A Multilevel Gaming Intervention for Persons on PrEP

The use of antiretroviral medications to reduce the risk of acquiring HIV infection
(Pre-exposure Prophylaxis, PrEP) is an efficacious and promising new prevention strategy. In
published studies, failure of PrEP was associated with poor adherence and low plasma drug
levels. This indicates that optimal PrEP treatment will require behavioral interventions to
promote adherence. Averting increases in risk behavior will also be essential for maintaining
PrEP's protective effects. Interventions will need to address on-going HIV risk behavior and
be relevant for persons using PrEP (e.g. young adult MSM). Borrowing from recent literature
in HIV prevention and treatment adherence, interventions that utilize intuitive easy to use
technologies with motivational components show promise for behavior change and dissemination.

This study will examine a multi-level technology that integrates a medication monitoring
device (Wisepill dispenser) WITH an interactive smartphone based app/game that is immersive
and appealing. This novel, but intuitive multi-level technology will measure PrEP adherence,
promote engagement in treatment and safe sexual behavior. The smartphone app/game will be
developed to include content consistent with the Information-Motivation-Behavioral Skills
(IMB) Model. While gaming, participants will experience absorbing action-oriented adventures
that increase information about their health (e.g. knowledge about PrEP treatment and HIV),
improve motivation (e.g. action-figures experience health benefits of adherence), and build
skills (e.g. utilize clinicians as partners, condom self efficacy). Adherence data from
participants' Wisepill device will be integrated into the app/game wirelessly and will
translate into enhancements during game play. In-depth interviews with young adults on PrEP
and an open trial of the intervention will inform the development of the intervention and
procedures. A small randomized controlled pilot study among 50 participants on PrEP will
examine the preliminary efficacy of the intervention (integration of the Wisepill dispenser
with the IMB informed app/game). It is hypothesized that, compared to subjects in the control
group, participants in the IMB Gaming Intervention will show: improved adherence to PrEP,
higher blood ARV levels, decreased HIV risk behaviors, and improved self efficacy and
attitudes for PrEP treatment adherence.

The specific aims are:

1. To create an engaging and absorbing smartphone based app/game with content consistent
with the Information-Motivation-Behavioral Skills (IMB) model to measure and improve
PrEP treatment adherence and safer sex behaviors, and to receive feedback on the game's
utility and acceptability from in-depth interviews with MSM (estimated mean age 27).

2. To conduct an open trial of the IMB Gaming Intervention (that integrates the electronic,
portable medication dispenser and the IMB game, Viral Combat) with MSM to obtain further
qualitative and quantitative information on its acceptability, and feasibility. These
data will be used to modify the approach and technology as needed.

3. To evaluate, in a 24 week randomized controlled pilot study (n=50), the preliminary
efficacy of the IMB Gaming Intervention that integrates the electronic medication
dispenser and the IMB informed app/game compared to a time, attention, and technology
matched group. We will examine the impact of the IMB Gaming Intervention in improving
treatment adherence (measured by medication dispenser openings, clinic visits attended,
self-report) and biological measures (ARV levels). We will also examine the impact on
HIV risk behaviors.

Inclusion Criteria: All males on PrEP over the age of 18

- English speaking

- Receiving prophylactic antiretroviral treatment

- Not enrolled in another PrEP related study

- Able to give consent/assent and not impaired by cognitive or medical limitations as
per clinical assessment.

Exclusion Criteria: