P3 (Prepared, Protected, emPowered)
- Conditions
- Sexually Transmitted DiseasesSafe SexAdherence, Medication
- Interventions
- Behavioral: P3Behavioral: P3+Behavioral: Control
- Registration Number
- NCT03320512
- Lead Sponsor
- University of North Carolina, Chapel Hill
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 246
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description P3 P3 Participants will use P3 P3+ P3+ Participants will use P3+ Control Control Participants will receive the standard of care
- Primary Outcome Measures
Name Time Method PrEP Adherence Defined by Emtricitabine Triphosphate (P3 and P3+ vs Control) Month 3, Month 6 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.
PrEP Adherence Defined by Tenofovir Diphosphate (P3 and P3+ vs Control) Month 3, Month 6 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.
- Secondary Outcome Measures
Name Time Method PrEP Adherence Defined by Tenofovir Diphosphate (P3 vs Control and P3+ vs Control) Month 3, Month 6 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.
PrEP Adherence Defined by Emtricitabine Triphosphate (P3 vs Control and P3+ vs Control) Month 3, Month 6 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.
Insertive Condomless Anal Sex Month 3, Month 6 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.
Receptive Condomless Anal Sex Month 3, Month 6 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.
Number of Participants With Self-reported Retention in PrEP Clinical Care Month 3, Month 6 The investigators define "retention in care" as at least 1 PrEP clinical visit occurring in the last 3 months.
PrEP Persistence Month 3, Month 6 PrEP persistence will be measured by self-report at follow up of current PrEP use.
Mean Site-Level Intervention Cost Throughout the duration of the study, approximately 1.5 years 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.
Sexually Transmitted Infections (STI) Incidence Month 3, Month 6 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.
Self-Reported Weekly PrEP Use Month 3, Month 6 Number of participants reported taking their PrEP medication \>/= 4 days in the past week.
Self-Reported Monthly PrEP Use Month 3, Month 6 Median self-reported percent of time in the past month that participants' took their PrEP as prescribed.
Trial Locations
- Locations (9)
UNC-Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
The Fenway Institute
🇺🇸Boston, Massachusetts, United States
PRISM Health
🇺🇸Atlanta, Georgia, United States
The Adolescent and Young Adult Research (AYAR) at the CORE Center
🇺🇸Chicago, Illinois, United States
RAIN
🇺🇸Charlotte, North Carolina, United States
Adolescent Initiative at Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital at Montefiore
🇺🇸Bronx, New York, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
University of South Florida Infectious Diseases
🇺🇸Tampa, Florida, United States