Management of Gonorrhea and Chlamydia in Patients with HIV

Management of Gonorrhea and Chlamydia in Patients with HIV

Purpose of this Guideline

Sexually Transmitted Infections (STIs) Guideline Committee, March 2018

This guideline on the treatment of uncomplicated gonococcal and chlamydial infections in adult patients with HIV was developed by the New York State (NYS) Department of Health (NYSDOH) AIDS Institute (AI) for clinicians in NYS who manage the care of patients with HIV who are at risk of or diagnosed with gonorrhea or chlamydia coinfection. Accordingly, this guideline addresses the following topics: transmission and prevention of gonorrhea and chlamydia, screening, presentation, diagnosis, reporting, and treatment and aims to achieve the following goals:

  • Increase the numbers of NYS residents with HIV and gonococcal or chlamydial coinfection who are identified and treated with effective interventions.
  • Support the following NYSDOH Prevention Agenda 2013-2018 goals: 1) reduce the gonorrhea case rate by 10% among persons aged 15 to 44 years to no more than 183.1 cases per 100,000 women and 199.5 per 100,000 men; and 2) reduce the chlamydia case rate by 10% among women aged 15 to 44 years to no more than 1,458 cases per 100,000 [Mayer et al. 2012; Do et al. 2001].
  • Reduce the growing burden of morbidity associated with gonococcal and chlamydial infections.
  • Integrate current evidence-based clinical recommendations into the healthcare-related implementation strategies of the Ending the Epidemic initiative, which seeks to end the AIDS epidemic in NYS by the end of 2020.

The Burden of Gonococcal and Chlamydial Infections

Gonorrhea, an infection caused by Neisseria gonorrhoeae, and chlamydia, an infection caused by the bacterium Chlamydia trachomatis, are among the most frequently reported sexually transmitted infections (STIs) in NYS [CDC 2017a; NYSDOH 2016]. These infections are the primary causes of pelvic inflammatory disease, which can lead to tubal infertility, ectopic pregnancy, and pelvic pain and tenderness in women [CDC 2017a, 2017b]. Complications in men include urethritis, epididymitis, and proctitis.

The most common forms of gonococcal and chlamydial infections occur at urogenital, anogenital, and/or pharyngeal mucosal sites; however, ocular infections may occur as well. Disseminated gonococcal infection, with infection spread throughout the body, occurs in up to 3% of individuals with gonorrhea [Rice 2005]. Reports of disseminated chlamydial infection are rare.

High prevalence and incidence of gonococcal and chlamydial infections have been reported in people with HIV [Mayer et al. 2012; Do et al. 2001; Taylor et al. 2013; Pathela et al. 2013], particularly in New York City [Taylor et al. 2013; Pathela et al. 2013]. In 2014, the burden of gonococcal infection in NYS was highest among young people aged 15 to 24 years; this age group accounted for 56% of cases overall in 2014. In NYS, the majority of chlamydia diagnoses in 2014 were among persons aged 20 to 24 years (70%) [NYSDOH 2016]. These findings are consistent with national surveillance data from the Centers for Disease Control and Prevention indicating that young people aged 15 to 25 years account for half of all new STIs [CDC 2017a]. Several studies have demonstrated that infection with N. gonorrhoeae or C. trachomatis may increase the risk of transmission and acquisition of HIV [Cohen et al. 1997; Laga et al. 1993; Levine et al. 1998; ACHSP 1998]. However, with the exception of studies of women hospitalized with pelvic inflammatory disease, no formal studies have been published to date that evaluate differences in clinical presentation, diagnosis, or response to treatment of gonococcal or chlamydial infections in patients with HIV.

In patients with HIV, STIs increase transmission of HIV and can lead to costly health complications that may affect reproductive health and fetal and perinatal health [Ota et al. 2009]. Data suggest that the annual, direct cost of treating STIs in the United States is $15.6 billion [Radix et al. 2012].

Box 1: Chlamydia and Gonorrhea Cases Reported in New York State and Nationwide, 2016 [CDC 2017a]

New York State (including New York City)

  • Chlamydia: 109,433 cases reported in 2016
    • Women: 67,602 cases
    • Men: 41,722 cases
  • Gonorrhea: 29,000 cases reported in 2016
    • Women: 8,709
    • Men: 20,224

Nationwide

  • Chlamydia: 1,598,354 cases reported in 2016 (4.7% increase from 2015)
  • Gonorrhea: 468,514 cases reported in 2016 (18.5% increase from 2015)

The Role of New York State Primary Care Providers in Managing STIs

The goal of this guideline is to aid primary care providers and other clinicians in NYS in diagnosing and treating gonococcal and chlamydial infections in adult patients with HIV. Primary care providers are often the first to see patients with symptoms of an STI [CDC 2016]. Nurses in NYS are authorized to execute non-patient specific orders and protocols (ordered by a physician or nurse practitioner) for administering HIV testing and medically screening at-risk persons for syphilis, chlamydia, and/or gonorrhea. As such, primary care providers and other clinicians assume an important role in the diagnosis and treatment of STIs in patients with HIV and in counseling patients to avoid or prevent high-risk behaviors that might expose them to STIs. In 2016, more than 75% of chlamydia cases were reported by sites other than STI clinics. Among women, about one-third of cases were reported from private physicians/health maintenance organizations, representing a change in the facilities reporting chlamydial infections over the last decade [CDC 2017a].

The NYSDOH AI STI Committee has developed a set of measures designed to assess providers’ quality of STI care and treatment and identify areas for improvement, with the goal of reversing the rising rate of STI transmissions and recognizing sexual health as a primary care priority.

Development of this Guideline

This guideline was developed by the Sexually Transmitted Infections Guidelines Committee of the NYSDOH AI Clinical Guidelines Program. The program is a collaborative effort of the NYSDOH AI Office of the Medical Director and the Johns Hopkins University School of Medicine, Division of Infectious Diseases.

Established in 1986, the goal of the Clinical Guidelines Program is to develop and disseminate evidence-based, state-of-the-art clinical practice guidelines to improve the quality of care provided to people with HIV, hepatitis C virus, and STIs and to improve drug user health and LGBT health throughout the state of New York. NYSDOH AI guidelines are developed by committees of clinical experts through a consensus-driven process. For more details on the guideline development process, please see How This Guideline Was Developed.

The NYSDOH AI Sexually Transmitted Infections Guidelines Committee was charged with developing evidence-based clinical recommendations for clinicians in NYS who treat adult patients with HIV who are at risk of or diagnosed with gonorrhea or chlamydia coinfection. The resulting recommendations are based on an extensive review of the medical literature and reflect consensus among Committee experts. Each recommendation is rated for strength and for quality of the evidence (see below). If recommendations are based on expert opinion, the rationale for the opinion is included.

AIDS Institute HIV Clinical Guidelines Program Recommendations Rating Scheme
Strength of Recommendation Quality of Supporting Evidence
A = Strong 1 = At least 1 randomized trial with clinical outcomes and/or validated laboratory endpoints
B = Moderate 2 = One or more well-designed, nonrandomized trial or observational cohort study with long-term clinical outcomes
C = Optional 3 = Expert opinion
References

Advisory Committee for HIV and STD Prevention (ACHSP). HIV prevention through early detection and treatment of other sexually transmitted diseases–United States. Recommendations of the Advisory Committee for HIV and STD prevention. MMWR Recomm Rep 1998;47(Rr-12):1-24. [PMID: 9701544]

CDC. 2015 Sexually Transmitted Diseases Surveillance. 2016 Oct 18. https://www.cdc.gov/std/stats15/STD-Surveillance-2015-print.pdf [accessed 2018 Nov 28]

CDC. 2016 Sexually Transmitted Diseases Surveillance. 2017a Oct 17. https://www.cdc.gov/std/stats16/CDC_2016_STDS_Report-for508WebSep21_2017_1644.pdf [accessed 2018 Mar 2]

CDC. Pelvic Inflammatory Disease (PID) – CDC Fact Sheet. 2017b Jan 25. https://www.cdc.gov/std/pid/stdfact-pid-detailed.htm [accessed 2018 Mar 2]

Cohen MS, Hoffman IF, Royce RA, et al. Reduction of concentration of HIV-1 in semen after treatment of urethritis: implications for prevention of sexual transmission of HIV-1. AIDSCAP Malawi Research Group. Lancet 1997;349(9069):1868-73. [PMID: 9217758]

Do AN, Hanson DL, Dworkin MS, et al. Risk factors for and trends in gonorrhea incidence among persons infected with HIV in the United States. Aids 2001;15(9):1149-55. [PMID: 11416717]

Laga M, Manoka A, Kivuvu M, et al. Non-ulcerative sexually transmitted diseases as risk factors for HIV-1 transmission in women: results from a cohort study. AIDS 1993;7(1):95-102. [PMID: 8442924]

Levine WC, Pope V, Bhoomkar A, et al. Increase in endocervical CD4 lymphocytes among women with nonulcerative sexually transmitted diseases. J Infect Dis 1998;177(1):167-74. [PMID: 9419184]

Mayer KH, Bush T, Henry K, et al. Ongoing sexually transmitted disease acquisition and risk-taking behavior among US HIV-infected patients in primary care: implications for prevention interventions. Sex Transm Dis 2012;39(1):1-7. [PMID: 22183836]

NYSDOH. HIV Epidemiological Profile September 2016. 2016 Sep. https://www.health.ny.gov/diseases/aids/general/statistics/epi/docs/epi_profile2016.pdf [accessed 2018 Mar 2]

Ota KV, Fisman DN, Tamari IE, et al. Incidence and treatment outcomes of pharyngeal Neisseria gonorrhoeae and Chlamydia trachomatis infections in men who have sex with men: a 13-year retrospective cohort study. Clin Infect Dis 2009;48(9):1237-43. [PMID: 19323630]

Pathela P, Braunstein SL, Blank S, et al. HIV incidence among men with and those without sexually transmitted rectal infections: estimates from matching against an HIV case registry. Clin Infect Dis 2013;57(8):1203-9. [PMID: 23800942]

Radix A, Mayer G, Weiss S, et al. Beyond the Guidelines: Clinic-Based Screening for Pharyngeal Chlamydia Trachomatis. National STD Prevention Conference; 2012 Mar 15; Minneapolis, MN. https://cdc.confex.com/cdc/std2012/webprogram/Paper29839.html

Rice PA. Gonococcal arthritis (disseminated gonococcal infection). Infect Dis Clin North Am 2005;19(4):853-61. [PMID: 16297736]

Taylor MM, Schillinger JA, Furness BW, et al. Gonorrhea infections diagnosed among persons living with HIV/AIDS: identifying opportunities for integrated prevention services in New York City, Washington, DC, Miami/Dade County, and Arizona. J Acquir Immune Defic Syndr 2013;64(1):115-20. [PMID: 23945254]

Transmission and Prevention

Sexually Transmitted Infections (STIs) Guideline Committee, March 2018

RECOMMENDATIONS
Transmission and Prevention
  • Clinicians should inform patients with HIV about the risk of acquiring or transmitting chlamydia, gonorrhea, and other sexually transmitted infections (STIs) from close physical contact with all sites of possible exposure, including the penis, vagina, mouth, or anus. (A3)
Patient Education
  • When patients with HIV are diagnosed with gonococcal or chlamydial infections, clinicians should educate patients about the following:
    • Risk-reduction strategies, including the value of correct condom use. (A2)
    • The potential for oral transmission of gonorrhea and chlamydia. (A3)
    • The benefits of identifying STIs early. (A3)
    • The need for prompt evaluation and treatment of partners. (A3)

Gonorrhea, chlamydia, and other STIs are transmitted primarily through close physical contact with genital, rectal, or oral mucosal surfaces. Clinicians should inform patients about the risk of acquiring gonorrhea and chlamydia at all sites of possible exposure and should educate patients about the value of male and female condom use. Consistent and correct condom use may reduce the risk of gonorrhea and chlamydia acquisition by 62% and 26%, respectively [Holmes et al. 2004]; however, clinicians should inform patients that gonorrhea and chlamydia may be transmitted at areas that are not covered by a condom, such as the rectum or the mouth [CDC 2016; Ward and Ronn 2010].

In patients with HIV, untreated STIs are associated with an increase in HIV shedding [Ward and Ronn 2010; Johnson and Lewis 2008] and have been associated with an increased risk of transmitting HIV to partners [Fleming and Wasserheit 1999].

References

Centers for Disease Control and Prevention (CDC). Gonorrhea – CDC Fact Sheet (Detailed Version). 2016 Oct 28. https://www.cdc.gov/std/gonorrhea/stdfact-gonorrhea-detailed.htm [accessed 2018 Mar 2]

Fleming DT, Wasserheit JN. From epidemiological synergy to public health policy and practice: the contribution of other sexually transmitted diseases to sexual transmission of HIV infection. Sex Transm Infect 1999;75(1):3-17. [PMID: 10448335]

Holmes KK, Levine R, Weaver M. Effectiveness of condoms in preventing sexually transmitted infections. Bull World Health Organ 2004;82(6):454-61. [PMID: 15356939]

Johnson LF, Lewis DA. The effect of genital tract infections on HIV-1 shedding in the genital tract: a systematic review and meta-analysis. Sex Transm Dis 2008;35(11):946-59. [PMID: 18685546]

Ward H, Ronn M. Contribution of sexually transmitted infections to the sexual transmission of HIV. Curr Opin HIV AIDS 2010;5(4):305-10. [PMID: 20543605]

Screening

Sexually Transmitted Infections (STIs) Guideline Committee, March 2018

RECOMMENDATIONS
Screening Frequency
  • For men who have sex with men (MSM) and transgender women (individuals assigned male at birth but who identify as female) who have sex with men, clinicians should perform three-site screening (genital, pharyngeal, rectal) at the following intervals:
    • At first visit and annually thereafter if the patient is at low risk of infection. (A2)
    • At first visit and every 3 months thereafter if the patient is at high risk of infection. (A2)
      • See Box 2: Description of Risk Status for Sexual Exposure to Gonorrhea and Chlamydia.
  • For all other patients, clinicians should perform genital screening (urine/urethra, vagina/cervix) and extragenital screening (pharyngeal and/or rectal) at sites of contact at the following intervals:
    • At first visit and annually thereafter if the patient is at low risk of infection. (A2)
    • At first visit and every 3 months thereafter if the patient is at high risk of infection. (A2)
  • Clinicians should screen pregnant patients with HIV for gonococcal and chlamydial infections at the first prenatal visit. (A2)
Sexual History
  • Clinicians should ask all patients about sexual behaviors and new sex partners at each routine monitoring visit to assess for risk behaviors that indicate the need for repeat or ongoing screening. (A3)
Box 2: Description of Risk Status for Sexual Exposure to Gonorrhea and Chlamydia
No/Low Risk Patient reports no sexual activity or sex only within a mutually monogamous relationship within the year prior.
Moderate Risk Patient reports a new sex partner within the year prior.
High Risk

Patient self-identifies as being at high risk of sexually transmitted infections (STIs) and/or reports any of the following for self or sex partner(s):

  • Multiple or anonymous sex partners.
  • Bacterial STI diagnosed since last STI screening.
  • Participation in sex parties or sex in other high-risk venues.
  • Participation in any type of transactional sex.
  • Use of recreational substances during sex.

A large proportion of gonorrheal and chlamydial infections are asymptomatic [CDC 2015, 2016a], which supports the recommendation for regular screening in individuals with HIV who are risk of acquiring sexually transmitted infections (STIs) [CDC 2015; LeFevre 2014; Aberg et al. 2014]. Less than 50% of the estimated 820,000 cases of gonorrhea and 2.86 million cases of chlamydia each year are detected and reported to the CDC [CDC 2016a, 2016b]. Intensified gonorrhea and chlamydia screening (3 sites every 3 months) for individuals with HIV who are at high risk may result in early identification of disease and allow for early intervention to decrease complications and reduce rates of both transmission and reinfection [LeFevre 2014]. For women, early intervention can also prevent reproductive health complications [CDC 2015]. The purpose of screening, therefore, is to identify gonococcal and chlamydial infection in asymptomatic patients, prevent the spread of infection, and reduce morbidity associated with untreated infections.

KEY POINT
  • Because most gonorrheal and chlamydial infections are asymptomatic [CDC 2016a, 2016b], regular screening is essential to protect patients’ health and prevent the spread of sexually transmitted infections. This is an essential component of patient education.

Rates of STIs are highest in sexually active women aged 25 years or younger and in sexually active MSM of any age [CDC 2015, 2017a]. Although data regarding STI rates in transgender populations are limited, higher rates of sexual risk behavior and laboratory-confirmed gonorrhea have been reported among transgender women [Herbst et al. 2008; Nemoto et al. 2004; Reisner et al. 2015]. Studies have reported elevated rates of sexual risk behaviors among transgender men (individuals assigned female at birth but who identify as male) [Stephens et al. 2011; Green et al. 2015], highlighting the need for a careful sexual history to determine risk. Data on gonorrhea and chlamydia rates among women who have sex with women (WSW) are also limited. Although WSW are usually considered to be at lower risk of STIs, this group may engage in diverse sexual activity and a range of risk behaviors. In one study, a substantial proportion (5% to 28%) of WSW reported having sex with men in the year prior [CDC 2015]. Higher rates of sexual risk behaviors [Goodenow et al. 2008] and higher rates of gonorrhea and chlamydia have been reported in women who have sex with men than in women who exclusively engage in sex with women [Muzny et al. 2011]. Data from more than 9,000 family planning clinics indicated a higher rate of chlamydia infection (7.1%) in WSW and women who have sex with men and women (WSMW) than in women who exclusively engage in sex with men (5.3%) [Singh et al. 2011]. In contrast, reported rates of chlamydial and gonococcal infection in women who are older than 25 years and in men who have sex with women are lower than in other groups [Ciemins et al. 2000; Jackson et al. 2015].

On the basis of the available evidence, this Committee recommends annual screening for gonococcal and chlamydial infections for all individuals with HIV. Those who engage, or whose partners may engage, in ongoing high-risk sex should be screened at least every 3 months. Factors that may prompt more frequent screening include multiple or anonymous sex partners, sexual activity at sex parties or other high-risk venues, or involvement in transactional sex (e.g., sex workers and their clients). The diagnosis of another bacterial STI in a patient with HIV or a patient’s sex partner should prompt a clinician to perform gonococcal and chlamydial screening tests and to consider screening every 3 months for gonorrhea and chlamydia. Screening at three sites (i.e., genital, pharyngeal, and rectal) is recommended for patients who are included in recognized high-risk groups and for those who report exposure at extragenital sites.

Some individuals for whom screening is indicated, such as MSM or women younger than 25 years of age, may report no sexual activity since their last STI screening. If an individual reports no sexual activity, then good practice is to document in the medical record the reason why screening was not performed.

KEY POINTS
  • Gonococcal and chlamydial screening at least every 3 months is recommended for all individuals at high risk of exposure, including those who:
    • Have, or whose partners may have, multiple or anonymous sex partners.
    • Engage, or whose partners may engage, in sexual activity at sex parties or other high-risk venues.
    • Are, or whose partners may be, involved in transactional sex (i.e., sex workers and their clients).
    • Have been diagnosed, or whose partners have been diagnosed, with a bacterial STI in the previous 12 months.
    • Report recreational substance use during sexual activity.
    • Self-identify as at high risk for STIs.

New York State (NYS) closely monitors local epidemiology, and information is available regarding areas with a high incidence of STIs (see the CDC’s Sexually Transmitted Disease Surveillance [CDC 2017b] report and County Health Rankings & Roadmaps [RWJF/UWPHI 2012]).

Rationale for Extragenital (3-Site) Screening

Multiple studies have reported high rates of rectal and pharyngeal infections, mostly asymptomatic, among MSM [CDC 2009; Kent et al. 2003; Mayer 2011; Peters et al. 2011; Patton et al. 2014; Chan et al. 2016]. The CDC reports a higher burden of urethral, rectal, and pharyngeal infections with gonorrhea and chlamydia among MSM with HIV attending STI clinics than among MSM who do not have HIV [CDC 2017b]. The rectum and pharynx serve as reservoirs of gonococcal and chlamydial infection and may be associated with persistent infection or transmission to sex partners [Rank and Yeruva 2014; Chow et al. 2016; Barbee et al. 2016; Marcus et al. 2011]. Moreover, sexual histories are often incomplete for many reasons, such as patient or provider discomfort, time constraints, or limited training, and may not elicit important information on extragenital exposure [Barbee et al. 2015; Cachay et al. 2009; van Liere et al. 2013].

In MSM, urine-based screening alone is not appropriate. It misses the majority of rectal and pharyngeal infections because of discordance between urethral and nonurethral gonococcal and chlamydial infections among MSM [Kent et al. 2005; Mayer 2011; Peters et al. 2011]. Among MSM attending STI clinics participating in the CDC STD Surveillance Network, more than 70% of extragenital gonococcal infections and 85% of extragenital chlamydial infections were associated with negative urethral tests at the same visit and would not have been detected with urethral screening alone [Patton et al. 2014]. However, a review of multicity HIV clinics, including clinics in New York City (NYC) [Hoover et al. 2010], found that less than 10% of MSM received nonurethral screening, indicating a need to increase screening that includes extragenital testing in this population.

Due to the high prevalence of asymptomatic rectal and pharyngeal infections in MSM who engage in high-risk behaviors and the low predictive value of patient sexual history to predict risk of extragenital exposure, this Committee supports routine three-site (urine, pharyngeal, and rectal) screening in sexually active MSM and transgender women who have sex with men. This Committee does not recommend screening only at sites where contact has been reported in these populations.

Available data are mixed regarding the benefit of routine nonvaginal gonococcal and chlamydial screening in all women. Most studies have utilized reported anatomic sites of sexual exposure to select women for extragenital screening and have demonstrated greater concordance between cervical and rectal infections in women [Dukers-Muijrers et al. 2015; Chandra et al. 2018]. Genital screening alone detects more infections in women than in MSM.

The recommendation for extragenital (three-site) screening should be discussed with the patient. If an individual opts out of three-site screening and testing only at sites of reported contact is performed, then the reasoning behind that decision should be noted in the medical record.

Self-collected screening specimens: Because evidence exists supporting the efficacy of self-collected rectal, pharyngeal, and vaginal swabs [Alexander et al. 2008; Moncada et al. 2009; Freeman et al. 2011; Geelen et al. 2013], these options may be considered when this is the patient’s preference. However, a thorough physical examination is still essential as part of the sexual health assessment (see NYS Department of Health [NYSDOH] AIDS Institute guideline Primary Care Approach).

Obtaining a Sexual History

To assess behavioral risk, clinicians should obtain a sexual history at each routine visit for patients with HIV. Information about the patient’s sexual behaviors informs decisions about the frequency and type (genital only or three-site) of screening and points clinicians to key areas to address in risk-reduction counseling. Respect, compassion, and a nonjudgmental attitude are essential components of effective sexual history-taking. Clinicians should ask open-ended questions using language that is clear, jargon-free, and not stigmatizing in discussing a patient’s sexual activities. The CDC recommends addressing the “Five Ps: Partners, Practices, Prevention of Pregnancy, Protection from STDs, and Past History of STDs,” as outlined in Box 3, below.

Box 3: The Five P’s: Partners, Practices, Prevention of Pregnancy, Protection from STDs, and Past History of STDs (Reprinted from CDC 2015 STD Treatment Guideline: Clinical Prevention Guidance)

Partners

  • “Do you have sex with men, women, or both?”
  • “In the past 2 months, how many partners have you had sex with?”
  • “In the past 12 months, how many partners have you had sex with?”
  • “Is it possible that any of your sex partners in the past 12 months had sex with someone else while they were still in a sexual relationship with you?”

Practices

  • “To understand your risks for STDs, I need to understand the kind of sex you have had recently.”
  • “Have you had vaginal sex, meaning ‘penis in vagina sex’?” If yes, “Do you use condoms: never, sometimes, or always?”
  • “Have you had anal sex, meaning ‘penis in rectum/anus sex’?” If yes, “Do you use condoms: never, sometimes, or always?”
  • “Have you had oral sex, meaning ‘mouth on penis/vagina’?”
  • For condom answers:
    • If “never”: “Why don’t you use condoms?”
    • If “sometimes”: “In what situations (or with whom) do you use condoms?”

Prevention of Pregnancy

  • “What are you doing to prevent pregnancy?”

Protection from STDs

  • “What do you do to protect yourself from STDs and HIV?”

Past History of STDs

  • “Have you ever had an STD?”
  • “Have any of your partners had an STD?”

Additional questions to identify HIV and viral hepatitis risk include:

  • “Have you or any of your partners ever injected drugs?”
  • “Have your or any of your partners exchanged money or drugs for sex?”
  • “Is there anything else about your sexual practices that I need to know about?”

When obtaining a sexual history, questions should focus primarily on the patient’s sexual behavior and not solely on sexual and gender identity (e.g., avoid use of such labels as “lesbian,” “homosexual,” “gay,” or “transgender”). A study conducted in NYC found that self-reported sexual identity could not independently establish patients’ risk. Many MSM in the study did not identify as “gay,” underscoring the importance of assessing sexual behavior when determining a patient’s risk [Bernstein et al. 2008; Pathela et al. 2006]. Transgender people differ widely in terms of sexual behavior and anatomy. It is helpful to ask about the type of sex a person is having and the parts of anatomy used for sex, as well as about the anatomy of partners [TransHealth 2016]. A patient’s openness to discuss his or her sexual and gender identity may be important for the clinician’s understanding of health status and the individual’s perceived stigma and ability to accurately assess the patient’s risk of acquiring or transmitting STIs. Therefore, clinicians should stress the confidential nature of discussions about sexual activities and maintain a nonjudgmental attitude to encourage patients to disclose all sexual behaviors.

Clinicians who are uncomfortable discussing sexual behaviors may benefit from training to increase their comfort level and assist in development of a nonjudgmental approach to educating patients about the importance of STI screening. The NYSDOH Clinical Education Initiative Line (866-637-2342) enables clinicians in NYS to discuss post-exposure prophylaxis, pre-exposure prophylaxis, HIV, hepatitis C virus, and STI management with a specialist, and the NYC STD/HIV Prevention Training Center provides HIV-related educational resources and training for providers. The CDC’s Guide to Taking a Sexual History offers parameters for discussing sexual health issues with patients. The NYC Department of Health and Mental Hygiene’s one-page sexual history and counseling form is available online. More information on sexual history and risk assessment among transgender people is available from the Center of Excellence for Transgender Health, Department of Family and Community Medicine, University of California San Francisco.

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Ciemins EL, Kent CK, Flood J, et al. Evaluation of chlamydia and gonorrhea screening criteria: San Francisco sexually transmitted disease clinic: 1997 to 1998. Sex Transm Dis 2000;27(3):165-7. [PMID: 10726651]

Dukers-Muijrers NH, Schachter J, van Liere GA, et al. What is needed to guide testing for anorectal and pharyngeal Chlamydia trachomatis and Neisseria gonorrhoeae in women and men? Evidence and opinion. BMC Infect Dis 2015;15:533. [PMID: 26576538]

Freeman AH, Bernstein KT, Kohn RP, et al. Evaluation of self-collected versus clinician-collected swabs for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae pharyngeal infection among men who have sex with men. Sex Transm Dis 2011;38(11):1036-9. [PMID: 21992980]

Geelen TH, Rossen JW, Beerens AM, et al. Performance of cobas(R) 4800 and m2000 real-time assays for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in rectal and self-collected vaginal specimen. Diagn Microbiol Infect Dis 2013;77(2):101-5. [PMID: 23891224]

Goodenow C, Szalacha LA, Robin LE, et al. Dimensions of sexual orientation and HIV-related risk among adolescent females: evidence from a statewide survey. Am J Public Health 2008;98(6):1051-8. [PMID: 18445809]

Green N, Hoenigl M, Morris S, et al. Risk Behavior and Sexually Transmitted Infections Among Transgender Women and Men Undergoing Community-Based Screening for Acute and Early HIV Infection in San Diego. Medicine (Baltimore) 2015;94(41):e1830. [PMID: 26469928]

Herbst JH, Jacobs ED, Finlayson TJ, et al. Estimating HIV prevalence and risk behaviors of transgender persons in the United States: a systematic review. AIDS Behav 2008;12(1):1-17. [PMID: 17694429]

Hoover KW, Butler M, Workowski K, et al. STD screening of HIV-infected MSM in HIV clinics. Sex Transm Dis 2010;37(12):771-6. [PMID: 20585275]

Jackson JA, McNair TS, Coleman JS. Over-screening for chlamydia and gonorrhea among urban women age >/=25 years. Am J Obstet Gynecol 2015;212(1):40.e1-6. [PMID: 24983680]

Kent CK, Chaw JK, Wong W, et al. Prevalence of rectal, urethral, and pharyngeal chlamydia and gonorrhea detected in 2 clinical settings among men who have sex with men: San Francisco, California, 2003. Clin Infect Dis 2005;41(1):67-74. [PMID: 15937765]

LeFevre ML. Screening for Chlamydia and gonorrhea: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med 2014;161(12):902-10. [PMID: 25243785]

Marcus JL, Kohn RP, Barry PM, et al. Chlamydia trachomatis and Neisseria gonorrhoeae transmission from the female oropharynx to the male urethra. Sex Transm Dis 2011;38(5):372-3. [PMID: 21183864]

Mayer KH. Sexually transmitted diseases in men who have sex with men. Clin Infect Dis 2011;53 Suppl 3:S79-83. [PMID: 22080272]

Moncada J, Schachter J, Liska S, et al. Evaluation of self-collected glans and rectal swabs from men who have sex with men for detection of Chlamydia trachomatis and Neisseria gonorrhoeae by use of nucleic acid amplification tests. J Clin Microbiol 2009;47(6):1657-62. [PMID: 19369445]

Muzny CA, Sunesara IR, Martin DH, et al. Sexually transmitted infections and risk behaviors among African American women who have sex with women: does sex with men make a difference? Sex Transm Dis 2011;38(12):1118-25. [PMID: 22082722]

Nemoto T, Operario D, Keatley J, et al. HIV risk behaviors among male-to-female transgender persons of color in San Francisco. Am J Public Health 2004;94(7):1193-9. [PMID: 15226142]

Pathela P, Hajat A, Schillinger J, et al. Discordance between sexual behavior and self-reported sexual identity: a population-based survey of New York City men. Ann Intern Med 2006;145(6):416-25. [PMID: 16983129]

Patton ME, Kidd S, Llata E, et al. Extragenital gonorrhea and chlamydia testing and infection among men who have sex with men–STD Surveillance Network, United States, 2010-2012. Clin Infect Dis 2014;58(11):1564-70. [PMID: 24647015]

Peters RP, Verweij SP, Nijsten N, et al. Evaluation of sexual history-based screening of anatomic sites for chlamydia trachomatis and neisseria gonorrhoeae infection in men having sex with men in routine practice. BMC Infect Dis 2011;11:203. [PMID: 21791061]

Rank RG, Yeruva L. Hidden in plain sight: chlamydial gastrointestinal infection and its relevance to persistence in human genital infection. Infect Immun 2014;82(4):1362-71. [PMID: 24421044]

Reisner SL, Vetters R, White JM, et al. Laboratory-confirmed HIV and sexually transmitted infection seropositivity and risk behavior among sexually active transgender patients at an adolescent and young adult urban community health center. AIDS Care 2015;27(8):1031-6. [PMID: 25790139]

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Singh D, Fine DN, Marrazzo JM. Chlamydia trachomatis infection among women reporting sexual activity with women screened in Family Planning Clinics in the Pacific Northwest, 1997 to 2005. Am J Public Health 2011;101(7):1284-90. [PMID: 20724697]

Stephens SC, Bernstein KT, Philip SS. Male to female and female to male transgender persons have different sexual risk behaviors yet similar rates of STDs and HIV. AIDS Behav 2011;15(3):683-6. [PMID: 20694509]

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van Liere GA, Hoebe CJ, Niekamp AM, et al. Standard symptom- and sexual history-based testing misses anorectal Chlamydia trachomatis and neisseria gonorrhoeae infections in swingers and men who have sex with men. Sex Transm Dis 2013;40(4):285-9. [PMID: 23486492]

Presentation, Diagnosis, and Reporting

Sexually Transmitted Infections (STIs) Guideline Committee, March 2018

RECOMMENDATIONS
Presentation of Symptomatic Infection
  • When patients with HIV present with symptoms suggestive of gonococcal or chlamydial infection, clinicians should perform diagnostic testing as recommended in Table 1, below. (A1)
  • Clinicians should include lymphogranuloma venereum (LGV) infection in the differential diagnosis for patients who test positive for rectal chlamydial infection or who present with such symptoms as rectal pain, tenesmus, bloody rectal discharge, or isolated, atypical perianal ulcerative lesions and adenopathy. (A2)
    • See the Centers for Disease Control and Prevention’s (CDC) guideline on LGV.
Laboratory-Based Diagnosis 
  • Clinicians should obtain nucleic acid amplification testing (NAAT) on samples collected from genital and extragenital sites (A1); if NAAT is not available, clinicians should:
    • Send alternative samples for culture in accordance with the protocols of the laboratory performing the analysis, with the understanding that culture is significantly less sensitive than NAAT. (A1)
  • If a patient has a known exposure to a cephalosporin-resistant strain of gonorrhea, clinicians should obtain samples for both culture/susceptibility and NAAT testing from the patient and his/her sex partner(s). (A3)
  • Clinicians should perform syphilis testing for any patient with HIV who is diagnosed with a gonorrheal or chlamydial infection. (A2)
    • For more information, contact the NYSDOH Wadsworth Center Laboratory at 1-518-474-4177.
Reporting

Presentation of Symptomatic Infection

There have been no reports of atypical presentations of gonococcal or chlamydial infections in patients with HIV.

In men, genital symptoms and signs of either gonococcal or chlamydial infection may include dysuria or urethral discharge; in cases in which urethral infection is complicated by epididymitis, patients may report testicular pain [CDC 2016a, 2016b]. A woman with symptomatic genital gonococcal or chlamydial infection may present with dysuria, increased vaginal discharge, or vaginal bleeding between periods [CDC 2016a, 2016b].

Rectal gonococcal and chlamydial infections may be asymptomatic in both men and women. When present, symptoms and signs may include anal itching, soreness, proctitis, discharge, and/or bleeding.

Pharyngeal gonococcal infection may cause symptoms in the throat, with or without cervical lymphadenopathy, but this infection is often asymptomatic [CDC 2016b]. Reports of pharyngeal symptoms associated with chlamydial infection are extremely rare, and chlamydial infection is not thought to cause pharyngitis [CDC 2016a]. Gonococcal infection should be considered as part of the differential diagnosis for sexually active patients who present with pharyngeal symptoms.

Spread of N. gonorrhoeae into disseminated gonococcal infection may cause arthritis, tenosynovitis, skin lesions, and sepsis in both men and women [Belkacem et al. 2013].

Lymphogranuloma venereum: LGV is caused by unique serovars of C. trachomatis (L1, L2, L3) that are unlike those that typically cause urethritis, cervicitis, and proctitis (D through K). LGV should be included in the differential diagnosis for all patients with HIV who test positive for rectal chlamydial infection or who present with rectal signs or symptoms, such as rectal pain; tenesmus; bloody rectal discharge; or isolated, atypical genital or perianal ulcerative lesions and adenopathy.

LGV is typically diagnosed based on clinical examination because testing to determine LGV serovars is often unavailable. The classic presentation of LGV infection is unilateral or bilateral tender inguinal lymphadenopathy that evolves dramatically 2 to 6 weeks after the primary ulcerative lesion. However, in both men and women, infection occurring as a result of anal intercourse can cause proctocolitis. Colonic mucosal ulcerations develop and may be replaced by progressively enlarging areas of granulation tissue, which, in time, lead to fistulas and strictures. Clinicians should have a low threshold for empirically treating patients with suspected LGV or documented rectal chlamydia infection. For information regarding diagnosis, including instructions for obtaining chlamydial polymerase chain reaction testing, and treatment of LGV, see the CDC’s guideline on LGV.

KEY POINT
  • Although LGV occurs only sporadically in the United States, outbreaks of LGV proctocolitis have been reported among men who have sex with men (MSM) in New York and other U.S. cities [Martin-Iguacel et al. 2010; Ahdoot et al. 2006], and many of these cases occurred in individuals with HIV [Martin-Iguacel et al. 2010; Ahdoot et al. 2006].

Laboratory-Based Diagnosis of Gonorrheal and Chlamydial Infections

Whenever possible, NAAT should be performed to detect and diagnose gonococcal and chlamydial infection. NAAT is more sensitive than culture, particularly for detecting C. trachomatis and N. gonorrhoeae in extragenital samples [Ota et al. 2009b; Schachter et al. 2008]. Although the U.S. Food and Drug Administration has not yet approved use of NAAT for rectal and pharyngeal specimens, this Committee concurs with the Centers for Disease Control and Prevention (CDC) recommendation that NAAT should be used to detect rectal and pharyngeal infection. NAAT should be performed by a laboratory with a Clinical Laboratory Evaluation Program (CLEP)-specified protocol.

Performance specifications for use of NAAT on rectal and pharyngeal samples have been established according to CLEP regulations by a number of laboratories. The NYSDOH and CDC strongly recommend that laboratories adopt CLEP testing protocols for rectal and pharyngeal specimens. CLEP specifications for rectal and pharyngeal testing and information about participating laboratories can be obtained by contacting the NYSDOH Wadsworth Center Laboratory at 1-518-474-4177.

For clinicians who are unable to obtain NAAT, culture may be used for the diagnosis of gonorrhea. Antimicrobial sensitivity testing cannot be performed on NAAT specimens.

Although there are limited data available specifically regarding the rate of syphilis coinfection identified in patients diagnosed with gonococcal or chlamydial infections, surveillance reports identify high rates of gonococcal or chlamydial infections and syphilis among MSM. Because exposure resulting in the acquisition of one sexually transmitted infection (STI) has long been recognized to be a risk for other STIs/HIV, this Committee recommends testing for syphilis when a patient is diagnosed with a new gonococcal or chlamydial infection [Bala et al. 2011; Foschi et al. 2014; CDC 2017].

Table 1: Sample Collection and Testing Methods for Laboratory Detection of Gonococcal and Chlamydial Infection
Exposure Site Sample Collection Method [a] Comments
Urethra First-catch urine for nucleic acid amplification testing (NAAT) [b]
  • In males, for ease of collection, first-catch urine [c] is recommended over urethral swab. Some studies have demonstrated equal specificity but lower sensitivity with urethral swab compared with urine for NAAT [CDC 2014]. However, additional data are needed to establish the relative effectiveness of these collection methods.
Vagina/cervix Vaginal or cervical swab (recommended) or first-catch urine (alternative) NAAT
  • The recommended sample collection method is a vaginal swab for testing with a U.S. Food and Drug Administration (FDA)-approved assay; this method is equivalent to cervical swab [CDC 2014].
  • First-catch urine testing, which is inferior to swab, may be used as an alternative.
  • Some NAAT assays are approved for self-collected vaginal samples and perform as well as NAAT for other specimens [Soni and White 2011].
Rectum Males and females: Rectal swab for NAAT [b]
  • Culture is not sufficiently sensitive for detection of rectal C. trachomatis.
Pharynx Males and females: Pharyngeal swab for NAAT [b]
  • Culture is not sufficiently sensitive for detection of pharyngeal C. trachomatis.
  • The incidence of pharyngeal chlamydial infection is lower than pharyngeal gonorrheal infection [Soni and White 2011; Ota et al. 2009a; Radix et al. 2012], and data on the clinical benefit of treating patients with asymptomatic pharyngeal infection are limited.
  • To reduce the risk of transmission, this Committee recommends treatment for pharyngeal chlamydial infection, even if the pharynx is the only site of infection.
  1. Handling of specimens: Conditions for collection and transport of samples for laboratory testing for C. trachomatis and N. gonorrhoeae may greatly affect the sensitivity of culture because the organisms can degrade easily during transport [Rishmawi et al. 2007; Human and Jones 2004]. Guidance regarding sample collection with either direct plating or the use of specialized transport media for culture should be obtained from the clinician’s laboratory. After collection, culture samples should be stored in the referring laboratory’s recommended transport media and transported at ≤4°C to the laboratory within 24 hours [CDC 2014].
  2. NAAT testing is more sensitive than culture for the detection of gonococcal or chlamydial infections. Although NAAT has not yet received FDA approval for rectal or pharyngeal specimens, NAAT performed by a laboratory with a Clinical Laboratory Evaluation Program-specified protocol is recommended for detecting both rectal and pharyngeal C. trachomatis and N. gonorrhoeae. If NAAT is not available, then culture should be obtained according to the protocols of the clinician’s institution.
  3. For urine screening, clinicians should provide patients with clear instructions for obtaining a first-catch sample.

Reporting

NYS Law: Prompt reporting of suspected or confirmed cases of gonorrhea and chlamydia is mandated under the NYS Sanitary Code (10NYCRR 2.10). In NYS, cases must be reported to the local health department where the patient resides within 24 hours from the time the case is first seen.

For more information about disease reporting, clinicians should contact the local health department where the patient resides or the NYSDOH Bureau of Communicable Disease Control at 518-473-4439 (after hours: 1-866-881-2809). To obtain reporting forms, call 518-474-0548.

NYC Law: NYC’s Health Code Article 11 requires that all cases of gonorrhea and chlamydia be reported using the Universal Reporting Form, which can be submitted online, by fax (call 866-692-3641 for the appropriate fax number), or by mail (NYC Department of Health and Mental Hygiene, 42-09 28th Street, CN-22, Long Island City, NY 11101). See How to Report Diseases, Events, and Conditions to the NYC Health Department for more information.

Partner notification: The local health department may contact the patient for epidemiological investigation or to offer assistance with partner notification.

References

Ahdoot A, Kotler DP, Suh JS, et al. Lymphogranuloma venereum in human immunodeficiency virus-infected individuals in New York City. J Clin Gastroenterol 2006;40(5):385-90. [PMID: 16721218]

Bala M, Mullick JB, Muralidhar S, et al. Gonorrhoea & its co-infection with other ulcerative, non-ulcerative sexually transmitted & HIV infection in a Regional STD Centre. Indian J Med Res 2011;133:346-9. [PMID: 21441694]

Belkacem A, Caumes E, Ouanich J, et al. Changing patterns of disseminated gonococcal infection in France: cross-sectional data 2009-2011. Sex Transm Infect 2013;89(8):613-5. [PMID: 23920397]

CDC. 2016 Sexually Trasmitted Diseases Surveillance: STDs in Men Who Have Sex With Men. 2017 Aug 18. https://www.cdc.gov/std/stats16/msm.htm [accessed 2018 Mar 2]

CDC. Chlamydia – CDC Fact Sheet (Detailed Version). 2016a Oct 4. https://www.cdc.gov/std/chlamydia/stdfact-chlamydia-detailed.htm [accessed 2018 Mar 2]

CDC. Gonorrhea – CDC Fact Sheet (Detailed Version). 2016b Oct 28. https://www.cdc.gov/std/gonorrhea/stdfact-gonorrhea-detailed.htm [accessed 2018 Mar 2]

CDC. Recommendations for the laboratory-based detection of Chlamydia trachomatis and Neisseria gonorrhoeae–2014. MMWR Recomm Rep 2014;63(Rr-02):1-19. [PMID: 24622331]

Foschi C, Marangoni A, D’Antuono A, et al. Prevalence and predictors of Lymphogranuloma venereum in a high risk population attending a STD outpatients clinic in Italy. BMC Res Notes 2014;7:225. [PMID: 24716676]

Human RP, Jones GA. Evaluation of swab transport systems against a published standard. J Clin Pathol 2004;57(7):762-3. [PMID: 15220372]

Martin-Iguacel R, Llibre JM, Nielsen H, et al. Lymphogranuloma venereum proctocolitis: a silent endemic disease in men who have sex with men in industrialised countries. Eur J Clin Microbiol Infect Dis 2010;29(8):917-25. [PMID: 20509036]

Ota KV, Fisman DN, Tamari IE, et al. Incidence and treatment outcomes of pharyngeal Neisseria gonorrhoeae and Chlamydia trachomatis infections in men who have sex with men: a 13-year retrospective cohort study. Clin Infect Dis 2009a;48(9):1237-43. [PMID: 19323630]

Ota KV, Tamari IE, Smieja M, et al. Detection of Neisseria gonorrhoeae and Chlamydia trachomatis in pharyngeal and rectal specimens using the BD Probetec ET system, the Gen-Probe Aptima Combo 2 assay and culture. Sex Transm Infect 2009b;85(3):182-6. [PMID: 19126571]

Radix A, Mayer G, Weiss S, et al. Beyond the Guidelines: Clinic-Based Screening for Pharyngeal Chlamydia Trachomatis. National STD Prevention Conference; 2012 Mar 15; Minneapolis, MN. https://cdc.confex.com/cdc/std2012/webprogram/Paper29839.html

Rishmawi N, Ghneim R, Kattan R, et al. Survival of fastidious and nonfastidious aerobic bacteria in three bacterial transport swab systems. J Clin Microbiol 2007;45(4):1278-83. [PMID: 17267627]

Schachter J, Moncada J, Liska S, et al. Nucleic acid amplification tests in the diagnosis of chlamydial and gonococcal infections of the oropharynx and rectum in men who have sex with men. Sex Transm Dis 2008;35(7):637-42. [PMID: 18520976]

Soni S, White JA. Self-screening for Neisseria gonorrhoeae and Chlamydia trachomatis in the human immunodeficiency virus clinic–high yields and high acceptability. Sex Transm Dis 2011;38(12):1107-9. [PMID: 22082720]

Treatment

Sexually Transmitted Infections (STIs) Guideline Committee, updated June 2019

RECOMMENDATIONS
Treatment of Uncomplicated Gonococcal Infection
  • Clinicians should treat uncomplicated gonococcal infections of the cervix, urethra, rectum, or pharynx as follows:
    • Preferred: Ceftriaxone 250 mg intramuscular (IM) injection in a single dose plus azithromycin 1 g by mouth in a single dose. (A2)
    • Alternative, for patients who are allergic to azithromycin: Ceftriaxone 250 mg IM in a single dose plus doxycycline 100 mg by mouth twice daily for 7 days. (A2)
    • Alternative, if ceftriaxone is not available: Cefixime 400 mg by mouth in a single dose plus azithromycin 1 g by mouth in a single dose. This regimen is not recommended for treatment of pharyngeal infection. (A2)
  • Clinicians should instruct patients to abstain from sexual activity for at least 7 days after starting treatment, and to continue to abstain until symptoms resolve and all sex partners have completed treatment. (A2)
Treatment of Gonococcal Infection in Patients with Penicillin Allergy
  • For patients without prior severe allergic responses to penicillin (e.g., severe IgE-mediated response, such as anaphylaxis or urticaria with pruritic rash; or a severe non-IgE-mediated response, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug-induced hypersensitivity with inflammation of internal organs), clinicians should treat gonococcal infection with a cephalosporin-containing regimen, as recommended above, and monitor carefully for adverse effects. (A2)
  • For patients with prior severe allergic responses to penicillin, clinicians should treat gonococcal infection with a single dose of azithromycin 2 g by mouth plus a single dose of either gentamicin 240 mg IM or gemifloxacin 320 mg by mouth. (A2) 
Treatment of Uncomplicated Chlamydial and LGV Infections
  • Clinicians should treat uncomplicated chlamydial infection of the cervix, urethra, rectum, or pharynx as indicated in Table 2: Recommended Treatment for Uncomplicated Chlamydial and Lymphogranuloma Venereum (LGV) Infections. (A2)
  • Clinicians should treat symptomatic chlamydial proctitis with a medication regimen sufficient to treat lymphogranuloma venereum (LGV). (A3)

Treatment of Uncomplicated Gonococcal Infection

Treatment of gonorrhea and chlamydia in patients with HIV is the same as for patients who do not have HIV [CDC 2015]. The New York State Department of Health and the Centers for Disease Control and Prevention (CDC) recommend ceftriaxone 250 mg IM plus 1 g of azithromycin by mouth as a single dose for effective treatment of uncomplicated gonococcal infections of the cervix, urethra, rectum, or pharynx. Ideally, this regimen should be administered together simultaneously onsite under direct observation to maximize treatment adherence [CDC 2015]. Regimens containing alternatives to ceftriaxone are no longer recommended as first-line treatment for gonococcal infections due to increasing gonococcal antibiotic resistance in the United States and worldwide [CDC 2012; NYSDOH 2012; Kirkcaldy et al. 2016]. Combination treatment with two drugs with different mechanisms of action is recommended to slow emergence and spread of gonococcal antibiotic resistance. Ceftriaxone has remained highly effective in the United States, although several other countries have reported decreased susceptibility [CDC 2015; Kirkcaldy et al. 2016]. Reduced susceptibility of N. gonorrhoeae to azithromycin has increased in recent years but remains low [Kirkcaldy et al. 2016; NYCDHMH 2016]. Alarmingly, a small cluster of cases with decreased susceptibility to ceftriaxone and azithromycin were reported in Hawaii in 2016, and a case of ceftriaxone-resistant N. gonorrhoeae was reported in Canada in 2017, leading to increased concern about emergence of resistance to this last remaining effective regimen [Papp et al. 2017; Lefebvre et al. 2018]. It is essential that clinicians follow up-to-date treatment recommendations and immediately report cases of treatment failure to local health departments to prevent further development of resistance [CDC 2015; Bolan 2017].

Azithromycin is preferred as the second antimicrobial in the treatment regimen because of the higher prevalence of gonococcal resistance to tetracycline reported by the Gonococcal Isolate Surveillance Project [CDC 2017; Kirkcaldy et al. 2014]. In cases of azithromycin allergy, doxycycline 100 mg by mouth twice daily for 7 days may be substituted. Both azithromycin and doxycycline are also effective against concomitant chlamydial infections, which are common among patients with gonorrhea [CDC 2015].

When ceftriaxone is not available, a single dose of cefixime 400 mg can be substituted in combination with a single dose of azithromycin 1 g by mouth. However, ceftriaxone is preferred whenever possible because rising minimum inhibitory concentrations for cefixime suggest that resistance may develop in the near future, and continued use of cefixime may also contribute to development of resistance to ceftriaxone. In addition, cefixime has a lower cure rate for pharyngeal gonorrhea [CDC 2015].

Data are limited regarding recommendations for alternative antimicrobials if treatment with a cephalosporin is unavailable, declined, or cannot be used due to a drug allergy (see Treatment of Gonococcal Infection in Patients with Penicillin Allergy, below). Azithromycin monotherapy is no longer recommended due to concerns about development of resistance and documented treatment failures [CDC 2015; Kirkcaldy et al. 2016; NYCDHMH 2016; Papp et al. 2017]. Treatment with a single dose of either gemifloxacin 320 mg by mouth or gentamicin 240 mg IM plus a 2 g dose of azithromycin by mouth has been effective [Kirkcaldy et al. 2014]. If regimens other than those recommended above are used, culture and antibiotic susceptibility testing should be performed to guide treatment. If susceptibility testing is not available, then a test of cure should be performed 2 weeks after completion of treatment (see the Follow-Up and Management of Treatment Failure section of this guideline).

KEY POINTS
  • Directly observed treatment provided on site maximizes adherence [CDC 2015].
  • N. gonorrhoeae has developed resistance to nearly all previously effective antimicrobials, leaving cephalosporins as the only available class of drugs recommended for treatment of gonococcal infections [CDC 2015].
  • Cephalosporin-resistant N. gonorrhoeae has been reported outside of the United States [CDC 2011; Bolan et al. 2012], and reduced susceptibility to cephalosporins has been observed with isolates of N. gonorrhoeae from residents of New York City [NYCDHMH 2013].
  • Combination treatment with two antimicrobials with different mechanisms of action is recommended to slow further emergence of resistance [CDC 2015].
  • People infected with N. gonorrhoeae are frequently coinfected with C. trachomatis [Lyss et al. 2003].
  • Significant levels of quinolone-resistant N. gonorrhoeae are present in the United States (26.9% of isolates in 2016) [CDC 2017].
  • Because of fluoroquinolone-resistant N. gonorrhoeae in the United States, fluoroquinolones other than gemifloxacin* should not be used to empirically treat proven or suspected gonococcal infections [CDC 2007]; however, if fluoroquinolones are being considered, then clinicians should perform fluoroquinolone susceptibility testing before initiating treatment.

For additional information regarding antibiotic-resistant N. gonorrhoeae, refer to CDC > Antibiotic-Resistant Gonorrhea, which provides updated information and resources on surveillance and trends.

*Gemifloxacin was shown to have in vitro activity against gonorrhea (including quinolone-resistant organisms) [Pottumarthy et al. 2006] and in one clinical trial when dosed with azithromycin [Lyss et al. 2003].

Treatment of Gonococcal Infection in Patients with Penicillin Allergy

With the emergence of antibiotic-resistant N. gonorrhoeae, patients should be treated for gonococcal infection with a regimen including ceftriaxone unless contraindicated. Most patients who report a previous penicillin allergy can be treated safely with ceftriaxone when monitored for side effects since allergy to penicillin does not appear to predict severe reaction to cephalosporins [Yates 2008; Campagna et al. 2012; Novalbos et al. 2001; Pichichero and Casey 2007]. Rates of cross-reactivity between penicillins and cephalosporins are lower than previously reported and are highest for 1st-generation and 2nd-generation cephalosporins, particularly with amoxicillin, which has a similar side chain [Campagna et al. 2012]. Rates of cross-reactivity between penicillins and 3rd-generation cephalosporins are negligible [Yates 2008; Campagna et al. 2012; Novalbos et al. 2001; Pichichero and Casey 2007; Pichichero 2005]. Rates of anaphylaxis to cephalosporins among patients with penicillin allergy are rare (0.0001%-0.1%) [Pegler and Healy 2007; Meyers 1985; Lin 1992].

An accurate history of the nature of past reactions is important to determine the circumstances before identifying the patient as allergic. Many patients who have experienced a side effect of the drug may have been incorrectly identified as having a penicillin allergy [Saxon et al. 1987]. Previous reactions that are less concerning when subsequent use of cephalosporins is considered include diarrhea, nausea, mild nonpruritic rash, or pain and inflammation at the injection site. These reactions can be anticipated and managed carefully.

Severe penicillin reactions may include IgE-mediated responses, such as anaphylaxis or urticaria with pruritic rash, or non-IgE-mediated responses, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms involving inflammation of internal organs. Before treating patients who report penicillin allergy but for whom the history is unclear, or in whom desensitization may be applicable, consultation with a clinician (e.g., allergist) who has experience managing drug allergies is advisable.

In the case of prior severe allergic response to penicillin, cephalosporins are not recommended. Gentamicin 240 mg IM in a single dose or gemifloxacin 320 mg by mouth in a single dose have been effective alternatives to cephalosporins in recommended treatment regimens. To prevent future development of gonococcal resistance, these drugs should be used in combination with a single dose of azithromycin 2 g by mouth, which is double the dose used in the standard treatment regimens [CDC 2015; NYCDHMH 2016; Kirkcaldy et al. 2014]. Oral doses of two-gram azithromycin have been associated with gastrointestinal events, including nausea, loose stools, vomiting, and abdominal pain. In one study, nearly 7.7% of patients reported vomiting within 1 hour of gemifloxacin/azithromycin administration, and 3.3% reported vomiting within 1 hour of gentamicin/azithromycin administration, necessitating retreatment [CDC 2015; Kirkcaldy et al. 2014].

Penicillin skin testing may also be useful in cases in which history is unclear. Protocols for desensitization to cephalosporins are available for patients with a history of severe IgE-mediated penicillin reaction, avoiding the need for alternative treatment with potentially less effective antimicrobials [Castells 2009]; however, they may be difficult to administer in an outpatient setting. Ceftriaxone 250 mg IM plus a single 1 g dose of azithromycin by mouth may be prescribed after negative skin testing, and, if necessary, desensitization to ceftriaxone.

Treatment of Uncomplicated Chlamydial and LGV Infections

Table 2: Recommended Treatment for Uncomplicated Chlamydial and Lymphogranuloma Venereum (LGV) Infections (Adapted from Centers for Disease Control and Prevention [CDC 2015])
Infection Regimen Comments
Uncomplicated cervical, urethral, rectal, or pharyngeal infection

Recommended:

  • Azithromycin 1 g by mouth as a single dose OR
  • Doxycycline 100 mg by mouth twice daily for 7 days.

Alternatives:

  • Erythromycin base 500 mg by mouth four times per day for 7 days OR
  • Erythromycin ethylsuccinate 800 mg by mouth four times per day for 7 days OR
  • Levofloxacin 500 mg by mouth once daily for 7 days OR
  • Ofloxacin 300 mg by mouth twice per day for 7 days.
  • Treat asymptomatic pharyngeal infection even if it is the only site of infection.
  • Alternative regimens are NOT recommended for pharyngeal infections.
Symptomatic proctitis
  • Doxycycline 100 mg by mouth twice daily for 21 days OR
  • Azithromycin 1 g by mouth as a single dose once weekly for 3 weeks [Blanco et al. 2018].*
  • Presumptively treat for LGV; see the CDC’s guideline on LGV.
  • If LGV is excluded by testing, then patients should complete the standard seven-day regimen for uncomplicated chlamydial infection.
*Added June 13, 2019.

Treatment of chlamydia for patients with HIV is the same as for patients who do not have HIV [CDC 2015]. The recommended treatment for uncomplicated chlamydial infections of the cervix, urethra, rectum, or pharynx is either 1 g of azithromycin by mouth as a single dose or 100 mg of doxycycline by mouth twice daily for 7 days. Once-daily, delayed-release doxycycline (200 mg) was as effective as the recommended twice-daily dosing of doxycycline in one study [Geisler et al. 2012]. Erythromycin, levofloxacin, and ofloxacin in 7-day dosing regimens are also acceptable alternatives [CDC 2015].

Although antimicrobial-resistant C. trachomatis is thought to be rare [Ison 2012; Ljubin-Sternak et al. 2013], some studies have suggested that treatment with doxycycline may be more effective than azithromycin, particularly in rectal sites of infection. However, there may be greater concerns about patient adherence with the 7-day doxycycline regimen [Schwebke et al. 2011; Manhart et al. 2013; Sena et al. 2012; Hathorn et al. 2012; Lau et al. 2002; Geisler et al. 2015]. Patients with symptomatic chlamydial proctitis should be treated empirically for LGV with 100 mg of doxycycline by mouth twice daily for 21 days [CDC 2015] or azithromycin 1 g weekly for 3 weeks [Blanco et al. 2018]. Doxycycline has been the recommended therapy for many years. Azithromycin was recently found to be equivalent in a randomized trial conducted in patients with HIV diagnosed with LGV proctitis. The impact of longer courses of azithromycin on the possible development of gonococcal or mycoplasma resistance is not known. If additional laboratory testing to differentiate LGV from non-LGV serovars is available, then the duration of treatment can be limited to 7 days of doxycycline or 1 dose of azithromycin if LGV is reliably ruled out.

Although transmission of C. trachomatis from the pharynx has been documented [Bernstein et al. 2009; Marcus et al. 2011], the clinical benefit of treating patients with asymptomatic pharyngeal infection is less well studied than treatment of genital and rectal infections. To reduce the risk of transmission, this Committee concurs with the CDC recommendation to treat pharyngeal chlamydial infection, even if the pharynx is the only site of infection. Patients should be treated with azithromycin 1 g by mouth as a single dose or doxycycline 100 mg by mouth twice daily for 7 days. The efficacy of alternative treatment regimens is not known [CDC 2015].

References

Bernstein KT, Stephens SC, Barry PM, et al. Chlamydia trachomatis and Neisseria gonorrhoeae transmission from the oropharynx to the urethra among men who have sex with men. Clin Infect Dis 2009;49(12):1793-7. [PMID: 19911970]

Blanco JL, Fuertes I, Bosch J, et al. Effective treatment of lymphogranuloma proctitis with extended azithromycin regimen. CROI; 2019 Mar 4-7; Seattle, WA. http://www.croiconference.org/sessions/effective-treatment-lymphogranuloma-proctitis-extended-azithromycin-regimen

Bolan G. Emerging Drug-Resistant Gonorrhea: What’s New and What Now? 2017 Mar 6. http://www.medscape.com/viewarticle/876378?src=par_cdc_stm_mscpedt&faf=1 [accessed 2018 Mar 2]

Bolan GA, Sparling PF, Wasserheit JN. The emerging threat of untreatable gonococcal infection. N Engl J Med 2012;366(6):485-7. [PMID: 22316442]

Campagna JD, Bond MC, Schabelman E, et al. The use of cephalosporins in penicillin-allergic patients: a literature review. J Emerg Med 2012;42(5):612-20. [PMID: 21742459]

Castells M. Rapid desensitization for hypersensitivity reactions to medications. Immunol Allergy Clin North Am 2009;29(3):585-606. [PMID: 19563999]

Centers for Disease Control and Prevention (CDC). 2015 Sexually Transmitted Diseases Treatment Guidelines. 2015 Jun 4. https://www.cdc.gov/std/tg2015/default.htm [accessed 2018 Mar 2]

Centers for Disease Control and Prevention (CDC). 2016 Sexually Transmitted Diseases Surveillance. 2017 Oct 17. https://www.cdc.gov/std/stats16/CDC_2016_STDS_Report-for508WebSep21_2017_1644.pdf [accessed 2018 Mar 2]

Centers for Disease Control and Prevention (CDC). Cephalosporin susceptibility among Neisseria gonorrhoeae isolates–United States, 2000-2010. MMWR Morb Mortal Wkly Rep 2011;60(26):873-7. [PMID: 21734634]

Centers for Disease Control and Prevention (CDC). Update to CDC’s Sexually transmitted diseases treatment guidelines, 2010: oral cephalosporins no longer a recommended treatment for gonococcal infections. MMWR Morb Mortal Wkly Rep 2012;61(31):590-4. [PMID: 22874837]

Centers for Disease Control and Prevention (CDC). Update to CDC’s sexually transmitted diseases treatment guidelines, 2006: fluoroquinolones no longer recommended for treatment of gonococcal infections. MMWR Morb Mortal Wkly Rep 2007;56(14):332-6. [PMID: 17431378]

Geisler WM, Koltun WD, Abdelsayed N, et al. Safety and efficacy of WC2031 versus vibramycin for the treatment of uncomplicated urogenital Chlamydia trachomatis infection: a randomized, double-blind, double-dummy, active-controlled, multicenter trial. Clin Infect Dis 2012;55(1):82-8. [PMID: 22431798]

Geisler WM, Uniyal A, Lee JY, et al. Azithromycin versus Doxycycline for Urogenital Chlamydia trachomatis Infection. N Engl J Med 2015;373(26):2512-21. [PMID: 26699167]

Hathorn E, Opie C, Goold P. What is the appropriate treatment for the management of rectal Chlamydia trachomatis in men and women? Sex Transm Infect 2012;88(5):352-4. [PMID: 22517887]

Ison CA. Antimicrobial resistance in sexually transmitted infections in the developed world: implications for rational treatment. Curr Opin Infect Dis 2012;25(1):73-8. [PMID: 22143116]

Kirkcaldy RD, Harvey A, Papp JR, et al. Neisseria gonorrhoeae Antimicrobial Susceptibility Surveillance – The Gonococcal Isolate Surveillance Project, 27 Sites, United States, 2014. MMWR Surveill Summ 2016;65(7):1-19. [PMID: 27414503]

Kirkcaldy RD, Weinstock HS, Moore PC, et al. The efficacy and safety of gentamicin plus azithromycin and gemifloxacin plus azithromycin as treatment of uncomplicated gonorrhea. Clin Infect Dis 2014;59(8):1083-91. [PMID: 25031289]

Lau CY, Qureshi AK. Azithromycin versus doxycycline for genital chlamydial infections: a meta-analysis of randomized clinical trials. Sex Transm Dis 2002;29(9):497-502. [PMID: 12218839]

Lefebvre B, Martin I, Demczuk W, et al. Ceftriaxone-Resistant Neisseria gonorrhoeae, Canada, 2017. Emerg Infect Dis 2018;24(2). [PMID: 29131780]

Lin RY. A perspective on penicillin allergy. Arch Intern Med 1992;152(5):930-7. [PMID: 1580718]

Ljubin-Sternak S, Mestrovic T, Vilibic-Cavlek T, et al. In vitro susceptibility of urogenital Chlamydia trachomatis strains in a country with high azithromycin consumption rate. Folia Microbiol (Praha) 2013;58(5):361-5. [PMID: 23271498]

Lyss SB, Kamb ML, Peterman TA, et al. Chlamydia trachomatis among patients infected with and treated for Neisseria gonorrhoeae in sexually transmitted disease clinics in the United States. Ann Intern Med 2003;139(3):178-85. [PMID: 12899585]

Manhart LE, Gillespie CW, Lowens MS, et al. Standard treatment regimens for nongonococcal urethritis have similar but declining cure rates: a randomized controlled trial. Clin Infect Dis 2013;56(7):934-42. [PMID: 23223595]

Marcus JL, Kohn RP, Barry PM, et al. Chlamydia trachomatis and Neisseria gonorrhoeae transmission from the female oropharynx to the male urethra. Sex Transm Dis 2011;38(5):372-3. [PMID: 21183864]

Meyers BR. Comparative toxicities of third-generation cephalosporins. Am J Med 1985;79(2a):96-103. [PMID: 4025384]

New York City Department of Health and Mental Hygiene (NYCDHMH). 2016 Health Alert #32: Gonorrhea with Reduced Susceptibility to Azithromycin Increasing in New York City. 2016 Aug 9. https://www1.nyc.gov/assets/doh/downloads/pdf/std/han-gonorrhea-treatment.pdf [accessed 2018 Mar 2]

New York City Department of Health and Mental Hygiene (NYCDHMH). 2013 Alert #6: Gonorrhea with Reduced Susceptibility to Cephalosporins Isolated from New York City Residents. 2013. https://www.cdc.gov/std/gonorrhea/arg/nyc-health-alert-2013.pdf [accessed 2018 Mar 2]

New York State Department of Health (NYSDOH). Oral cephalosporins no longer recommended for treatment of gonococcal infections in the United States. 2012 Sep. https://www.health.ny.gov/diseases/communicable/std/docs/oral_cephalosporin_update.pdf [accessed 2018 Mar 2]

Novalbos A, Sastre J, Cuesta J, et al. Lack of allergic cross-reactivity to cephalosporins among patients allergic to penicillins. Clin Exp Allergy 2001;31(3):438-43. [PMID: 11260156]

Papp JR, Abrams AJ, Nash E, et al. Azithromycin Resistance and Decreased Ceftriaxone Susceptibility in Neisseria gonorrhoeae, Hawaii, USA. Emerg Infect Dis 2017;23(5):830-32. [PMID: 28418303]

Pegler S, Healy B. In patients allergic to penicillin, consider second and third generation cephalosporins for life threatening infections. Bmj 2007;335(7627):991. [PMID: 17991982]

Pichichero ME, Casey JR. Safe use of selected cephalosporins in penicillin-allergic patients: a meta-analysis. Otolaryngol Head Neck Surg 2007;136(3):340-7. [PMID: 17321857]

Pichichero ME. A review of evidence supporting the American Academy of Pediatrics recommendation for prescribing cephalosporin antibiotics for penicillin-allergic patients. Pediatrics 2005;115(4):1048-57. [PMID: 15805383]

Pottumarthy S, Fritsche TR, Jones RN. Activity of gemifloxacin tested against Neisseria gonorrhoeae isolates including antimicrobial-resistant phenotypes. Diagn Microbiol Infect Dis 2006;54(2):127-34. [PMID: 16423492]

Saxon A, Beall GN, Rohr AS, et al. Immediate hypersensitivity reactions to beta-lactam antibiotics. Ann Intern Med 1987;107(2):204-15. [PMID: 3300459]

Schwebke JR, Rompalo A, Taylor S, et al. Re-evaluating the treatment of nongonococcal urethritis: emphasizing emerging pathogens–a randomized clinical trial. Clin Infect Dis 2011;52(2):163-70. [PMID: 21288838]

Sena AC, Lensing S, Rompalo A, et al. Chlamydia trachomatis, Mycoplasma genitalium, and Trichomonas vaginalis infections in men with nongonococcal urethritis: predictors and persistence after therapy. J Infect Dis 2012;206(3):357-65. [PMID: 22615318]

Yates AB. Management of patients with a history of allergy to beta-lactam antibiotics. Am J Med 2008;121(7):572-6. [PMID: 18589051]

Follow-Up and Management of Treatment Failure

Sexually Transmitted Infections (STIs) Guideline Committee, March 2018

RECOMMENDATIONS
Post-Treatment Follow-Up
  • Clinicians should follow up with patients who have completed treatment for gonococcal and chlamydial infections as detailed in Table 3: Recommended Follow-Up after Completion of Treatment for Uncomplicated Gonococcal and Chlamydial Infection. (A3)
  • Clinicians should rescreen patients who had confirmed gonococcal or chlamydial infection at 3 months post-treatment for evidence of reinfection. (A2)
Retreatment of Uncomplicated Gonococcal Infection After Suspected Treatment Failure
  • Clinicians should re-treat cases of uncomplicated gonococcal infection following suspected treatment failure according to recommendations in Table 4: Recommended Retreatment Regimens after Suspected Failure of Treatment for Uncomplicated Gonococcal Infection. (A3)
New York State Reporting Requirement
  • Clinicians must report cases of suspected gonorrhea treatment failure that are not due to reinfection:
    • Report suspected treatment failures to the local health department within 24 hours.
    • Call 866-692-3641 to notify the health department of suspected treatment failures.

Post-Treatment Follow-Up

Table 3: Recommended Follow-Up after Completion of Treatment for Uncomplicated Gonococcal and Chlamydial Infection (Adapted from Centers for Disease Control and Prevention [CDC], 2015 [CDC 2015])
Gonococcal Infection
Clinical Circumstance Recommended Clinician Follow-Up

Asymptomatic after treatment with recommended regimen:

  • Urogenital or rectal infection treated with preferred or appropriate alternative regimens.
  • Pharyngeal gonorrhea treated with preferred regimen.
  • Retest at 3 months (or as close to 3 months as possible) post-treatment to assess for reinfection.
  • If laboratory test is positive for N. gonorrhoeae, assess for re-exposure and partner treatment, and re-treat with recommended regimen.

Asymptomatic after possibly ineffective course of treatment:

  • Urogenital or rectal infection treated with regimen other than preferred or alternative regimens.
  • Pharyngeal infection treated with an alternative regimen.
  • Suspected nonadherence to full course of treatment.
  • Assess for re-exposure and partner treatment.
  • Perform a test of cure at site of infection with N. gonorrhoeae nucleic acid amplification test (NAAT) 14 days after completion of treatment.
  • If test of cure is positive, perform culture and susceptibility testing before retreatment and re-treat with recommended regimen if possible.
  • If recommended regimen cannot be used, re-treat with an alternative regimen or according to susceptibility test results.
Symptomatic post-treatment: Persistent symptoms post-treatment; infection at any site.
  • Assess for re-exposure and partner treatment.
  • Assess patient adherence and use of preferred or appropriate alternative regimen.
  • Swab symptomatic site(s) for N. gonorrhoeae culture and antibiotic susceptibility testing ≥72 hours after treatment. NAAT may be obtained in addition to culture ≥7 days after treatment.
  • Re-treat for suspected treatment failure (see Table 4, below).
  • Assess for other sexually transmitted infections (STIs) that may cause persistent or recurrent symptoms.* For persistent or recurrent urethritis negative for N. gonorrhoeae and C. trachomatis, treat empirically for M. genitalium and/or T. vaginalis according to CDC recommendations [CDC 2015].
  • Assess for non-STI etiologies as part of the differential diagnosis if a patient is repeatedly symptomatic.
Chlamydial Infection
Clinical Circumstance Recommended Clinician Follow-Up
Asymptomatic after treatment with preferred or alternative regimen.
  • Retest at 3 months (or as close to 3 months a possible) post-treatment to assess for reinfection.
  • If laboratory test is positive for C. trachomatis, assess for re-exposure and partner treatment and re-treat with recommended regimen.
Symptomatic post-treatment: Persistent symptoms post-treatment; infection at any site.
  • Perform a test of cure at site of infection with C. trachomatis NAAT 3 weeks after treatment.
  • If test of cure is positive, assess for re-exposure and partner treatment, and re-treat with recommended treatment regimen using azithromycin or doxycycline. Azithromycin is preferred to maximize adherence.
  • If test of cure is negative, consider other STIs* that may cause persistent or recurrent symptoms.
  • Consider non-STI etiologies as part of the differential diagnosis when the patient is repeatedly symptomatic.
*Other STIs may include M. genitalium, T. vaginalis, herpes simplex virus, adenovirus, and enteric bacteria.

Retreatment After Suspected Treatment Failure

Table 4: Recommended Retreatment Regimens after Suspected Failure of Treatment for Uncomplicated Gonococcal Infection (Adapted from Centers for Disease Control and Prevention, 2015 [CDC 2015])
Clinical Circumstance Recommended Treatment
Possible reinfection (most cases). Ceftriaxone 250 mg by mouth in a single dose plus azithromycin 1 g by mouth in a single dose.
Low reinfection risk; initial treatment was incomplete or regimen administered was not preferred or alternative. Ceftriaxone 250 mg by mouth in a single dose plus azithromycin 1 g by mouth in a single dose.
Low reinfection risk; initial treatment with cefixime and azithromycin [CDC 2012]. Ceftriaxone 250 mg by mouth in a single dose plus azithromycin 2 g by mouth in a single dose.
Low reinfection risk; initial treatment with ceftriaxone 250 mg intramuscular (IM) and azithromycin 1 g by mouth. Gentamicin 240 mg IM or gemifloxacin 320 mg by mouth plus azithromycin 2 g by mouth in a single dose.
Reduced susceptibility to relevant antibiotics on antimicrobial susceptibility testing. Consult local health department.
Patient cannot follow above regimens due to allergies. Obtain clinical consultation with infectious disease specialist.

The majority of infections identified after treatment with one of the recommended regimens results from reinfection rather than from treatment failure [Kissinger et al. 2009; Hosenfeld et al. 2009]. Clinicians should consider the following when assessing patients for apparent treatment failure:

  • A patient may be reinfected by a new partner or an untreated current partner.
  • Treatment of the patient and partner may not have overlapped, allowing the infection to pass back and forth between partners.
  • Treatment may fail to eradicate organisms from the pharynx of the patient or partner [Ota et al. 2009].
KEY POINT
  • Gonococcal and chlamydial reinfection rates are high among people who have been successfully treated [Kissinger et al. 2009; Hosenfeld et al. 2009].

Test of cure for gonorrhea includes nucleic acid amplification test (NAAT) testing performed at least 2 weeks after treatment to avoid false-positive results and should also include culture and susceptibility testing when the purpose is to evaluate for cephalosporin-resistant N. gonorrhoeae (see Table 3: Recommended Follow-Up after Completion of Treatment for Uncomplicated Gonococcal and Chlamydial Infection, above). If the patient is symptomatic, culture and sensitivity may be performed after 3 to 5 days of treatment; however, NAAT testing should be delayed for at least 7 days after treatment. Test of cure for chlamydia includes NAAT testing at least 3 weeks after the course of treatment is finished [CDC 2015].

Because of current concerns regarding cephalosporin-resistant gonococcal infections, and the previous difficulty in eradicating pharyngeal gonococcal infections [Ota et al. 2009], a test of cure for pharyngeal infections treated with alternative therapy should be performed.

Surveillance data from the Centers for Disease Control and Prevention (CDC) have demonstrated patterns of isolates of gonococcal infection with increased minimum inhibitory concentrations (MICs) of oral cephalosporins that may indicate early stages of clinically significant cephalosporin resistance in the United States [CDC 2013]. Treatment failure should be considered in patients who report no sexual contact in the post-treatment period and have persistent symptoms for 3 to 5 days after appropriate treatment and/or a positive test of cure [CDC 2015]. Isolates from suspected treatment failures should be tested for antibiotic resistance [NYCDHMH 2013; Bolan et al. 2012]. Cephalosporin treatment failure should also be considered among patients with elevated cephalosporin MICs on antibiotic susceptibility testing (cefixime MIC ≥0.25 μg/mL or ceftriaxone MIC ≥0.125 μg/mL), even if the patient reports sexual activity in the post-treatment period [CDC 2012, 2015]. Cases of suspected treatment failure after completion of a recommended or alternate regimen and with a low risk of reinfection should be reported to the local health department.

Other sexually transmitted infections (STIs) should be considered in patients whose symptoms persist after appropriate treatment, especially when test of cure is negative. Urethritis, cervicitis, and proctitis caused by other sexually transmitted pathogens may be clinically indistinguishable from gonococcal and chlamydial infections. Mycoplasma genitalium is a common cause of urethritis in men, accounting for 10% to 35% of nongonococcal and nonchlamydial urethritis and up to 40% of cases of persistent urethritis after treatment with doxycycline [Taylor-Robinson and Jensen 2011; Jensen et al. 2016]. M. genitalium also has been associated with cervicitis and pelvic inflammatory disease among women [Lis et al. 2015; Falk et al. 2005]. Other pathogens to consider include T. vaginalis, herpes simplex virus, adenovirus, and enteric bacteria. Trichomoniasis or bacterial vaginosis may cause cervicitis, and syphilis or herpes simplex virus may cause proctitis. For additional information on diagnosis and management of other STIs that cause urethritis, cervicitis, and proctitis, refer to the CDC’s STD Guidelines.

Other pathogens that are not sexually transmitted may be responsible for continuing symptoms. For patients with persistent symptoms suggestive of gonococcal or chlamydial infection, assessment for non-STI etiologies, such as Reiter’s syndrome, strictures, hemorrhagic cystitis, or candidal urethritis, should be performed.

References

Bolan GA, Sparling PF, Wasserheit JN. The emerging threat of untreatable gonococcal infection. N Engl J Med 2012;366(6):485-7. [PMID: 22316442]

CDC. 2015 Sexually Transmitted Diseases Treatment Guidelines. 2015 Jun 4. https://www.cdc.gov/std/tg2015/default.htm [accessed 2018 Mar 2]

CDC. Antibiotic-Resistant Gonorrhea. 2013 Nov 15. https://www.cdc.gov/std/gonorrhea/arg/default.htm [accessed 2018 Mar 2]

CDC. Cephalosporin-resistant neisseria gonorrhoeae public health response plan. 2012 Aug. https://www.cdc.gov/std/treatment/ceph-r-responseplanjuly30-2012.pdf [accessed 2018 Mar 2]

Falk L, Fredlund H, Jensen JS. Signs and symptoms of urethritis and cervicitis among women with or without Mycoplasma genitalium or Chlamydia trachomatis infection. Sex Transm Infect 2005;81(1):73-8. [PMID: 15681728]

Hosenfeld CB, Workowski KA, Berman S, et al. Repeat infection with Chlamydia and gonorrhea among females: a systematic review of the literature. Sex Transm Dis 2009;36(8):478-89. [PMID: 19617871]

Jensen JS, Cusini M, Gomberg M, et al. Background review for the 2016 European guideline on Mycoplasma genitalium infections. J Eur Acad Dermatol Venereol 2016;30(10):1686-93. [PMID: 27605499]

Kissinger PJ, Reilly K, Taylor SN, et al. Early repeat Chlamydia trachomatis and Neisseria gonorrhoeae infections among heterosexual men. Sex Transm Dis 2009;36(8):498-500. [PMID: 19617870]

Lis R, Rowhani-Rahbar A, Manhart LE. Mycoplasma genitalium infection and female reproductive tract disease: a meta-analysis. Clin Infect Dis 2015;61(3):418-26. [PMID: 25900174]

New York City Department of Health and Mental Hygiene (NYCDHMH). 2013 Alert #6: Gonorrhea with Reduced Susceptibility to Cephalosporins Isolated from New York City Residents. 2013. https://www.cdc.gov/std/gonorrhea/arg/nyc-health-alert-2013.pdf [accessed 2018 Mar 2]

Ota KV, Fisman DN, Tamari IE, et al. Incidence and treatment outcomes of pharyngeal Neisseria gonorrhoeae and Chlamydia trachomatis infections in men who have sex with men: a 13-year retrospective cohort study. Clin Infect Dis 2009;48(9):1237-43. [PMID: 19323630]

Taylor-Robinson D, Jensen JS. Mycoplasma genitalium: from Chrysalis to multicolored butterfly. Clin Microbiol Rev 2011;24(3):498-514. [PMID: 21734246]

Sex Partner Exposure to HIV and Gonorrhea/Chlamydia

Sexually Transmitted Infections (STIs) Guideline Committee, March 2018

RECOMMENDATIONS AND REQUIREMENTS
Management of HIV Exposure in Sex Partners
  • Clinicians should educate patients with partners who do not have HIV or partners of unknown HIV status to be vigilant for any post-exposure acute HIV symptoms in their partners, such as febrile illness accompanied by rash, lymphadenopathy, myalgias, and/or sore throat. (A3)
  • Partners who present within 36 hours of an HIV exposure should be evaluated as soon as possible for initiation of post-exposure prophylaxis therapy. (A2)
Management of Partners Exposed to N. gonorrhoeae or C. trachomatis
  • Clinicians should advise their patients that sex partners who were exposed up to 60 days before the source case’s onset of symptoms or diagnosis of gonococcal or chlamydial infection should seek evaluation and treatment and HIV testing. (A2)
  • When a patient with HIV is diagnosed with gonorrhea or chlamydia, clinicians should advise the patient to encourage sex partners to seek medical care for possible exposure to HIV and gonorrhea and chlamydia and should inform the patient that NYSDOH Partner Services offers free, confidential partner notification assistance. (A2)
New York State Reporting Requirements
Expedited Partner Therapy

Management of HIV Exposure in Sex Partners

Presentation of a new STI in a patient with HIV suggests exposure of both HIV and the STI to their sex partner(s). However, offering non-occupational post-exposure prophylaxis (nPEP) to partners is usually not an option because the period before STI symptom onset is usually longer than the 36-hour window for initiating HIV nPEP. Therefore, clinicians should inform patients that any sex partner who does not have confirmed HIV infection should have sequential HIV testing for early identification of HIV acquisition. However, if a patient with an HIV exposure does present within 36 hours, evaluation for nPEP should occur.

When possible, onsite availability of HIV testing and STI treatment for partners is ideal because it may increase the likelihood that partners will receive timely access to HIV testing and appropriate treatment, including HIV post-exposure prophylaxis and treatment for the STI as needed (see the NYSDOH AI guideline PEP for Non-Occupational Exposure to HIV). Such strategies may also increase identification of individuals who require ongoing medical care. Partner education about reducing high-risk behaviors, including counseling about the use of barriers, such as male and female condoms, and making condoms visibly available in the clinic, may further decrease the risk of transmission of both HIV and other STIs.

Condoms, dental dams, and lubricants are available to non-profit organizations and healthcare facilities through the NYS Condom Program and can be ordered online. In NYC, free male and female condoms can be obtained through the NYC Free Condom Initiative, which includes a condom locator that can be downloaded to a smartphone. Patient handouts on how to properly use male and female condoms are available online through the NYSDOH publications office.

KEY POINTS: PATIENT EDUCATION
  • When a patient with HIV is diagnosed with gonococcal or chlamydial infection, the clinician should inform the patient about the implications of the diagnosis for his/her sex partner(s):
    • A new STI diagnosis signals that the patient was engaging in sexual behaviors that place any sex partner at increased risk of acquiring HIV, and sex partners should be tested for HIV.
    • A sex partner also may have been exposed to gonorrhea or chlamydia and should be tested and evaluated for treatment.
    • A local health department may contact sex partners confidentially about the potential exposure and treatment options.
  • Clinicians should provide patients with information and counseling about risk reduction and safer sex practices.

Management of Partners Exposed to N. gonorrhoeae or C. trachomatis

To prevent serial reinfection and curtail further transmission, sex partners of patients with gonococcal and chlamydial infections should be treated or referred for treatment if the sex partner was exposed within 60 days before symptom onset or diagnosis. No data are available regarding the optimal contact interval.

The NYS EPT policy allows healthcare providers who diagnose chlamydial infection in a patient to prescribe or provide prescription antibiotics to that patient’s sex partner(s) without examining the sex partner(s). However, EPT is not recommended for partners of patients with chlamydial infection who also have gonorrhea, syphilis, and/or HIV because partners should also receive medical care, including testing for STIs and HIV. For general information about EPT, see the CDC’s Expedited Partner Therapy. For information about EPT in NYS and NYC see the following: NYSDOH > Expedited Partner Therapy and NYC Health > Expedited Partner Therapy.

All Recommendations

Sexually Transmitted Infections (STIs) Guideline Committee, March 2018

ALL RECOMMENDATIONS: MANAGEMENT OF GONORRHEA AND CHLAMYDIA IN PATIENTS WITH HIV
Transmission and Prevention
  • Clinicians should inform patients with HIV about the risk of acquiring or transmitting chlamydia, gonorrhea, and other sexually transmitted infections (STIs) from close physical contact with all sites of possible exposure, including the penis, vagina, mouth, or anus. (A3)
Patient Education
  • When patients with HIV are diagnosed with gonococcal or chlamydial infections, clinicians should educate patients about the following:
    • Risk-reduction strategies, including the value of correct condom use. (A2)
    • The potential for oral transmission of gonorrhea and chlamydia. (A3)
    • The benefits of identifying STIs early. (A3)
    • The need for prompt evaluation and treatment of partners. (A3)
Screening Frequency
  • For men who have sex with men (MSM) and transgender women (individuals assigned male at birth but who identify as female) who have sex with men, clinicians should perform three-site screening (genital, pharyngeal, rectal) at the following intervals:
    • At first visit and annually thereafter if the patient is at low risk of infection. (A2)
    • At first visit and every 3 months thereafter if the patient is at high risk of infection. (A2)
      • See Box 2: Description of Risk Status for Sexual Exposure to Gonorrhea and Chlamydia.
  • For all other patients, clinicians should perform genital screening (urine/urethra, vagina/cervix) and extragenital screening (pharyngeal and/or rectal) at sites of contact at the following intervals:
    • At first visit and annually thereafter if the patient is at low risk of infection. (A2)
    • At first visit and every 3 months thereafter if the patient is at high risk of infection. (A2)
  • Clinicians should screen pregnant patients with HIV for gonococcal and chlamydial infections at the first prenatal visit. (A2)
Sexual History
  • Clinicians should ask all patients about sexual behaviors and new sex partners at each routine monitoring visit to assess for risk behaviors that indicate the need for repeat or ongoing screening. (A3)
Presentation of Symptomatic Infection
  • When patients with HIV present with symptoms suggestive of gonococcal or chlamydial infection, clinicians should perform diagnostic testing as recommended in Table 1, below. (A1)
  • Clinicians should include lymphogranuloma venereum (LGV) infection in the differential diagnosis for patients who test positive for rectal chlamydial infection or who present with such symptoms as rectal pain, tenesmus, bloody rectal discharge, or isolated, atypical perianal ulcerative lesions and adenopathy. (A2)
    • See the Centers for Disease Control and Prevention’s (CDC) guideline on LGV.
Laboratory-Based Diagnosis 
  • Clinicians should obtain nucleic acid amplification testing (NAAT) on samples collected from genital and extragenital sites (A1); if NAAT is not available, clinicians should:
    • Send alternative samples for culture in accordance with the protocols of the laboratory performing the analysis, with the understanding that culture is significantly less sensitive than NAAT. (A1)
  • If a patient has a known exposure to a cephalosporin-resistant strain of gonorrhea, clinicians should obtain samples for both culture/susceptibility and NAAT testing from the patient and his/her sex partner(s). (A3)
  • Clinicians should perform syphilis testing for any patient with HIV who is diagnosed with a gonorrheal or chlamydial infection. (A2)
    • For more information, contact the NYSDOH Wadsworth Center Laboratory at 1-518-474-4177.
Reporting
Treatment of Uncomplicated Gonococcal Infection
  • Clinicians should treat uncomplicated gonococcal infections of the cervix, urethra, rectum, or pharynx as follows:
    • Preferred: Ceftriaxone 250 mg intramuscular (IM) injection in a single dose plus azithromycin 1 g by mouth in a single dose. (A2)
    • Alternative, for patients who are allergic to azithromycin: Ceftriaxone 250 mg IM in a single dose plus doxycycline 100 mg by mouth twice daily for 7 days. (A2)
    • Alternative, if ceftriaxone is not available: Cefixime 400 mg by mouth in a single dose plus azithromycin 1 g by mouth in a single dose. This regimen is not recommended for treatment of pharyngeal infection. (A2)
  • Clinicians should instruct patients to abstain from sexual activity for at least 7 days after starting treatment, and to continue to abstain until symptoms resolve and all sex partners have completed treatment. (A2)
Treatment of Gonococcal Infection in Patients with Penicillin Allergy
  • For patients without prior severe allergic responses to penicillin (e.g., severe IgE-mediated response, such as anaphylaxis or urticaria with pruritic rash; or a severe non-IgE-mediated response, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug-induced hypersensitivity with inflammation of internal organs), clinicians should treat gonococcal infection with a cephalosporin-containing regimen, as recommended above, and monitor carefully for adverse effects. (A2)
  • For patients with prior severe allergic responses to penicillin, clinicians should treat gonococcal infection with a single dose of azithromycin 2 g by mouth plus a single dose of either gentamicin 240 mg IM or gemifloxacin 320 mg by mouth. (A2) 
Treatment of Uncomplicated Chlamydial and LGV Infections
  • Clinicians should treat uncomplicated chlamydial infection of the cervix, urethra, rectum, or pharynx as indicated in Table 2: Recommended Treatment for Uncomplicated Chlamydial and Lymphogranuloma Venereum (LGV) Infections. (A2)
  • Clinicians should treat symptomatic chlamydial proctitis with a medication regimen sufficient to treat lymphogranuloma venereum (LGV). (A3)
Post-Treatment Follow-Up
  • Clinicians should follow up with patients who have completed treatment for gonococcal and chlamydial infections as detailed in Table 3: Recommended Follow-Up after Completion of Treatment for Uncomplicated Gonococcal and Chlamydial Infection. (A3)
  • Clinicians should rescreen patients who had confirmed gonococcal or chlamydial infection at 3 months post-treatment for evidence of reinfection. (A2)
Retreatment of Uncomplicated Gonococcal Infection After Suspected Treatment Failure
  • Clinicians should re-treat cases of uncomplicated gonococcal infection following suspected treatment failure according to recommendations in Table 4: Recommended Retreatment Regimens after Suspected Failure of Treatment for Uncomplicated Gonococcal Infection. (A3)
New York State Reporting Requirement
  • Clinicians must report cases of suspected gonorrhea treatment failure that are not due to reinfection:
    • Report suspected treatment failures to the local health department within 24 hours.
    • Call 866-692-3641 to notify the health department of suspected treatment failures.
Management of HIV Exposure in Sex Partners
  • Clinicians should educate patients with partners who do not have HIV or partners of unknown HIV status to be vigilant for any post-exposure acute HIV symptoms in their partners, such as febrile illness accompanied by rash, lymphadenopathy, myalgias, and/or sore throat. (A3)
  • Partners who present within 36 hours of an HIV exposure should be evaluated as soon as possible for initiation of post-exposure prophylaxis therapy. (A2)
Management of Partners Exposed to N. gonorrhoeae or C. trachomatis
  • Clinicians should advise their patients that sex partners who were exposed up to 60 days before the source case’s onset of symptoms or diagnosis of gonococcal or chlamydial infection should seek evaluation and treatment and HIV testing. (A2)
  • When a patient with HIV is diagnosed with gonorrhea or chlamydia, clinicians should advise the patient to encourage sex partners to seek medical care for possible exposure to HIV and gonorrhea and chlamydia and should inform the patient that NYSDOH Partner Services offers free, confidential partner notification assistance. (A2)
New York State Reporting Requirements
Expedited Partner Therapy

How This Guideline Was Developed

Sexually Transmitted Infections (STIs) Guideline Committee (see below), March 2018

The New York State Department of Health (NYSDOH) AIDS Institute (AI) protects and promotes the health of New York State’s diverse population through disease surveillance and the provision of quality services for prevention, health care, and psychosocial support for those affected by HIV/AIDS, sexually transmitted infections, viral hepatitis, and related health concerns. In addition, the NYSDOH AI promotes the health of LGBT populations, substance users, and the sexual health of all New Yorkers.

Sexually Transmitted Infections Guidelines Committee

The NYSDOH AI charged the Sexually Transmitted Infections (STI) Guidelines Committee (see Box 4, below) with developing evidence-based clinical recommendations for primary care clinicians in NYS who treat individuals with gonorrhea or chlamydia and HIV coinfection. The purpose of the Management of Gonorrhea and Chlamydia in Patients with HIV clinical practice guideline is to aid primary care providers and other clinicians in New York State who manage the care of adult patients with HIV who are at risk of or diagnosed with gonorrhea or chlamydia coinfection.

Committee Makeup: Members of the STI Guidelines Committee (see Box 5, below) were appointed by the Medical Director of the NYSDOH AI to ensure representation of clinical practice in all major regions of the state, relevant medical disciplines and sub-specialties, key NYS agencies, community stakeholders, and patient advocates. Individuals confirmed as Committee members are required to disclose any potential conflicts of interest; disclosures are reviewed and approved by the NYSDOH AIDS Institute Office of the Medical Director (see the section on Funding and Financial Disclosure of Potential Conflicts of Interest, below).

Committee Role: Committee members actively participated in guideline development, reviewed and approved all recommendations, and reviewed and commented on the manuscript.

Committee Leadership: Working with a contractual medical writer, Celine Daly, MD, the STI Committee Chair and the Vice-Chair reviewed and refined the manuscript, facilitated consensus approval of all recommendations, and addressed feedback from committee members, peer reviewers, consumer reviewers, and members of the Medical Care Criteria Committee (MCCC), which is charged with developing clinical guidelines for the care of adults with HIV.

External review: Two external peer reviewers recognized for their experience and expertise in STI and HIV care were identified by program leaders (see Box 4, below). Peer reviewers were asked to review the guideline for accuracy, balance, clarity, and practicality of the recommendations for primary care providers. The Committee leadership addressed peer review feedback; any conflicting opinions were resolved by the Committee chairs. Members of NYSDOH AI Community Advisory Committee also reviewed and commented on the guideline.

Box 4: STI Guidelines Committee Leaders, Members (when this guideline was developed), and Guideline Reviewers

Leadership

  • Chair: Marguerite A. Urban, MD, University of Rochester Medical Center, Rochester, NY
  • Vice-Chair: Michael H. Augenbraun, MD, FACP, FIDSA  SUNY Downstate, Brooklyn, NY  
  • Acting Medical Director: Lyn Stevens, MS, NP, ACRN, New York State Department of Health AIDS Institute, Albany, NY
  • JHU Principal Investigator: Christopher J. Hoffmann, MD, MPH, Johns Hopkins University School of Medicine, Division of Infectious Diseases, Baltimore, MD

Contributing Members

  • Elizabeth Asiago-Reddy, MD, SUNY Upstate, Syracuse, NY
  • Gale R. Burstein, MD, MPH, FAAP, Erie County Department of Health, Buffalo, NY
  • Michael M. Gaisa, PhD, MD, Mount Sinai, New York, NY
  • Shelley Gilroy, MD, Albany Medical College, Albany, NY
  • Sachin Jain, MD, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY
  • Marla J. Keller, MD, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY
  • Anita P. LaSala, MD, Columbia University Medical Center, New York, NY
  • Robert Murayama, MD, MPH, Apicha Community Health Center, New York, NY
  • Michel Ng, NP, Mount Sinai School of Medicine, New York, NY
  • Thomas Panzella, PAC, HEAT/Downstate, Brooklyn, NY
  • Asa Radix, MD, MPH, FACP, AAHIVS, Callen-Lorde Community Health Center, New York, NY
  • David W. Rosenthal, DO, PhD, Northwell Health Physician Partners, Great Neck, NY
  • Heather M. Territo, MD, University at Buffalo-SUNY, Buffalo, NY

Agency, Consumer, and Program Liaisons

  • Bisrat K. Abraham, MD, NYC DOHMH, Long Island City, NY 
    New York City Department of Health and Mental Hygiene
  • Beatrice Aladin, MD, MPH, NYSDOH AI, New York, NY
    New York State Department of Health AIDS Institute Clinical Education Initiative
  • Richard Greene, MD, FACP, FIDSA, New York, NY
    New York City Health + Hospitals
  • David Martin, New York, NY
    New York State Department of Health AIDS Institute Consumer Advisory Committee
  • Tarek Mikati, MD, MPH, NYC DOHMH, Long Island City, NY 
    New York City Department of Health and Mental Hygiene

Medical Care Criteria Committee (Adult HIV guidelines) Reviewers

  • Chair: Samuel T. Merrick, MD, New York Presbyterian-Weill Cornell, New York, NY
  • Vice-Chair: Joseph P. McGowan, MD, FACP, FIDSA, North Shore University Hospital, Manhasset, NY
  • Chair Emeritus: Judith A. Aberg, MD, FIDSA, FACP, Icahn School of Medicine at Mount Sinai, New York, NY

Peer Reviewers

  • Anna Huang, MD, Bureau of STD Control, New York City Department of Health and Mental Hygiene, New York, NY
  • Allison Muse, MPH, Emerging Infections Program, New York State Department of Health, New York, NY

Johns Hopkins University (JHU) Editorial Role: The JHU editorial team coordinated, guided, and documented all Committee activities, and edited the guideline material for clarity, flow, and style.

AIDS Institute and JHU editorial and program management team:

  • Laura Duggan Russell, MPH, AIDS Institute Guidelines Program Coordinator
  • Mary Beth Hansen, MA, JHU Guidelines Project Director
  • Christina Norwood, MS, ELS, JHU Senior Editor
  • Johanna Gribble, MA, JHU Medical Editor
  • Jen Ham, MPH, JHU Medical Editor
  • Jesse Ciekot, JHU Program Coordinator

Funding and Disclosure of Potential Conflicts of Interest (COIs)

Funding: New York State funds supported development of the Management of Gonorrhea and Chlamydia in Patients with HIV guideline through a grant awarded to the Johns Hopkins University School of Medicine, Division of Infectious Diseases, from the New York State Department of Health AIDS Institute.

Conflicts of interest: All active STI Guidelines Committee members, invited consultants and coauthors, peer reviewers, and program staff are required to disclose financial relationships with commercial entities, including gifts that may be actual conflicts of interest or may be perceived as conflicts. These individuals must disclose financial relationships annually, for themselves, their partners/spouses, and their organization/institution. On their annual disclosures, STI Guidelines Committee members are asked to report for the previous 12 months and the upcoming 12 months. Box 5, below, lists reported conflicts.

Management of COIs: All reported financial relationships with commercial entities are reviewed by the NYSDOH AI guidelines program to assess the potential for undue influence on guideline recommendations made by the Committee. For the Committee members reporting potential conflicts, it was determined that the nature of the reported financial relationships with commercial entities would not pose undue influence on the guideline recommendations.

All guideline recommendations received consensus approval of the full STI Guidelines Committee, and the final review and approval of the recommendations was performed by the Committee Chair, and the NYSDOH AI Deputy Medical Director, none of whom reported conflicts of interest.

External peer reviewers were also required to submit conflict of interest/financial disclosure information, which were similarly screened. Neither peer reviewer reported conflicts.

Box 5: Reported Conflicts of Interest/Financial Disclosure Results
Committee Member’s Role  Disclosures
Vice-Chair Grant/research support: Starpharma Holdings Limited; Becton Dickinson
Contributor Speakers’ Bureau: Gilead
Contributor Pharmacy and Therapeutic Committee: Capital District Physicians’ Health Plan, Inc.; Research support: Gilead, KOWA Pharmaceuticals

Evidence Collection and Review and Rating of Recommendations

The NYSDOH AI guideline development process is based on a strategic search and analysis of the published evidence.

  • NYSDOH AI and STI Guidelines Committee defined the goal of the guideline: To provide evidence-based clinical recommendations for the management of gonorrheal and chlamydial infection in individuals with HIV.
  • JHU engaged a contractual medical writer and researcher, Celine Daly, MD, to conduct an extensive literature search in PubMed using MeSH terms, with the goal of identifying studies of human subjects published in English within the previous 5 years.
  • The medical writer reviewed and summarized the evidence related to guideline recommendations, updated the text of the guideline, and submitted it for review and approval of the STI committee leadership, the MCCC leadership, and the full STI committee.
  • Once consensus was reached on all recommendations, four committee members independently assigned a two-part rating to each recommendation to indicate the strength of the recommendation and the quality of the supporting evidence (see below). Raters then reviewed evidence and ratings collectively to reach consensus on each rating.
  • NYSDOH AI will publish a comprehensive update 5 years after the original publication date.
AIDS Institute HIV Clinical Guidelines Program Recommendations Rating Scheme
Strength of Recommendation Quality of Supporting Evidence
A = Strong 1 = At least 1 randomized trial with clinical outcomes and/or validated laboratory endpoints
B = Moderate 2 = One or more well-designed, nonrandomized trial or observational cohort study with long-term clinical outcomes
C = Optional 3 = Expert opinion

Guideline Updates

Clinical Guideline Program committee members will monitor developments in the management of gonorrhea and chlamydia in patients with HIV in an ongoing structured manner to maintain guideline currency. Once the guidelines are published on the program website: www.hivguidelines.org, any updates will be made to the HTML document as needed as new peer reviewed literature on the management of gonorrhea and chlamydia in general and in the setting of HIV infection specifically is published. The full guideline will be reviewed and updated on the 4th anniversary of original publication to prepare for publication of an updated guideline on or before the 5th anniversary of original publication.

Updates to This Guideline

Sexually Transmitted Infections (STIs) Guideline Committee, March 2018

June 2019

Azithromycin 1 gm by mouth as a single dose once weekly for 3 weeks was added as an alternative regimen for treatment of symptomatic proctitis. Go to the updated page.

March 2018

The March 2018 edition of this guideline reflects a comprehensive revision and replaces entirely all previous editions.