N/A
N=246
P3 (Prepared, Protected, emPowered)
Sexually Transmitted Diseases · Safe Sex · Adherence, Medication
Bottom Line
View on ClinicalTrials.gov: NCT03320512 ↗Enrolled (actual)
246
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: PrEP Adherence Defined by Tenofovir Diphosphate (P3 and P3+ vs Control) — 24; 33; 23; 18 Participants — p=0.04965
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- P3 (Behavioral); P3+ (Behavioral); Control (Behavioral)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- Male
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PrEP Adherence Defined by Tenofovir Diphosphate (P3 and P3+ vs Control) |
24; 33; 23; 18; 25; 20 | 0.04965 sig |
| PRIMARY PrEP Adherence Defined by Emtricitabine Triphosphate (P3 and P3+ vs Control) |
36; 38; 29; 31; 31; 24 | 0.11 |
| SECONDARY Number of Participants With Self-reported Retention in PrEP Clinical Care |
38; 43; 38; 32; 34; 25 | 0.68 |
| SECONDARY PrEP Persistence |
66; 64; 59; 52; 49; 52 | 0.53 |
| SECONDARY Insertive Condomless Anal Sex |
1; 0; 0; 0; 0; 0 | 0.93 |
| SECONDARY Receptive Condomless Anal Sex |
1; 0; 1; 1; 0; 0 | 0.60 |
| SECONDARY Sexually Transmitted Infections (STI) Incidence |
12; 14; 14; 11; 6; 10 | 0.60 |
| SECONDARY PrEP Adherence Defined by Tenofovir Diphosphate (P3 vs Control and P3+ vs Control) |
24; 33; 23; 18; 25; 20 | — |
| SECONDARY PrEP Adherence Defined by Emtricitabine Triphosphate (P3 vs Control and P3+ vs Control) |
36; 38; 29; 31; 31; 24 | — |
| SECONDARY Self-Reported Weekly PrEP Use |
58; 59; 51; 49; 48; 47 | 0.11 |
| SECONDARY Self-Reported Monthly PrEP Use |
100; 100; 90; 90; 90; 90 | 0.05 |
| SECONDARY Mean Site-Level Intervention Cost |
551.88; 673.52 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03320512). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.