Agenda

1. Adolescents and Adults Living with Perinatal HIV Cohort (AALPHI)Steering Committee Meeting3 June 2013

2. Agenda • Welcome and introductions • Recruitment (Discussion) • Characteristic of cohort to date • Collaborations and funding • Sub-studies (Discussion) • AOB and date of next meeting

3. Recruitment

4. HIV-infected cases (PHIV+) n=400 13-21 years Previous paediatric HIV care In UK for >6 months Understand English Assent/consent HIV negative controls (HIV-) n=300 13-21 years HIV negative and aware of HIV in family/ household Living with case or sibling/ parent with HIV In UK for >6 months Understand English Assent/ consent Inclusion criteria

5. Participating clinics

6. Cumulative monthlyrecruitment (actual)

7. Cumulative monthly targets and actual recruitment

8. PHIV+ recruitment by clinicbased on cumulative monthly targets

9. HIV- recruitment by clinic

10. How we have been improving recruitment since Jan • Practical changes at sites following last SC: • Room all day at St Georges on 1st and 2nd Wed • Room at GOS • ‘Recruitment facilitator’ at B&S • Agreed with camp organisers and CHIVA exec for us to recruit at Camp in July • Recruitment update e-mails • Staffing changes • ‘Recruitment Days’ & setting up Virtual Recruitment Group • Widening HIV- eligibility

11. Recruitment update e-mails • Every site to receive monthly up-date • First e-mail sent out at beginning of May. Included: • Graph 1 Total recruited by all of the individual sites • Graph 2 Cumulative accrual against targets • Graph 3 Site specific information

12. Staffing changes • Staffing changes: • Marthe’s maternity leave covered by Kate Sturgeon • Linda’s role currently being advertised • Out of London research nurse (Katie Rowson) • Saves travel time • Access to potential new sites (Liverpool / Blue Sky Trust – Newcastle) • Katie has already established contacts

13. Staffing changes cont. • In-house research nurses • At three main London sites • Allows more flexibility for interviews (where often high DNA rates) • Implications of changes • Database changes (offline to web based) • Data quality and reliability • Pros and cons of using in-house CNSs as RNs • Training / handover

14. ‘Recruitment Days’ & setting up Virtual Recruitment Group • Following SC discussion re: HIV- recruitment • 2 pilot days • Positively UK (recruited 7 HIV-) • Faith in People (recruited 6 PHIV+ and 1 HIV-) • Mixed half-days at PPC and B&S • All during holidays or at weekend • First e-mail sent to set up Virtual Recruitment Group • Organising teleconference to feedback on pilot days and to stimulate ideas and additional AALPHI days • Further ‘AALPHI days’ • Currently 3 being planned for summer holidays • Excellent way of seeing large numbers in one day • Planned activates around day for YP

15. Widening HIV- eligibility • Following discussions with other national cohorts at IWHOD, we will widen HIV- eligibility to include friends and partners • We will monitor the characteristics of the group • Aware may have small impact on science but believe benefits outweigh costs • Additional data items to be collected: • If born outside UK, date came to UK • How they know the case and for how long • What city they live in

16. Other issues • Two areas we will also be focusing on in next few months: • PHIV+ blood samples • PHIV+ casenote review • PHIV+ blood samples: • not collected if seen in voluntary sector or not due bloods on day of interview • Need to catch up • RN will provide each clinic with a list

17. Other issues continued • PHIV+ casenote review: • Additional to CHIPS form • Clinic staff need to: • complete front page • bring notes of PHIV+ already interviewed • RN will send e-mail prior to visit with details of notes required

18. Discussion

19. Characteristics of cohort to dateBased on 128 participants recruited up to 9th May 2013

20. Ethnicity, sex and age (n=126/8)

21. Marital status, children and current living situation (n=126)

22. Work/education status (n=115)

23. Drinking, smoking & drugs (n=125)

24. Drinking, smoking & drugs (n=125) 38% of 16-24yr olds ever taken illegal drugs** 5% of 11-15yr olds regular smokers* 45% of 11-15yr olds ever drunk alcohol* * Source: The Information Centre for Health and Social Care ** Source: Home Office

25. Sexual activity (n=124) *6 participants chose not to answer these questions. Percentages are based on all 124 participants.

26. Sexual activity (n=124) 88% men, 70% women aged 16-24 years used condoms in last 12 months** * 6 participants chose not to answer these questions. Percentages are based on all 124 participants. ** Source: Office for National Statistics

27. Neurocognitive testing (n=123)

28. Cogstate (n=108) * Source: Cogstate normative data for 25-30 year olds

29. HADS anxiety score (n=120)

30. HADS depression score (n=120)

31. Counselling and self-harm (n=120)

32. Counselling and self-harm (n=120) 19% in ALSPAC* 16% in ALSPAC* *Source: ALSPAC 2012

33. Self worth (n=121)

34. Disclosure and ART (PHIV+) (n=102)

35. Viral loads by ART status (n=69)

36. CD4 by ART status (n=67)

37. CDC stage by ART status (n=65)

38. Relationship to case (HIV-)(n=18)

39. Collaborations and funding

40. Presentations Characteristics and risk behaviours of perinatally HIV-infected and HIV-uninfected young people recruited into a new adolescent cohort, UK. 5th International Workshop on HIV Pediatrics, Kuala Lumpur, 2013 (forthcoming). Recruiting HIV negative siblings into research studies of perinatally HIV-infected young people: experiences from the first 9 months of the Adolescents and Adults Living with Perinatal HIV (AALPHI) cohort, UK. CHIVA Spring Conference, Leeds, 2013. Prize for best poster. Sex, drugs and mental health characteristics of perinatally HIV-infected young people recruited into the new Adolescents and Adults Living with Perinatal HIV (AALPHI) cohort, UK. 17thIWHOD, Cavtat, 2013.

41. Authorship guidelines Named authorship: “Firstperson A, Secondperson B, Thirdperson C, etc…., on behalf of the Adolescents and Adults Living with Perinatal HIV (AALPHI) Steering Committee” Authorship based on uniform requirements Full acknowledgements lists of all participating sites + funders 10 day lead time for abstracts, talks, posters; 15 for papers Reviewed by AALPHI project team and circulated to SC for information (members may be invited to provide comments)

42. US PHACS AMP Growth & puberty; CVD; bone; neurologic, neurodevelopment; language, hearing; behavioural function; STIs 451 cases: 7-15 yrs, PHIV+ (median age 12) 228 controls: 7-15 yrs, PHEU (median age 10) Annual visits up to 18 years Re-consent all participants at age 18 years Face-to-face interviews at 18 and 21 years Web-based interviews at 19 and 20 years Several papers published and in press

43. French “Coverte” Transition to adulthood schooling, jobs, sexual and reproductive health morbidity and mortality, adverse events indicators of premature ageing (CVD, metabolic, immunology) 400 cases: 18-25 yrs, diagnosed <13 years 75 controls: 18-25 yrs, HIV- (sibling/ relative) Baseline and month 36 assessments

44. ANRS CO19 Coverte • COMMON MODULE • Clinical examination • Self-administered Q « living conditions & behaviour » • Blood sampling • Biobank 18-25 y HIVdiagnosis before the age of 13 N=400 expected Sample of 200 HIV+ • +/- PHYSIOPATHOLOGICAL MODULE • (J0 & M36) • Self-administered Q (nutritional habits) • OGTT • CT-scan and DXA-scan • Cardiovascular: IMT, pulse wave velocity Healthy adult controls 18-25 y HIV- (siblings and other relatives) N=75 expected J0 & M36 : Common module & physiopathological module

45. ANRS CO19 Coverte • COMMON MODULE • Clinical examination • Self-administered Q « living conditions & behaviour » • Blood sampling • Biobank 18-25 y HIVdiagnosisbefore the age of 13 N=400 expected Recruitment since June 2010: 234 HIV+ 5 HIV- Sample of 200 HIV+ • +/- PHYSIOPATHOLOGICAL MODULE • (J0 & M36) • Self-administered Q (nutritional habits) • OGTT • CT-scan and DXA-scan • Cardiovascular: IMT, pulse wave velocity Healthy adult controls 18-25 y HIV- (siblings and other relatives) N=75 expected J0 & M36 : Common module & physiopathological module

46. Timelines 2013 onwards Funding started September 2011 Year 1 interviews started July 2012

47. Planning for Year 2 • Face-to-face • Web-based software to facilitate downloading/ syncing from multiple sources • Comprehensive review of data quality and initial findings • Contact key experts to discuss year 2 content • Review papers from PHACS

48. Retention Explore access to internet Do you have a mobile phone? Can you access the internet on it? Do you normally have credit for your phone? Do you have private internet access apart from on your phone? If so where? Would you be happy to fill out Alfie questions without the research nurse: on your phone; on your computer where you have private access; in the HIV clinic/NGO?

49. Current funding Monument Trust £200,000 per year for 3 years Funding commenced in Sept 2011 so runs to Aug 2014 EuroCoord (EU FP7) €10K per year for 5 years

50. Future funding ideas Key objectives of AALPHI: Neurocognitive and psychosocial outcomes Short-term and long-term morbidity Wellcome Trust Strategic Award or Fellowship Immunology basic science – t cell repertoires Cardiovascular markers – clinical PhD Bone biochemistry – DEXAs and portable scanners NIHR Programme Grant for applied research What are the problems/ what services needed/ what cost Co-funding from Monument Trust