1. CD4 assessment among newly diagnosed HIV-infected pregnant women in India’s National Prevention of Parent to Child Transmission Programme (PPTCT) Implications for a ‘Test and Treat’ Approach
S. K. Mohammed1
R.S. Gupta2
R. Rao2
V. Joseph2
P. Srikantiah3
1Reproductive and Child Health Division, Ministry of Health and Family Welfare, New Delhi, India
2National AIDS Control Organisation, Ministry of Health and Family Welfare, New Delhi, India
3HIV/AIDS Division, San Francisco General Hospital, UCSF, San Francisco, USA
It is my pleasure to present data from India’s National PPTCT programme on behalf of the Ministry of Health and Family Welfare, Government of India

2. Importance of CD4 assessment in HIV-infected pregnant women
WHO 2010 Guidelines
Strongly recommend initiation of lifelong ART for all HIV+ pregnant women with CD4 ≤350 cells/mm3
Highlight importance of prompt CD4 assessment and linkage to treatment for HIV-infected pregnant women
Globally, estimated that 20-60% of HIV+ pregnant women require lifelong ART
Data from large national programme settings in low and middle income countries are limited
In 2010, the World Health Organization’s revised PMTCT guidelines strongly recommended initiation of lifelong ART for all HIV+ pregnant women with CD4 counts below 350.
These guidelines highlighted the importance of prompt CD4 assessment and linkage to ARV services for all HIV-infected pregnant women.
Globally, it is estimate that 20-60% of HIV-positive pregnant women require lifelong ART. However, data from large national programme settings are limited.

3. HIV among pregnant women in India
Estimated 2.4 million people live with HIV in India
ANC prevalence 0.42%
India ranks as one of the 10 “highest burden” countries for MTCT
27 million pregnancies/year
Estimated 43,000 HIV+ pregnant women per year
MTCT accounts for 5.2% of new HIV infections
In India, there are an estimated 2.4 million people living with HIV, with an HIV seroprevalence among antenatal clinic attendees of 0.42%.
Despite this low overall prevalence, India ranks as one of the 10 “highest burden” countries for mother to child transmission of HIV.
With 27 million annual pregnancies, there are an estimated 43,000 HIV+ pregnant women each year in need of PMTCT services.
Currently, parent to child transmission accounts for over 5% of new HIV infections in India.

4. PPTCT Programme in India
Pregnant Women Who Receive Antenatal HIV Testing,
Number Pregnant Women Tested
The national Prevention of Parent to Child Transmission or PPTCT programme was launched in India in Since then, there has been dramatic scale-up of services, from fewer than 50,000 pregnant women screened for HIV in 2001 to almost 8 million tested in 2011 at over 7,000 integrated counseling and testing centres, or ICTCs that are integrated within standard district hospital and community health centres.

5. PPTCT Guidelines - India, 2010
CD4 < 350
CD4 > 350
Specimen transport for those who cannot travel
HIV+ pregnant woman detected
Referred for HIV clinical assessment and CD4 testing at nearest
ART centre
Lifelong ART
sd-NVP
According to the 2010 PPTCT national guidelines, pregnant women who were detected to be HIV-positive were routinely referred for HIV clinical assessment and CD4 testing at the nearest ART centre. For women who could not travel to the ART centre, whole blood specimens were collected on a designated day at the ICTC and transported to the ART centre for CD4 assessment once a month.
As of September 2010, the guidelines recommended initiation of lifelong ART for any HIV+ pregnant women found to have stage 3 or 4 HIV disease or CD4 cell count <350 . Intra-partum single-dose nevirapine (NVP) was the recommended antiretroviral (ARV) prophylaxis for women with CD4 count above 350 in India.

6. Objectives of the Study
Evaluate CD4 testing practices and results among newly diagnosed HIV+ pregnant women identified through the national programme in 2009 and 2010
Examine strength of linkages between PPTCT and HIV treatment services
Use data to guide programme policy regarding the selection of a revised national PPTCT ARV regimen in India
We conducted a programmatic evaluation of the CD4 testing practices and results among pregnant women identified with HIV infection through the Indian national programme in 2009 and We further examined the strength of linkages between PPTCT and HIV treatment services in order to guide programme policy regarding the selection of a revised national PPTCT ARV regimen in India.

7. Methods
Antenatal HIV testing data were routinely collected from HIV Integrated Counselling and Testing Centres (ICTCs)
ICTC and ART centre records abstracted to evaluate:
Proportion of HIV-infected pregnant women who received CD4 testing
Proportion with CD4 count <350 cells/mm3,
Number of women initiated on lifelong ART
Antenatal HIV testing data were routinely collected from HIV Integrated Counselling and Testing Centres (ICTCs). ICTC and ART centre records in each state were abstracted to evaluate the number and proportion of HIV-infected pregnant women who received CD4 testing, proportion with CD4 count <350 cells/mm3, and number initiated on lifelong ART.

8. Results Indicator 2009 2010 Number of HIV testing sites 6,297 7,548
Pregnant women screened for HIV
5,807,778
6,877,617
HIV+ pregnant women detected (%)
18,692 (0.32%)
16,024 (0.24%)
Pregnant HIV+ women received CD4 assessment (%)
10,192 (54.5%)
9,917 (61.2%)
HIV+ pregnant women with CD4 < 350 cells/mm3 ( %)
3,082 (30.2%)
3,934 (39.7%)
Number HIV+ pregnant women started lifelong ART
2,154
2,292
Of 5,807,778 pregnant women tested across India in 2009, 18,692 or 0.32% were detected HIV-positive. Among HIV+ pregnant women, 10,192 or 54.5% received CD4 testing, of whom 3,082 or 30.2% had a CD4 count <350 cells/mm3. In 2010, 16,204 or 0.24% of 6,877,617 tested pregnant women were detected HIV-positive. Among these, 9,917 or 61.2% received CD4 assessment, and 3,934 or 39.7% had a CD4 count <350 cells/mm3. In 2010, 2,292 pregnant women started lifelong ART, representing 58% of those with CD4 <350 cells/mm3.

9. Conclusions
Among those tested, close to 40% of pregnant women diagnosed HIV+ve require ART for their own health
This underscores importance of ANC settings as key entry point for HIV care/treatment for women
Highlights importance of pursuing universal antenatal HIV testing even in concentrated epidemic setting
Universal testing is officially endorsed by Indian National Programme since August 2010
Examination of national programme data from 2009 and 2010 indicate that close to 40% of pregnant women diagnosed with HIV infection in India require ART for their own health.
These data are in line with global estimates, are critical for programme planning, and highlight the importance of antenatal HIV testing as a key entry point to HIV care and treatment for women in India.
This is particularly relevant in a concentrated epidemic setting like India, where the vast majority of these women are unlikely to access HIV testing services outside of routine ANC services. These findings highlight the importance of universal antenatal HIV testing even in lower HIV prevalence settings, which has been officially endorsed by the Indian national AIDS programme since August 2010

10. Conclusions & Policy Implications
Almost 40% of detected HIV+ pregnant women did not receive CD4 assessment or linkage to treatment
In light of this data, the national programme selected a single maternal triple ARV prophylaxis regimen (Option B) :
To be used in all detected HIV+ pregnant women, irrespective of CD4 count
Can be started before CD4 results known
A “Test and Treat” Approach
Prevent delays in ART initiation
Help reduce loss to follow up
Notably, however, close to 40% of pregnant women identified with HIV infection in the national programme in 2009 and 2010 did not receive prompt CD4 assessment. As in other resource-limited settings, the lack of access to CD4 testing within ANC settings is a major barrier to decisions on treatment versus prophylaxis for HIV-infected pregnant women, especially at the primary care level.
Taking these programmatic findings and realities into account, the Indian national AIDS control programme elected in November 2011 to revise PPTCT guidelines to select maternal triple ARV prophylaxis (“Option B”) for all pregnant women detected to have HIV infection. This decision was made in part because of the increased operational feasibility of providing a single maternal triple ARV regimen (Tenofovir+Lamivudine+ Efavirenz) to all pregnant women detected to have HIV infection, irrespective of CD4 cell count. The selected maternal ARV regimen can be initiated even before CD4 results are known. This type of “test and treat” approach has the potential to prevent delays in ART initiation and reduce the risks of loss to follow-up

11. Conclusions & Policy Implications
Continued expansion of prompt CD4 assessment still remains a priority
CD4 results will be used to decide duration of triple ARVs (lifetime vs. through breastfeeding period)
India has committed to working towards elimination of new pediatric HIV infections
Implementation of universal antenatal HIV screening that is integrated with MCH services
Strengthening CD4 assessment and linkages between ANC and ART services
The Indian national programme has still placed high priority on expanding and improving prompt CD4 assessment of HIV-positive pregnant women. In accordance with current global guidelines, CD4 count results will be used to guide the duration of maternal ARVs: lifelong ART for women with CD4 <350 cells/mm3 vs. maternal triple ARV prophylaxis for the duration of pregnancy and breastfeeding for women with CD4>350 cells/mm3.
The Indian national programme has committed to working towards elimination of new paediatric HIV infections. Expansion and implementation of universal antenatal HIV testing that is integrated within existing maternal and child health services, as well as efforts to strengthen CD4 testing and ART services for HIV-infected pregnant women are essential components of India’s national strategy to work towards a generation free of HIV.
Thank you for your attention.

12. Thank You