P3 (Prepared, Protected, emPowered)
P3 (Prepared, Protected, emPowered) is an interactive smartphone app for HIV-uninfected YMSM and YTW 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 and persistence in PrEP care.
- Sexually Transmitted Diseases
- Safe Sex
- Adherence, Medication
- Eligible Ages
- Between 16 Years and 24 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Are aged 16-24
- Were assigned male sex at birth
- Report sex with men
- Are able to speak and read English
- Have reliable daily access to an Android or iOS smartphone with a data plan
- Are HIV-uninfected (self-report)
- Are not currently on PrEP but plan to initiate in the next 7 days and have an active PrEP prescription (prescription confirmed by study staff) OR initiated PrEP within the last 30 days (<30 days) and have an active PrEP prescription (prescription confirmed by study staff) OR on PrEP >30 days but self-report adherence on average <6 pills per week over the past month and have an active PrEP prescription (prescription confirmed by study staff)
- Recruited from one of 7 subject recruitment venues (SRV) cities (Atlanta, Georgia; Boston, Massachusetts; Bronx, New York; Chicago, Illinois; Houston, Texas; Philadelphia, Pennsylvania; Tampa, Florida)
- Aged younger than 15 years or older than 24 years
- Not available to meet with project staff for planned study visit(s)
- Non-English speaking
- Not currently prescribed PrEP (study staff unable to verify participant has an active PrEP prescription by a health provider)
- Anticipate not having reliable access to a smartphone with a data plan for 2 or more days during field testing or 1 or more weeks during the RCT intervention period
- Planning to move out of study area during the study period
- Unwilling or unable to comply with protocol requirements.
- Participated in field trial phase of P3 study
- Unable to be consented due to active substance use or psychological condition.
- Study Type
- Intervention Model
- Factorial Assignment
- Intervention Model Description
- The trial will consist of a three-arm RCT to test intervention efficacy among young men who have sex with men (YMSM) and young transgender women who have sex with men (YTWSM) who are starting PrEP or are non-adherent to PrEP. Study arms will include P3, P3+, and standard of care (SOC). Participants will be recruited from seven cities. The investigators will enroll up to 240 participants and randomize them 2:2:1 to receive P3, P3+, or SOC. Assessments will be completed at months 0, 3, and 6.
- Primary Purpose
- None (Open Label)
|Participants will use P3||
|Participants will use P3+||
|Participants will receive the standard of care||
- University of North Carolina, Chapel Hill
Study ContactKelly A Knudtson, MPH
Sustainable, integrated PrEP adherence interventions are critically needed to reduce HIV incidence among YMSM and YTW. It is imperative that the investigators develop adherence interventions for YMSM and YTW initiating PrEP that are engaging, age-appropriate and take advantage of technologies that are already embedded in these individual's lives. A smartphone-delivered PrEP adherence intervention is well suited for this population, given they have a high-uptake and utilization of smartphone technology. The use of smartphones to deliver HIV prevention and care interventions has grown substantially in recent years due to: a) wide-scale adoption of smartphone technology among high-risk groups, b) the ability to deliver interventions in real-time within risk contexts, and c) low implementation costs.The accessibility, affordability, anonymity and acceptability of smartphones make them the intervention medium of choice for engaging youth and a logical platform to deliver an adherence intervention targeting PrEP. Further, smartphone interventions address can overcome issues that impede engagement with in-person interventions such as transportation logistics, stigma and confidentiality. Further youth, including YMSM and YTW are receptive to smartphone delivered interventions and these interventions can impact HIV related prevention behaviors.
P3 (Prepared, Protected, emPowered) is an interactive smartphone app for HIV-uninfected YMSM and YTW 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 and persistence in PrEP care. Built on a successful, evidence-based platform designed and tested by our collaborating technology partner, Ayogo, P3 is flexible and responsive to changes in technology. This flexibility will also allow us to quickly respond to and modify our intervention to align with emerging PrEP practice standards and guidelines.
Despite the benefits of app-based interventions, maintaining engagement over time can be particularly challenging. Lack of rapport building may contribute 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. To investigate this possibility, the investigators will include a study arm (P3+) that includes P3 and adherence counseling delivered by a counselor through the P3 app.
This study has three phases, usability testing, field testing, and a randomized-controlled trial (RCT). In usability testing the investigators will test beta versions of the app and gain feedback about the intervention from the target population, identify any technical issues, and get feedback on app content. Field testing is to ensure that the features, platform and content of P3 and P3+ are acceptable to the target population and that there are no technical challenges or user concerns with either the app, the dried blood spot (DBS), hair, or mitra sampling collection.
The last phase is a three arm, RCT that will test the efficacy of P3, a novel, theory-based mobile app that utilizes game mechanics and social networking features to improve PrEP adherence, retention in PrEP clinical care, and PrEP persistence among young men who have sex with men (YMSM) and young trans women (YTW) who have sex with men, ages 16-24. The investigators will test the efficacy of P3 and P3+, which adds Next Step Counseling delivered by an adherence counselor through the app, against PrEP standard of care. Participants will be randomized to P3, P3+, or standard of care. A cost comparison between P3 and P3+ will be conducted.