PrEPsmart 2-1-1 Pilot
- Registration Number
- NCT06631365
- Lead Sponsor
- Public Health Foundation Enterprises, Inc.
- Brief Summary
This is a pilot study to assess the feasibility, acceptability, and preliminary effectiveness of pre-exposure prophylaxis (PrEP)smart among cisgender sexual minority males (SMM) taking on-demand PrEP over a 6-month period.
Upon project completion, the investigators will have developed a highly innovative tool to support men who have sex with men (MSM) using on-demand PrEP ready for testing in a larger efficacy trial
- Detailed Description
This study is designed to enroll a diverse population of English-speaking cisgender sexual minority males (SMM) in the United States. The study team will enroll up to 60 participants who are taking or are interested in taking on-demand pre-exposure prophylaxis (PrEP). Participants will be randomized 2:1 to receive (intervention arm) or not receive (control arm) the PrEPsmart app at enrollment. Participants will complete follow-up visits at 3 and 6 months.
Participants newly starting 2-1-1 PrEP will be seen at the Bridge HIV clinic (prescribed group), while those already on PrEP may be seen at the clinic or complete visits virtually (non-prescribed group). Although no restrictions are put on the racial/ethnic make-up of the study participants, the site will strive to enroll at least 50% African American or Latino SMM into this study. The study will also strive to enroll at least 30% of participants who are newly starting or restarting 2-1-1 PrEP. Upon project completion, the study team will have developed a highly innovative tool to support men who have sex with men (MSM) using on-demand PrEP ready for testing in a larger efficacy trial.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 60
- Age 18 years or older
- Cisgender-male who reports sex with persons assigned male at birth
- Willing and able to provide written informed consent
- HIV-uninfected by negative 4th generation HIV test during screening (prescribed group)
- Documentation of negative HIV test within the last 3 months by outside laboratory OR evidence of PrEP prescription within the last 6 months based on medical records or pharmacy/provider communication
- Owns an iOS or Android mobile phone with a camera and has private access to the internet
- Able to understand, read, and speak English
- Able to attend study visits at a local research site in San Francisco (Bridge HIV) (prescribed and non-prescribed groups) or virtual visits via a HIPAA-compliant teleconferencing platform (non-prescribed group)
- Interested in starting or currently taking on-demand PrEP with TDF/FTC
- Report having anal sex at least once a month and expecting to maintain at least this frequency of anal sex during study participation by self-report
- Creatinine clearance ≥60 mL/min based on testing done during screening (prescribed group)
- Have PrEP clinical and laboratory monitoring by another provider or clinic by self-report (non-prescribed group)
- No contraindications to TDF/FTC use
- No evidence of chronic HBV infection based on testing done during screening (prescribed group)
- Willing to self-collect urine samples weekly
- Repeatedly reactive HIV test at screening or enrollment or self-reported reactive HIV test (prescribed group)
- Signs or symptoms of acute HIV infection at screening or enrollment
- Currently enrolled in another PrEP intervention study.
- Unable to commit to study participation for the duration of the study
- Any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PrEPsmart intervention (N=40) Truvada Participants will be randomized in a 2:1 ratio to the intervention (N=40) For the pre-exposure prophylaxis (PrEP)smart intervention group, a study clinician will perform a medical history and limited physical exam to confirm eligibility to enroll in the study, a 4th generation rapid Human immunodeficiency virus (HIV) test will be performed, and labs drawn for creatinine, sexual transmitted infection (STI) testing (Neisseria gonorrhoeae/Chlamydia trachomatis (GC/CT)), syphilis), and hepatitis B testing. For participants newly starting 2-1-1 PrEP (PrEPsmart intervention group), study drug will be offered to participants to ensure that they will have access to PrEP during the study to be able to adequately test the app. PrEPsmart intervention (N=40) PrEPsmart mobile app Participants will be randomized in a 2:1 ratio to the intervention (N=40) For the pre-exposure prophylaxis (PrEP)smart intervention group, a study clinician will perform a medical history and limited physical exam to confirm eligibility to enroll in the study, a 4th generation rapid Human immunodeficiency virus (HIV) test will be performed, and labs drawn for creatinine, sexual transmitted infection (STI) testing (Neisseria gonorrhoeae/Chlamydia trachomatis (GC/CT)), syphilis), and hepatitis B testing. For participants newly starting 2-1-1 PrEP (PrEPsmart intervention group), study drug will be offered to participants to ensure that they will have access to PrEP during the study to be able to adequately test the app.
- Primary Outcome Measures
Name Time Method Acceptability of the PrEPsmart mobile app 6 months Acceptability will be measured using the Client Satisfaction Questionnaire (CSQ-8) adapted for use in PrEPsmart pilot. The study team will also assess interest in future use of the app at study completion.
Usability of the PrEPsmart mobile app 6 months Usability will be measured using the System Usability Scale (SUS) adapted for use in PrEPsmart pilot. A score \>50 (out of 100) on the SUS indicates the app is acceptable.
- Secondary Outcome Measures
Name Time Method To compare PrEP coverage of sex acts as measured by weekly urine tenofovir test strips among SMM in the PrEPsmart vs. control arms 6 months PrEP coverage will be primarily defined as self-reported sex acts in which the participant reported at least one pill taken within 24 hours before sex and one pill taken within 24 hours after sex, as defined in the Ipergay study. Additionally, the study team will conduct an analysis in which weekly PrEP dosing is confirmed by having a detectable TFV urine test within 7 days of reported sex.
To compare switching of PrEP regimens among SMM in the PrEPsmart vs. control arms 6 months The proportion of participants who switch from on-demand PrEP to daily PrEP (or another regimen, e.g.
injectable PrEP) will be calculated and compared between arms using chi-square tests.To compare rates of PrEP discontinuation among SMM in the PrEPsmart vs. control arm 6 months PrEP discontinuation and retention rates will be calculated, with 95% binomial confidence intervals, and compared between arms using log-binomial models. The study team will also estimate and compare time to discontinuation using Kaplan Meier methods and the log-rank test, accounting for censoring by end of study or dropout.
Elicit feedback on areas for improvement for PrEPsmart to guide further app refinement 6 months Ideas for improvement of PrEPsmart elicited through exit interviews will be tabulated, discussed with the protocol team, and prioritized for development.
Trial Locations
- Locations (1)
Bridge HIV, San Francisco Department of Public Health
🇺🇸San Francisco, California, United States