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

Public Health Foundation Enterprises, Inc.

Status: Enrolling

Conditions: Sexually Transmitted Diseases; HIV Infections

Treatments: Device: Dot Diary; Other: PrEPmate

Study type: Interventional

Funder types: Other

Identifiers

NCT04855773

20-32976

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

PrEPmate

Experimental group

Description:

Participants randomized to this study arm will receive the PrEPmate mHealth intervention (bi-directional text messaging with PrEP navigators/clinic staff) to support PrEP adherence and continuation.

Treatment:

Other: PrEPmate

Dot Diary mobile application

Experimental group

Description:

Participants randomized to this study arm will download and use the Dot Diary mobile application on a personal device, to support PrEP adherence and continuation.

Treatment:

Device: Dot Diary