P3 (Prepared, Protected, emPowered)

NCT03320512 | Completed Results

• 2 other identifiers: 17-19515U19HD089881-02
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 9

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.

Conditions

Sexually Transmitted Diseases; Safe Sex; Adherence, Medication

Keywords

PrEP; gamification; mHealth; HIV prevention; truvada; eHealth; app; adherence; ymsm; transgender women

Outcome Measures

Primary Outcomes (2)

• PrEP Adherence Defined by Tenofovir Diphosphate (P3 and P3+ vs Control)

  PrEP adherence is measured by blood sample levels of tenofovir diphosphate (TFV-DP) with blood concentration consistent with \> 4 doses/week at 3- and 6- month follow-ups. The estimation of the average treatment effect compared P3 and P3+ combined to Control.

  Month 3, Month 6

• PrEP Adherence Defined by Emtricitabine Triphosphate (P3 and P3+ vs Control)

  PrEP adherence is measured by blood sample levels of emtricitabine triphosphate (FTC-TP) with blood concentration consistent with \> 4 doses/week at 3- and 6- month follow-ups. The estimation of the average treatment effect compared P3 and P3+ combined to Control.

  Month 3, Month 6

Secondary Outcomes (10)

• Number of Participants With Self-reported Retention in PrEP Clinical Care

  Month 3, Month 6

• PrEP Persistence

  Month 3, Month 6

• Insertive Condomless Anal Sex

  Month 3, Month 6

• Receptive Condomless Anal Sex

  Month 3, Month 6

• Sexually Transmitted Infections (STI) Incidence

  Month 3, Month 6

Study Arms (3)

P3

EXPERIMENTAL

Participants will use P3

Behavioral: P3

P3+

EXPERIMENTAL

Participants will use P3+

Behavioral: P3+

Control

PLACEBO COMPARATOR

Participants will receive the standard of care

Behavioral: Control

Interventions

P3+ BEHAVIORAL

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+.

P3+

Control BEHAVIORAL

Control participants will receive the standard of care for receiving a prescription for PrEP.

Control

Eligibility Criteria

• Age: 16 Years - 24 Years
• Gender Eligibility Details: Self-identify as MSM or TW who has sex with men
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Emory University: collaborator
• Duke University: collaborator
• Children's Hospital of Philadelphia: collaborator
• The Fenway Institute: collaborator
• Montefiore Medical Center: collaborator
• Baylor College of Medicine: collaborator
• Ruth M. Rothstein CORE Center: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of South Florida: collaborator

Study Sites (9)

University of South Florida Infectious Diseases

Tampa, Florida, 33606, United States

Location

PRISM Health

Atlanta, Georgia, 30322, United States

Location

The Adolescent and Young Adult Research (AYAR) at the CORE Center

Chicago, Illinois, 60612, United States

Location

The Fenway Institute

Boston, Massachusetts, 02215, United States

Location

Children's Hospital at Montefiore

The Bronx, New York, 10467, United States

Location

UNC-Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

RAIN

Charlotte, North Carolina, 29202, United States

Location

Adolescent Initiative at Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (4)

• 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.

  PMID: 39804696 DERIVED

• 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.

  PMID: 39250643 DERIVED

• 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.

  PMID: 36306520 DERIVED

• 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.

  PMID: 30563818 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases; Safe Sex; Medication Adherence; Alzheimer Disease

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sexual Behavior; Behavior; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

Despite the sample including about a quarter Black (20.7%) and another quarter Hispanic or Latinx (28.9%) participants, a majority of the sample was White (55.7%). And while the study was conducted across nine U.S. cities (Atlanta, Boston, Chicago, Chapel Hill, Charlotte, Houston, New York, Philadelphia, and Tampa) the results may not be generalizable to entire populations of young men who have sex with men (YMSM) and young transgender women who have sex with men (YTWSM).

Results Point of Contact

• Title: Lisa Hightow-Weidman
• Organization: University of North Carolina at Chapel Hill

lisa_hightow@med.unc.edu

919-843-0033

Study Officials

• Lisa Hightow-Weidman, MD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: October 25, 2017
• Study Start: May 15, 2019
• Primary Completion: September 16, 2021
• Study Completion: September 16, 2021
• Last Updated: October 25, 2022
• Results First Posted: September 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)