Objective Measures Of Adherence Research Articles

Patterns of daily oral HIV PrEP adherence among people who inject drugs in Ukraine: an analysis of biomarkers.

Daily oral HIV pre-exposure prophylaxis (PrEP) with tenofovir/emtricitabine (TDF/FTC) is recommended for people who inject drugs (PWID) but coverage is low. The real-life effectiveness of PrEP among PWID is unknown as previous studies were conducted in controlled settings and mainly relied on self-report. Analysis of PrEP metabolites-tenofovir diphosphate (TFVdp) and emtricitabine triphosphate (FTCtp)-offers an objective measure of adherence. To analyse longitudinal patterns of PrEP adherence among PWID in Ukraine, we used data from a community-based implementation trial conducted in Kyiv between July 2020 and March 2021 to test the efficacy of SMS reminders to improve adherence. Among 199 enrolled participants, 156 (78.4%) were retained through 6 months. Based on TFVdp/FTCtp levels assessed at 3 and 6 months, we identified groups with various adherence patterns (adherent at ≥2 doses/week, improved, worsened, non-adherent). Correlates of adherence were analysed using multinomial logistic regression. Most participants (53.8%, n = 84/156) had no detectable metabolites at both assessments; 7.1% (n = 11/156) were consistently taking ≥2 doses/week; 1.3% (n = 2/156) were consistently taking ≥4 doses/week; 13.5% (n = 21/156) exhibited improved and 21.8% (n = 34/156) had worsened adherence at 6 compared to 3 months. "White coat compliance" (increased dosing prior to assessment) was common. Consistent adherence was associated with SMS reminders, younger age, employment, lower income, longer injection drug use duration, recent high-risk injecting (receptive syringe sharing, using pre-filled syringe, back- or front-loading, container sharing), absence of overdose in the past 6 months, perceived HIV risk through sexual intercourse and higher PrEP self-efficacy. Alcohol consumption was associated with inconsistent PrEP use. Groups with improved and worsened adherence did not differ. Daily oral PrEP may not achieve the desired effectiveness among PWID as a standalone intervention, calling for testing of alternative PrEP formulations and innovative integrated risk reduction strategies, especially in the context of HIV epidemics associated with injection drug use in eastern Europe and central Asia and the public health crisis in Ukraine caused by the war with Russia. SMS reminders may be effective among PWID who prioritize PrEP. Our findings offer practical guidance in identifying PWID who are likely to benefit from PrEP and those who need additional support.

Comparison of treatment adherence among TB patients with and without COVID-19 in South India

AimThe present study aimed to compare the adherence to anti-TB treatment among post-COVID-19 pulmonary TB cases and TB patients without a history of COVID-19 in South India. MethodsA prospective, cross sectional study was conducted in all drug-sensitive pulmonary tuberculosis patients in National TB Elimination Program. The research investigates the impact of the COVID-19 pandemic on TB management, considering both subjective and objective measures of adherence. Data were collected using a validated instrument for subjective assessment and urine metabolite testing for objective evaluation. ResultsThe results reveal significant differences (p < 0.05) between subjective and objective adherence measures, emphasizing the need for accurate and comprehensive assessment methods. However, there is no statistically significant difference (p > 0.05) in adherence to anti-TB treatment among post-COVID-19 pulmonary TB cases and TB patients without a history of COVID-19 in South India. The reason for non-adherence in both groups were ATT side effects, loss of daily wages, forgetting to take medication and lazy to take medications. ConclusionThe study concluded that there is no statistically significant difference (p > 0.05) in adherence to anti-TB treatment among post-COVID-19 pulmonary TB cases and TB patients without a history of COVID-19.

Adherence to Background Antipsychotic and Pimavanserin in Patients with Schizophrenia: Post Hoc Analyses from the ENHANCE and ADVANCE Studies.

In patients with schizophrenia, study design to optimize adherence and objective measurement of adherence is critical for interpreting results. Two randomized, double-blind studies evaluating adjunctive pimavanserin in patients with schizophrenia who received stable antipsychotic treatment included measures to encourage and assess treatment adherence. This post hoc analysis evaluated adherence levels achieved in the Phase III ENHANCE study (NCT02970292) and the Phase II ADVANCE study (NCT02970305). Blood levels of participants receiving adjunctive treatment with pimavanserin or placebo added to their ongoing antipsychotic medication were tested and evaluated regularly throughout both studies. For both the background antipsychotic and pimavanserin, treatment adherence was defined as a blood sample test result above the lower limit of quantification. Overall, 392 of 633 screened patients and 403 of 608 screened patients were in the safety populations in ENHANCE and ADVANCE, respectively. In ENHANCE, at weeks 1, 3, and 6/early termination (ET), the adherence rates remained ≥ 95.1% for the background antipsychotic in both pimavanserin and placebo treatment groups and ≥ 96.8% for pimavanserin. In ADVANCE, high adherence rates (≥90.6%) with the background antipsychotic (for both treatment groups) and pimavanserin (≥95.0%) were observed at weeks 2, 8, 14, and 26/ET. Rigorous screening was performed to exclude patients not adherent to their background antipsychotic before enrollment and to pimavanserin during study visits by using regular blood sampling. Mandatory caregiver participation further supported adherence to study treatment and procedures. These efforts may have contributed to the high levels of adherence to both background antipsychotic and pimavanserin reported in ENHANCE and ADVANCE.

Unannounced phone-based pill counts for monitoring antiretroviral medication adherence in South Africa

Background Unannounced phone-based pill counts (UPC) are an objective measure of medication adherence that may be used in resource limited settings. The current study reports the feasibility and validity of UPC for monitoring antiretroviral therapy (ART) adherence among people living with HIV in South Africa. People living with HIV (N = 434) in an economically impoverished township and receiving ART for at least 3-months completed: two UPC in a one-month period; measures of clinic and medication experiences; and provided blood samples for HIV viral load and CD4 testing. Analyses compared two methods for managing values of over-dosing (> 100%), specifically censoring values to 100% (> 100% = 100%) vs. subtracting over-dosing from two months of perfect adherence (200% - > 100% value). Results Findings showed that two UPC calls were successfully completed with 91% of participants in a one-month period. The average number of call attempts needed to reach participants was 2.4. Results showed that lower UPC adherence was significantly associated with male gender, alcohol use, higher HIV viral loads, lower CD4 cell counts, running out of ART, and intentionally not taking ART. Comparisons of methods for adjusting over-dosing found subtraction yielding a better representation of the data than censoring. Conclusions UPC were demonstrated feasible and valid with patients receiving ART in a resource limited setting and offers a viable method for objectively measuring ART adherence in these settings.

Adherence to Clotting Factor Treatment and Association with Bleeding and Health-Related Quality of Life in Persons with Hemophilia

Introduction: Measuring patient adherence to prophylactic treatment with clotting factor in persons with hemophilia includes both subjective and objective measurements. There are limited studies conducted in adherence research using objective measures and a few studies revealed lack of correlation between subjective and objective adherence measurement. The study objectives are 1) to develop an objective adherent measurement; and 2) to assess it's association with bleeding and health-related quality of life (HRQoL) using the data collected from the Hemophilia Utilization Group Study Part VI (HUGS VI), which was an observational, non-interventional study investigating adherence to factor replacement therapy among persons with hemophilia A or B. Methods: HUGS VI enrolled participants from eight U.S. federally-supported hemophilia treatment centers in seven states (California, Colorado, Georgia, Indiana, Pennsylvania, Texas, and Washington) from 2015 to 2017. We enrolled eligible participants who either used standard half-life (SHL) products or used extended half-life (EHL) products for less than six weeks. We collected data on socio-demographics, bleeds, joint problems, and pain via surveys, as well as HRQoL, as measured by SF-12 at enrollment and at each three-month follow-up. We collected monthly factor prescription data from the clinical chart, and monthly factor dispensing records from the participants' pharmacy. We calculated factor treatment for the proportion of days covered (PDC) as the sum of the days of treatment available based on dispensing records, divided by the sum of the days of treatment prescribed based on prescription records for nine months post-enrollment. PDC ≥0.8 was considered an objective measure of adherence to factor treatment. The number of bleeds was summed from each of three quarterly follow-up surveys. We defined EHL users as participants who started an EHL product during the study period, either six weeks prior to enrollment or anytime during the nine months follow up. Association of PDC with nine months bleeds, ratings of chronic pain, and SF-12 scores in the nine-month follow-up were analyzed using Pearson correlation and Student T-Tests. Results: We analyzed a sample of 69 adults (age ≥18 years) with moderate or severe hemophilia using prophylactic treatment who completed at least baseline and nine-month follow-up surveys and had both prescription and dispensing records. Mean age was 28.9±10.3 (standard deviation) years, 91.3% were hemophilia A, and 65.2% were adherent to clotting factor treatment with PDC ≥0.8. EHL users were less likely to be adherent to the treatment than non-EHL users (adherence rate was 47.4% vs. 72.0%, p=0.06). PDC was significantly and negatively correlated with nine months of joint bleeds (correlation coefficient r=-0.30, p=0.01), and total bleeds (r=-0.33, p=0.026), but positively correlated with SF-12 physical composite score (r=0.32, p=0.009). PDC was not correlated with chronic pain (r=0.08, p=0.51) or SF-12 mental composite score (r=0.03, p=0.79). The participants who were adherent to factor treatment had fewer mean joint and total bleeds (2.6±4.1 vs. 1.3±2.1, p=0.08, and 4.9±5.6 vs. 2.9±3.8, p=0.07, respectively) than those non-adherent to treatment, although the differences did not reach statistical significance. Compared to participants who were adherent to treatment, non-adherent participants had a lower SF-12 physical composite score, with an approximately 5-point difference (43.4±10.6 vs. 48.0±9.1, p=0.07). Conclusions: As the data collection period occurred when EHL products became commercially available, treatment adherence may have led to treatment selection as participants switched from SHL to EHL products. Our data showed that participants who were non-adherent to treatment were more likely to be EHL users. Better adherence with higher PDC was moderately correlated with fewer bleeds, but higher HRQoL physical health composite score. The objective adherence measurement developed in this study should be further studied to investigate whether switching from SHL to EHL improves treatment adherence and its association with clinical outcomes.

Mass spectrometry imaging of hair identifies daily maraviroc adherence in HPTN 069/ACTG A5305.

Objective measures of adherence for antiretrovirals used as pre-exposure prophylaxis (PrEP) are critical for improving preventative efficacy in both clinical trials and real-world application. Current objective adherence measures either reflect only recent behavior (eg days for plasma or urine) or cumulative behavior (eg months for dried blood spots). Here, we measured the accumulation of the antiretroviral drug maraviroc (MVC) in hair strands by infrared matrix-assisted laser desorption electrospray ionization (IR-MALDESI) mass spectrometry imaging (MSI) to evaluate adherence behavior longitudinally at high temporal resolution. An MSI threshold for classifying daily adherence was established using clinical samples from healthy volunteers following directly observed dosing of 1 to 7 doses MVC/week. We then used the benchmarked MSI assay to classify adherence to MVC-based PrEP regimens in hair samples collected throughout the 48-week HPTN069/ACTGA5305 study. We found that only ~32% of investigated hair samples collected during the study's active dosing period showed consistent daily PrEP adherence throughout a retrospective period of 30 days, and also found that profiles of daily individual adherence from MSI hair analysis could identify when patients were and were not taking study drug. The assessment of adherence from MSI hair strand analysis was 62% lower than adherence classified using paired plasma samples, the latter of which may be influenced by white-coat adherence. These findings demonstrate the ability of MSI hair analysis to examine daily variability of adherence behavior over a longer-term measurement and offer the potential for longitudinal comparison with risk behavior to target patient-specific adherence interventions and improve outcomes.

#4951 NON-ADHERENCE TO CARDIOMETABOLIC DRUGS AS ASSESSED BY LS-MS/MS IN URINE AND ITS ASSOCIATION WITH RENAL AND CARDIOVASCULAR OUTCOMES IN T2DM

Abstract Background and Aims Cardiovascular and renal complications have a detrimental impact on the prognosis and quality of life of patients with type 2 diabetes mellitus (T2DM). Guidelines recommend combination drug therapy to prevent or delay these complications[1]. However, non-adherence to medication is common and a barrier to successful disease management[2]. Most previous studies on adherence and outcome used indirect methods to assess adherence[3]. In this study we used liquid chromatography-tandem mass spectrometry (LC-MS/MS), a direct and objective adherence measure, to asses adherence to cardiometabolic drugs in a large real-world cohort of individuals with T2DM and analyzed non-adherence in the context of cardiovascular and renal outcomes. Method 1125 eligible PROVALID participants were included. PROVALID is a prospective observational cohort study of patients with T2DM followed annually at the primary health care level. Urine samples from the PROVALID biobank were screened for 79 cardiometabolic drugs and metabolites thereof by LC-MS/MS. An individual was classified as fully adherent when markers for all prescribed drugs were detected, partially non-adherent when at least a marker for one drug was detected and totally non-adherent when no marker for any prescribed drug was detectable. In order to assess outcome by adherence we defined a cardiovascular (myocardial infarction, stroke, and cardiovascular death) and a renal (ESKD, renal death, sustained 40% reduction in eGFR to &amp;lt; 60 ml/min per 1.73 m², sustained progression of albuminuria) composite endpoint. Results The mean age was 64.2 (±8.9) years and 46.1% were female. The mean duration of T2DM was 11.4 (±7.9) years. The mean HbA1c was 7.1 (±1.1)%, the mean eGFR was 77.6 (±23.6) ml/min/1.73 m2 and mean albuminuria 67.3 (±287.9) mg/g creatinine. Participants were prescribed 5.4 (±2.0) cardiometabolic drugs on average. Based on the results of LC-MS/MS measurements, 56.3% were totally adherent, 42.0% were partially adherent, and 1.7% were totally non-adherent to screened cardiometabolic drugs. Adherence was highest to antiplatelet and glucose lowering drugs and lowest to lipid lowering drugs (totally adherent individuals 90.1%, 89.2% and 70.7%, respectively). Non-adherent patients had a longer history of T2DM (12.3 ± 8.5 vs. 10.7 ± 7.5, p = 0.003) and a higher number of prescribed drugs (5.8 ± 2.1 vs. 5.1 ± 1.9, p &amp;lt; 0.001). Age per se had no influence on adherence, however the number of prescribed medications had more impact on adherence in younger patients (Fig. 1). Ex-smokers were more likely to be adherent than current or never-smokers (odds ratio 1.4, p-value = 0.014). Patients who were adherent to lipid lowering drugs had significantly lower LDL (82.4 ± 29.8 vs. 111.4 ± 39.7 mg/dl, p &amp;lt; 0.001). A trend for lower HbA1c with adherence to glucose-lowering drugs and lower systolic blood pressure with adherence to antihypertensive drugs could be observed, however these differences were not statistically significant. In the longitudinal analysis, worse cardiovascular prognosis was especially seen with non-adherence to antiplatelet drugs and worse renal outcome especially with non-adherence to antihypertensive drugs (Fig. 2). Conclusion Our analysis confirms that non-adherence, especially partial non-adherence, to cardiometabolic drugs is common in T2DM. A higher incidence of cardiovascular events was observed with non-adherence to antiplatelet drugs, whereas non-adherence to antihypertensive drugs was associated with a higher renal event rate.

Point of care assay for blood aripiprazole concentrations: development, validation and utility.

The antipsychotic aripiprazole is often used in the treatment of first-episode psychosis. Measuring aripiprazole blood levels provides an objective measure of treatment adherence, but this currently involves taking a venous blood sample and sending to a laboratory for analysis. To detail the development, validation and utility of a new point of care (POC) test for finger-stick capillary blood concentrations of aripiprazole. Analytical performance (sensitivity, precision, recovery and linearity) of the assay were established using spiked whole blood and control samples of varying aripiprazole concentration. Assay validation was performed over a 14-month period starting in July 2021. Eligible patients were asked to provide a finger-stick capillary sample in addition to their usual venous blood sample. Capillary blood samples were tested by the MyCare™ Insite POC analyser, which provided measurement of aripiprazole concentration in 6 min, and the venous blood sample was tested by the standard laboratory method. A total of 101 patients agreed to measurements by the two methods. Venous blood aripiprazole concentrations as assessed by the laboratory method ranged from 17 to 909 ng/mL, and from 1 to 791 ng/mL using POC testing. The correlation coefficient between the two methods (r) was 0.96 and there was minimal bias (slope 0.91, intercept 4 ng/ml). The MyCare Insite POC analyser is sufficiently accurate and reliable for clinical use. The availability of this technology will improve the assessment of adherence to aripiprazole and the optimising of aripiprazole dosing.

Dual trajectories of antiretroviral therapy adherence and polypharmacy in women with HIV in the United States

BackgroundPolypharmacy, using five or more medications, may increase the risk of nonadherence to prescribed treatment. We aimed to identify the interrelationship between trajectories of adherence to antiretroviral therapy (ART) and polypharmacy.MethodsWe included women with HIV (aged ≥ 18) enrolled in the Women’s Interagency HIV Study in the United States from 2014 to 2019. We used group-based trajectory modeling (GBTM) to identify trajectories of adherence to ART and polypharmacy and the dual GBTM to identify the interrelationship between adherence and polypharmacy.ResultsOverall, 1,538 were eligible (median age of 49 years). GBTM analysis revealed five latent trajectories of adherence with 42% of women grouped in the consistently moderate trajectory. GBTM identified four polypharmacy trajectories with 45% categorized in the consistently low group.ConclusionsThe joint model did not reveal any interrelationship between ART adherence and polypharmacy trajectories. Future research should consider examining the interrelationship between both variables using objective measures of adherence.

The Validity and Reliability of Self-Reported Adherence to Using Offloading Treatment in People with Diabetes-Related Foot Ulcers.

Adherence to using offloading treatment is crucial to healing diabetes-related foot ulcers (DFUs). Offloading adherence is recommended to be measured using objective monitors. However, self-reported adherence is commonly used and has unknown validity and reliability. This study aimed to assess the validity and reliability of self-reported adherence to using removable cast walker (RCW) offloading treatment among people with DFUs. Fifty-three participants with DFUs using RCWs were included. Each participant self-reported their percentage adherence to using their RCW of total daily steps. Participants also had adherence objectively measured using dual activity monitors. After one week, a subset of 19 participants again self-reported their percentage adherence to investigate test-retest reliability. Validity was tested using Pearson's r and Bland-Altman tests, and reliability using Cohen's kappa. Median (IQR) self-reported adherence was greater than objectively measured adherence (90% (60-100) vs. 35% (19-47), p < 0.01). There was fair agreement (r = 0.46; p < 0.01) and large 95% limits of agreement with significant proportional bias (β = 0.46, p < 0.01) for validity, and minimal agreement for test-retest reliability (K = 0.36; p < 0.01). The validity and reliability of self-reported offloading adherence in people with DFU are fair at best. People with DFU significantly overestimate their offloading adherence. Clinicians and researchers should instead use objective adherence measures.

P106 Feasibility Study of Methotrexate use Improvement in Rheumatoid Arthritis using Biomarker Feedback: The MIRA Trial

Abstract Background/Aims MTX non-adherence is associated with reduced response, increased healthcare costs to the NHS and reduced quality of life for the patient. Often the prescriber is unable to determine if a patient is taking their medication as prescribed. There is a need to measure adherence directly to facilitate more precise and objective measurements of adherence to add to the clinicians tools and help to open up honest discussions and supportive interventions with patients. Our group has previously developed a sensitive biochemical assay for the detection of MTX adherence, MIRA is a feasibility trial designed to assess the feasibility of a randomised controlled trial of MTX biochemical adherence biofeedback. Methods MIRA is a prospective multi-centre randomised controlled trial to examine the feasibility of a fully powered randomised controlled trial to examine if a biochemical adherence guided intervention is superior to standard clinical care in RA patients prescribed MTX. RA patients prescribed oral MTX for ≥ two years were randomised 1:1 to receive biochemical adherence biofeedback or control. Clinico-demographics, biochemical MTX adherence and DAS-28 and were measured at baseline and three months. Participants in the intervention cohort were telephoned with their biochemical adherence results and adherence was explored. Ethical approval for MIRA was given by the North West - Haydock Research Ethics Committee (19/NW/0047) and all participants provided written informed consent. Results 57 participants were recruited, withdrawal rate was 14% and reasons given were intercurrent illness, lost contact, withdrawn consent and one patient died during follow-up leaving full outcome data available for 49 participants. Baseline clinico-demographics were similar in control and intervention cohorts (Table 1). Biochemical adherence worsened in the control cohort and improved in the intervention cohort (17 to 30%, 15 to 8% respectively). Change in DAS(CDP)-28 during the trial worsened in the control cohort but improved in the intervention cohort (-0.04 STD 1.26 and 0.38 STD 0.78 respectively). Conclusion The results of the MIRA trial have demonstrated that the use of a biochemical adherence blood test with biofeedback is feasible as part of a clinical trial. The intervention demonstrated early evidence for efficacy justifying the need for a full definitive trial. Disclosure J. Bluett: None. K.L. Hyrich: None. B. Keevil: None. P. Doran: None. A. Barton: None.

Adherence in young people living with juvenile arthritis: A systematic review.

Juvenile idiopathic arthritis (JIA) is one of the leading causes of chronic pain in pediatric patients. Treatment regimens, which are critical to symptom management, can be burdensome, involving medication with potentially aversive side effects and exercise that can cause joint pain. Thus, it is important to examine the barriers and facilitators to adherence in JIA. While systematic reviews exist for rheumatic disease in adults, there has not yet been a synthesis of the literature examining adherence in JIA. PsychINFO, PubMed and MEDLINE databases were systematically searched to identify qualitative and quantitative empirical studies that investigate adherence for JIA. Keywords included: patient compliance OR adherence OR persistence; youth OR children OR juvenile OR pediatric OR teen OR child OR adolescent; and rheumatoid arthritis OR idiopathic arthritis OR arthritis. Articles were excluded from the review if they involved non-human or adult samples, were non-experimental (e.g., practice recommendations), were not peer-reviewed, or were not written in English. After abstract selection, 32 articles were included in the analyses. Adherence to exercise regimens was consistently lower than adherence to medication. Researchers relied heavily on self-report of adherence, which suggests a need for additional research with more objective measures of adherence. Across studies, psychological treatment was not included, so adherence to this treatment component in JIA remains understudied. Results suggest that future research should target devising and evaluating interventions to improve adherence to exercise and perhaps psychological treatment. To facilitate adherence in JIA, behavioral health providers should focus on building a strong therapeutic alliance between provider and child, fostering positive coping skills in parents and children, and monitoring the parent-child relationship.

Comparing Predictive Ability of Two Objective Adherence Measures in a Community-Based Cohort on Antiretroviral Therapy in South Africa: Tenofovir Diphosphate Concentrations and Electronic Adherence Monitors.

Electronic adherence (EA) and tenofovir diphosphate (TFV-DP) in dried blood spots (DBS) are objective measures of antiretroviral therapy (ART) adherence. We characterized the association between these measures in a prospective cohort of persons with HIV (PWH) on ART. Four primary health clinics in Cape Town, South Africa. We enrolled 250 virally suppressed PWH receiving tenofovir-based ART. We collected EA data, monthly viral load, and TFV-DP in DBS for 12 months. We used logistic regression to estimate the adjusted odds ratio (aOR) and 95% confidence intervals (CIs) for future viral breakthrough (VB) (>400 copies/mL) for each adherence measure. Receiver operating characteristics (ROCs) provided the predictive power of these measures. Participants had a median (IQR) age of 34 (27-42); 78% were women. Twenty-one (8%) developed VB. Logistic regression showed that when percent EA and TFV-DP concentrations increased, the odds of VB decreased. This relationship was consistent at the time of VB (aOR of 0.41 [95% CI: 0.25 to 0.66] for TFV-DP and aOR of 0.64 [95% CI: 0.54 to 0.76] for EA) and for up to 2 months before VB. Both adherence measures predicted future VB at both 1 month and 2 months before viral load measurement. We established that 2 objective adherence measures, EA and TFV-DP in DBS, have a positive association with, and are both strongly predictive of, VB in a community-based South African cohort on ART. Future research is needed to determine the feasibility of implementing these adherence measures in resource-limited settings to facilitate adherence interventions.

Self-Reported Medication Adherence Among Older People Admitted to Hospital: A Descriptive Study.

Poor medication adherence is prevalent among older people. To optimize therapeutic outcomes, it is crucial to understand the underlying causes and perceptions. We aimed to investigate the extent of self-reported medication adherence and associated factors among older people admitted to hospital. Individuals living at home aged ≥ 75 years with an emergency admission at a university hospital between September 2018 and September 2021 were included. Participants answered the Medication Adherence Report Scale (MARS-5) questionnaire upon admission regarding their prescribed long-term medications. Participants with a MARS-5 score of 23-25 were defined as adherent and with a score of 5-22 as nonadherent. A multivariable logistic regression analysis was performed to investigate possible factors independently associated with self-reported medication adherence. A total of 261 individuals were included. The mean age was 84 years (standard deviation 5.7) and the mean MARS-5 score was 23.9 (standard deviation 1.8). Overall, 227 (87%) participants were classified as adherent to their prescribed treatment, while 34 (13%) participants were classified as nonadherent. Participants with cognitive impairment (odds ratio = 0.40, 95% confidence interval 0.18-0.90, p = 0.027) and depression (odds ratio = 0.29, 95% confidence interval 0.10-0.87, p = 0.028) had a lower odds of reporting adherence to their medications. The majority of individuals aged ≥ 75 years who were recently hospitalized rated themselves as adherent to their prescribed medications according to MARS-5. Future studies would benefit from adding more possible explanatory factors and combining a self-reported assessment with a more objective measurement of medication adherence.

Abstract B070: Longitudinal patterns of executive functioning and adherence in an ethnically diverse sample of pediatric patients with cancer

Abstract Introduction: Executive functioning (EF) is a set of cognitive abilities that includes working memory, flexible thinking, and self-control. EF has been linked to medication adherence in different pediatric populations (e.g., asthma, diabetes, transplant recipients), with greater EF associated with better adherence. The purpose of this study was to examine ethnic and racial differences in EF and medication adherence in a sample of pediatric patients with cancer. Methods: Participants were 39 pediatric cancer patients ages 2-18 years who were in active treatment (Mage = 11.03). Twenty patients (51.3%) identified as non-Hispanic, White; while the remaining 19 (48.7%) identified as other minority status (e.g., non-Hispanic, Black; Hispanic). Parents completed the Behavior Rating of Executive Functioning (BRIEF) at baseline, 6 months, and 12 months. The BRIEF yields an overall Global Executive Composite score (GEC) composed of two indexes: the Behavioral Regulation Index (BRI) and the Metacognition Index (MI). The BRI is composed of the Inhibit, Shift, and Emotional Control scales. The MI is composed of the Initiate, Working Memory, Plan/Organize, Organization of Materials, and Monitor scales. Adherence was measured across the same timepoints using the Medication Event Monitoring System (MEMS), which is an objective measure of daily adherence to medication. Results: When identifying ethnic and racial differences in EF over time, there were no significant effects of time or minority status on MI and GEC scores. For the BRI overall, there was no significant main effect of time (p=0.5), or minority status (p=0.66). However, there was a significant interaction between time and minority status on BRI, F(2,56)=5.26, p=0.01, ηp 2=0.16), with parents of non-minoritized patients observing more executive functioning deficits over time, and parents of minoritized patients observing improvements in executive functioning across 1-year. Finally, when examining EF and adherence, MI at Month 6 was significantly correlated with cumulative adherence at Month 6, even when controlling for minority status and age, r(27) = -0.45, p=0.01. Conclusions: Parents of minoritized patients observed improvements in behavioral regulation over time; whereas parents of non-Hispanic White patients reported worsening behavioral regulation. Additionally, MI was significantly correlated with medication adherence at 6 months, even when controlling for minority status and age. This suggests that deficits in a child’s ability to initiate, plan, organize, self-monitor, and sustain working memory can result in lower adherence regardless of minority status and age. Culturally-sensitive psychological interventions targeting meta-cognition domains may ameliorate nonadherence for pediatric patients with cancer, ultimately improving health outcomes. Citation Format: Clara Ko, Andrea Jewell, Evrosina Isaac, Tanvi Verma, Jennifer M. Rohan. Longitudinal patterns of executive functioning and adherence in an ethnically diverse sample of pediatric patients with cancer [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr B070.

Improving the accuracy of adherence data collected using medication monitoring technology in clinical research

Ambiguous adherence data adversely effects the statistical analyses, study conclusions, and generalizability of research findings for clinical trials. Fortunately, technology-based measures of drug dosing provide more objective measures of medication adherence. While adherence data obtained through monitoring technology avoids the well documented shortcomings of self-reported adherence data, there are important limitations and nuances with use of these technologies that should be considered at study inception, conduct, and analysis. This article describes considerations for data collection and management with use of electronic adherence monitoring, specifically mobile-phone video applications or electronic pillbox devices. The overall aim of this communique is to provide research teams the ability to collect more accurate adherence data and ultimately improve the quality and outcome of their research.

Adherence challenges with daily oral pre-exposure prophylaxis during pregnancy and the postpartum period in South African women: a cohort study.

Daily oral pre-exposure prophylaxis (PrEP) can reduce HIV acquisition. However, prevention effectiveness requires daily adherence prior to and during periods of sexual activity. Little is known about pharmacologic measures of PrEP adherence during pregnancy and postpartum and the factors related to optimal adherence during periods of sexual activity in this population. Between August 2019 and October 2021, we enrolled pregnant women without HIV at their first antenatal care visit followed-up through 12 months postpartum. Eligible women ≥16 years old received HIV prevention counselling and were offered oral PrEP (TDF-FTC). We quantified tenofovir-diphosphate (TFV-DP) in dried blood spots in women who reported taking PrEP in the past 30 days (at quarterly follow-up visits). We used regression models with generalized estimating equations to evaluate correlates of TFV-DP (any vs. none, and ≥2 vs. <2 doses/week), adjusting for maternal age and pregnancy status. In 382 women who started PrEP in pregnancy, returned for follow-up and reported PrEP use in the past 30 days, the median age was 27 years (interquartile range [IQR] = 23-32), and the median time on PrEP was 168 days (IQR = 84-252 days). Half of the samples had quantifiable TFV-DP at any time point (52%), declining from 67% of pregnant women 3 months post-initiation to 31% of postpartum women by 12 months. Overall, 72% had concentrations corresponding to <2 doses/week; 25% ≥2 doses/week; 3% 7 doses/week. Concentrations were lower in postpartum versus pregnancy (age-adjusted odds ratio [aOR] = 0.44; 95% confidence interval [CI] = 0.35-0.54). The correlation of self-reported adherence and TFV-DP ranged from -0.07 in pregnancy to 0.25 in postpartum women. Variables associated with having quantifiable TFV-DP included partner living with HIV/unknown serostatus (aOR = 1.50; 95% CI = 1.01-2.22), and reported frequency of sexual activity in the past month (aOR sex >5/month vs. no sex or <5 times/month = 2.11; 95% CI = 1.58-2.82) adjusting for age and pregnancy versus postpartum status. TFV-DP concentrations declined over follow-up time (aOR for 6 vs. 3 months = 0.49; 95% CI = 0.36-0.67). Objectively measured adherence to PrEP was low overall and did not correlate with self-reported use. There is an urgent need for objective adherence measures to support clinical decision-making as well as adherence support interventions as part of PrEP services for pregnant and postpartum women at risk of HIV.

Level of adherence to anti-tubercular treatment among drug-sensitive tuberculosis patients on a newly introduced daily dose regimen in South India: A cross-sectional study.

Tuberculosis (TB) patients on the National Tuberculosis Elimination Program (NTEP) treatment protocol receive daily doses without health professional-supervised drug intake as during the previous directly observed treatment short-course (DOTS) regimen. We aimed to measure the level of adherence to anti-tubercular treatment (ATT) and the reasons for non-adherence among drug-sensitive TB patients on a daily-dose regimen in South India. A cross-sectional study was conducted among TB patients who received ATT as part of the standard treatment protocol in NTEP. Patients were interviewed to capture their understanding of TB, adherence, and the reason for non-adherence to ATT using validated instruments. Urine drug metabolite testing was performed using the high-performance liquid chromatography (HPLC) technique to confirm adherence. A total of 488 patients were recruited for the study. 64.8% of patients had 'good knowledge' about TB and ATT. According to the subjective report, 63.7% of patients were adherent, but urine drug metabolite testing revealed 53.4% adherence. A statistically significant difference (p< 0.05) exists between subjective and objective adherence measures. Patient-reported reasons for non-adherence were side effects of ATT (18.6%), loss of daily wages (15.0%), and forgetfulness (10.0%), among others. Nearly half of the patients were non-adherent to the daily dosing regimen. Adherence as reported by the patients is unreliable, and urine testing could be used in routine care to assess adherence. CTRI/2020/04/024941.

Agreement Between Measures of Adherence to Isoniazid Preventive Therapy Among People With HIV in Uganda.

Isoniazid (INH) preventative therapy is recommended for people with HIV (PWH) in resource-constrained settings. Valid measures are needed to assess adherence. We aimed to examine agreement between measures overall and by level of social desirability. PWH with latent tuberculosis (TB) were recruited in Mbarara, Uganda. Past 30-day adherence was measured by the number of days with pill bottle openings using a medication event monitoring system (MEMS) and self-reported number of days pills taken. INH concentration (INH plus acetyl INH and their ratio) in hair samples was measured. We used Bland-Altman plots to examine agreement between adherence measures and calculated the area under the receiver operating characteristics curve (AUROC) to determine if INH hair concentration predicted optimal MEMS-measured adherence (≥90%). A total of 301 participants enrolled; 92% were virologically suppressed, and adherence was high. The median (interquartile range [IQR]) number of pill bottle openings in 30 days was 28 (24-30) compared with 30 (28-30) via self-report. The median INH concentration (IQR) was 36.2 (17.2-62.4), and the INH:acetyl ratio was 2.43 (0.99-3.92). Agreement between self-reported and MEMS adherence was greater at more optimal adherence levels. INH:acetyl INH ratio was not predictive of optimal adherence according to MEMS (AUROC, 0.62; 95% CI, 0.52-0.72) in a subset (n = 161). Lower MEMS adherence levels compared with self-report suggest the need for objective adherence measures. Biologic measures have potential, although in this study INH concentration was not predictive of MEMS measured adherence. More data are needed to assess the accuracy of biologic measures.

SPUR: psychometric properties of a patient-reported outcome measure of medication adherence in type 2 diabetes

IntroductionPoor medication adherence is associated with worsening patient health outcomes and increasing healthcare costs. A holistic tool to assess both medication adherence and drivers of adherence behaviour has yet to...