Sexually Transmitted Diseases Clinical Trial
— P3Official title:
P3 (Prepared, Protected, emPowered): Promoting Pre-exposure Prophylaxis (PrEP) Adherence Through a Social Networking, Gamification, and Adherence Support App
Verified date | August 2022 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 246 |
Est. completion date | September 16, 2021 |
Est. primary completion date | September 16, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 16 Years to 24 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | PRISM Health | Atlanta | Georgia |
United States | The Fenway Institute | Boston | Massachusetts |
United States | Children's Hospital at Montefiore | Bronx | New York |
United States | UNC-Chapel Hill | Chapel Hill | North Carolina |
United States | RAIN | Charlotte | North Carolina |
United States | The Adolescent and Young Adult Research (AYAR) at the CORE Center | Chicago | Illinois |
United States | Texas Children's Hospital | Houston | Texas |
United States | Adolescent Initiative at Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | University of South Florida Infectious Diseases | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | Baylor College of Medicine, Children's Hospital of Philadelphia, Duke University, Emory University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Montefiore Hospital, Ruth M. Rothstein CORE Center, The Fenway Institute, University of South Florida |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | Month 3, Month 6 | |
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. | 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. | Month 3, Month 6 | |
Secondary | PrEP Persistence | PrEP persistence will be measured by self-report at follow up of current PrEP use. | 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. | 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. | 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. | 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. | 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. | Month 3, Month 6 | |
Secondary | Self-Reported Weekly PrEP Use | Number of participants reported taking their PrEP medication >/= 4 days in the past week. | 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. | 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. | Throughout the duration of the study, approximately 1.5 years |
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