This document summarizes a presentation on assessing adherence to HIV treatment. It defines adherence to care and treatment, describes various methods to measure adherence including patient recall, pill counts, and qualitative assessments. Program examples from Swaziland, South Africa, and Mozambique are provided. Visual, qualitative, and partnership-based approaches aim to facilitate patient understanding and ongoing monitoring to support optimal adherence. Barriers to and facilitators of adherence are identified to guide interventions.

1. Assessing adherence to Treatment: A Partnership Plenary Session: Tuesday, October 20, 2009 Supporting Sustainable Adherence to HIV Prevention, Care & Treatment ICAP Technical Workshop October 19-22, 2009Kigali, Rwanda Shekinah Elmore Scott Worley SthembileMatse Milena Mello

2. Sustainable Adherence: What & Why Multilevel Concept Dynamic Process and Not Static Outcome Adherence to Care AND Treatment A Transition from Evaluation to Partnership between Client and Counselor

3. Key Adherence Strategies Appointment systems Integrated tracking and tracing systems MDT approach to adherence counseling and assessment Peer education/expert client programs Community linkages and referral

4. Adherence Assessment: The Process The process Measuring—allows you to monitor Monitoring—allows you to intervene Intervening– allows you to achieve a good outcome

5. Overview of Presentation How do we define adherence to care? How do we define adherence to treatment? What methods can we use to assess adherence to treatment? Programmatic examples of adherence assessment from Swaziland, South Africa, and Mozambique

6. Defining Adherence to Care What is Adherence to Care? Adherence to the entire, holistic package of HIV services, not just ART ICAP countries define elements of ‘Care’ differently Marked by a continued engagement with the plan of care Often measured by proxy as adherence to scheduled clinic visits This presentation will focus on treatment, several small group sessions will focus on care.

7. Defining Adherence to Treatment Broader Definition: Adherence as a Biosocial Phenomenon “A complex process embedded in the clinical and social course of AIDS.” (Castro, 2005)

8. Adherence to Treatment: 8 Broad Categories Socioeconomic factors Health-care system Social capital Cultural models of health and disease Personal characteristics Psychological factors Clinical factors Antiretroviral regimen (Castro, 2005)

9. Defining Adherence to Treatment Specific Definition: >90-95% of doses taken as prescribed Correlates with undetectable viral load Works well for adult care, but we encounter complexities with pediatric (e.g. syrups) and PMTCT (e.g. single dose NVP) dosing

10. Methods that Assess Adherence Clinical and ‘Gold Standard’ Methods Quantitative Methods Qualitative Methods

11. Clinical & ‘Gold Standard’ Measures

12. Clinical and ‘Gold Standard’ Methods Viral Load and CD4 Count Therapeutic Drug Monitoring (TDM) Electronic Drug Monitoring (EDM) e.g. MEMS Caps, Cell Phones, Other Observed Therapy

13. Quantitative Methods

14. Patient Recall Methods 3-day, 7-day, or 30-day Recall Visual Analog Scales (VAS) – Milena on Mozambique Report of Missed Doses

15. Patient Recall Methods Patient recall is valid and reliable: Meta-analysis by Simoni et al. (2006) confirms that patient recall methods perform well across 77 independent trials However, no consensus on which performs best Lu et al. (2007): 30-day VAS better correlated with clinical measures than 3-day and 7-day recall, because participants were less likely to over-report adherence Mannheimer et al. (2008): participants were more likely to over-report adherence on the 3-day vs. 7-day scale Choice of measure should be context-specific

16. Pill Count Counting the pills that a patient has left after a specified period (e.g. 30 days) Often conducted by the pharmacist Can be announced or unannounced More to come by Sthembile on Swaziland

17. 7 Day Recall: Pediatric Example Which doses were you not able to give in the last 7 days? A)Write in days of the week for the last seven days, and mark an “X” for missed morning and/or evening doses.

18. 7 Day Recall: Pediatric Example (Cont.) B) Check the option below that captures the level of adherence in the last 7 days:  Low (5 or more missed)  Medium (3 or 4 missed)  High (0 - 2 missed)

19. 7 Day Recall: Pediatric Example (Cont.) Part of a broader adherence assessment and counseling encounter, which includes: Review of ART regimen Reasons doses were missed Plan for follow-up and referrals So we have… Measured Monitored Intervened

20. Qualitative Methods

21. Barriers and Facilitators Analysis Open-ended or multiple choice questions: What are the barriers to adherence that you’ve had in the past month? What has helped you to adhere in the past month? Link patient with support interventions that address barriers and strengthen facilitators Track changes in barriers and facilitators over time Open ended questions may provide more honest, rich answers, yet, are harder to track over time Scott on South Africa

22. Choosing a Method

23. Programmatic Considerations for Choosing a Method Participatory and interactive Situated within a counseling framework Sensitive to staffing and time constraints Counselors trained and mentored MDT involvement Implementation must be systematic and reach each patient on a consistent basis Linked to appropriate adherence support interventions Structured enough to be evaluated Doing adherence assessment (MOC, yes/no) Level of adherence (SOC, quantitative measure)

24. Client and Counselor Partnership Adherence happens outside the clinic Need assessment methods that allow clients to understand and manage their own adherence Tools that allow clients to track adherence in parallel with counselors records Assessing adherence in partnership gets clients invested in their own adherence outcomes, and in turn, provides a forum for adherence support Example: Pediatric Adherence Calendar & Coloring Book

25. B. Scott Worley Technical Advisor for Care & Support ICAP – South Africa Missed Doses & Barriers Analysis

27. South Africa: Recall and Barriers Assessments Patient asked what medications they take, when and how Patient asked if they have missed any doses (and how many) in the past month Potential reasons for missed doses listed as a guide to help determine causes of poor adherence This helps identify the most common barriers to adherence, for consideration with improved patient and program support Implemented since 2005 This is part of an ongoing psychosocial assessment – detailing patient & family info, clinic accessibility, pregnancy & contraceptive use, ART preparation guide, ART adherence, and issues for follow-up counseling and education

28. South Africa: Results (EL region, Aug 09)

29. South Africa: Successes & Challenges Strengths – addresses patient understanding of medications and how to take them; analyzes possible clinical and/or psychosocial reasons for missed doses, for purposes of further helping the patient (when possible) Weaknesses – Limitations with recall method (esp. over prolonged time); only reinforced with pill count Next Steps – Collaboration with Pharmacy Advisor, for training of peers & lay counselors to use VAS method (as directed by new national DOH guidelines)

30. SthembileMatse Psychosocial Support Officer ICAP- Swaziland Pill Count Form

32. Pill Count Form: How it can be used Implemented in January 2009 to provide a systematic way to conduct pill count Peer educator/expert client, physician, nurse, pharmacist Due to time constraints, usually conducted by expert client Use to assess adherence monthly for newly enrolled; every six months for patients on treatment for >6 months If adherence <95% or >105%, ask patient about adherence challenge

33. Pill Count Form: Strengths and Challenges Successes Trained expert clients now successfully conducting pill count for all patients Patients appreciate the positive feedback provided by the assessment Challenges Expert client assess adherence, but clinicians don’t always interpret the result to provide necessary adherence support Since patients are aware of pill count, medications are often not brought to the clinic

34. Pill Count Form: Next Steps Getting physicians to recognize the importance of utilizing pill count data to support adherence as part of the clinic visit – physicians must attach meaning to the pill count, especially for patients who have been on treatment for a long time

35. Milena Mello Technical Advisor: APS, C&T + Training ICAP - Mozambique Visual Analog Scale

36. Visual Analog Scale Description of Measure Visual Analog Scale that measures the average adherence by patient self-report. Reason for Measure Choice Many patients have low literacy and numeracy, and thus difficulty reporting numbers and times of doses Necessary to use a visual, concrete instrument that facilitates the patient’s understanding about the medication, while allowing an open conversation with the counselor about adherence difficulties. Therefore, this tool is used in conjunction with an adherence questionnaire Short time per patient to implement (on average, 2 minutes for VAS)

37. Visual Analog Scale Date of Implementation Developed Larissa Polejack’s dissertation research (2007) Followed by pilot implementation in selected sites (Military Hospital in Maputo and Zambézia Sites) Details on Implementation: Scale was developed to supplement a longer adherence questionnaire, but can be implemented as a stand alone tool Psychologists have been trained to implement (Military Hospital) Presented to MISAU (Ministry of Health) and recognized as a unique instrument Possible use by clinicians when they are assess adherence to medication regimens

38. Visual Analog Scale ALMOST ALWAYS ALWAYS SOMETIMES RARELY NEVER

40. Facilitates patient comprehension of adherence by using a concrete, real-world example: cups ranging from “full” (high adherence) to “empty” (low adherence)

41. Adopted as a method of adherence assessment in other ICAP studies

42. Challenges:

43. Difficult to utilize an adherence assessment during each patient visit

44. Resistance from clinicians for adherence assessment extending the visit length

45. Next Steps:

46. Pilot alternative versions of the scale (e.g. inversion of the cups – low to high; empty cups = all medications taken; etc.)

47. Expand to more sites