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Phone-delivered mindfulness training to promote medication adherence and reduce sexual risk behavior among persons living with HIV: Design and methods.

ABSTRACT: Two-thirds of people living with HIV (PLWH) show sub-optimal adherence to antiretroviral therapy (ART) and one-third engages in risky sex. Both non-adherence and risky sex have been associated with emotional distress and impulsivity. To allay distress and lessen impulsivity, mindfulness training (MT) can be helpful. In this trial, we will investigate the utility of phone-delivered MT for PWLH. The primary outcomes comprise feasibility and acceptability of phone-delivery; secondary outcomes are estimates of efficacy of MT on adherence to ART and safer sexual practices as well as on their hypothesized antecedents.Fifty participants will be enrolled in this parallel-group randomized clinical trial (RCT). Outpatients recruited from an HIV treatment clinic will be randomized (1:1 ratio) to either MT or to an attention-control intervention; both interventions will be administered during 8 weekly phone calls. ART adherence (self-reported measure and unannounced phone pill counts), sexual behavior (self-reports and biomarkers), mindfulness, depression, stress, and impulsivity will be measured at baseline, post-intervention, and 3months post-intervention.MT has great potential to help PLWH to manage stress, depressive symptoms, and impulsivity. Positive changes in these antecedents are expected to improve safer sex practices and ART adherence. If results from this exploratory trial support our hypotheses, we will conduct a large RCT to test (a) the efficacy of MT on ART adherence and safer sex practices and (b) the hypothesis that improved ART adherence and safer sex will reduce viral load, and decrease the incidence of sexually transmitted infections, respectively.

SUBMITTER: Salmoirago-Blotcher E

PROVIDER: S-EPMC5274627 | biostudies-other | 2017 Feb

REPOSITORIES: biostudies-other

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Phone-delivered mindfulness training to promote medication adherence and reduce sexual risk behavior among persons living with HIV: Design and methods.

Salmoirago-Blotcher Elena E Rich Carla C Rosen Rochelle K RK Dunsiger Shira S Rana Aadia A Carey Michael P MP

Contemporary clinical trials 20161223

<h4>Introduction</h4>Two-thirds of people living with HIV (PLWH) show sub-optimal adherence to antiretroviral therapy (ART) and one-third engages in risky sex. Both non-adherence and risky sex have been associated with emotional distress and impulsivity. To allay distress and lessen impulsivity, mindfulness training (MT) can be helpful. In this trial, we will investigate the utility of phone-delivered MT for PWLH. The primary outcomes comprise feasibility and acceptability of phone-delivery; sec ...[more]

PMID: 28017907

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Project description:High levels of adherence to medications for HIV infection are essential for optimal clinical outcomes and to reduce viral transmission, but many patients do not achieve required levels. Clinician-delivered interventions can improve patients' adherence, but usually require substantial effort by trained individuals and may not be widely available. Computer-delivered interventions can address this problem by reducing required staff time for delivery and by making the interventions widely available via the Internet. We previously developed a computer-delivered intervention designed to improve patients' level of health literacy as a strategy to improve their HIV medication adherence. The intervention was shown to increase patients' adherence, but it was not clear that the benefits resulting from the increase in adherence could justify the costs of developing and deploying the intervention. The purpose of this study was to evaluate the relation of development and deployment costs to the effectiveness of the intervention.Costs of intervention development were drawn from accounting reports for the grant under which its development was supported, adjusted for costs primarily resulting from the project's research purpose. Effectiveness of the intervention was drawn from results of the parent study. The relation of the intervention's effects to changes in health status, expressed as utilities, was also evaluated in order to assess the net cost of the intervention in terms of quality adjusted life years (QALYs). Sensitivity analyses evaluated ranges of possible intervention effectiveness and durations of its effects, and costs were evaluated over several deployment scenarios.The intervention's cost effectiveness depends largely on the number of persons using it and the duration of its effectiveness. Even with modest effects for a small number of patients the intervention was associated with net cost savings in some scenarios and for durations greater than three months and longer it was usually associated with a favorable cost per QALY. For intermediate and larger assumed effects and longer durations of intervention effectiveness, the intervention was associated with net cost savings.Computer-delivered adherence interventions may be a cost-effective strategy to improve adherence in persons treated for HIV.Clinicaltrials.gov identifier NCT01304186.

Project description:BackgroundCurrently, various phone apps have been developed to assist patients. Many of these apps are developed to assist patients in the self-management of chronic diseases such as diabetes. It is essential to analyze these various apps to understand the key features that would potentially be instrumental in helping patients successfully achieve goals in disease self-management.ObjectiveThe objective of this study was to conduct a review of all the available diabetes-related apps in the iOS App Store to evaluate which diabetic app is more interactive and offers a wide variety of operations such as monitoring glucose, water, carbohydrate intake, weight, body mass index (BMI), medication, blood pressure (BP) levels, reminders or push notifications, food database, charts, exercise management, email, sync between devices, syncing data directly to the prescribers, and other miscellaneous functions such as (Twitter integration, password protection, retina display, barcode scanner, apple watch functionality, and cloud syncing).MethodsData was gathered using the iOS App Store on an iPad. The search term "diabetes" resulted in 1209 results. Many of the results obtained were remotely related to diabetes and focused mainly on diet, exercise, emergency services, refill reminders, providing general diabetes information, and other nontherapeutic options. We reviewed each app description and only included apps that were meant for tracking blood glucose levels. All data were obtained in one sitting by one person on the same device, as we found that carrying out the search at different times or on different devices (iPhones) resulted in varying results. Apps that did not have a feature for tracking glucose levels were excluded from the study.ResultsThe search resulted in 1209 results; 85 apps were retained based on the inclusion criteria mentioned above. All the apps were reviewed for average customer ratings, number of reviews, price, and functions. Of all the apps surveyed, 18 apps with the highest number of user ratings were used for in-depth analysis. Of these 18 apps, 50% (9/18) also had a medication adherence function. Our analysis revealed that the Diabetes logbook used by the mySugr app was one of the best; it differentiated itself by introducing fun as a method of increasing adherence.ConclusionsA large variation was seen in patient ratings of app features. Many patient reviewers desired simplicity of app functions. Glucose level tracking and email features potentially helped patients and health care providers manage the disease more efficiently. However, none of the apps could sync data directly to the prescribers. Additional features such as graph customization, availability of data backup, and recording previous entries were also requested by many users. Thus, the use of apps in disease management and patient and health-care provider involvement in future app refinement and development should be encouraged.

Project description:BACKGROUND:With the accessibility and widespread use of mobile phones, mobile phone apps targeting medication adherence may be useful tools to help patients take medications as prescribed. OBJECTIVE:Our objectives were to (1) characterize and assess mobile phone medication adherence apps guided by a conceptual framework on the focus of adherence interventions and (2) conduct a content analysis of Web-based reviews to explore users' perspectives and experiences with mobile phone medication adherence apps. METHODS:We searched for mobile phone medication adherence apps using keyword searches in Apple and Android operating systems. We characterized all apps in terms of number of downloads, ratings, languages, cost, and disease target. We categorized apps according to 4 key features of (1) alerting to take medication, (2) tracking medication taking, (3) reminding to refill or indicating amount of medication left, and (4) storing medication information. We then selected representative apps from each operating system for detailed quality assessment and user testing. We also downloaded Web-based reviews for these selected apps and conducted a qualitative content analysis using an inductive approach involving steps of initial open coding, construction of categories, and abstraction into themes. RESULTS:We identified 704 apps (443 from Apple and 261 from Android). The majority of apps across both operating systems had 1 or 2 features-specifically, 37.2% (165/443) and 38.1% (169/443) of Apple apps, respectively, and 41.4% (108/261) and 31.4% (108/261) of Android apps, respectively. Quality assessment and user testing of 20 selected apps revealed apps varied in quality and commonly focused on behavioral strategies to enhance medication adherence through alerts, reminders, and logs. A total of 1323 eligible Web-based reviews from these 20 selected apps were analyzed, and the following themes emerged: (1) features and functions appreciated by users, which included the ability to set up customized medication regimen details and reminders, monitor other health information (eg, vitals, supplements, and manage multiple people or pets), support health care visits (eg, having a list of medications and necessary health information in 1 app); (2) negative user experiences that captured technical difficulties (glitches, confusing app navigation, and poor interoperability), dosage schedule, and reminder setup inflexibility; and (3) desired functions and features related to optimization of information input, improvement of reminders, and upgrading app performance (better synchronization or backup of data and interoperability). CONCLUSIONS:A large number of mobile phone medication adherence apps are currently available. The majority of apps have features representing a behavioral approach to intervention. Findings of the content analysis offer mostly positive feedback as well as insights into current limitations and improvements that could be addressed in current and future medication adherence apps.

Project description:BackgroundDespite the abundant availability of effective medication adherence interventions, uptake of these interventions into routine care often lacks. Examples of effective medication adherence interventions include telephone counseling, consult preparation and the teach-back method. Assessing context is an important step in understanding implementation success of interventions, but context is often not reported or only moderately described. This study aims to describe context-specific characteristics in four living labs prior to the implementation of evidence-based interventions aiming to improve medication adherence.MethodsA qualitative study was conducted within four living labs using individual interviews (n = 12) and focus groups (n = 4) with project leaders and involved healthcare providers. The four living labs are multidisciplinary collaboratives that are early adopters of medication adherence interventions in the Dutch primary care system. Context is defined as the environment or setting in which the proposed change is to be implemented. Interview topics to assess context were formulated based on the 'inner setting' and 'outer setting' domains of the Consolidated Framework for Implementation Research (CFIR). Interviews were recorded and transcribed verbatim. Transcripts were deductively analyzed.ResultsA total of 39 community pharmacists, pharmacy technicians, general practitioners and a home care employee participated in the (focus group) interviews. All four living labs proved to be pharmacy-driven and characterized by a high regard for innovation by staff members, a positive implementation climate, high levels of leadership engagement and high compatibility between the living labs and the interventions. Two living labs were larger in size and characterized by more formal communication. Two living labs were characterized by higher levels of cosmopolitanism which resulted in more adaptable interventions. Worries about external policy, most notably lack of reimbursement for sustainment and upscaling of the interventions, were shared among all living labs.ConclusionsContextual characteristics of four living labs that are early adopters of medication adherence interventions provide detailed examples of a positive implementation setting. These can be used to inform dissemination of medication adherence interventions in settings less experienced in implementing medication adherence interventions.

Dataset Information

Phone-delivered mindfulness training to promote medication adherence and reduce sexual risk behavior among persons living with HIV: Design and methods.

Publications

Phone-delivered mindfulness training to promote medication adherence and reduce sexual risk behavior among persons living with HIV: Design and methods.

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