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