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| ID | Type | Description | Link |
|---|---|---|---|
| 5U19HD089881-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Emory University | OTHER |
| Duke University | OTHER |
| Children's Hospital of Philadelphia | OTHER |
| The Fenway Institute |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P3 | Experimental | Participants will use P3 |
|
| P3+ | Experimental | Participants will use P3+ |
|
| Control | Placebo Comparator | Participants will receive the standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P3 | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Month 3, Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 3, Month 6 |
| PrEP Persistence |
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Inclusion Criteria:
Exclusion Criteria:
Self-identify as MSM or TW who has sex with men
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Hightow-Weidman, MD | UNC Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida Infectious Diseases | Tampa | Florida | 33606 | United States | ||
| PRISM Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39804696 | Derived | Williams MP, Manjourides J, Smith LH, Rainer CB, Hightow-Weidman LB, Haley DF. Studying the Digital Intervention Engagement-Mediated Relationship Between Intrapersonal Measures and Pre-Exposure Prophylaxis Adherence in Sexual and Gender Minority Youth: Secondary Analysis of a Randomized Controlled Trial. J Med Internet Res. 2025 Jan 13;27:e57619. doi: 10.2196/57619. | |
| 39250643 | Derived | Yigit I, Budhwani H, Rainer CB, Claude K, Muessig KE, Hightow-Weidman LB. Associations Between PrEP Stigma, PrEP Confidence, and PrEP Adherence: Conditional Indirect Effects of Anticipated HIV Stigma. J Acquir Immune Defic Syndr. 2024 Oct 1;97(2):99-106. doi: 10.1097/QAI.0000000000003474. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Pre-Exposure Prophylaxis (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. |
| FG001 | 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+. |
| FG002 | Control | Participants will receive the standard of care Control: Control participants will receive the standard of care for receiving a prescription for PrEP. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Count of Participants | Participants | Month 3, Month 6 |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Despite the sample including about a quarter Black (20.7%) and another quarter Hispanic or Latinx (28.9%) participants, a majority of the sample was White (55.7%). And while the study was conducted across nine U.S. cities (Atlanta, Boston, Chicago, Chapel Hill, Charlotte, Houston, New York, Philadelphia, and Tampa) the results may not be generalizable to entire populations of young men who have sex with men (YMSM) and young transgender women who have sex with men (YTWSM).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Hightow-Weidman | University of North Carolina at Chapel Hill | 919-843-0033 | lisa_hightow@med.unc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 11, 2022 | Jul 20, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 21, 2022 | Jul 21, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| D021841 | Safe Sex |
| D055118 | Medication Adherence |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| OTHER |
| Montefiore Medical Center | OTHER |
| Baylor College of Medicine | OTHER |
| Ruth M. Rothstein CORE Center | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| University of South Florida | OTHER |
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.
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|
|
| P3+ | Behavioral | 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 | Behavioral | Control participants will receive the standard of care for receiving a prescription for PrEP. |
|
PrEP persistence will be measured by self-report at follow up of current PrEP use.
| 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. | 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. | 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. | 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. | 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. | Month 3, Month 6 |
| Self-Reported Weekly PrEP Use | Number of participants reported taking their PrEP medication >/= 4 days in the past week. | 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. | 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. | Throughout the duration of the study, approximately 1.5 years |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| The Adolescent and Young Adult Research (AYAR) at the CORE Center | Chicago | Illinois | 60612 | United States |
| The Fenway Institute | Boston | Massachusetts | 02215 | United States |
| Children's Hospital at Montefiore | The Bronx | New York | 10467 | United States |
| UNC-Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| RAIN | Charlotte | North Carolina | 29202 | United States |
| Adolescent Initiative at Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| 36306520 | Derived | Budhwani H, Yigit I, Maragh-Bass AC, Rainer CB, Claude K, Muessig KE, Hightow-Weidman LB. Validation of HIV Pre-Exposure Prophylaxis (PrEP) Medication Scales with Youth on PrEP: PrEP Confidence Scale and PrEP Difficulties Scale. AIDS Patient Care STDS. 2022 Nov;36(11):443-450. doi: 10.1089/apc.2022.0072. Epub 2022 Oct 27. |
| 30563818 | Derived | LeGrand S, Knudtson K, Benkeser D, Muessig K, Mcgee A, Sullivan PS, Hightow-Weidman L. Testing the Efficacy of a Social Networking Gamification App to Improve Pre-Exposure Prophylaxis Adherence (P3: Prepared, Protected, emPowered): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Dec 18;7(12):e10448. doi: 10.2196/10448. |
| BG001 | 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+. |
| BG002 | Control | Participants will receive the standard of care Control: Control participants will receive the standard of care for receiving a prescription for PrEP. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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+. |
| OG002 | Control | Participants will receive the standard of care Control: Control participants will receive the standard of care for receiving a prescription for PrEP. |
|
|
|
| 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. | 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). | Posted | Count of Participants | Participants | Month 3, Month 6 |
|
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Month 3, Month 6 |
|
|
|
|
| Secondary | PrEP Persistence | PrEP persistence will be measured by self-report at follow up of current PrEP use. | 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. | Posted | Count of Participants | Participants | Month 3, Month 6 |
|
|
|
|
| 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. | 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. | Posted | Median | Inter-Quartile Range | sex acts | Month 3, Month 6 |
|
|
|
|
| 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. | 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. | Posted | Median | Inter-Quartile Range | sex acts | Month 3, Month 6 |
|
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Month 3, Month 6 |
|
|
|
|
| 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. | 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). | Posted | Count of Participants | Participants | Month 3, Month 6 |
|
|
|
|
| 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. | 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). | Posted | Count of Participants | Participants | Month 3, Month 6 |
|
|
|
|
| Secondary | Self-Reported Weekly PrEP Use | Number of participants reported taking their PrEP medication >/= 4 days in the past week. | 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. | Posted | Count of Participants | Participants | Month 3, Month 6 |
|
|
|
|
| Secondary | Self-Reported Monthly PrEP Use | Median self-reported percent of time in the past month that participants' took their PrEP as prescribed. | 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. | Posted | Median | Inter-Quartile Range | percentage of time compliant | Month 3, Month 6 |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | average cost per participant in USD | Throughout the duration of the study, approximately 1.5 years | Participating Sites | Participating Sites |
|
|
|
|
| 0 |
| 82 |
| 0 |
| 82 |
| 0 |
| 82 |
| EG001 | 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+. | 0 | 81 | 0 | 81 | 0 | 81 |
| EG002 | Control | Participants will receive the standard of care Control: Control participants will receive the standard of care for receiving a prescription for PrEP. | 0 | 83 | 0 | 83 | 0 | 83 |
Not provided
Not provided
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Month 6 |
|
|
| TMLE estimation of ATE and Wald test |
| 0.38 |
| Average Treatment Effect |
| 0.06 |
| 2-Sided |
| 95 |
| -0.08 |
| 0.21 |
| Superiority |
| Month 6 |
|
|
Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control. |
| TMLE estimation of ATE and Wald test |
| 0.53 |
P-values adjusted using the Benjamini Hochberg procedure. |
| Average Treatment Effect |
| 0.11 |
| 2-Sided |
| 95 |
| -0.03 |
| 0.25 |
| Superiority |
| Month 6 |
|
|
Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control. |
| TMLE estimation of ATE and Wald test |
| 0.96 |
P-values adjusted using the Benjamini Hochberg procedure. |
| Average Treatment Effect |
| 0 |
| 2-Sided |
| 95 |
| -0.12 |
| 0.12 |
| Superiority |
| Month 6 |
|
|
Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control. |
| TMLE estimation of ATE and Wald test |
| 0.60 |
P-values adjusted using the Benjamini Hochberg procedure. |
| Average Treatment Effect |
| -1.12 |
| 2-Sided |
| 95 |
| -4.16 |
| 1.91 |
| Superiority |
| Month 6 |
|
|
Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control. |
| TMLE estimation of ATE and Wald test |
| 0.60 |
P-values adjusted using the Benjamini Hochberg procedure. |
| Average Treatment Effect |
| -0.91 |
| 2-Sided |
| 95 |
| -2.86 |
| 1.04 |
| Superiority |
| Month 6 Gonorrhea |
|
|
| Month 3 Chlamydia |
|
|
| Month 6 Chlamydia |
|
|
| Month 3 Syphilis |
|
|
| Month 6 Syphilis |
|
|
Month 6 Gonorrhea The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control. |
| TMLE estimation of ATE and Wald test |
| 0.60 |
P-values adjusted using the Benjamini Hochberg procedure. |
| Average Treatment Effect |
| -0.06 |
| 2-Sided |
| 95 |
| -0.21 |
| 0.09 |
| Superiority |
| Month 3 Chlamydia The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control. | TMLE estimation of ATE and Wald test | 0.53 | P-values adjusted using the Benjamini Hochberg procedure. | Average Treatment Effect | -0.13 | 2-Sided | 95 | -0.30 | 0.03 | Superiority |
| Month 6 Chlamydia The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control. | TMLE estimation of ATE and Wald test | 0.60 | P-values adjusted using the Benjamini Hochberg procedure. | Average Treatment Effect | -0.08 | 2-Sided | 95 | -0.24 | 0.08 | Superiority |
| Month 3 Syphillis The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control. | TMLE estimation of ATE and Wald test | 0.53 | P-values adjusted using the Benjamini Hochberg procedure. | Average Treatment Effect | -0.11 | 2-Sided | 95 | -0.25 | 0.04 | Superiority |
| Month 6 Syphillis The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control. | TMLE estimation of ATE and Wald test | 0.60 | P-values adjusted using the Benjamini Hochberg procedure. | Average Treatment Effect | -0.07 | 2-Sided | 95 | -0.20 | 0.07 | Superiority |
| Month 6 |
|
|
Month 3 The analysis includes the intent-to-treat population and compares P3+ vs. Control.
| Average Treatment Effect |
| 0.19 |
| 2-Sided |
| 95 |
| 0.03 |
| 0.34 |
TMLE estimation of ATE and Wald Confidence Interval |
| Superiority |
| Month 6 The analysis includes the intent-to-treat population and compares P3 vs. Control. | Average Treatment Effect | -0.06 | 2-Sided | 95 | -0.27 | 0.15 | TMLE estimation of ATE and Wald Confidence Interval | Superiority |
| Month 6 The analysis includes the intent-to-treat population and compares P3+ vs. Control. | Average Treatment Effect | -0.02 | 2-Sided | 95 | -0.21 | 0.16 | TMLE estimation of ATE and Wald Confidence Interval | Superiority |
| Month 6 |
|
|
Month 3 The analysis includes the intent-to-treat population and compares P3+ vs. Control.
| Average Treatment Effect |
| 0.13 |
| 2-Sided |
| 95 |
| -0.04 |
| 0.29 |
TMLE estimation of ATE and Wald Confidence Interval |
| Superiority |
| Month 6 The analysis includes the intent-to-treat population and compares P3 vs. Control. | Average Treatment Effect | 0.09 | 2-Sided | 95 | -0.08 | 0.26 | TMLE estimation of ATE and Wald Confidence Interval | Superiority |
| Month 6 The analysis includes the intent-to-treat population and compares P3+ vs. Control. | Average Treatment Effect | 0.03 | 2-Sided | 95 | -0.13 | 0.19 | TMLE estimation of ATE and Wald Confidence Interval | Superiority |
| Month 6 |
|
|
Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.
| TMLE estimation of ATE and Wald test |
| 0.82 |
| Average Treatment Effect |
| -0.01 |
| 2-Sided |
| 95 |
| -0.14 |
| 0.11 |
| Superiority |
| Month 6 |
|
|
Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control. |
| TMLE estimation of ATE and Wald test |
| 0.45 |
| Average Treatment Effect |
| -3.69 |
| 2-Sided |
| 95 |
| -13.33 |
| 5.95 |
| Superiority |