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

NCT07146139 | Terminated

• 1 other identifier: Pro00083027
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

PrEP; Pre-exposure prophylaxis; MyPrEP; Website; Decision Support

Outcome Measures

Primary Outcomes (1)

• Feasibility and acceptability of the MyPrEP Plus package for PrEP uptake in TGW as assessed by the Client Satisfaction Questionnaire, System Usability Scale, and intervention metrics.

  Participant responses to the Client Satisfaction Questionnaire (CSQ-8) and the System Usability Scale (SUS) assessment tools which assess the various domains of the combined tools will be used to evaluate the acceptability of the MyPrEP Plus package. Scores for the CSQ-8 and the SUS range from 8-32 and 0-100, respectively with higher scores representing greater satisfaction and usability. Web-based analytics of the MyPrEP website combined with responses within the PrEPmate tool and time spent using PrEPmate to interact with staff will be used as a measure of feasibility.

  3 months

Secondary Outcomes (3)

• Participants' change in knowledge of PrEP and doxycycline PEP (Doxy-PEP) after three months of study participation as assessed by a set of knowledge questions at baseline and follow up.

  3 months

• Preliminary impact of the MyPrEP Plus package on PrEP uptake in TGW compared to that of pleaseprepme.org by evaluating the number of people who access PrEP after 3 months.

  3 months

• Preliminary impact of the MyPrEP Plus package on Doxy-PEP uptake by evaluating the number of people who access Doxy-PEP after 3 months.

  3 months

Study Arms (2)

Experimental Conditon: MyPrEP Plus

EXPERIMENTAL

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

Device: MyPrEP Plus Package

Control Condition: Standard of Care

OTHER

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

Behavioral: Standard of Care (SOC)

Interventions

MyPrEP Plus Package 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.

Experimental Conditon: MyPrEP Plus

Standard of Care (SOC) BEHAVIORAL

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

Control Condition: Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Transgender woman or woman and was assigned male sex at birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Public Health Foundation Enterprises, Inc.: lead

Study Sites (1)

Bridge HIV, San Francisco Department of Public Health

San Francisco, California, 94102, United States

Location

MeSH Terms

Interventions

Drug Packaging; Standard of Care

Intervention Hierarchy (Ancestors)

Technology, Pharmaceutical; Investigative Techniques; Drug Industry; Manufacturing Industry; Industry; Technology, Industry, and Agriculture; Product Packaging; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Susan Buchbinder, MD

  Bridge HIV, San Francisco Department of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 28, 2025
• Study Start: March 18, 2023
• Primary Completion: March 21, 2025
• Study Completion: March 21, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)