BridgeMD
New treatment option for HIV-1-infection
Official title PrEPsmart 2-1-1 Pilot
ClinicalTrials.gov ID: NCT06631365
What this study is testing
What is Truvada?
Truvada is an investigational medicine, being studied as a potential treatment for hiv-1-infection.
Also referred to as Emtricitabine, Tenofovir disoproxil fumarate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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. Upon project completion, the investigators will have developed a highly innovative tool to support men who have sex with men (MSM) using on-demand PrEP ready for testing in a larger efficacy trial
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- 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...
See the full eligibility 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.