CDC Clinical Guidelines for the Use of Doxycycline Post-Exposure Prophylaxis for the Prevention of Bacterial Sexually Transmitted Infections, United States, 2024

Methods

The guidelines were developed by a multidisciplinary working group of CDC physicians with expertise in infectious diseases, STIs, HIV and public health. A systematic review of the literature was conducted to answer the question: Does doxycycline taken after vaginal, anal, or oral sex reduce bacterial STIs (i.e., syphilis, chlamydia, and gonorrhea) compared to not taking doxycycline? Studies published through June 2023 using MEDLINE/PubMed and Embase were included. Studies that met the inclusion criteria (i.e., randomized controlled trials, written in English, evaluating doxy-PEP as STI prophylaxis) received a summary assessment of the strength of evidence using the same approach as that of the U.S. Department of Health and Human Services Antiretroviral Guidelines Panel. Adults and adolescents (table) (12). The Recommendations, Assessment, Development, and Evaluations scoring framework was used to weigh pros and cons, values, acceptability, equity, and feasibility. Abstracts presented at major scientific meetings (i.e., Conference on Retroviruses and Opportunistic Infections and World Congress on STIs and HIV) were also reviewed. Literature reviews were also conducted to answer the question: does long-term use of doxycycline lead to significant harm such as the development of antimicrobial-resistant pathogens and dermatological, gastrointestinal side effects? -intestinal, neuropsychiatric and metabolic? The evidence was not noted. Further details regarding search strategies are available https://www.cdc.gov/std/treatment/guidelines-for-doxycycline.htm.

In addition to the literature reviews, the National Association of County and City Health Officials hosted a two-day virtual consultation on December 5-6, 2022, during which several experts, stakeholders, and members of the community have discussed doxy PEP, including the potential benefits and harms of doxy PEP. to use. The meeting report (https://www.naccho.org/uploads/downloadable-resources/STI-Post-Exposure-Prophylaxis-with-Doxycycline-Report.pdf) was considered by the Doxy PEP guideline development working group, and the results of the consultation were taken into account when developing these recommendations. A virtual bioethics consultation took place April 14 and May 1, 2023 and brought together 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 taken into account when developing the guidelines and implementation plans.

Working group members provided names of potential reviewers, targeting the diversity of backgrounds and regions of the United States and their expertise in infectious diseases, STI and HIV prevention, antimicrobial resistance and therapeutic. Peer reviewers reviewed the draft recommendations, answered five specific questions, and provided additional feedback. Reviewers disclosed any potential conflicts of interest and conflicts, if any, were resolved. The document was published on October 2, 2023 for 45 days on the Federal Register for public comment. Comments from peer reviewers and the public were considered and the paper was revised as appropriate. The evidence and comments 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 defined by the studies that provided the evidence base for this guidance. However, the language used to describe the target populations in this guide confuses both gender identity, sexual orientation, and sexual behavior which may be separate and distinct for some people. Furthermore, the likelihood of infection with a bacterial STI is linked to both behavior and the sexual networks within which the behavior occurs.