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Individualized texting for adherence building (iTAB) for methamphetamine users living with HIV: A pilot randomized clinical trial.

ABSTRACT: BACKGROUND:Methamphetamine (METH) use poses a barrier to antiretroviral therapy (ART) adherence. We evaluated the efficacy of the individualized texting for adherence building (iTAB) intervention among persons living with HIV (PLWH) who meet criteria for METH use disorder. We examined daily associations between ART adherence and text-reported METH use and depressed mood. METHODS:We conducted a single site, 2-arm, 6-week, pilot randomized clinical trial comparing a personalized, bidirectional, text messaging system (iTAB; n?=?50) to an active control condition (n?=?25). All participants received adherence psychoeducation and daily texts assessing METH use and depressed mood. The iTAB group received personalized daily ART reminder texts. ART adherence was monitored using Medication Event Monitoring System (MEMS) caps. RESULTS:Response rates to daily ART reminder texts were high (79%), with good concordance between MEMS-derived and text-reported ART adherence (p?

SUBMITTER: Moore DJ

PROVIDER: S-EPMC6324532 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Individualized texting for adherence building (iTAB) for methamphetamine users living with HIV: A pilot randomized clinical trial.

Moore David J DJ Pasipanodya Elizabeth C EC Umlauf Anya A Rooney Alexandra S AS Gouaux Ben B Depp Colin A CA Atkinson J Hampton JH Montoya Jessica L JL

Drug and alcohol dependence 20180621

<h4>Background</h4>Methamphetamine (METH) use poses a barrier to antiretroviral therapy (ART) adherence. We evaluated the efficacy of the individualized texting for adherence building (iTAB) intervention among persons living with HIV (PLWH) who meet criteria for METH use disorder. We examined daily associations between ART adherence and text-reported METH use and depressed mood.<h4>Methods</h4>We conducted a single site, 2-arm, 6-week, pilot randomized clinical trial comparing a personalized, bi ...[more]

PMID: 29958127

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Project description:IntroductionAchieving optimal adherence to antiretroviral therapy (ART) among adolescents living with HIV (ALWHIV) is challenging, especially in low-resource settings. To help accurately determine who is at risk of poor adherence, we developed and internally validated models comprising multi-level factors that can help to predict the individualized risk of poor adherence among ALWHIV in a resource-limited setting such as Uganda.MethodsWe used data from a sample of 637 ALWHIV in Uganda who participated in a longitudinal study, "Suubi+Adherence" (2012 to 2018). The model was developed using the Least Absolute Shrinkage and Selection Operator (LASSO) penalized regression to select the best subset of multi-level predictors (individual, household, community or economic-related factors) of poor adherence in one year's time using 10-fold cross-validation. Seventeen potential predictors included in the model were assessed at 36 months of follow-up, whereas adherence was assessed at 48 months of follow-up. Model performance was evaluated using discrimination and calibration measures.ResultsFor the model predicting poor adherence, five of the 17 predictors (adherence history, adherence self-efficacy, family cohesion, child poverty and group assignment) were retained. Its ability to discriminate between individuals with and without poor adherence was acceptable; area under the curve (AUC) = 69.9; 95% CI: 62.7, 72.8. There was no evidence of possible areas of miscalibration (test statistic = 1.20; p = 0.273). The overall performance of the model was good.ConclusionsOur findings support prediction modelling as a useful tool that can be leveraged to improve outcomes across the HIV care continuum. Utilizing information from multiple sources, the risk prediction score tool applied here can be refined further with the ultimate goal of being used in a screening tool by practitioners working with ALWHIV. Specifically, the tool could help identify and provide early interventions to adolescents at the highest risk of poor adherence and/or viral non-suppression. However, further fine-tuning and external validation may be required before wide-scale implementation.

Project description:Tenofovir diphosphate (TFV-DP) concentrations measured with dried blood spots (DBS) can be used to classify adherence to emtricitabine/tenofovir disoproxil fumarate (F/TDF) for HIV pre-exposure prophylaxis (PrEP). A TFV-DP of 700 fmol/punch was previously associated with high PrEP efficacy, and was estimated to represent ≥4 doses/week on average. However, interindividual variability in TFV-DP concentrations may lead to adherence misclassification and decrease the precision of adherence-efficacy relationships. The purpose of this analysis was to evaluate sources of TFV-DP variability to improve the precision of TFV-DP for adherence assessments by incorporating individual characteristics. Data and samples from a 36-week study of TFV-DP in DBS, collected biweekly, among 48 HIV-negative volunteers (25 Females/26 Caucasian/10 African American/14 Hispanic) receiving F/TDF at 33%, 67%, and 100% of daily dosing under directly observed therapy were used for analysis. The simplest pharmacokinetic model to describe TFV-DP accumulation with acceptable performance was a one-compartment constant input model. Covariates, including laboratory values and demographics were ranked in importance of their association with post hoc pharmacokinetic (PK) parameters using random forest analyses. Weight and platelet count were included in the final model and simulations were conducted to generate benchmarks for <2, 2-3, 4-5, and 6-7 doses/week. Based on these simulations, the previously established protective TFV-DP concentration of ≥700 fmol/punch was observed in those taking 2-3 (in individuals ≤110 kg) and ≥4 (in individuals >110 kg) doses/week, amounting to a much lower rate of misspecification (17% vs. 30%) with this individualized model versus previous interpretations. Incorporating body weight and platelet count improved the precision of TFV-DP concentrations for adherence assessments. Previous benchmarks were conservative, indicating that the pharmacological forgiveness of F/TDF may be higher than currently recognized and supports continued investigation of intermittent PrEP dosing regimens. Clinical Trial Registration number, NCT02022657.

Dataset Information

Individualized texting for adherence building (iTAB) for methamphetamine users living with HIV: A pilot randomized clinical trial.

Publications

Individualized texting for adherence building (iTAB) for methamphetamine users living with HIV: A pilot randomized clinical trial.

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