Adherence, Medication, Safe Sex, Sexually Transmitted Diseases
Conditions
Keywords
PrEP, gamification, mHealth, HIV prevention, truvada, eHealth, app, adherence, ymsm, transgender women
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.
Interventions
BEHAVIORALP3
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.
BEHAVIORALP3+
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+.
BEHAVIORALControl
Control participants will receive the standard of care for receiving a prescription for PrEP.
Sponsors
Emory University
Duke University
Children's Hospital of Philadelphia
The Fenway Institute
Montefiore Medical Center
Baylor College of Medicine
Ruth M. Rothstein CORE Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of South Florida
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
The trial will consist of a three-arm RCT to test intervention efficacy among young men who have sex with men (YMSM) and young transgender women who have sex with men (YTWSM) who are starting PrEP or are non-adherent to PrEP. Study arms will include P3, P3+, and standard of care (SOC). Participants will be recruited from seven cities. The investigators will enroll up to 240 participants and randomize them 1:1:1 to receive P3, P3+, or SOC. Assessments will be completed at months 0, 3, and 6.
Eligibility
Sex/Gender
MALE
Age
16 Years to 24 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| PrEP Persistence | Month 3, Month 6 | PrEP persistence will be measured by self-report at follow up of current PrEP use. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| P3 Application Participants will use P3
P3: 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. | 82 |
| P3+ Application Participants will use P3+
P3+: 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+. | 81 |
| Control Participants will receive the standard of care
Control: Control participants will receive the standard of care for receiving a prescription for PrEP. | 83 |
| Total | 246 |
Baseline characteristics
| Characteristic | P3 Application | P3+ Application | Control | Total |
|---|---|---|---|---|
| Age, Continuous | 22 years | 22 years | 22 years | 22 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 26 Participants | 18 Participants | 27 Participants | 71 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants | 63 Participants | 56 Participants | 175 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 5 Participants | 4 Participants | 16 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 19 Participants | 16 Participants | 51 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 4 Participants | 9 Participants | 16 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 6 Participants | 11 Participants | 23 Participants |
| Race (NIH/OMB) White | 49 Participants | 46 Participants | 42 Participants | 137 Participants |
| Region of Enrollment United States | 82 Participants | 81 Participants | 83 Participants | 246 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 82 Participants | 81 Participants | 83 Participants | 246 Participants |
| Sex/Gender, Customized Declined to answer | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Sex/Gender, Customized Genderqueer, gender non-conforming, or non-binary | 3 Participants | 2 Participants | 4 Participants | 9 Participants |
| Sex/Gender, Customized Male | 71 Participants | 71 Participants | 74 Participants | 216 Participants |
| Sex/Gender, Customized Multiple genders reported | 8 Participants | 3 Participants | 3 Participants | 14 Participants |
| Sex/Gender, Customized Trans female, trans woman, or transfeminine | 0 Participants | 3 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 82 | 0 / 81 | 0 / 83 |
| other Total, other adverse events | 0 / 82 | 0 / 81 | 0 / 83 |
| serious Total, serious adverse events | 0 / 82 | 0 / 81 | 0 / 83 |
Outcome results
Primary
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
Population: Data were included if 3- and/or 6-month samples were available. A participant's data was available if at least one sample was returned and that sample was readable (i.e., sample was not degraded).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| P3 Application | PrEP Adherence Defined by Emtricitabine Triphosphate (P3 and P3+ vs Control) | Month 3 | 36 Participants |
| P3 Application | PrEP Adherence Defined by Emtricitabine Triphosphate (P3 and P3+ vs Control) | Month 6 | 31 Participants |
| P3+ Application | PrEP Adherence Defined by Emtricitabine Triphosphate (P3 and P3+ vs Control) | Month 3 | 38 Participants |
| P3+ Application | PrEP Adherence Defined by Emtricitabine Triphosphate (P3 and P3+ vs Control) | Month 6 | 31 Participants |
| Control | PrEP Adherence Defined by Emtricitabine Triphosphate (P3 and P3+ vs Control) | Month 3 | 29 Participants |
| Control | PrEP Adherence Defined by Emtricitabine Triphosphate (P3 and P3+ vs Control) | Month 6 | 24 Participants |
Comparison: Month 3 The analysis includes the intent-to-treat populationp-value: 0.1195% CI: [-0.03, 0.26]TMLE estimation of ATE and Wald test
Comparison: Month 6 The analysis includes the intent-to-treat populationp-value: 0.3895% CI: [-0.08, 0.21]TMLE estimation of ATE and Wald test
Primary
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
Population: Data were included if 3- and/or 6-month samples were available. A participant's data was available if at least one sample was returned and that sample was readable (i.e., sample was not degraded and participant was not using Descovy).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| P3 Application | PrEP Adherence Defined by Tenofovir Diphosphate (P3 and P3+ vs Control) | Month 3 | 24 Participants |
| P3 Application | PrEP Adherence Defined by Tenofovir Diphosphate (P3 and P3+ vs Control) | Month 6 | 18 Participants |
| P3+ Application | PrEP Adherence Defined by Tenofovir Diphosphate (P3 and P3+ vs Control) | Month 3 | 33 Participants |
| P3+ Application | PrEP Adherence Defined by Tenofovir Diphosphate (P3 and P3+ vs Control) | Month 6 | 25 Participants |
| Control | PrEP Adherence Defined by Tenofovir Diphosphate (P3 and P3+ vs Control) | Month 6 | 20 Participants |
| Control | PrEP Adherence Defined by Tenofovir Diphosphate (P3 and P3+ vs Control) | Month 3 | 23 Participants |
Comparison: Month 3 The analysis includes the intent-to-treat populationp-value: 0.0496595% CI: [0, 0.29]TMLE estimation of ATE and Wald test
Comparison: Month 6 The analysis includes the intent-to-treat populationp-value: 0.6295% CI: [-0.21, 0.13]TMLE estimation of ATE and Wald test
Secondary
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
Population: Data were included if 3- and/or 6-month responses were available. A participant's data was available if they sufficiently responded to the sexual activity survey questions and the survey was submitted within appropriate time window.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| P3 Application | Insertive Condomless Anal Sex | Month 6 | 0 sex acts |
| P3 Application | Insertive Condomless Anal Sex | Month 3 | 1 sex acts |
| P3+ Application | Insertive Condomless Anal Sex | Month 6 | 0 sex acts |
| P3+ Application | Insertive Condomless Anal Sex | Month 3 | 0 sex acts |
| Control | Insertive Condomless Anal Sex | Month 6 | 0 sex acts |
| Control | Insertive Condomless Anal Sex | Month 3 | 0 sex acts |
Comparison: Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.p-value: 0.9395% CI: [-0.84, 1]TMLE estimation of ATE and Wald test
Comparison: Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.p-value: 0.695% CI: [-4.16, 1.91]TMLE estimation of ATE and Wald test
Secondary
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
Population: This outcome pertains to participating sites rather than actual participants. The analysis was applicable only to the intervention arms; the control arm is excluded since there was no intervention or associated cost. Data were not reported for 1 site which was inactive during the data collection periods.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| P3 Application | Mean Site-Level Intervention Cost | 551.88 average cost per participant in USD | Standard Deviation 160.43 |
| P3+ Application | Mean Site-Level Intervention Cost | 673.52 average cost per participant in USD | Standard Deviation 161.06 |
Comparison: Participants were included if they were at an active site with cost data and had a 3-month binary TFV measure.95% CI: [-194.05, 236.81]
Secondary
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
Population: Data were included if 3- and/or 6-month samples were available. A participant's data was available if they sufficiently responded to the clinical care survey questions and the survey was submitted within appropriate time window.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| P3 Application | Number of Participants With Self-reported Retention in PrEP Clinical Care | Month 3 | 38 Participants |
| P3 Application | Number of Participants With Self-reported Retention in PrEP Clinical Care | Month 6 | 32 Participants |
| P3+ Application | Number of Participants With Self-reported Retention in PrEP Clinical Care | Month 6 | 34 Participants |
| P3+ Application | Number of Participants With Self-reported Retention in PrEP Clinical Care | Month 3 | 43 Participants |
| Control | Number of Participants With Self-reported Retention in PrEP Clinical Care | Month 6 | 25 Participants |
| Control | Number of Participants With Self-reported Retention in PrEP Clinical Care | Month 3 | 38 Participants |
Comparison: Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.p-value: 0.6895% CI: [-0.09, 0.16]TMLE estimation of ATE and Wald test
Comparison: Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.p-value: 0.5395% CI: [-0.03, 0.25]TMLE estimation of ATE and Wald test
Secondary
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
Population: Data were included if 3- and/or 6-month samples were available. A participant's data was available if at least one sample was returned and that sample was readable (i.e., sample was not degraded).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| P3 Application | PrEP Adherence Defined by Emtricitabine Triphosphate (P3 vs Control and P3+ vs Control) | Month 3 | 36 Participants |
| P3 Application | PrEP Adherence Defined by Emtricitabine Triphosphate (P3 vs Control and P3+ vs Control) | Month 6 | 31 Participants |
| P3+ Application | PrEP Adherence Defined by Emtricitabine Triphosphate (P3 vs Control and P3+ vs Control) | Month 3 | 38 Participants |
| P3+ Application | PrEP Adherence Defined by Emtricitabine Triphosphate (P3 vs Control and P3+ vs Control) | Month 6 | 31 Participants |
| Control | PrEP Adherence Defined by Emtricitabine Triphosphate (P3 vs Control and P3+ vs Control) | Month 3 | 29 Participants |
| Control | PrEP Adherence Defined by Emtricitabine Triphosphate (P3 vs Control and P3+ vs Control) | Month 6 | 24 Participants |
Comparison: Month 3 The analysis includes the intent-to-treat population and compares P3 vs. Control.95% CI: [-0.05, 0.26]
Comparison: Month 3 The analysis includes the intent-to-treat population and compares P3+ vs. Control.95% CI: [-0.04, 0.29]
Comparison: Month 6 The analysis includes the intent-to-treat population and compares P3 vs. Control.95% CI: [-0.08, 0.26]
Comparison: Month 6 The analysis includes the intent-to-treat population and compares P3+ vs. Control.95% CI: [-0.13, 0.19]
Secondary
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
Population: Data were included if 3- and/or 6-month samples were available. A participant's data was available if at least one sample was returned and that sample was readable (i.e., sample was not degraded and participant was not using Descovy).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| P3 Application | PrEP Adherence Defined by Tenofovir Diphosphate (P3 vs Control and P3+ vs Control) | Month 3 | 24 Participants |
| P3 Application | PrEP Adherence Defined by Tenofovir Diphosphate (P3 vs Control and P3+ vs Control) | Month 6 | 18 Participants |
| P3+ Application | PrEP Adherence Defined by Tenofovir Diphosphate (P3 vs Control and P3+ vs Control) | Month 3 | 33 Participants |
| P3+ Application | PrEP Adherence Defined by Tenofovir Diphosphate (P3 vs Control and P3+ vs Control) | Month 6 | 25 Participants |
| Control | PrEP Adherence Defined by Tenofovir Diphosphate (P3 vs Control and P3+ vs Control) | Month 3 | 23 Participants |
| Control | PrEP Adherence Defined by Tenofovir Diphosphate (P3 vs Control and P3+ vs Control) | Month 6 | 20 Participants |
Comparison: Month 3 The analysis includes the intent-to-treat population and compares P3 vs. Control.95% CI: [-0.07, 0.29]
Comparison: Month 3 The analysis includes the intent-to-treat population and compares P3+ vs. Control.95% CI: [0.03, 0.34]
Comparison: Month 6 The analysis includes the intent-to-treat population and compares P3 vs. Control.95% CI: [-0.27, 0.15]
Comparison: Month 6 The analysis includes the intent-to-treat population and compares P3+ vs. Control.95% CI: [-0.21, 0.16]
Secondary
PrEP Persistence
PrEP persistence will be measured by self-report at follow up of current PrEP use.
Time frame: Month 3, Month 6
Population: Data were included if 3- and/or 6-month responses were available. A participant's data was available if they sufficiently responded to the PrEP persistence survey questions and the survey was submitted within appropriate time window.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| P3 Application | PrEP Persistence | Month 3 | 66 Participants |
| P3 Application | PrEP Persistence | Month 6 | 52 Participants |
| P3+ Application | PrEP Persistence | Month 3 | 64 Participants |
| P3+ Application | PrEP Persistence | Month 6 | 49 Participants |
| Control | PrEP Persistence | Month 3 | 59 Participants |
| Control | PrEP Persistence | Month 6 | 52 Participants |
Comparison: Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.p-value: 0.5395% CI: [-0.02, 0.15]TMLE estimation of ATE and Wald test
Comparison: Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.p-value: 0.9695% CI: [-0.12, 0.12]TMLE estimation of ATE and Wald test
Secondary
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
Population: Data were included if 3- and/or 6-month responses were available. A participant's data was available if they sufficiently responded to the sexual activity survey questions and the survey was submitted within appropriate time window.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| P3 Application | Receptive Condomless Anal Sex | Month 6 | 1 sex acts |
| P3 Application | Receptive Condomless Anal Sex | Month 3 | 1 sex acts |
| P3+ Application | Receptive Condomless Anal Sex | Month 6 | 0 sex acts |
| P3+ Application | Receptive Condomless Anal Sex | Month 3 | 0 sex acts |
| Control | Receptive Condomless Anal Sex | Month 6 | 0 sex acts |
| Control | Receptive Condomless Anal Sex | Month 3 | 1 sex acts |
Comparison: Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.p-value: 0.695% CI: [-1.03, 2.48]TMLE estimation of ATE and Wald test
Comparison: Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.p-value: 0.695% CI: [-2.86, 1.04]TMLE estimation of ATE and Wald test
Secondary
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
Population: Data were included if 3- and/or 6-month responses were available. A participant's data was available if they sufficiently responded to the PrEP use survey questions and the survey was submitted within appropriate time window.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| P3 Application | Self-Reported Monthly PrEP Use | Month 3 | 100 percentage of time compliant |
| P3 Application | Self-Reported Monthly PrEP Use | Month 6 | 90 percentage of time compliant |
| P3+ Application | Self-Reported Monthly PrEP Use | Month 3 | 100 percentage of time compliant |
| P3+ Application | Self-Reported Monthly PrEP Use | Month 6 | 90 percentage of time compliant |
| Control | Self-Reported Monthly PrEP Use | Month 3 | 90 percentage of time compliant |
| Control | Self-Reported Monthly PrEP Use | Month 6 | 90 percentage of time compliant |
Comparison: Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.p-value: 0.0595% CI: [0.07, 17.83]TMLE estimation of ATE and Wald test
Comparison: Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.p-value: 0.4595% CI: [-13.33, 5.95]TMLE estimation of ATE and Wald test
Secondary
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
Population: Data were included if 3- and/or 6-month responses were available. A participant's data was available if they sufficiently responded to the PrEP use survey questions and the survey was submitted within appropriate time window.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| P3 Application | Self-Reported Weekly PrEP Use | Month 3 | 58 Participants |
| P3 Application | Self-Reported Weekly PrEP Use | Month 6 | 49 Participants |
| P3+ Application | Self-Reported Weekly PrEP Use | Month 3 | 59 Participants |
| P3+ Application | Self-Reported Weekly PrEP Use | Month 6 | 48 Participants |
| Control | Self-Reported Weekly PrEP Use | Month 3 | 51 Participants |
| Control | Self-Reported Weekly PrEP Use | Month 6 | 47 Participants |
Comparison: Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.p-value: 0.1195% CI: [-0.02, 0.19]TMLE estimation of ATE and Wald test
Comparison: Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.p-value: 0.8295% CI: [-0.14, 0.11]TMLE estimation of ATE and Wald test
Secondary
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
Population: Data were included if 3- and/or 6-month responses were available. A participant's data was available if they sufficiently responded to the STI survey questions and the survey was submitted within appropriate time window.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| P3 Application | Sexually Transmitted Infections (STI) Incidence | Month 3 Syphilis | 9 Participants |
| P3 Application | Sexually Transmitted Infections (STI) Incidence | Month 3 Chlamydia | 11 Participants |
| P3 Application | Sexually Transmitted Infections (STI) Incidence | Month 6 Syphilis | 11 Participants |
| P3 Application | Sexually Transmitted Infections (STI) Incidence | Month 3 Gonorrhea | 12 Participants |
| P3 Application | Sexually Transmitted Infections (STI) Incidence | Month 6 Chlamydia | 11 Participants |
| P3 Application | Sexually Transmitted Infections (STI) Incidence | Month 6 Gonorrhea | 11 Participants |
| P3+ Application | Sexually Transmitted Infections (STI) Incidence | Month 3 Chlamydia | 14 Participants |
| P3+ Application | Sexually Transmitted Infections (STI) Incidence | Month 3 Syphilis | 8 Participants |
| P3+ Application | Sexually Transmitted Infections (STI) Incidence | Month 6 Chlamydia | 8 Participants |
| P3+ Application | Sexually Transmitted Infections (STI) Incidence | Month 3 Gonorrhea | 14 Participants |
| P3+ Application | Sexually Transmitted Infections (STI) Incidence | Month 6 Syphilis | 3 Participants |
| P3+ Application | Sexually Transmitted Infections (STI) Incidence | Month 6 Gonorrhea | 6 Participants |
| Control | Sexually Transmitted Infections (STI) Incidence | Month 6 Syphilis | 9 Participants |
| Control | Sexually Transmitted Infections (STI) Incidence | Month 3 Chlamydia | 17 Participants |
| Control | Sexually Transmitted Infections (STI) Incidence | Month 6 Gonorrhea | 10 Participants |
| Control | Sexually Transmitted Infections (STI) Incidence | Month 3 Gonorrhea | 14 Participants |
| Control | Sexually Transmitted Infections (STI) Incidence | Month 6 Chlamydia | 12 Participants |
| Control | Sexually Transmitted Infections (STI) Incidence | Month 3 Syphilis | 12 Participants |
Comparison: Month 3 Gonorrhea The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.p-value: 0.695% CI: [-0.2, 0.08]TMLE estimation of ATE and Wald test
Comparison: Month 6 Gonorrhea The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.p-value: 0.695% CI: [-0.21, 0.09]TMLE estimation of ATE and Wald test
Comparison: Month 3 Chlamydia The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.p-value: 0.5395% CI: [-0.3, 0.03]TMLE estimation of ATE and Wald test
Comparison: Month 6 Chlamydia The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.p-value: 0.695% CI: [-0.24, 0.08]TMLE estimation of ATE and Wald test
Comparison: Month 3 Syphillis The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.p-value: 0.5395% CI: [-0.25, 0.04]TMLE estimation of ATE and Wald test
Comparison: Month 6 Syphillis The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.p-value: 0.695% CI: [-0.2, 0.07]TMLE estimation of ATE and Wald test