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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
2
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.
Participants in the control condition will receive PrEP support according to local standard of care while using the website pleaseprepme.org.
Bridge HIV, San Francisco Department of Public Health
San Francisco, California, United States
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.
Time frame: 3 months
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.
Participant responses to a series of true/false questions about PrEP and Doxy-PEP. Items assess knowledge of the various kinds of PrEP, knowledge of Doxy-PEP, how each type of PrEP is taken, conditions that Doxy-PEP can help prevent and common side effects of the various forms of PrEP as well as Doxy-PEP. Responses will be labeled as correct or incorrect. The change in the proportion of correct answers to the PrEP and Doxy-PEP knowledge questionnaire at three months from baseline will be calculated for each participant.
Time frame: 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.
The number of participants using the MyPrEP Plus Package vs. the number of participants using pleaseprepme.org who demonstrate PrEP uptake by confirming PrEP acquisition with a physical bottle for oral PrEP or documented administration of injectable PrEP.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The number of participants using the MyPrEP Plus Package vs. the number of participants using pleaseprepme.org who demonstrate Doxy-PEP uptake by confirming Doxy-PEP acquisition with a physical bottle.
Time frame: 3 months