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PrEP Clinical Trials

Research and Prevention of Infectious Disease


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The IMPOWER 22 study is testing the safety and effectiveness of a PrEP study drug in cisgender women (female at birth) who are at high risk of getting HIV-1 infection. The study drug is a pill taken by mouth once a month and is being compared to an approved PrEP pill that is taken once a day. All women who take part in this study will have their health closely monitored by an experienced HIV study team. Tests that take place during the study include physical exams, blood, and urine tests, viral signs, a vaginal swab, and HIV tests. Cisgender women who are sexually active with men may qualify.


The IMPOWER 24 study is testing the safety and effectiveness of a PrEP study drug in men who have sex with men, and who are at high risk of getting HIV-1 infection. The study drug is a pill taken by mouth, once a month, and is being compared to an approved PrEP pill that is taken once a day. Men who have sex with men and transgender women who are sexually active may qualify. People who are currently taking PrEP may also qualify.


The purpose of this study is to compare two mobile health technologies (text messaging or a mobile app) that are 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.

PrEP is not provided in this study, because we are only testing the mobile app and text messaging technologies. Participants will be responsible for any costs associated with getting PrEP, which may include using your insurance or a PrEP assistance program, if eligible.

Implementation Research

“Mobile Prevention Services to Respond to Expanding HIV Clusters in South Florida”
Ending the HIV Epidemic CFAR Supplement 2019-2020

Miami-Dade and Broward counties in South Florida have among the highest rates of new HIV infections in the United States. Access to biomedical prevention, including pre-exposure prophylaxis (PrEP) remains challenging for many individuals at risk due to structural and social barriers. In response, our group has developed and implemented a system for delivery of PrEP care through a mobile clinic that bundles services to provide a convenient, low-barrier-to-entry, holistic, and non-stigmatizing approach to care.

This platform, which is highly acceptable to the community and can be successful for service delivery, also has the possibility of allowing targeted delivery of biomedical prevention services to priority locations and populations as determined by near real-time genetic distance network transmission data obtained by the Florida Department of Health.

In this project, through community-informed development of process to translate available molecular and social epidemiological data into action, we identified locations for best placement of our mobile clinic. We began services at the Liberty City site in September 2020 and are currently evaluating outcomes and planning next placements.

“Adaptation of the Mobile PrEP Implementation Strategy for Equitable Scale-Out”
Ending the HIV Epidemic CFAR Supplement 2020-2022

While our barrier-lowering Mobile PrEP approach has been successful in engagement of many minority clients with structural and logistical barriers to PrEP care, community consultation suggests that others may require additional facilitators, including peer and community support, to effectively enter care.

In this project, we will introduce two new implementation strategy elements:

  • navigation from community testing sites, and social network engagement for HIV testing and PrEP referrals
  • our standard outreach using predominately electronic recruitment (social media and dating apps)

Using the RE-AIM implementation assessment framework as a guide, we will assess the reach of each referral strategy as well as implementation needs including resources required for each strategy.

Completion of this project will increase external validity of the strategy, allowing larger randomized trials evaluating the impact of the Mobile PrEP implementation strategy in increasing PrEP uptake and interrupting HIV transmission clusters in diverse priority areas identified through near-real-time epidemiological analysis.

Interested in learning more about our studies and clinical trials?

Please let us know more about you. We will contact you for further information to determine eligibility for current and future studies.

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