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

Public Health Foundation Enterprises, Inc.

Status: Terminated

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

Treatments: Behavioral: Standard of Care (SOC); Device: MyPrEP Plus Package

Study type: Interventional

Funder types: Other

Identifiers

NCT07146139

Pro00083027

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Experimental Conditon: MyPrEP Plus

Experimental group

Description:

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

Treatment:

Device: MyPrEP Plus Package

Control Condition: Standard of Care

Other group

Description:

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

Treatment:

Behavioral: Standard of Care (SOC)