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

September 27, 2022 updated by: Albert Liu, Public Health Foundation Enterprises, Inc.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94102
        • Active, not recruiting
        • Bridge HIV, San Francisco Department of Public Health
      • San Francisco, California, United States, 94114
        • Recruiting
        • San Francisco AIDS Foundation
        • Contact:
        • Contact:
          • Jorge Roman, MSN, FNP-BC
          • Phone Number: 415-437-3417
          • Email: jroman@sfaf.org
        • Principal Investigator:
          • Jorge Roman, MSN, FNP-BC
    • District of Columbia
      • Washington, District of Columbia, United States, 20009
        • Recruiting
        • Whitman-Walker Health
        • Contact:
        • Principal Investigator:
          • Rupa Patel, MD, MPH
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Contact:
        • Principal Investigator:
          • Susanne Doblecki-Lewis, MD, MSPH, FIDSA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: 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.
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PrEP adherence as measured by tenofovir diphosphate levels in dried blood spots
Time Frame: DBS measured through 12 months
PrEP adherence will be measured by tenofovir diphosphate (TFV-DP) levels in dried blood spots (DBS). Adequate adherence will be defined as having a TFV-DP ≥ 700 femtomoles/punch in DBS for daily PrEP users, which has been associated with high levels of protection in prior PrEP trials.
DBS measured through 12 months
Satisfaction with medical care
Time Frame: Satisfaction measured through 12 months
Satisfaction with medical care will be measured by the Consumer Assessment of Health Care Processes and Services (CAHPS), a critical tool for evaluating patient satisfaction and patient-centeredness of care
Satisfaction measured through 12 months
Patient engagement
Time Frame: Patient engagement measured through 12 months
Patient engagement will be measured by the short-version Patient Activation Measure (PAM).
Patient engagement measured through 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PrEP continuation based on medication refills
Time Frame: PrEP continuation measured through 12 months
PrEP discontinuation will be defined as having a PrEP interruption of ≥30 days based on medication refill dates using blinded outcome ascertainment of electronic medical and pharmacy refill records.
PrEP continuation measured through 12 months
Sexual satisfaction
Time Frame: Sexual satisfaction measured through 12 months
Sexual satisfaction will be measured by the New Sexual Satisfaction Scale Short Version (NSSS-S), a validated 12-item questionnaire in which patients score their sexual satisfaction on five dimensions (sexual sensations, sexual presence/awareness, sexual exchange, emotional connection/closeness, and sexual activity)
Sexual satisfaction measured through 12 months
Adherence self-efficacy
Time Frame: Adherence self-efficacy measured through 12 months
Patient-reported adherence self-efficacy will be measured by the self-efficacy scale for PrEP use, which has been validated for PrEP use
Adherence self-efficacy measured through 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Public Health Foundation Enterprises, Inc.

Collaborators

Patient-Centered Outcomes Research Institute
University of Miami
University of California, San Francisco
San Francisco AIDS Foundation
San Francisco Department of Public Health
Whitman-Walker Health
WelTel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2021

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

April 1, 2021

First Submitted That Met QC Criteria

April 19, 2021

First Posted (Actual)

April 22, 2021

Study Record Updates

Last Update Posted (Actual)

September 28, 2022

Last Update Submitted That Met QC Criteria

September 27, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-32976

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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