Wearable Sensor-Based Detection of Influenza in Presymptomatic and Asymptomatic Individuals.

BACKGROUND: The COVID-19 pandemic highlighted the need for early detection of viral infections in symptomatic and asymptomatic individuals to allow for timely clinical management and public health interventions. METHODS: Twenty healthy adults were challenged with an influenza A (H3N2) virus and prospectively monitored from 7 days before through 10 days after inoculation, using wearable electrocardiogram and physical activity sensors. This framework allowed for responses to be accurately referenced to the infection event. For each participant, we trained a semisupervised multivariable anomaly detection model on data acquired before inoculation and used it to classify the postinoculation dataset. RESULTS: Inoculation with this challenge virus was well-tolerated with an infection rate of 85%. With the model classification threshold set so that no alarms were recorded in the 170 healthy days recorded, the algorithm correctly identified 16 of 17 (94%) positive presymptomatic and asymptomatic individuals, on average 58 hours postinoculation and 23 hours before the symptom onset. CONCLUSIONS: The data processing and modeling methodology show promise for the early detection of respiratory illness. The detection algorithm is compatible with data collected from smartwatches using optical techniques but needs to be validated in large heterogeneous cohorts in normal living conditions. Clinical Trials Registration. NCT04204493.

Supporting informed clinical trial decisions: Results from a randomized controlled trial evaluating a digital decision support tool for those with intellectual disability.

BACKGROUND: Informed consent requires that individuals understand the nature of the study, risks and benefits of participation. Individuals with intellectual disabilities (ID) have cognitive and adaptive impairments that may affect their ability to provide informed consent. New treatments and clinical trials for fragile X syndrome, the most commonly known inherited cause of ID, necessitate the development of methods to improve the informed consent process. The goal of this study was to compare the efficacy of a digital decision support tool with that of standard practice for informed consent and to examine whether the tool can improve decisional capacity for higher functioning individuals. METHODS: Participants (N = 89; mean age = 21.2 years) were allocated to the experimental group (consenting information provided via the digital decision support tool), or the comparison group (information provided via standard practice). Participants were assessed on four aspects of decisional capacity (Understanding, Appreciating, Reasoning, and Expressing a choice). We used regression analyses to test the impact of the tool on each outcome, repeating the analyses on the higher functioning subsample. RESULTS: No differences existed in any domain of decisional capacity for the sample in full. However, participants in the higher IQ subsample who used the tool scored better on Understanding after adjustment (ß = 0.25, p = 0.04), but not on Appreciating or Reasoning. No differences by experimental group existed in the decision to join the hypothetical trial for the full sample or higher functioning subsample. CONCLUSIONS: A decision support tool shows promise for individuals with fragile X syndrome with higher cognitive abilities. Future studies should examine the level of cognitive ability needed for sufficient understanding, whether these findings can be translated to other clinical populations, and the impact of the tool in larger trials and on trial retention.

Implementing Web-Based Interventions in HIV Primary Care Clinics: Pilot Implementation Evaluation of Positive Health Check.

BACKGROUND: Web-based interventions can help people living with HIV achieve better clinical outcomes and behaviors, but integrating them into clinical practice remains challenging. There is a gap in understanding the feasibility of implementing these interventions in HIV clinic settings from the clinicians' perspective. OBJECTIVE: The goal of the research was to determine whether Positive Health Check (PHC)-a Web-based, tailored video counseling tool focused on increasing patient adherence and retention in care and reducing HIV risk among HIV-positive patients-was acceptable, appropriate, and feasible for HIV primary care clinic staff to implement in clinic workflows. METHODS: A multiple-case study design was used to evaluate the pilot implementation. Four primary care clinics located in the southeastern United States implemented PHC over a 1-month period. Nine clinic staff across the clinics participated in structured interviews before, during, and after the implementation. In total, 54 interviews were conducted. We used a framework analysis approach to code the data and identify themes related to implementation outcomes, including acceptability, appropriateness, and feasibility. We also analyzed patient intervention use metrics (n=104) to quantify patient intervention completion rates (n=68). RESULTS: Overall, clinicians viewed PHC as acceptable and appropriate. Themes that emerged related to these implementation outcomes include the ability for PHC to increase provider-patient communication and its ability to engage patients due to the tailored and interactive design. While generally feasible to implement, challenges to the clinic workflow and physical environment were areas that clinics needed to manage to make PHC work in their clinics. CONCLUSIONS: Findings from this pilot implementation suggest that clinical staff viewed PHC as acceptable and appropriate, especially as more patients used the intervention over the pilot period. Feasibility of implementation was challenging in some cases, and lessons learned from this pilot implementation can provide information for larger scale tests of the intervention that include assessment of both implementation outcomes and clinical outcomes.

A Digital Health App to Assess Decisional Capacity to Provide Informed Consent: Protocol for a Randomized Controlled Trial.

BACKGROUND: Any study with human subjects must have a robust consent process to ensure that participants understand the study and can decide whether they want to be involved. Investigators must determine whether a potential study participant is able to make an informed decision and what modifications or supports are needed to maximize participation in decision making. A variety of approaches have been used to modify consent forms and the consent process to increase the research participants' decisional capacity. This protocol describes a randomized controlled trial (RCT) of a digital health app to support decision making among individuals contemplating providing consent to participate in a clinical trial. OBJECTIVE: The objective of this RCT will be to determine if the use of a tablet-based app facilitates greater participation in and satisfaction with the consent process compared with standard practice and identify which individual factors are associated with better response to the decision aid. We hypothesize that the tablet-based version of the consent process will promote more informed decision making, including decisions that are more consistent with individual preferences and values expressed during qualitative data collection. METHODS: A two-arm RCT will be conducted in a sample of approximately 100 individuals with fragile X syndrome in their homes across the United States. RESULTS: Data analysis will be completed by late 2018. CONCLUSIONS: By developing and testing a novel consent decision aid, we will have a better understanding of whether and how technological support can optimize the fit between the decisional capacity and the decisional process. TRIAL REGISTRATION: ClinicalTrials.gov NCT02465931; https://clinicaltrials.gov/ct2/show/NCT02465931 (Archived by WebCite at http://www.webcitation.org/72Q3xJQAw). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/10360.

A Digital Decision Support Tool to Enhance Decisional Capacity for Clinical Trial Consent: Design and Development.

BACKGROUND: Challenges in the clinical and research consent process indicate the need to develop tailored, supportive interventions for all individuals, especially those with limited decisional capacity. We developed a tool to enhance shared decision making and the decisional capacity for individuals with fragile X syndrome engaged in the informed consent process for a clinical trial. OBJECTIVE: We describe the design and development process of a tablet-based decision support tool. METHODS: Our development process for the decision support tool employed a user-centered, feature-driven design approach. We began with an environmental scan to catalog relevant mobile apps, and we conducted interviews with people with a diagnosis of fragile X syndrome and clinicians at fragile X syndrome clinics. To develop content for the decision support tool, we extracted key concepts and elements from a real clinical trial consent form and rewrote it using plain-language principles. RESULTS: We used iterative testing to continuously evaluate and revise the decision support tool content. The tool was finalized in 2016 and contained a series of vignettes, quiz questions, and a sorting activity. A randomized controlled trial was then conducted to compare the efficacy of the decision support tool with a standard verbal presentation of material that mimicked typical informed consent practice. CONCLUSIONS: The informed consent process is primed to leverage digital health resources that promote increased understanding and engagement of research participants in the consent and research process. The process and experiences we describe may provide a model for other digital health design and development initiatives seeking to create more interactive and accessible decision support resources. TRIAL REGISTRATION: ClinicalTrials.gov NCT02465931; https://www.clinicaltrials.gov/ct2/show/NCT02465931 (Archived by WebCite at http://www.webcitation.org/6zx2KY9YW).

Establishing Linkages Between Distributed Survey Responses and Consumer Wearable Device Datasets: A Pilot Protocol.

BACKGROUND: As technology increasingly becomes an integral part of everyday life, many individuals are choosing to use wearable technology such as activity trackers to monitor their daily physical activity and other health-related goals. Researchers would benefit from learning more about the health of these individuals remotely, without meeting face-to-face with participants and avoiding the high cost of providing consumer wearables to participants for the study duration. OBJECTIVE: The present study seeks to develop the methods to collect data remotely and establish a linkage between self-reported survey responses and consumer wearable device biometric data, ultimately producing a de-identified and linked dataset. Establishing an effective protocol will allow for future studies of large-scale deployment and participant management. METHODS: A total of 30 participants who use a Fitbit will be recruited on Mechanical Turk Prime and asked to complete a short online self-administered questionnaire. They will also be asked to connect their personal Fitbit activity tracker to an online third-party software system, called Fitabase, which will allow access to 1 month's retrospective data and 1 month's prospective data, both from the date of consent. RESULTS: The protocol will be used to create and refine methods to establish linkages between remotely sourced and de-identified survey responses on health status and consumer wearable device data. CONCLUSIONS: The refinement of the protocol will inform collection and linkage of similar datasets at scale, enabling the integration of consumer wearable device data collection in cross-sectional and prospective cohort studies.

A Mobile Clinical Decision Support Tool for Pediatric Cardiovascular Risk-Reduction Clinical Practice Guidelines: Development and Description.

BACKGROUND: Widespread application of research findings to improve patient outcomes remains inadequate, and failure to routinely translate research findings into daily clinical practice is a major barrier for the implementation of any evidence-based guideline. Strategies to increase guideline uptake in primary care pediatric practices and to facilitate adherence to recommendations are required. OBJECTIVE: Our objective was to operationalize the US National Heart, Lung, and Blood Institute's Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents into a mobile clinical decision support (CDS) system for healthcare providers, and to describe the process development and outcomes. METHODS: To overcome the difficulty of translating clinical practice guidelines into a computable form that can be used by a CDS system, we used a multilayer framework to convert the evidence synthesis into executable knowledge. We used an iterative process of design, testing, and revision through each step in the translation of the guidelines for use in a CDS tool to support the development of 4 validated modules: an integrated risk assessment; a blood pressure calculator; a body mass index calculator; and a lipid management instrument. RESULTS: The iterative revision process identified several opportunities to improve the CDS tool. Operationalizing the integrated guideline identified numerous areas in which the guideline was vague or incorrect and required more explicit operationalization. Iterative revisions led to workable solutions to problems and understanding of the limitations of the tool. CONCLUSIONS: The process and experiences described provide a model for other mobile CDS systems that translate written clinical practice guidelines into actionable, real-time clinical recommendations.

Biometrics and Policing: A Protocol for Multichannel Sensor Data Collection and Exploratory Analysis of Contextualized Psychophysiological Response During Law Enforcement Operations.

BACKGROUND: Stress experienced by law enforcement officers is often extreme and is in many ways unique among professions. Although past research on officer stress is informative, it is limited, and most studies measure stress using self-report questionnaires or observational studies that have limited generalizability. We know of no research studies that have attempted to track direct physiological stress responses in high fidelity, especially within an operational police setting. The outcome of this project will have an impact on both practitioners and policing researchers. To do so, we will establish a capacity to obtain complex, multisensor data; process complex datasets; and establish the methods needed to conduct idiopathic clinical trials on behavioral interventions in similar contexts. OBJECTIVE: The objective of this pilot study is to demonstrate the practicality and utility of wrist-worn biometric sensor-based research in a law enforcement agency. METHODS: We will use nonprobability convenience-based sampling to recruit 2-3 participants from the police department in Durham, North Carolina, USA. RESULTS: Data collection was conducted in 2016. We will analyze data in early 2017 and disseminate our results via peer reviewed publications in late 2017. CONCLUSIONS: We developed the Biometrics & Policing Demonstration project to provide a proof of concept on collecting biometric data in a law enforcement setting. This effort will enable us to (1) address the regulatory approvals needed to collect data, including human participant considerations, (2) demonstrate the ability to use biometric tracking technology in a policing setting, (3) link biometric data to law enforcement data, and (4) explore project results for law enforcement policy and training.

ActiviTeen: A Protocol for Deployment of a Consumer Wearable Device in an Academic Setting.

BACKGROUND: Regular physical activity (PA) can be an important indicator of health across an individual's life span. Consumer wearables, such as Fitbit or Jawbone, are becoming increasingly popular to track PA. With the increased adoption of activity trackers comes the increased generation of valuable individual-based data. Generated data has the potential to provide detailed insights into the user's behavior and lifestyle. OBJECTIVE: The primary objective of the described study is to evaluate the feasibility of individual data collection from the selected consumer wearable device (the Fitbit Zip). The rate of user attrition and barriers preventing the use of consumer wearable devices will also be evaluated as secondary objectives. METHODS: The pilot study will occur in two stages and employs a long-term review and analysis with a convenience sample of 30 students attending Research Triangle High School. For the first stage, students will initially be asked to wear the Fitbit Zip over the course of 4 weeks. During which time, their activity data and step count will be collected. Students will also be asked to complete a self-administered survey at the beginning and conclusion of the first stage. The second stage will continue to collect students' activity data and step count over an additional 3-month period. RESULTS: We are anticipating results for this study by the end of 2016. CONCLUSION: This study will provide insight into the data collection procedures surrounding consumer wearable devices and could serve as the future foundation for other studies deploying consumer wearable devices in educational settings.

Supporting Tablet Configuration, Tracking, and Infection Control Practices in Digital Health Interventions: Study Protocol.

BACKGROUND: Tablet-based health care interventions have the potential to encourage patient care in a timelier manner, allow physicians convenient access to patient records, and provide an improved method for patient education. However, along with the continued adoption of tablet technologies, there is a concomitant need to develop protocols focusing on the configuration, management, and maintenance of these devices within the health care setting to support the conduct of clinical research. OBJECTIVE: Develop three protocols to support tablet configuration, tablet management, and tablet maintenance. METHODS: The Configurator software, Tile technology, and current infection control recommendations were employed to develop three distinct protocols for tablet-based digital health interventions. Configurator is a mobile device management software specifically for iPhone operating system (iOS) devices. The capabilities and current applications of Configurator were reviewed and used to develop the protocol to support device configuration. Tile is a tracking tag associated with a free mobile app available for iOS and Android devices. The features associated with Tile were evaluated and used to develop the Tile protocol to support tablet management. Furthermore, current recommendations on preventing health care-related infections were reviewed to develop the infection control protocol to support tablet maintenance. RESULTS: This article provides three protocols: the Configurator protocol, the Tile protocol, and the infection control protocol. CONCLUSIONS: These protocols can help to ensure consistent implementation of tablet-based interventions, enhance fidelity when employing tablets for research purposes, and serve as a guide for tablet deployments within clinical settings.

Usability Testing and Adaptation of the Pediatric Cardiovascular Risk Reduction Clinical Decision Support Tool.

BACKGROUND: Cardiovascular disease (CVD) is 1 of the leading causes of death, years of life lost, and disability-adjusted years of life lost worldwide. CVD prevention for children and teens is needed, as CVD risk factors and behaviors beginning in youth contribute to CVD development. In 2012, the National Heart, Lung, and Blood Institute released their "Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents" for clinicians, describing CVD risk factors they should address with patients at primary care preventative visits. However, uptake of new guidelines is slow. Clinical decision support (CDS) tools can improve guideline uptake. In this paper, we describe our process of testing and adapting a CDS tool to help clinicians evaluate patient risk, recommend behaviors to prevent development of risk, and complete complex calculations to determine appropriate interventions as recommended by the guidelines, using a user-centered design approach. OBJECTIVE: The objective of the study was to assess the usability of a pediatric CVD risk factor tool by clinicians. METHODS: The tool was tested using one-on-one in-person testing and a "think aloud" approach with 5 clinicians and by using the tool in clinical practice along with formal usability metrics with 14 pediatricians. Thematic analysis of the data from the in-person testing and clinical practice testing identified suggestions for change in 3 major areas: user experience, content refinement, and technical deployment. Descriptive statistical techniques were employed to summarize users' overall experience with the tool. RESULTS: Data from testers showed that general reactions toward the CDS tool were positive. Clinical practice testers suggested revisions to make the application more user-friendly, especially for clinicians using the application on the iPhone, and called for refining recommendations to be more succinct and better tailored to the patient. Tester feedback was incorporated into the design when feasible, including streamlining data entry during clinical visits, reducing the volume of results displayed, and highlighting critical results. CONCLUSIONS: This study found support for the usability of our pediatric CVD risk factor tool. Insights shared about this tool may be applicable for designing other mHealth applications and CDS tools. The usability of decision support tools in clinical practice depends critically on receiving (ie, through an accessible device) and adapting the tool to meet the needs of clinicians in the practice setting.

Supporting Parental Decisions About Genomic Sequencing for Newborn Screening: The NC NEXUS Decision Aid.

Advances in genomic sequencing technology have raised fundamental challenges to the traditional ways genomic information is communicated. These challenges will become increasingly complex and will affect a much larger population in the future if genomics is incorporated into standard newborn screening practice. Clinicians, public health officials, and other stakeholders will need to agree on the types of information that they should seek and communicate to parents. Currently, few evidence-based and validated tools are available to support parental informed decision-making. These tools will be necessary as genomics is integrated into clinical practice and public health systems. In this article we describe how the North Carolina Newborn Exome Sequencing for Universal Screening study is addressing the need to support parents in making informed decisions about the use of genomic testing in newborn screening. We outline the context for newborn screening and justify the need for parental decision support. We also describe the process of decision aid development and the data sources, processes, and best practices being used in development. By the end of the study, we will have an evidenced-based process and validated tools to support parental informed decision-making about the use of genomic sequencing in newborn screening. Data from the study will help answer important questions about which genomic information ought to be sought and communicated when testing newborns.

Systematic review of the validity and reliability of consumer-wearable activity trackers.

BACKGROUND: Consumer-wearable activity trackers are electronic devices used for monitoring fitness- and other health-related metrics. The purpose of this systematic review was to summarize the evidence for validity and reliability of popular consumer-wearable activity trackers (Fitbit and Jawbone) and their ability to estimate steps, distance, physical activity, energy expenditure, and sleep. METHODS: Searches included only full-length English language studies published in PubMed, Embase, SPORTDiscus, and Google Scholar through July 31, 2015. Two people reviewed and abstracted each included study. RESULTS: In total, 22 studies were included in the review (20 on adults, 2 on youth). For laboratory-based studies using step counting or accelerometer steps, the correlation with tracker-assessed steps was high for both Fitbit and Jawbone (Pearson or intraclass correlation coefficients (CC) > =0.80). Only one study assessed distance for the Fitbit, finding an over-estimate at slower speeds and under-estimate at faster speeds. Two field-based studies compared accelerometry-assessed physical activity to the trackers, with one study finding higher correlation (Spearman CC 0.86, Fitbit) while another study found a wide range in correlation (intraclass CC 0.36-0.70, Fitbit and Jawbone). Using several different comparison measures (indirect and direct calorimetry, accelerometry, self-report), energy expenditure was more often under-estimated by either tracker. Total sleep time and sleep efficiency were over-estimated and wake after sleep onset was under-estimated comparing metrics from polysomnography to either tracker using a normal mode setting. No studies of intradevice reliability were found. Interdevice reliability was reported on seven studies using the Fitbit, but none for the Jawbone. Walking- and running-based Fitbit trials indicated consistently high interdevice reliability for steps (Pearson and intraclass CC 0.76-1.00), distance (intraclass CC 0.90-0.99), and energy expenditure (Pearson and intraclass CC 0.71-0.97). When wearing two Fitbits while sleeping, consistency between the devices was high. CONCLUSION: This systematic review indicated higher validity of steps, few studies on distance and physical activity, and lower validity for energy expenditure and sleep. The evidence reviewed indicated high interdevice reliability for steps, distance, energy expenditure, and sleep for certain Fitbit models. As new activity trackers and features are introduced to the market, documentation of the measurement properties can guide their use in research settings.

Formative Evaluation of a Text Messaging Intervention to Promote Varenicline Adherence Among Tobacco-Dependent Persons with HIV.

Few published studies describe processes in the development of mobile health interventions. This study reports data from a formative evaluation of a text messaging intervention being developed to increase adherence to smoking cessation medication (varenicline) among tobacco-dependent persons with HIV/AIDS. Four focus groups were conducted (N = 29) using a mixed-methods approach to assess: (a) beliefs and preferences regarding the use of varenicline, (b) preferences for receiving tobacco-related texts, and (c) the acceptability of draft text messages. Themes that emerged from the focus groups were that (a) participants were cautious and wanted to discuss varenicline carefully with health care providers, (b) participants preferred simple messages that were positive and encouraging, (c) messages should emphasize tobacco cessation and not varenicline adherence, and (d) texts would serve as a reminder about goals and foster support and connectedness with the health care team. Overall, 47 out of the 100 messages received a grade of C or less (rated on a 5-point grade scale: A, B, C, D, or F), the majority of which focused on medication adherence. All participants reported that they were likely to read the messages. The majority (64%) indicated that they preferred receiving 2 or more messages per day. Gathering systematic participant feedback provides critical input in intervention planning.

Adoption of cardiovascular risk reduction guidelines: a cluster-randomized trial.

BACKGROUND AND OBJECTIVES: Cardiovascular disease (CVD) and underlying atherosclerosis begin in childhood and are related to CVD risk factors. This study evaluates tools and strategies to enhance adoption of new CVD risk reduction guidelines for children. METHODS: Thirty-two practices, recruited and supported by 2 primary care research networks, were cluster randomized to a multifaceted controlled intervention. Practices were compared with guideline-based individual and composite measures for BMI, blood pressure (BP), and tobacco. Composite measures were constructed by summing the numerators and denominators of individual measures. Preintervention and postintervention measures were assessed by medical record review of children ages 3 to 11 years. Changes in measures (pre-post and intervention versus control) were compared. RESULTS: The intervention group BP composite improved by 29.5%, increasing from 49.7% to 79.2%, compared with the control group (49.5% to 49.6%; P < .001). Intervention group BP interpretation improved by 61.1% (from 0.2% to 61.3%), compared with the control group (0.4% to 0.6%; P < .001). The assessment of tobacco exposure or use for 5- to 11-year-olds in the intervention group improved by 30.3% (from 3.4% to 49.1%) versus the control group (0.6% to 21.4%) (P = .042). No significant change was seen in the BMI or tobacco composites measures. The overall composite of 9 measures improved by 13.4% (from 48.2% to 69.8%) for the intervention group versus the control group (47.4% to 55.2%) (P = .01). CONCLUSIONS: Significant improvement was demonstrated in the overall composite measure, the composite measure of BP, and tobacco assessment and advice for children aged 5 to 11 years.

Implementation of the NHLBI integrated guidelines for cardiovascular health and risk reduction in children and adolescents: rationale and study design for young hearts, strong starts, a cluster-randomized trial targeting body mass index, blood pressure, and tobacco.

BACKGROUND: Cardiovascular disease (CVD) and the underlying atherosclerosis begin in childhood, and their presence and intensity are related to known cardiovascular disease risk factors. Attention to risk factor control in childhood has the potential to reduce subsequent risk of CVD. OBJECTIVE: The Young Hearts Strong Starts Study was designed to test strategies facilitating adoption of the National, Heart, Lung and Blood Institute supported Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents. This study compares guideline-based quality measures for body mass index, blood pressure, and tobacco using two strategies: a multifaceted, practice-directed intervention versus standard dissemination. STUDY DESIGN: Two primary care research networks recruited practices and provided support for the intervention and outcome evaluations. Individual practices were randomly assigned to the intervention or control groups using a cluster randomized design based on network affiliation, number of clinicians per practice, urban versus nonurban location, and practice type. The units of observation are individual children because measure adherence is abstracted from individual patient's medical records. The units of randomization are physician practices. This results in a multilevel design in which patients are nested within practices. The intervention practices received toolkits and supported guideline implementation including academic detailing, an ongoing e-learning group. This project is aligned with the American Board of Pediatrics Maintenance of Certification requirements including monthly physician self-abstraction, webinars, and other elements of the trial. SIGNIFICANCE: This trial will provide an opportunity to demonstrate tools and strategies to enhance CV prevention in children by guideline-based interventions.

Communicating risk of hereditary breast and ovarian cancer with an interactive decision support tool.

OBJECTIVE: Women with hereditary breast and ovarian cancer syndrome (HBOC) face a higher risk of earlier, more aggressive cancer. Because of HBOC's rarity, screening is recommended only for women with strong cancer family histories. However, most patients do not have accurate history available and struggle to understand genetic concepts. METHODS: Cancer in the Family, an online clinical decision support tool, calculated women's HBOC risk and promoted shared patient-provider decisions about screening. A pilot evaluation (n=9 providers, n=48 patients) assessed the tool's impact on knowledge, attitudes, and screening decisions. Patients used the tool before wellness exams and completed three surveys. Providers accessed the tool during exams, completed exam checklists, and completed four surveys. RESULTS: Patients entered complete family histories (67%), calculated personal risk (96%), and shared risk printouts with providers (65%). HBOC knowledge increased dramatically for patients and providers, and many patients (75%) perceived tool results as valid. The tool prompted patient-provider discussions about HBOC risk and cancer family history (88%). CONCLUSIONS: The tool was effective in increasing knowledge, collecting family history, and sparking patient-provider discussions about HBOC screening. PRACTICE IMPLICATIONS: Interactive tools can effectively communicate personalized risk and promote shared decisions, but they are not a substitute for patient-provider discussions.

Tailored text messaging intervention for HIV adherence: a proof-of-concept study.

OBJECTIVE: This study sought to determine if dynamically tailored medication messages delivered to people living with HIV (PLWH) via text messaging would be well received and enhance adherence and clinical outcomes. METHODS: A preexperimental proof-of-concept study with 52 men who have sex with men (MSM) recruited from a health clinic focused on promoting the well-being of gay, lesbian, bisexual, and transgender people. Inclusion criteria were being an English speaking HIV-positive MSM, aged 25 or older. Participants also had to agree to allow access to their medical records, have a cell phone, and be able to receive text messages over the 3-month intervention period. Participants completed baseline surveys that assessed various demographic, social, and health questions; received text messages over 3 months; answered weekly adherence questions via two-way messaging; and completed a follow-up survey at the end of the intervention period. Clinical outcomes were abstracted from participants' medical records at baseline and follow-up. Self-reported medication adherence and clinical outcomes, including CD4 counts and viral load. RESULTS: Participants were receptive to the text messaging intervention, and reported reading and liking the messages. Self-reported medication adherence significantly improved among participants who began the study as nonadherent and received tailored medication reminders. Overall viral load significantly decreased and CD4 count significantly increased from baseline to follow-up. CONCLUSIONS: The results demonstrate that using two-way text messaging to dynamically tailor adherence messages may enhance adherence and improve important clinical outcomes for PLWH.

Addressing HIV knowledge, risk reduction, social support, and patient involvement using SMS: results of a proof-of-concept study.

Men who have sex with men continue to be severely and disproportionately affected by the HIV/AIDS epidemic in the United States. Effective antiretroviral therapy has altered the HIV epidemic from being an acute disease to a chronic, manageable condition for many people living with HIV. The pervasiveness, low cost, and convenience of short message service suggests its potential suitability for supporting the treatment of conditions that must be managed over an extended period. The purpose of this proof-of-concept study was to develop, implement, and test a tailored short message service-based intervention for HIV-positive men who have sex with men. The messages focused on reducing risk-taking behaviors and enhancing HIV knowledge, social support, and patient involvement. Participants reported strong receptivity to the messages and the intervention. The authors detected a statistically significant increase in HIV knowledge and social support from baseline to follow-up. Among participants who received sexual risk reduction messages, the authors also detected a statistically significant reduction in reported risk behaviors from baseline to follow-up. Results confirm the feasibility of a tailored, short message service-based intervention designed to provide ongoing behavioral reinforcement for HIV-positive men who have sex with men. Future research should include a larger sample, a control group, multiple sites, younger participants, and longer term follow-up.