PrEP provides a strong preventative benefit to youth at-risk for HIV infection and there is overwhelming evidence supporting its efficacy. While oral PrEP adherence is highly correlated with its efficacy in clinical trials, adherence rates are variable. In real-world practice settings, PrEP adherence may even be lower, particularly among youth. As such, interventions are needed to improve and sustain adherence to oral PrEP, thereby maximizing its preventative benefits in at-risk populations. P3 (Prepared, Protected, emPowered): Promoting PrEP adherence through a social networking, gamification, and adherence support app is an interactive smartphone app for HIV-uninfected YMSM that utilizes social networking and game-based mechanics as well as a comprehensive understanding of what constitutes ?best practices? in app development to improve PrEP adherence, retention in PrEP clinical care, and PrEP persistence among young MSM ages 16-24. Despite the benefits of app-based interventions, maintaining engagement over time can be particularly challenging. Some have suggested that lack of rapport building contributes to lower retention rates in technology-based interventions. Further, the available literature suggests that some tools, including technology based tools, may be more beneficial to patient adherence when combined with education or counseling. In this 4-year study, 240 YMSM between the ages of 16-24 initiating PrEP will be randomized to P3, P3+ (app intervention plus adherence counseling delivered by a counselor through the app) or standard of care for routine PrEP support as recommended in the CDC guidelines. The primary outcome measure is PrEP adherence measured by TFV-DP levels. The randomized controlled trial to test the intervention will be conducted at six iTech SRV cities (Houston, Philadelphia, Bronx, Chicago, Tampa and New Orleans). Built using the most advanced applications on a successful, evidence-based platform designed and tested by our collaborating technology partner, Ayogo, P3 is flexible and responsive to changes in technology and changes in PrEP practice standards and guidelines recommendations. Empower is Ayogo's health gamification platform for patient engagement that embeds social networking and fundamental game mechanics, such as challenges, points, and social connectivity. Empower blends social features, a condition-specific Knowledge Center, game elements, loss aversion mechanics, biometric device integration, and a daily-habit building interface. The Empower platform also includes a Provide/Counselor Interface that facilitates, secure, two-way communication between a provider/counselor and participant that will be used for, P3+. Developed, piloted and iterated upon over several years, customizations of Empower have now been deployed commercially and have been demonstrated to significantly improve self-efficacy and proven health outcomes. This application supports the overall objectives of the iTech and benefits from the expertise and support provided by Management, Analytic and Technology Cores to achieve our study aims.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Program--Cooperative Agreements (U19)
Project #
5U19HD089881-05
Application #
9955298
Study Section
Special Emphasis Panel (ZHD1)
Project Start
Project End
Budget Start
2020-06-01
Budget End
2021-05-31
Support Year
5
Fiscal Year
2020
Total Cost
Indirect Cost
Name
University of North Carolina Chapel Hill
Department
Type
DUNS #
608195277
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599
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