Pilot program for on-demand HIV prevention using a mobile app
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
This study is testing a mobile app called PrEPsmart to see if it helps cisgender sexual minority males who are using on-demand HIV prevention medication feel more comfortable and effective in their prevention efforts.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Public Health Foundation Enterprises, Inc. Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06631365 on ClinicalTrials.gov |
What this trial studies
This pilot program aims to evaluate the feasibility, acceptability, and preliminary effectiveness of the PrEPsmart mobile app among cisgender sexual minority males (SMM) taking on-demand pre-exposure prophylaxis (PrEP) over a 6-month period. The study will enroll up to 60 participants who are either currently using or interested in using on-demand PrEP. Participants will be randomly assigned to receive the PrEPsmart app or not, with follow-up visits scheduled at 3 and 6 months. The study seeks to ensure diversity in its participant pool, aiming for at least 50% representation from African American or Latino SMM.
Who should consider this trial
Good fit: Ideal candidates include cisgender males aged 18 and older who engage in anal sex and are either interested in starting or currently taking on-demand PrEP.
Not a fit: Patients who are not cisgender males or those who are already HIV-positive may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could enhance the accessibility and effectiveness of on-demand PrEP for preventing HIV among sexual minority males.
How similar studies have performed: Other studies have shown promise in using mobile health tools for HIV prevention, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
San Francisco, California
- Bridge HIV, San Francisco Department of Public Health — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Albert Liu — albert.liu@sfdph.org
- Study coordinator: Juwann Moss
- Email: Juwann.moss@sfdph.org
- Phone: 628-217-7443
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.