CDC clinical guideline on the use of doxycycline postexposure prophylaxis for the prevention of bacterial sexually transmitted infections, United States, 2024

Methods

The guidelines were developed by a multidisciplinary working group of CDC staff who are clinicians with expertise in infectious diseases, STIs, HIV, and public health. A systematic literature review was conducted to address the question: Does doxycycline taken after vaginal, anal, or oral sex reduce bacterial STIs (i.e., syphilis, chlamydia, and gonorrhea) compared with not taking doxycycline? Studies published through June 2023 were included using Medline/PubMed and Embase. Studies that met inclusion criteria (i.e., randomized controlled trials written in English and evaluating doxy PEP as STI prophylaxis) were given a summary strength of evidence rating using an approach similar to that of the US Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents (table,12) The Grading of Recommendations, Assessment, Development, and Evaluation evidence-for-decisions framework was used to weigh benefits and harms, value, acceptability, equivalence, and feasibility. Abstracts presented at major scientific meetings (i.e., Conference on Retroviruses and Opportunistic Infections and STI and HIV World Congress) were also reviewed. A literature review was also conducted to address the question: Does long-term doxycycline use cause major harms such as the development of antimicrobial resistant pathogens and dermatological, gastrointestinal, neuropsychiatric, and metabolic side effects? The evidence was not graded. More information about the search strategies is available at https://www.cdc.gov/std/treatment/guidelines-for-doxycycline.htm.

In addition to the literature review, the National Association of County and City Health Officials held a virtual 2-day consultation on December 5 and 6, 2022, during which a number of experts, stakeholders, and community members discussed Doxy PEP, including the benefits and potential harms of use. Report of the meeting (https://www.naccho.org/uploads/downloadable-resources/STI-Post-Exposure-Prophylaxis-with-Doxycycline-Report.pdf) was reviewed by the Doxy PEP Guideline Development Workgroup, and findings from the consultation were considered during the development of these recommendations. A virtual bioethics consultation took place on April 14 and May 1, 2023, and included bioethics experts, academic experts in infectious diseases and health equity, community advocates, and CDC staff. This consultation resulted in a publication (https://journals.lww.com/stdjournal/citation/9900/ethical_considerations_in_implementing_doxycycline.282.aspx), and the opinions of individual experts were considered in the development of guidelines and implementation plans.

Working group members provided the names of potential reviewers, who were intended to represent a diversity of backgrounds and regions in the United States and across the globe with expertise in infectious diseases, STI and HIV prevention, antimicrobial resistance, and therapeutics. Peer reviewers reviewed the draft recommendations, answered five specific questions, and provided additional comments. Reviewers disclosed any potential conflicts of interest and resolved conflicts if they existed. The document was posted on the federal registry for public comment for 45 days, through October 2, 2023. Comments from peer reviewers and the public were addressed and the document revised as appropriate. Evidence and feedback were reviewed by the working group, and final recommendations were developed by CDC staff.

In this report, the terms MSM and TGW who have sex with men are used, as were defined by the studies that provided the evidence base for this guidance. However, the language used to describe the focus populations in this guidance conflates gender identity, sexual orientation, and sexual behaviors that may be distinct and specific to some individuals. In addition, the likelihood of infection with a bacterial STI is related to both the behavior and the sexual network within which the behavior occurs.

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