Project Summary
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
In the United States, 36,000 people are infected with HIV each year. Pre-exposure prophylaxis, or PrEP, is medicine that helps prevent HIV when taken daily. But many people face barriers to taking PrEP every day. For example, people may not remember to take it or may have side effects. Men who have sex with men and people who are transgender, especially those who are young and African-American or Latinx, have notably high rates of stopping PrEP.
Mobile health technologies, such as text messaging and mobile apps, can help people take PrEP regularly. In this study, the research team is comparing how well two mobile health technologies support people taking PrEP.
Who can this research help?
Results may help clinic managers and healthcare providers when considering ways to support people taking PrEP.
What is the research team doing?
The research team is recruiting 300 men and transgender women who have sex with men. All participants are ages 15 and older and receive treatment at one of three clinics in Miami, Washington, DC, and San Francisco that serve diverse patient populations. Participants recently started taking PrEP or are having a hard time continuing to take PrEP. The team is assigning participants by chance to receive one of two mobile health programs for one year.
The first program is PrEPmate, a two-way text messaging system that helps people taking PrEP communicate with their healthcare providers. People in PrEPmate have weekly check-ins with clinic staff via text message. They also receive daily texts with reminders to take PrEP, fun facts, and encouraging messages. People in this program have access to online information and resources about PrEP.
The second program is DOT Diary, a mobile app that people can download to their phones. This app sends reminders to take PrEP each day. The app also includes an electronic diary that helps people track their PrEP use, sexual encounters, and sexual behaviors. Based on this information, DOT Diary estimates the level of protection people are receiving from PrEP. The app also advises people when additional doses would provide greater protection.
The research team is looking at how well the two programs help people take PrEP as of 6 and 12 months after the programs start. The team is checking medicine refill records and using blood tests to check people’s PrEP levels. The team is also asking people about
- Their satisfaction with medical care
- Their satisfaction with sex
- Their confidence in taking PrEP every day
- How empowered they feel to take care of their sexual health
The research team is also conducting interviews to learn how well each program works for people in the study. For example, the team is asking clinic staff how the two programs affect their work and interactions with patients.
Patients taking PrEP, healthcare providers, HIV advocates, health department staff, health insurers, and policy experts are helping to design and conduct this study.
Research methods at a glance
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 300 individuals who self-identify as a cisgender man, transgender man, or transgender woman. All participants report having sex with a cisgender man or transgender woman, are ages 15 and older, are at risk for HIV infection, and have initiated PrEP within the past 6 months or are on PrEP and at risk for discontinuation |
| Interventions/ Comparators |
|
| Outcomes |
Primary: PrEP adherence, satisfaction with medical care, patient engagement Secondary: PrEP continuation, sexual satisfaction, adherence self-efficacy |
| 1-year follow-up for primary outcomes |