USPSTF Publishes Research Plan for Review of PrEP Recommendation
On January 13, 2022, the U.S. Preventive Services Task Force published its final research planExit Disclaimer on pre-exposure prophylaxis (PrEP) for the prevention of HIV infection. The USPSTF is an independent panel of non-Federal experts that makes recommendations on clinical preventive services, such as screenings, counseling, and preventive medications, to primary care clinicians. The Task Force uses gold standard methods to review the evidence and is transparent at each step of the recommendation development process.
Posting the final research plan is the third step in a five-step process that the task force follows when developing all recommendations. Next, the task force will review evidence and develop draft recommendations, which will be posted for public comment. Then, in the final step, the task force will review public comments and finalize their recommendation.
According to the final research plan for PrEP, among the questions to be systematically reviewed are:
- What are the benefits of pre-exposure prophylaxis (PrEP) in persons without pre-existing HIV infection vs. placebo or no PrEP (including deferred PrEP) on the prevention of HIV infection and quality of life?
- How do the benefits of PrEP differ by populations of interest (e.g., defined by age, sex, gender identity, race and ethnicity, and HIV risk category)?
- How do the benefits of PrEP differ by dosing strategy or regimen?
- What are the benefits of newer PrEP regimens (oral tenofovir alafenamide-emtricitabine [TAF-FTC], injectable cabotegravir, or the dapivirine vaginal ring) vs. tenofovir disoproxil fumarate-emtricitabine (TDF-FTC)?
- What is the diagnostic accuracy of provider or patient risk assessment tools in identifying persons at increased risk of HIV acquisition who are candidates for PrEP?
- What are the harms of PrEP vs. placebo or no PrEP when used for the prevention of HIV infection?
- What are the harms of newer PrEP regimens (oral TAF-FTC, injectable cabotegravir, or the dapivirine vaginal ring) vs. TDF-FTC?
The research plan also discusses the analytical framework to be used, contextual questions to be considered, the research approach, and the additions and changes to the research plan made in response to public comments received on the draft research plan that was posted in late 2021.
The Task Force keeps recommendations as current as possible by routinely updating existing recommendations and developing new recommendations. USPSTF recommendations apply to people with no signs or symptoms of the disease, and are based on a rigorous, systematic review of peer-reviewed evidence. Members of the task force are primary care providers (such as internists, pediatricians, family physicians, nurses, gynecologists/obstetricians, and health behavior specialists) who are experts in prevention and evidence-based medicine.