Epic Allies: Development of a Gaming App to Improve Antiretroviral Therapy Adherence Among Young HIV-Positive Men Who Have Sex With Men

Background: In the United States, the human immunodeficiency virus (HIV) disproportionately affects young men who have sex with men (YMSM). For HIV-positive individuals, adherence to antiretroviral therapy (ART) is critical for achieving optimal health outcomes and reducing secondary transmission of HIV. However, YMSM often struggle with ART adherence. Novel mobile phone apps that incorporate game-based mechanics and social networking elements represent a promising intervention approach for improving ART adherence among YMSM. Objective: This study used a multiphase, iterative development process to create an ART adherence app for YMSM. Methods: The three-phase development process included: (1) theory-based concept development jointly by public health researchers and the technology team, (2) assessment of the target population’s ART adherence needs and app preferences and development and testing of a clickable app prototype, and (3) development and usability testing of the final app prototype. Results: The initial theory-based app concept developed in Phase One included medication reminders, daily ART adherence tracking and visualization, ART educational modules, limited virtual interactions with other app users, and gamification elements. In Phase Two, adherence needs, including those related to information, motivation, and behavioral skills, were identified. Participants expressed preferences for an ART adherence app that was informational, interactive, social, and customizable. Based on the findings from Phase Two, additional gaming features were added in Phase Three, including an interactive battle, superhero app theme, and app storyline. Other features were modified to increase interactivity and customization options and integrate the game theme. During usability testing of the final prototype, participants were able to understand and navigate the app successfully and rated the app favorably. Conclusions: An iterative development process was critical for the development of an ART adherence game app that was viewed as highly acceptable, relevant, and useful by YMSM.


Introduction
In the United States, youth accounted for approximately 26% of new human immunodeficiency virus (HIV) infections in 2010 [1]. Among youth, young men who have sex with men (YMSM) accounted for 72% of new HIV infections and were the only risk group that experienced a significant increase in HIV incidence [1,2]. Once diagnosed with HIV, youth are less likely to engage in HIV care, receive a prescription for antiretroviral therapy (ART), and have sustained adherence [3]. For those on ART, daily, lifelong adherence is necessary to maximize health benefits and reduce the likelihood of onward HIV transmission [4][5][6][7][8]. Novel, sustainable interventions that improve adherence to ART among HIV-positive YMSM are needed to improve individual health, decrease health care costs, and reduce HIV transmission risk [8].
The near saturation of the smartphone market among youth and young adults in the United States has created opportunities for reaching a large number of young people with health behavior interventions, including those that address ART adherence [9]. In a recent review of the literature on smartphone, Internet, and Web 2.0 interventions for HIV prevention and care, 10 published or ongoing studies were identified that used smartphones to improve ART adherence, including the intervention described in this paper, Epic Allies. Epic Allies was the only intervention identified that was explicitly designed to meet the specific adherence needs of YMSM [10].
Games are increasingly used to address behavioral and psychological factors associated with adherence to medical treatment regimens [11]. Games are goal-oriented, immersive, challenging, and motivating and can be used to improve attitudes and self-efficacy for health behavior change [12][13][14][15]. Social engagement and provision of support are also powerful tools for behavior change, particularly for HIV-positive YMSM who often experience social isolation from HIV-related stigma and homophobia [16][17][18]. Social networking is one tool that can be used to connect individuals around a specific health issue and allow for the provision and receipt of social support [19]. Because youth and young adults are the most avid users of games and social media [20,21], inclusion of gaming and social networking-based elements into mobile phone applications represents a promising health behavior change intervention strategy. The purpose of this study was to develop Epic Allies, a gaming app with behavior tracking features and social networking elements, to improve ART adherence among HIV-positive YMSM. This paper highlights the importance of using an iterative design process, including obtaining feedback from YMSM at each stage of development, to achieve optimal app design and functionality.

Introduction
The Epic Allies development team was assembled in September 2013. The team consisted of medical and public health researchers from University of North Carolina (UNC) and Duke University (Duke) and a technology team from Caktus Consulting Group (Caktus) with expertise in app design, development, and programming. During the initial meeting, the team agreed to a three-phase approach to app development. The first phase included the development of the initial app concept, which was theoretically grounded in the Information, Motivation, and Behavioral Skills (IMB) model of behavior change (September 2013) [22]. The second phase involved the development and refinement of an early prototype of selected app features and collection of formative data from HIV-positive YMSM, ages 18 to 29, to inform app development (October-December 2013). The third phase consisted of final app prototype development and internal and external usability testing (January-May 2014).

Phase One
Weekly team meetings focused on app concept development based on the IMB model. The IMB, which has frequently been used to guide the development of ART adherence interventions, conceptualizes health behavior change (eg, medication adherence) as a product of mediators including information about the behavior, motivation to change, and the skills needed to achieve change [22]. Using this model as a guide, our multidisciplinary team outlined and iteratively created a paper prototype of potential features, including gaming and social networking elements.

Phase Two
At the beginning of Phase Two, a clickable prototype of the Epic Allies app was developed for the Android operating system. Three focus groups were then conducted in Raleigh, Durham, and Charlotte, North Carolina with 20 HIV-positive YMSM, ages 20 to 28 to (1) assess ART adherence information, motivation, and behavioral skills needs, (2) determine strategies to address these needs via a mobile app, and (3) gather feedback on the evolving features of Epic Allies and future feature concepts. Before the focus groups began, each participant completed a brief survey on sociodemographics, Internet/mobile phone use, and ART adherence and selected a pseudonym to protect participant confidentiality during the focus group. After discussing adherence needs and strategies for addressing them through an app, participants used study smartphones to explore and provide feedback on the current Epic Allies prototype. The duration of the focus groups was approximately 90 minutes. Groups were audio recorded, transcribed, and then analyzed using Dedoose qualitative data analysis software [23] to identify a range of themes across participants. Quotes representing common responses and variations within each theme were identified by study team consensus. After each focus group, the study team met to discuss preliminary findings and themes and to identify key features to add or remove from the Epic Allies prototype. An updated clickable prototype was created prior to each subsequent focus group in an iterative development process.

Phase Three
The team worked collaboratively to modify the initial conceptual design of the app based on the focus group findings and created a final plan for app features and functionality. The final app prototype was developed incrementally with components added and refined weekly. Research staff members from UNC and Duke conducted ongoing testing of new versions of the prototype to identify bugs and provide feedback on the user interface and navigation experience. After a full prototype was completed, five new internal testers assessed all functionality of the app to identify any remaining technical glitches or usability concerns. Caktus used the detailed feedback from this internal testing to develop a polished version of the final app prototype for external usability testing.
In April and May 2014, external usability testing was conducted with seven HIV-positive YMSM, ages 20 to 28. External usability testing aimed to assess whether users: could successfully navigate features and functions of the app, could comprehend the educational content, and found the app to be engaging and relevant. After providing informed consent and completing a brief survey on sociodemographics, Internet/mobile phone use, and ART adherence, participants met with a member of the development team and a member of the research team to "walk through" the app. Other members of the team (including developers and researchers) watched a live audio-video stream of the testing in a separate room. To protect participant confidentiality during the audio-video streaming, participants used pseudonyms and the video only captured the participant's hand movements and the app screen. Participants were given a checklist of tasks to complete within the app at hypothetical intervention days 1, 21, and 42. These days were selected to give usability participants an opportunity to test features they would see on day 1, representing the first time they had used the app, and on days 21 and 42 after they had been tracking their adherence and gaining power and points within the game. A checklist was provided to guide users through the tasks for each day. Participants were asked to "think aloud" and share thoughts and questions that came up as they were completing tasks. After completing the tasks and providing feedback, participants completed a 9-question survey adapted from the System Usability Scale [24][25][26][27]. Usability testing sessions were recorded, transcribed and analyzed using the same methods described for the focus groups. Quantitative survey and usability results were summarized using Excel.

Phase One
The initial Epic Allies app concept included features designed to address potential IMB ART adherence needs of HIV-positive YMSM based on clinical expertise and a review of the literature. The initial proposed features and their relationship to the IMB are highlighted in Table 1.

Descriptive Statistics
The mean age of focus group participants (n=20) was 24 years. All participants identified as black or African American. Most (15/19, 79%) earned less than US$20,999 per year. All participants owned a smartphone (20/20, 100%) and (11/20, 55%) had used a health app in the past 3 months. There was substantial variation in medication adherence patterns among the 19 participants currently on ART: five had missed at least one dose in the past week, five had missed at least one dose in the past month, and four reported never missing any doses. Key focus group findings are organized into three sections: medication adherence information, motivation, and behavioral skills needs; strategies for addressing medication adherence information, motivation, and behavioral skills needs in an app; and strategies to motivate app use.

Medication Adherence Information, Motivation, and Behavioral Skills Needs
Information needs identified by participants included understanding dosing times and information about side effects and side effects management. Participants also expressed confusion about appropriate dosing times and the number of pills required per week to constitute medication adherence. In one focus group, participants discussed differences in provider instructions regarding missed doses.

Grayland: Goku, it's strange that you say your doctor gave you a 4-hour time window to take your meds. Mine only gave me like an hour. I mean he [doctor] said if you happen to miss, you have an hour window. If you don't take it by then you might as well skip it and take it the next day. [Goku & Grayland, Raleigh]
Side effects knowledge and management was also a consistent theme across focus groups. Participants felt that those new to medications or switching medications should be aware of potential side effects and how to cope with them.
Acceptance of HIV status was identified as a key adherence motivation need. Participants spoke of the denial and internalized stigma they experienced around their diagnosis and the fear they had around living with a highly stigmatized health condition that would require lifelong medical management. Those who had not accepted their status were less motivated to take their medication, as taking their medication was a daily reminder that they had HIV.
Yeah, cause honestly, it was a good few months before I ever took medication. And in that timeframe of diagnosis to taking medication, it was very easy for me to detach. It was very easy for me to say, this is not real, nahhh, whatever. It didn't become real until I had to take a pill. When you take a pill, it's real.

[Brett, Raleigh]
A lot of the people who you say do forget to take their medications, those are the people who have the mind set of they don't want the disease, or the health condition, to be a banner for them, they don't want that to be the representation of them. [Crowned, Charlotte] Social support had a strong influence on motivation to adhere to medications. Some of the participants who disclosed their status reported receiving social support that helped them deal with the fear and uncertainty of an HIV diagnosis. The support often motivated individuals to receive HIV care and adhere to medications. However, many participants did not feel they had people that they could talk to about their diagnosis due to both the fear of HIV stigma or previously experienced stigma associated with their sexuality. Individuals who had not disclosed their status to their social circle often relied on social workers, case managers, or therapists for adherence motivation.
Participants who experienced medication side effects also had less motivation and lower self-efficacy in their ability to fully adhere to their medication.

Strategies for Addressing Medication Adherence Information, Motivation, and Behavioral Skills Needs in an App
After discussing general adherence needs, participants were asked about the ways an app could help them with adherence. Medication reminders were suggested as an important tool for those who had difficulty remembering to take their medications. Participants emphasized the importance of discreet reminders so that their HIV status would not be revealed if someone saw the message on their phone. Several participants felt that it was important to provide other types of information through the app, including current information about HIV.

Strategies to Motivate App Use
Participants were asked about features that would motivate them to use a medication adherence app. Several overarching themes emerged including the importance of creating an app that is interactive, engaging, social, informational, customizable, and personalized. The men noted that these features would help capture their attention, motivate them to use the app regularly, and improve the likelihood of sustained use.
Participants emphasized the importance of interactivity. Games were seen as a good way to increase app use. In addition, many participants thought rewards for activities within the app would be highly motivating and promote ongoing engagement. Customization was important so users could selectively choose the features most relevant for them.
Put it this way: you want people to use the app daily, it needs to be as comfortable for them as possible. They need to be able to do whatever they want to do with it…because it's their phone, it's their medication, it's their health care. [Brett, Raleigh] Avatars were discussed as a way for users to have a virtual representation within the app and were highly acceptable. There were different perspectives on the level of customization needed to sustain interest, but all participants preferred a personalized avatar.

Development of Full Prototype for Usability Testing
Focus group findings informed the development of the full prototype for usability testing. Changes to the features initially conceptualized in Phase One are highlighted in Table 2. The app storyline and screenshots of selected features are included in Textbox 1 and Figures 1-3.     The storyline and superhero theme were added in response to focus group participants' request for an engaging and interactive user experience that would motivate regular app use.
An app storyline was developed to explain the superhero theme, provide a backstory for the app and to introduce users to their role in the game (Textbox 1). A virtual guide, Walter, was created to present the storyline to users and provide a tour of the app. Superhero theme, app storyline, virtual guide -The Battle feature was introduced to increase app engagement, motivate participants to complete activities within the app, and encourage interactions with Allies.
The objective of the Battle is to collect virtual cards used to defeat the monsters in the city of Medopolis. Each day, players fight a new battle to defeat a monster; success or failure depends on the set of three cards they have in their hand. Players can buy and upgrade their cards using points earned by engaging in other parts of the app. Within the Battle, a new social component called the "Spotlight" was created. Using the spotlight, participants can call on their Allies to help defeat difficult monsters.
The Battle -Focus group participants emphasized the need for social support for adherence. The profile was changed to create a stronger sense of community among users.
The avatar concept was expanded to include more detailed information about users such as interests, hobbies, and current ART use.

Profile Customizable avatars
This change responded to focus group participants' request for customization within the app.
The Dashboard feature expanded to include additional tracking options such as exercise, smoking, drug and alcohol use, and mood.

Dashboard Dashboard
Focus group participants noted that reminders are an important feature to include in an adherence app. However, those who already have strategies for remembering to take their medications may not need them. The change allows users to customize the app to their needs. Expansion of tailored feedback was designed to provide additional customized feedback on factors related to adherence.
Reminder messages were made optional. Tailored feedback was expanded to include messages on new tracking options (ie, exercise, smoking).

Reminder messages and tailored feedback
The name was changed to align with the storyline and superhero theme. The "Spotlight" feature enhanced the ability for users to interact with their Allies in an interactive and fun way.
The name was changed from "Friends" to "Allies". The feature was expanded to include the "Spotlight" feature described in the Battle section above.

Allies Friends
The Daily Dose replaced the educational modules so that informational needs could be addressed in an engaging and interactive manner (ie, proper dosing guidelines, common medication side effects, coping with side effects, HIV acceptance process, identifying sources of social support). Users are encouraged to log into the app daily to get a new article. Awarding points increases motivation for reading articles and app engagement.
The information modules were replaced with the Daily Dose, an app newspaper that follows a curriculum of daily short articles and tips to address HIV and ART knowledge and promote disease management. Reading an article earns users points that can be used to buy new cards for the Battle.

Daily Dose Information modules
The additional gamification features were added to increase motivation for behavior change and app use.
The gamification principles were expanded so that users earned points for each completed activity in the app. A "leveling up" feature was added so that users could unlock new battles.

Gamification Gamification
The year is 2024, a pharmaceutical plant has just exploded sending poisonous rays throughout the city of Medopolis. Walter, the scientist responsible for the accident, has managed to escape, though not without sustaining some damage. The poison has wreaked havoc in Medopolis and unleashed monsters who are trying to destroy the city. Only you and your superhero allies can help. Walter will be your guide as you work together to gain knowledge and power to fight the monsters and restore Medopolis to its former glory.

Usability Testing Results
The mean and median age of participants was 23 years (n=7). Six participants identified as black or African American and one identified as white. Over half (4/7) earned less than US$20,999 per year. All participants owned a smartphone and more than half (4/7) had used a health app in the past 3 months. All participants were on ART to treat their HIV infection, but less than a third (2/7) said they never missed any of their medication.
Usability testing assessed participants' ability to successfully navigate the app, comprehend the educational content, and determine if they found the app to be engaging and relevant. Usability scores are presented in Table 3. For all items, the mean responses indicated a favorable evaluation (agree/strongly agree) of Epic Allies. All participants were able to successfully complete the checklist of tasks representing days 1, 21, and 42 of app use. The checklist included tasks such as entering medications, setting up a medication reminder, reading the Daily Dose newspaper, upgrading Battle cards, playing Battles, and calling on an Ally to help them during a battle using the "Spotlight" card ( Figure 4). Overall, usability testing participants found the app to be engaging and relevant to their lives. As one man noted: Several participants commented on the importance of the Allies social networking element. The overarching theme was that the feature could help participants feel they are not alone in taking medications for HIV.

The app gives you the sense that you aren't alone. I'm not the only one keeping up with my meds everyday and playing the game everyday. [Participant 3]
While most feedback about the app was positive, participants also made suggestions for app improvement. Some men felt the Battle feature of the app would be more engaging with increased interactivity. They expressed concerns about the turn-based mechanics in the card game: Well, I don't like the fact that the enemy just automatically 'gets his turn' and I just gotta stand back for the enemy to just demolish me. I would really like, if it's possible, you know how like computer video games are…I guess more of an interactive fight.

[Participant 3]
After completing the tasks assigned for hypothetical Day 1 of app use, over half (4/7) of usability testing participants did not fully understand how the character in the Battle was associated with adherence. By the end of the usability session, all participants were able to describe the relationship between the Battle character and adherence. However, participants noted that it is important to clearly establish this link during the first day of app use.

Discussion
Overview Smartphone app interventions are increasingly used to promote positive health behaviors among individuals living with HIV, including ART adherence [10,[28][29][30]. In this study, a smartphone app was viewed as a highly acceptable tool for the delivery of an ART adherence intervention. Other studies have also found that adult men who have sex with men and YMSM view smartphone apps as an acceptable delivery mechanism for HIV-related interventions [31][32][33][34]. However, to our knowledge, no ART adherence apps have been designed to meet the unique adherence needs of YMSM. This study used an iterative development process to create a theory-based game adherence app for YMSM. Based on input and feedback from study participants, the initial app concept was incrementally modified and enhanced to create the final app prototype. This highlights the importance of seeking target population input and using an iterative process in the development of behavior change apps.
Focus group participants identified key IMB needs and proposed strategies for addressing these needs through a smartphone app. The men identified a need for specific information about adherence-related topics, such as dosing schedules and side effects, and recommended that the app provide general information about HIV and adherence. Medication side effects and side effects management was a specific area of interest because, as in other studies of HIV-positive youth side effects were identified as a barrier to adherence [35,36]. The Daily Dose feature, a virtual newspaper delivered through the app daily, was developed for the final prototype. The daily nature of the feature allowed for an increase in the amount of content delivered and provided an opportunity to address the specific and general informational needs identified in the focus groups.
A key theme associated with motivation for adherence was acceptance of HIV status. Several men noted that those who have not yet accepted their diagnosis might not be motivated to take their medications because doing so reminds them that they have HIV. Pill taking as a reminder of HIV infection has been found to be a key barrier to adherence in other studies of youth and young adults [35]. In contrast, social support was viewed as a motivating factor for adherence and participants recommended that the app include opportunities for users to give and receive social support. Among youth and young adults, social support has been identified as a facilitator for ART adherence while lack of support is a barrier [35,37]. In one study of racial and ethnic minority youth, greater social support predicted greater self-efficacy, which was associated with improved adherence [37]. In other studies, YMSM have indicated a preference for HIV-related apps that provide a platform for giving and receiving support [32,33]. Presenting opportunities for interactions with other HIV-positive YMSM through the Allies feature of Epic Allies may help those struggling with acceptance of HIV status feel like a part of a community and increase perceptions of support for adherence.
Consistent with other studies on ART adherence among youth and young adults [35,38], forgetting to take medications was identified as a challenge. Even though some men had developed strategies for remembering to take their medications and did not need reminders, participants agreed that reminders should be included in an ART adherence app. In response to the desire for customization, the medication reminder feature was made optional in the final prototype developed in Phase Three.
Participants also provided important guidance on app characteristics that would motivate regular and sustained app use. Interactivity through games, points, rewards, and social interactions were discussed as motivating factors for app use. Among adult and young MSM, interactivity has been emphasized as a necessary function of mobile apps [33,39]. The superhero theme and Battle feature introduced during the last focus group was viewed as a promising approach to further enhance app interactivity. While customization was viewed as important for meeting unique adherence needs, it was also important for motivation for app use. For example, participants noted that unnecessary reminders would be annoying and intrusive and increase the likelihood that they would discontinue app use. Another study of YMSM also found a preference for customization in HIV-related app interventions with unnecessary reminders and alerts resulting in app avoidance or deletion [33].
The feedback gathered during usability testing in Phase Three was generally positive and constructive and offered actionable guidance for changes to the app features prior to further testing. In response to suggestions provided during usability testing, the turn-based mechanics in the Battle were eliminated to increase interactivity and engagement. In order to quickly establish the link between real-world medication adherence and the character's strength and performance in the game, the virtual guide's initial app introduction was modified to explicitly explain the relationship. The Dashboard was changed so that it featured more prominently in the app and now serves as a constant reminder of the relationship between the user's adherence behaviors and game play.

Limitations
Our study was limited by its small sample size and geographical region. Though common in qualitative research, this limits the ability to generalize the study findings to all YMSM in the United States. Further, the majority of study participants identified as black or African American, which reflects the high burden of infection among black or African American individuals in study area [40]. While this may limit generalizability of findings to YMSM of other races or ethnicities, it should be noted that none of the app recommendations were unique to black MSM [39,41]. It is highly likely that the findings are relevant for YMSM of all races and ethnicities. However, future studies are needed to test the app with a more racially and ethnically diverse sample.
Epic Allies represents only one type of technology-based intervention that could be developed to address ART adherence among YMSM. Other less costly approaches could be used, such as interventions built on existing social media sites or adaption of currently available medication adherence apps for other medical conditions. However, our formative work with YMSM in the United States found a demand for an app intervention that integrates multiple features including behavior tracking, social networking features, and gaming features [32,33]. Existing commercial HIV apps often lack a theoretical basis, are limited in the topics they address and features they offer, have failed to capture the attention of end users and have not undergone rigorous evaluation [28,29]. If successful, the planned commercialization of Epic Allies would justify the costs invested and address the dearth of theoretically grounded, multicomponent commercial apps designed to address ART adherence.
The IMB is a well-established model of behavior change that has been used by researchers to guide the development of technology-based HIV interventions [42][43][44]. However, modifications of existing behavior change models or theories, including the IMB, are needed to more effectively account for the dynamic nature of technology-based interventions [45,46]. Such modifications will help guide future intervention development and evaluation of engagement and effectiveness [45,46]. With an eye toward adapting existing theories, our team has developed alternative measures of engagement in technology-based interventions and will be exploring these and other approaches in the randomized controlled trial of Epic Allies [47]. Furthermore, we will seek to identify the specific elements of Epic Allies that contribute to changes in information, motivation, and behavioral skills and, ultimately, medication adherence.
The results from usability testing indicated a positive response to the Epic Allies app. However, these findings were limited to a walk-through of the app in a controlled environment. This type of testing, while appropriate for app development, may not reveal barriers to implementation in the real world. The app was carefully designed to quickly engage users, sustain motivation for daily, long-term app use, and minimize the usage of phone data; however, the success of these strategies will not be known until the app is tested in a randomized controlled trial. In spite of these limitations, this study provides key insights into a process of app development that engages the target population to develop an app appropriate for end-user needs and preferences.

Conclusion
Focus group and usability findings confirmed the appropriateness of a game-based app with social networking features to address ART adherence for YMSM. As evidenced by the changes made to the app between initial concept and final prototype, an iterative approach is critical for developing an app that is relevant, engaging and useful. This multistage process of development can be used to develop different types of health behavior apps for a wide range of populations.