Comparing Mobile Health Strategies to Improve Pre-exposure Prophylaxis Use (PrEP) for HIV Prevention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15+
SponsorPublic Health Foundation Enterprises, Inc.
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
PrEPmate
Other interventionPrEPmate 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
DeviceDot 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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: PrEPmateExperimental treatment 1 intervention
Group B: Dot Diary mobile applicationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
PrEP adherence as measured by tenofovir diphosphate levels in dried blood spots
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.
Time frame
DBS measured through 12 months2
Satisfaction with medical care
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
Time frame
Satisfaction measured through 12 months3
Patient engagement
Patient engagement will be measured by the short-version Patient Activation Measure (PAM).
Time frame
Patient engagement measured through 12 monthsSecondary outcomes
1
PrEP continuation based on medication refills
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.
Time frame
PrEP continuation measured through 12 months2
Sexual satisfaction
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)
Time frame
Sexual satisfaction measured through 12 months3
Adherence self-efficacy
Patient-reported adherence self-efficacy will be measured by the self-efficacy scale for PrEP use, which has been validated for PrEP use
Time frame
Adherence self-efficacy measured through 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Public Health Foundation Enterprises, Inc.
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
University of California, San Francisco
Collaborator
University of Miami
Collaborator
Whitman-Walker Health
Collaborator
San Francisco AIDS Foundation
Collaborator
WelTel
Collaborator
San Francisco Department of Public Health
Collaborator
Source ClinicalTrials.gov