1. International Network for the Rational Use of Drugs Initiative on Adherence to Antiretrovirals (INRUD-IAA) Measuring Adherence Using Paper-Based Facility Records: Methods of the INRUD Initiative for Improving Antiretroviral Adherence in Africa ICIUM 2011 John Chalker, MSH -UK

2. Why Measure Patient ART Adherence at Facility Level?  Need standardized adherence measures to:  Assess facility/program performance over time  Compare facilities, programs  Identify poorly performing facilities  Evaluate interventions  Build evidence about successful interventions  BUT are indicators measured with routine data in real-life facilities feasible, reliable, and valid?

3. East African Survey: Current Facility Adherence Measurement Practices  Teams from INRUD and national AIDS control programs  5 East African countries in Feb/Mar 2006  USAID funding  What information is recorded routinely that can be easily retrieved?  What indicators are currently utilized?  What are their precise definitions?  What are their values?

4. Potential Availability of Data for Adherence Monitoring Type of Data UsuallySometimesNever Patient self-reported adherence632710 Pill count384815 Reported reasons for non-adherence44 13 Prescribed ARV dose9640 Number of pills dispensed9820 Date of next scheduled visit9820 Date of actual vs. scheduled visit291060 CD4 count01000 Viral load03169 48 Facilities Reporting Availability of Data by Type, %

5. Candidate Adherence Measures  Appointments  % of patients attending on or before the day scheduled  % of patients attending within 3 days of the day scheduled  Dispensing  % days covered by ART dispensed over 6 months  % of pts with a gap in medicines dispensed of 30 or more days over the last 6 months  Self-reported adherence  % patients who self-report full adherence over the last three days

6. Indicator Feasibility and Reliability Surveys  Four surveys of 20 facilities each  Kenya (Oct 2006), Rwanda (Nov 2006), Uganda (Mar 2007) and Ethiopia (June 2007)  In each facility aimed for  At least 100 patient records to review Days covered by dispensed medicine Attendance at appointment  30 exit interviews for patient self-report

7. Sampling ART Patients

8. Patient level: % of Days Covered by Dispensed Drugs # records counted for dispensed medicine Percentage of days covered (+/- 1.96*SE) % patients with gap of 30 days or more (+/- 1.96*SE) Kenya936 81.6 (1.7)25.1 (2.8) Rwanda1,279 95.1 (0.5)4.0 (1.1) Uganda1,693 81.8 (0.7)18.1 (1.8) Ethiopia1,982 93.0 (0.6)10.2 (1.3) TOTAL 5,890 91.1 (0.4)13.7 (0.9)

9. Facility-level Indicators: % of Days Covered by Dispensed Drugs

10. Validation of Adherence Indicators Using Routine Data in Real-world Programs  Does adherence predict clinical changes in newly treated patients  Weight gain and CD4 counts  Ethiopia, Kenya, Rwanda, Uganda  4 varied health facilities per country  30 patients per facility, with 10 beginning ART in each of three periods : 7-13 months ago: 14-19 months ago: and 20-25 months ago

11. Validation: Weight Gain at 9 Months by % of Days Covered with ART

12. Validation: Adjusted CD4 Gain at 4-9 Months by Days Covered with ART

13. Implications (1)  Self-report in medical record shows promise  If routine recording with standardized question  Not good for evaluating interventions  Patients with less than full self-reported adherence should be sent for intensive counseling  Dispensing coverage from routine data  Validated against change in weight and CD4 gain  Useful for monitoring intervention impacts  BUT measured over longer term (over 6 months)

14. Implications (2)  Appointment Book to manage HIV/AIDS  Good for rationing clinic workload  Way of immediately knowing non-attendance  Easy way to check facility performance  Also way of improving adherence  Facilities can contact patients or community organization after missed appointment  Tracking missed appointments could be basic monitoring method for adherence performance

15. INRUD-IAA Trial Interventions to Improve ART Adherence  Trial interventions in four countries  Kenya, Rwanda, Tanzania and Uganda  In all 4 countries most facilities did not have functioning appointment system  All interventions introduce appointment books  Appointment system accepted and appreciated  Results reported in other ICIUM presentations

16. Summary  Routine data can be used to measure adherence in most real world facilities  Survey methods and tools available  http://www.inrud.org/ARV-Adherence- Project/Adherence-Survey-Tools-and-Manual.cfm http://www.inrud.org/ARV-Adherence- Project/Adherence-Survey-Tools-and-Manual.cfm  Regular monitoring of appointments is possible and highly desirable  HIV/AIDS and other chronic diseases  Works with paper records, but electronic records would be even better!!

17. Acknowledgements: INRUD IAA  Staff at the National AIDS Control Programs  Local INRUD groups, and local MSH offices in Ethiopia, Kenya, Rwanda, Tanzania, Uganda  Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, USA  Division of Global Health IHCAR, the Karolinska Institutet, Stockholm, Sweden;  Center for Pharmaceutical Management, MSH  Department of Essential Medicines and Pharmaceutical Policies, WHO

18. Acknowledgements  This work was made possible through a grant provided by the Swedish International Development Cooperation Agency  Additional funding for specific tasks  The World Health Organization  Rational Pharmaceutical Management Plus Program: funded by the U.S. Agency for International Development

19. Publications  Chalker J, Andualem T, Minzi O, Ntaganira J, Ojoo A, Waako P, Ross-Degnan D. Monitoring Adherence and Defaulting for Antiretroviral Therapy in 5 East African Countries: An Urgent Need for Standards; Journal of the International Association of Physicians in AIDS Care, 2008, 7 (4): 193-199  Chalker J. Wagner A, Tomson G, Laing R, Johnson K, Wahlstrom R, and Ross-Degnan D, on behalf of INRUD-IAA. Urgent need for coordination in adopting standardized antiretroviral adherence performance indicators. Journal of Acquired Immune Deficiency Syndromes 2010.53(2):159-161  Chalker J, Andualem T, Gitau L, Ntaganira J, Obua C, Tadeg H, Waako P, Ross-Degnan D. Measuring adherence to antiretroviral treatment in resource-poor settings: The feasibility of collecting routine data for key indicators. BMC Health Services Research 2010 10:43. http://www.biomedcentral.com/1472-6963/10/43http://www.biomedcentral.com/1472-6963/10/43  Ross-Degnan D, Pierre-Jacques M, Zhang F, Tadeg H, Gitau L, Ntaganira J, Balikuddembe R, Chalker J, Wagner A. Measuring adherence to antiretroviral treatment in resource-poor settings: The clinical validity of key indicators. BMC Health Services Research 2010 10:42. http://www.biomedcentral.com/1472-6963/10/42http://www.biomedcentral.com/1472-6963/10/42  Gusdal AK, Obua C, Andualem T, Wahlström R, Chalker J, Fochsen G, on behalf of the INRUD-IAA project. Peer Counselor’s role in supporting patients’ adherence to ART in Ethiopia and Uganda. AIDS Care, June 2011 23:6, 657-662 Gusdal AK, Obua C, Andualem T, Wahlström R, Tomson G, Peterson S, Ekström AM, Thorson A, Chalker J, Fochsen G, on behalf of the INRUD-IAA project. Voices on adherence to ART in Ethiopia and Uganda: A matter of choice or simply not an option? AIDS Care, 2009, 21 (11):1381 – 1387,2111  Gusdal AK, Obua C, Andualem T, Wahlström R, Tomson G, Peterson S, Ekström AM, Thorson A, Chalker J, Fochsen G, on behalf of the INRUD-IAA project. Voices on adherence to ART in Ethiopia and Uganda: A matter of choice or simply not an option? AIDS Care, 2009, 21 (11):1381 – 1387,2111  Obua C, Gusdal A, Waako P, Chalker J, Tomson G, Wahlström R, and The INRUD-IAA Team. Multiple ART Programs Create a Dilemma for Providers to Monitor ARV Adherence in Uganda. The Open AIDS Journal, 2011, 5, 17-24.