Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 21, 2025
Date Accepted: Nov 30, 2025
Establish a PrEP Epidemiology, Modeling, and Surveillance System (PREMISE) to Analyze trends in PrEP Uptake and the impact of PrEP Programs and Policies: Protocol for a Natural Experiment and Modeling Study in the US
ABSTRACT
Background:
Pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV transmission, yet many people who would benefit from PrEP are not currently using it. Numerous programs and policies, including those provided under the US Ending the HIV Epidemic effort, have been implemented to increase PrEP use. Programs vary enormously, ranging from telemedicine PrEP support to electronic medical record prompts to social marketing messaging campaigns. However, limited evidence exists regarding the relative impact of these programs and policies on PrEP uptake.
Objective:
The aims of the PREMISE (PrEP Epidemiology, Modeling, and Surveillance) research program are to (1) provide context for PrEP scale-up in the United States, (2) assess the impact of different programs and policies on PrEP use, and (3) model the impact of PrEP-related programs and policies on population health.
Methods:
The implementation of policies will be assessed using legal coding at the state-level, and the implementation of programs across health jurisdictions will be assessed using a jurisdiction survey conducted in collaboration with participating health departments. Guided by a legal implementation framework, we will use descriptive and regression analyses to contextualize PrEP scale-up and use quasi-experimental designs to inform casual assessments of the effect of programs and policies. The primary outcomes of PrEP use and PrEP-to-Need ratios will be extracted from a national medical data aggregator database. Here, we provide as preliminary data our extraction of PrEP prescribing from the national dataset.
Results:
From 2016-2024, there were 20,394,619 total claims for medications that were FDA-approved for PrEP. We excluded 5,997,614 medication claims that were part of multiple drug antiretrovial (ARV) HIV treatment regimens and 700,733 claims based on evidence of a prior HIV diagnosis data and assessment of other periods of triple ARV therapy. We determined a total of 13,644,979 claims to be PrEP prescriptions, representing over 1 million PrEP users during the period. For medical benefit claims, there were 34,525 total procedure claims for PrEP medications. We excluded 564 procedure claims that were part of ARV HIV treatment regimens, and 1680 claims based on evidence of prior HIV diagnosis data and other period of triple ARV therapy. We determined a total of 23,406 procedure claims to be for PrEP, representing over 6000 PrEP users during the period.
Conclusions:
To optimally use HIV prevention resources, it is critical to understand the effects of different programs and policies. Over 1 million people have started PrEP, and tracking how this scale-up has occurred by PrEP modality and user groups will inform future HIV prevention efforts. By collaborating with health jurisdictions, we will provide systematic data regarding the panoply of programs and policies that have been enacted to support PrEP use.
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