Methods
The guidelines were developed by a multidisciplinary working group of CDC staff consisting of physicians with expertise in infectious diseases, sexually transmitted diseases, HIV, and public health. A systematic literature review was conducted to inform the question: Does doxycycline taken after vaginal, rectal, or oral sex reduce the incidence of bacterial STDs (ie, syphilis, chlamydia, and gonorrhea) versus not taking doxycycline? Studies published up to June 2023 using MEDLINE/PubMed and Embase were included. Studies that met the inclusion criteria (i.e., randomized controlled trials, written in English and reviewed for use of Doxy-PEP as STI prophylaxis) were given a strength of evidence of conclusion according to the US Department of Health and Human Services Antiretroviral Guidelines for Adults and Adolescents (table)12). An evidence-to-decision framework for rating, evaluating, developing, and evaluating recommendations was used to assess the pros and cons, values, acceptability, equity, and feasibility. Abstracts presented at major scientific meetings (ie, the Conference on Retroviruses and Accidental Infections and the World Congress on Sexually Transmitted Diseases and HIV) were also reviewed. Literature reviews were also conducted to answer the question: Does long-term use of doxycycline cause significant adverse effects such as antimicrobial-resistant pathogens and dermatologic, gastrointestinal, neuropsychiatric, and metabolic side effects? The evidence is not graded. More details about search strategies are available
In addition to the literature reviews, the National Association of County and City Health Officials held a 2-day virtual consultation on December 5 and 6, 2022, during which several experts, stakeholders, and community members discussed the pros and cons of Doxy PEP. to use. The report of the meetinghttps://www.naccho.org/uploads/downloadable-resources/STI-Post-Exposure-Prophylaxis-with-Doxycycline-Report.pdf) was reviewed by the Doxy PEP Guidelines Development Workgroup, and the findings of the consultation were considered when developing these recommendations. The Virtual Bioethics Consultation was held April 14 and May 1, 2023, and included bioethicists, academics on infectious diseases and health equity, community advocates, and CDC staff. This consultation resulted in publications (https://journals.lww.com/stdjournal/citation/9900/ethical_considerations_in_implementing_doxycycline.282.aspx), and the opinions of individual experts were taken into account in the preparation of guidelines and implementation plans.
Members of the working group nominated reviewers from diverse backgrounds and regions in the United States and with expertise in infectious diseases, STI and HIV prevention, antimicrobial resistance, and therapeutics. Peer reviewers reviewed draft recommendations, responded to five specific questions, and provided additional comments. Reviewers disclosed conflicts of interest and, if conflicts existed, were resolved. The document was posted in the Federal Register for public comment on October 2, 2023 for 45 days. Feedback from peer reviewers and the public was provided and the document was revised as appropriate. Evidence and feedback were reviewed by the task force, and final recommendations were developed by CDC staff.
In this report, the terms MSM and TGW are used as defined by studies that provide evidence for this guideline. However, the language of focus in this guideline combines both gender identity, gender orientation, and sexual behavior that may be different for certain individuals. In addition, the risk of contracting a bacterial STI infection is related to both the behavior and the sexual networks in which the behavior occurs.