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

NCT ID: NCT07146139

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-18

Study Completion Date

2025-03-21

Brief Summary

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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

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized controlled trial with two participants randomized to the main study intervention (MyPrEP Plus) for every one participant randomized to PrEP support with the standard of care.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Experimental Conditon: MyPrEP Plus

The intervention administered in the experimental condition includes PrEP decisional and adherence support with the MyPrEP Plus package.

Group Type EXPERIMENTAL

MyPrEP Plus Package

Intervention Type DEVICE

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.

Control Condition: Standard of Care

Participants randomized to the control condition will receive PrEP support through the standard of care.

Group Type OTHER

Standard of Care (SOC)

Intervention Type BEHAVIORAL

Participants in the control condition will receive PrEP support according to local standard of care while using the website pleaseprepme.org.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Are age 18 or older
* Identify as a transgender woman or woman and was assigned male sex at birth
* Are not currently on PrEP in the last three months and interested in learning more about PrEP
* Able to successfully send and receive text messages
* HIV negative by self-report
* Are able to speak, read and write in English or Spanish
* Report any of the following in the last 12 months:

* Having anal or vaginal sex with a person assigned male at birth
* Exchange of sex for money, goods, or services
* Received a diagnosis of a sexually transmitted infection
* Sharing injection equipment
* Are able and willing to provide written informed consent and participate for the duration of the study

Exclusion Criteria

* In a mutually monogamous sexual relationship with an HIV-negative partner for the past 12 months
* Of any medical, psychiatric, or social condition that in the opinion of the investigator would preclude participation or their ability to remain in the trial
* Study site staff member
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Public Health Foundation Enterprises, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan Buchbinder, MD

Role: PRINCIPAL_INVESTIGATOR

Bridge HIV, San Francisco Department of Public Health

Locations

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Bridge HIV, San Francisco Department of Public Health

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00083027

Identifier Type: -

Identifier Source: org_study_id

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