Clinical trial NCT03320512: P3 (Prepared, Protected, emPowered)
Official title: P3 (Prepared, Protected, emPowered): Promoting Pre-exposure Prophylaxis (PrEP) Adherence Through a Social Networking, Gamification, and Adherence Support App
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexually Transmitted Diseases
Safe Sex
Adherence, Medication
Keywords: PrEP
gamification
mHealth
HIV prevention
truvada
eHealth
app
adherence
ymsm
transgender women
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Emory University
name: Duke University
name: Children's Hospital of Philadelphia
name: The Fenway Institute
name: Montefiore Medical Center
name: Baylor College of Medicine
name: Ruth M. Rothstein CORE Center
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: University of South Florida
First posted: 2017-10-25
Enrollment: 246
Sex: MALE
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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 1:1:1 to receive P3, P3+, or SOC. Assessments will be completed at months 0, 3, and 6.
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: PrEP Adherence Defined by Tenofovir Diphosphate (P3 and P3+ vs Control)
timeFrame: Month 3, Month 6
measure: PrEP Adherence Defined by Emtricitabine Triphosphate (P3 and P3+ vs Control)
timeFrame: Month 3, Month 6
Secondary outcomes:
measure: Number of Participants With Self-reported Retention in PrEP Clinical Care
timeFrame: Month 3, Month 6
measure: PrEP Persistence
timeFrame: Month 3, Month 6
measure: Insertive Condomless Anal Sex
timeFrame: Month 3, Month 6
measure: Receptive Condomless Anal Sex
timeFrame: Month 3, Month 6
measure: Sexually Transmitted Infections (STI) Incidence
timeFrame: Month 3, Month 6
measure: PrEP Adherence Defined by Tenofovir Diphosphate (P3 vs Control and P3+ vs Control)
timeFrame: Month 3, Month 6
measure: PrEP Adherence Defined by Emtricitabine Triphosphate (P3 vs Control and P3+ vs Control)
timeFrame: Month 3, Month 6
measure: Self-Reported Weekly PrEP Use
timeFrame: Month 3, Month 6
measure: Self-Reported Monthly PrEP Use
timeFrame: Month 3, Month 6
measure: Mean Site-Level Intervention Cost
timeFrame: Throughout the duration of the study, approximately 1.5 years
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida Infectious Diseases
state: Florida
city: Atlanta
country: United States
facility: PRISM Health
state: Georgia
city: Chicago
country: United States
facility: The Adolescent and Young Adult Research (AYAR) at the CORE Center
state: Illinois
city: Boston
country: United States
facility: The Fenway Institute
state: Massachusetts
city: Bronx
country: United States
facility: Children's Hospital at Montefiore
state: New York
city: Chapel Hill
country: United States
facility: UNC-Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: RAIN
state: North Carolina
city: Philadelphia
country: United States
facility: Adolescent Initiative at Children's Hospital of Philadelphia
state: Pennsylvania
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: UNC Chapel Hill
name: Lisa Hightow-Weidman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.