PrEPsmart 2-1-1 Pilot
ConditionHIV-1-infection
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorPublic Health Foundation Enterprises, Inc.
About this trial
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
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- PrEPsmart mobile app
- Truvada
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Public Health Foundation Enterprises, Inc.
Lead sponsor
Gilead Sciences
Collaborator
Source ClinicalTrials.gov