Last updated: September 16, 2022
Sponsor: Public Health Foundation Enterprises, Inc.
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
N/AClinical Study ID
NCT05474313
21-35533
Ages > 18 Male Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 18 years or older
- Assigned male at birth 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
- Owns a smartphone and has private access to the internet
- Able to understand, read, and speak English or Spanish
- Lives in California
- Self-reported evidence of being at-risk for HIV acquisition, including at least one ofthe following in the past 6 months:
- ≥ 1 episode of anal/vaginal sex with a male or transgender female partner;
- Diagnosed with a bacterial sexually transmitted infection (STI).
- Interested in taking daily TDF/FTC or TAF/FTC PrEP
- Willing and able to receive PrEP prescriptions through Alto Pharmacy (e.g., nospecific pharmacy required by health plan, such as Kaiser HMO)
- Creatinine clearance >30 mL/min
- No contraindications to TDF/FTC or TAF/FTC use
Exclusion
Exclusion Criteria:
- Repeatedly reactive HIV test at screening or enrollment
- Signs or symptoms of acute HIV infection at screening or enrollment
- Currently enrolled in another HIV 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 thejudgment of the investigator, would make participation in the study unsafe, complicateinterpretation of study outcome data, or otherwise interfere with achieving the studyobjectives.
Study Design
Total Participants: 150
Study Start date:
April 08, 2022
Estimated Completion Date:
December 31, 2023
Study Description
Connect with a study center
Alto Pharmacy
San Francisco, California 94107
United StatesSite Not Available
Bridge HIV, San Francisco Department of Public Health
San Francisco, California 94102
United StatesActive - Recruiting
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