The adherence‐outcome relationship is not altered by diary‐driven adjustments of microelectronic monitor data

Abstract

Purpose The purpose of this study was to determine whether diary-driven adjustment of Medication Event Monitoring System (MEMS) data based on supplementary information strengthens the relationship between measured antiretroviral medication adherence and plasma HIV viral load (VL). Methods HIV+ adolescents on antiretroviral treatment were monitored with MEMS for 30 days preceding a VL measurement. The primary outcome was VL ≥400 copies/ml. Handwritten diaries were used to comprehensively record deviations from recommended use (bottle opened but dose not taken or bottle not opened and dose taken). Data were adjusted (“cleaned”) based on diary events. Data were “capped” at the prescribed number of doses/day. Receiver operator characteristic analysis compared the relationships between 1) Raw MEMS data, 2) diary-cleaned, 3) capped, or 4) cleaned and capped MEMS data and VL. Results Over 30 days preceding VL measurements, 273 adolescents had 465 diary events. Capping resulted in fewer patients classified as 95% adherent (65.2%) compared to raw data (71.4%), p<0.001. Adherence was highly associated with VL (OR 1.05, p<0.001). The area under the ROC curve for continuous adherence compared to VL was 0.89 (95% CI: 0.82 – 0.95). Neither diary-cleaning, capping, nor cleaning and capping MEMS data significantly altered the association between adherence and VL (p = 0.14, 0.40, and 0.19, respectively). Conclusion MEMS data-cleaning based on diary entries did not affect the adherence-VL relationship.

Distinctive barriers to antiretroviral therapy adherence among non-adherent adolescents living with HIV in Botswana

“…Defining adolescents’ adherence patterns to allow for purposive sampling for this qualitative study was one of the a priori reasons for establishing the longitudinal cohort. Other aims included describing changes in adherence over time across the adolescent age spectrum, identifying potentially modifiable risk factors for poor adherence, and elucidating the utility of different adherence monitoring strategies in adolescents on ART (Eby et al, 2015; Ioannides et al, 2016; Lowenthal, Marukutira, Tshume, Chapman, Anabwani, et al, 2015; Lowenthal, Marukutira, Tshume, Chapman, Nachega, et al, 2015; Okatch et al, 2016). “Adherent” adolescents maintained HIV virologic suppression during 12 month follow-up with quarterly viral load measurements and maintained at least 95% adherence by all adherence measures at all time points (self-report based on 4-day recall, parent-report based on 4-day recall, pill count, medication:possession ratio, and Medication Event Monitoring System (MEMS) microelectronic medication cap data).…”

Adherence to antiretroviral therapy in a clinical cohort of HIV-infected children in East Africa

“…Other studies in sub-Saharan Africa have been able to prospectively measure adherence with more intensive and typically more valid methods, but these evaluations usually involve smaller numbers of children and collect adherence data prospectively for research. Such methods include home-based pill counts [ 35 , 40 ], clinic-based pill counts [ 39 ], medication event monitoring systems (MEMS®) [ 36 , 42 , 43 ], plasma drug concentrations [ 38 ] and hair drug concentrations [ 41 ]. Few treatment programs in sub-Saharan Africa have been able to report on children’s adherence over the long-term or within large cohorts.…”

Measuring patient engagement with HIV care in sub‐Saharan Africa: a scoping study

“…Many studies attempted to find or evaluate “more objective” measures of adherence to overcome the social desirability and recall biases associated with self‐reported measures [ 4 , 82 , 93 , 136 ], which may result in overestimation of adherence [ 10 , 72 , 84 ]. Some measures were considered more objective than self‐reports [ 55 , 62 , 75 , 79 , 159 ], but even these remain indirect measures of behaviour taking place outside the facility [ 55 ]: laboratory tests use changes associated with ART as proxies [ 81 , 87 ], pill counts measure whether pills were removed from the bottle rather than if they were taken [ 55 ] and pharmacy refills reflect a maximum possible level of adherence through ART on hand, leading to possible overestimation of “true” adherence [ 2 , 93 ]. Antiretroviral concentrations were considered to quantify adherence independent of other influences such as resistance [ 10 ] and were often used as an “objective” gold standard to compare other measures of adherence against [ 160 ].…”