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 2011John Chalker, MSH -UK

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?

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?

Potential Availability of Data for Adherence Monitoring

Type of Data Usually Sometimes Never

Patient self-reported adherence 63 27 10Pill count 38 48 15Reported reasons for non-adherence 44 44 13Prescribed ARV dose 96 4 0Number of pills dispensed 98 2 0Date of next scheduled visit 98 2 0Date of actual vs. scheduled visit 29 10 60CD4 count 0 100 0Viral load 0 31 69

48 Facilities Reporting Availability of Data by Type, %

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

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

Sampling ART Patients Functioning attendance register and patient ID

numbersYes

Randomly sample ART patients attending in relevant month and pull pharmacy records

No

ART initiation register YesEvenly sample ART patients from clinic start to end of the target month

No

Patient ID in order of initiation Yes

Sample all patients who had started before target month

No

None of the above YesSample patients according to proportion starting before month of interest

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)

Kenya 936 81.6 (1.7) 25.1 (2.8)

Rwanda 1,279 95.1 (0.5) 4.0 (1.1)

Uganda 1,693 81.8 (0.7) 18.1 (1.8)

Ethiopia 1,982 93.0 (0.6) 10.2 (1.3)

TOTAL 5,890 91.1 (0.4) 13.7 (0.9)

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

0.5 1 1.5 2 2.5 3 3.5 4 4.5 520%

30%

40%

50%

60%

70%

80%

90%

100%

% days covered by dispensed drugs

UgandaKenya Rwanda Ethiopia

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

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

0

1

2

3

4

5

6

7

8

<80% 80% to <90% 90% to <100% 100%

Percentage of days covered with antiretrovirals

Adj

uste

d w

eigh

t gai

n fr

om b

asel

ine

FemaleMale

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

0

20

40

60

80

100

120

140

160

<80% 80% to <90% 90% to <100% 100%

Percentage of days covered with antiretrovirals

Adj

uste

d ga

in in

CD

4 co

unt f

rom

bas

elin

e

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)

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

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

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

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!!

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

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

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/1472-6963/10/43

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/1472-6963/10/42

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,

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,

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.