Recruiting

Digital Diary

Sponsor:

Public Health Foundation Enterprises, Inc.

Code:

NCT05474313

Conditions

HIV Prevention

Pre-exposure Prophylaxis (PrEP)

Risk Reduction

Adherence, Medication

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Interventions

PrEP-3D package

Standard of Care

Study Details

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

Study ID

NCT05474313

Start date

Apr 8, 2022

Status verified date

Sep, 2022

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: PrEP-3D

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

other: Control Arm

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

Interventions

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.

Standard of Care

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

Primary outcome measure

  • Effectiveness of PREP-3D on PREP use [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Kenneth Coleman, MA

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

Locations

Bridge HIV, San Francisco Department of Public Health

Recruiting

San Francisco, California, United States, 94102

Contacts

Kenneth Coleman, MA

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

Principal Investigator:

Susan Buchbinder, MD

More Information

Sponsor

Public Health Foundation Enterprises, Inc.

Last update posted

Sep 21, 2022

Last verified

Sep, 2022

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Public Health Foundation Enterprises, Inc. on 2022-09-21.