PrEPsmart 2-1-1 Pilot
PrEPsmart Pilot: a Trial to Evaluate a Mobile App to Support the Safe and Effective Use of On-demand Pre-exposure Prophylaxis (PrEP) Among Sexual Minority Men in the US
Public Health Foundation Enterprises, Inc.
60 participants
Oct 2, 2023
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Inclusion Criteria15
- 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 Criteria5
- 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.
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Interventions
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
Combination medication used in Human immunodeficiency virus (HIV) prevention, it blocks virus pathways to infection.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06631365