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Who Starts ART in Durban, South Africa? …Not Everyone Who Should

Ingrid V. Bassett, MD, MPH Massachusetts General Hospital Harvard Medical School May 25, 2010. Who Starts ART in Durban, South Africa? …Not Everyone Who Should. St Mary’s Hospital. Conflict of Interest Disclosure Ingrid V. Bassett, MD, MPH. Has no real or apparent

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Who Starts ART in Durban, South Africa? …Not Everyone Who Should

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  1. Ingrid V. Bassett, MD, MPH Massachusetts General Hospital Harvard Medical School May 25, 2010 Who Starts ART in Durban, South Africa?…Not Everyone Who Should St Mary’s Hospital

  2. Conflict of Interest DisclosureIngrid V. Bassett, MD, MPH Has no real or apparent conflicts of interest to report

  3. Overview • 2.9 million on ART in sub-Saharan Africa, but 6.7 million need it • How much of this gap is due to failure to link to care after a new HIV diagnosis? • What can be done to improve linkage? WHO, 2009

  4. Road Map • Retention versus Linkage • Linkage in resource-limited settings • Durban, South Africa study • Strategies to improve Linkage

  5. Poor retention well-documented • Systematic review sub-Saharan Africa of adult patient retention in ART programs • Non-research ART programs, 2000-2007 • 33 patient cohorts (>74,000 patients) • Very high rates of loss • ~40% not in care at 2 years: • Loss to follow-up 56% • Death 40% Rosen, PLos Medicine, 2007

  6. Background: Poor retention substantial during scale-up • Updated systematic review 2007-2009 • >226,000 patients, 39 cohorts, 80% in Afr • ~25% lost at 2 years, ~35% lost at 3 years • Slightly better than before, but still substantial losses after ART initiation • Routine M+E and PEPFAR reporting focus on ART patients Fox, Trop Med & Intl Health, 2010

  7. Retention On ART

  8. What is known about rates of linkage to HIV care after a new HIV diagnosis? What are risk factors for failing to enter care? Do these differ by setting? Linkage Psychosocial Assessment HIV Test CD4 count On ART Training 1,2,3

  9. Determinants of mortality and non-death losses: Cape Town • Community-based ART program, 2002-2005 • 1235 enrolled in ART program • 121 died (46% pre-tx; 40% early tx) • Risk: symptomatic disease and CD4 <100 • After first year of ART, low mortality rate <1%/year • High risk of pre-ART and early ART deaths Lawn, AIDS, 2006

  10. What is rate of mortality and retention pre-ART in Uganda? • TASO ART Clinic, Jinja, rural Uganda • Focus on 4-8 week pre-ART screening period • 26% of ART-eligibles did not finish screening • Risk: lower median CD4, male gender • Increased over time with clinic expansion • Home visits to ascertain status • 30% on ART with different provider • 25% alive and not on ART (44% due to transport) • 28% died • 17% LTFU • High rate of pre-ART mortality Amuron, BMC Public Health, 2009

  11. Why failing to link in Malawi? Cross-sectional study • Rural Malawi (MSF), 2004-2007 • Defaulters missed appointment by >1 mo • 874 adults pre-ART traced, 71% found: • 51% dead, most within 3 months of last visit • Reasons for defaulting: stigma, dissatisfaction with care/staff, perceived improved health, transport costs McGuire, Trop Med & Intl Health, 2010

  12. From HIV test through ART start in Mozambique: a retrospective study • Routine care data from 2 HIV care networks • HIV tested 2004-2005, first year after free ART in public sector • 7005 with HIV • Only 56% enrolled ART clinic within 30d • 1506 ART-eligible • Only 31% start ART within 90d of CD4 Micek, JAIDS, 2009

  13. Failure to Link: Open questions • What proportion of newly identified HIV-infected don’t start ART? What are the risk factors for failing to link to care? • Few prospective data about losses and mortality before HIV clinic entry • Valuable to design interventions to improve linkage to HIV care

  14. Who Starts ART in Durban, South Africa?…Not Everyone Who Should Ingrid V. Bassett, MD, MPH Susan Regan, PhD Senica Chetty, MSc Janet Giddy, MBChB, MFamMed Lauren M. Uhler, BA Helga Holst, MD, MBA Douglas Ross, MBChB, MBA Rochelle P. Walensky, MD, MPH Kenneth A. Freedberg, MD, MSc Elena Losina, PhD St Mary’s Hospital

  15. Background: HIV in South Africa • > 5 million people HIV-infected • Largest ART program in the world • Only ~40% of HIV-infected who need ART are receiving it • Few data why HIV-infected fail to link to care WHO 2009; PEPFAR 2008; Lawn, AIDS, 2008

  16. Objectives • To evaluate rates of ART initiation within 12 months of a positive HIV test in Durban, South Africa • To identify baseline factors that predict failure to be on ART at 1 year

  17. Methods: Two Study Sites • Prospective, observational cohort • Sites: Outpatient departments in Durban • McCord (urban) • St. Mary’s Mariannhill (semi-rural) • Partially government subsidized • Patients pay a fee for care • PEPFAR-funded HIV clinics

  18. Methods: Study population • Adults (≥18y) • English or Zulu speaking • Enrolled prior to rapid HIV test • Enrolled November 2006-October 2008 • Follow-up through June 2009

  19. Methods: Data collection • Baseline enrollment interview • 6, 12 month questionnaire • Domains: demographic, geographic, clinical • Electronic medical record review at enrollment site: CD4, ART start

  20. Methods: Two Outcomes 1) Obtaining CD4 count within 90 days 2) ART initiation within 12 months for eligible patients • CD4 ≤ 200/µl within 90 days of HIV test • ART initiation at study site documented in medical record

  21. Methods: Data analysis • Predictors of failing to initiate ART evaluated with multivariate logistic regression • Kaplan-Meier curve of time to ART initiation • Mortality pre- and post-ART initiation

  22. Results: Cohort enrollment Screened 3,401 HIV Test Enrolled 2,775 No test/result: 71 Indeterminate: 6 HIV-negative 1,308 HIV-infected 1,467 54% HIV prevalence Bassett, AIDS, 2010

  23. HIV-infected cohort characteristics • Female 54% • Median age 34 yrs (IQR 28-41) • Median follow-up time 12 mos (IQR 8-14) • Follow up available 70% Bassett, AIDS, 2010

  24. Results: CD4 count within 90 days HIV-infected 1,467 Yes 607 No 862 CD4 count within 90 days 59% no CD4 within 90 days CD4<200/μl 368 CD4≥200/μl 237 Unknown 2 61% CD4<200/µl ART eligible at baseline Bassett, AIDS, 2010

  25. How many start ART? HIV Tested* HIV+ CD4/results Eligible for ART Start ART 2,775 1,467 605 368 154 Failure to obtain CD4 Failure to start ART when eligible *Screened 11/06-10/08, enrolled in study and have known HIV status Bassett, AIDS, 2010

  26. Results: Long delay from HIV diagnosis to ART start Females: 55% started ART by 6 months Males: 40% started ART by 6 months P<0.001 P<0.001 days Bassett, AIDS, 2010

  27. Results: Predictors of failure to start ART within 12 months • Male gender RR 1.5 (1.1-2.1) • No HIV+ family/friend RR 5.1 (1.8-14.9) • Adjusting for: age, CD4 count, prior HIV test, work outside the home Bassett, AIDS, 2010

  28. Results: High rate of mortality • 15% of HIV-infected cohort (216 deaths/1,467) • 21% of ART eligible cohort (76 deaths/368) % dead HIV+ cohort with CD4 CD4 (/µl) strata P<0.001 Bassett, AIDS, 2010

  29. High rate of mortality pre-ART • Most patients died pre-ART or with unknown ART status Overall Pre-ART % dead HIV+ cohort with CD4 P<0.001 CD4 (/µl) strata Bassett, AIDS, 2010

  30. Limitations • Sites may not be representative of public sector hospitals in South Africa • 30% of pre-ART patients were unreachable • Likely underestimates mortality and ART initiation that occurred at non-study sites Bassett, AIDS, 2010

  31. Study conclusions • Substantial pre-ART loss along care path • Men less likely to initiate ART • Severe immune suppression at diagnosis • Long delays to ART initiation • High rates of pre-ART mortality Bassett, AIDS, 2010

  32. Implications • Promote early HIV diagnosis and care • Monitor mortality and losses pre-ART • Improve access for men • Interventions needed to improve linkage to care/minimize delays • Following new HIV diagnosis • After ART eligibility determined

  33. Learning from on-ART strategies: patient tracking • 2 ART facilities Lilongwe, Malawi, 2006-09 • Patients who missed clinic appt >3 weeks • 2,653 patients identified, 85% traced by phone and home visit • 30% died • 1,158 found alive, not transferred • 74% returned to clinic (women, age >39 at ART start) Tweya, Trop Med & Int Hlth, 2010

  34. Learning from on-ART strategies • “Patient tracers” phone calls or home visits to ascertain vital status, help subjects return to care • Proactive adherence support, including home visits, community-based collaborations • Transportation vouchers • Eliminate co-pays • Reliable (electronic) monitoring Geng, JAMA, 2008; Ochieng, IAS, 2007; Tweya, Trop Med & Intl Health, 2010; Rosen, Trop Med & Intl Health, 2010; Etienne, Trop Med & Intl Health, 2010; Forster, Bull WHO,2008

  35. Learning from on-ART strategies: efficiency • Johannesburg 4-month pilot study of telephone tracing by social worker • Average $432/patient returned to care Lessons learned from this and others: • Maintain updated contact information • Capacity to know about clinic transfers • Capacity to access national death registry Rosen, Trop Med & Intl Health, 2010 Bassett, JAIDS, 2009; Mwanaga, CROI, 2008;Tweya, Trop Med & Intl Health, 2010;

  36. Learning from US linkage to care trial • HIV-infected, recently diagnosed, multi-site US • RCT case management vs standard of care • Primary outcome in-care at 12 months • A higher proportion in intervention arm visited HIV clinician at least once within 6 months (78% versus 60%, p < 0.01) and at least twice within 12 months (64% versus 49%, p < 0.01) • No similar RCT has yet been performed in resource-limited settings Gardner, AIDS, 2005

  37. Upcoming NIMH-funded linkage to care trial • Multi-site RCT in Durban starting in 2010 • Assess clinical impact and cost-effectiveness of a health system navigator assigned in the outpatient setting • Navigator in-person, SMS, phone contacts • Evaluate linkage to HIV care and TB treatment completion

  38. Durban Team Janet Giddy Senica Chetty Douglas Ross Lindeni Sangweni Aletta Maphasa Success Mncwabe Yolisa Mgobhozi Bongiwe Mdadane Matilda Mazibuko Helga Holst Acknowledgements US Team and Funders • Rochelle Walensky • Ken Freedberg • Elena Losina • Susan Regan • Sarah Bancroft • Harv Univ Program on AIDS • Harvard CFAR AI60354 • NIAID K23 AI068458 • Harvard Catalyst Grant • Upcoming trial: NIMH R01 MH090326 Study participants at McCord and St. Mary’s Hospitals, Durban

  39. St Mary’s Hospital

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