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Adherence to antiretroviral therapy (ART) in Rwanda: Preliminary results from a national public health evaluation ICAP Data Dissemination Meeting June 3, 2009 Batya Elul Harriet Nuwagaba-Biribonwoha Deb Horowitz Denis Nash. Presentation outline. Background and rationale

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  1. Adherence to antiretroviral therapy (ART) in Rwanda: Preliminary results from a national public health evaluation ICAP Data Dissemination Meeting June 3, 2009 Batya Elul Harriet Nuwagaba-Biribonwoha Deb Horowitz Denis Nash

  2. Presentation outline • Background and rationale • Study objectives and methods • Preliminary results • Preliminary conclusions, strengths, limitations, and next steps

  3. Background and rationale

  4. Why study ART adherence? • Strict ART adherence (≥95%) required for: • better immunological, virologic, and survival outcomes • reducing risk of developing drug resistance • Critical to improve how we deliver services and support patients to achieve and maintain optimal ART adherence

  5. ART adherence estimates in US and sub-Saharan Africa (Mills et al, JAMA 2006) Sub-SaharanAfrica United States

  6. ART adherence • Pooled adherence estimates from meta-analysis (Mills et al, JAMA 2006) • N. America: 55% (95% CI, 49%-62%) • Sub-Saharan Africa: 77% (95% CI,68%-85%) • Very early in scale-up experience • Mostly smaller, non-representative samples • Generally involving treatment-naïve patients

  7. Barriers to ART adherence (Mills et al, PLOS Medicine 2006) • Consistent barriers to adherence across resource-rich and -limited settings • Fear of disclosure • Forgetfulness • Lack of understanding of treatment benefits • Complicated regimens • Being away from medications • Barriers found more commonly in resource-limited settings • Access • Financial constraints

  8. Rwandan context • ~150,000 HIV-positive adults and children including 49,000 on ART at 165 facilities (UNAIDS, Dec 07) • Demeester et al (2005) : Cross-sectional study • ESTHER program at largest teaching hospital (CHUK) • 95 adults who initiated ART within 2-5 months of interview • 87% of patients reported taking all doses in previous month • 85-93% had therapeutic levels of NNRTI in serum • Au et al (2006): Cross-sectional study • Project San Francisco research clinic in Kigali • 71 adults who initiated ART within 2 weeks of interview • Obstacles to ART adherence included: • Fear medication would increase appetite (76%) • Interruption in daily schedule due to work (29%) • Not accepting HIV as life-threatening disease (28%)

  9. Measuring ART adherence • No gold standard exists for measuring ART adherence • Commonly used measures • Self-report (questionnaire and/or visual analogue scale) • Pharmacy refill records • Pill counts • MEMS (medication event monitoring systems) • Therapeutic drug monitoring • Clinician observation • Few studies have validated self-report/pill count in resource-constrained settings • CD4 count and viral load often used as objective indirect measures of ART adherence

  10. Study objectives and methods

  11. Among adults on ART for 6, 12, and 18 months as of September 2008-April 2009: Assess current ART adherence; Identify patient-level factors that are associated with current sub-optimal ART adherence; Identify site-level and contextual factors that are associated with current ART adherence, after adjusting for patient-level factors; and Compare current self-reported ART adherence, pill counts and pharmacy dispensing data as measures of ART adherence against CD4 cell count and viral load Study objectives

  12. Study design: Cross-sectional study of persons on ART with retrospective data collection Data Collection 18 month cohort started ART 12 month cohort started ART 6 month cohort started ART -6 months -18 months -12 months Sep 08-Apr 09 Time on ART relative to data collection

  13. Multistage sampling • Site sampling • 113 public and faith-based clinics providing ART for >18 months in national ART program • 20 sites randomly selected stratified by sector • 14 public and 6 faith-based • 7 private sites excluded • Patient sampling • 9,693 patients on ART for 6, 12, and 18 months at the 113 public and faith-based clinics • 1,951 adult patients on ART for 6, 12, and 18 months at selected sites • 1,798 randomly selected to participate in study

  14. Age ≥18 years Initiated 1st line ART at study site 6, 12 or 18 months prior to study start (+/- 2 months) Still receiving ART at initiating site Willing to provide informed consent Patient eligibility criteria

  15. Data collection • Sept 08 – April 09 • 15 interviewers, 3 research coordinators • 4 study assessments • Patient interview • Data abstraction • Non-routine blood draw for viral load (~50% of sample) • Site characteristics questionnaire

  16. Socio-demographic information Self-reported adherence Side effects Knowledge of and attitudes towards HIV/ART Quality of life Satisfaction and utilization of services Psychosocial factors (e.g. disclosure, support) Herbal, traditional and other medicine Risky behaviors Patient questionnaire – 9 sections

  17. Demographic information Treatment information (regimen(s) and start dates) Medication pick-up (number of pills prescribed at last pick-up) Clinic visits (dates, WHO stage, weight and type of visit) Immunologic outcomes (CD4 counts) Patient status (alive and attending clinic, transferred out, died, LFU) Data abstraction – 6 sections

  18. Done for ~50% of sample Five cc blood drawn Depending on distance of site from NRL: ≤4 hours: Samples transported directly to NRL in cool box >4 hours: Centrifuged at site or nearby hospital and transported on ice in cool box within 18 hours Centrifuged samples aliquoted and stored at -70 degrees Celsius Processed using real-time PCR Cobas TaqMan 48 with detection limit of 40 RNA copies / ML Viral load assessments

  19. Based on ICAP PFACTS tool Site and contextual characteristics Location Type of facility HIV prevalence Facility characteristics Funder Care and treatment enrollment figures Hours, facilities and staffing configuration Availability and type of supportive services (e.g. food, adherence, peer educators, outreach, home visits) Site assessment – 2 sections

  20. Primary outcome measures

  21. 3-day self-reported adherence: Modified ACTG questions Step One—Identification of antiretroviral medications It looks like you’re supposed to take (read the names, color and shape of all of the antiretroviral drugs the patient is supposed to take from Columns A, C and D). Is this correct? If not, ask the patient to show you their medication and complete the drug names in the table below. Step Two—Self-reported adherence behavior for specific time periods Starting with the drug in Row 1 and using the information in Columns A-E, say the following to complete cells B01-B04: Now for (read drug name and describe the color and shape from Columns A, C and D),it looks like (read the number of pills per day in column E) pills of this medicine need to be takeneach day. Now think about yesterday. Of the (read the number of pills in column E) prescribed pills, how many did you miss yesterday? Record this number in Column F. Now think about the day before that. That would have been (say the day of the week). Of the (read the number of pills in column E) prescribed pills, how many did you miss on (say the day of the week)? Record this number in Column G. Go back just one more day. That would have been (say the day of the week). Of the (read the number of pills in column E) prescribed pills, how many did you miss? Record this number in Column H.

  22. 30-day self reported adherence: VAS

  23. Self-reported treatment interruptions Number of times ever missed all pills for ≥3 consecutive days Drug possession ratio Data cleaning ongoing Only ~1/3 of sample brought pills to interview CD4 response Data cleaning ongoing Additional outcome measures

  24. Preliminary Results

  25. Started ART 6, 12 or 18 months prior to study start at selected sites, N=1951 Randomly selected for participation in study, N=1798 6 month cohort N=701 (38.9%) 12 month cohort N=602 (33.5%) 18 month cohort N=495 (27.3%) Determined to be ineligible, N=305 Confirmed to be eligible for study, N=1493 (100.0%) Not located by study team, N=37 (2.5%) Declined to participate, N=18 (1.2%) Enrolled in study, N=1438 (96.3%)

  26. Enrolled in study, N=1438 Incomplete data, N=11 (0.8%) 6 month cohort, N=2 12 month cohort, N=3 18 month cohort , N=6 Included in analysis, N=1427 (99.2%)* 6 month cohort N=577 (40.4%) 12 month cohort N=494 (34.6%) 18 month cohort N=356 (24.9%) Viral load sub-sample, N=842 (59.0%) 6 month cohort N=335 (58.1%) 12 month cohort N=285 (57.7%) 18 month cohort N=222 (62.4%) *The 1427 patients included in the analysis represent 95.5% of all patients confirmed to be eligible

  27. Site characteristics, N=20

  28. Patient socio-demographic characteristics

  29. Median CD4 count at ART initiation CD4 cell count (cells/uL) 6 months 12 months 18 months N=497 N=444 N=326

  30. Current ART regimens N=355 N=575 N=491

  31. Self-reported 100% adherence: 3-day recall % reporting 100% adherence 6 months 12 months 18 months N=576 N=493 N=356

  32. Timing of missed pills among patients reporting ≤100% adherence in 3 days preceding interview N=38 N=37 N=23

  33. Followed dietary and timing instructions for taking ART in previous 3 days 18months 6 months 12 months N=576 N=493 N=356

  34. Self-reported adherence: 30-day recall N=575 N=489 N=352

  35. 30-day recall: Distribution of VAS responses 6 months, N=577 12 months, N=494 Poor adherence Good adherence Poor adherence Good adherence 18 months, N=356 Poor adherence Good adherence

  36. Current viral load N=335 N=285 N=222

  37. Association between self-reported 3-day adherence and viral load P<0.05 N=335 N=285 N=222

  38. Association between self-reported 30-day adherence and viral load P<0.05 N=335 N=285 N=222

  39. Treatment interruptions among patients who ever missed ART N=212 N=198 N=154

  40. % reporting reason Most common reasons for ever missing ART

  41. % reporting reason Least common reasons for ever missing ART

  42. % reporting side effect Most common side effects

  43. Side effects considered “most bothersome”

  44. % reporting side effect Least common side effects

  45. Side effects considered “least bothersome”

  46. Attitudes towards ART * No significant differences between cohorts

  47. Preliminary conclusions, strengths, limitations, and next steps

  48. Preliminary conclusions • Self-reported adherence to ART is high among Rwandans remaining on ART 6, 12 and 18 months after ART initiation • >80% of patients on ART have undetectable viral load • Self-reported adherence and viral suppression do not vary by time on ART • Some correlation between self-reported adherence (3 day and 30 day recall) and viral load • High prevalence of non-specific side effects • Well-tolerated in many instances • Can’t directly attribute to ART (background prevalence unknown) • Patients on ART have « positive » knowledge and attitudes about ART but also a few misconceptions

  49. Study strengths • First nationally representative ART adherence study in Africa (worldwide?) • Availability of virologic data on random subset of patients • Obtained rapid estimates of adherence and risk factors at different time points after ART initiation (6, 12, 18 months) among patients currently on ART • Multiple direct and indirect ART adherence measures used • Varied patient-level predictors of adherence assessed, including include clinical, socio-demographic, psycho-social and behavioral factors • Multi-site (n=20) nature allows assessment of association of site-level factors with adherence measures • Provides rich dataset on other important outcomes related to ART scale-up, e.g. risky behaviors, quality of life, etc. • Multi-institutional collaboration with capacity building (e.g., GCP and analysis training)

  50. Study limitations • Limited to adults • Did not include private clinics (n=7) • Only one time point measured per patient • Could not examine adherence as a predictor of death or LTF • i.e., could not estimate within individual variation in adherence over time (reliability) • Did not include provider perspective • Pill count could not be done for ~2/3 of patients • Definition of adherence not predicated on patient taking pills at right time or in right way • Different questions used for 3-day and 30-day recall (ACTG vs. VAS)

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