A Study Evaluating An Integrated Pharmacy Digital Diary and Delivery Strategy to Increase PrEP Use Among MSM and TGW

Last updated: September 16, 2022
Sponsor: Public Health Foundation Enterprises, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05474313
21-35533
  • Ages > 18
  • Male
  • Accepts Healthy Volunteers

Study Summary

The PrEP 3D randomized controlled trial (RCT) will study the effectiveness of the PrEP-3D app compared to standard of care for starting pre-exposure prophylaxis (PrEP), continuing PrEP, and adherence to PrEP.

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

The investigators will be testing a pharmacist-led model of PrEP delivery combined with mobile app-based PrEP support developed by the investigator's team to improve PrEP initiation and persistence. Alto Pharmacy is a full-service online pharmacy already using mobile and web apps to communicate with patients, providers, laboratories, and insurers to provide timely medication delivery. Alto can provide PrEP prescriptions, order laboratory tests, and perform clinical referrals through a collaborative practice agreement (CPA) with SFDPH that allows transfer of these responsibilities. The investigators have integrated online tools with Alto Pharmacy's technology platform to create PrEP-3D: Digital Diary and Delivery, combining a tailored online support tool with the personalized service of a community pharmacy and the convenience of medication delivery. By removing the requirement for initiation and quarterly visits with a primary care physician for PrEP, the PrEP-3D model will expand access to PrEP visits (including for persons who choose not to go to their primary care provider for PrEP) and reduce burden on the health care system.

Connect with a study center

  • Alto Pharmacy

    San Francisco, California 94107
    United States

    Site Not Available

  • Bridge HIV, San Francisco Department of Public Health

    San Francisco, California 94102
    United States

    Active - Recruiting

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