Introduction and Methods

Introduction

The term sexually transmitted diseases (STDs) refers to a variety of clinical syndromes and infections caused by pathogens that can be acquired and transmitted through sexual activity. Physicians and other health-care providers play a critical role in preventing and treating STDs. These guidelines for the treatment of STDs are intended to assist with that effort. Although these guidelines emphasize treatment, prevention strategies and diagnostic recommendations also are discussed.

This document updates CDC’s Sexually Transmitted Diseases Treatment Guidelines, 2010 (1). These recommendations 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 STDs, including family-planning clinics, HIV-care clinics, correctional health-care settings, private physicians’ offices, Federally Qualified Health Centers (FQHCs), and other primary-care facilities. These guidelines focus on treatment and counseling and do not address other community services and interventions that are essential to STD/HIV prevention efforts.

Methods

These guidelines were developed by CDC staff and an independent workgroup for which members were selected on the basis of their expertise in the clinical management of STDs. Members of the multidisciplinary workgroup included representatives from federal, state, and local health departments; public- and private-sector clinical providers; clinical and basic science researchers; and numerous professional organizations. All workgroup members disclosed potential conflicts of interest; several members of the workgroup acknowledged receiving financial support for clinical research from commercial companies. All potential conflicts of interest are listed at the end of the workgroup member section.

In 2012, CDC staff and workgroup members were charged with identifying key questions regarding treatment and clinical management that were not addressed in the 2010 STD Treatment Guidelines (1). To answer these questions and synthesize new information available since publication of the 2010 Guidelines, workgroup members collaborated with CDC staff to conduct a systematic literature review using an extensive MEDLINE database evidence-based approach (e.g., using published abstracts and peer-reviewed journal articles). These reviews also focused on four principal outcomes of STD therapy for each individual disease or infection: 1) treatment of infection based on microbiologic eradication; 2) alleviation of signs and symptoms; 3) prevention of sequelae; 4) prevention of transmission, including advantages such as cost-effectiveness and other advantages (e.g., single-dose formulations and directly observed therapy) and disadvantages (e.g., side effects) of specific regimens. The outcome of the literature review informed 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 April 2013, the workgroup’s research was presented at an in-person meeting of the multidisciplinary workgroup members. Each key question was discussed, and pertinent publications were reviewed in terms of strengths, weaknesses, and relevance. The workgroup evaluated the quality of evidence, provided answers to the key questions, and rated the recommendations based on the United Services Preventive Services Task Forces (USPSTF) modified rating system (http://www.uspreventiveservicestaskforce.org/uspstf/grades.htm). The discussion culminated in a proposal of recommendations to be adopted for consideration by CDC. (More detailed description of the key questions, search terms, and systematic search and review process is available at www.cdc.gov/std/tg2015/evidence.htm). Following the April meeting, the literature was searched periodically by CDC staff to identify subsequently published articles warranting consideration by the workgroup either through e-mail or conference calls.

CDC developed draft recommendations based on the workgroup’s proposal. To ensure development of evidence-based recommendations, a second independent panel of public health and clinical experts reviewed the draft recommendations. The recommendations for STD screening during pregnancy, cervical cancer screening, and HPV vaccination were developed after CDC staff reviewed the published recommendations from other professional organizations, including the American College of Obstetricians and Gynecologists (ACOG), USPSTF, American Cancer Society (ACS), American Society for Colposcopy and Cervical Pathology (ASCCP), and the Advisory Committee on Immunization Practices (ACIP) as part of the initial review process. The sections on hepatitis B virus (HBV) and hepatitis A virus (HAV) infections are based on previously published recommendations (2-4).

Throughout this report, the evidence used as the basis for specific recommendations is discussed briefly. More comprehensive, annotated discussions of such evidence will appear in background papers that will be available in a supplement issue of the journal Clinical Infectious Diseases after publication of these treatment guidelines. When more than one therapeutic regimen is recommended, the recommendations are listed alphabetically unless prioritized based on efficacy, tolerance, or costs. For infections with more than one recommended regimen, listed regimens have similar efficacy and similar rates of intolerance or toxicity unless otherwise specified. 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.

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