Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

P3 (Prepared, Protected, emPowered) (P3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03320512
Recruitment Status : Completed
First Posted : October 25, 2017
Last Update Posted : September 28, 2021
Sponsor:
Collaborators:
Emory University
Duke University
Children's Hospital of Philadelphia
The Fenway Institute
Children's Hospital at Montefiore
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
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE October 3, 2017
First Posted Date  ICMJE October 25, 2017
Last Update Posted Date September 28, 2021
Actual Study Start Date  ICMJE May 15, 2019
Actual Primary Completion Date September 16, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2019)
Changes in PrEP adherence from Baseline to Month 6 [ Time Frame: Baseline, Month 3, Month 6 ]
PrEP adherence is measured by blood sample levels of tenofovir diphosphate and emtricitabine triphosphate (TFV-DP/FTC-TP) with blood concentration consistent with > 4 doses/week at 3- and 6- month follow-ups
Original Primary Outcome Measures  ICMJE
 (submitted: October 20, 2017)
Change in PrEP adherence from Baseline to Month 6 [ Time Frame: Baseline, Month 6 ]
PrEP adherence is measured by DBS levels of tenofovir diphosphate and emtricitabine triphosphate (TFV-DP/FTC-TP) blood plasma concentration consistent with > 4 doses/week at 3- and 6- month follow-ups.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
  • Long-term adherence durability [ Time Frame: Month 6 ]
    Protective levels of TFV-DP/FTC-TP at month 6.
  • Self-reported retention in PrEP clinical care [ Time Frame: Month 6 ]
    The investigators define "retention in care" as PrEP clinical visits every 3 months.
  • PrEP persistence [ Time Frame: Month 6 ]
    PrEP persistence will be measured by the average duration of PrEP use before an individual temporarily or permanently discontinues PrEP. This will be collected via self-report at follow up.
  • Sexual Risk Behaviors [ Time Frame: Month 6 ]
    Sexual Practices Assessment Schedule will be used to measure changes in sexual behavior by gender (man, transgender woman, non-binary), three different types of partners (romantic interest, casual partner "hookup" or friend with benefits), use of condoms during the past 3 months, and knowledge about partners' HIV status or PrEP use.
  • Changes in Sexually Transmitted Infections (STI) Incidence [ Time Frame: Baseline, Month 3, Month 6 ]
    Self-reported STIs (rectal and urethral gonorrhea and chlamydia, syphilis) in last 3 months.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2017)
  • Long-term adherence durability [ Time Frame: Month 9 ]
    Protective levels of TFV-DP/FTC-TP at month 9.
  • Self-reported retention in PrEP clinical care [ Time Frame: Month 9 ]
    The invesigators define "retention in care" as PrEP clinical visits every 3 months.
  • PrEP persistence [ Time Frame: Month 9 ]
    PrEP persistence will be measured by the duration of PrEP use before an individual temporarily or permanently discontinues PrEP. This will be collected via self-report at follow up.
  • Sexual Risk Behaviors [ Time Frame: Month 9 ]
    Sexual Practices Assessment Schedule will be used to explore the number of occasions of different sexual acts (oral, anal; receptive, insertive) with three different types of partners (romantic interest, casual partner "hookup" or friend with benefits), use of condoms during the past 3 months, and knowledge about partners' HIV status or PrEP use.
  • Sexually Transmitted Infections (STI) Incidence [ Time Frame: Month 9 ]
    Self-reported STIs (rectal and urethral gonorrhea and chlamydia, syphilis) in last 3 months.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE P3 (Prepared, Protected, emPowered)
Official Title  ICMJE P3 (Prepared, Protected, emPowered): Promoting Pre-exposure Prophylaxis (PrEP) Adherence Through a Social Networking, Gamification, and Adherence Support App
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Sexually Transmitted Diseases
  • Safe Sex
  • Adherence, Medication
Intervention  ICMJE
  • 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 Name: Prepared, Protected, emPowered
  • 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.
Study Arms  ICMJE
  • Experimental: P3
    Participants will use P3
    Intervention: Behavioral: P3
  • Experimental: P3+
    Participants will use P3+
    Intervention: Behavioral: P3+
  • Placebo Comparator: Control
    Participants will receive the standard of care
    Intervention: Behavioral: Control
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2021)
246
Original Estimated Enrollment  ICMJE
 (submitted: October 20, 2017)
400
Actual Study Completion Date  ICMJE September 16, 2021
Actual Primary Completion Date September 16, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Self-identify as MSM or TW who has sex with men
Ages  ICMJE 16 Years to 24 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03320512
Other Study ID Numbers  ICMJE 17-1951
5U19HD089881-02 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE
  • Emory University
  • Duke University
  • Children's Hospital of Philadelphia
  • The Fenway Institute
  • Children's Hospital at Montefiore
  • 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
Investigators  ICMJE
Principal Investigator: Lisa Hightow-Weidman, MD UNC Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP