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Recruiting Phase 2 NCT06631365

PrEPsmart 2-1-1 Pilot

Trial Parameters

Condition HIV-1-infection
Sponsor Public Health Foundation Enterprises, Inc.
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 60
Sex MALE
Min Age 18 Years
Max Age N/A
Start Date 2023-10-02
Completion 2025-01-01
Interventions
PrEPsmart mobile appTruvada

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

Eligibility Criteria

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 st

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