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

NCT05474313 | Unknown DMC

• 1 other identifier: 21-35533
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

PrEP; pre-exposure prophylaxis (PrEP); Adherence; HIV Risk Reduction; Mobile App; Pharmacy

Outcome Measures

Primary Outcomes (1)

• Effectiveness of PREP-3D on PREP use

  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

Study Arms (2)

PrEP-3D

EXPERIMENTAL

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

Behavioral: PrEP-3D package

Control Arm

OTHER

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

Behavioral: Standard of Care

Interventions

PrEP-3D package BEHAVIORAL

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.

PrEP-3D

Standard of Care BEHAVIORAL

Participants are given local standard of care navigation for initiation of PrEP

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Public Health Foundation Enterprises, Inc.: lead
• San Francisco Department of Public Health: collaborator
• Alto Pharmacy: collaborator

Study Sites (2)

Bridge HIV, San Francisco Department of Public Health

San Francisco, California, 94102, United States

RECRUITING

Alto Pharmacy

San Francisco, California, 94107, United States

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Risk Reduction Behavior; Medication Adherence

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavior; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Susan Buchbinder, MD

  Bridge HIV, San Francisco Department of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth Coleman, MA

CONTACT

628-217-7443; kenneth.coleman@sfdph.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Bridge HIV, SFDPH

Model Details: Randomized, controlled study

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: July 26, 2022
• Study Start: April 8, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)