NCT05474313

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

PrEP-3D RCT: A Randomized Controlled Trial Evaluating An Integrated Pharmacy Digital Diary and Delivery Strategy to Increase PrEP Use Among Persons Assigned Male at Birth Who Have Sex With Persons Assigned Male at Birth

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Public Health Foundation Enterprises, Inc. · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• HIV Prevention
• Pre-exposure Prophylaxis (PrEP)
• Risk Reduction
• Adherence, Medication

Interventions

Type	Name	Description
BEHAVIORAL	PrEP-3D package	A package of support tools for accessing, adhering to, and monitoring PrEP use, including Alto Pharmacy delivery services, PrEP-3D mobile app, and home laboratory testing.
BEHAVIORAL	Standard of Care	Participants are given local standard of care navigation for initiation of PrEP

Timeline

• Start date: 2022-04-08
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2022-07-26
• Last updated: 2022-09-21

Locations

2 sites across 1 country: United States