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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
The PrEPsmart mobile app is an innovative and comprehensive app to support sexual minority men (SMM) using on-demand pre-exposure prophylaxis (PrEP) or daily PrEP. The PrEPsmart app consists of the following components: 1. PrEP 211 dosing/sex diary and reminders 2. Feedback on PrEP protection levels 3. Quick tips 4. Bi-directional secure messaging
Combination medication used in Human immunodeficiency virus (HIV) prevention, it blocks virus pathways to infection.
Bridge HIV, San Francisco Department of Public Health
San Francisco, California, United States
RECRUITINGAcceptability of the PrEPsmart mobile app
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.
Time frame: 6 months
Usability of the PrEPsmart mobile app
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.
Time frame: 6 months
To compare PrEP coverage of sex acts as measured by weekly urine tenofovir test strips among SMM in the PrEPsmart vs. control arms
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.
Time frame: 6 months
To compare switching of PrEP regimens among SMM in the PrEPsmart vs. control arms
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.
Time frame: 6 months
To compare rates of PrEP discontinuation among SMM in the PrEPsmart vs. control arm
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 6 months
Elicit feedback on areas for improvement for PrEPsmart to guide further app refinement
Ideas for improvement of PrEPsmart elicited through exit interviews will be tabulated, discussed with the protocol team, and prioritized for development.
Time frame: 6 months