A Study Evaluating An Integrated Pharmacy Digital Diary and Delivery Strategy to Increase PrEP Use Among MSM and TGW (PrEP-3D RCT)

Public Health Foundation Enterprises, Inc.

Status: Enrolling

Conditions: Pre-exposure Prophylaxis (PrEP); Adherence, Medication; HIV Prevention; Risk Reduction

Treatments: Behavioral: Standard of Care; Behavioral: PrEP-3D package

Study type: Interventional

Funder types: Other

Identifiers

NCT05474313

21-35533

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 of the 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., no specific pharmacy required by health plan, such as Kaiser HMO)

• Creatinine clearance >30 mL/min

• No contraindications to TDF/FTC or TAF/FTC use

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 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

PrEP-3D

Experimental group

Description:

Use of Alto Pharmacy, PrEP-3D mobile app and home laboratory testing.

Treatment:

Behavioral: PrEP-3D package

Control Arm

Other group

Description:

Participants in the control arm will receive standard of care PREP navigation.

Treatment:

Behavioral: Standard of Care