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

Phase

N/A

Condition

Hiv Infections

Treatment

N/A

Clinical Study ID

NCT04855773

20-32976

Ages > 15
All Genders
Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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 malesex 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 andreceive text messages
Able to understand, read, and speak English or Spanish
Newly initiated PrEP or currently on PrEP and at risk for PrEP discontinuation basedon 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 clinicvisits; age < 30; African-American or Latino; transgender gender identity; orself-reported illicit substance use

Exclusion

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 thejudgment of the investigator, would make participation in the study unsafe, complicateinterpretation of study outcome data, or otherwise interfere with achieving the studyobjectives.

Study Design

July 21, 2021

August 31, 2023

Study 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.

Connect with a study center

Bridge HIV, San Francisco Department of Public Health
San Francisco, California 94102
United States
Site Not Available
San Francisco AIDS Foundation
San Francisco, California 94114
United States
Active - Recruiting
Whitman-Walker Health
Washington, District of Columbia 20009
United States
Active - Recruiting
University of Miami
Miami, Florida 33136
United States
Active - Recruiting

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