Objective Measures Of Adherence Research Articles

Sociodemographic and Clinical Factors Affecting Treatment Adherence in Adults with Attention Deficit and Hyperactivity Disorder.

This study aims to explore sociodemographic and clinical factors affecting medication adherence in adults with attention deficit and hyperactivity disorder and elicit dysfunctional domains and comorbidities with a focus on gender differences. Patients were recruited from 2 specialty clinics using chart records in a natural treatment design. Adult attention deficit and hyperactivity disorder self-report scale, Diagnostic Interview for attention deficit and hyperactivity disorder in adults, was applied. Adherence is defined if the patient declared ≥80% adherence to medication throughout the last 8-12 weeks. From 205 attention deficit and hyperactivity disorder patients (male = 112 female = 93 (age (median) min-max = 29 (18-56)), 29% were non-adherent to attention deficit and hyperactivity disorder medication. In the multivariate analysis, having 2 or more comorbid disorders (P = .009), dysfunctions in academic/work (P = .049), and dysfunctions in family and other relationships (P = .047) increased the likelihood of adherence. Adherence rates did not significantly differ between methylphenidate and atomoxetine (P = .405). Women were more likely to have 2 or more comorbid psychiatric disorders (P = .004) and dysfunctions in social relationships (P = .001), free time activities, hobbies (P < .001), self-confidence, and self-image (P < .001). Nearly one-third of adult patients with attention deficit and hyperactivity disorder did not adhere to medication treatment. Comorbid psychiatric disorders and dysfunctions in life domains appear to increase the likelihood of adherence to attention deficit and hyperactivity disorder medications, possibly through increasing motivation for treatment. The effect of cognitive-behavioral therapy on compliance with attention deficit and hyperactivity disorder medication should further be explored with prospective controlled studies. We suggest that future longitudinal studies use objective measures of adherence and confirm the role of dysfunctional life domains and comorbid psychiatric disorders as correlates of medication adherence.

913-P: The Relationship between ASK12 Patient-Reported Medication Adherence Scores and Objective Measures of Adherence among Patients with Type 2 Diabetes

Background: Medication adherence may be measured either by (a) patient-reported measurement or (b) objective measurement using medication dispense data. Proportion of days covered (PDC) is an objective measure of adherence becoming more readily available in the electronic health record (EHR) and a threshold of &amp;lt; 80% is commonly used to identify a potential adherence problem. Using PDCs may be more efficient and clinically practical than using longer patient-reported adherence questionnaires. However, it is unknown how well the PDC and patient reported measures correlate. Methods: As part of a pragmatic randomized trial to evaluate an intervention designed to improve medication adherence in a Midwest health care system, 1,423 adults with type 2 diabetes (T2D) were identified at an index visit in primary care based on suboptimal diabetes control (AIC &amp;gt;8%) and at least one oral diabetes medication with PDC &amp;lt; 80%. They were surveyed shortly after the index visit to assess adherence using a validated 12 question ASK-12 instrument, with a response rate of 29% (80/280) . We evaluated the relationship between PDC and ASK-12 total/subscale scores using linear regression. Results: There were no significant associations found between PDC scores and the total ASK-12 score (β=-0.4, p=0.47) , or ASK-12 subscales of inconvenience/forgetfulness (β=-1.1, p=0.42) , treatment beliefs (β=-0.4, p=0.77) , behavior (β=-0.7, p=0.55) , or barriers (β=-0.7, p=0.44) . Conclusions: For patients above recommended A1C goal with a medication PDC &amp;lt; 80%, there was no correlation between PDC scores and patient-reported measures of adherence using ASK-12 total or component scores. This analysis raises questions about the validity and usefulness of EHR-derived PDC scores to identify poor medication adherence for patients with T2D. Disclosure P.Pawloski: None. M.Pankonin: None. D.Rehrauer: None. C.Frail: None. J.Anderson: None. L.Chumba: None. J.Ziegenfuss: None. P.J.O'connor: None. S.P.Dehmer: None. H.Ekstrom: None. J.Haapala: None. J.M.Sperl-hillen: None. M.Becker: None. A.Truitt: None. Funding NHLBI #R01HL136937

Relationship Dynamics are Associated with Self-Reported Adherence but not an Objective Adherence Measure in Malawi.

Couple relationships can be leveraged to improve adherence to antiretroviral therapy (ART), but few studies have identified relationship factors to target in interventions in sub-Saharan Africa. We conducted a cross-sectional study with 211 couples in southern Malawi with at least one partner on ART to test for associations between ART adherence and relationship dynamics (intimacy, trust, relationship satisfaction, unity, commitment, and partner support). We measured ART adherence through subjective measures (patient and partner reports) and an objective measure (ART drug levels in hair) and hypothesized that more positive relationship dynamics (e.g., higher intimacy) would be associated with better adherence. Multi-level logistic and linear regression models were used to evaluate study hypotheses, controlling for the clustering of individuals within couples. High levels of adherence were found by all three measures. Unity, satisfaction, and partner support were associated with higher patient and partner reports of adherence, and additional relationship dynamics (intimacy, trust) were associated with higher partner reported adherence. No associations were found between relationship dynamics and drug levels in hair, although drug levels were high overall. Future studies should perform longitudinal assessments of relationship dynamics and objective metrics of adherence, and examine these associations in populations with lower adherence levels such as young women or individuals starting ART.

Patterns and Predictors of Air Cleaner Adherence Among Adults with COPD.

Poor indoor air quality has been associated with worse chronic obstructive pulmonary disease (COPD) morbidity. In-home portable air cleaners reduce indoor pollutants and could improve respiratory health. Factors associated with air cleaner adherence among adults with COPD remains unknown. In a 6-month trial of former smokers with COPD, participants (n=116) received active or sham portable air cleaners. Air cleaner adherence was measured by electronic monitors. Potential baseline predictors of adherence included individual factors (demographics, socioeconomic status, smoking history, psychological well-being), COPD disease severity, and housing characteristics. Time and season were also considered. Stepwise logistic regression and longitudinal fixed effect analysis were performed to assess independent predictors of adherence. A total of 109 participants had an objective measure of adherence, and 76.1% used at least 1 air cleaner 80% of the time (defined a priori as adherent). Higher annual household income ≥$35,000 (odds ratio [OR]=4.4, 95% confidence interval [CI], 1.1-18.0) and use of heat pump/electricity (versus gas) for heating (OR=6.1, 95%CI, 1.7-22.4) were associated with higher odds of adherence. Further, poor quality of life (St George's Respiratory Questionnaire, per 10-point increase) and prior year exacerbations were associated with lower odds of adherence (OR=0.65, 95%CI, 0.4-1.0) and (OR=0.26, 95%CI, 0.1-0.9), respectively. Adherence was highest during the first month and lower during winter compared to other seasons. These findings suggest that cold weather season, use of gas for home heating, and lower annual income negatively impact adherence. Poor quality of life and worse disease control may also decrease adherence. Addressing factors associated with air cleaner adherence should be considered when designing future environmental studies.

Objective measurement of adherence to topical steroid medication after penetrating keratoplasty using an electronic monitoring aid: A pilot study.

ObjectivesCorneal transplantation is the most common transplant worldwide and its success critically depends on the management of corneal graft rejection through topical steroid therapy during the first 12 months after surgery. There is currently no published data on adherence after keratoplasty. This pilot study aims to explore the adherence to topical steroid after penetrating keratoplasty using a smart electronic device.MethodsThirty patients undergoing penetrating keratoplasty were included to evaluate the adherence to topical dexamethasone medication for 12 months after surgery. Patients received the usual post-transplantation treatment (topical dexamethasone) and follow-up after surgery (day 15, months 1, 2, 3, 4, 5, 6, 9, and 12). Adherence to treatment was monitored using the KaliJAR device (Kali Care, Santa Clara, CA, USA), which recorded the number of single-dose units (SDU) discarded. At control visits, data recorded by the device were compared to the manually count of SDU. Adherence ratio and individual adherence curve were explored for all patients.ResultsData from 27 patients showed a high agreement between adherence ratio calculated based on the device data and obtained from manual counting of the discarded SDU (intraclass coefficient correlation of 0.87 [95% CI: 0.738–0.938]). Mean adherence to the treatment over the 12-month study period was 95.2 ± 4%.ConclusionsAdherence to topical dexamethasone for 12 months after corneal transplantation was high. The connected device was able to record accurately the discarded SDU. This approach would be a particular interest in the early identification and personalized follow-up of poorly adherent patients.

Medication Nonadherence: Implications for patient health outcomes in pharmacy practice

ABSTRACT&#x0D; Objectives: The primary objective of this review is (1) to better understand the prevalence and impact of medication nonadherence, (2) to identify risk factors for medication nonadherence, (3) to understand the association between nonadherence and its implications on patient health outcomes in pharmacy practice, and (4) to study interventions designed to improve patient adherence to prescribed medications for medical conditions, considering its impact on both medication adherence and patient health outcomes.&#x0D; &#x0D; Methods: Published journal articles were manually sorted. Additional references were obtained from citations within the retrieved articles. This review surveyed the findings of the identified articles with data extracted to presents various strategies and resources on medication nonadherence related to patients and healthcare providers. English languages were considered inclusion criteria in reviewing published articles related to medication nonadherence. This review also surveyed identified articles to determine both subjective and objective medication adherence measures.&#x0D; Key findings: The research in this field needs advances, including improved design of feasible long‐term interventions, objective adherence measures, and sufficient study power to detect improvements in patient health outcomes.&#x0D; &#x0D; Conclusion:&#x0D; Current methods of improving medication adherence for chronic health problems are mostly complex and ineffective so full benefits of treatment cannot be realized. To date, monitoring of patient medication adherence and use of interventions to improve adherence are rare in routine clinical practice.

866. Adherence to F/TDF for PrEP in Dried Blood Spots and HIV Infection Rates: A Pooled Analysis of Global PrEP Studies

BackgroundThe use of daily F/TDF for HIV pre-exposure prophylaxis (PrEP) substantially reduces HIV acquisition. Dried blood spot (DBS) tenofovir-diphosphate (TFV-DP) levels reflect TDF use over the past 6-8 weeks, providing an objective measure of adherence in people taking PrEP.MethodsIn a pooled analysis of 19 PrEP demonstration projects and clinical studies, 6,613 participants had at least one TFV-DP measurement in DBS and followed for at least 48 weeks and up to 96 weeks. We used a piecewise linear mixed-effects model to plot the least-square means with corresponding 95% confidence intervals (CI) of TFV-DP for adherence over time, and Poisson regressions to calculate HIV incidence rates (IR) by level of weighted average of TFV-DP.ResultsOf 6,613 participants, median age was 30 years (interquartile range 24−38), 5,449 (82%) were cisgender men, 806 (12%) were cisgender women, and 349 (5%) were transgender (316 transgender women, 2 transgender men, 31 unspecified). Adherence based on TFV-DP in DBS was consistently higher among participants who did not acquire HIV compared to those who did (Figure). Among all participants, 21%, 14%, 36%, and 29% has DBS consistent with taking < 2, 2−3, 4−6, and ≥7 tablets of F/TDF PrEP per week (Table). Sixty-nine participants acquired HIV, with a median PrEP exposure of 0.82 years and an overall HIV IR (95% CI) of 1.16 (0.92, 1.47) per 100 person years. There was a strong association between adherence and HIV incidence [among individuals who took < 2, 2−3, 4−6, and ≥7 tablets/week, the HIV IRs (95% CI) were 5.20 (4.03, 6.71), 0.38 (0.12, 1.18), 0.28 (0.12, 0.61), and 0.06 (0.01, 0.39), respectively. Overall IR (95% CI) of HIV infection among cisgender men was 1.25 (0.98, 1.60) per 100 patient-years. Four cisgender women and 2 transgender participants acquired HIV, corresponding to IRs (95% CI) of 0.71 (0.27, 1.90) and 0.63 (0.16, 2.53).Adherence by TFV-DP in DBS for F/TDF users who acquired HIV compared to those who did not. Note: ‘x’ on the Figure represents visit week when a new HIV infection was detected.HIV incidence rates (95% confidence intervals) by adherence to PrEP measured by level of TFV-DP in DBS up to 96 weeks after PrEP Initiation ConclusionThis diverse, multi-national pooled analysis of F/TDF PrEP use provides the largest assessment to date of the adherence-HIV incidence relationship in people taking F/TDF for PrEP. The results suggest a high background HIV incidence in the pooled cohort and high efficacy in those adherent to PrEP. These findings support ongoing efforts to increase PrEP use among people who would benefit.Disclosures Albert Liu, MD, MPH, Gilead Sciences (Individual(s) Involved: Self): Gilead has donated study drug for studies I have led., Grant/Research Support, Other Financial or Material Support, Research Grant or Support; IAS-USA (Individual(s) Involved: Self): Honorarium for manuscript writing, Other Financial or Material Support; Viiv Healthcare (Individual(s) Involved: Self): Grant/Research Support, Research Grant or Support Raphael J. Landovitz, MD, MSc, Gilead Sciences (Individual(s) Involved: Self): Consultant; Janssen (Individual(s) Involved: Self): Consultant; Merck Inc (Individual(s) Involved: Self): Consultant; Roche (Individual(s) Involved: Self): Consultant Jared Baeten, MD, PHD, Gilead Sciences Inc. (Employee, Shareholder) David Magnuson, PharmD, Gilead Sciences Inc (Employee, Shareholder) Moupali Das, MD, Gilead Sciences Inc. (Employee, Shareholder) Christoph C. Carter, MD, Gilead Sciences Inc. (Employee, Shareholder) Li Tao, MD, PhD, Gilead Sciences Inc (Employee, Shareholder)

High residual inflammation despite HIV viral suppression: Lessons learned from real-time adherence monitoring among people with HIV in Africa.

Lower antiretroviral therapy (ART) adherence is associated with higher systemic inflammation in virally suppressed people with HIV (PWH); however, previous studies have mostly relied on subjective adherence measures and have not assessed this association by disease stage upon ART initiation. In the Monitoring Early Treatment Adherence study, adherence was monitored electronically in real time among adult, treatment-naïve PWH in Uganda and South Africa who initiated tenofovir disoproxil fumarate/emtricitabine/efavirenz during early-stage (CD4 >350 cells/µL) or late-stage (CD4 <200 cells/µL) disease. Participants who achieved viral suppression (<400 copies/mL) at 6months and remained suppressed after 12months were analysed. The association between average ART adherence and plasma concentrations of interleukin 6 (IL-6), soluble CD14 (sCD14) and D-dimer was evaluated using adjusted multivariable linear regression, stratified by disease stage. In all, 488 PWH (61% women, mean age 35years) were included in the analysis. Median ART adherence overall was 87%. In adjusted models, every 10% increase in average adherence was associated with a 3.0% decrease in IL-6 [95% confidence interval (CI): -5.9 to -0.01, p=0.05] at 12months. This relationship was observed in PWH with both early-stage (5.9%, 95% CI: -10.1 to -1.6, p=0.009) and late-stage disease (3.7%, 95% CI: -7.2 to -0.2, p=0.039). No significant associations were found with sCD14 or D-dimer. Objective ART adherence measurement was inversely associated with systemic inflammation in PWH who achieved viral suppression after ART initiation in sub-Saharan Africa, with a greater association in those with early-stage HIV. This finding underscores the importance of ART adherence beyond establishing viral suppression.

The use of objective adherence measures targeting four placebo microbicide delivery forms in the Quatro Clinical Crossover Study

AbstractBackgroundAdherence to topical microbicides for HIV prevention has been a challenge for women using them and those developing novel products. The Quatro Clinical Crossover Study investigated user preference and acceptability of four different placebo‐based vaginal delivery forms among young African women. The objective of this sub‐study was to test the ability of objective adherence measures in assessing placebo product usage.MethodsA total of two hundred women from Zimbabwe and South Africa used placebo vaginal gel, insert, and film once per week, with or without sex, for 1 month and an intravaginal ring continuously for one month (Months 1–4). Women then chose their preferred product and used it with sex each week during Month 5. Women self‐collected vaginal swabs after using the gel, insert and film. Collected vaginal swabs and used intravaginal rings were analysed for placebo‐based adherence measures using spectroscopy and excipient‐based analyses to determine product use. Vaginal insertion and semen exposure was determined using previously developed and published adherence biomarkers. Intravaginal rings were extracted for residual excipient (glycerin) and penetrated bioanalytes.ResultsBoth methodologies showed that women used gel the most during Months 1–4 (75% by excipient methods, 85% by spectroscopy). The methodologies also determined that nearly all swabs from both sites were vaginally inserted, and 51–86% had detectable placebo product. Semen was detected in more swabs collected during Month 5 from women in Zimbabwe than the swabs from women in South Africa, and most of those swabs had placebo product present as well. The majority of women used the ring for the required four weeks. Sixty‐eight per cent of women who used the ring for the required 4 weeks increased to 78% during Month 5.ConclusionThis sub‐study demonstrated how these objective placebo‐based measures of adherence determined product use of various microbicide delivery forms.

Physical activity is important for cardiovascular health and cardiorespiratory fitness in patients with psoriasis.

SummaryBackgroundPatients with psoriasis have a level of physical activity below that recommended for cardiovascular health, which is significantly limited by disease severity and other psoriasis‐specific barriers. We hypothesized that physical activity is important for cardiovascular health in patients with psoriasis and that its objective measurement could have clinical utility.AimTo explore whether physical activity influences the risk of cardiovascular disease (CVD) in patients with psoriasis.MethodsIn total, 242 patients with chronic plaque psoriasis were recruited. History, examination and physical activity were assessed and arteriography, the noninvasive measurement of arterial function, was performed for each participant.ResultsWe observed a significant relationship between volume of physical activity and the likelihood of future CVD as measured by pulse wave velocity (PWV; P < 0.02). We identified a significant relationship between the diastolic reflection area (DRA) and health‐promoting levels of physical activity (P < 0.001), in addition to a significant correlation between DRA and the likelihood of future CVD (P < 0.001). The DRA is a complex, dimensionless variable that describes the intensity of diastolic wave reflection and the duration of diastole, which are key determinants of the blood supply to the left ventricle. Our data suggest that DRA may represent a surrogate marker for cardiorespiratory fitness.ConclusionOur study describes a significant relationship between exercise, cardiorespiratory fitness and PWV, a preclinical indicator of future CVD risk, in patients with psoriasis. The DRA offers a noninvasive, objective measurement of exercise adherence, which could have clinical utility in the future.

A Survey of Potentially Modifiable Patient-Level Factors Associated with Self-Report and Objectively Measured Adherence to Adjuvant Endocrine Therapies After Breast Cancer.

PurposeDespite the efficacy of adjuvant endocrine therapy (AET) in reducing breast cancer recurrence and mortality, suboptimal AET adherence is common and hence an important clinical issue among breast cancer survivors. Delineating potentially modifiable patient-level factors associated with AET adherence may support the development of successful adherence-enhancing interventions.Patients and MethodsThe present study included 133 breast cancer survivors prescribed AET recruited from a cancer pharmacy. Women completed a baseline questionnaire examining psychosocial factors and self-reported adherence and consented to their prescription records being monitored for the proceeding 12 months to ascertain proportion of days covered (PDC), an objective measure of adherence. Regression analyses were used to identify the factors most strongly associated with both self-reported and objective adherence. Exploratory moderation analyses examined whether factors were differentially associated with adherence based on AET type (aromatase inhibitors or tamoxifen).ResultsAdherence was high in this sample (PDC over 12 months was 95%). Side effect severity was most strongly associated with self-reported adherence, followed by self-efficacy, and medication/healthcare system-related barriers. Medication/healthcare system-related barriers was the only factor that uniquely predicted objective adherence. Within medication/healthcare system-related barriers, fear of side effects was most strongly associated with both measures of adherence. There were no significant interactions between AET type and potentially modifiable factors in predicting self-reported or objective adherence.ConclusionSide effects, reactions to side effects, and self-efficacy may represent modifiable targets through which AET adherence can be improved. Associations between potentially modifiable factors and adherence did not vary by AET type, despite distinct side-effect profiles.

Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults.

Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults.

Real-Time Monitoring and Point-of-Care Testing: A Review of the Current Landscape of PrEP Adherence Monitoring.

BackgroundDespite pre-exposure prophylaxis (PrEP) being highly effective at preventing HIV, HIV infections among individuals prescribed PrEP continue to occur. The vast majority of these new infections occur among individuals with sub-optimal adherence. One factor that is likely to decrease HIV incidence among PrEP users is a real-time, objective measurement of adherence. Monitoring adherence to PrEP can identify those at risk of becoming lost to follow-up and therefore at greater risk of HIV infection, those in need of additional layers of support to overcome barriers to PrEP, and individuals who need enhanced adherence support.ObjectiveThis paper reviews subjective and objective methods for monitoring PrEP including self-report, drug level monitoring (including serum, plasma, peripheral blood mononuclear cells [PBMC], red blood cell dried blood spots [DBS], hair, and urine) and by measuring participant interaction with the study drug (pill counts, medication event monitoring systems [MEMS] caps).Clinical UseA multitude of methods exist for monitoring and supporting adherence. Objective monitoring using DBS and urine will provide a more accurate picture of adherence compared to subjective and non-biomarker objective methods. Preliminary data show that detection of non-adherence using biomarkers, followed by augmented adherence support and counseling, is associated with improved adherence, although more research is needed. PrEP providers will need knowledge of and access to these various strategies, which will require investment and resource allocation from clinics and other PrEP care sites to provide these tools.

Objective measurement of adherence to wearing foot orthoses using an embedded temperature sensor

The objective of this study was to evaluate the validity of a temperature sensor for the measurement of adherence to wearing foot orthoses. Ten participants were provided with foot orthoses containing an embedded temperature sensor and wore the orthoses for a randomly-determined duration over a five-day period. Sensor-detected wear time was compared to a reference standard (objectively measured wear time using a smart-phone application). Ambient temperature and physical activity were recorded with a temperature gauge and wearable activity tracker, respectively. A simple peak detection algorithm which identified the largest one-minute changes in sensor temperature provided highly accurate wear time values (r = 0.999, coefficient of variation=0.2%). Ambient temperature and physical activity did not significantly influence temperature sensor scores. These findings demonstrate that the temperature sensor provides accurate foot orthosis wear time data and may therefore be a useful tool for documenting adherence in clinical practice and intervention studies.

Greater dapivirine release from the dapivirine vaginal ring is correlated with lower risk of HIV-1 acquisition: a secondary analysis from a randomized, placebo-controlled trial.

IntroductionA vaginal ring containing 25 mg of the antiretroviral dapivirine has demonstrated efficacy in reducing women’s risk of sexually acquiring HIV‐1; however, imperfect ring use likely diluted efficacy estimates in clinical trials. The amount of dapivirine remaining in returned rings may reflect the extent of product use, permitting estimation of HIV protection in the context of consistent use.MethodsWe measured the amount of dapivirine in returned rings from a placebo‐controlled trial of the dapivirine vaginal ring conducted between August 2012 and June 2015 among 2629 African women. Phase I/II studies established that greater than 4 mg of dapivirine on average is released from the ring when used consistently over 28 days and ≤0.9 mg released suggested non‐use. We assessed the relative risk reduction associated with levels of ring use using residual dapivirine in returned rings as a time‐dependent covariate for HIV‐1 infection in multivariable Cox models, including multiple exploratory analyses designed to estimate upper limits of efficacy given uncertainty in timing of HIV‐1 acquisition. All models were adjusted for baseline covariates associated with HIV risk and adherence.ResultsResidual dapivirine levels indicating at least some use (>0.9 mg released over a month) were associated with a 48% relative reduction in HIV‐1 acquisition risk (95% confidence interval (CI): 21% to 66%; p = 0.002) compared to the placebo. Exploratory analyses accounting for potential misclassification in timing of HIV‐1 acquisition estimated 75% to 91% HIV‐1 risk reduction with> 4 mg released when compared to placebo. Results limited to the subgroup of women <25 years of age, who tended to have lower adherence, were generally consistent to those overall.ConclusionsResidual dapivirine levels, an objective measure of adherence, were correlated with HIV‐1 protection in a secondary analysis of a randomized trial. Periods of ring use were associated with approximately 50% protection, with exploratory analyses suggesting higher protection with more consistent use. The dapivirine vaginal ring is the first method to fulfil the promise of a fully reversible, long‐acting, woman‐initiated approach for discreet HIV‐1 prevention.

Using prednisolone and cortisol assays to assess adherence in oral corticosteroid dependant asthma: An analysis of test-retest repeatability

Background and objectiveNon-adherence is an important issue within severe asthma. Prednisolone and cortisol assays have been proposed as an inexpensive, objective measure of adherence for oral corticosteroid (OCS)-dependent asthmatics, however, little is known about the reliability of these tests. Methods41 severe OCS-dependent asthmatics had their prednisolone and cortisol measured during six study visits over a three month time period. Subjects were classed as non-adherent/variably-adherent if they had undetectable prednisolone and/or cortisol >100 nmol/L. Intraclass correlation coefficients (ICCs) were used to assess the test-retest reliability of prednisolone and cortisol, and Gwets AC1 kappa was used to assess the reliability of the adherence classification. Mean change in blood eosinophils for adherent and variably/non-adherent visits were calculated and linear regression with cluster-robust standard errors was used to test for differences. Results30 subjects were included in the analysis. Reliability was poor for prednisolone (ICC: 0.43; 95% CI: 0.27, 0.59), and moderate for cortisol (ICC: 0.60; 95% CI: 0.44, 0.74). Using the combined rule, subjects were classified as adherent during 141 (88%) visits, with 21 subjects (70%) adherent during all study visits. The adherence classification had almost perfect reliability (Kappa: 0.84; 95% CI: 0.74, 0.95). Blood eosinophils were decreased by 47 cells/μl (95% CI: 11, 84) during adherent visits but increased by 65 cells/μl (95% CI: 4, 134; Pdifference = 0.03) during variably/non-adherent visits. ConclusionsAssessing adherence to maintenance OCS using a simple rule based on prednisolone and cortisol assays is highly reliable and correlated with blood eosinophil changes. Clinicians should have confidence in the results of this rule.

Sharing Objective Measures of Adherence to a Vaginal Microbicide Promotes Candor About Actual Use and Bolsters Motivation to Prevent HIV.

Discrepancies between self-reported and actual adherence to biomedical HIV interventions is common and in clinical trials can compromise the integrity of findings. One solution is to monitor adherence biomarkers, but it is not well understood how to navigate biomarker feedback with participants. We surveyed 42 counselors and interviewed a subset of 22 to characterize their perspectives about communicating with participants about residual drug levels, an objective marker of adherence, within MTN-025/HOPE, a Phase 3b clinical trial of a vaginal ring to prevent HIV. When biomarkers indicated low drug levels that mismatched high adherence by self-report, counselors encountered barriers to acceptance and comprehension among participants. However, discrepancies between low self-report and higher drug levels generally stimulated candor. Women recollected times they had not used the product and disclosed problems that counselors thought might otherwise have remained forgotten or concealed. Navigating conversations toward HIV prevention was easier at mid-range drug levels and when women indicated motivation to prevent HIV. Ratings of residual drug level offered a somewhat objective measure of adherence and protection that counselors perceived as meaningful to participants and as a valuable catalyst for broaching conversation about HIV prevention. However, communication about drug levels required that counselors navigate emotional barriers, respond skillfully to questions about accuracy, and pivot conversations non-judgmentally away from numerical results and toward the priority of HIV prevention. Findings suggest a role for biomarker feedback in future clinical trials as well as other clinical contexts where biomarkers may be monitored, to motivate disclosure of actual adherence and movement toward HIV prevention.Clinical Trial Number NCT02858037.

A group-based mental health intervention for young people living with HIV in Tanzania: results of a pilot individually randomized group treatment trial

BackgroundIncreasing numbers of young people living with HIV (YPLWH) have unaddressed mental health challenges. Such challenges are associated with poor antiretroviral therapy (ART) adherence and high mortality. Few evidence-based mental health interventions exist to improve HIV outcomes among YPLWH.MethodsThis pilot group treatment trial individually randomized YPLWH from two clinical sites in Tanzania, evaluated acceptability, feasibility, and preliminary effectiveness of a mental health intervention, Sauti ya Vijana (SYV; The Voice of Youth), was compared to the local standard-of-care (SOC) for improving ART adherence and virologic suppression. Enrolled YPLWH were 12–24 years of age and responded to mental health and stigma questionnaires, self-reported adherence, objective adherence measures (ART concentration in hair), and HIV RNA at baseline and 6-months (post-intervention). Feasibility and acceptability were evaluated, and potential effectiveness was assessed by comparing outcomes between arms using mixed effects modeling.ResultsBetween June 2016 and July 2017, 128 YPLWH enrolled; 105 were randomized and 93 (55 in SYV) followed-up at 6-months and were thereby included in this analysis. Mean age was 18.1 years; 51% were female; and 84% were HIV-infected perinatally. Attendance to intervention sessions was 86%; 6-month follow-up was 88%, and fidelity to the protocol approached 100%. Exploratory analyses of effectiveness demonstrated self-reported adherence improved by 7.3 percentage points (95% CI: 2.2, 12.3); and the pooled standard deviation for all ART concentration values increased by 0.17 units (95% CI: − 0.52, 0.85) in the SYV arm compared to SOC. Virologic suppression rates (HIV RNA < 400 copies/mL) at baseline were 65% in both arms but increased to 75% in the SYV arm while staying the same in the SOC arm (RR 1.13; 95% CI: 0.94, 1.36).ConclusionsYPLWH often have poor HIV outcomes, making interventions to improve outcomes in this population critical. This pilot trial of the Tanzania-based SYV intervention demonstrated trends towards improvement in ART adherence and virologic outcomes among YPLWH, supporting efforts to scale the intervention into a fully-powered effectiveness trial.Trial registrationClinicalTrials.gov Identifier: NCT02888288. Registered August 9, 2016. Retrospectively registered as first participant enrolled June 16, 2016.

Client-Centered Adherence Counseling with Adherence Measurement Feedback to Support Use of the Dapivirine Ring in MTN-025 (The HOPE Study)

Fostering adherence and open communication about adherence challenges is key to harnessing the potential of biomedical HIV prevention products. We describe the counseling intervention and objective adherence measure feedback process implemented to support adherence to the dapivirine vaginal ring among participants in four sub-Saharan countries and present findings on the counselors' likeability andacceptability of the intervention. Most counselors (N = 42; 86%) liked Options counseling "very much" and during in-depth interviews (N = 22), reported that the intervention reshaped their adherence counselling approach by emphasizing understanding participants' experiences using the ring, which facilitated open discussion of adherence challenges. Counselors found that reframing residual drug level (RDL) discussions from the "adherence" to "protection" perspective encouraged adherence among consistent users and facilitated decisions to switch to a different HIV prevention approach among infrequent users. Among counselors, 24% said participants "liked it very much" while 26% said that participants "liked it a little" possibly due to two main complaints: perceived repetitiousness of sessions and variability in the RDL assay, which at times resulted in unexpected low RDLs.

Racial disparities in positive airway pressure therapy adherence among veterans with obstructive sleep apnea.

Black individuals are disproportionately affected by diabetes, cardiovascular disease, obesity, and OSA. Adherence to PAP therapy has been reported to be lower among black individuals. This study seeks to examine associations between black race and PAP adherence among veterans with OSA. This was a retrospective study. Veterans newly diagnosed with OSA at a single Department of Veterans Affairs sleep center who were prescribed a modem-enabled PAP device between January 2015 and November 2017 were enrolled. PAP adherence was defined as ≥ 4 hours nightly usage for at least 70% of nights measured at 30 days from PAP setup. We examined the relationship between race and adherence, controlling for sex, marital status, age, socioeconomic status, residual apnea-hypopnea index), and mask leak. Of 3013 patients identified with OSA, 2571 (85%) were newly started on PAP therapy (95% male, aged 59 years ± 14 years, 45% married, 8% with neighborhood socioeconomic disadvantage). Twenty-five percent of participants were black, and 57% were white. PAP adherence at 30 days was 50% overall (42% among blacks, 53% among nonblacks). Black race was associated with reduced 30-day PAP adherence in unadjusted (P < .001) and adjusted logistic regression models (odds ratio = 0.64; 95% CI, 0.53 - 0.78; P < .001). Among veterans with OSA, black race was associated with reduced PAP adherence. These findings suggest health inequality among black individuals in the treatment of OSA.