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

  • STATUS
    Recruiting
  • End date
    Aug 12, 2023
  • participants needed
    300
  • sponsor
    Public Health Foundation Enterprises, Inc.
Updated on 12 October 2022
pre-exposure prophylaxis (prep)
HIV Vaccine
Accepts healthy volunteers

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 directed by the clinic. PrEP is the use of a daily anti-HIV medications by HIV-negative people to help prevent HIV infection.

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 men who have sex with men (MSM) and transgender women (TGW). All study participants will receive PrEP per standard of care at each of the study sites.

Participants randomized to PrEPmate will receive an interactive bidirectional text-messaging intervention that supports PrEP use through personalized communication between patients and providers. Key components include (1) weekly short message service (SMS) check-ins and a bidirectional SMS messaging platform; (2) customized daily SMS pill-taking reminders; (3) link to online PrEP Basics and videos and testimonials.

Participants randomized to Dot Diary will receive a mobile app that promotes self-management of PrEP use and sexual health. Key components include (1) a digital pill-taking and sexual diary, with pill-taking reminders; (2) sex-positive badges earned via app use; and (3) real-time feedback on protection levels afforded by PrEP. Each participant will be followed for approximately 12 months. Staff at the participating clinics will also participate in in-depth interviews to give feedback on implementation challenges and experiences in the clinic-setting, and experience working with patients using the mobile technologies.

Details
Condition HIV Infections, Sexually Transmitted Diseases
Treatment PrEPmate, Dot Diary
Clinical Study IdentifierNCT04855773
SponsorPublic Health Foundation Enterprises, Inc.
Last Modified on12 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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