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Morbidity and Mortality Weekly ReportRecommendations and Reports / Vol. 70 / No. 4 July 23, 2021

Sexually Transmitted Infections Treatment Guidelines, 2021U.S. Department of Health and Human Services

Centers for Disease Control and Prevention

The MMWR series of publications is published by the Center for Surveillance, Epidemiology, and Laboratory Services, Centers for Disease Control and Prevention (CDC),

U.S. Department of Health and Human Services, Atlanta, GA 30329-4027.

Suggested citation: [Author names; first three, then et al., if more than six.] [Title]. MMWR Recomm Rep 2021;70(No. RR-#):[inclusive page numbers].

Centers for Disease Control and Prevention

Rochelle P. Walensky, MD, MPH, Director

Debra Houry, MD, MPH, Acting Principal Deputy Director Daniel B. Jernigan, MD, MPH, Acting Deputy Director for Public Health Science and Surveillance Rebecca Bunnell, PhD, MEd, Director, Office of Science Jennifer Layden, MD, PhD, Deputy Director, Office of Science

Michael F. Iademarco, MD, MPH, Director, Center for Surveillance, Epidemiology, and Laboratory Services

MMWR Editorial and Production Staff (Serials)

Charlotte K. Kent, PhD, MPH, Editor in Chief

Christine G. Casey, MD, Editor

Mary Dott, MD, MPH, Online Editor

Terisa F. Rutledge, Managing Editor

David C. Johnson, Lead Technical Writer-Editor

Marella Meadows, Project Editor

Martha F. Boyd, Lead Visual Information Specialist

Alexander J. Gottardy, Maureen A. Leahy,

Julia C. Martinroe, Stephen R. Spriggs, Tong Yang,

Visual Information Specialists

Quang M. Doan, MBA, Phyllis H. King,

Terraye M. Starr, Moua Yang,

Information Technology Specialists

MMWR Editorial Board

Timothy F. Jones, MD, Chairman

Matthew L. Boulton, MD, MPH

Carolyn Brooks, ScD, MA

Jay C. Butler, MD

Virginia A. Caine, MD

Jonathan E. Fielding, MD, MPH, MBA

David W. Fleming, MD

William E. Halperin, MD, DrPH, MPH

Jewel Mullen, MD, MPH, MPA

Jeff Niederdeppe, PhD

Celeste Philip, MD, MPH

Patricia Quinlisk, MD, MPH

Patrick L. Remington, MD, MPH

Carlos Roig, MS, MA

William Schaffner, MD

Nathaniel Smith, MD, MPH

Morgan Bobb Swanson, BS

Abbigail Tumpey, MPH

Ian Branam, MA, Acting Lead

Health Communication Specialist

Shelton Bartley, MPH,

Lowery Johnson, Amanda Ray,

Jacqueline N. Sanchez, MS,

Health Communication Specialists

Will Yang, MA,

Visual Information Specialist

Recommendations and Reports

CONTENTS

Introduction ........................................................................ ....................................1 Methods ........................................................................

Clinical Prevention Guidance ........................................................................

....2 STI Detection Among Special Populations ...............................................11 HIV Infection ........................................................................ .................................24 Diseases Characterized by Genital, Anal, or Perianal Ulcers ...............27 Syphilis ........................................................................ Management of Persons Who Have a History of Penicillin Allergy ..56 Diseases Characterized by Urethritis and Cervicitis ...............................60 Chlamydial Infections ........................................................................ ...............65 Gonococcal Infections ........................................................................ ..............71 Mycoplasma genitalium ........................................................................ ............80 Diseases Characterized by Vulvovaginal Itching, Burning, Irritation, Odor, or Discharge ........................................................................ ...................82 Pelvic Inflammatory Disease ........................................................................ ..94 Epididymitis ........................................................................ ..................................98 Human Papillomavirus Infections ..............................................................100 Viral Hepatitis ........................................................................ .............................113

Proctitis, Proctocolitis, and Enteritis ..........................................................124

Ectoparasitic Infections ........................................................................ ..........126 Sexual Assault and Abuse and STIs ............................................................128 References ........................................................................ ...................................135

Recommendations and Reports

MMWR

July 23, 2021

Vol. 70 / No. 4 1US Department of Health and Human Services/Centers for Disease Control and Prevention

Sexually Transmitted Infections Treatment Guidelines, 2021

Kimberly A. Workowski, MD

1,2 ; Laura H. Bachmann, MD 1 ; Philip A. Chan, MD 1,3 ; Christine M. Johnston, MD 1,4 ; Christina A. Muzny, MD 1,5

Ina Park, MD

1,6 ; Hilary Reno, MD 1,7 ; Jonathan M. Zenilman, MD 1,8 ; Gail A. Bolan, MD 1 1

Division of STD Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC, Atlanta, Georgia;

2

Emory University, Atlanta, Georgia;

3

Brown University, Providence, Rhode Island;

4

University of Washington, Seattle, Washington;

5 University of Alabama at Birmingham, Birmingham, Alabama; 6 University of California San Francisco, San Francisco, California; 7

Washington University, St. Louis, Missouri;

8

Johns Hopkins University, Baltimore, Maryland

Summary

These guidelines for the treatment of persons who have or are at risk for sexually transmitted infections (STIs) were updated by

CDC after consultation with professionals knowledgeable in the field of STIs who met in Atlanta, Georgia, June 11-14, 2019.

The information in this report updates the 2015 guidelines. These guidelines discuss 1) updated recommendations for treatment of

Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis; 2) addition of metronidazole to the recommended

treatment regimen for pelvic inflammatory disease; 3) alternative treatment options for bacterial vaginosis; 4) management of

Mycoplasma genitalium; 5) human papillomavirus vaccine recommendations and counseling messages; 6) expanded risk factors

for syphilis testing among pregnant women; 7) one-time testing for hepatitis C infection; 8) evaluation of men who have sex with

men after sexual assault; and 9) two-step testing for serologic diagnosis of genital herpes simplex virus. Physicians and other health

care providers can use these guidelines to assist in prevention and treatment of STIs. Corresponding preparer: Kimberly A. Workowski, MD, Division of STD Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC. Telephone: 404-639-1898; Email: kgw2@cdc.gov.

Introduction

The term "sexually transmitted infection" (STI) refers to a pathogen that causes infection through sexual contact, whereas the term "sexually transmitted disease" (STD) refers to a recognizable disease state that has developed from an infection. Physicians and other health care providers have a crucial role in preventing and treating STIs. These guidelines are intended to assist with that effort. Although the guidelines emphasize treatment, prevention strategies and diagnostic recommendations also are discussed. This report updates Sexually Transmitted Diseases Treatment Guidelines, 2015 (1) and should be regarded as a source of clinical guidance rather than prescriptive standards. Health care providers should always consider the clinical circumstances of each person in the context of local disease prevalence. These guidelines are applicable to any patient care setting that serves persons at risk for STIs, including family planning clinics, HIV care clinics, correctional health care settings, private physicians' offices, Federally Qualified Health Centers, clinics for adolescent care, and other primary care facilities. These guidelines are focused on treatment and counseling and do not address other community services and interventions that are essential to STI and HIV prevention efforts. These STI treatment guidelines complement Recommendations for Providing Quality Sexually Transmitted Diseases Clinical Services, 2020 (2) regarding quality clinical services for STIs in primary care and STD specialty care settings. This guidance specifies operational determinants of quality services in various clinical settings, describes on-site treatment and partner services, and indicates when STI-related conditions should be managed through consultation with or referral to a specialist.

Methods

These guidelines were developed by CDC staff who worked with subject matter experts with expertise in STI clinical management from other federal agencies, nongovernmental academic and research institutions, and professional medical organizations. CDC staff identified governmental and nongovernmental subject matter experts on the basis of their expertise and assisted them in developing questions to guide individual literature reviews. CDC staff informed the subject matter experts that they were being consulted to exchange information and observations and to obtain their individual input. All subject matter experts disclosed potential conflicts of interest. STI Treatment Guidelines, 2021, Work Group members are listed at the end of this report. In 2018, CDC staff identified key questions about treatment and clinical management to guide an update of the 2015 STD treatment guidelines (1). To answer these questions and synthesize new information available since publication of the 2015 guidelines, subject matter experts and CDC staff

Recommendations and Reports

2

MMWR / July 23, 2021 / Vol. 70 / No. 4US Department of Health and Human Services/Centers for Disease Control and Prevention

collaborated to conduct systematic literature reviews by using an extensive MEDLINE database evidence-based approach for each section of the 2015 guidelines (e.g., using English-language published abstracts and peer reviewed journal articles). These systematic reviews were focused on four principal outcomes of STI therapy for each disease or infection: 1) treatment of infection on the basis of microbiologic eradication;

2) alleviation of signs and symptoms; 3) prevention of sequelae;

and 4) prevention of transmission, including advantages (e.g., cost-effectiveness, single-dose formulations, and directly observed therapy) and disadvantages (e.g., adverse effects) of specific regimens. The outcome of the literature reviews guided development of background materials, including tables of evidence from peer-reviewed publications summarizing the type of study (e.g., randomized controlled trial or case series), study population and setting, treatments or other interventions, outcome measures assessed, reported findings, and weaknesses and biases in study design and analysis. In June 2019, the subject matter experts presented their assessments of the literature reviews at an in-person meeting of governmental and nongovernmental participants. Each key question was discussed and pertinent publications were reviewed in terms of strengths, weaknesses, and relevance. Participants evaluated the quality of evidence, provided their input, and discussed findings in the context of the modified rating system used by the U.S. Preventive Services Task Force (USPSTF). The discussions were informal and not structured to reach consensus. CDC staff also reviewed the publications from other professional organizations, including the American College of Obstetricians and Gynecologists (ACOG), USPSTF, the American Cancer Society (ACS), the American Society for Colposcopy and Cervical Pathology (ASCCP), and the Advisory Committee on Immunization Practices (ACIP). The discussion culminated in a list of participants' opinions on all the key STI topic areas for consideration by CDC. (More detailed descriptions of the key questions, search terms, systematic search, evidence tables, and review process are available at https://www.cdc.gov/std/treatment-guidelines/ default.htm). CDC staff then independently reviewed the tables of evidence prepared by the subject matter experts, individual comments from the participants and professional organizations, and existing guidelines from other organizations to determine whether revisions to the 2015 STD treatment guidelines were warranted. CDC staff ranked evidence as high, medium, and low on the basis of each study's strengths and weaknesses according to the USPSTF ratings (https://www.uspreventiveservicestaskforce. org/uspstf/us-preventive-services-task-force-ratings). CDC staff then developed draft recommendations that were peer reviewed by public health and clinical experts as defined by the Office of Management and Budget for influential scientific information. A public webinar was held to provide an overview of the draft recommendations and invite questions and comments on the draft recommendations. The peer review comments, webinar, questions, and responses were considered by CDC staff in developing the final recommendations for the updated STI treatment guidelines. Recommendations for HIV, hepatitis C, cervical cancer screening, STI screening in pregnancy, human papillomavirus (HPV) testing, and hepatitis A virus (HAV) and hepatitis B virus (HBV) vaccination were developed after CDC staff reviewed existing published recommendations. The English- language literature was searched periodically by CDC staff to identify subsequently published articles warranting consideration. Throughout this report, the evidence used as the basis for specific recommendations is discussed briefly. Publication of comprehensive, annotated discussions of such evidence is planned in a supplemental issue of the journal Clinical Infectious Diseases after publication of the treatment guidelines. When more than one therapeutic regimen is recommended and the listed regimens have similar efficacy and similar rates of intolerance or toxicity, the recommendations are listed alphabetically. If differences are specified, regimens are prioritized on the basis of these differences. Recommended regimens should be used primarily; alternative regimens can be considered in instances of notable drug allergy or other medical contraindications to the recommended regimens. Alternative regimens are considered inferior to recommended regimens on the basis of available evidence regarding the principal outcomes and disadvantages of the regimens.

Clinical Prevention Guidance

Prevention and control of STIs are based on the following five major strategies (3): 1. Accurate risk assessment and education and counseling of persons at risk regarding ways to avoid STIs through changes in sexual behaviors and use of recommended prevention services 2. Pre-exposure vaccination for vaccine-preventable STIs 3.

Identification of persons with an asymptomatic

infection and persons with symptoms associated with an STI 4. Effective diagnosis, treatment, counseling, and follow- up of persons who are infected with an STI 5. Evaluation, treatment, and counseling of sex partners of persons who are infected with an STI

Recommendations and Reports

MMWR

July 23, 2021

Vol. 70 / No. 4 3US Department of Health and Human Services/Centers for Disease Control and Prevention

STI and HIV Infection Risk Assessment

Primary prevention of STIs includes assessment of behavioral risk (i.e., assessing the sexual behaviors that can place persons at risk for infection) and biologic risk (i.e., testing for risk markers for STI and HIV acquisition or transmission). As part of the clinical encounter, health care providers should routinely obtain sexual histories from their patients and address risk reduction as indicated in this report. Guidance for obtaining a sexual history is available at the Division of STD Prevention resource page (https://www.cdc.gov/std/treatment/resources. htm) and in the curriculum provided by the National Network of STD Clinical Prevention Training Centers (https://www. nnptc.org). Effective interviewing and counseling skills, characterized by respect, compassion, and a nonjudgmental attitude toward all patients, are essential to obtaining a thorough sexual history and delivering effective prevention messages. Effective techniques for facilitating rapport with patients include using open-ended questions (e.g., "Tell me about any new sex partners you've had since your last visit" and "What has your experience with using condoms been like?"); understandable, nonjudgmental language (e.g., "What gender are your sex partners?"and "Have you ever had a sore or scab on your penis?"); and normalizing language (e.g., "Some of my patients have difficulty using a condom with every sex act. How is it for you?"). The "Five P's" approach to obtaining a sexual history is one strategy for eliciting information about the key areas of interest (Box 1). In addition, health care professionals can consider assessing sexual history by asking patients such questions as, "Do you have any questions or concerns about your sexual health?" Additional information about gaining cultural competency when working with certain populations (e.g., gay, bisexual, or other men who have sex with men [MSM]; women who have sex with women [WSW] or with women and men [WSWM]; or transgender men and women or adolescents) is available in sections of these guidelines related to these populations. In addition to obtaining a behavioral risk assessment, a comprehensive STI and HIV risk assessment should include STI screening as recommended in these guidelines because STIs are biologic markers of risk, particularly for HIV acquisition and transmission among certain MSM. In most clinical settings, STI screening is an essential and underused component of an STI and HIV risk assessment. Persons seeking treatment or evaluation for a particular STI should be screened for HIV and other STIs as indicated by community prevalence and individual risk factors (see Chlamydial Infections; Gonococcal Infections; Syphilis). Persons should be informed about all the tests for STIs they are receiving and notified about tests for common STIs (e.g., genital herpes,

BOX 1. The Five P"s approach for health care providers obtaining sexual histories: partners, practices, protection from sexually

transmitted infections, past history of sexually transmitted infections, and pregnancy intention

1. Partners

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