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Trial record 1 of 1 for:    NCT03320512
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P3 (Prepared, Protected, emPowered) (P3)

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ClinicalTrials.gov Identifier: NCT03320512
Recruitment Status : Recruiting
First Posted : October 25, 2017
Last Update Posted : July 24, 2020
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

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.

Condition or disease Intervention/treatment Phase
Sexually Transmitted Diseases Safe Sex Adherence, Medication Behavioral: P3 Behavioral: P3+ Behavioral: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
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
Official Title: P3 (Prepared, Protected, emPowered): Promoting Pre-exposure Prophylaxis (PrEP) Adherence Through a Social Networking, Gamification, and Adherence Support App
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

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 Name: 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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Long-term adherence durability [ Time Frame: Month 6 ]
    Protective levels of TFV-DP/FTC-TP at month 6.

  2. Self-reported retention in PrEP clinical care [ Time Frame: Month 6 ]
    The investigators define "retention in care" as PrEP clinical visits every 3 months.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-identify as MSM or TW who has sex with men
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03320512


Contacts
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Contact: Kelly A Knudtson, MPH 9199624640 knudtson@med.unc.edu
Contact: Lisa Hightow-Weidman, MD (919) 843- 0033 lisa_hightow@med.unc.edu

Locations
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United States, Florida
University of South Florida Infectious Diseases Recruiting
Tampa, Florida, United States, 33606
Contact: Patricia Emmanuel, MD    813-844-4187    pemmanue@health.usf.edu   
Principal Investigator: Patricia Emmanuel, MD         
United States, Georgia
PRISM Health Recruiting
Atlanta, Georgia, United States, 30322
Contact: Patrick Sullivan, DVM, PhD    404-727-3038    pssulli@emory.edu   
Principal Investigator: Patrick Sullivan, DVM, PhD         
United States, Illinois
The Adolescent and Young Adult Research (AYAR) at the CORE Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Temitope Oyedele, MD    312-572-4500    toyedele@cookcountyhhs.org   
Principal Investigator: Temitope Oyedele, MD         
United States, Massachusetts
The Fenway Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Kenneth Meyer, MD    617-927-6400    kmayer@fenwayhealth.org   
Principal Investigator: Kenneth Meyer, MD         
United States, New York
Children's Hospital at Montefiore Recruiting
Bronx, New York, United States, 10467
Contact: Donna Futterman, MD    718-882-0232    dfutterman@adolescentaids.org   
Principal Investigator: Donna Futterman, MD         
United States, North Carolina
UNC-Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Lina Rosengren, MD    919-962-4640    lina_roho@med.unc.edu   
RAIN Recruiting
Charlotte, North Carolina, United States, 29202
Contact: jesse Elkins       j.elkins@carolinarain.org   
United States, Pennsylvania
Adolescent Initiative at Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Marné Castillo, PhD, MED         
Contact    215-590-3800    Castillo@email.chop.edu   
Principal Investigator: Marné Castillo, PhD, MED         
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Mary Paul, MD    832-822-1038    ATN_team@texaschildrens.org   
Principal Investigator: Mary Paul, MD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
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
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Principal Investigator: Lisa Hightow-Weidman, MD UNC Chapel Hill
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03320512    
Other Study ID Numbers: 17-1951
5U19HD089881-02 ( U.S. NIH Grant/Contract )
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
PrEP
gamification
mHealth
HIV prevention
truvada
eHealth
app
adherence
ymsm
transgender women
Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Infection
Virus Diseases