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

September 16, 2022 updated by: Susan Buchbinder, Public Health Foundation Enterprises, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94102
        • Recruiting
        • Bridge HIV, San Francisco Department of Public Health
        • Principal Investigator:
          • Susan Buchbinder, MD
        • Sub-Investigator:
          • Albert Liu, MD, MPH
        • Sub-Investigator:
          • Hyman Scott, MD, MPH
      • San Francisco, California, United States, 94107
        • Active, not recruiting
        • Alto Pharmacy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PrEP-3D
Use of Alto Pharmacy, PrEP-3D mobile app and home laboratory testing.
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.
OTHER: Control Arm
Participants in the control arm will receive standard of care PREP navigation.
Behavioral: Standard of Care
Participants are given local standard of care navigation for initiation of PrEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of PREP-3D on PREP use
Time Frame: 12 months
Measurement of PrEP adherence using dried blood spot measurements of tenofovir-diphosphate (TFV-DP) levels greater than or equal to 700 fmol/punch
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Public Health Foundation Enterprises, Inc.

Collaborators

San Francisco Department of Public Health
Alto Pharmacy

Investigators

  • Principal Investigator: Susan Buchbinder, MD, Bridge HIV, San Francisco Department of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 8, 2022

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

July 22, 2022

First Submitted That Met QC Criteria

July 22, 2022

First Posted (ACTUAL)

July 26, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 16, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 21-35533

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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