Actively Recruiting
Comparing Mobile Health Strategies to Improve Pre-exposure Prophylaxis Use (PrEP) for HIV Prevention
Led by Public Health Foundation Enterprises, Inc. · Updated on 2022-09-28
300
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
P
Public Health Foundation Enterprises, Inc.
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating two mobile health technologies designed to support people in taking HIV pre-exposure prophylaxis (PrEP) correctly to help prevent HIV infection. This study focuses on cisgender and transgender men who have sex with men, and transgender women, assessing how well these technologies encourage adherence and continuation of PrEP over time. Participants are randomly assigned to one of two groups. One group uses PrEPmate, an interactive text messaging system offering weekly check-ins, daily pill reminders, personalized communication with clinic staff, and access to educational materials. The other group uses Dot Diary, a mobile app that helps users track their pill-taking and sexual activity, offers real-time feedback on protection levels, and includes gamified features to encourage engagement. Both groups receive standard PrEP care from their clinics and are followed for about 12 months. Throughout the study, participants will be monitored for adherence to PrEP by measuring drug levels in blood samples. Researchers will also assess satisfaction with medical care, patient engagement, continuation of PrEP based on medication refills, sexual satisfaction, and confidence in sticking to the medication. Clinic staff will provide feedback on how the technologies are used in their settings. The total study period for participants is around one year.
CONDITIONS
Brief Title
Comparing Mobile Health Strategies to Improve Pre-exposure Prophylaxis Use (PrEP) for HIV Prevention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Self-identifies as a cisgender man, transgender man, or transgender woman
- Has had sex with a cisgender man, transgender woman, or someone 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 can access the internet and send and receive text messages
- Able to understand, read, and speak English or Spanish
- Newly started PrEP or currently on PrEP and at risk for stopping it, including those who started PrEP within the past 6 months or have risk factors such as missed clinic visits, age under 30, African-American or Latino background, transgender identity, or illicit substance use
You will not qualify if you...
- Currently enrolled in another PrEP intervention study
- Unable to complete 12 months of study participation
- Any medical, psychiatric, or social condition or other responsibilities that would make study participation unsafe, interfere with study goals, or complicate study results according to the investigator's judgment
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 months
Participants receive one of two mobile health interventions to support PrEP adherence and continuation while taking PrEP as part of routine care.
Regular interaction with mobile app or text messaging; clinic visits as per routine care
Trial Site Locations
Total: 4 locations
1
Bridge HIV, San Francisco Department of Public Health
San Francisco, California, United States, 94102
Active, Not Recruiting
2
San Francisco AIDS Foundation
San Francisco, California, United States, 94114
Actively Recruiting
3
Whitman-Walker Health
Washington D.C., District of Columbia, United States, 20009
Actively Recruiting
4
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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