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The New DOH PMTCT Policy Challenges and Opportunities. A H Coovadia ECHO Enhancing Childhood HIV Outcomes Department of Paediatrics and Child Health Coronation Women and Children Hospital University of The Witwatersrand. Overview. PMTCT - Background The Old PMTCT Policy
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The New DOH PMTCTPolicyChallenges and Opportunities A H Coovadia ECHO Enhancing Childhood HIV Outcomes Department of Paediatrics and Child Health Coronation Women and Children Hospital University of The Witwatersrand
Overview • PMTCT - Background • The Old PMTCT Policy • Where are we with PMTCT today ? • The NSP (2007-2011) • The New Revised PMTCT Policy • PMTCT – The ‘Gateway Programme’ • Challenges and Opportunities
Background • 55% of all HIV-1 positive adults are women of child bearing age. • Seroprevalence rates among pregnant women exceeds 30% in many urban populations in sub-Saharan Africa
MTCT Rates • ~10 - 30% in non-breastfeeding population of HIV-1 positive women in more developed countries • 25 -45% in breast-feeding populations in Africa
Risk Factors for Mother-to-child-transmission • High maternal viral load • Low maternal CD4 count • Vaginal delivery • Premature rupture of membranes • Breast milk
Risk Factors for Mother-to-child-transmission • chorioamnionitis • low birth weight of the baby • the first twin born • unprotected intercourse with an HIV-infected partner • IV drug abuse • STI’s
History of PMTCT and ARV interventions • ACTG 076 • 1994, AZT to mother from 2nd trimester, IV during labour and delivery, 6 weeks to infant; transmission reduced from 25%-8% • Shorter course therapies sought • Thai regimen • PETRA • HIVNET 012 • Nevirapine one dose to mother and one dose to baby (transmission reduced to 13%)
PACTG 076 USPHS AZT Recommendations 80% decline Number of cases
What did we know and when did we know it? Perinatal HIV Clinical Trial Results 1994 2004 • 1994 U.S. AZT Trial ACTG 076 • 67% reduction in transmission • 2004 ThailandPHPT • 1.9% AZT + NVP • 1998 Thai Bangkok short AP/IP AZT trial • 50% reduction in transmission • 2003 DITRAME + 1201.1 • 4.7% TR with AZT/3TC & IP/PP NVP • 1998 Cote d‘Ivoire short AP/IP AZT trials • 37% reduction in transmission (breastfeeding) • 2002 Cote d’Ivoire DITRAME + • 6.2% TR with AZT & IP/PP NVP • 2000 ThailandLong vs short AZT regimens • 4% TR in LL (non BF) • 1999 PETRA AZT/3TC trial (6 wk results) • 50% reduction with longest arm. • 38% reduction with the IP/PP arm • 1999 Uganda 2-dose IP/PP NVP trial (HIVNET 012) • 47% reduction in transmission (breastfeeding)
PMTCT: The four-pronged strategy • Primary prevention of HIV in parents-to-be • Prevention of unwanted pregnancies • Prevention of transmission from HIV-infected mother to infant • Appropriate treatment and care
SA pMTCT Programme2001 - 2007 • Nevirapine as single dose (sd) administration • Dose= 1 tablet to mum at onset of labour and a dose to baby within 72 hours after birth • Provision of infant formula for six months to mothers choosing this option. • NVP prevents MTCT by ~50% (Transmission Rates of approximately 10%)
Non-pregnancy related infections mainly HIV, TB and Pneumonia were the leading cause of death in 38% of women However probably an underestimate as only 46% of women who died were tested for HIV, and 78% of those tested were HIV positive PMTCT is an opportunity to save the lives of mothers and not only babies !
National Antenatal Testing Rate was 75% compared with 45% (2005/6) HIV prevalence rate amongst ANC attendees = 29% Compared with 30.2% (2005/6) Percentage of Women receiving Nevirapine was 61% Compared with 52% (2005/6) Percentage of Babies receiving Nevirapine was 45% Lower than 2005/6 BUT more likely reflecting better quality data
National HIV and Syphilis Prevalence Survey 2006 30.2 29.5 29.1
NSP Goals KEY Priority Area 1 – PREVENTION Reduce the rate of new infections by 50% by 2011 • Section 3 of the Key Priority area 1 • 3.1 Broaden existing mother to child transmission services to include other related services and target groups • 3.2 Scale up coverage and improve quality of PMTCT to reduce MTCT to less than 5%”
The New Revised PMTCT Policy2008 • ‘Routine offer of VCT’ (Provider Initiated) • Addition of AZT (Dual Therapy) • Emphasis on getting CD4 counts on all pregnant women to start HAART in pregnancy (CD4 < 200 OR WHO stage 4) • Infant Feeding Options – better guidance • Emphasis on infant diagnosis at 6 weeks
SA pMTCT Programme2008 DUAL THERAPY • Women who need ARVs – get put onto this ASAP (CD4 count less than 200) FOR WOMEN WITH CD4 COUNTS ABOVE 200 OR IF NOT YET ON ARVs (I.E ALL WOMEN) • Mother - AZT during pregnancy from 28 weeks gestation + single tablet Nevirapine in Labour • Baby – Single dose Nevirapine + AZT for 7 days (and in some cases upto 28 days) • Able to reduce MTCT to 5% with new policy !
AZT TO BABY FOR 4 WEEKS IF: • Mother received no PMTCT • Mother received only nevirapine for PMTCT • Less than 4 weeks of AZT/HAART taken by mother • Mother diagnosed for the first time in labour or postpartum – AZT to baby best given within 12 hours of birth
Mother to Child Transmission One out of four babies (25%) born to all HIV positive mothers will acquire HIV from their mother ( if no intervention is offered ) That means at least 75% of babies are uninfected at birth!
PMTCT RATES Of all HIV Infected Women 95 % HIV Negative Babies ! 75 % HIV Negative Babies 25 % HIV Infected Babies Where no intervention Old policy Sd NVP 10% Infected 5% Infected New policy AZT + Sd NVP
First StepTesting Testing
SCREENING HIV TEST SCREENING POSITIVE SCREENING NEGATIVE CONFIRMATORY HIV TEST NEGATIVE CONFIRMATORY POSITIVE CONFIRMATORY NEGATIVE REPEAT TEST AT AROUND 34 WEEKS FINAL RESULT POSITIVE INDETERMINATE SEND FOR HIV ELISA INDETERMINATE ELISA SEND FOR HIV DNA PCR (diagnostic PCR) POSITIVE / NEGATIVE ELISA FINAL RESULT
Management of HIV infected Pregnant Woman First Visit (WHO stage I-III) If 28 wks or more Hb ≥8g/dl StartAZT 300mg BD If < 28 weeks Or Hb <8g/dl Do NOT Start AZT Hb CD4 Gestation Week ?
Assessment of HIV infected Pregnant Woman Second Visit CD4 < 200 OR WHO Stage IV CD4 WHO Stage CD4 > 200 OR WHO Stage I-III HAART If previously on AZT Switch to 3TC/d4T/NVP PMTCT Regimen If ≥ 28weeks AZT until Delivery
LABOUR AND DELIVERY • At onset of labour, woman to take 600mg AZT (2 tablets) stat plus 200mg sd (1 tablet) nevirapine. • If Nevirapine already taken previously with false labour, do not repeat nevirapine dose and neonate receives standard post exposure prophylaxis. • Continue AZT 300mg 12 hourly at the usual times until the neonate is delivered. • Mother on HAART, continue treatment as usual during labour.
POSTNATAL CARE Baby: Nevirapine 0.6 ml as soon as possible after delivery (under 2.5kg give 0.2ml/kg), plus AZT 4mg/kg 12 hourly for 7 days or 28 days (premature <35 weeks 2mg/kg) • Above the same for women on AZT or on HAART • Enquire about feeding options from the mother
Babies Requiring 28 days ofAZT • Where mother had no ARVS at all during antenatal period or labour i.e unbooked • Mother had < 4 weeks of AZT or • Mother had < 4 weeks of HAART • Mother received only sd NVP
What about the women testing Negative ? Repeat HIV testing at or around 34 weeks of gestation About 5% of women will seroconvert during pregnancy HIV NEG ----------------- HIV POS
What about the women who haven’t been tested ? Postnatal Ward Labour Ward No women should leave a healthcare facility without being offered an HIV test. Not doing so is tantamount to being negligent Remember too our responsibility to both mother and the child
Challenges to Success of the Programme • Political leadership • Testing rates below target • Adequacy of human resources (e.g trained counsellors) • Information transfer between facilities. • Stigma • Drug supply – NVP + AZT (no stock outs) • No widespread campaign explaining benefits of programme • Lack of integration with other services such as family planning/CCMT/EPI • Community and NGO involvement largely lacking • Not seen as priority programme by healthcare facilities that have other competing demands • Public sector focussed rather than larger public health concern, where only addressing attendees to the public health service
Which Services need integration ? • VCT – Family Planning • VCT – PMTCT • PMTCT – CCMT (ARV sites) • PMTCT – Infant Diagnosis and Follow up (IDFU) • Infant Diagnosis and Paediatric ARV site • EPI – IDFU • TB - CCMT • STI - CCMT
Meeting the challenges • Political Commitment • Increase effective coverage - PMTCT programme in 100% of healthcare facilities providing ANC • Testing strategy needs revisiting – Provider initiated TC • Adequate staffing with role clarification and systems improvement to enable better coverage of all women. • Prioritization of programme within healthcare facility. All staff at facilities must understand importance of the programme. • Programme leadership with dedicated and responsible team who monitor progress in on-going manner i.e M&E at local level. • Integration of PMTCT with CCMT services to enable smooth transfer of patients needing treatment • Community education and involvement in getting testing rates up. • Mass media and educational campaigns to raise awareness of the programme and it’s benefits. • INFANTS - Need to ensure that ALL HIV exposed infants reap the benefits of an enhanced PMTCT programme, which would include • Abandoned infants (upto 50% have been noted to have had HIV exposure) • Infants whose mothers are indisposed – death, coma, serious post-partum illness, mental confusion • Infants whose mothers refuse testing - • Infants whose mothers refuse any intervention despite knowing their status
Opportunities • Improve overall maternal antenatal care and outcomes • Through training on basic ANC • Reduction in maternal mortality (NCCEMD) • Improvement in basic infrastructure/equipment • Improve HIV testing rates amongst adults (women and men) • Expedited entry onto ARVs for women with low CD4 counts • Increasing access points for ARVs for patients • Drastically reducing numbers of infected infants • Establishing follow up for infants with early diagnosis and treatment if needed • Decreasing orphanhood
PMTCT‘The Gateway Programme’ • Thesaurus • Entry • Opening • Access • First step • Opportunity • Chance • Longman Dictionary • An opening in a fence or way etc, across which a gate may be put • A way of finding e.g Hardwork is the gateway to success
What are we aiming for ? 95 % HIV Negative Babies 5% Infected
Decrease number of infected Women In SA Early Identification Of Sick Women Decrease number of infected Children In SA PMTCT 95% HIV negatives Decrease morbidity And mortality in HIV infected Women in SA +ves Early Identification Of all infected infants Decrease morbidity And mortality in HIV infected Children in SA Early initiation of HAART in infants
References • SA National DOH PMTCT Policy (2008) • District Health Barometer (HST 2006/7) • Every Death Counts Report • Lancet – Every Death Counts Would like to thank Prof James McIntyre for use of some slides. Ashraf.Coovadia@wits.ac.za