Status:
COMPLETED
P3 (Prepared, Protected, emPowered)
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Emory University
Duke University
Conditions:
Sexually Transmitted Diseases
Safe Sex
Eligibility:
MALE
16-24 years
Phase:
NA
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 o...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2021
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT03320512
Start Date
May 15 2019
End Date
September 16 2021
Last Update
October 25 2022
Active Locations (9)
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1
University of South Florida Infectious Diseases
Tampa, Florida, United States, 33606
2
PRISM Health
Atlanta, Georgia, United States, 30322
3
The Adolescent and Young Adult Research (AYAR) at the CORE Center
Chicago, Illinois, United States, 60612
4
The Fenway Institute
Boston, Massachusetts, United States, 02215