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Improving adherence and quality of care and prevention through mobile technology and patient education. IAS Workshop

Improving adherence and quality of care and prevention through mobile technology and patient education. IAS Workshop Rome 2011. Linda-Gail Bekker The Desmond Tutu HIV Centre UCT. Todays workshop…. The Importance of ART Adherence in HIV Treatment and Prevention

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Improving adherence and quality of care and prevention through mobile technology and patient education. IAS Workshop

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  1. Improving adherence and quality of care and prevention through mobile technology and patient education.IAS Workshop Rome 2011 Linda-Gail Bekker The Desmond Tutu HIV Centre UCT

  2. Todays workshop….. • The Importance of ART Adherence in HIV Treatment and Prevention • Adherence Interventions - What the Science Tells Us • Panel Discussion • Presentation of An Adherence Counseling Program (Life Steps) • Key Components of Adherence Programming • Panel Discussion

  3. Panel • ConallO’Cleirigh, PhD • Kenneth Mayer, MD • Francois Venter, MD • Ian Sanne, MD • Daniella Mark, PhD • Linda-Gail Bekker, MD,PhD.

  4. Delivering high quality care is a necessary, but not sufficient, factor in achieving optimal outcomes

  5. Adherence • To Prevention • To Testing • To Care • To Treatment • To Programs

  6. Why would poor adherence be a problem? • Poor outcomes on the individual level • Treatment failure • Resistance and fewer treatment options • Viral rebound • Illness • Death • Poor outcomes in prevention effectiveness • Risk inhibition • Condom migration • Increased susceptibility • Poor outcomes on the population level • Resistant virus emergence and fewer treatment options • Increased transmission • Higher morbidity and mortality burdens

  7. The Challenge of Adherence

  8. MEMS Adherence and Incomplete Viral Suppression     Paterson DL et al. Ann Intern Med. 2000:133:21

  9. Adherence to therapy is a strong predictor of viral load suppression, immune recovery, lack of disease progression, and reduction in mortality. Poor adherence can cost lives…

  10. Mellors JW, Munoz A, Giorgi JV, et al. Ann Intern Med. 1997;126:946-954.

  11. Near perfect adherence is required to maintain low viral load….. Clinical trials 80-90% remain undetectable at one year Only 50 % undetectable in clinical practice (Deeks et al Toronto 1997).

  12. 7 6 5 4 Log10 HIV RNA copy numbers 3 2 1 0 0 10 20 30 40 50 60 70 80 90 100 Adherence, Viral Load, and Resistance Resistant* Sensitive Pill count percent adherence *Primary Drug Resistant Mutation IAS-USA Bangsberg D, et al. AIDS. 2000:14:357

  13. Adherence O 90–100% O50–89% O 0–49% Adherence and AIDS-Free Survival 10% Adherence difference = 21% reduction in risk of AIDS 1.00 0.75 Proportion AIDS-Free 0.50 0.25 P = .0012 0.00 0 5 10 15 20 25 30 Months from entry Bangsberg D, et al. AIDS. 2001:15:1181

  14. Summary of Mean Adherence Using Objective Measures

  15. “[some] claim that a lack of compliance is the only reason for a treatment-naïve patient to fail therapy within the first 6 months”[Don Smith 2000]

  16. Will “widespread, unregulated access to antiretroviral drugs in sub-Saharan Africa, [in the absence of directly observed therapy] lead to the rapid emergence of drug resistant viral strains, spelling doom for the individual, curtailing future treatment options, and [leading] to transmission of resistant virus?” Harries AD, Nyangulu DS, Hargreaves NJ, Kaluwa O, Salaniponi FM. Preventing antiretroviral anarchy in sub-Saharan Africa. Lancet 2001; 358:410-4.

  17. There is an expectation that patients in Africa will be poorly adherent to antiretroviral therapy: “One of the barriers in the expansion of ARV programmes is the widely held prejudicial view that, due to poverty and lack of education, individuals in Africa may be less likely to maintain adherence to antiretroviral therapy than their HIV-positive counterparts in the developed world.” Orrell et al, Barcelona 2002 “Ask Africans to take their drugs at a certain time of day, and they do not know what you are talking about” [Natsios, USAIDS,2001].

  18. The Back Story: 1990s - early 2000 “Adherence seen as potential barrier to ART in RLS”

  19. Directly Observed vs Self Administered Therapy During Incarceration: Proportion with < 50 Copies/ml Fischl et al 8th CROI, 2001 abstract 528

  20. HIV DOT in Haiti • 60 patients with late stage clinical disease • Enteropathy with severe weight loss • CNS dysfunction or severe neuropathy • Repeated opportunistic infections unresponsive to antimicrobials • Excellent clinical response • Toxicity uncommon • Promoted as a model for resource poor settings

  21. TuberculosisWitnessed Therapy vs Self Administered Therapy • South Africa Zwarenstein Lancet 1998; 352:1340-3. • No difference • Thailand Kamolratanakul Trans R Soc Trop Med Hyg 1999; 93:552-7. • Rural areas: DOTS better than SAT • Urban areas: no difference • Pakistan Walley Lancet 2001; 357:664-9. • Clinic DOTS, family DOTS, SAT: no difference

  22. Self report mean Adherence = 90% • UDVL = 71% • Compared to Avg US Adherence • ~70-80% AIDS 2003

  23. Somerset Hospital data, Cape Town (Orrell et al): • Adherence assessed by counting tablet returns. • Increasing adherence significantly associated with reduction in VL.

  24. Somerset Hospital data, Cape Town (Orrell et al): Discontinuations • 16.2% discontinued therapy over 48 wks -were younger, had higher viral loads, lower CD4 counts. • Socioeconomic status, gender, home language, WHO stage not associated with discontinuation • only 4% dropouts were due to adverse events

  25. Somerset Hospital data, Cape Town (Orrell et al) Factors predicting poor adherence: • Three times a day dosing • Younger age • Not speaking English (language of site staff) Factors NOT predicting adherence: • Socio-economic status • Gender • Symptomatic HIV disease/baseline viral load

  26. Somerset Hospital data, Cape Town (Orrell et al) Factors predicting virological failure: • Adherence <95% • Complex dosing (food, 3 times a day) • Dual nucleoside regimens • High baseline viral load / low baseline CD4 South Africa Clinical Trials: 63% VL<400 Sanne I, Ive P, Mcintyre J 1st IAS Conference on HIV Pathogenesis and Treatment, Buenos Aires, 2001 #321

  27. Data from Senegal: Good adherence in 87.9% accessing ART through a government treatment programme. [AIDS 2002, 16: 1361]

  28. The Response

  29. 2. Resistance patterns are different with similar adherence to different regimens Bangsberg NY PRN 2009 NNRTI Resistance develops quickly and nearly linearly Boosted PI Resistance develops more slowly and in a bell shaped curve

  30. Adherence and virological outcome –PIs Ann Intern Med 2000;133:21

  31. Relationship between resistance & adherence -NNRTIs Clinical Infectious Diseases 2003; 37:1112–8

  32. Adherence declines over time

  33. Most recent meta-analysisReview of Adherence at 2 years Rosen et al. PLoS 2007 • 32 studies in SSA 1996-2007 • ~75,000 patients in non-research ART programs • Average follow-up time reported 9.9 mo, 77% retention • 6 mo = 80% pts retained • 12 mo = 60% pts retained • At 2 Years*: • BEST CASE = 84% • WORST CASE = 46% • AVERAGE = 61% 61% at 24 months

  34. 0.25 0.25 First HIV RNA > 1000 copies/ml First and second consecutive HIV RNA > 1000 copies/ml 0.20 0.20 0.15 0.15 Proportion of patients on program 0.10 0.10 0.05 0.05 0.00 0.00 0 0 4 4 8 8 12 12 16 16 20 20 24 24 28 28 32 32 36 36 Duration on Treatment (months) 929 641 421 328 229 162 127 86 51 Patients at Risk of starting Second Line therapy Virological failure vs. single breakthrough? Kaplan-Meier failure estimate for time to first, then second consecutive HIV RNA level > 1000 copies/ml. 75% Antiviral Therapy 2007; 12: 83-88

  35. Nonadherence Predicts Early Treatment Discontinuation REACH unpublished data

  36. Retention in care • Adherence is more than just beginning therapy, it is sticking to it. LTFU rates are high…

  37. Resistance at fist-line failure Of 110 people, most had dual class resistance. Only 7% wild-type. Orrell, Antiviral Therapy , 2009

  38. Results from Gugulethu * T74S

  39. Probability of virologic failure stratified by the interval of time between 1st-line ART failure and 2nd-line ART initiation. Levison, AIDS 2011, in press

  40. So we know adherence is key….. • How do we then ensure it ? • At initiation • In a sustainable way • How do we measure it • In the treatment setting • In the prevention setting

  41. Objective vs. Subjective Adherence Measurement Tools Subjective Measures Patient interview Pill recognition 3, 4, 7, 30 day patient report Visual-analog scale Rating scale Computer assisted self interview (CASI) Objective Measures Electronic monitoring Announced pill count -- Clinic/Private Practice Unannounced pill count Home or usual place of residence Telephone a la Kalichman Pharmacy refill Drug/biomarker levels Plasma Hair Breath In the absence of viral loads – use adherence measures as a marker.

  42. Monitoring adherence • Physician assessment - poor (no better than random!) • Questionnaires - specific, insensitive (only last 3 days) • Pill counts - good (overestimate in general; pill dumpers) • Pharmacy records – fair (monthly medicine collection) • Drug levels - single time points only • Electronic monitoring – better but expensive! … use a combination

  43. Physicians Predict Adherence Not Much Better Than Random Bangsberg 2001 JAIDS HAART Paterson 2000 Annals Int Med HAART Haubrich 1999 AIDS HAART Steiner 1995 Arch Int Med AZT Bosely 1995 EurResp J Inhaled terbutaline Charney 1967 Pediatrics Penicillin Caron 1978 ClinPharmacolAnatacids Gilbert 1980 Can Med Assoc J Digoxin Blowey 1997 Ped Nephrology Cyclosporin Mushlin 1977 Arch Int Med Hypertensive

  44. Wisebag, Wisecase

  45. REACH Adherence Measures • 3-day patient report • MEMS electronic cap • Unannounced pill count • home or usual place of residence

  46. Other ways to monitor Drug levels • Plasma • Other body fluids • PBMC • breath • Hair

  47. Approaches to managing adherence • Treatment readiness vs. adherence – data show that “readiness” is a distinct factor that influences adherence - Study in 828 people from Sweden (SÖdergard, Patient Educ Couns 2007) focus on individuals readiness for change, examine factors than CAN change and be changed by the individuals.

  48. Approaches to managing adherence • Psycho-social interventions: establishing provider-patient relationships. Adherence a process of negotiating a tailored plan – “flexible rigidity” (Reir, Soc Work Health Care 2006) • Treating depression improves adherence (Yun, JAIDS 2005)

  49. Approaches to managing adherence • Different population in developed world – more marginalised, homeless, drug users. • Predictors of discontinuing therapy = injection drug use and early poor adherence. (Moss, CID 2004)  WATCH adherence at week 4 and 8. Viral loads highest at the beginning, so adherence then is especially key.

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