P3 (Prepared, Protected, emPowered) (P3)

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

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 Overview

• Status: Completed
• Conditions: Sexually Transmitted Diseases; Adherence, Medication; Safe Sex
• Intervention / Treatment: Behavioral: P3; Behavioral: P3+; Behavioral: Control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 246
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • University of South Florida Infectious Diseases
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • PRISM Health
  • Illinois
    • Chicago, Illinois, United States, 60612
      • The Adolescent and Young Adult Research (AYAR) at the CORE Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • The Fenway Institute
  • New York
    • Bronx, New York, United States, 10467
      • Children's Hospital at Montefiore
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC-Chapel Hill
    • Charlotte, North Carolina, United States, 29202
      • RAIN
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Adolescent Initiative at Children's Hospital of Philadelphia
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 24 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Are aged 16-24
• Were assigned male sex at birth
• Report sex with men or transgender women
• 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 on PrEP have an active PrEP prescription (prescription confirmed by study staff)
• Recruited from one of 9 subject recruitment venues (SRV) cities (Atlanta, Georgia; Boston, Massachusetts; Bronx, New York; Chicago, Illinois; Houston, Texas; Philadelphia, Pennsylvania; Tampa, Florida; Chapel Hill, NC; Charlotte, NC)

Exclusion Criteria:

• 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
• Living with HIV
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: P3; Participants will use P3	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.; Other Names: Prepared, Protected, emPowered
EXPERIMENTAL: P3+; Participants will use 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+.
PLACEBO_COMPARATOR: Control; Participants will receive the standard of care	Behavioral: Control; Control participants will receive the standard of care for receiving a prescription for PrEP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP Adherence Defined by Tenofovir Diphosphate (P3 and P3+ vs Control)	PrEP adherence is measured by blood sample levels of tenofovir diphosphate (TFV-DP) with blood concentration consistent with > 4 doses/week at 3- and 6- month follow-ups. The estimation of the average treatment effect compared P3 and P3+ combined to Control.	Month 3, Month 6
PrEP Adherence Defined by Emtricitabine Triphosphate (P3 and P3+ vs Control)	PrEP adherence is measured by blood sample levels of emtricitabine triphosphate (FTC-TP) with blood concentration consistent with > 4 doses/week at 3- and 6- month follow-ups. The estimation of the average treatment effect compared P3 and P3+ combined to Control.	Month 3, Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Self-reported Retention in PrEP Clinical Care	The investigators define "retention in care" as at least 1 PrEP clinical visit occurring in the last 3 months.	Month 3, Month 6
PrEP Persistence	PrEP persistence will be measured by self-report at follow up of current PrEP use.	Month 3, Month 6
Insertive Condomless Anal Sex	Sexual Practices were assessed by self-reported number of insertive condomless anal sex occurrences during the past 3 months. This question is asked at the 3- and 6-month follow-up surveys.	Month 3, Month 6
Receptive Condomless Anal Sex	Sexual Practices were assessed by self-reported number of receptive condomless anal sex occurrences during the past 3 months. This question is asked at the 3- and 6-month follow-up surveys.	Month 3, Month 6
Sexually Transmitted Infections (STI) Incidence	Self-reported STIs (combined rectal and urethral gonorrhea and chlamydia, syphilis) in last 3 months. This question is asked at the 3- and 6-month follow-up surveys.	Month 3, Month 6
PrEP Adherence Defined by Tenofovir Diphosphate (P3 vs Control and P3+ vs Control)	PrEP adherence is measured by blood sample levels of tenofovir diphosphate (TFV-DP) with blood concentration consistent with > 4 doses/week at 3- and 6- month follow-ups. The estimation of the average treatment effect compared P3 to Control and also P3+ to Control.	Month 3, Month 6
PrEP Adherence Defined by Emtricitabine Triphosphate (P3 vs Control and P3+ vs Control)	PrEP adherence is measured by blood sample levels of emtricitabine triphosphate (FTC-TP) with blood concentration consistent with > 4 doses/week at 3- and 6- month follow-ups. The estimation of the average treatment effect compared P3 to Control and also P3+ to Control.	Month 3, Month 6
Self-Reported Weekly PrEP Use	Number of participants reported taking their PrEP medication >/= 4 days in the past week.	Month 3, Month 6
Self-Reported Monthly PrEP Use	Median self-reported percent of time in the past month that participants' took their PrEP as prescribed.	Month 3, Month 6
Mean Site-Level Intervention Cost	Information was collected on (1) time spent by study staff for training and supervision of adherence counselor(s); (2) time participants spent in the adherence counseling sessions; and (3) costs associated with the delivery of both P3 and P3+. Resources were organized into standard expenditure categories and attributed to the corresponding P3 or P3+ arm and study site as appropriate.	Throughout the duration of the study, approximately 1.5 years

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Baylor College of Medicine; Children's Hospital of Philadelphia; University of South Florida; Emory University; Duke University; Ruth M. Rothstein CORE Center; The Fenway Institute; Montefiore Hospital
• Investigators: Principal Investigator: Lisa Hightow-Weidman, MD, UNC Chapel Hill

Publications and helpful links

General Publications

• Budhwani H, Yigit I, Maragh-Bass AC, Rainer CB, Claude K, Muessig KE, Hightow-Weidman LB. Validation of HIV Pre-Exposure Prophylaxis (PrEP) Medication Scales with Youth on PrEP: PrEP Confidence Scale and PrEP Difficulties Scale. AIDS Patient Care STDS. 2022 Nov;36(11):443-450. doi: 10.1089/apc.2022.0072. Epub 2022 Oct 27.
• LeGrand S, Knudtson K, Benkeser D, Muessig K, Mcgee A, Sullivan PS, Hightow-Weidman L. Testing the Efficacy of a Social Networking Gamification App to Improve Pre-Exposure Prophylaxis Adherence (P3: Prepared, Protected, emPowered): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Dec 18;7(12):e10448. doi: 10.2196/10448.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 15, 2019
• Primary Completion (ACTUAL): September 16, 2021
• Study Completion (ACTUAL): September 16, 2021

Study Registration Dates

• First Submitted: October 3, 2017
• First Submitted That Met QC Criteria: October 20, 2017
• First Posted (ACTUAL): October 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 4, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: truvada; adherence; PrEP; HIV prevention; mHealth; eHealth; gamification; app; transgender women; ymsm
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Sexually Transmitted Diseases
• Other Study ID Numbers: 17-1951; 5U19HD089881-02 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No