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

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ClinicalTrials.gov Identifier: NCT04855773
Recruitment Status : Recruiting
First Posted : April 22, 2021
Last Update Posted : September 8, 2021
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
University of California, San Francisco
University of Miami
Whitman-Walker Health
San Francisco AIDS Foundation
WelTel
San Francisco Department of Public Health
Information provided by (Responsible Party):
Albert Liu, Public Health Foundation Enterprises, Inc.

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.

Condition or disease Intervention/treatment Phase
HIV Infections Sexually Transmitted Diseases Other: PrEPmate Device: Dot Diary Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparing Mobile Health Strategies to Improve Pre-exposure Prophylaxis Use (PrEP) for HIV Prevention
Actual Study Start Date : July 21, 2021
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.




Primary Outcome Measures :
  1. 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.

  2. 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

  3. Patient engagement [ Time Frame: Patient engagement measured through 12 months ]
    Patient engagement will be measured by the short-version Patient Activation Measure (PAM).


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   cisgender man, transgender man (assigned female sex at birth, trans-masculine spectrum), or transgender woman (assigned male sex at birth, trans-feminine spectrum)
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04855773


Locations
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United States, California
Bridge HIV, San Francisco Department of Public Health Active, not recruiting
San Francisco, California, United States, 94102
San Francisco AIDS Foundation Recruiting
San Francisco, California, United States, 94114
Contact: Kelvin Moore, Jr.    415-437-3406    kmoore@sfaf.org   
Contact: Janessa Broussard, RN, MSN, AGNP-C    415-581-1602    jbroussard@sfaf.org   
Principal Investigator: Janessa Broussard, RN, MSN, AGNP-C         
United States, District of Columbia
Whitman-Walker Health Recruiting
Washington, District of Columbia, United States, 20009
Contact: Christopher Cannon, MPH    202-745-6157    ccannon@whitman-walker.org   
Principal Investigator: Christopher Cannon, MPH         
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Susanne Doblecki-Lewis, MD, MSPH, FIDSA    305-243-9213    sdoblecki@med.miami.edu   
Principal Investigator: Susanne Doblecki-Lewis, MD, MSPH, FIDSA         
Sponsors and Collaborators
Public Health Foundation Enterprises, Inc.
Patient-Centered Outcomes Research Institute
University of California, San Francisco
University of Miami
Whitman-Walker Health
San Francisco AIDS Foundation
WelTel
San Francisco Department of Public Health
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Responsible Party: Albert Liu, Clinical Research Director, Public Health Foundation Enterprises, Inc.
ClinicalTrials.gov Identifier: NCT04855773    
Other Study ID Numbers: 20-32976
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Albert Liu, Public Health Foundation Enterprises, Inc.:
Pre-exposure Prophylaxis (PrEP)
HIV Prevention
Mobile health (mHealth)
Medication adherence
Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Communicable Diseases
Infections
Disease Attributes
Pathologic Processes