CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 246 enrolled
Drug / intervention
P3 +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03320512
NCT03320512N/ACompleted
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P3 (Prepared, Protected, emPowered): Promoting Pre-exposure Prophylaxis (PrEP) Adherence Through a Social Networking, Gamification, and Adherence Support App

University of North Carolina, Chapel Hill·interventional·Posted Oct 25, 2017·Updated Oct 25, 2022

In Brief

A clinical study evaluating P3, P3+, and 1 other intervention for Sexually Transmitted Diseases and 2 related conditions. Completed, enrolled 246 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSexually Transmitted Diseases, Safe Sex, Adherence, Medication
CountriesUnited States
CollaboratorsEmory University, Duke University, Children's Hospital of Philadelphia, The Fenway Institute, Montefiore Medical Center, Baylor College of Medicine, Ruth M. Rothstein CORE Center, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of South Florida

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 25, 2017
Enrollment StartMay 15, 2019
Primary CompletionSep 16, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 8.7 years ago

Interventions

P3behavioral

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.

P3+behavioral

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+.

Controlbehavioral

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