State of the Art Measuring and understanding adherence to ART in Resource poor settings

What is medication adherence? degree to which patient’s medicine use coincides with prescription by health worker Has different dimensions, including doses missed, adequate timing of medication use, compliance to additional requirements like food-intake, non-alcohol use. Changes over time

Three approaches to adherence Descriptive: to measure non-compliance Analytical: define determinants of non- adherence (comparative approach) Intervention oriented -- defining problems in use of medications and seeking solutions  Beware: authoritative versus empathy approach

Different methods to measure adherence Self-report in patient interviews Patient-kept diaries Semi-structured interviews Focus group discussions Projective techniques, including visual analogue scales Pill counts Electronic monitoring Prescription record reviews Drug levels in biological fluids

Adherence methods Bad news: no gold standard Good news: many methods have acceptable sensitivity and specificity for our purpose Mix of methods can be used to increase validity

Self-report/diaries PROS Easy to use in resource poor settings Inexpensive Can be used to identify high and low adherers Can be used to explore why non-adherence occurs and possible solutions CONS Time-intensive Influenced by question construction and interviewer skill Patient likely to report desirable behavior Over-estimates use

Semi-structured interviews PROS Depth of understanding Unexpected issues can come up Less ‘authoritative’ style, more empathy possible Generates understanding of reasons for non- adherence and possible solutions CONS Time consuming skilled interviewer required Analysis is demanding

Focus group discussions PROs Inexpensive Participants encourage each other to talk Less authoritative Provides information on general patterns of use, reasons for non-use and possible solutions CONS Cannot be used to measure individual adherence Does not quantify adherence levels Requires skilled moderator Analysis challenging

Projective techniques PROS Good to encourage discussion Visual analogues can indicate adherence levels Inexpensive CONS Underdeveloped Difficult to interpret

Pill counts PROS Easy to use Inexpensive Non-invasive CONS Does not reflect actual ingestion of drugs Participants have to remember to bring the pill bottles Patients can dump pills to appear to be good adherers Patients may share pills Does not measure actual use patterns on a daily basis.

Medical/pharmacy records review PROS Rapid Inexpensive Large populations possible Non-invasive CONS Often records missing No data on patients who don’t come back for check-up or refill Need permission from facility Limited set of data collected routinely

Electronic monitoring PROS Can increase validity of data More resistant to desirability effect Provides details on daily use CONS Does not confirm ingestion Expensive Vulnerable to mechanical problems Does not provide data on medicine sharing

Drugs levels in biological fluids PROS Objective measure Recent use verified No details on timing of use Data limited to recent use Expensive Difficult to manage – fluids have to be collected/transported/a analysed

Mix of methods Combine qualitative and quantitative - Qualitative: measures dimensions and ways of and reasons for non-adherence, and can be used to identify possible solutions - Quantitative measure how often non-adherence occurs Tri-angulate Phase methods Validate by correlating with health outcomes

Measures of adherence Many different ones used in literature Definition often not explicit Need to be clear about which dimensions of adherence are being measured, which not Should relate to health outcomes Be appropriate to the situation

Kinds of adherence measures Numerical: 95% or 80% of prescribed in - 24 hours - 3 days - 1 week - 1 month Five point scale: always/mostly used in accordance with prescription Binary: Adherent – Not Composite: adding up different dimensions of adherence

Usually more than one measure Analyzed separately Analyzed together to increase validity of measure (includes more dimensions of validity, relates better to health outcomes) But, no analysis of divergences qualitatively– why do they occur?

Validity Relevant dimensions of adherence measured The measures make sense to respondents The measures predict relevant outcomes (viral load/CD4 counts/health outcomes)

Ways to increase validity…. Be non-adherer friendly: Most people with HIV have many pills to take at different times during the day. Many people find it hard to always remember their pills...

Reliability The same is measured across time and settings

What influences Adherence? Treatment related Disease state Patient ideas, practices Social environment Health facility National policy  Usually focus is on patient factors – blame the victim!  Very few exploratory studies to define which factors are relevant in specific situations

Treatment related Number of pills Number of times per day Dosage level Adverse effects (of each pill) Characteristics of drug (branded, colour, administration form) Additional requirements, such as food intake, non-alcohol use

Disease related Health state at initiation of therapy Seriousness of disease over time Concurrent Depression/fatigue Concurrent opportunistic infections requiring additional medication (TB) Individual response to therapy (can vary)

Patient ideas Trust in health services Changes in identity related to using ART Ideas about HIV-causation Ideas about disease progression Ideas about efficacy of HIV medications Ideas about risks of missed doses Ideas about toxicity of medicines Tolerance to side/effects Lack of knowledge on HIV/Medicine use

Patient practices Disciplined life-style Disclosure of HIV/AIDS status Way medicines are used in every-day life, including at school/work/when traveling Forgetfulness, taking drugs and medical appointments Substance abuse

Patient background variables Socio-economic status Gender Age Religion Employment status Marital status Number and age of children

Social environment Level of community preparedness for treatment Adherence support mechanisms, if any Stigma/fear for HIV/AIDS Discrimination of particular sub-groups of AIDS patients (drug-users, prostitutes) Gender-differentials in support to people on HAART Levels of employer support Levels of privacy Communication channels on HIV/AIDS and treatment

Health facility structural Accessibility Regularity of supply Cost of medicines Range of medicines available Spatial dimensions, and cleanliness Workload of staff Diagnostic facilities Guidelines Records present

Health facility processes Quality of patient-provider interactions Treatment eligibility and choice Constellation of care provided Monitoring/response treatment outcome Adherence support and follow-up Respect for privacy and informed consent Over and under the counter payment Motivation and training of staff

Counseling: information Info (oral/written) provided on -How ARVs work - How to use them - The need to continue treatment - What to do if a pill is forgotten - Which side effects can occur and what to do if they occur - (breast) feeding requirements - when and where to get re-supply Info understood?

Counseling: interpersonal Client treated with respect, and in privacy? Clients feel listened to and do they get a chance to ask questions about the treatments and the effects on their bodies and their lives?

National level Political commitment to ART scale-up Implementation, kinds of ARVs distributed, supply chain, training, guidelines Specifics for adherence support program Monitoring and Evaluation Health policy maker views on adherence problems

Challenges Be cost-effective Describe and understand adherence Allow for comparison Select appropriate adherence measure Select appropriate mix of methods Define feasible sampling strategy Overcoming sensitivities Avoid authoritative approach Conduct good analysis And identify solutions with stakeholders