Recruiting

Mobile Health Strategies

Sponsor:

Public Health Foundation Enterprises, Inc.

Code:

NCT04855773

Conditions

HIV Infections

Sexually Transmitted Diseases

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Accepted

Interventions

PrEPmate

Dot Diary

Study Details

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

Conditions

HIV Infections

Sexually Transmitted Diseases

Study ID

NCT04855773

Start date

Jul 21, 2021

Status verified date

Sep, 2022

Completion date

Aug, 2023

Anticipated

Primary completion date

Aug, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: PrEPmate

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.

experimental: Dot Diary mobile application

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.

Interventions

PrEPmate

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.

Dot 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.

Primary outcome measure

  • PrEP adherence as measured by tenofovir diphosphate levels in dried blood spots [ Time Frame: DBS measured through 12 months ]
  • Satisfaction with medical care [ Time Frame: Satisfaction measured through 12 months ]
  • Patient engagement [ Time Frame: Patient engagement measured through 12 months ]

Central Contacts and Locations

Locations

San Francisco AIDS Foundation

Recruiting

San Francisco, California, United States, 94114

Contacts

Rikki Montoya

415-920-3653rmontoya@sfaf.org

Jorge Roman, MSN, FNP-BC

415-437-3417jroman@sfaf.org

Principal Investigator:

Jorge Roman, MSN, FNP-BC

Whitman-Walker Health

Recruiting

Washington, District of Columbia, United States, 20009

Contacts

Rupa Patel, MD, MPH

202-745-7000rpatel@whitman-walker.org

Principal Investigator:

Rupa Patel, MD, MPH

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Susanne Doblecki-Lewis, MD, MSPH, FIDSA

305-243-9213sdoblecki@med.miami.edu

Principal Investigator:

Susanne Doblecki-Lewis, MD, MSPH, FIDSA

More Information

Sponsor

Public Health Foundation Enterprises, Inc.

Last update posted

Sep 28, 2022

Last verified

Sep, 2022

Keywords

  • Pre-exposure Prophylaxis (PrEP)
  • HIV Prevention
  • Mobile health (mHealth)
  • Medication adherence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Public Health Foundation Enterprises, Inc. on 2022-09-28.