1. Evaluating Cost Gavin Steel, Jude Nwokike, Mohan P. Joshi & Mupela Ntengu Development and Implementation of a Multi-Method Medication Adherence Assessment Tool Suitable for Antiretroviral Therapy Facilities in Resource-Constrained Settings

2. Project Plan  Phase I – Feasibility of the tool  Phase II – Validation  Phase III – Dissemination of results  Phase IV - Training 2

3. Phase I — Feasibility - Design  The four measures included in the multi method pilot tool were —  Self-report  Visual Analogue Scale (VAS)  Pill identification test (PIT)  Pill count  The adherence tool developed was administered to patients presenting for routine follow-up ART care  After each patient contact, the administering health care worker was asked to rank his or her experience with the tool

4. Phase I — Feasibility - Results 4 N = 440

5. Phase I — Feasibility – Results (2)  The interview took an average of 5 minutes  In the self-report, “YES/NO” style responses were recommended above rank order because: o 20% of interviewers described rank order as “difficult” to administer. o Difficulty was linked to patient’s level of education. o Ranking numbers had a weaker correlation with MEMS {r = 0.42 vs r = 0.53}. o Ranking process was time consuming to administer.

6. Phase II — Validation – Final tool Self report Visual Analogue Scale Pills Identification test Pill Count Multi Method assessment

7. Phase II — Validation - Design  To provide objective data to validate the tool, the following data was collected in a smaller group o Medication Event Monitoring System (MEMS) o Viral load and CD 4 count o A blinded pill count where patients were randomly assigned to receive an undisclosed quantity of medication

8. MEMS

9. Phase II — Validation – Results (1) Multi method score (r = 0.73; 95% CI 0.5 – 0.85) Correlation of measures with MEMS

10. Phase II — Validation – Results (2) Pill dumping occurred in 8% of blinded patients Pill count over estimates adherence Pill Count 60% of the 440 patients were blinded to quantity

11. Phase II — Validation – Results (3) Overall validation findings: No single method was superior Each method overestimated adherence Individual methods identified different types of adherence difficulties The multi method adherence rating was conservative.

12. Phase III – Dissemination of results  Findings were presented to the South African: o Policy makers o Professional societies. o HIV clinical scientific community  Adherence tool formally adopted in 2008 o Essential Drug List –Primary Health Care edition. o ARV treatment guidelines.

13. Phase IV - Training  Users manual and training tools were developed.  24 workshops where 635 health care providers were trained on the use of the tool.  2010 Medicine Utilization Evaluation MUE comparing two hospitals ARV prescribing: o 71% adoption of the tool by personnel trained 2 years previously o 18% where no training had been received

14. Conclusion (1)  Multi method adherence assessment provided the best correlation with MEMS data.  Simple Yes/No responses were preferable to rank order in self reporting.  Pill counts were susceptible to pill dumping and hence overestimated adherence.  A multi method approach identifies more patients in need of adherence support.

15. Conclusion (2)  Researchers developing RMU tools need to take into consideration the implementation plan.  Educational interventions improve the uptake of tools disseminated via guidelines.

16. Acknowledgments  Gillian Collet & Mark Patterson  SPS South Africa Senior Program Associates  USAID & PEPFAR