Dataset Information

A Mobile Health App (WYZ) for Engagement in Care and Antiretroviral Therapy Adherence Among Youth and Young Adults Living With HIV: Single-Arm Pilot Intervention Study.

ABSTRACT:

Background

Youth are globally recognized as being vulnerable to HIV. Younger age has been correlated with worse health outcomes. Mobile health (mHealth) interventions have the potential to interact with youth where they are, using a device they already access.

Objective

Using predefined benchmarks, we sought to evaluate the feasibility and acceptability of WYZ, an mHealth app, for improved engagement in care and antiretroviral therapy (ART) adherence among youth and young adults living with HIV. WYZ was designed and developed with input from youth and young adults living with HIV using a human-centered design approach and was based on the information, motivation, and behavioral skills framework to address common barriers to care and ART adherence among youth and young adults living with HIV.

Methods

We recruited youth and young adults living with HIV (18-29 years old) from the San Francisco Bay Area to take part in a 6-month pilot trial. Their participation included completing baseline and exit surveys, and participating in seven phone check-ins about their use of WYZ.

Results

Youth and young adults living with HIV (N=79) reported high levels of feasibility and acceptability with WYZ use. We met predefined benchmarks for recruitment (79/84, 94%), mean logins per week (5.3), tracking ART adherence (5442/9393, 57.9%), posting chat topics per week (4.8), and app crashes reported per week (0.24). The ease of app download, install, and setup, and comfort with security, privacy, and anonymity were highly rated (all over 91%). Additionally, participants reported high satisfaction for a research project that was remotely conducted. Participants used the app for shorter timeframes compared to the predefined benchmark.

Conclusions

We noted high feasibility and acceptability with WYZ. Further research to examine the efficacy of WYZ will enable youth and young adults living with HIV and their providers to make informed decisions when using, recommending, and prescribing the app for improved engagement in HIV care and ART adherence.

Trial registration

ClinicalTrials.gov NCT03587857; https://clinicaltrials.gov/ct2/show/NCT03587857.

SUBMITTER: Saberi P

PROVIDER: S-EPMC8441610 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionYouth and young adults bear a disproportionate share of the HIV burden and there is a critical need for interventions to curb health disparities experienced among these age groups. The purpose of our research is to build on our theory-guided model and formative research to develop a mobile health application, called WYZ, for improved engagement in HIV care and antiretroviral therapy adherence, and pilot test it among youth and young adults living with HIV (YLWH). In this paper, we explain the design and development of WYZ for YLWH, describe the design of a forthcoming pilot trial for evaluating the feasibility and acceptability of WYZ and compare WYZ with other mobile health applications being developed to improve engagement in HIV care and antiretroviral medication adherence.Methods and analysisWe used an agile methodology, shown to be useful in software development, and elicited feedback during beta testing to develop WYZ. WYZ is a modular, adaptive and personalised intervention delivered via a mobile phone. It is grounded in the information, motivation, behaviouralskills model which has been valuable for understanding and guiding the development of interventions for complex health behaviours. WYZ was created in collaboration with YLWH aged 18-29 years using a human-centred design approach that emphasises understanding the perspective of the users of the technology. WYZ is intended to improve engagement in HIV care by: (1) enhancing medication adherence self-efficacy, (2) increasing awareness and use of community resources, (3) reducing barriers to communication between youth and their healthcare team, and (4) providing a secure platform for the formation of a private online community of YLWH. We will conduct a 6-month single-arm pilot study to examine feasibility and acceptability of WYZ among 76 YLWH who live or receive care in the San Francisco Bay Area. All study activities, including recruitment, screening, enrolment, study assessments, provision of incentives and exit interviews, will be conducted remotely. We will explore feasibility and acceptability outcomes of the intervention using quantitative and qualitative methods.Ethics and disseminationStudy staff will obtain written consent for study participation from all participants. This study and its protocols have been approved by the University of California San Francisco (UCSF) Institutional Review Board. Study staff will work with the UCSF Center for AIDS Prevention Studies' Community Engagement Core and the Youth Advisory Panel to disseminate results to the participants and the community using presentations, community forums, journal publications and/or social media.Trial registration numberNCT03587857; Pre-results.

Project description:BackgroundInternalizing disorders are the most common psychiatric problems observed among youth in Canada. Sadly, youth with internalizing disorders often avoid seeking clinical help and rarely receive adequate treatment. Current methods of assessing internalizing disorders usually rely on subjective symptom ratings, but internalizing symptoms are frequently underreported, which creates a barrier to the accurate assessment of these symptoms in youth. Therefore, novel assessment tools that use objective data need to be developed to meet the highest standards of reliability, feasibility, scalability, and affordability. Mobile sensing technologies, which unobtrusively record aspects of youth behaviors in their daily lives with the potential to make inferences about their mental health states, offer a possible method of addressing this assessment barrier.ObjectiveThis study aims to explore whether passively collected smartphone sensor data can be used to predict internalizing symptoms among youth in Canada.MethodsIn this study, the youth participants (N=122) completed self-report assessments of symptoms of anxiety, depression, and attention-deficit hyperactivity disorder. Next, the participants installed an app, which passively collected data about their mobility, screen time, sleep, and social interactions over 2 weeks. Then, we tested whether these passive sensor data could be used to predict internalizing symptoms among these youth participants.ResultsMore severe depressive symptoms correlated with more time spent stationary (r=0.293; P=.003), less mobility (r=0.271; P=.006), higher light intensity during the night (r=0.227; P=.02), and fewer outgoing calls (r=-0.244; P=.03). In contrast, more severe anxiety symptoms correlated with less time spent stationary (r=-0.249; P=.01) and greater mobility (r=0.234; P=.02). In addition, youths with higher anxiety scores spent more time on the screen (r=0.203; P=.049). Finally, adding passively collected smartphone sensor data to the prediction models of internalizing symptoms significantly improved their fit.ConclusionsPassively collected smartphone sensor data provide a useful way to monitor internalizing symptoms among youth. Although the results replicated findings from adult populations, to ensure clinical utility, they still need to be replicated in larger samples of youth. The work also highlights intervention opportunities via mobile technology to reduce the burden of internalizing symptoms early on.

Project description:BackgroundIn the United States, young men who have sex with men (YMSM) and transgender women who have sex with men (YTWSM) bear a disproportionate burden of prevalent and incident HIV infections. Once diagnosed, many YMSM and YTWSM struggle to engage in HIV care, adhere to antiretroviral therapy (ART), and achieve viral suppression. Computer-based interventions, including those focused on behavior change, are recognized as effective tools for engaging youth.ObjectiveThe purpose of the study described in this protocol is to evaluate the efficacy of Epic Allies, a theory-based mobile phone app that utilizes game mechanics and social networking features to improve engagement in HIV care, ART uptake, ART adherence, and viral suppression among HIV-positive YMSM and YTWSM. The study also qualitatively assesses intervention acceptability, perceived impact, and sustainability.MethodsThis is a two-group, active-control randomized controlled trial of the Epic Allies app. YMSM and YTWSM aged 16 to 24 inclusive, with detectable HIV viral load are randomized 1:1 within strata of new to care (newly entered HIV medical care ≤12 months of baseline visit) or ART-nonadherent (first entered HIV medical care >12 months before baseline visit) to intervention or control conditions. The intervention condition addresses ART adherence barriers through medication reminders and adherence monitoring, tracking of select adherence-related behaviors (eg, alcohol and marijuana use), an interactive dashboard that displays the participant's adherence-related behaviors and provides tailored feedback, encouragement messages from other users, daily HIV/ART educational articles, and gamification features (eg, mini-games, points, badges) to increase motivation for behavior change and app engagement. The control condition features weekly phone-based notifications to encourage participants to view educational information in the control app. Follow-up assessments are administered at 13, 26, and 39 weeks for each arm. The primary outcome measure is viral suppression. Secondary outcome measures include engagement in care, ART uptake, ART adherence, and psychosocial barriers to engagement in care and ART adherence, including psychological distress, stigma, and social support.ResultsBaseline enrollment began in September 2015 and was completed in September 2016 (n=146), and assessment of intervention outcomes continued through August 2017. Results for primary and secondary outcome measures are expected to be reported in ClinicalTrials.gov by April 30, 2018.ConclusionsIf successful, Epic Allies will represent a novel adherence intervention for a group disproportionately impacted by HIV in the United States. Adherent patients would require less frequent clinic visits and experience fewer HIV-related secondary infections, thereby reducing health care costs and HIV transmission. Epic Allies could easily be expanded and adopted for use among larger populations of YMSM and YTWSM, other HIV-positive populations, and for those diagnosed with other chronic diseases such as diabetes and hypertension.Trial registrationClinicalTrials.gov NCT02782130; https://clinicaltrials.gov/ct2/show/NCT02782130 (Archived by Webcite at http://www.webcitation.org/6yGODyerk).

Project description:BackgroundLong-term maintenance of preventive activities is fundamental for achieving improved outcomes in cardiac rehabilitation (CR). Despite this, it has been shown to be a major challenge for many patients to follow recommendations and thereby adhere to a heart-healthy lifestyle. Mobile phone apps have been emphasized as potential tools to promote preventive activities after attendance in a CR program. Before commencing a trial to assess the potential effect of using an app to promote long-term adherence to preventive activities after attendance in CR, a study to assess if it is feasible to use an app is warranted.ObjectiveThe goal of the research is to assess if it is feasible to use a mobile phone app for promoting and monitoring patients' adherence to a heart-healthy lifestyle after CR.MethodsThe study included an experimental, pre-post single-arm trial lasting for 12 weeks. All patients received access to an app aimed to guide individuals to change or maintain a heart-healthy lifestyle. During the study period, patients received weekly, individualized monitoring through the app, based on their own goals. Feasibility outcomes assessed were recruitment rate, adherence to the app, resource requirements, and efficacy regarding capability to detect a change in quality of life, health status, and perceived goal achievement as well as evaluating ceiling and floor effect in these outcomes. Criteria for success were preset to be able to evaluate whether the app was feasible to use in a potential future RCT.ResultsIn total, 71% (17/24) of the patients who completed CR were eligible for a potential RCT as well as for this study. All 14 patients included in the study used the app to promote preventive activities throughout the study. Satisfaction with the technology was high, and the patients found the technology-based follow-up intervention both useful and motivational. Ceiling effect was present in more than 20% of the patients in several domains of the questionnaires evaluating quality of life (36-Item Short Form Health Survey and COOP/WONCA functional health assessments) and health status (EQ-5D). Overall self-rated health status (EuroQol Visual Analog Scale) and perceived goal achievement were found to be outcomes able to detect a change.ConclusionsIndividual follow-up through an app after attendance in CR is feasible. All patients used the app for preventive activities and found the app both useful and motivating. Several points of guidance from the patients in the study have been adopted and incorporated into the final design of the RCT now in the field.

Project description:BackgroundHighly active combination antiretroviral treatment has been shown to markedly improve the health of HIV-infected adolescents and young adults. Adherence to antiretroviral treatment leads to decreased morbidity and mortality and decreases the number of hospitalizations. However, these clinical achievements can only occur when young persons with HIV are adherent to care. Unfortunately, adolescents and young adults have poorer rates of adherence to antiretroviral medications and poorer rates of retention in care than older adults. Novel and engaging digital approaches are needed to help adolescents and young adults living with HIV be adherent to treatment.ObjectiveThe aim of this study was to develop an immersive, action-oriented iPhone gaming intervention to improve adherence to antiretroviral medication and treatment.MethodsGame development was guided by social learning theory, taking into consideration the perspectives of adolescents and young adults living with HIV. A total of 20 adolescents and young adults were recruited from an HIV care clinic in Rhode Island, and they participated in qualitative interviews guided by the information-motivation-behavioral skills model of behavior change. The mean age of participants was 22 years, 60% (12/20) of the participants identified as male, and 60% (12/20) of the sample reported missing a dose of antiretroviral medication in the previous week. Acceptability of the game was assessed with client service questionnaire and session evaluation form.ResultsA number of themes emerged that informed game development. Adolescents and young adults living with HIV desired informational game content that included new and comprehensive details about HIV, details about HIV as it relates to doctors' visits, and general health information. Motivational themes that emerged were the desire for enhancement of future orientation; reinforcement of positive influences from partners, parents, and friends; collaboration with health care providers; decreasing stigma; and increasing personal relevance of HIV care. Behavioral skills themes centered on self-efficacy and strategies for medical adherence and self-care. On the client service questionnaire, 10 out of the 11 participants indicated they were "satisfied with the game activities," and 9 out of 11 "would recommend it to a friend." On the session evaluation form, 9 out of 11 agreed that they "learned a lot from the game."ConclusionsWe utilized youth feedback, social learning theory (information-motivation-behavioral skills), and agile software development to create a multilevel, immersive, action-oriented iPhone gaming intervention to measure and improve treatment adherence for adolescents and young adults living with HIV. There is a dearth of gaming interventions for this population, and this study is a significant step in working toward the development and testing of an iPhone gaming app intervention to promote adherence to antiretroviral treatment.Trial registrationClinicalTrials.gov NCT01887210; http://clinicaltrials.gov/ct2/show/NCT01887210 (Archived by WebCite at http://www.webcitation.org/6xHMW0NI1).

Project description:IntroductionYouth suicidal ideation and behaviour is concerning due to its widespread prevalence, morbidity and potentially fatal consequences. Digital mental health interventions have been found to improve access to low-cost and high-quality support for a range of mental health issues, yet there are few digital interventions available for suicide prevention in young people. In addition, no studies have examined how digital engagement strategies may impact the engagement and efficacy of digital interventions in suicide prevention. The current protocol describes a three-arm parallel randomised controlled trial. A therapeutic smartphone application ('LifeBuoy'; intervention condition) will be tested against a condition that consists of the LifeBuoy application plus access to a digital engagement strategy ('LifeBuoy+engagement'; intervention condition) to determine whether the addition of the digital strategy improves app engagement metrics. To establish the efficacy of the LifeBuoy application, both of these intervention conditions will be tested against an attention-matched control condition (a placebo app).Methods and analysis669 young Australians aged 17-24 years who have experienced suicidal ideation in the past 30 days will be recruited by Facebook advertisement. The primary outcomes will be suicidal ideation severity and level of app engagement. Primary analyses will use an intention-to-treat approach and compare changes from baseline to 30-day, 60-day and 120-day follow-up time points relative to the control group using mixed-effect modelling. A subset of participants in the intervention groups will be interviewed on their experience with the app and engagement strategy. Qualitative data will be analysed using an inductive approach, independent of a theoretical confirmative method to identify the group themes.Ethics and disseminationThe study has been approved by the University of New South Wales Human Research Ethics Committee (HC210400). The results of the trial will be disseminated via peer-reviewed publications in scientific journals and conferences.Trial registration numberACTRN12621001247864.

Project description:BackgroundEmpowering young people with type 1 diabetes (T1D) to manage their blood glucose levels during exercise is a complex challenge faced by health care professionals due to the unpredictable nature of exercise and its effect on blood glucose levels. Mobile health (mHealth) apps would be useful as a decision-support aid to effectively contextualize a blood glucose result and take appropriate action to optimize glucose levels during and after exercise. A novel mHealth app acT1ve was recently developed, based on expert consensus exercise guidelines, to provide real-time support for young people with T1D during exercise.ObjectiveOur aim was to pilot acT1ve in a free-living setting to assess its acceptability and functionality, and gather feedback on the user experience before testing it in a larger clinical trial.MethodsA prospective single-arm mixed method design was used. Ten participants with T1D (mean age 17.7 years, SD 4.2 years; mean HbA1c, 54 mmol/mol, SD 5.5 mmol/mol [7.1%, SD 0.5%]) had acT1ve installed on their phones, and were asked to use the app to guide their exercise management for 6 weeks. At the end of 6 weeks, participants completed both a semistructured interview and the user Mobile Application Rating Scale (uMARS). All semistructured interviews were transcribed. Thematic analysis was conducted whereby interview transcripts were independently analyzed by 2 researchers to uncover important and relevant themes. The uMARS was scored for 4 quality subscales (engagement, functionality, esthetics, and information), and a total quality score was obtained from the weighted average of the 4 subscales. Scores for the 4 objective subscales were determined by the mean score of each of its individual questions. The perceived impact and subjective quality of acT1ve for each participant were calculated by averaging the scores of their related questions, but were not considered in the total quality score. All scores have a maximal possible value of 5, and they are presented as medians, IQRs, and ranges.ResultsThe main themes arising from the interview analysis were "increased knowledge," "increased confidence to exercise," and "suitability" for people who were less engaged in exercise. The uMARS scores for acT1ve were high (out of 5) for its total quality (median 4.3, IQR 4.2-4.6), engagement (median 3.9, IQR 3.6-4.2), functionality (median 4.8, IQR 4.5-4.8), information (median 4.6, IQR 4.5-4.8), esthetics (median 4.3, IQR 4.0-4.7), subjective quality (median 4.0, IQR 3.8-4.2), and perceived impact (median 4.3, IQR 3.6-4.5).ConclusionsThe acT1ve app is functional and acceptable, with a high user satisfaction. The efficacy and safety of this app will be tested in a randomized controlled trial in the next phase of this study.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12619001414101; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378373.

Project description:HIV disproportionately impacts young men who have sex with men (YMSM) who experience disparities across the HIV care continuum. Addressing antiretroviral therapy (ART) adherence among YMSM is an urgent public health priority. Technology-based interventions-particularly mobile health platforms-can provide tailored adherence interventions and allow YMSM to engage and connect with others.The objective of this study was to describe the development of AllyQuest, a novel, theoretically-based, smartphone app designed to improve engagement in care and ART adherence and social support among HIV-positive YMSM.AllyQuest was built on an established platform for patient engagement that embeds social networking and fundamental game mechanics, such as challenges, points, and rewards. A medication tracker provides reminders to promote ART adherence via personalized adherence strategies that are user and context specific; a calendar allows for reflection on adherence over time. After iterative development with input from two youth advisory boards, usability testing was conducted to assess app functionality, comprehension of the educational content, use of intervention features, and overall impressions of app relevance and appeal. A 28-day pilot trial was conducted with 20 HIV+ YMSM to evaluate intervention feasibility and acceptability.Mean age of participants was 21.8 years (range 19-24), and 95% (19/20) of the participants were nonwhite. The mean time of app use was 158.4 min (SD 114.1), with a range of 13 to 441 min. There was a mean of 21.2 days of use (out of a total possible 28 days). There were 222 posts to the daily discussion social wall. Feasibility and acceptability ratings were high. Overall, participants found the app easy to use and navigate, not intrusive, and had few reported technical issues. Higher levels of app usage were positively correlated with HIV self-management outcomes, and there was a statistically significant (P<.05) positive association between the number of days logged into the app and knowledge and confidence in ability to reliably take HIV medications.AllyQuest represents a new, highly scalable solution that is well-suited to meet the specific prevention and care needs of HIV+ YMSM. The development of this intervention is both timely and vital, given the urgency of the ongoing HIV epidemic among YMSM.