Status:

RECRUITING

Comparing Mobile Health Strategies to Improve Pre-exposure Prophylaxis Use (PrEP) for HIV Prevention

Lead Sponsor:

Public Health Foundation Enterprises, Inc.

Collaborating Sponsors:

Patient-Centered Outcomes Research Institute

University of California, San Francisco

Conditions:

HIV Infections

Sexually Transmitted Diseases

Eligibility:

All Genders

15+ years

Phase:

NA

Brief Summary

The purpose of this study is to compare the effectiveness of two mobile health technologies (text messaging or a mobile app) designed to help people take HIV pre-exposure prophylaxis (PrEP) as directe...

Detailed Description

This is a clinic-based, multi-site, randomized, two-arm study to compare the effectiveness of two mobile technologies designed to support PrEP adherence and continuation in cisgender and transgender m...

Eligibility Criteria

Inclusion

  • Self-identifies as a cisgender man, transgender man (assigned female at birth, trans-masculine spectrum), or transgender woman (assigned male sex at birth, trans-feminine spectrum)
  • Report sex with a cisgender man or transgender woman or any individual assigned male sex at birth in the past 12 months
  • Age 15 years or older
  • Willing and able to provide written informed consent
  • Owns an iOS or Android mobile phone and able to access the internet and send and receive text messages
  • Able to understand, read, and speak English or Spanish
  • Newly initiated PrEP or currently on PrEP and at risk for PrEP discontinuation based on at least one of the following:
  • Initiated PrEP within the past 6 months, or
  • Has any of the following risk factors for PrEP discontinuation: missed clinic visits; age \< 30; African-American or Latino; transgender gender identity; or self-reported illicit substance use

Exclusion

  • Currently enrolled in another PrEP intervention study
  • Unable to complete 12 month study participation
  • 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.

Key Trial Info

Start Date :

July 21 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2023

Estimated Enrollment :

300 Patients enrolled

Trial Details

Trial ID

NCT04855773

Start Date

July 21 2021

End Date

August 1 2023

Last Update

September 28 2022

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Bridge HIV, San Francisco Department of Public Health

San Francisco, California, United States, 94102

2

San Francisco AIDS Foundation

San Francisco, California, United States, 94114

3

Whitman-Walker Health

Washington D.C., District of Columbia, United States, 20009

4

University of Miami

Miami, Florida, United States, 33136