RecruitingNot ApplicableNCT04855773

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

Sponsor

Public Health Foundation Enterprises, Inc.

Enrollment

300 participants

Start Date

Jul 21, 2021

Study Type

INTERVENTIONAL

Conditions

HIV Infections Sexually Transmitted Diseases

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.

Eligibility

Min Age: 15 Years

Inclusion Criteria9

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 Criteria3

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.

Interventions

OTHERPrEPmate

PrEPmate is a multi-component mHealth intervention grounded in the information, motivation, behavioral skills (IMB) theory of behavior change and developed through user-centered design. PrEPmate promotes personalized communication between patients and providers through interactive weekly "check-in" messages asking participants how PrEP is going, allowing navigators to identify patients needing more help in taking PrEP, and customized daily pill-taking reminder messages. Trained PrEP navigators reach out to participants who indicate they need assistance via text or phone call and provide tailored support. Additionally, the platform supports 2-way communication between patients and PrEP navigators, including reminders for upcoming clinic visits. Participants are provided links to key information about PrEP (PrEP Basics), and video testimonials of peers taking PrEP. Messages are available in English and Spanish. PrEPmate is aimed at both patients and PrEP navigators.

DEVICEDot Diary

Dot Diary is a mobile phone app that integrates an electronic pill-taking and sex diary and delivers real-time feedback on PrEP protection. Using the self-management model to increase self-efficacy and patient empowerment, participants log daily PrEP pill-taking and sexual behaviors in the app, which then provides real-time feedback on the level of protection achieved from PrEP (high, medium, low), and customized instructions on doses of PrEP needed to achieve or maintain high protection. Participants can also view a weekly and monthly calendar, including visualizations of the proportion of sex acts covered by PrEP. Finally, the Dot Diary app incorporates gamification components, including an ability to earn sex-positive badges, to increase engagement. Dot Diary is aimed only at patients.