NCT06631365 · Public Health Foundation Enterprises, Inc.
PrEPsmart 2-1-1 Pilot
What this study is about
This is a pilot study to assess the feasibility, acceptability, and preliminary effectiveness of pre-exposure prophylaxis (PrEP)smart among cisgender sexual minority males (SMM) taking on-demand PrEP over a 6-month period.
View original scientific description
This is a pilot study to assess the feasibility, acceptability, and preliminary effectiveness of pre-exposure prophylaxis (PrEP)smart among cisgender sexual minority males (SMM) taking on-demand PrEP over a 6-month period.
Interventions
DEVICE
PrEPsmart mobile app
The PrEPsmart mobile app is an innovative and comprehensive app to support sexual minority men (SMM) using on-demand pre-exposure prophylaxis (PrEP) or daily PrEP. The PrEPsmart app consists of the following components: 1. PrEP 211 dosing/sex diary and reminders 2. Feedback on PrEP protection levels 3. Quick tips 4. Bi-directional secure messaging
DRUG
Truvada
Combination medication used in Human immunodeficiency virus (HIV) prevention, it blocks virus pathways to infection.
Primary outcome measures
Acceptability of the PrEPsmart mobile app
Time frame: 6 months
Acceptability will be measured using the Client Satisfaction Questionnaire (CSQ-8) adapted for use in PrEPsmart pilot. The study team will also assess interest in future use of the app at study completion.
Usability of the PrEPsmart mobile app
Time frame: 6 months
Usability will be measured using the System Usability Scale (SUS) adapted for use in PrEPsmart pilot. A score \>50 (out of 100) on the SUS indicates the app is acceptable.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 18 years or older
- Cisgender-male who reports sex with persons assigned male at birth
- Willing and able to provide written informed consent
- HIV-uninfected by negative 4th generation HIV test during screening (prescribed group)
- Documentation of negative HIV test within the last 3 months by outside laboratory OR evidence of PrEP prescription within the last 6 months based on medical records or pharmacy/provider communication
- Owns an iOS or Android mobile phone with a camera and has private access to the internet
- Able to understand, read, and speak English
- Able to attend study visits at a local research site in San Francisco (Bridge HIV) (prescribed and non-prescribed groups) or virtual visits via a HIPAA-compliant teleconferencing platform (non-prescribed group)
- Interested in starting or currently taking on-demand PrEP with TDF/FTC
- Report having anal sex at least once a month and expecting to maintain at least this frequency of anal sex during study participation by self-report
- Creatinine clearance ≥60 mL/min based on testing done during screening (prescribed group)
- Have PrEP clinical and laboratory monitoring by another provider or clinic by self-report (non-prescribed group)
- No contraindications to TDF/FTC use
- No evidence of chronic HBV infection based on testing done during screening (prescribed group)
- Willing to self-collect urine samples weekly
Exclusion criteria
- Repeatedly reactive HIV test at screening or enrollment or self-reported reactive HIV test (prescribed group)
- Signs or symptoms of acute HIV infection at screening or enrollment
- Currently enrolled in another PrEP intervention study.
- Unable to commit to study participation for the duration of the study
- Any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Where
- San Francisco, California
Collaborators
Gilead Sciences
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 8, 2024 · Source of record for eligibility and locations