Development of an mHealth App to Support the Prevention of Sexually Transmitted Infections Among Black Men Who Have Sex With Men Engaged in Pre-exposure Prophylaxis Care in New Orleans, Louisiana: Qualitative User-Centered Design Study.

BACKGROUND: Sexual health disparities exist for Black men who have sex with men (BMSM) in New Orleans, Louisiana. Rates of sexually transmitted infections (STIs) are high for both BMSM and those taking HIV pre-exposure prophylaxis (PrEP). OBJECTIVE: In this study, we introduced an existing PrEP adherence app to new potential users-BMSM engaged in PrEP care in New Orleans-to guide app adaptation with STI prevention features and tailoring for the local context. METHODS: Using a user-centered design, we conducted 4 focus group discussions (FGDs), with interim app adaptations from December 2020 to March 2021. During the FGDs, a video of the app, app website, and mock-ups were shown to participants. We asked about facilitators of and barriers to STI prevention in general, current app use, impressions of the existing app, new app features to potentially facilitate STI prevention, and how the app should be tailored for BMSM. We used applied qualitative thematic analysis to identify themes and needs of the population. RESULTS: Overall, 4 FGDs were conducted with 24 BMSM taking PrEP. We grouped themes into 4 categories: STI prevention, current app use and preferences, preexisting features and impressions of the prep'd app, and new features and modifications for BMSM. Participants noted concern about STIs and shared that anxiety about some STIs was higher than that for others; some participants shared that since the emergence of PrEP, little thought is given to STIs. However, participants desired STI prevention strategies and suggested prevention methods to implement through the app, including access to resources, educational content, and sex diaries to follow their sexual activity. When discussing app preferences, they emphasized the need for an app to offer relevant features and be easy to use and expressed that some notifications were important to keep users engaged but that they should be limited to avoid notification fatigue. Participants thought that the current app was useful and generally liked the existing features, including the ability to communicate with providers, staff, and each other through the community forum. They had suggestions for modifications for STI prevention, such as the ability to comment on sexual encounters, and for tailoring to the local context, such as depictions of iconic sights from the area. Mental health emerged as an important need to be addressed through the app during discussion of almost all features. Participants also stressed the importance of ensuring privacy and reducing stigma through the app. CONCLUSIONS: A PrEP adherence app was iteratively adapted with feedback from BMSM, resulting in a new app modified for the New Orleans context and with STI prevention features. Participants gave the app a new name, PCheck, to be more discreet. Next steps will assess PCheck use and STI prevention outcomes.

Development of a Digital Behavioral Intervention to Reduce the Consumption of Sugar-Sweetened Beverages Among Rural Appalachian Adults: Multiphased, Human-Centered Design Approach.

BACKGROUND: To avoid the low engagement and limited efficacy of digital behavioral health interventions, robust human-centered design (HCD) processes are needed. OBJECTIVE: The primary objective of this study was to describe a flexible, step-by-step HCD process to develop digital behavioral health interventions by illustrating iSIPsmarter as an example. iSIPsmarter is a digital intervention for reducing the consumption of sugar-sweetened beverages (SSBs) that comprises 6 internet-based cores metered out over time to deliver the program content, an integrated SMS text message strategy to engage users in reporting SSB behaviors, and an electronic cellular-enabled scale for in-home weighing. The secondary objective is to illustrate the key components and characteristics of iSIPsmarter that resulted from the HCD process. METHODS: The methods were guided by the Model for Internet Interventions and by best practices in HCD and instructional design processes (eg, rapid prototype development and think-aloud protocol). The 3-phased (ie, contextual, prototype testing, end user testing phases) process followed in this study included a series of 13 semistructured one-on-one interviews with 7 advisory team participants from the targeted Appalachian user group. The interviews were content coded by 2 researchers and then deductively coded to the suggested areas of digital behavioral health interventions. RESULTS: The participants provided rich perspectives pertaining to iSIPsmarter's appearance, behavioral prescriptions, burdens, content, delivery, message, participation, and assessment. These inputs included requests for built-in flexibility to account for varying internet and SMS text message accessibility among users; ideas to resolve the issues and problems encountered when using the prototypes, including those related to navigation and comprehension of content; ideas to enhance personalized feedback to support motivation and goal setting for SSB consumption and weight; and feedback to refine the development of realistic and relatable vignettes. The participants were able to interact with multiple prototype drafts, allowing researchers to capture and incorporate feedback related to the iSIPsmarter dashboard, daily SSB and weight diaries, action planning, core content, interactions, and vignettes. CONCLUSIONS: Using scientific models and established processes is critical for building robust and efficacious interventions. By applying an existing model and HCD and instructional design processes, we were able to identify assumptions and address the key areas of the iSIPsmarter intervention that were hypothesized to support users' engagement and promote behavior change. As evidenced by the rich feedback received from the advisory team members and the resulting iSIPsmarter product, the HCD methodology was instrumental in the development process. Although the final iSIPsmarter content is specific to improving SSB consumption behaviors among adults in rural areas, the intent is that this HCD process will have wide applications in the development of digital behavioral health interventions across multiple geographic and behavioral contexts.

Study protocol for iSIPsmarter: A randomized-controlled trial to evaluate the efficacy, reach, and engagement of a technology-based behavioral intervention to reduce sugary beverages among rural Appalachian adults.

Sugar-sweetened beverage (SSB) consumption is disproportionately high among rural Appalachian adults, with intakes double the national average and nearly four times the recommended amount. This trial targets this major dietary risk factor and addresses notable gaps in the rural digital health intervention literature. iSIPsmarter is a technology-based behavior and health literacy intervention aimed at improving SSB behaviors. It is comprised of six Internet-delivered, interactive Cores delivered weekly, an integrated short message service (SMS) strategy to engage users in tracking and reporting SSB behaviors, and a cellular-enabled scale for in-home weighing. iSIPsmarter is adapted from an evidence-based intervention and is grounded by the Theory of Planned Behavior and health literacy, numeracy, and media literacy concepts. The RCT is guided by the RE-AIM framework and targets 244 rural Appalachian adults. The goal is to examine the efficacy of iSIPsmarter to reduce SSB in a two-group design [iSIPsmarter vs. static Participant Education website] with four assessment points. Changes in secondary outcomes (e.g., diet quality, weight, quality of life) and maintenance of outcomes will also be evaluated. Additional secondary aims are to examine reach and representativeness, patterns of user engagement, and cost. Two tertiary aims are exploratory mediation analyses and a systems-level, participatory evaluation to understand context for future organizational-level adoption of iSIPsmarter. The long-term goal is to sustain an effective, scalable, and high reach behavioral intervention to reduce SSB-related health inequities and related chronic conditions (i.e., obesity, diabetes, some obesity-related cancers, heart disease, hypertension, dental decay) in rural Appalachia and beyond. ClinicalTrial registry: NCT05030753.

Adapting an m-Health Intervention for Spanish-Speaking Latinx People Living with HIV in the Nonurban Southern United States.

Background: Latinx people in the United States are disproportionately diagnosed with HIV and are more likely to experience worse HIV-related health outcomes. Although m-health has demonstrated success in improving HIV care, a gap remains in the development of m-health platforms tailored to Latinx populations. Methods: We conducted formative study to guide the adaptation of an evidence-based m-health intervention, PositiveLinks (PL), for Spanish-speaking Latinx people living with HIV (PLWH). Spanish-speaking Latinx PLWH in the nonurban Southern United States completed semistructured interviews and viewed a demo version of the m-health intervention. Qualitative analysis was performed using a grounded theory approach. Emerging themes were identified in four topic areas: (1) prior experiences with technology, (2) desired m-health features, (3) experiences with prototype app, and (4) iteration of prototype. Results: All PLWH who participated (n = 22) were born outside the continental United States. Participants included 10 men, 10 women, and 2 transgender participants. Mean age was 41.1 years (standard deviation 11.6 years). Participants expressed concerns about privacy, a need for reliable information, and interest in practical m-health features such as appointment and medication reminders. After trialing the Spanish-language PL prototype, participants reported that peer support and positive reinforcement were strong motivators to use the app. The ability to individualize the app to meet one's own needs was also considered important. Conclusion: This formative study provides baseline attitudes about m-health among Latinx PLWH as well as desired m-health features. m-Health interventions are acceptable to Spanish-speaking PLWH and involving the target population in a user-centered formative process led to improvements in app accessibility and usability.

A Mobile Health App to Support Patients Receiving Medication-Assisted Treatment for Opioid Use Disorder: Development and Feasibility Study.

BACKGROUND: Opioid use disorder (OUD) is a public health crisis with more than 2 million people living with OUD in the United States. Medication-assisted treatment (MAT) is an evidence-based approach for the treatment of OUD that relies on a combination of behavioral therapy and medication. Less than half of those living with OUD are accessing this treatment. Mobile technology can enhance the treatment of chronic diseases in readily accessible and cost-effective ways through self-monitoring and support. OBJECTIVE: The aim of this study is to describe the adaptation of a mobile platform for patients undergoing treatment for OUD and preliminary pilot testing results. METHODS: Our study was conducted with patient and provider participants at the University of Virginia MAT clinic and was approved by the institutional review board. The formative phase included semistructured interviews to understand the needs of patients with OUD, providers' perspectives, and opportunities for MAT support via a mobile app. A second round of formative interviews used mock-ups of app features to collect feedback on feature function and desirability. Formative participants' input from 16 interviews then informed the development of a functional smartphone app. Patient participants (n=25) and provider participants (n=3) were enrolled in a 6-month pilot study of the completed platform. Patient app use and usability interviews, including a system usability score and open-ended questions, were completed 1 month into the pilot study. Open-ended responses were analyzed for prevalent themes. RESULTS: Formative interviews resulted in the development of a mobile app, named HOPE, which includes both evidence-based and participant-suggested features. The features included daily prompts for monitoring mood, stress, treatment adherence, and substance use; patient tracking of goals, reminders, and triggering or encouraging experiences; informational resources; an anonymous community board to share support with other patients; and secure messaging for communication between patients and providers. All patient participants engaged with at least one app feature during their first month of pilot study participation, and the daily self-monitoring prompts were the most used. Patients and providers reported high levels of system usability (mean 86.9, SD 10.2 and mean 83.3, SD 12.8, respectively). Qualitative analysis of open-ended usability questions highlighted the value of self-monitoring, access to support through the app, and perceived improvement in connection to care and communication for both patient and provider participants. CONCLUSIONS: The use of the HOPE program by pilot participants, high usability scoring, and positive perceptions from 1-month interviews indicate successful program development. By engaging with end users and eliciting feedback throughout the development process, we were able to create an app and a web portal that was highly usable and acceptable to study participants. Further work is needed to understand the program's effect on clinical outcomes, patient linkage, and engagement in care.

Randomized controlled trial of the mySmartSkin web-based intervention to promote skin self-examination and sun protection behaviors among individuals diagnosed with melanoma: study design and baseline characteristics.

>1.2 million people in the United States have a personal history of melanoma skin cancer and are at increased risk for disease recurrence and second primary melanomas. Many of these individuals do not follow recommendations to conduct regular, thorough skin self-examinations that facilitate early disease detection and do not sufficiently engage in sun protection behaviors. In this project, we are conducting a randomized controlled trial of an innovative, tailored, theory-driven Internet intervention-called mySmartSkin-to promote these behaviors among melanoma patients. This paper outlines the study design and characteristics of the study sample. A total of 441 patients were recruited (40.9% response rate) and randomized to the mySmartSkin or a Usual Care condition. Participants complete surveys at baseline and 8 weeks, 24 weeks, and 48 weeks later. The primary aim of the project is to examine the impact of mySmartSkin versus Usual Care on skin self-examination and sun protection behaviors. The secondary aim focuses on identifying mediators of the intervention's effects. In an exploratory aim, we will examine potential moderators of the impact of the intervention. At baseline, the recruited participants had a mean age of 61 years, 49% were female, 7.5% met criteria for having conducted a recent, thorough skin self-examination, and the mean score on the index of sun protection behaviors was 3.3 (on a scale from 1 to 5). The results of the project will determine whether the mySmartSkin intervention is efficacious in promoting skin self-examination and sun protection behaviors among individuals diagnosed with melanoma. Trial registration: ClinicalTrials.govNCT03028948.

eSCCIP: A Psychosocial eHealth Intervention for Parents of Children with Cancer.

Objective: eHealth interventions may facilitate the dissemination of evidence-based psychosocial interventions to families of children with chronic illnesses, including cancer. This article describes a four-phase, mixed-methods, user-centered approach to the design and evaluation of a novel psychosocial intervention for parents of children with cancer (Electronic Surviving Cancer Competently Intervention Program [eSCCIP]), adapted from an in-person intervention (Surviving Cancer Competently Intervention Program). Methods: Development of eSCCIP involved a multidisciplinary design team of content and eHealth experts. Iterative Think Aloud testing and beta testing with parents of children with cancer was also completed. Results: An intensive, user-centered development and evaluation process was utilized to develop an eHealth intervention for parents of children with cancer. Initial testers rated eSCCIP favorably on questionnaires evaluating user experience and perceptions, and provided positive feedback and suggestions for additional improvement through qualitative interviews. Conclusions: Initial results suggest that eSCCIP may be an acceptable, feasible, and usable intervention for parents of children with cancer. eSCCIP is now ready for a larger pilot evaluation of usability, feasibility, and impact on target outcomes, including the reduction of anxiety and PTSS and improvements in family functioning.

Using instructional design process to improve design and development of Internet interventions.

Given the wide reach and extensive capabilities of the Internet, it is increasingly being used to deliver comprehensive behavioral and mental health intervention and prevention programs. Their goals are to change user behavior, reduce unwanted complications or symptoms, and improve health status and health-related quality of life. Internet interventions have been found efficacious in addressing a wide range of behavioral and mental health problems, including insomnia, nicotine dependence, obesity, diabetes, depression, and anxiety. Despite the existence of many Internet-based interventions, there is little research to inform their design and development. A model for behavior change in Internet interventions has been published to help guide future Internet intervention development and to help predict and explain behavior changes and symptom improvement outcomes through the use of Internet interventions. An argument is made for grounding the development of Internet interventions within a scientific framework. To that end, the model highlights a multitude of design-related components, areas, and elements, including user characteristics, environment, intervention content, level of intervention support, and targeted outcomes. However, more discussion is needed regarding how the design of the program should be developed to address these issues. While there is little research on the design and development of Internet interventions, there is a rich, related literature in the field of instructional design (ID) that can be used to inform Internet intervention development. ID models are prescriptive models that describe a set of activities involved in the planning, implementation, and evaluation of instructional programs. Using ID process models has been shown to increase the effectiveness of learning programs in a broad range of contexts. ID models specify a systematic method for assessing the needs of learners (intervention users) to determine the gaps between current knowledge and behaviors, and desired outcomes. Through the ID process, designers focus on the needs of learners, taking into account their prior knowledge; set measurable learning objectives or performance requirements; assess learners' achievement of the targeted outcomes; and employ cycles of continuous formative evaluation to ensure that the intervention meets the needs of all stakeholders. The ID process offers a proven methodology for the design of instructional programs and should be considered an integral part of the creation of Internet interventions. By providing a framework for the design and development of Internet interventions and by purposefully focusing on these aspects, as well as the underlying theories supporting these practices, both the theories and the interventions themselves can continue to be refined and improved. By using the behavior change model for Internet interventions along with the best research available to guide design practice and inform development, developers of Internet interventions will increase their ability to achieve desired outcomes.

Pressure ulcer prevention and management in spinal cord-injured adults: analysis of educational needs.

OBJECTIVE: The authors assessed the educational needs of adults with spinal cord injury (SCI) in the prevention and early detection of pressure ulcers (PrUs). Specific recommendations are provided for the top needs identified, along with key issues to consider in implementing solutions. DESIGN: The authors used a needs assessment methodology using a purposeful, maximum variation sampling strategy that was based on age, injury level and completeness, time since injury, and PrU history to select cases that would identify the diverse influences on PrU education. PARTICIPANTS: The authors interviewed 16 adults with SCI concerning perception of PrU risk, education, environmental considerations, and access to care. Also interviewed were 8 SCI professionals, including a physician specializing in rehabilitation medicine, physical and occupational therapists, a nurse case manager, and a wound care nurse practitioner. MAIN OUTCOME: The outcome of this research is the identification of educational needs for adults with SCI in PrU prevention and early detection. RESULTS: The needs identified are rank-ordered, and possible educational objectives are considered for each. Education needs identified include the following: *Awareness of lifelong risk for developing PrUs, including the ability to assess own risk factors and how risk changes over time. *Ability to take charge of own skin care regimen and to partner with health care providers. *Perform prevention strategies consistently that fit level of functioning and activity, and update practices as risk changes. *Ability to coordinate social supports. CONCLUSION: The need for effective education among adults with SCI in the prevention and early detection of PrUs is critical.