CompletedNot Applicable

P3 (Prepared, Protected, emPowered)

United States246 participantsStarted 2019-05-15

Plain-language 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.

Who can participate

Age range

16 Years – 24 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Month 3, Month 6

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

Timeframe: Month 3, Month 6

Trial details

NCT IDNCT03320512

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-16

Results submitted2022-07-21

View on ClinicalTrials.gov More Sexually Transmitted Diseases trials