NCT07146139

MyPrEP Plus: Development and Pilot Testing of Novel Preexposure Prophylaxis Decision Support Tools for Transgender Women

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

Summary

The primary goal of this randomized controlled trial is to learn if a decision support tool called MyPrEP Plus can help transgender women make decisions about taking pre-exposure prophylaxis (PrEP) for HIV prevention.

Detailed description

In this clinical study, 60 transgender women will be randomly assigned to one of two groups, either PrEP support via standard of care through pleaseprepme.org (control condition) or PrEP support with the MyPrEP Plus package (experimental condition) which includes access to the MyPrEP website which provides information on the various types of PrEP as well as information on Doxy-PEP. Participants will also have access to PrEPmate, a two-way PrEP support tool that is meant to help participants stay engaged in their PrEP care and is meant to support starting PrEP and staying on PrEP. Participants in each group will start out by completing a baseline questionnaire that will ask about demographics, behaviors, and PrEP and Doxy-PEP knowledge. Each participant will be followed for three months while deciding to take PrEP or actively taking PrEP. At the end of three months, participants will be administered another survey which will assess PrEP uptake, change in PrEP and Doxy-PEP knowledge, and how well the MyPrEP Plus package helped with starting and staying on PrEP. Around 20 participants in the experimental condition will be invited for an in-depth interview to discuss their experience using the MyPrEP Plus package.

Conditions

• HIV Pre-exposure Prophylaxis
• HIV Prevention and Care
• Mobile Health Technology (mHealth)
• Adherence
• Doxycycline STI PEP

Interventions

Type	Name	Description
DEVICE	MyPrEP Plus Package	Participants receiving the MyPrEP Plus Package will utilize the interactive MyPrEP website to learn about PrEP and the various kinds of PrEP available as well as information about Doxy-PEP. While on PrEP, participants will be able sign up for PrEPmate, a tool designed to support PrEP adherence.
BEHAVIORAL	Standard of Care (SOC)	Participants in the control condition will receive PrEP support according to local standard of care while using the website pleaseprepme.org.

Timeline

• Start date: 2023-03-18
• Primary completion: 2025-03-21
• Completion: 2025-03-21
• First posted: 2025-08-28
• Last updated: 2025-08-28

Locations

1 site across 1 country: United States