In the United States, there are over 1 million people living with HIV and about 40,000 people becoming newly infected each year. Pre-exposure prophylaxis (also known as PrEP) is an anti-HIV pill (Truvada) that is very effective in preventing HIV when taken daily. However, people face a number of challenges with taking this regimen over time, with higher rates of stopping PrEP among young people, African-American and Latinx individuals, and transgender people, groups that are particularly vulnerable to HIV.
Mobile health technologies (text messaging and mobile apps) are promising approaches to supporting people taking PrEP, however, the most effective way to support different groups of PrEP users is not known. The research team wants to compare two different mobile health technologies to see which provides the best support and meets the needs of different types of people taking PrEP. One way involves a two-way text messaging system designed to support PrEP users that increases communication between patients and their providers. The other way is a mobile app that can be downloaded to users’ phones and helps them track their PrEP pill-taking and sexual encounters in a private, electronic diary and provides feedback on the level of protection they are receiving from PrEP. Results from this research can help patients and health administrators decide which strategy to choose to support diverse patients taking PrEP.
The research team is working with three public health and community clinics in Miami; Washington, DC; and San Francisco that have a large number of people taking PrEP yet high rates people stopping PrEP. Each of these areas has a high number of new HIV infections and needs new ways to support people taking PrEP for HIV prevention. The research team will recruit and enroll 300 men who have sex with men and transgender women ages 15 and older who have either recently started PrEP within these clinics or are having challenges staying on PrEP. Patients who are enrolled will be assigned to receive PrEPmate or DOT Diary and followed for one year. The team is comparing how well people in each group are able to take PrEP every day by measuring their blood levels of Truvada at 6 and 12 months and reviewing their medication refill records. They will also look at satisfaction with medical care, whether people feel empowered in taking care of their sexual health, sexual satisfaction, and their confidence in taking PrEP every day. Additionally, the research team will look at factors within the clinic which influence how successful each intervention is for different people in the study. This will include interviews with staff in the clinic to get their impressions about PrEPmate and DOT Diary and how each affects their workflow and interactions with patients.
The research team is working with patients, healthcare providers, HIV advocates and activists, local and state health departments, health systems payers, policy experts, and researchers to design and conduct this study.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.