P3 (Prepared, Protected, emPowered)

Summary

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.

Conditions

• Sexually Transmitted Diseases
• Safe Sex
• Adherence, Medication

Interventions

BEHAVIORAL

P3

P3 is an interactive smartphone app that utilizes social networking and game-based mechanics to improve PrEP adherence and persistence in PrEP care. The participant will install P3 on their phone, receive a guided tour of the app and a reminder card with the research coordinator's phone number and email address and instructed to contact the research coordinator immediately to report difficulties with any app components or to report any problems with their phone or phone service. A help link is embedded within the app that directly links to study staff if assistance is needed. P3 arm participants will have 24-hour access to all features of P3.

BEHAVIORAL

P3+

In P3+, participants receive all of P3 and the ability to text in the app with an adherence counselor, using Next Step Counseling (NSC). NSC is an interactive, client-centered motivational intervention to improve PrEP adherence. Key components of NSC include: review experiences with adherence, exploration of adherence facilitators and barriers, identification of adherence needs, identification of strategies to meet needs, and development of an adherence action plan. Participants will install P3+ on their phone. The adherence counselor feature will be unlocked for those in the P3+ arm. P3+ participants will have 24-hour access to all features of P3+.

BEHAVIORAL

Control

Control participants will receive the standard of care for receiving a prescription for PrEP.

Sponsors & Collaborators

• Emory University

  collaborator OTHER

• Duke University

  collaborator OTHER

• Children's Hospital of Philadelphia

  collaborator OTHER

• The Fenway Institute

  collaborator OTHER

• Montefiore Medical Center

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• Ruth M. Rothstein CORE Center

  collaborator OTHER

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• University of South Florida

  collaborator OTHER

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Lisa Hightow-Weidman, MD · UNC Chapel Hill

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

16 Years

Max Age

24 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-05-15

Primary Completion

2021-09-16

Completion

2021-09-16

Countries

• United States

Study Locations