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PrEPsmart 2-1-1 Pilot

NCT06631365 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-10-08

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Public Health Foundation Enterprises, Inc.

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-02
Primary Completion
2025-01-01
Completion
2025-04-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06631365 on ClinicalTrials.gov