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Aids and maternity in India

 | 
Patrice Cohen
, 
Suniti Solomon

Part 2. Prevention of HIV/AIDS mother to child transmission

6. UNICEF Programme For the Prevention of Parent-to-Child HIV/AIDS Transmission, Tamil Nadu1

P. Kuganantham et Sheila Shyamprasad

Texte intégral

  • 1 This text written in June 2003 brings updated information on the prevention of MTCT in Tamil Nadu.
  • 2 Note from the editors: Appendix 1 following this text will give details on the national study on pr (...)

1The state of Tamil Nadu has been implementing HIV/AIDS control programmes for the past 15 years through the Tamil Nadu State Aids Control Society (TNSACS). The programme for the prevention of parent-to-child transmission of HIV with Nevirapine was launched in September 2002. This followed a pilot study conducted from the year 2000 that was directed by the National Aids Control Society (NACO) in eleven centres of excellence in India2. Three of these centres have been chosen in Tamil Nadu: namely IOG-Chennai, KGH and RSRM hospitals, Chennai. AZT and Nevirapine feasibility studies were conducted in these institutions. Nevirapine was found to be more advantageous than AZT when used as a single dose for the mother and child.

2The three centres have trained all the medical colleges of the state for the implementation of the PPTCT through “PPTCT teams” formed in the respective medical colleges. Each medical college in turn trained at least two district headquarters hospitals for the PPTCT programme. TNSACS now implements the programme with the technical support and training of UNICEF. All the hospitals in the state are provided funds by TNSACS for procuring refrigerators, infantometers, laboratory equipment, stationery, for making civil modifications in the antenatal clinics and for improving the quality of service in the clinics, labour wards and postpartum wards.

3The PPTCT teams are comprised of a principal investigator (obstetrician and gynaecologist), a paediatrician, a microbiologist/ lab technician, a health educator/ counsellor and a staff nurse. These teams were formed in all the hospitals. The counsellors are recruited and posted in most of the centres by identified NGOs, namely Gramodhaya and South India AIDS Action Programme (SIAAP). The lab technicians are also recruited by the individual hospital authorities according to the qualifications specified by NACO.

4All the antenatal mothers in the antenatal OP are initially given group education by the counsellors followed by pre-test counselling. The antenatal women who volunteer for testing are tested for HIV status and subsequently, after a few days, called for post-test counselling. The negative mothers are given counselling on sustaining their negative status and also on primary prevention. The positive mothers are counselled along with their spouses and are encouraged to undertake institutional delivery and nevirapine prophylaxis.

5Every mother is counselled on infant-feeding practices, especially exclusive breastfeeding: for six months for the positive mothers and for two years for the negative mothers. The use of condoms during the antenatal period and during the breastfeeding period is emphasized for the HIV-positive mothers. Condom demonstration is done for all the antenatal mothers so as to promote primary prevention among young people.

6In the past ten months of the implementation of the programme, UNICEF Chennai and TNSACS have trained 50 PPTCT centres: all the government and private medical colleges and hospitals (numbering about 19), 29 district headquarters hospitals, and 2 private. maternity hospitals. UNICEF is planning to train another eight private maternity centres and ten municipal corporation maternity centres.

7HIV test kits are supplied to all the centres from the TNSACS and quality is being studied by the team of microbiologist and EQAS. The district headquarters hospitals are required to send 2 out of 20 negative blood samples and all the positive samples to the nearby medical college hospital for cross-checking. At the PPTCT centres, where either the lab technicians or the counsellors are posted, the VCTC counsellors and the technicians support the programme. The PPTCT programme is strengthened through developing facilities and infrastructures and through various advocacy programmes and motivational training.

8Additional funds were also provided to all the centres for the following: implementation of PEP, universal work precautions, hospital waste management, the purchase of needle destroyers, disposables in the labour wards, T.V., DVD and audio visual cassettes in the group education unit, the provision of nutritive food supplements for the positive mothers, and also to make separate cubicles with aluminium and glass partitions for group education, pre- and post-test counselling and for the laboratory. At least 50 % of the institutions are so far utilized the funds have been allotted to them.

9The programme has resulted in perceptible changes among the doctors, paramedicals, antenatal mothers and their spouses, the community, and especially the HIV-negative antenatal mothers. The change of behaviour brought about among the antenatal mothers, their spouses and family is one of the major outcomes of the programme. A vast majority (up to 90 %) of the couples visiting the PPTCT centres are young people between the ages of 18 to 25 years, who are mostly primigravidae and married less than 5 years. These are the most vulnerable groups for intervention to bring about behavioural changes and primary prevention.

10The sharing of experiences among the three centres, advocacy workshops for the joint and deputy directors of health services, sensitization and in-house training programmes for more than 6,000 hospital workers, participation of NGOs and support of positive-mother networks have resulted in many changes and in the up-scaling the PPTCT programme.

11In Tamil Nadu, we can draw the following picture up to now:

  • About 1.5 lakhs antenatal mothers have been counselled.
  • Nearly about 90 000 mothers opted for testing.
  • 342 mothers were found to be HIV-positive.
  • 330 mothers and infants were given Nevirapine.
  • About 110 mothers and infants have been followed-up in the well baby clinics.
  • 60 % of the children are given exclusive breastfeeding and survive without significant complications.
  • HIV testing for infants is encouraged only after 18 months.

12The PPTCT programme is expected to bring more success in the forthcoming years with the reduction of HIV among young people and antenatal mothers, reducing HIV prevalence among the general population.

Annexes

Appendix 6.1: National Study on Prevention of MTCT NACO3

The transmission efficiency of mother to child transmission of HIV infection ranges from 13-60 %. With increasing HIV infection among antenatal women in certain high prevalent states, paediatric AIDS is poised to become a major public health problem.

The ACTG 076 trial of AZT, given to HIV infected pregnant women between 14-34 weeks of gestation orally till delivery and intravenously during labour and newborns for 6 weeks postnatally reduced transmission by 2/3rds. This led to the recommendation of use of AZT in HIV infected women in the US as a public health policy. Reports of a 50 % efficacy from a collaborative study conducted in Thailand where AZT was administered after 36 weeks of gestation to the mother in the dosage of 300mg twice a day and 300 mg every three hours during delivery increased the feasibility of extending this short course Thai regime in other developing countries including India. Recent reports of single dose Nevirapine to the mother and child with similar efficacy needs to be studied further for long term side-effects before it is widely accepted. (…)

A pilot study on Mother to child transmission (MTCT):

The feasibility study of AZT intervention and primary prevention was conducted among pregnant women at 11 institutions located in 5 states of India which had reported a high prevalence of HIV infection during annual sentinel surveillance exercises. The feasibility study was conducted by NACO, GOI between April 2000 and July 2001. The following institutions participated in the feasibility study:

Maharashtra State:

1. Seth G.S. Medical College & KEM Hospital Mumbai

2. Grant Medical College & JJ Group of Hospitals, Mumbai

3. T.N. Medical College & B.Y.L. Nair Hospital, Mumbai

4. B.J. Medical College & Sassoon Hospital, Pune

5. Government Medical College Sangli

Tamil Nadu

6. Institute of Obstetrics & Gynecology Chennai

7. RSRM Hospital, Chennai

8. Kasturba Gandhi Hospital, Chennai

Andhra Pradesh

9. Osmania Medical College, Hyderabad

Karnataka

10. Vani Vilas Maternity Hospital, Bangalore

Manipur

11. JN Hospital, Imphal

During 173 months (average of 15.7 months at each institution) of the study, active group education, counselling of women and their husbands, HIV testing, cost-free AZT for seropositive women, and intra- and postpartum services were offered. Of 192,474 women offered group education, 171,471 (89.1 %) received one-to-one counselling for HIV/STI/RTI

Conclusions

1. Due to a lag in establishing HIV counselling and testing (VCT) services at several institutions, fewer than 192,474 women were offered these services. Of 103,681 women tested for HIV-1/2, 1724 (1.7 %) tested seropositive. Despite efforts of project staff at these institutions, 751/1724 (43.6 %) of seropositive women took AZT prophylaxis. The major reasons for lower recruitment for AZT were: intention of women to return to their parents’ town during third trimester, refusal of women/family to take AZT etc.

2. The study has shown that antenatal clinics can be utilized effectively for imparting education to pregnant women about prevention and control of HIV/AIDS through trained counsellors.

3. Among the HIV seropositive women, 80 % were in the age range of 16- 25 years; mean age being 23.2 years. The majority (72.7 %) of women were married for a period of <=5 years (mean duration 3.9 years). About 27 % of the antenatal women were primigravida (mean gravida of 1.73 and mean parity of 0.7). These figures indicate that women were generally getting infected with HIV at a younger age and, if not detected early on, they may continue to bear children who might be HIV-infected, besides women endangering their own health due to repeated pregnancies. Hence, timely detection and counselling will prevent further pregnancies and consequent transmission of HIV infection to the offspring. This necessitates inclusion of PMTCT as an integral component of maternal and child health services in the country.

4. As 40 % of the antenatal women reported that their spouses have multiple sexual partners, their exposure to the PMTCT programme will enhance their capacity to protect themselves from acquiring HIV infection and other sexually transmitted infections.

5. The cost effectiveness of the PMTCT programme, as measured by the number of HIV infections averted in the babies born to seropositive women, may not be high since the prevalence of HIV in the community in most parts of the country is still low; hence, the number of new born HIV infections averted would also be very low. However, as seen in this study, the programme becomes cost effective when primary prevention among 98.3 % HIV seronegative antenatal women is considered as an important outcome indicator. The cost of intervention was determined at Rs.175 per woman based on the following calculations: Budget for intervention project Rs. 3 crore, Number women benefited is 171,000.

6. The study showed that the MTCT rate was reduced from historical rate of 33 % (Mumbai study) to 8.4 % at birth OR 10.1 % at age of two months. Thus, the study was able to avert infection in the following number of babies: Expected number of infected babies born without AZT prophylaxis 658@33 % =217 Estimated number of infected babies born with AZT prophylaxis 658@10.1 % =66 Infection averted due to AZT prophylaxis = 217-66 = 151

7. This study has clearly brought out that the Government of India should have a firm policy on infant feeding practices of HIV-infected mothers. This should be done keeping in view the high risk of mortality associated with replacement feeding under unhygienic conditions and poverty situation vis-à-vis risk of HIV transmission from breast feeding by HIV infected mothers. It can be concluded from the study that exclusive breastfeeding for the first four months of life, gradual weaning between 4-6 months and termination of breastfeeding at the end of 6 months will be the best possible option. Also, as Indian culture and traditions promote breastfeeding, the community might discriminate against an HIV-seropositive mother who is not breastfeeding.

8. The 11 institutions have successfully completed the feasibility study of AZT. The evaluation report showed a good capacity of PMTCT at these institutions, improved credibility of the institutions in their communities, and the study enlisted substantial media support.

9. Preventive education of families through pregnant women is a good strategy. Its spin-off impact on the epidemic should be evident over the next few years.

Recommendations

Since the feasibility study has established that PMTCT is a cost-effective strategy for prevention and control of the epidemic, it is recommended that NACO, GOI should expand the strategy to the programme -level across the country. This will require a massive training exercise to cover 600 districts in India in a phased manner.

It is recommended that the 11 institutions that participated in the feasibility study should be designated as “Centres of Excellence for PMTCT programme” and their technical experience should be utilized in scaling up the PMTCT activities. These institutions shall act as nodal training centres for the country.

These institutions should also undertake operational research, especially with Nevirapine. More data needs to be collected on breastfeeding and its association with HIV transmission.

Appendix 6.2: A Pilot Study on Prevention of MTCT from the NGO Sector in Chennai, India4

The CSI Rainy Multi-speciality Hospital in Chennai is a 400-bed mission hospital widely recognized for its services in maternity care for the last 115 years. There are approximately 2,000 deliveries a year, the highest in the private sector in Chennai. At present it is among the few hospitals in the city offering surgical, intensive care services and labour room facilities for HIV-positive persons. The hospital has been involved in the prevention of mother-to-child transmission since 1996. However, it is only during the last two years that the hospital has seen increasing numbers of HIV-positive mothers needing intervention. This is because of the affiliation with the YRG CARE, which has resulted in many referrals.

A Pilot Study with Combination Drugs and Elective Caesarean

Prevention of MTCT in the CSI Rainy Hospital was routinely done using the Thai regimen with AZT 300mg bd from 36 weeks onwards and oral AZT 300mg bd every three hours during labour. The decision of breastfeeding was left to the mother. In 1999, CSI Rainy Hospital, in collaboration with YRG CARE and Brown University, launched a new study.

Aim of the Study:

1. Assess the rate of mother-to-child transmission of HIV employing a combination regimen of drugs, elective Caesarean section and avoidance of breastfeeding.

2. To identify risk factors that determines transmission from mother to child.

Counselling and Recruitment:

HIV-positive antenatal women attending the YRG CARE centre, as well as those detected positive at CSI Rainy, were enrolled in the study. All women were antiretroviral naïve. The women enrolled from CSI Rainy were those who were attending the routine antenatal OPD and had been detected as positive during the investigations. All antenatal women have a group counselling session before being tested for HIV. Those testing positive have an individual post-test counselling before confirmation of test results. At YRG CARE, the women are usually referred from other hospitals and clinics with a known HIV-positive status. Test results are confirmed with two ELISAs. The woman and her partner are both counselled and written consent is taken before recruitment into the study.

Protocol:

1. The women were started on a combination of AZT and 3TC from the 34th week onwards; AZT was given in a dose of 300mg twice daily and 3TC, 150mg twice daily.

2. A complete haemogram was done to exclude any anaemia, blood dyscrasias and infections.

3. A CD4 count was done at the time of booking.

4. Women were scheduled for an elective Caesarean section at 38 weeks.

5. A single dose of Nevirapine 200mg was given to patients 6 hours before elective surgery.

6. Infant’s cord blood was taken for RT PCR at the time of birth, one week, 6 months and ELISA at 18 months. A CD4 count for the mother was done at 6 weeks postpartum to note the progress or otherwise of the HIV infection.

7. Formula feeding was followed and infants were given a single dose of Nevirapine and, in addition, were also give AZT/3TC syrup starting from within 6 hours of birth and discontinued once their PCR results were reported negative.

Population

• 30 women were enrolled in this study from September 1999 to January 2001.

• Average age: 22.1 yrs and 70 % primigravidae.

• 6.7 % had acquired the infection heterosexually, 10 % by blood transfusion and 3.3 % unknown.

• Average CD4 count: 778 cells/cmm at the time of enrolment - ranging from 182 to 2071

Results

• 26 (86.6 %) women completed the full course of AZT and 3TC;

• of these 25 had elective caesarean section

• and one had a vaginal delivery.

• 4 (13.4 %) women could not complete the full course –

• 3 of them because they had premature vaginal deliveries and one woman booked late and had only one week of medication and elective section. The average weight of the babies was 2.6kg. Morbidity following Caesarean section was similar to the general population. There were no wound infections and no prolonged hospital stay in any of the patients. 3 babies had hyperbilirubinemia. The average CD4 count at 6 weeks postpartum was 827/cmm ranging from 217 to 2958. All infant HIV PCR results were negative.

Conclusion and Discussion

A multi-prolonged approach with combination antiretrovirals to mother and infant, elective Caesarean section and avoidance of breastfeeding has proved extremely effective and safe in this pilot study. The maximum risk of transmission to the infant is during the process of vaginal delivery. French studies have clearly shown the superiority and effectiveness of elective Caesarean in reducing the rate of transmission to less than 2 %. Elective Caesarean section also has the added benefit of preparedness of the staff in the hospital. This factor is important in a set-up which is relatively new to handling HIV-positive patients where labour emergencies in a HIV-positive patient can add to the confusion.

The nil rate of transmission in this small study may be attributed to the fact that the majority of patients were primigravidae in a relatively early stage of infection. This again could contribute to the fact that none of our patients had post-operative wound infections or prolonged hospital stay.

The avoidance of breastfeeding in this study has further contributed to the decrease in transmission. This may prove to be a point of contention when applied to larger populations where breastfeeding is the cultural norm and the high cost of formulae precludes their use among the poorer sections of society. However, most mothers when counselled and made aware of the risk of transmission chose to formula-feed their infants. The success of this study makes it worthwhile to apply this regimen in appropriate populations.

Notes

1 This text written in June 2003 brings updated information on the prevention of MTCT in Tamil Nadu.

2 Note from the editors: Appendix 1 following this text will give details on the national study on prevention of MTCT initiated by NACO, and on recommendations for national policy. Appendix 2 will propose a pilot study on prevention of MTCT initiated by the NGO sector in Chennai, Tamil Nadu.

3 Excerpts from Naco website proposed by the editors, as in August 2003: http://www.naco.nic.in/nacp/program/pmtct.htm

4 The Indian protocols for medical drugs therapy for PMTCT have been presented in the Indo-French round-table seminar in April 2002. This appendix is the oral presentation of Dr. Sheila Shyamprasad about protocols initiatives in NGOs.

Auteurs

UNICEF, Chennai
UNICEF Consultant for PMTCT-Tamil Nadu, India. / 91-44- 25505060.

CSI Rainy Hospital, Chennai
CSI Rainy Hospital is the official obstetric and gynaecologist hospital for YRG CARE.

© Institut Français de Pondichéry, 2004

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