Study Results
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View full resultsBasic Information
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COMPLETED
NA
246 participants
INTERVENTIONAL
2019-05-15
2021-09-16
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
NONE
Study Groups
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P3
Participants will use P3
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.
P3+
Participants will use P3+
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+.
Control
Participants will receive the standard of care
Control
Control participants will receive the standard of care for receiving a prescription for PrEP.
Interventions
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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.
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+.
Control
Control participants will receive the standard of care for receiving a prescription for PrEP.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
16 Years
24 Years
MALE
Yes
Sponsors
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Emory University
OTHER
Duke University
OTHER
Children's Hospital of Philadelphia
OTHER
The Fenway Institute
OTHER
Montefiore Medical Center
OTHER
Baylor College of Medicine
OTHER
Ruth M. Rothstein CORE Center
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of South Florida
OTHER
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Lisa Hightow-Weidman, MD
Role: PRINCIPAL_INVESTIGATOR
UNC Chapel Hill
Locations
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University of South Florida Infectious Diseases
Tampa, Florida, United States
PRISM Health
Atlanta, Georgia, United States
The Adolescent and Young Adult Research (AYAR) at the CORE Center
Chicago, Illinois, United States
The Fenway Institute
Boston, Massachusetts, United States
Children's Hospital at Montefiore
The Bronx, New York, United States
UNC-Chapel Hill
Chapel Hill, North Carolina, United States
RAIN
Charlotte, North Carolina, United States
Adolescent Initiative at Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Texas Children's Hospital
Houston, Texas, United States
Countries
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References
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Williams MP, Manjourides J, Smith LH, Rainer CB, Hightow-Weidman LB, Haley DF. Studying the Digital Intervention Engagement-Mediated Relationship Between Intrapersonal Measures and Pre-Exposure Prophylaxis Adherence in Sexual and Gender Minority Youth: Secondary Analysis of a Randomized Controlled Trial. J Med Internet Res. 2025 Jan 13;27:e57619. doi: 10.2196/57619.
Yigit I, Budhwani H, Rainer CB, Claude K, Muessig KE, Hightow-Weidman LB. Associations Between PrEP Stigma, PrEP Confidence, and PrEP Adherence: Conditional Indirect Effects of Anticipated HIV Stigma. J Acquir Immune Defic Syndr. 2024 Oct 1;97(2):99-106. doi: 10.1097/QAI.0000000000003474.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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17-1951
Identifier Type: -
Identifier Source: org_study_id
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