An interventional study of P3 and P3+ in Sexually Transmitted Diseases, Safe Sex and Adherence, Medication, sponsored by University of North Carolina, Chapel Hill. Completed at 9 sites in United States. Open to male participants aged 16 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-25.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Prevention
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.
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.
523 studies on the registry are indexed under Sexually Transmitted Diseases; 77 are open to participants now.
This study's enrollment of 246 is below the median of 449 across 425 interventional studies indexed under Sexually Transmitted Diseases.
Browse Sexually Transmitted Diseases studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will use P3
Behavioral: P3
Participants will use P3+
Behavioral: P3+
Participants will receive the standard of care
Behavioral: Control
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.
Also known as: Prepared, Protected, emPowered
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+.
Control participants will receive the standard of care for receiving a prescription for PrEP.
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.
Time frame: Month 3, Month 6
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.
Time frame: Month 3, Month 6
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.
Time frame: Month 3, Month 6
PrEP Persistence
PrEP persistence will be measured by self-report at follow up of current PrEP use.
Time frame: Month 3, Month 6
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.
Time frame: Month 3, Month 6
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.
Time frame: Month 3, Month 6
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.
Time frame: Month 3, Month 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.
Time frame: Month 3, Month 6
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.
Time frame: Month 3, Month 6
Self-Reported Weekly PrEP Use
Number of participants reported taking their PrEP medication \>/= 4 days in the past week.
Time frame: Month 3, Month 6
Self-Reported Monthly PrEP Use
Median self-reported percent of time in the past month that participants' took their PrEP as prescribed.
Time frame: Month 3, Month 6
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.
Time frame: Throughout the duration of the study, approximately 1.5 years
| Milestone | P3 Application | P3+ Application | Control |
|---|---|---|---|
| Started | 82 | 81 | 83 |
| Month 3 survey started | 69 | 72 | 71 |
| Month 3 survey completed | 69 | 72 | 68 |
| Month 3 lab sample collected | 51 | 54 | 51 |
| Month 6 survey started | 67 | 72 | 69 |
| Month 6 survey completed | 65 | 71 | 68 |
| Month 6 lab sample collected | 53 | 59 | 51 |
| Completed | 82 | 81 | 83 |
| Not completed | 0 | 0 | 0 |
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.
| Participants | P3 Application | P3+ Application | Control |
|---|---|---|---|
| Month 3 | 24 | 33 | 23 |
| Month 6 | 18 | 25 | 20 |
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.
| Participants | P3 Application | P3+ Application | Control |
|---|---|---|---|
| Month 3 | 36 | 38 | 29 |
| Month 6 | 31 | 31 | 24 |
The investigators define "retention in care" as at least 1 PrEP clinical visit occurring in the last 3 months.
| Participants | P3 Application | P3+ Application | Control |
|---|---|---|---|
| Month 3 | 38 | 43 | 38 |
| Month 6 | 32 | 34 | 25 |
PrEP persistence will be measured by self-report at follow up of current PrEP use.
| Participants | P3 Application | P3+ Application | Control |
|---|---|---|---|
| Month 3 | 66 | 64 | 59 |
| Month 6 | 52 | 49 | 52 |
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.
| sex acts | P3 Application | P3+ Application | Control |
|---|---|---|---|
| Month 3 | 1 (0 to 2) | 0 (0 to 2) | 0 (0 to 2) |
| Month 6 | 0 (0 to 2) | 0 (0 to 1) | 0 (0 to 1) |
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.
| sex acts | P3 Application | P3+ Application | Control |
|---|---|---|---|
| Month 3 | 1 (0 to 3) | 0 (0 to 2) | 1 (0 to 3) |
| Month 6 | 1 (0 to 3) | 0 (0 to 1) | 0 (0 to 2) |
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.
| Participants | P3 Application | P3+ Application | Control |
|---|---|---|---|
| Month 3 Gonorrhea | 12 | 14 | 14 |
| Month 6 Gonorrhea | 11 | 6 | 10 |
| Month 3 Chlamydia | 11 | 14 | 17 |
| Month 6 Chlamydia | 11 | 8 | 12 |
| Month 3 Syphilis | 9 | 8 | 12 |
| Month 6 Syphilis | 11 | 3 | 9 |
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.
| Participants | P3 Application | P3+ Application | Control |
|---|---|---|---|
| Month 3 | 24 | 33 | 23 |
| Month 6 | 18 | 25 | 20 |
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.
| Participants | P3 Application | P3+ Application | Control |
|---|---|---|---|
| Month 3 | 36 | 38 | 29 |
| Month 6 | 31 | 31 | 24 |
Number of participants reported taking their PrEP medication \>/= 4 days in the past week.
| Participants | P3 Application | P3+ Application | Control |
|---|---|---|---|
| Month 3 | 58 | 59 | 51 |
| Month 6 | 49 | 48 | 47 |
Median self-reported percent of time in the past month that participants' took their PrEP as prescribed.
| percentage of time compliant | P3 Application | P3+ Application | Control |
|---|---|---|---|
| Month 3 | 100 (80 to 100) | 100 (90 to 100) | 90 (72.5 to 100) |
| Month 6 | 90 (50 to 100) | 90 (25 to 100) | 90 (67.5 to 100) |
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.
| average cost per participant in USD | P3 Application | P3+ Application | Control |
|---|---|---|---|
| Mean Site-Level Intervention Cost | 551.88 ± 160.43 | 673.52 ± 161.06 | — |
Collected over Adverse events were collected from the signing of the Informed consent by each participant until the end of the study, a duration of up to 6 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| P3 Application | 0/82 (0%) | 0/82 (0%) | 0/82 (0%) |
| P3+ Application | 0/81 (0%) | 0/81 (0%) | 0/81 (0%) |
| Control | 0/83 (0%) | 0/83 (0%) | 0/83 (0%) |
| Age, Continuous(years) | P3 Application | P3+ Application | Control | Total |
|---|---|---|---|---|
| Median | 22 (20 to 23) | 22 (20 to 23) | 22 (21 to 23) | 22 (20 to 23) |
| Sex/Gender, Customized(Participants) | P3 Application | P3+ Application | Control | Total |
|---|---|---|---|---|
| Male | 71 | 71 | 74 | 216 |
| Trans female, trans woman, or transfeminine | 0 | 3 | 2 | 5 |
| Genderqueer, gender non-conforming, or non-binary | 3 | 2 | 4 | 9 |
| Multiple genders reported | 8 | 3 | 3 | 14 |
| Declined to answer | 0 | 2 | 0 | 2 |
| Sex: Female, Male(Participants) | P3 Application | P3+ Application | Control | Total |
|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 |
| Male | 82 | 81 | 83 | 246 |
| Ethnicity (NIH/OMB)(Participants) | P3 Application | P3+ Application | Control | Total |
|---|---|---|---|---|
| Hispanic or Latino | 26 | 18 | 27 | 71 |
| Not Hispanic or Latino | 56 | 63 | 56 | 175 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | P3 Application | P3+ Application | Control | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 1 | 3 |
| Asian | 7 | 5 | 4 | 16 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 16 | 19 | 16 | 51 |
| White | 49 | 46 | 42 | 137 |
| More than one race | 3 | 4 | 9 | 16 |
| Unknown or Not Reported | 6 | 6 | 11 | 23 |
| Region of Enrollment(Participants) | P3 Application | P3+ Application | Control | Total |
|---|---|---|---|---|
| United States | 82 | 81 | 83 | 246 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2019 to primary completion in Sep 2021, 28 months.
Results were first posted in Sep 2022, 1 year after primary completion.
Of 172 non-industry interventional studies with no phase under Sexually Transmitted Diseases, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 47. This study's 28 months is below that.
Counting every sponsor, half of 182 studies reached it within 31 months; a quarter within 16 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Sexually Transmitted Diseases →
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