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Sexually Transmitted DiseasesP3NCT03320512

P3 (Prepared, Protected, emPowered)

A study testing P3 and P3+ in people with Sexually Transmitted Diseases and Safe Sex, run by University of North Carolina, Chapel Hill at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 24 years, men onlyHealthy volunteers can take part
What is being tested?
P3 and P3+
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
246 participants
Where
9 sitesUnited States
Study dates
15 May 2019to 16 Sep 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 24 years
  • Men only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • PRISM Health

    Atlanta, Georgia, 30322

  • The Fenway Institute

    Boston, Massachusetts, 02215

  • UNC-Chapel Hill

    Chapel Hill, North Carolina, 27599

  • RAIN

    Charlotte, North Carolina, 29202

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

    Chicago, Illinois, 60612

  • Texas Children's Hospital

    Houston, Texas, 77030

  • Adolescent Initiative at Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • University of South Florida Infectious Diseases

    Tampa, Florida, 33606

  • Children's Hospital at Montefiore

    The Bronx, New York, 10467

Other trials in United States

About this study

Official title: P3 (Prepared, Protected, emPowered): Promoting Pre-exposure Prophylaxis (PrEP) Adherence Through a Social Networking, Gamification, and Adherence Support App

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.

Read the 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.

Being tested
P3, P3+, Control
Keywords
PrEP, gamification, mHealth, HIV prevention, truvada, eHealth, app, adherence, ymsm, transgender women
Medical subject headings
Sexually Transmitted Diseases, Safe Sex, Medication Adherence, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • P3Behavioural

    Also called Prepared, Protected, emPowered

    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+Behavioural

    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+.

  • ControlBehavioural

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

Study groups in NCT03320512
Study groupRoleWhat they receive
P3ExperimentalParticipants will use P3
Receives: Behavioral: P3
P3+ExperimentalParticipants will use P3+
Receives: Behavioral: P3+
ControlPlacebo comparatorParticipants will receive the standard of care
Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Month 3, Month 6

  2. 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.

    Measured: Month 3, Month 6

Secondary outcomes (10)

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

    The investigators define "retention in care" as at least 1 PrEP clinical visit occurring in the last 3 months.

    Measured: Month 3, Month 6

  2. PrEP Persistence

    PrEP persistence will be measured by self-report at follow up of current PrEP use.

    Measured: Month 3, Month 6

  3. Insertive Condomless Anal Sex

    Sexual Practices were assessed by self-reported number of insertive condomless anal sex occurrences during the past 3 months. This question is asked at the 3- and 6-month follow-up surveys.

    Measured: Month 3, Month 6

  4. Receptive Condomless Anal Sex

    Sexual Practices were assessed by self-reported number of receptive condomless anal sex occurrences during the past 3 months. This question is asked at the 3- and 6-month follow-up surveys.

    Measured: Month 3, Month 6

  5. Sexually Transmitted Infections (STI) Incidence

    Self-reported STIs (combined rectal and urethral gonorrhea and chlamydia, syphilis) in last 3 months. This question is asked at the 3- and 6-month follow-up surveys.

    Measured: Month 3, Month 6

  6. PrEP Adherence Defined by Tenofovir Diphosphate (P3 vs Control 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 to Control and also P3+ to Control.

    Measured: Month 3, Month 6

  7. PrEP Adherence Defined by Emtricitabine Triphosphate (P3 vs Control 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 to Control and also P3+ to Control.

    Measured: Month 3, Month 6

  8. Self-Reported Weekly PrEP Use

    Number of participants reported taking their PrEP medication >/= 4 days in the past week.

    Measured: Month 3, Month 6

  9. Self-Reported Monthly PrEP Use

    Median self-reported percent of time in the past month that participants' took their PrEP as prescribed.

    Measured: Month 3, Month 6

  10. Mean Site-Level Intervention Cost

    Information was collected on (1) time spent by study staff for training and supervision of adherence counselor(s); (2) time participants spent in the adherence counseling sessions; and (3) costs associated with the delivery of both P3 and P3+. Resources were organized into standard expenditure categories and attributed to the corresponding P3 or P3+ arm and study site as appropriate.

    Measured: Throughout the duration of the study, approximately 1.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2017
  2. Study start15 May 2019
  3. Primary completion16 Sep 2021
  4. Study completion16 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
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.
Masking
None (open label)
Enrolment
246 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03320512
Sponsor's protocol ID
17-1951
Other IDs
5U19HD089881-02
Acronym
P3
Status last verified
Aug 2022
First submitted
3 Oct 2017
Last updated
25 Oct 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hightow-Weidman L, Choi SK, Yigit I, Rainer C, Phillips V, Muessig K. Improving Pre-Exposure Prophylaxis Adherence in People at Risk for HIV: Secondary Analysis of a Digital Health Intervention to Enhance User Engagement. JMIR Mhealth Uhealth. 2026 Mar 10;14:e66837. doi: 10.2196/66837.

    PubMed 41805538

  • 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.

    PubMed 39804696

  • 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.

    PubMed 39250643

  • 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.

    PubMed 36306520

  • 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.

    PubMed 30563818

Questions about this trial

What is this clinical trial studying?

A study testing P3 and P3+ in people with Sexually Transmitted Diseases and Safe Sex, run by University of North Carolina, Chapel Hill at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PrEP Adherence Defined by Tenofovir Diphosphate (P3 and P3+ vs Control) (time frame: Month 3, Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03320512, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.

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