PrEPsmart 2-1-1 Pilot

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.

Inclusion criteria

• 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

Exclusion criteria

• 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.