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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 : Not yet recruiting
First Posted : October 25, 2017
Last Update Posted : March 7, 2019
Sponsor:
Collaborators:
Emory University
Duke University
Children's Hospital of Philadelphia
The Fenway Institute
Children's Hospital at Montefiore
Texas Children's Hospital
Ruth M. Rothstein CORE Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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 YMSM and YTWSM who are starting PrEP or are non-adherent to PrEP. Study arms will include P3, P3+, and SOC. Participants will be recruited from six iTech 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
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

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. Change in PrEP adherence from Baseline to Month 6 [ Time Frame: Baseline, Month 6 ]
    PrEP adherence is measured by dried blood spot (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.


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 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 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. Sexually Transmitted Infections (STI) Incidence [ Time Frame: Month 6 ]
    Self-reported STIs (rectal and urethral gonorrhea and chlamydia, syphilis) in last 3 months.



Information from the National Library of Medicine

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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:

  • Assigned male sex at birth
  • Self-identify as MSM or TW who has sex with men
  • Ages 16-24, inclusive
  • Able to speak and read English
  • are not currently on PrEP but plan to initiate in the next 7 days and have at least 30 days of medication available or currently on PrEP but self-report adherence < 3 pills per week in each of the past 2 weeks and have at least 30 days of medication available (prescription confirmed by study staff)
  • HIV-negative confirmed by rapid HIV test performed at study pre-enrollment visit
  • Reliable daily access to Android or iOS smartphone with a data plan

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 HIV-positive (confirmed rapid HIV-positive test at enrollment visit)
  • 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

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: Sara Legrand, PhD (919) 438-0448 sara.legrand@duke.edu

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
Texas Children's Hospital
Ruth M. Rothstein CORE Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Sara Legrand, PhD Duke
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     History of Changes
Other Study ID Numbers: 17-1951
5U19HD089881-02 ( U.S. NIH Grant/Contract )
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
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
Genital Diseases, Male
Genital Diseases, Female