NCT06631365

PrEPsmart 2-1-1 Pilot

PrEPsmart Pilot: a Trial to Evaluate a Mobile App to Support the Safe and Effective Use of On-demand Pre-exposure Prophylaxis (PrEP) Among Sexual Minority Men in the US

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Public Health Foundation Enterprises, Inc. · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DEVICE	PrEPsmart mobile app	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
DRUG	Truvada	Combination medication used in Human immunodeficiency virus (HIV) prevention, it blocks virus pathways to infection.

Timeline

• Start date: 2023-10-02
• Primary completion: 2025-01-01
• Completion: 2025-04-01
• First posted: 2024-10-08
• Last updated: 2024-10-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study