delivery points, including prevention
and family planning services.
„ Provision of support to pregnant women for travel for confirmation of HIV infection
in screen positive pregnant women, travel to ART centre for enrolment and drug
collection and travel to facilities for institutional delivery.
„ Facilitate regular meetings of the Joint District EVTHS implementation committee.
„ Facilitate involvement of PHC medical officers and concerned ANM and other health
system functionaries in the Case Management Team.
„ Ensure involvement of medical officers at PHCs and ANMs in monitoring the linkages
to HIV and Syphilis confirmatory facilities, ART Centres, Syphilis treatment sites and
prevention Centres.
„ Ensure linkages to confirmatory sites for Syphilis and management of Syphilis sero-
reactive pregnant women.
„ Management of Syphilis-exposed infants at the nearest treatment facility with
availability of pediatrician.
„ Provision of support to capacity building of health care workers facilitating EVTHS
services.

42 Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


District HIV Programme Manager – DAPCU / DNO
„ In-charge of planning and implementation of EVTHS programme at the district level.
„ Ensure formation of the Joint District EVTHS implementation committee and Case
Management Team in all districts of the state.
„ Ensure regular meetings of Joint District EVTHS implementation committee.
„ Establish confirmatory facilities at all CHC level health facilities.
„ Ensure availability of HIV & Syphilis screening facilities at all high delivery points below
CHCs in the form of Facility integrated- HCTS screening facilities and sub-centre level
screening using Dual RDT (PoC for Syphilis/HIV, in absence of Dual RDT).
„ Ensure availability of EVTHS services at all high delivery points, including prevention
and family planning services.
„ Ensure mechanisms for quick linkage of screened positive pregnant women to
Confirmatory facilities for confirmation, linkage to ART centre for initiation of life-
long ART and EID services for HIV exposed infants and children.
„ Ensure mechanisms for linkages for Syphilis confirmation and management of sero-
positive pregnant women and management of infants exposed to Syphilis.
„ Monitoring of compliance of EVTHS guidelines through regular follow-up visits by
NACP outreach workers and other health system human resources.
„ Assessment of training needs for staff across all facilities involved in EVTHS services.
„ Establish close liaison with District Health & Family Welfare Officers (CMHO/ Dy.
CMHOs/ RCH Officers), for smooth implementation and review of the EVTHS services.
„ Ensure establishment of M&E tools for EVTHS and regular up-dation of these tools at
all EVTHS facilities and timely reporting to state level.
„ Regular supervisory and mentoring visits to ART centres HCTS centres, prevention
sites to review and mentor the staff for implementation of EVTHS guidelines.
„ Close liaison with professional association like FOGSI, IAP, IMA to facilitate involvement
of private nursing homes & institutions.
„ Advocacy, Communication, and social mobilization activities for effective
implementation of EVTHS guidelines.
„ Provision of support for capacity building of health care workers facilitating EVTHS
services.

District RCH Officer


„ Ensure availability of EVTHS services at all high delivery points, including prevention
and family planning services.
„ Advocacy with District Health & Family Welfare Officers (CMHOs Civil surgeons) for
ownership of EVTHS programme.
„ Ensure ownership of EVTHS activities by PHC medical officers and their field staff.

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note 43


„ Facilitate establishment of HIV & Syphilis screening facilities at all high delivery
points in the form of Facility integrated HCTS screening facilities and sub-centre level
screening using Dual RDT (PoC for Syphilis / HIV, in absence of Dual RDT).
„ Provision of support to pregnant women for travel for confirmation of HIV infection
in screen positive pregnant women, travel to ART centre for enrolment and drug
collection and travel to facilities for institutional delivery.
„ Ensure regular meetings of Joint District EVTHS implementation committee.
„ Ensure involvement of PHC medical officer, concerned ANM and other health system
functionaries in Case Management Team for smooth implementation of the EVTHS
services including prevention and family planning services.
„ Provision of support to capacity building of Health care workers facilitating EVTHS
services.

Monitoring and evaluation assistant at DAPCU / Confirmatory facility


counsellor at the district headquarter
„ Maintenance of consolidated EVTHS line-lists.
„ Updating EVTHS line-lists with all events, compilation, analysis, and interpretation
etc.
„ Timely reporting of EVTHS line-lists to SACS.
„ Regular supervisory and mentoring visits to ART centres HCTS centres, prevention
sites to review and mentor the staff for regular up-dation of M&E tools of EVTHS
services.

District HCTS Supervisor


„ Regular supervisory and mentoring visits to ART centres HCTS centres, prevention
sites, NTEP centres to review and mentor the staff for implementation of EVTHS
programme.
„ Facilitate co-ordination between Confirmatory facility/ART centre staff with general
health staff (RMNCH+/NHM).
„ Ensure preparedness of maternity wards and labour rooms for conducting deliveries
of HIV /Syphilis infected mothers.
„ Ensure linkage of HIV exposed infants to Early Infant diagnosis sites.
„ Ensure follow-up home visits to HIV/ Syphilis infected pregnant women by NACP
staff / outreach workers/District Level Networks.
„ Facilitate reporting of all key EVTHS indicators to the district M&E assistants for
updating line-lists.

In-Charge Medical Officer at Confirmatory Facility


„ Ensure 100% screening of all pregnant women enrolled into Ante-Natal Care.
„ Ensure HIV, STI, and TB screening early in pregnancy.

44 Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


„ Ensure uninterrupted supply of commodities, including test-kits, drugs, referral
forms, registers, etc.
„ Ensure prompt referral and linkages of HIV/Syphilis infected pregnant women to the
nearest treatment facility.
„ Ensure safe institutional deliveries.
„ Ensure provision of ARV prophylaxis for HIV exposed infants as per EVTHS programme.
„ Ensure linkage of the HIV exposed infants to EID services.
„ Clinical assessment and care of pregnant WLHIV.
„ Monitoring pregnant WLHIV for adherence to ART.
„ Ensure home visits to pregnant WLHIV.
„ Ensure timely follow-up visits by pregnant WLHIV to ART centres.

Counsellor at Confirmatory Facility/Facility Integrated Screening Site:


„ Provision of preventive health education to all pregnant women visiting the ante-
natal clinics.
„ Ensure counselling services regarding importance of screening pregnant women for
HIV, Syphilis and TB.
„ Ensure coverage of HIV counselling and testing services at all registered Ante natal
clinics in their area of jurisdiction.
„ Ensure prompt linkage of newly diagnosed HIV infected mothers to ART centres for
availing EVTHS services.
„ Coordination with ART centres/ LAC Plus / LAC/ DSRC for confirmation of linkages of
infected pregnant women.
„ Regular up-dation of EVTHS line lists and M&E tools.
„ Encouraging and ensuring institutional delivery.
„ Ensure provision of ARV prophylaxis to baby as prescribed by ART Medical Officer.
„ Ensure provision of ART drugs to all HIV infected mothers reporting direct-in- labour
room and dual ARV prophylaxis for her baby.
„ Ensure linkage of HIV exposed infants to EID services.
„ Maintain recordings of all events and communications of with District M&E Assistants.

Nurse at Facility integrated screening sites.


„ All responsibilities mentioned for counsellors above.
„ ART Centre Senior Medical Officer/Medical Officer
„ Counsel WLHIV in reproductive age group for family planning, unintended
pregnancies, and positive prevention practices.
„ Link WLHIV in reproductive age group to family planning services and counsel for
unintended pregnancies.

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note 45


„ Link adolescents living with HIV to adolescent friendly clinics for SRH services.
„ Prompt evaluation of all pregnant WLHIV reporting to ART centre.
„ Counsel all pregnant WLHIV about
y Role of ART adherence for her health and preventing transmission of HIV infection
to her baby
y Regular Ante-natal visits
y Protected sex practices to avoid fresh HIV infection.
y Ante-natal counselling for selecting feeding option by parents.
y Care of nipples and breasts.
y Nutritional counselling.
y Iron, folic acid and calcium supplementation
y Institutional delivery: for Interventions during labour and delivery and timely
initiation of ARV prophylaxis for the baby
y Viral load testing at 32-36 weeks of gestation to decide the risk of HIV transmission
to baby and the ARV prophylaxis to the baby to reduce this risk.
„ Rapid ART initiation in new pregnant WLHIV regardless of CD4 levels or clinical stage
„ Management of Syphilis in WLHIV as per the EVTHS guidelines.
„ Ensure feedback to referring Confirmatory facility regarding ART centre registration
and ART initiation in all pregnant WLHIV.
„ Formulation of Case Management Team comprising of Confirmatory facility
counsellor, concerned ANM, concerned out-reach worker.
„ Plan for linkage to LAC in consultation with pregnant WLHIV, for follow-up visits and
drug collections.
„ Ensure uninterrupted supply of ARV drugs and to LAC-Plus, LAC.
„ Ensure provision of information on all events to the districts M&E assistant for
updating in PPTCT line-lists.
„ Ensure viral load testing in all pregnant WLHIV at 32-36 weeks of gestation and fast
-racking collection of the viral load report. Ensure documentation in the mother’s
green book of the viral load report and plan for single or dual ARV prophylaxis for her
baby.
„ Regular monitoring and follow-up of HIV exposed infants as per EVTHS guidelines
and ensuring timely EID testing.

DSRC Medical Officer


„ Link adolescents infected with HIV/Syphilis to adolescent friendly clinics for SRH
services.
„ Prompt evaluation and management of all pregnant women infected with syphilis.

46 Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


„ Counsel all positive pregnant about:
y Role of adequate treatment on her health and prevention of transmission of
syphilis infection to her baby
y Regular Ante-natal visits
y Protected sex practices to avoid fresh HIV/syphilis infection.
y Nutritional counselling.
y Iron, folic acid and calcium supplementation
y Institutional delivery & linkage to paediatric care
„ Management of Syphilis in WLHIV as per the EVTHS guidelines.
„ Ensure treatment monitoring of syphilis infected pregnant women
„ Regular monitoring and follow-up of syphilis exposed infants as per EVTHS guidelines.

ART centre counsellor/staff nurse


„ Prioritisation of pregnant WLHIV for ART preparedness and adherence counselling.
„ Counsel all pregnant WLHIV about
y Role of ART adherence for her health and preventing transmission of HIV infection
to her baby.
y Regular Ante-natal visits.
y Protected sex practices to avoid fresh HIV infection.
y Ante-natal counselling for selecting feeding option by parents.
y Care of nipples and breasts.
y Nutritional counselling.
y Iron, folic acid and calcium supplementation.
y Institutional delivery: for Interventions during labour and delivery and timely
initiation of ARV prophylaxis for the baby.
y Viral load testing at 32-36 weeks of gestation to decide the risk of HIV transmission
to baby and the ARV prophylaxis to the baby to reduce transmission risk.
„ Counsel WLHIV in reproductive age group for family planning, unintended
pregnancies, and positive prevention practices.
„ Link WLHIV in reproductive age group to family planning services and counsel for
unintended pregnancies.
„ Link adolescents living with HIV to adolescent friendly clinics for SRH services.
„ Maintain EVTHS registers and M&E tools.
„ Regular follow up of due dates of pregnant WLHIV to ensure tracking of missed cases.
„ Liaison with referring Confirmatory facility counsellor, outreach workers for
compliance to follow-up visits dates for pill pick and VL testing at ART centre.

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note 47


„ Counselling all pregnant women living with HIV on feeding practices and
documentation of chosen feeding option in the green book. This would be useful for
initiating the chosen feeding option by the Labour room Nurse/MO within one hour
of delivery.
„ Documentation of the due date for Viral load testing at 32-36 weeks of gestation in
the green book.

Counsellor at DSRC
„ Provision of preventive health education to all pregnant women.
„ Ensure counselling services regarding importance of screening pregnant women for
HIV, Syphilis and TB.
„ Ensure coverage of HIV & Syphilis counselling and testing services at all registered
Ante natal clinics in their area of jurisdiction.
„ Ensure adequate treatment and follow-up of syphilis infected mothers as per updated
guidelines.
„ Regular up-dation of EVTHS line lists and M&E tools.
„ Encouraging and ensuring institutional delivery.
„ Ensure referral & linkage of syphilis-exposed infants to paediatric treatment facility.
„ Ensure adequate follow-up of all syphilis-exposed infants.
„ Ensure adequate treatment and coordination of HIV – Syphilis co-infected pregnant
women.
„ Ensure testing and adequate treatment of all partners of positive pregnant women.
„ Adequate counselling to prevent infection/re-infection during pregnancy.
„ Maintain recordings of all events and communications of with District M&E Assistants.

ANM
„ Counsel for women in reproductive age group for prevention of STI and HIV infections.
„ Link women in reproductive age group to family planning services and counsel for
unintended pregnancies.
„ Link adolescent girls to adolescent friendly clinics for SRH services.
„ Ensure all pregnant women undergo screening test for HIV and Syphilis using Dual
RDT (PoC for Syphilis/HIV, in absence of Dual RDT). If reactive, refer these women to
confirmatory sites for confirmation of HIV/ Syphilis infection.
„ Ensure screening of pregnant women for Syphilis using Dual RDT (PoC for Syphilis/
HIV, in absence of Dual RDT), if reactive then refer to STI clinic/PHC for further
management.
„ Ensure screening the pregnant women for TB if symptomatic refer to a health facility
where Gene-expert testing is done or PHC with DMC.
„ Ensure confirmation of HIV/Syphilis status among screened positive ANCs.

48 Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


„ Establishing linkages for pregnant WLHIV to ART centres to avail HIV care and
treatment services.
„ Facilitate institutional deliveries of HIV and Syphilis infected mothers.
„ Ensure follow-up with the mother after delivery to monitor compliance in ART
consumption.
„ Facilitate linkages of HIV exposed babies to EID services.
„ Provide reminders to mother on ART regarding visit to ART centre, CD4 test, etc.

Confirmatory Facility Lab Technician


„ Conduct HIV/Syphilis testing as per guidelines and provide feedback to referring PHC
MO regarding status with concurrence of patient.
„ Liaison with facility integrated-screening sites and sub-centre screening facility
staff for early information on screening positive women and track their arrival for
confirmation collection and dispatch of blood specimen for CD4 testing.
„ Collection and dispatch of blood specimen for CD4 testing.
„ Maintaining stock of Dual RDT/ WBFPT/ RPR for facility integrated screening sites
and sub-centre screening facilities.
„ Ensure uninterrupted supply of test kits to screening facility in the jurisdiction with
cold -chain maintenance.
„ Record maintenance and timely reporting to district and state level.
„ Conduct RPR testing for screening/confirmation of Syphilis.

Outreach Worker (ILFS/Link-workers, CSC outreach worker, etc.)


„ Mobilize pregnant women screened positive with Dual RDT (PoC for Syphilis/HIV, in
absence of Dual RDT) to visit Confirmatory facilities for confirmation.
„ Facilitate Linkage of HIV/Syphilis infected pregnant women for treatment to ART
centre or STI clinic or Gene-expert testing site/DMC for TB.
„ Facilitate institutional delivery of HIV and Syphilis infected pregnant women.
„ Facilitate visit of the HIV Exposed Infants to Confirmatory facility for EID services.
„ Facilitate visit of the Syphilis-exposed infants to health facilities with paediatrician.
„ Facilitate regular follow-up visits of pregnant WLHIV to ART centre for clinical
evaluation, pill pick up, lab monitoring and viral load/CD4 testing etc.
„ Ensure home visit to monitor adherence to ART drugs in pregnant WLHIV.
„ Liaison with ANMs/ASHAs/Community Outreach Workers/DLNs for follow-up of HIV/
Syphilis infected Pregnant women.

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note 49


Medical Officer of Facilities Conducting Delivery of HIV/Syphilis Infected
Women
„ Ensure standard safety precautions in labour rooms, and availability of safe delivery
equipment.
„ Ensure continuation of ART during labour and delivery.
„ Ensure provision of ARV prophylaxis to baby as prescribed by ART Medical Officer
„ Screening of pregnant who report direct in labour for HIV & Syphilis and provide
further management as per the HIV/Syphilis screening results.
„ Ensure provision of ART drugs to all HIV infected/screened HIV positive mothers
reporting direct-in- labour room and dual ARV prophylaxis for her baby.
„ Ensure confirmation of HIV status of screened HIV positive mothers reporting direct-
in- labour room.
„ Counsel the HIV infected women regarding importance of enrolling ART centre and
receiving life-long ART.
„ Counsel infected pregnant women regarding importance of EID for her HIV exposed
infant.
„ Ensure assessment and management of Syphilis exposed infants by a paediatrician.
„ Facilitate linkage of newly diagnosed HIV/Syphilis infected women to treatment sites.

Labour Room Nurse


„ Ensure standard safety precautions in labour rooms, and availability of safe delivery
equipment.
„ Ensure continuation of ART during labour and delivery.
„ Ensure provision of ARV prophylaxis to baby as prescribed by ART Medical Officer.
„ Perform screening tests for HIV & Syphilis in pregnant who report direct in labour
room and provide counselling for further management as per the HIV/Syphilis
screening results.
„ Ensure provision of ART drugs to all HIV infected/screened HIV positive mothers
reporting direct-in- labour room and dual ARV prophylaxis for her baby.
„ Ensure confirmation of HIV status of screened HIV positive mothers reporting direct-
in- labour room.
„ Counsel the HIV infected women regarding importance of enrolling ART centre and
receiving life-long ART.
„ Ensure initiation of Feeding within one hour of delivery in HIV exposed infant based
on feeding plan documented by ART counsellor/MO.
„ Ensure referral of Syphilis exposed infants to Special New-born Care Units.

50 Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


Chapter Training and

10 Capacity Building

Without appropriately trained personnel, revised EVTHS guidelines under NACP V


cannot be implemented successfully. Along with the current modules, a standardized
training programme will be developed to increase the capacity of SACS staff. The staff
will receive training on a variety of topics in accordance with the plan of implementation.
Both induction and refresher training will be conducted.

The proposed training schedule is mentioned in mentioned in Table 10.1.

Table 10.1. Proposed Training at National and State Level for EVTHS Implementation

Level Participants Conducted Batch Frequency Mode


by
State RCH NACO/NHM 2 batches - Hybrid Mode
officers,
At National officers from
Level Directorate
MO ARTC of NACO/NHM 10 batches Quarterly Hybrid Mode
7 States
ICTC, ART SACS/SHS To be Quarterly Physical
& DSRC decided by
Counsellors the State
[NACP
Counsellors]/
Staff Nurse
At State MO-ART, SACS/SHS To be Quarterly Physical
Level MO district decided by
Hospital & the State
District RCH
officers
Data Entry SACS/SHS To be Quarterly Hybrid Mode
Operators decided by
the State
Filed level Disha/DHS To be Quarterly Physical
At District Staff (ASHA, decided by Mode
Level ANM, MO, the State
BMO etc)

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note 51


The components which will be covered for training and Capacity Building are as follows:

„ HIV/AIDS Background
„ Syphilis and STI Background
„ Addressing the Gap of 95-95-95
„ Epidemiology-Global and Indian Scenario
„ EVTHS New Guidelines
„ Client Flows
„ Role and Responsibilities of SACS Staff under new Guidelines
„ VL testing
„ EID testing
„ Supportive Supervision & Reporting
„ Supportive Supervision Process
„ Reporting in IIMS/HMIS/RCH portal-ANMOL
„ Reporting in Excel Sheet
„ Qualitative Reporting
„ Monitoring & Evaluation
„ Project Management

Beside this, there will be Review Meetings with the High Priority States at the National
Level by NACO Team.

Table 10.2. Frequency of Virtual Review Meetings during the Implementation Phase

Participants By Frequency Mode Duration


7 High Priority By NACO Team 1 Review per Virtual Mode From Feb –
States state/ month Nov 2023
(10 months)

Supportive Supervision
In line with NACP V, EVTHS will be deployed as an “Immersion Learning Model” in order
to determine the optimal course of action, gather feedback, and modify methods as
needed. Based on field experiences and lessons learned, the model will be adjusted,
changed, and revised.

Therefore, supportive supervision will enable staff to consistently enhance their own
work performance, provide them a chance to advance their knowledge and abilities, and
assist programme modification in line with client needs. The supportive supervisors will
provide mentoring for the SACS staff.

The supervision of the Confirmatory Facilities/ LAC/ ARTC/ DSRC Staff is to be done by
the respective Nodal officers of the district to be appointed by the EVTHS Coordination

52 Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


Committee or by the external agency/experts engaged in the different programmes in
the area.

The immersion learning model for revised EVTHS implementation in high priority states
will be monitored by NACO at the national level, followed by SACS at the state level,
district nodal officer or concerned Medical Officer I/C at the facility level as described in
Figure 8.

At NACO, the 1st phase Implementation will be under the supervision of National Task
Force of EVTHS as mentioned earlier. The programme will be managed by EVTHS
Consultant/s/Experts under BSD division and supported by CST, SI and Lab services
Division.

At the state level, the programme will be managed by the Basic Service Division (BSD)
and supported by CST, STI, SI and Lab services Division.

Figure 10.1. Supportive Supervision Framework of EVTHS

At the SACS level, the overall In-charge of the EVTHS programme will be under the
supervisory control of PD of the respective State.

Supportive Supervision visits:


„ The first three months should be monthly and subsequently quarterly visits. Should
include observation of counseling services provided by the counselors.
„ Conduct Client feedback/exit interview for assessing quality.
„ Real time monitoring could be considered.
„ Review records, counselling notes, referral services and reports.

Field visits: Field visits for programme monitoring will be on-site visits made by designated
programme nodal officers to assess the progress and implementation of the programme.

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note 53


The purpose of these visits will be to gather data, observe activities, and interact with
stakeholders/beneficiaries to ensure that the programme is on track and making
progress towards its goals and objectives.

Field visits will provide a firsthand understanding of the implementation process and
will help identify any issues or challenges that need to be addressed.

Table 10.3. Frequency & Reporting During the Implementation Phase

Level By Whom Frequency Reporting to


At National Level Team of Nodal Quarterly National Task Force
Officers (NACO) of EVTHS
At SACS Level Team of Nodal Fortnightly/ As and PD SACS & NACO
Officers (SACS) when required

Visit by the Central Team


„ During the programme implementation, the team from NACO or nominated by
NACO will visit the States and the sites to review the programme.
„ Corrective measures will have to be taken by the EVTHS Sites as per the observations
done by the reviewing team.
„ There might be changes to the programme activities or plan, based on the learnings
at the field level.
„ If required, there might be changes in the budget accordingly.

The programme design, operations and project implementation plan will have to be
flexible.

For the EVTHS program to be successful, the patient care cascade must have minimal
gaps and good patient outcomes. For continual program improvement, close assessment
of these key events is needed, and any gaps identified must be immediately addressed:
The key programme events requiring close monitoring are:

1. HIV positive mothers with unsuppressed viral load


2. HIV exposed babies identified positive (Each step of the EID cascade must be
analyzed, and any missed opportunity must be identified)
3. Syphilis exposed babies identified as congenital syphilis
4. Babies identified HIV positive as general client
5. Women identified as HIV positive Direct in Labour
6. Maternal mortality rate
7. HIV exposed infant mortality rate
8. Number of Adverse Birth Outcomes in Syphilis
9. No. of stillbirths to Syphilis sero-reactive pregnant women

54 Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


Annexure HIV-1 Viral Load Sample Collection,
Processing, Storage, Packaging and

I Transportation at Linked
ARTC/ICTC for Pregnant Women

A) Purpose
The purpose is to provide technical guidelines for HIV-1 VL sample collection of pregnant
women at the sample collection facility (ICTC/Link ARTC) and then dispatched to ARTC
for ID generation and IIMS entries. Thereafter, ARTC will further dispatch the plasma
sample to the linked viral load laboratory. The document aims to ensure that sample
integrity is maintained, and no sample is rejected.

B) Activities at the Linked ART Centre/ICTC


I. Pre-collection:
y Laboratory technician at the sample collection facility should ensure that all the
necessary materials required for VL sample collection are available.
y Ensure the TRF is properly filled with a ARTC unique identifier before the sample
collection process is started. The blood collection tube should be labelled with
the same UID.

II. Sample collection:


y Standard precautions should be strictly followed.
y Powder-free gloves are to be used for sample collection.
y 3 ml of whole blood sample should be collected in a K2 EDTA tube.
y EDTA tube should be gently inverted 8-10 times to ensure proper mixing of whole
blood and prevent clotting.
y The tubes should be kept upright for 30 minutes at room temperature (15-30˚C).

III. Sample Processing:


y Plasma should be separated from whole blood within six hours of sample
collection by centrifuging at 2000-2500 rpm for 10-15 minutes at the collection
facility (LAC/ICTC) only.
y Using a sterile Pasteur pipette, transfer the plasma to the prelabelled storage
vials (2.0 ml polypropylene tube with O ring screw cap)
y Seal the tube with parafilm to avoid leakage during transportation.
y Keep the aliquots in storage box for aliquots

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note 55


IV. Sample Storage:
y Separated plasma samples are to be stored in a refrigerator maintained at 2-8°C
and sent to the ARTC for ID generation in IIMS.
y The samples should be sent to the linked ARTC lab at the earliest to the linked
ARTC. Samples are to reach the linked Viral Load lab within 5 days from the date
of sample collection. (LAC /ICTC lab should coordinate with linked ARTC to know
the date of shipment to VL Lab)

V. Sample Packaging and Transportation:


y Laboratory technicians at the sample collection facility and ARTC will ensure
triple packaging instructions are followed as per the national testing guidelines
for sample transportation. This is to maintain the biosafety and integrity of the
sample.
y During packaging, it is important to record the temperature inside the box after
the ice packs are kept and before sealing. (Refer Annexure 1 for transportation
guidelines).
y The proper shipping name “BIOLOGICAL SUBSTANCE, CATEGORY B” should be
mentioned.
y All the waste generated during sample collection, processing and packaging
should be disposed of according to institution/ hospital BMW guidelines.
(Note: Sample collection facility to ensure that plasma sample reaches testing
laboratory within 5 days of sample collection)

VI. Documentation:
y Sample collection facility (ICTC/Link ARTC) should duly maintain the records of
the samples sent to ARTC.
y ARTC technician will enter the VL sample details in the viral load register/IIMS at
the ART center.
y ARTC will initiate the process of dispatching VL samples to the linked VL lab
through the NACO IIMS (SOCH) portal.
y ARTC LT to duly fill the sample transportation sheets for VL samples to be
transported.

REFERENCE: National Guidelines for HIV-1 Viral Load Laboratory testing 2018. Chapters
4 and 5, pg. 15-23.

56 Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note


Annexure Sample Packaging and
Transportation

II Requirements

„ Laboratory technicians at the sample collection facility will ensure triple packaging
instructions are followed as per the national testing guidelines for sample
transportation to maintain the biosafety and integrity of the sample.
„ During packaging, it is important to record the temperature inside the box after the
ice packs are placed inside and before sealing.

Requirements for triple packaging system:

y Overnight frozen gel packs


y Labelled and parafilm M-sealed plasma tubes
y Aliquot storage box
y Sample Transport sheet
y Sealable plastic bag
y Absorbent pad or brown paper
y Clean sample transport box
y Biohazard symbol label
y Label with name, address and contact number of Viral load lab
y Thermometer

The triple packaging system includes 3 layers:

a) Primary Receptacle
y Tube containing sample for viral load testing
y Tube must be watertight and leakproof
y Must be appropriately labelled

b) Secondary Packaging
y The aim of this layer is for enclosure and protection of the primary receptacle
y Must be watertight and leakproof
y Aliquot storage box compatible to store
2.0 ml aliquot vials
y Seal the aliquot storage box and keep it in a
zip lock bag along with absorbent material.

Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note 57


c) Outer Packaging
y Protects secondary packaging from physical damage while in transit
y Insulated box (sample transport box) or thermocol box
y Should be labelled with biohazard symbol.
y The outside of the third container should remain clean to be easily handled
without any need for PPE
y The filled transport sheet should be sent along with the samples shipped.
y The proper shipping name “BIOLOGICAL SUBSTANCE, CATEGORY B” should be
mentioned. The labelling should include Bio-hazard symbol.

Clean Sample transport Box Arrange pre cooled ice pack Place absorbent material

Keep sample aliquot box in zip Cover the lip and label with Keep transport sheet in envelop.
lock bag and place in the sample Biohazard symbol Keep the sample trasnport box and
transport box transport sheet in card board box.

58 Elimination of Vertical Transmission of HIV & Syphilis: Guidance Note

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