Method
The guidelines were developed by an interdisciplinary working group of CDC staff who are physicians with expertise in infectious diseases, STIs, HIV, and public health. A systematic literature review was conducted to identify the following question: Does taking doxycycline after vaginal, anal, or oral sex reduce bacterial STIs (syphilis, chlamydia, gonorrhea) compared with not taking doxycycline? Studies published through June 2023 using MEDLINE/PubMed and Embase were included. Studies that met the inclusion criteria (randomized controlled trials written in English that evaluated doxy-PEP as STI prevention) included studies from the U.S. Department of Health and Human Services’ Committee on Antiretroviral Guidelines for Adults and Adolescents (table) (12The evidence-to-decision framework of Grading Recommendations, Assessment, Development and Evaluation was used to weigh benefits and harms, value, acceptability, equity and feasibility. Abstracts presented at major scientific meetings (e.g., Congress on Retroviruses and Opportunistic Infections, World Congress on STIs and HIV) were also reviewed. A literature review was also conducted to address the question of whether long-term use of doxycycline causes significant harms, including the development of antimicrobial-resistant pathogens, and cutaneous, gastrointestinal, neuropsychiatric and metabolic side effects. The evidence was not graded. More information on the search strategy 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 hosted a two-day virtual consultation on December 5 and 6, 2022, where multiple experts, stakeholders, and community members discussed doxycycline PEP, including its benefits and potential harms.https://www.naccho.org/uploads/downloadable-resources/STI-Post-Exposure-Prophylaxis-with-Doxycycline-Report.pdf) was reviewed by the Doxy PEP Guideline Development Working Group, and the findings of the consultation were taken into consideration during the development of these recommendations. A virtual bioethics consultation was held on April 14 and May 1, 2023, which included bioethics experts, academic experts in infectious diseases and health equity, community advocates, and CDC staff. This consultation resulted in the publication (https://journals.lww.com/stdjournal/citation/9900/ethical_considerations_in_implementing_doxycycline.282.aspxIn formulating the guidelines and implementation plan, we also took into consideration the opinions of various experts.
Working group members provided the names of potential peer reviewers, aiming for diversity of backgrounds and geographic regions in the United States, expertise in infectious diseases, STI and HIV prevention, antimicrobial resistance, and treatment. Peer reviewers reviewed the draft recommendation, responded to five specific questions, and provided additional comments. Peer reviewers disclosed potential conflicts of interest and resolved any conflicts of interest. The document was posted in the Federal Registry for public comment for 45 days on October 2, 2023. We responded to comments from peer reviewers and the public and revised the document as needed. Evidence and feedback were reviewed by the working group, and a final recommendation was made by CDC staff.
In this report, the terms MSM who have sex with men and TGW are used as defined in the research underlying this guidance. However, the language used to describe the populations addressed in this guidance confounds both gender identity, sexual orientation, and sexual behaviors that may be separate and distinct for certain people. Additionally, the likelihood of acquiring a bacterial STI is related to both the behavior and the sexual network in which the behavior occurs.
