PrEPsmart 2-1-1 Pilot

Part of paid clinical trials in San Francisco, California.

Sponsor
Public Health Foundation Enterprises, Inc.
Study ID
NCT06631365
Phase
PHASE2
Status
Recruiting
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Conditions

  • HIV-1-infection

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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

Key Dates

Start date
Oct 2, 2023
Status verified
Oct 2024
Primary completion
Jan 1, 2025
Completion
Apr 1, 2025

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: PrEPsmart intervention (N=40)
    Participants will be randomized in a 2:1 ratio to the intervention (N=40) For the pre-exposure prophylaxis (PrEP)smart intervention group, a study clinician will perform a medical history and limited physical exam to confirm eligibility to enroll in the study, a 4th generation rapid Human immunodeficiency virus (HIV) test will be performed, and labs drawn for creatinine, sexual transmitted infection (STI) testing (Neisseria gonorrhoeae/Chlamydia trachomatis (GC/CT)), syphilis), and hepatitis B testing. For participants newly starting 2-1-1 PrEP (PrEPsmart intervention group), study drug will be offered to participants to ensure that they will have access to PrEP during the study to be able to adequately test the app.
  • No Intervention: control (N=20)
    For the non-prescribed group, study staff will request documentation of an HIV-negative test within the last 3 months OR evidence of pre-exposure prophylaxis (PrEP) prescription within the last 6 months from medical records or pharmacy/provider communication. Additionally, study staff will confirm via self-report that the participant's 2-1-1 PrEP use will be clinically monitored by another clinician or clinic for the duration of the study. Any individual with a positive HIV test will have a confirmation test sent to the lab and be referred immediately for HIV care and initiation of treatment. For participants already on PrEP (control group) may choose to continue to use their own supply of Truvada (tenofovir disoproxil fumarate/emtricitabine, or TDF/FTC).

Primary Outcome Measure

Acceptability of the PrEPsmart mobile app [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Bridge HIV, San Francisco Department of Public HealthSan FranciscoCalifornia94134
Juwann Moss
[email protected]
628-217-7443
Alicia Stephens
628-217-7439
Albert Liu, MD, MPH
Hyman Scott, MD, MPH
Susan Buchbinder, MD
Erin Wilson, PHD

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By research site
Bridge HIV, San Francisco Department of Public Health· San Francisco, CA

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