HIV Pre-exposure ProphylaxisNCT07146139
MyPrEP Plus: Development and Pilot Testing of Novel Preexposure Prophylaxis Decision Support Tools for Transgender Women
A study testing MyPrEP Plus Package in people with HIV Pre-exposure Prophylaxis and HIV Prevention and Care, run by Public Health Foundation Enterprises, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Pre-exposure Prophylaxis, HIV Prevention and Care, Mobile Health Technology (mHealth)
- What is being tested?
- MyPrEP Plus Package
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2023to 21 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Bridge HIV, San Francisco Department of Public Health
San Francisco, California, 94102
About this study
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.
Read the 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
- Being tested
- MyPrEP Plus Package, Standard of Care (SOC)
- Keywords
- PrEP, Pre-exposure prophylaxis, MyPrEP, Website, Decision Support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyPrEP Plus PackageDevice
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.
Standard of Care (SOC)Behavioural
Participants in the control condition will receive PrEP support according to local standard of care while using the website pleaseprepme.org.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Conditon: MyPrEP Plus | Experimental | The intervention administered in the experimental condition includes PrEP decisional and adherence support with the MyPrEP Plus package. Receives: 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. Receives: Behavioral: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start18 Mar 2023
- Primary completion21 Mar 2025
- Study completion21 Mar 2025
Why it stopped: Recruitment was halted prematurely as a result of the termination of the grant by the NIH.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Pre-exposure ProphylaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health Foundation Enterprises, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Buchbinder, MD, Principal investigator, Bridge HIV, San Francisco Department of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146139
- Sponsor's protocol ID
- Pro00083027
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyPrEP Plus: Development and Pilot Testing of Novel Preexposure Prophylaxis Decision Support Tools for Transgender Women
- ClinicalTrials.gov ID
- NCT07146139
- Acronym / sponsor ID
- Pro00083027
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was halted prematurely as a result of the termination of the grant by the NIH.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Public Health Foundation Enterprises, Inc.University, hospital or other
- Study start
- 18 Mar 2023 (actual)
- Primary completion
- 21 Mar 2025 (actual)
- Study completion
- 21 Mar 2025 (actual)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Conditon: MyPrEP Plus | Experimental | Device: MyPrEP Plus PackageThe intervention administered in the experimental condition includes PrEP decisional and adherence support with the MyPrEP Plus package. |
| Control Condition: Standard of Care | Other | Behavioral: Standard of Care (SOC)Participants randomized to the control condition will receive PrEP support through the standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyPrEP Plus PackageParticipants 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. | Device | Experimental Conditon: MyPrEP Plus |
| 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. | Behavioural | Control Condition: Standard of Care |
Primary outcome
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.
Time frame: 3 months
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 secondary outcomes
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.
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.
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.
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Recruitment was halted prematurely as a result of the termination of the grant by the NIH.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Buchbinder, MD principal investigator
Bridge HIV, San Francisco Department of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyPrEP Plus Package in people with HIV Pre-exposure Prophylaxis and HIV Prevention and Care, run by Public Health Foundation Enterprises, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment was halted prematurely as a result of the termination of the grant by the NIH.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.