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I nternational E pidemiologic D atabases to E valuate AIDS

I nternational E pidemiologic D atabases to E valuate AIDS. Patient retention and losses to follow-up. East Africa IeDEA Executive Committee meeting May 4-5, 2010 Zanzibar. Cumulative mortality & ascertainment bias. 6.4% 124 deaths 2236 PY. 2.3% 41 deaths in 1508 PY. 1.8%

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I nternational E pidemiologic D atabases to E valuate AIDS

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  1. International Epidemiologic Databases to Evaluate AIDS Patient retention and losses to follow-up East Africa IeDEA Executive Committee meeting May 4-5, 2010 Zanzibar

  2. Cumulative mortality & ascertainment bias 6.4% 124 deaths 2236 PY 2.3% 41 deaths in 1508 PY 1.8% 414 deaths in 20532 PY P Braitstein, M Brinkhof, et al. The Lancet 367(9513): 817-824. 2006

  3. Outline • LTFU in HIV-infected adults • Men vs. Women • LTFU in HIV-infected and HIV-exposed children • Outcomes of children LTFU • Implications for mortality estimates • Impact of outreach strategies on retention

  4. The USAID-AMPATH Partnership • 25 parent clinics • 23 satellites • ~110,000 patients enrolled • Enrolling1200/mth • > 66,000 active patients • 21% <14 years • 56% on cART • Active Outreach Program using peer phone calls and home visits

  5. Cumulative Patients Enrolled: Nov ’01 – Feb ‘09

  6. VO Ochieng , D Ochieng, J Sidle, M Holdsworth, AM Siika, M Owiti, S Kimaiyo, KK Wools-Kaloustian, C Yiannoutsos , and P Braitstein. Bulletin of the WHO (epub 16 April, 2010) Influence of gender on loss to follow-up in a large HIV treatment programme in western Kenya

  7. Methods 1 • Patient inclusion: • aged ≥14 years • enrolled between Nov 2001 and Nov 2007 • LTFU defined: • being absent from the clinic for >3 months if on cART • being absent from the clinic for >6 months if not on cART

  8. Methods 2 • Incidence rates: • With and without at least 1 day of follow-up • From date of enrolment into the program • Overall • Pre-cART (censored at date of cART initiation) • From date of cART initiation • Presented per 100 person-years • Analysis • Kaplan-Meier & Cox Regression methods • Event date: date of last visit if definition of LTFU met by close of database • Censor date: date of death or last visit

  9. Events & Person-Years

  10. Incidence Rates (IR) per 100 py

  11. Incidence Rates (IR)

  12. Incidence Rates (IR)

  13. Incidence Rates (IR)

  14. Predictors of Loss to Follow-up

  15. Predictors of Loss to Follow-up

  16. Predictors of Loss to Follow-up

  17. Predictors of Loss to Follow-up

  18. Predictors of Loss to Follow-up

  19. Predictors of Loss to Follow-up

  20. Predictors of Loss to Follow-up

  21. Predictors of Loss to Follow-up

  22. Implications • High rates of LTFU especially: • pre-ART among adults • after enrolment visit • among HIV-exposed children • Different mechanisms at play • Among the very sick and the relatively healthy • Potential interventions to improve retention: • Weekend, evening, and family clinics (accommodate men and women’s different needs) • Disclosure counseling • Support programs (e.g. food supplementation) • J Mamlin, T. Petersen, P. Braitstein et al. AJPH 2008

  23. Retention of HIV-infected and hiv-exposed children in a comprehensive clinical care program in western kenya P Braitstein, A Katschke, C Shen, et al. Invited manuscript Tropical Medicine & International Health (in press)

  24. Background • Of the 2.1 million children aged ≤15 years living with HIV/AIDS end of 2008:(WHO AIDS EpiUpdate 2009) • Only 38% of those in need receiving cART (given old treatment guidelines) (UNAIDS Towards Universal Access 2009) • Mortality after 2 years among children receiving cART is approximately 7% • 2-year risk of LTFU approximately 10% (KIDS ART-LINC JAIDS 2008; Bolton-Moore et al. JAMA 2007; Ellis et al. Ann TropPaediatr 2007; George et al. JID 2007) • Among HIV-infected children not on cART, and children whose last known serostatus was HIV-exposed, rates of LTFU are reported to be much higher (30%-40%)

  25. LTFU may be an even greater threat for children than adults: • HIV-infected children will need care and treatment for longer. • Vulnerable to and dependent upon their caregivers. • Ascertainment issues are critical: • Survival • HIV transmission • Issues surrounding pediatric LTFU are not yet well characterized • Rates in HIV-exposed, HIV-positive pre-ART • Impact of rapid and massive scale-up of programs • Risk and protective factors: opportunities to increase retention • Outcomes of those LTFU & impact on mortality estimates

  26. Study Objectives • Calculate the incidence of LTFU among HIV-exposed and HIV-infected children, the latter both pre- and post-cART initiation • Identify baseline and time-varying risk factors for LTFU for both HIV-exposed and HIV-infected children • Manuscript in press at TMIH • Identify outcomes of a random sample of HIV-positive and HIV-exposed children from an urban and a rural setting • Pedi-Up (Pediatric Losses to Follow-up) Study on-going

  27. Retrospective Analysis • N=13,510 • 3106 HIV-infected at enrolment • 10,404 HIV-exposed at enrolment • HIV status = at enrolment • up to 1st 3 clinic visits • Fixed covariates: • Gender, orphan status (at enrolment), clinic location at enrolment (urban vs. rural), enrolment period (<2005, 2005-2006, ≥2007), and receiving food supplementation (ever vs. never) • Time varying covariates: • Age, antiretroviral use, HIV status, immune status (CD4% per age specific categories), CDC clinical stage, weight for height (Epi-Info Z scores)

  28. Analysis Methods • LTFU: absent from clinic for >3 months if last on cART and >6 months if not on cART with no information as to vital status • Incidence rates • Point estimates • Confidence intervals constructed using exact binomial limits. • Presented per 100 child-years of follow-up • Time-dependent proportional hazard regression models were used • For missing time-dependent covariates, we searched within a 3-month window and imputed the closest observed value. • Included all LTFU events for each subject • Accounted for intra-patient clustering with sandwich estimator of the standard errors of the regression coefficients

  29. Incidence Rates of LTFU (per 100 CY) • Overall: 18.4 (17.8-18.9) • HIV-exposed at enrolment: 20.1 (19.4-20.7) • HIV-infected at enrolment: 14.2 (13.3-15.1) • HIV-infected pre-cART: 15.2 (13.8-16.7) • HIV-infected on cART: 14.1 (13.1-15.8)

  30. Incidence Rates of LTFU (per 100 CY) • Overall: 18.4 (17.8-18.9) • HIV-exposed at enrolment: 20.1 (19.4-20.7) • HIV-infected at enrolment: 14.2 (13.0-15.2) • HIV-infected pre-cART: 15.2 (13.8-16.7) • HIV-infected on cART: 14.1 (13.1-15.8)

  31. Incidence Rates of LTFU (per 100 CY) • Overall: 18.4 (17.8-18.9) • HIV-exposed at enrolment: 20.1 (19.4-20.7) • HIV-infected at enrolment: 14.2 (13.0-15.2) • HIV-infected pre-cART: 15.2 (13.8-16.7) • HIV-infected on cART: 14.1 (13.1-15.8)

  32. Risk & Protective Factors: HIV-exposed

  33. Risk & Protective Factors: HIV-exposed

  34. Risk & Protective Factors: HIV-exposed

  35. Risk & Protective Factors: HIV-infected

  36. Risk & Protective Factors: HIV-infected

  37. Implications • High rates of LTFU • In comparison to other published rates, our LTFU among HIV-infected is higher • Decreasing with time, in spite of massive scale-up since 2005 • AMPATH specific because of outreach program? • Irrespective of pre- or post-cART among HIV-infected • Both HIV-exposed and HIV-infected children more likely to become LTFU if sick, HIV-exposed if malnourished • High probability of mortality

  38. Implications (2) • Opportunities for intervention: • Strengthen care for HIV-exposed (link more strongly to mother’s care?) • Food supplementation • Consider earlier use of cART to preserve immunity and health

  39. “pedi-up”: prospective evaluation of the outcomes of children lost to follow-up from a comprehensive HIV clinical care program in western kenya (on-going study)

  40. Methods • Randomly selected 30% of children who became LTFU from 1 of 2 clinics (1 urban, 1 rural) • Defined as LTFU within prior 6 months from October 2009 • Same definition of LTFU (absence >3 months if last known to be on cART, absence >6 months if last known not to be on cART) • HIV-infected, HIV-exposed, or HIV status missing at last visit (determined using a combination of time-updated clinician documentation and laboratory results). • Community health workers recruited and trained • Each assigned up to 3 children • Using locator information on file with Outreach Program as starting point • ‘Primary reason’ for LTFU determined by 2 independent reviewers

  41. Preliminary Results • 100 children identified LTFU: 67 found (67%) • 44 HIV-infected • 28 found so far (64%) • 20 found alive • 7 (25%) found deceased • 9 have poor or missing locator information • Innovative strategies being employed to improve chances of finding them • 48 HIV-exposed children identified as LTFU • 34 found so far (71%) • 33 found alive • 1 (3%) found deceased • 8 HIV serostatus missing/unknown • 5 found so far (63%) • 2 found deceased (40%)

  42. Caregiver Reported Reasons for LTFU (other than death) • HIV-infected children (n=20): • 6 stated lack of transport or other financial difficulties • 4 transferred to another clinic • 4 displaced (from post-election violence) • 1 the caregiver refused care for the child • Child healed by faith • 2 indicated disclosure issues • 2 no easily identifiable single cause • 1 stated child was HIV-negative (to be confirmed by charts)

  43. Caregiver Reported Reasons for LTFU (other than death) • HIV-exposed children (n=30): • 6 not a single identifiable cause • 6 indicated disclosure issues (family or community) • 5 the caregiver refused care for the child (child healed by faith, using herbs/traditional medicine, family or community discrimination) • 4 the caregiver said child is HIV-negative • 3 said doctor told them child was HIV-negative and not to return (needs verification from chart) • 2 were displaced (post-election violence) • 1 had transferred to another AMPATH clinic • 2 child apparently didn’t miss appointment (needs verification from chart) • 1 caregiver died (not disclosing child’s status to others)

  44. Initial Thoughts • Next step: • Mortality estimates among HIV-infected children in AMPATH will need to be revised given these data • Data not necessarily generalizeable to other programs because of decentralization of AMPATH clinics and active outreach program • Programs like AMPATH need to improve documentation of mortality and HIV-status • Creative and rigorous education and sensitization initiatives are required to • Decrease HIV stigma • Improve caregivers understanding about HIV in children • Advocacy for children’s human rights

  45. Description of outreach strategies in hiv programs in east africa and their corresponding rates of losses to follow-up

  46. East Africa Site Assessments • Module 2, Section 4 (Follow-up and Death Ascertainment) • Is there an active system of follow-up? • Which patients trigger an outreach visit? • What is the main trigger (e.g. 1 missed appointment vs. defined as lost) • Do you staff dedicated? • What cadre are they? • What methods are used for home visits? • What is the major reason for LTFU?

  47. Key Outreach Model Characteristics • Personnel: Use of dedicated peers vs. dedicated professionals vs. a mix vs. no dedicated staff (or use of other NGO staff) • Patients: ART only vs. geographic radius vs. all • ART patients: geographic radius ART vs. ART all • How: Telephone only vs. home visits only vs. mix vs. nothing specific • When: After 1 missed visit vs. after LTFU vs. inconsistent • How: Car only vs. bike/foot/public transit vs. all available means vs. telephone only

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