SBIR-STTR Award

Although strict adherence to antiretroviral therapy (ART) is required to achieve health benefits of treatment, there are no known interventions that have improved ART adherence among young Black men who have sex with men (YBMSM). Novel, sustainable interventions that improve adherence to ART among HIV+ YBMSM are needed to improve individual health, decrease health care costs, and reduce HIV transmission risk. The overall objective of the proposed research is to design a novel mobile phone application ("app") utilizing game mechanics and social networking features to improve and optimize the durability of ART adherence among YBMSM ages18-29. The rationale that drives the proposed research is that innovative approaches that utilize widely available technology and are engaging, interactive, tailored and theory driven are more likely to improve ART adherence among YBMSM than existing interventions. Data demonstrating high levels of access to and use of mobile phones among YBMSM points to the importance of using tools based in these technologies. The proposed SBIR Phase I research has three specific aims: 1) Formative research: Conduct focus groups to better understand the ART information, motivation and behavioral skills needs of the target population and identify the best strategies for addressing these needs through the mobile game app; 2) Technology development: Develop the smartphone app (Daily Dose, or 2D) based on the Information, Motivation, and Behavior Skills model of ART adherence supplemented by gamification principles; and 3) Usability testing: Test the intervention with an internal testing group and members of the target population to identify any potential problems with the mobile game app and allow for optimization of the intervention. The proposed research is innovative because it will develop a mobile game app that uses a wide range of smartphone features to create an ART adherence intervention for HIV+ YBMSM that is individually tailored, highly interactive and engaging, provides opportunities to learn important self-management skills related to medication adherence and is highly relevant in today's world and the lives of YBMSM. This research is significant because it will address a critical need for effective ART interventions for HIV+ YBMSM that is delivered through a widely utilized technology medium and uses a game approach, which is expected to be highly appealing and engaging for the targeted population. Moreover, the creation of a novel technology based adherence tool could be easily adapted for other highly prevalent and costly chronic diseases that require consistent medication adherence. Key indicators of success in Phase I include: functional prototypes of the 2D app and mock- up representations of other app features; usability test results; and an action plan for Phase II.

Public Health Relevance Statement:


Public Health Relevance:
The development of a mobile phone ART adherence game app as we propose will have a high public health impact because it will reach the group with the highest incidence of new HIV infections, young black men who have sex with men (BMSM). Our intervention will address determinants of poor adherence behaviors such as a lack of adherence information, motivation, and behavioral skills and most importantly, engage young BMSM in a fun, ongoing and unremitting way. The advanced technologies used in the proposed novel intervention are consistent with NIH's emphasis on innovation. We plan to use the Information, Motivation Behavior (IMB) model to develop, and usability test a mobile phone based game app intervention called 2D (Daily Dose) to improve adherence to ART among HIV infected young BMSM.

NIH Spending Category:
Behavioral and Social Science; Bioengineering; Clinical Research; HIV/AIDS; Infectious Diseases; Mental Health; Prevention

Project Terms:
Acquired Immunodeficiency Syndrome; Address; Adherence (attribute); Adverse effects; Affect; Age; Alcohol or Other Drugs use; antiretroviral therapy; Back; base; Behavior; behavior change; Behavioral; Car Phone; Chronic Disease; coping; Data; design; Development; Disease; Dose; Educational aspects; experience; Family; Feedback; Focus Groups; Goals; Health; Health Benefit; Health Care Costs; HIV; HIV Infections; Immunologics; improved; Incidence; Individual; information gathering; innovation; Intervention; Learning; Link; Mechanics; medication compliance; member; men; men who have sex with men; Modeling; Modification; Motivation; new technology; novel; Outcome; Participant; Patient Self-Report; Persons; Phase; prototype; public health medicine (field); public health relevance; Randomized Controlled Trials; Reporting; Research; response; Risk; Risk Behaviors; Sampling; Self Management; sex; skills; Small Business Innovation Research Grant; Social isolation; Social Network; social networking website; social stigma; Social support; success; Target Populations; Technology; technology development; Telephone; Test Result; Testing; theories; therapy adherence; Time; tool; transmission process; usability; Viral Load result; Work

Men who have sex with men (MSM) account for nearly two-thirds of all new HIV infections in the United States (US) and young MSM (YMSM) are the only risk group experiencing an increase in HIV incidence.1,2 After diagnosis, many YMSM do not enter medical care, get prescribed antiretroviral therapy (ART), adhere to ART regimens or achieve viral suppression. Novel theory-based interventions that optimize engagement in care, ART uptake and ART adherence for HIV+ YMSM are urgently needed to achieve both individual and public health benefits. Our study will evaluate the efficacy Epic Allies, a theory-based mobile phone application (app) that utilizes game mechanics and social networking features to improve engagement in care, ART uptake, ART adherence and viral suppression rates among HIV+ YMSM. Social networking technologies enhance support and reduce social isolation,3-5 while game mechanics engage users to motivate and sustain behavior change. High mobile phone ownership among YMSM supports using intervention tools based in these familiar, available technologies. The app addresses the most common engagement and adherence barriers among youth is tailored for the target population and is customizable for individual users. Epic Allies targets HIV+ YMSM aged 16-24, who are new to care (naive) or non-adherent to ART. Funded by the National Institutes of Health, through a Phase I SBIR application we worked with programmers and designers at Caktus Consulting Group to develop and test the Epic Allies prototype and found it acceptable among a sample of HIV+ YMSM. Our current Phase II proposal has 3 aims: Aim 1: Refine Epic Allies for use in a clinic-based trial and expand the scope of the developed app to address engagement in care and ART uptake. Enhancements to the social networking features of the app will be made to ensure the communication and support needs of youth who are not currently on ART and those new to care are met. To inform these changes, we will conduct in-depth usability interviews with 8-10 YMSM not currently on ART and new to care. Aim 2: Test Epic Allies app among 300 HIV+ YMSM recruited from 14 Adolescent Trials Network (ATN) sites. We will conduct a 2-arm randomized controlled trial with measures at baseline 3, 6 and 12 months. Primary outcome measures will include engagement in care, ART uptake, medication adherence and viral load suppression. Aim 3: Conduct a process evaluation of Epic Allies including intervention acceptability, impact and long-term sustainability. Qualitative in-depth exit interviews (n=30) wil evaluate Epic Allies' acceptability with the target population and its potential to improve engagement in care, uptake of ART and adherence. This project has high public health impact as it will address the current gap in scientific knowledge regarding how to best assist YMSM who are newly diagnosed with HIV and those who have adherence difficulties in order to improve medical, psychological, and public health outcomes. Moreover, the creation of a novel technology based adherence tool could be easily adapted for other highly prevalent and costly chronic diseases.

Public Health Relevance Statement:


Public Health Relevance:
Engagement in care, antiretroviral (ART) uptake and medication adherence is crucial for youth diagnosed with HIV in order to improve individual and public health outcomes. HIV+ youth demonstrate lower rates of ART use, higher loss to follow-up, more difficulty with strict daily medication adherence, and ultimately worse clinical outcomes compared to adults. Young HIV+ men who have sex with men (YMSM) face additional barriers to care from added negative social and psychological challenges associated with their sexual identity. Epic Allies is a marketable, novel mobile phone application (app) that utilizes game mechanics and social networking features to improve engagement in care, ART uptake and medication adherence among HIV+ YMSM.

Project Terms:
Accounting; Address; Adherence (attribute); Adolescent Medicine Trials Network; Adult; Affect; Affective; Age; aged; AIDS/HIV problem; Alcohols; Ally; Anti-Retroviral Agents; antiretroviral therapy; arm; Award; base; Behavior; behavior change; Behavior Therapy; Car Phone; Caring; Cellular Phone; Chronic Disease; Clinic; Clinic Visits; Clinical; Communication; Consult; Data; Diagnosis; Drug usage; effective intervention; Effectiveness; Engineering; Ensure; Evaluation; Exercise; experience; Face; Family; follow-up; Friends; Funding; Health Benefit; Health Care Costs; Health Promotion; HIV; HIV diagnosis; HIV Infections; Imagery; improved; Individual; Insurance Carriers; Intervention; Interview; Knowledge; Lead; Learning; Life; Measures; Mechanics; Medical; medication compliance; meetings; men; men who have sex with men; Mental Depression; Modality; new technology; Newly Diagnosed; novel; Outcome; Outcome Measure; Ownership; patient population; Patients; Phase; primary outcome; Process; prototype; Provider; psychologic; public health medicine (field); public health relevance; Randomized Controlled Trials; Recruitment Activity; Regimen; Risk; Sampling; secondary infection; Self Management; sex; Site; skills; Small Business Innovation Research Grant; social; Social isolation; Social Network; Social support; Target Populations; Technology; Testing; theories; therapy adherence; Time; tool; United States; United States National Institutes of Health; uptake; usability; Viral; Viral Load result; Work; Youth