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CAB 34 – DHICE Community Training Day 18 June 2010
National Study of HIV in Pregnancy and Childhood
and
Collaborative HIV Paediatric Study
Pat Tookey, UCL Institute of Child Health
• Who we are • What we do • Current picture • Current work • Ethics and governance • CHIPS
Who we are
Based at UCL Institute of Child Health in the MRC Centre of Epidemiology for Child Health
Originally established in 1986 with core funding from AVERT (AIDS Education and Research Trust) and the Department of Health. Current contract with and core funding from the Health Protection Agency
Specific research projects funded or supported by departmental or other sources
Core team of three (Data Manager/Coordinator, Researcher, Administrative Assistant) with support from MRC Centre colleagues
What we do National surveillance of, and research on, obstetric and
paediatric HIV (UK and Ireland) Two reporting schemes run in collaboration with
the Royal College of Obstetricians and Gynaecologists (RCOG) since 1989
the Royal College of Paediatrics and Child Health’s British Paediatric Surveillance Unit (BPSU) since 1986
Comprehensive reporting of all pregnant women known to have HIV infection in pregnancy in
the UK or Ireland (diagnosed women) all infants born to diagnosed women (exposed infants) all children diagnosed in the UK or Ireland with HIV infection
(infected children), regardless of country of birth
Full details and summary data www.nshpc.ucl.ac.uk
What we do No enrolment, no interventions, no direct contact
with patients, no patient names or addresses NSHPC links mothers and babies by date, place
and other details Information collected on demographics, timing of
women’s diagnosis, treatment and outcome of pregnancy, infection status of infants, and diagnosis in children
Regular standard surveillance datasets to HPA to combine with adult HIV surveillance data www.hpa.org.uk
Children born to HIV infected women All children born to HIV infected women are
followed up to establish infection status Follow up information on treatment and health of
infected children collected every year (CHIPS) Uninfected children
Early information available for first year of life Minimal follow up at present Detailed follow up not possible (too many children) Flagging with ONS for death / cancer reports
HPA / HPS SOPHID
CDR / HPS Weekly Quarterly tables Annual reports
Uninfected children CHART
(enrolment closed)
DH / CHINN / CHIVA Commissioners,
clinicians, local and regional requests
Infected children CHIPS
NSHPC, MRC CTU, paediatric centres, transition clinics NSHPC
analyses and publications
Children born E&W ONS
Flagging for death and cancer
Provide data for WHO / APR
Other collaborations as appropriate
Antenatal HIV screening:
surveys, programme development
and evaluation
ECS Inter/national
collaborations …. Pharmacovigilance data provision
Perinatal HIV – 20 years of surveillance
Changing epidemiology of HIV Advances in treatment and prevention Success of routine antenatal testing Survival of infected infants into adult life
Challenges: maintaining high uptake of antenatal testing improving pregnancy care and further reducing MTCT rates long term management/ follow up of perinatally infected children transition from paediatric to adult care monitoring exposed uninfected children in long term
Current Picture Pregnant women and children in the UK and
Ireland Most recent NSHPC data available on website
www.nshpc.ucl.ac.uk
HIV prevalence1 among pregnant women by area of residence (diagnosed and undiagnosed women)
1Unlinked anonymous survey of newborn infant dried blood spots, England & Scotland.
Impact of current protocol • Antenatal HIV test recommended to all women since 2000 • Uptake of testing exceeds 90% in most regions • Overall detection rate exceeds 90% nationally • 60% of diagnosed women aware before current pregnancy • Antenatal detection rate exceeds 80% nationally
• Almost all diagnosed women accept interventions • MTCT rate from diagnosed women 1.2% (CI 0.9-1.5%) • Probable 25% transmission rate from undiagnosed women
(could be higher following seroconversion) • Most UK-born infected infants have undiagnosed mothers
HIV infected pregnant women Over 12,000 pregnancies reported in UK/Ireland
over 90% since 2000 About three-quarters of women were born in sub-
Saharan Africa, 1 in 8 in UK or Ireland, 1 in 10 born elsewhere
Currently About 10% of women have HIV symptoms in pregnancy Over half are diagnosed before current pregnancy Over half of English reports are from outside London
Timing of maternal HIV diagnosis UK/Ireland: all births/pregnancies reported by March 2010
*incomplete
Trends over time, diagnosed women (Townsend et al, BJOG 2008)
1990-93 1994-96 1997-99 2000-03 2004-06 N. pregnancies (per year)
376 (94)
325 (108)
576 (192)
2941 (735)
4009 (1336)
% TOP 30% 15% 12% 5% 3%
Region SWNI London Rest England
Ireland
24% 51% 17% 8%
15% 65% 16% 4%
5% 76% 13% 6%
3% 57% 27% 13%
4% 45% 43% 8%
Women IDU UK/Irish born SSA born =>35 yrs Symptoms
49% 49% 43% 4%
22%
29% 33% 58% 6%
25%
16% 25% 67% 16% 19%
6% 15% 77% 17% 11%
3% 13% 79% 20% 11%
Low rates of MTCT of HIV in the UK and Ireland, 2000-2006 Townsend et al. AIDS 2008;22:973-81
• Overall MTCT 1.2% (95% CI: 0.9-1.5%, 61/5151) – 0.8% in women with 14+ days of ART (40/4864)
• 464 women on ZDV mono with planned CS – No transmissions
• Minimal transmission from women on HAART delivering as planned – MTCT rate 0.7% (2286 women with planned CS) – MTCT rate 0.7% (559 women with planned VD) – Only 3 transmissions (0.1%) in 2117 women with VL<50
(2 infants with evidence of in utero transmission
Current work
Current work Usually through PhDs and Fellowships, eg Sequential pregnancies Pregnancies in African born women Pregnancies in perintally infected women Use of non-AZT ART in pregnancy Vaginal delivery and ruptured membranes New diagnoses in children
Why is MTCT still occurring? • 2007/8 audit of perinatal transmissions occurring in
England 2002-05 (NSHPC, AIAU, CHIVA) • 33 infants born to diagnosed women • 54 infants to women not diagnosed before delivery • Audit identified a number of factors which might have
contributed to transmissions occurring • Executive Summary and Recommendations at
www.nshpc.ucl.ac.uk/ and www.chiva.org.uk/
• Over 40 more perinatally children identified since then, born in that period, most to undiagnosed women
Timing of maternal infection
• Infected children whose mothers were not diagnosed before delivery have mothers who either – had long-standing infection but declined, or were not
offered, antenatal testing, or – tested negative at antenatal testing and seroconverted
during pregnancy, or – tested negative at antenatal testing, and seroconverted
while breastfeeding • some time between delivery and infant diagnosis
Perinatal infection – where now? • Further data on circumstances surrounding MTCT to
infants born to diagnosed women • Develop mechanisms for feedback to antenatal units
where undiagnosed women were delivered, and seek information on antenatal test offer in those cases
• Establish contribution of postnatal seroconversions to perinatally acquired infection
• Collect additional information on infected infants born to undiagnosed women (extending audit)
• If evidence available, identify likely timing of maternal seroconversion and paediatric infection
• Needs adequate support and extension to ethics
Ethics and governance Research Ethics Committee National Information Governance Board
previously Patient Information Advisory Group Institutional review Steering Group Peer review for publications Feedback to interested groups
Public websites Talks and presentations
Ethics and governance
Central London Research Ethics Committee Ref MREC/04/2/009 (NSHPC) Ref MREC/04/2/010 (CHIPS) Annual reports to REC
Any ‘Substantial Amendments’ to protocols have to be submitted for further review eg, Audit of perinatal HIV infections in England 2002-2005
Ethics and governance National Information Governance Board
previously Patient Information Advisory Group Established under Health & Social Care Act 2008, relating
to section 251 of the NHS Act 2006 which allows the common law duty of confidentiality to be set aside in specific circumstances
NIGB’s Ethics and Confidentiality Committee reviews applications relating to collection of identifiable data without individual patient consent Identifiable in this context means date of birth, NHS or clinic
number, postcode etc – rarely names or addresses Applicants have to provide compelling reasons why
consent is not sought, and make annual progress reports to NIGB http://www.nigb.nhs.uk/
Ethics and governance Institutional review
ICH and HPA Data protection Institutional security policies
Ethics and governance Steering Group, meets twice a year
Terms of reference • To ensure effective collection, use and dissemination of data, to
develop the research potential of the study, provide different perspectives on the study, provide specialist advice and support
Collaborating institutions (HPA, HPS, ICH) Clinical representatives Lay representatives
Positively Women African HIV Policy Network
http://www.nshpc.ucl.ac.uk/
Ethics and governance Peer review for publications Feedback to interested groups
Public websites http://www.nshpc.ucl.ac.uk/ http://www.chipscohort.ac.uk/ http://www.chiva.org.uk/ http://bpsu.inopsu.com/studies/hiv/index.html
Talks, presentations, reports National and international HIV conferences Clinical audiences, study days, research forums, interest groups Public health and policy groups Community settings eg Body & Soul,
Positively Women
www.chipscohort.ac.uk Collaborative HIV Paediatric Study established in
April 2000 as a multi-centre cohort study of HIV-1 infected children in the UK and Ireland
The collaboration is between – 70 clinics in the UK and Ireland
caring for HIV-infected children – The National Study of HIV in
Pregnancy and Childhood (NSHPC), and
– The MRC Clinical Trials Unit, where CHIPS is located
CHIPS Objectives To describe clinical, laboratory and treatment data for
these children, and To describe the use of paediatric HIV services CHIPS aims to enhance the exchange of information and
expertise between clinics in order to promote standardised high quality paediatrician-led care of all HIV-infected children in the UK and Ireland
CHIPS is primarily funded by the London HIV Consortium, and has received
additional support from Bristol-Myers Squibb, Boehringer Ingelheim, GlaxoSmithKline, Roche, Abbott and Gilead
How CHIPS works NSHPC provides initial data to CHIPS on all children with
confirmed HIV infection (date and place of birth, management in pregnancy if mother was diagnosed, perinatal details, confirmatory test results)
For each child CHIPS sends a baseline and prospective CHIPS questionnaire to the clinic of care
Follow up data then sought annually Current health and growth Treatment details, including reasons for change Clinical results (viral load, CD4s etc) Hospital admissions
MRC CTU
CHIPS
NSHPC
Participating centres
initial data on all infected children in participating centres
CHIPS data requested and supplied
summary annual data sent from CHIPS to NSHPC
Children seen elsewhere
NSHPC seeks summary annual data
Number of children followed up, and summary findings from 2009/10 Annual Report 1,645 children reported to CHIPS by end of March 2010
91% of infected children reported to NSHPC since 1996, and virtually all those in HIV-related care from 2006 onwards
206 had transferred to adult care (plans for follow up) 1,245 alive and in active follow-up at a CHIPS clinic
48% born in UK or Ireland 79% of black African ethnicity 97% infected through mother-to-child transmission 25% had progressed to CDC stage B and another 25% to CDC
stage C during follow up 1 in 8 remained ART naïve, and About 70% were on HAART About 1 in 10 were off all ART after previously taking it
697 (56%) London
46 (4%) Scotland
422 (34%) Rest of England
59 (5%) Ireland
16 (1%) Wales
Regional distribution of main follow-up clinic for 1245 children alive and followed up in CHIPS
Children who have died, lost to follow-up, left the UK & Ireland or transferred to adult care are excluded
5 (0%) N. Ireland
N 357 413 491 555 649 748 848 973 1070 1144 1208 1251 1232 1098
Age distribution* of children in follow-up by year, 1996-2009
* Age is taken to be age at start of the year, or age at presentation if child presented during that year
Publications and reports / Networks Numerous clinical and epidemiological papers, and
conference presentations Wide dissemination of data through clinical networks
http://www.chipscohort.ac.uk/default.asp
Plans for follow up into adult life AALPHI – Adolescents and Adults Living with Perinatally acquired
HIV Infection (funding just secured for consented follow up study)
Involvement in HYPNet, working on transition from paediatric to adult care http://www.hypnet.org.uk/index.html
Acknowledgments Respondents to NSHPC and CHIPS NSHPC and CHIPS teams and steering groups Royal College of Obstetricians and
Gynaecologists British Paediatric Surveillance Unit
NSHPC funding The NSHPC receives core funding from the Health Protection Agency
Any views expressed are those of the speaker/author and not necessarily those of the HPA