Sexually Transmitted Infections

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1 Quick Reference Quick Reference Quick Reference Quick Reference Quick Reference Quick Reference Quick Reference Quick Reference Quick Reference Quick Reference Quick Reference Quick Reference Quick Reference Quick Reference Quick Reference Quick Reference Quick Reference Quick Reference Quick Reference Quick Reference Quick Reference Quick Reference Quick Reference Quick Reference Quick Reference Quick Reference Quick Reference Quick Reference Quick Reference Quick Reference Quick Reference Canadian Guidelines on Sexually Transmitted Infections 2006 E D I T I O N S y p h i l i s H I V C h l a m y d i a H e r p e s H P V G o n o r r h e a L G V S y p h i l i s H I V C h l a m y d i a H e r p e s H P V G o n o r r h e a L G V S y p h i l i s H I V C h l a m y d i a H e r p e s H P V G o n o r r h e a L G V S y p h i l i s H I V C h l a m y d i a H e r p e s H P V G o n o r r h e a L G V S y p h i l i s H I V

2 Our mission is to promote and protect the health of Canadians through leadership, partnership, innovation and action in public health. Public Health Agency of Canada Revised edition of the Highlights 1998 Edition of the Canadian STD Guidelines. This publication can be made available in alternative formats upon request, and can also be found on the Internet at the following address: Disponible en français sous le titre : L essentiel Lignes directrices canadiennes sur les infections transmissibles sexuellement édition Correspondence: Sexual Health and Sexually Transmitted Infections Section Community Acquired Infections Division Infectious Disease and Emergency Preparedness Branch Public Health Agency of Canada Ottawa, Ontario K1A 0K9 Fax: (613) PHAC_Web_Mail@phac-aspc.gc.ca HER MAJESTY THE QUEEN IN RIGHT OF CANADA (2006) Catalogue number: HP40-1/2006-1E ISBN

3 PREFACE This document is not intended for use in the clinical investigation of prepubertal children. Please refer to the Sexual Abuse chapter in the complete Canadian Guidelines on Sexually Transmitted Infections 2006 Edition. For more detailed treatment recommendations, including those for children, pregnant or nursing mothers, or those with HIV co-infection, please refer to the complete STI guidelines. The recommendations presented in this document reflect the views of the Expert Working Group on Canadian Guidelines for Sexually Transmitted Infections. They should be construed not as rules but rather as recommendations. The advice and recommendations set out in this document are based upon the best current available scientific knowledge and medical practices. Persons administering or using drugs, vaccines or other products should also be aware of the contents of the individual product monograph(s) for those products, or other similarly approved standards or instructions for use provided by the licensed manufacturer(s). Recommendations for use and other information set out in these guidelines may differ from that set out in product monograph(s) or other similarly approved standards or instructions for use. Manufacturers have sought approval and provided evidence as to the safety and efficacy of their products only when used in accordance with the product monograph(s) or other similarly approved standards or instructions for use. Practitioners should report adverse drug reactions to the Canadian Adverse Drug Reaction Monitoring Program (CADRMP). For specifications and standards of reporting, consult Health Canada s CADRMP guidelines. This document includes levels of recommendation and quality of evidence indicators for the treatment recommendations. The indicators used reflect a combination of the methodologies from the U.S. Preventive Services Task Force and the Canadian Task Force on Preventive Health Care and have been modified and simplified for use in these guidelines (See Level and Quality of Evidence for Treatment Recommendations page 23). Preface

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5 Quick Reference Canadian Guidelines on Sexually Transmitted Infections 2006 Edition What s Inside Introduction to STI 4 STI Risk Factors 6 Patient History and Risk Assessment 7 The Physical Exam 8 Your Patient Has (STI Syndromes) No symptoms but Risk 10 Epididymitis 11 Genital Ulcer Disease (GUD) 12 Intestinal Symptoms 14 Mucopurulent Cervicitis 16 Papular Genital Lesions 18 Pelvic Inflammatory Disease (PID) 19 Urethritis 21 Vaginal Discharge 22 Treatment Recommendations Introduction 23 Level and Quality of Evidence for Treatment Recommendations 23 Statement on Quinolone Resistant N. gonorrhoeae 24 Bacterial Vaginosis 25 Candidiasis 26 Chancroid 27 Chlamydia 27 Epididymitis 28 External Genital Warts (HPV) 28 Genital Herpes (HSV) 29 Gonorrhea 30 Granuloma Inguinale 30 Hepatitis B (HBV) 31 Human Immunodeficiency Virus (HIV) 31 Lymphogranuloma Venereum (LGV) 31 Pelvic Inflammatory Disease (PID) 32 Pubic Lice/Scabies 32 Syphilis 33 Trichomoniasis 34 Partner Notification 35 Follow-up Recommendations 37 Interpretation of Serologic Tests for Syphilis 40 Post-treatment Monitoring of Non-Treponemal Tests (NTTs) 41 Management of Sexual/ Percutaneous/Mucosal Exposure to Infected HBsAg-Positive Individuals or High Risk Source 42 Algorithms Syndromic Management of Urethritis 43 Gram Stain Results Available 44 Minimum Screening and Treatment Recommendations for Anogenital or al Ulcers 45 Additional Testing Recommendations for Rare Causes of Genital Ulcer Disease 46 Syndromic Management of Vaginal Discharge 47 Vaginal Discharge - Microscopy Results available 48 Management of Cervicitis 49 Table of Contents 3

6 Introduction to STI Did you know? Chlamydia is the most common bacterial STI in Canada and across the world. Human papillomavirus (HPV) is estimated to be the most prevalent STI in Canada. Having an STI can significantly increase the risk of acquiring HIV. Since 1997, there has been a steady increase in the rates of chlamydia, gonorrhea and syphilis. Primary prevention aims to prevent exposure by identifying at-risk individuals and performing thorough assessments, patient-centred counselling and education. Secondary prevention involves reducing the prevalence of STIs through the detection of infections in at-risk populations, counselling, conducting partner notification and treating infected individuals in a timely manner, thus preventing and/or limiting further spread. Diagnosis of a syndrome according to standard criteria predicts the likelihood that a specific pathogen or pathogens is/are present and thus facilitates initiation of appropriate empiric treatment at the first visit rather than deferring treatment until there is microbiological confirmation. Although an infection may be suspected because of disease in a partner or the presence of another STI, the infection may be diagnosed only by using a specific laboratory test. In managing STIs, diagnosis by syndrome and laboratory diagnosis by testing for specific organisms are both important and complementary. Consult the chapters of the Management and Treatment of Specific Infections section in the STI guidelines for details on the diagnosis, treatment and management of specific infections. 4 Introduction to STI

7 This document contains recommendations for treatment, partner notification and follow-up of sexually transmitted infections without complications including: Bacterial Chancroid (Haemophilus ducreyi) Chlamydia (Chlamydia trachomatis) Gonorrhea (Neisseria gonorrhoeae) Granuloma Inguinale (Klebsiella granulomatosis) Lymphogranuloma Venereum (Chlamydia trachomatis L1-L3) Syphilis (Treponema pallidum) Viral Hepatitis B virus (HBV) Herpes simplex virus (HSV) Human immunodeficiency virus (HIV) Human papillomavirus (HPV) Ectoparasitic Pubic Lice Scabies Introduction to STI 5

8 STI risk factors Identifying the index of suspicion of STI in a patient requires the health care practitioner to understand the epidemiologic trends of STIs, as well as the risk factors associated with STI transmission and infection. Who s at risk? The following risk factors are associated with increased incidence of STI: Sexual contact with person(s) with a known STI Sexually active and under 25 years of age A new sexual partner or more than two sexual partners in the past year Serially monogamous individuals who have one partner at present but who have had a series of one-partner relationships over time No contraception or sole use of non-barrier methods of contraception such as oral contraceptives (OCP) Depo Provera (Depo), or intrauterine devices (IUD) Injection drug use Other substance use such as alcohol or chemicals (pot, cocaine, ecstasy, crystal meth), especially if associated with having sex Any individual who is engaging in unsafe sexual practices (i.e. unprotected oral, genital or anal sex; sex with blood exchange including sadomasochism (S&M); sharing sex toys) Sex workers and their clients Survival sex, exchanging sex for money, drugs, shelter or food Street involvement, homelessness Anonymous sexual partnering (i.e. Internet, bath house, rave party) Victims of sexual assault/abuse Previous STI STI Risk Factors

9 PATIENT HISTORY AND RISK ASSESSMENT Taking a Brief History The aim is to quickly identify or rule out major risk factors associated with an increased risk of STI. Use of a script such as the one below may be helpful in rapidly assessing your patient s risk. Part of my job is to assess sexual and reproductive health issues. Of course, everything we talk about is completely confidential. If it is OK with you, I would like to ask you a few questions. Are you sexually active now, or have you been sexually active? This includes oral sex or anal sex, not just vaginal sex. Do you have any symptoms that might make you think that you have an STI? (Do you have any sores on or around your genitals? Does it hurt or burn when you pee? Have you noticed an unusual discharge from your penis, vagina or anus? Do you have pain during sex?) What are you doing to avoid pregnancy? (Do you or your partner use any type of birth control?) What are you doing to avoid STI including HIV? Do you have any concerns about sexual or relationship violence or abuse? Have you or your partner(s) used injection or other drugs (i.e. crystal meth)? For women also ask: When was your last menstrual period? When was your last Pap test? Any patient whose current or past history identifies a potential risk factor for STI should have a more detailed history completed along with appropriate patient centred counselling. Refer to the Primary Care and Sexually Transmitted Infections chapter of the complete STI guidelines. Patient History and Risk Assessment 7

10 The Physical Exam General assessment: Look for systemic signs and symptoms of STI Weight loss Fever Enlarged lymph nodes Palpate inguinal lymph nodes Inspect mucocutaneous regions Inspect external genitalia for Cutaneous lesions Inflammation Genital discharge Anatomical irregularities Perianal inspection Consider anoscopy (or digital rectal exam) if history of anal sex AND anal symptoms Males: Palpate scrotal contents Retract foreskin (if present) for glans inspection Have patient milk the urethra to make any discharge more apparent Females: Separate labia to visualize the vaginal orifice Perform an illuminated speculum exam to: Visualize the cervix and vaginal walls Evaluate endocervical and vaginal discharges Bimanual pelvic examination Obtain specimens for laboratory testing as indicated. The Physical Exam

11 The Physical Exam Specimen collection for women undergoing a pelvic examination When using a combination of culture and NAAT testing 1. Endocervical swab for Gram stain (if available and if either cervicitis or vaginitis are suspected) and gonorrhea culture* 2. Endocervical swab for chlamydia NAAT 3. Pap smear using spatula for ectocervix and/or cytobrush for endocervix NAAT=nucleic acid amplification test Pap=Papanicolaou * If using NAAT for both chlamydia and gonorrhea the order of the swabs does not matter. In cases where transport and storage conditions are not conducive to maintaining the viability of N. gonorrhoea substitute with NAAT; culture is preferred as it allows for antimicrobial susceptibility testing. Specimen collection for men When using a combination of culture and NAAT testing 1. Urethral swab for Gram stain (if available) and gonorrhea culture* 2. FCU for chlamydia for NAAT NAAT= nucleic acid amplification test FCU=first catch urine * Substitute with FCU for gonorrhea (NAAT) in cases where transport and storage conditions are not conducive to maintaining the viability of N. gonorrhoea or a swab is not possible; culture is preferred as it allows for antimicrobial susceptibility testing. The Physical Exam

12 Your patient has No Symptoms, but is at Risk Symptoms None What could it be/etiology? Any STI Chlamydia Gonorrhea Syphilis HSV 1 or HSV 2 HPV HIV Viral hepatitis (HAV, HBV, HCV) Testing Vaginal swab or Endo-cervical swab or Urethral swab or First catch urine for Chlamydia and Gonorrhea Serology for Syphilis HIV HBV (if not immunized) HAV immunity (especially if history of oral-anal contact) HCV (if history of sharing injection drug or snorting equipment, non-sterile tattooing and/or body piercing equipment) Pap testing (if indicated as per local or provincial/territorial recommendations) Treatment As per test results Presumptive treatment for gonorrhea, chlamydia or syphilis may be indicated if the individual is a named sexual contact of a confirmed case 10 Your Patient Has

13 Your patient has Epididymitis Signs and symptoms Unilateral testicular pain/swelling (may occasionally be bilateral) Erythema and edema of overlying skin possible +/- urethral discharge Fever What could it be/etiology? Sexually transmitted Chlamydia Gonorrhea Not sexually transmitted Coliforms Pseudomonads Testicular torsion should be considered in all cases, as it is a surgical emergency. Torsion is more likely if onset of pain is sudden and the pain is severe. Specimen collection and testing Urethral swab for Gram stain and culture for gonorrhea First catch urine for chlamydia NAAT (may also test for gonorrhea using FCU where available) Midstream urine for culture and sensitivity and microscopy if available (enteric organisms coliforms) Urinalysis Doppler ultrasound if testicular torsion suspected Treatment Based on likelihood of whether infection is sexually transmitted (chlamydia, gonorrhea) or not (coliforms, pseudomonads). If sexual transmission is suspected, treat empirically for chlamydia and gonorrhea (if Gram stain is available can treat for chlamydia and/or gonorrhea, based on results). If sexual transmission is not suspected, treat empirically for coliforms and pseudomonads. Your Patient Has

14 Your patient has Genital Ulcer Disease (GUD) Signs and symptoms Anogenital region: Ulcers (erosive or pustular) Vesicles Papules +/- inguinal lymphadenopathy +/- systemic symptoms (fever, myalgia) +/- urinary symptoms (hesitation, dysuria) What could it be/etiology? Genital Herpes (HSV 1, HSV 2) Lesions tend to be grouped and painful with an erythematous base Fever and malaise common with primary infection Syphilis Chancre is classically single, painless, and indurated with a serous exudate LGV Small, painless papule at site of inoculation (vulva, vagina, penis, rectum, oral cavity, occasionally cervix), which may ulcerate Chancroid Painful, purulent, shallow ulcers with a granulomatous base that readily bleeds Granuloma Inguinale Single or multiple progressive ulcerative lesions, highly vascular (beefy red appearance) that bleed easily on contact Specimen collection and testing for all patients with anogenital ulcers Swab of lesion, ulcer or fluid from vesicle for HSV testing (culture/naat) and for dark field microscopy or FA for T. pallidum (where available). Serology for syphilis: Non-treponemal test (RPR/VDRL) and Treponemal test (MHA-TP/TP-PA/FTA-ABS) or treponemal specific EIA In cases suspected of having primary syphilis, repeat syphilis screening in 2 4 weeks if initially negative (Refer to the algorithm Minimum Screening and Treatment Recommendations for Anogenital or al Ulcers ). Recommend HIV testing if not already completed. Check Hepatitis B vaccination status and offer vaccine if no previous history of vaccine or evidence of immunity. 12 Your Patient Has

15 Your patient has Genital Ulcer Disease (continued) Assess for common risk factors for rare causes of GUD MSM, especially linked to anonymous partnering Self or partner HIV+ Self or partner had sex while travelling in a country/region where the infection is endemic Additional testing considerations for patients with GUD Depending on history and physical findings consider testing for: LGV Chancroid Granuloma inguinale Treatment of anogenital ulcers If HSV is suspected, consider empiric treatment while awaiting results. If syphilis is suspected, consider empiric treatment if follow-up is not assured, otherwise wait for results. If LGV is suspected, consider empiric treatment. If chancroid is suspected, treat empirically. If granuloma inguinale is suspected consider empiric treatment. If results are negative and lesions persist, biopsy may be required to rule out non-sti related causes of genital ulcer disease (GUD). Your Patient Has 3

16 Your patient has Intestinal Symptoms Signs and symptoms Mucopurulent rectal discharge Anorectal pain Constipation or diarrhea Bloody stools Nausea Abdominal pain/cramps Bloating Fever What could it be/etiology? Proctitis (inflammation of rectal mucosa) Gonorrhea Chlamydia (including LGV) Syphilis HSV Proctocolitis (inflammation of rectal mucosa and colon) LGV Entamoeba histolytica Campylobacter species Salmonella species Shigella species Enteritis (inflammation of small bowel) Giardia lamblia Specimen collection and testing Based on history and clinical picture. Anoscopic evaluation should be performed for patients presenting with symptoms of proctitis. Rectal swab for gonorrhea culture and chlamydia culture (although NAAT to detect rectal chlamydia is used in the diagnostic investigation of LGV, this use is not officially approved in Canada). If initial chlamydia culture is positive send for RFLP (restriction fragment length polymorphism) or DNA sequencing to identify LGV serovars. Stool for culture, and examination for ova and parasites. 14 Your Patient Has

17 Your patient has Intestinal Symptoms (continued) If lesions are present Swab for HSV Syphilis serology as dark-field microscopy and fluorescent antibody tests are not reliable for rectal lesions Treatment Based on history and clinical picture If anorectal discharge, treat for gonorrhea and chlamydia. If LGV is suspected, consider empiric treatment. If syphilis is suspected and follow-up is not assured, treat for syphilis. Consider treating for HSV if characteristic lesions are present. With suspected or proven enteric pathogen treat according to the specific pathogen. Your Patient Has 5

18 Your patient has Mucopurulent Cervicitis Signs and symptoms Mucopurulent cervical discharge Cervical friability Cervical erythema Strawberry cervix What could it be/etiology? Chlamydia Gonorrhea Trichomoniasis HSV Other possible causes: Bacterial vaginosis Mycoplasma genitalium Cytomegalovirus Streptococcus species Irritants such as chemical douches or spermicides Specimen collection and testing Endo-cervical swab for: Gram stain for Gram negative diplococci Gonorrhea culture or naat Chlamydia naat Vaginal swab for: Gram stain Wet mount (if available) Consider testing for HSV if lesions are present. Although not a sensitive test, Gram stain may be helpful in diagnosing mucopurulent cervicitis and gonorrhea in symptomatic females. Note: a diagnosis of mucopurulent cervicitis cannot be given to a pregnant woman due to the increase in normal vaginal discharge and the changes of the cervix during pregnancy. 16 Your Patient Has

19 Your patient has Mucopurulent Cervicitis (continued) Treatment If no microscopy results are available or if microscopy results are negative and the patient is symptomatic: Does the patient have any of the following risk factors? < 25 years of age or Have a new partner or have had more than 2 partners in the past year or HIV positive or Partner is symptomatic or Unlikely to return for follow-up If Yes to any treat immediately for chlamydia and consider treatment for gonorrhea if the local prevalence is high or if sexual contact occurred in a region with a high prevalence. If NO to all defer treatment until results are available. If positive treat accordingly. Mucopurulent Cervicitis: Microscopy Results Available For all patients If Gram stain and wetmount results are available and follow-up is assured treat according to microscopic findings If follow-up is not assured consider adding treatment for chlamydia and possibly treatment for gonorrhea if the local prevalence is high or if sexual contact occurred in a region with a high prevalence. Refer to the algorithm Management of Cervicitis. Your Patient Has 7

20 Your patient has Papular Genital Lesions Signs and symptoms Growths in anogenital region including mucous membranes Growths may be: Multiple Polymorphic Asymmetric Non-inflammatory May be accompanied by: Pruritis Bleeding Obstruction (urethral, vaginal rare finding) What could it be/etiology? Human papillomavirus (HPV) Molluscum contagiosum Skin tags Cancer Normal variation Clinical evaluation and specimen collection Visual examination Anal and/or vaginal examination Consider a Pap test if appropriate Treatment If single or multiple asymmetric, cauliflower-like lesions treat as HPV. If round, umbilicated papule treat as molluscum contagiosum. If flat, asymmetric lesions consider secondary syphilis and test and treat appropriately. If chronic lesion, with ulceration or pigmentation consider carcinoma and refer to a specialist for diagnosis and management. 18 Your Patient Has

21 Your patient has Pelvic Inflammatory Disease (PID) Signs and symptoms Lower abdominal pain Deep dyspareunia Abnormal vaginal bleeding Systemic symptoms (fever) What could it be/etiology? Usually considered a polymicrobial infection including: Gonorrhea Chlamydia HSV Trichomoniasis Genital tract mycoplasmas Other aerobic and anaerobic bacteria Clinical evaluation and specimen collection Assess for the presence of: Lower abdominal tenderness Adnexal tenderness Cervical motion tenderness Temperature > 38.3 C Laboratory testing: Stat serum beta HCG to rule out ectopic pregnancy Vaginal swab for wetmount, Gram stain and culture Endo-cervical swab for gonorrhea and chlamydia (and possibly HSV, if cervical lesions present) Transvaginal sonography (or other imaging) Erythrocyte sedimentation rate C-reactive protein Endometrial biopsy Laparoscopy (Gold Standard) Your Patient Has

22 Your patient has Pelvic Inflammatory Disease (continued) Criteria for hospitalization Surgical emergencies such as appendicitis cannot be excluded The patient is pregnant The patient does not respond clinically to oral antimicrobial therapy The patient is unable to follow or tolerate an outpatient oral regimen The patient has severe illness, nausea and vomiting, or high fever The patient has a tubo-ovarian abscess Consider hospitalization for observed oral or parenteral therapy in the following cases: HIV infection Youth/adolescents (particularly if compliance is an issue) Treatment Early diagnosis and treatment are crucial to the maintenance of fertility. An appropriate antibiotic therapy should be administered orally or parenterally in an inpatient or outpatient setting (refer to the complete STI guidelines). May need to consider hospitalization. Careful follow-up is required (refer to Follow-up Recommendations section). 20 Your Patient Has

23 Your patient has Urethritis (Males Only) Signs and symptoms Urethral discharge Burning with urination Irritation of the distal urethra or meatus Meatal erythema What could it be/etiology? Gonorrhea Chlamydia Other possible causes: Trichomonas vaginalis Herpes simplex virus Mycoplasma genitalium Ureaplasma urealyticum Specimen collection and testing Urethral swab for Gram stain (if available) and culture/naat for gonorrhea First catch urine for chlamydia NAAT (may also be used to test for gonorrhea where available) Treatment If discharge is present and no Gram stain results are available. Treat immediately for chlamydia and consider treatment for gonorrhea if the local prevalence is high or if sexual contact occurred in a region with a high prevalence. Gram stain results available Patient is symptomatic For patients presenting with symptoms treat for urethritis due to chlamydia and/or gonorrhea depending on results. Refer to the algorithm Management of Urethritis Gram stain results available. For recurrent symptoms refer to the complete STI guidelines. Patient is asymptomatic For patients presenting with no symptoms, treat depending on results. Refer to algorithm Management of Urethritis Gram stain results available. Your Patient Has 21

24 Your patient has Vaginal Discharge (in the absence of mucopurulent cervical discharge or other signs of cervicitis) Signs and symptoms Vaginal discharge Vaginal odour Vaginal/vulvar pruritis Vaginal/vulvar erythema Dysuria What could it be/etiology? Bacterial vaginosis White or grey, thin, copious discharge Fishy odour External dysuria Candidiasis White, clumpy, curdy discharge Vulvar/vaginal erythema and edema Trichomoniasis Off-white or yellow, frothy discharge Erythema of vulva and cervix ( strawberry cervix) Chlamydia* Gonorrhea* * Causes of vaginal discharge and not of vaginitis, although co-infection with vaginitis is always possible. Specimen collection and testing If low risk for STI: Vaginal swab for ph test and Gram stain Vaginal swab for wet-mount/amine odour on whiff test If higher risk for STI: As above and Endo-cervical swab/fcu for chlamydia and gonorrhea Treatment According to the clinical picture and microscopy test results (if available refer to the algorithm Vaginal Discharge Microscopy results available ). If higher risk and follow-up not assured consider treating for chlamydia, +/- gonorrhea,* trichomonas and bacterial vaginosis (refer to the algorithm Syndromic Management of Vaginal Discharge ). * Consider treatment for gonorrhea where local prevalence is high or if sexual contact occurred in a region with a high prevalence. 22 Your Patient Has

25 Treatment Recommendations The following section provides treatment recommendations for specific pathogens. They represent the recommendations for treatment of uncomplicated infections in the non-pregnant, non-lactating adult. For more detailed treatment recommendations, including those for children, pregnant or nursing mothers, or those with HIV co-infection, please refer to the complete Canadian Guidelines on Sexually Transmitted Infections 2006 Edition. Levels of treatment recommendation (Modified from Harris RP, et al 1 ) A B C D I Strongly recommends that clinicians routinely provide the treatment to eligible patients. Good evidence that the treatment improves important health outcomes and concludes that benefits substantially outweigh harms. Recommends that clinicians routinely provide the treatment to eligible patients. At least fair evidence that the treatment improves important health outcomes and concludes that benefits outweigh harms. No recommendation for or against routine provision of the treatment. At least fair evidence that the treatment can improve health outcomes but concludes that the balance of the benefits and harms is too close to justify a general recommendation. Recommends against routinely providing the treatment to asymptomatic patients. At least fair evidence that the treatment is ineffective or that harms outweigh benefits. Evidence is insufficient to recommend for or against routinely providing the treatment. Evidence that the treatment is effective is lacking, of poor quality or conflicting, and the balance of benefits and harms cannot be determined. 1. Harris RP, Hefland M, Woolf SH, et al. Current methods of the US Preventive Services Task Force: a review of the process. Am J Prev Med 2001;20(3 suppl): Quality of evidence indicators for treatment recommendations (Modified from Harris RP, et al 1 and Gross PA, et al 2 ) I II III Evidence from at least one properly randomized, controlled trial Evidence from at least one well-designed clinical trial without randomization, from cohort or case-control analytic studies (preferably from more than one centre), from multiple time-series studies or from dramatic results in uncontrolled experiments Evidence from opinions of respected authorities based on clinical experience, descriptive studies or reports of expert committees 1. Harris RP, Hefland M, Woolf SH, et al. Current methods of the US Preventive Services Task Force: a review of the process. Am J Prev Med 2001;20(3 suppl): Gross PA, Barrett TL, Dellinger EP, et al. Purpose of quality standards for infectious diseases. Infectious Diseases Society of America. CIin Infect Dis 1994;18:421. Treatment Recommendations 23

26 Treatment Recommendations Statement on quinolone resistant N. gonorrhoeae Quinolones are not recommended if the case or contact are from, or are epidemiologically linked to, any area with rates of quinolone-resistant N. gonorrhoeae >3 5%: Asia Pacific Islands (including Hawaii) India Israel Australia United Kingdom Regions of the United States (check with the U.S. Centers for Disease Control and Prevention for rates of quinolone resistance by geographic area) MSM with contact or epidemiologically linked to the United States Areas in Canada experiencing high rates of quinolone resistance; current numbers provided by the National Microbiology Laboratory place Quebec, Ontario, Alberta and British Columbia above the 3% threshold for quinolone resistance (see see the Gonococcal Infections chapter, under the Epidemiology section, in the complete STI guidelines for an explanation on national and regional quinolone resistance rates). Please check with your local public health officials to learn about quinolone resistance in your area. In Alberta all ciprofloxacin resistant cases in were in MSM or linked to travel outside of Alberta, therefore ciprofloxacin remains a recommended agent for the treatment of gonorrhea in Alberta except in these situations (source: Alberta Health and Wellness STD Services). For data on national quinolone resistance in Canada, please visit the Public Health Agency of Canada website ( 24 Treatment Recommendations

27 Treatment Recommendations Bacterial Vaginosis Symptomatic Preferred Metronidazole 500mg PO bid for 7 days [A-I] Metronidazole gel 0.75%, one applicator (5 g) once a day intravaginally for 5 days [A-I] Clindamycin cream 2%, one applicator (5 g) once a day intravaginally for 7 days [A-I] (caution: oil based ovules and creams may cause latex condoms or diaphragms to fail) Alternatives Metronidazole 2 g PO in a single dose [A-I] (but higher relapse rate) Clindamycin 300 mg PO bid for 7 days [A-I] Asymptomatic Treatment is unnecessary except in cases of: High-risk pregnancy (history of preterm delivery) Prior to IUD insertion Prior to gynecologic surgery, therapeutic abortion or upper tract instrumentation Recurrent Bacterial Vaginosis Metronidazole 500 mg PO bid for days [B-III] Metronidazole gel 0.75%, one applicator (5 g) once a day intravaginally for 10 days, followed by suppressive therapy of metronidazole gel twice a week for 4 6 months [B-III] Note: Patients should not drink alcohol during and for 24 hours after oral therapy with metronidazole because of a possible disulfiram (antabuse) reaction. Treatment Recommendations 25

28 Treatment Recommendations Candidiasis Symptomatic Intravaginal over-the-counter azole ovules and creams as directed [A-I] (caution: oil based ovules and cream may cause latex condoms or diaphragms to fail) Fluconazole 150mg PO in a single dose [A-I]. Contraindicated in pregnancy. Note: Topical and oral azoles are equally effective. Recurrent Vulvovaginal Candidiasis (VVC) Induction treatment Fluconazole 150 mg PO once every 72 hours for three doses [A-I]. Contraindicated in pregnancy. Topical azole for days [B-II]. Boric acid mg gelatin capsule intravaginally once a day for 14 days [B-II]. Less mucosal irritation experienced when 300 mg used. Contraindicated in pregnancy. Notes: Each individual episode of recurrent VVC caused by C. albicans usually responds to a course of oral or topical azoles, with a longer course usually more effective than a shorter one. Without maintenance therapy, VVC recurs in 50% of patients within 3 months. Start maintenance therapy as soon as initial treatment has been completed. Maintenance treatment Fluconazole 150 mg PO once a week [A-I]. Contraindicated in pregnancy. Ketoconazole 100 mg PO once a day [A-I] Patients receiving long-term ketoconazole should be monitored for hepatotoxicity (incidence 1 in 12,000) Itraconazole mg PO once a month [A-I] Clotrimazole 500 mg intravaginally once a month [A-I] Boric acid 300 mg capsule intravaginally for 5 days each month beginning the first day of the menstrual cycle [B-II]. Contraindicated in pregnancy. 26 Treatment Recommendations

29 Treatment Recommendations Candidiasis (continued) Notes: Duration of maintenance therapy is a minimum of 6 months. After 6 months, discontinue therapy and observe. Relapse rate is high, with approximately 60% of women relapsing within 1 2 months of discontinuing maintenance therapy. If recurrence occurs, treat the episode and then reintroduce a maintenance regimen. Fluconazole, other oral azoles and boric acid are contraindicated in pregnancy. Oil-based ovules and creams may cause latex condoms or diaphragms to fail. Chancroid Ciprofloxacin 500 mg PO in a single dose [A-I] Erythromycin 500 mg PO tid for 7 days [A-I] Azithromycin 1g PO in a single dose [A-I] Ceftriaxone 250 mg IM in a single dose [A-I] (treatment failure commonly reported in those with HIV co-infection) Chlamydia Urethral, endocervical, rectal, and conjunctival Preferred Doxycycline 100 mg PO bid for 7 days [A-I] Azithromycin 1g PO in a single dose if poor compliance is expected [A-I] Alternative Ofloxacin 300 mg PO bid for 7 days [B-II] Erythromycin base 2 g/day PO in divided doses for 7 days [B-II] Erythromycin base 1 g/day PO in divided doses for 14 days [B-I] Note: Erythromycin base may be substituted with equivalent dosages of other formulations. Estolate formulation is contraindicated in pregnancy. Treatment Recommendations 27

30 Treatment Recommendations Epididymitis If sexual transmission is suspected Doxycycline 100 mg PO bid for days [A-I] Plus one of the following: Ceftriaxone 250 mg IM in a single dose [A-I] Ciprofloxacin 500 mg PO in a single dose [A-I] (unless not recommended due to quinolone resistance see quinolone resistance statement on page 24) If sexual transmission is not suspected and an enteric organism is likely Ofloxacin 200 mg PO bid for 14 days [A-I] External Genital Warts No therapy guarantees eradication of HPV Patient-applied Imiquimod [A-I] self-applied 3x/week with at least one day between applications for up to 16 weeks (wash off after 6 8 h). Contraindicated in pregnancy. Podofilox/podophyllotoxin 0.5% solution [A-I] self-applied to warts every 12 hours for 3 days of each week (4 days off) for up to 6 weeks (total dose/day not to exceed 0.5mL). Contraindicated in pregnancy and for the treatment of cervical, meatal, vaginal or anal warts. Office-based Cryotherapy [A-I] liquid nitrogen, carbon dioxide, or nitrous oxide using cryoprobes provide sufficient freezing to cause 1 2 mm rim to form around lesion. Podophyllin 10 25% [A-I] apply directly to wart only and wash off after 1 4 hours (total dose/treatment not to exceed 1 2 ml). May be repeated 1 2x at weekly intervals. Contraindicated in pregnancy and for the treatment of cervical, meatal, vaginal or anal warts. Bi- or Trichloracetic acid [A-I] 50 80% solution in 70% alcohol applied directly to wart(s), does not need to be washed off. May be repeated weekly for 6 8 weeks. Electro-fulguration, CO 2 laser ablation, excision usually for more extensive genital, perineal or anal warts. 28 Treatment Recommendations

31 Treatment Recommendations Genital Herpes (HSV) First Episode (treatment is recommended for clinically important symptoms, analgesics and laxatives may also be required) Acyclovir 200 mg PO 5x/day for 5 10 days [A-I] Famciclovir 250 mg PO tid for 5 days [A-I] Valacyclovir 1000 mg PO bid for 10 days [A-I] Acyclovir 400 mg PO tid for 7 to 10 days is recommended by the U.S. Centers for Disease Control [A-III] For severe primary disease acyclovir 5 mg/kg IV infused over 60 minutes every 8 hours [A-I] (convert to oral therapy after substantial improvement) Note: Topical acyclovir should not be used [A-I] Recurrent Lesions Episodic Therapy Valacyclovir 500 mg PO bid for 3 days [B-I] Valacyclovir 1 g PO each day for 3 days [B-I] Famciclovir 125 mg PO bid for 5 days [B-I] Acyclovir 200 mg PO 5x/day for 5 days [C-I] Acyclovir 800 mg PO tid for 2 days [B-I] Suppressive Therapy (for non-pregnant patients) For patients with frequent recurrences (in general > every 2 months or > 6x/year) Acyclovir 200 mg PO tid to 5x/day [A-I] Acyclovir 400 mg PO bid [A-I] Famciclovir 250 mg PO bid [A-I] Valacyclovir 500 mg PO each day (if < 9 episodes/year) [A-I] Valacyclovir 1000 mg PO each day (if > 9 episodes/year) [A-I] Treatment Recommendations 29

32 Treatment Recommendations Gonorrhea All regimens should be followed by empiric treatment for chlamydial and non-gonococcal infections refer to appropriate sections. Preferred Cefixime 400 mg PO in a single dose [A-I]* Ciprofloxacin 500 mg PO in a single dose (unless not recommended due to quinolone resistance see quinolone resistance statement on page 24) [A-I] Contraindicated in pregnancy. Ofloxacin 400 mg PO in a single dose (unless not recommended due to quinolone resistance see quinolone resistance statement on page 24) [A-I] Contraindicated in pregnancy. Ceftriaxone 125 mg IM in a single dose [A-I] Notes: Ceftriaxone and cefixime should not be given to persons with a cephalosporin allergy or a history of immediate and/or anaphylactic reactions to penicillin. Cefixime is preferred over ceftriaxone as a factor of cost and ease of administration. Alternative Only if use of quinolones is not recommended and the patient has a known cephalosporin allergy OR a history of immediate/anaphylactic penicillin allergy. Azithromycin 2 g PO in a single dose [A-I] (antiemetics may be needed) OR Spectinomycin 2 g IM in a single dose [A-I] (available only through Special Access Program [SAP]) test of cure is recommended (not effective for pharyngeal infection) Granuloma Inguinale Preferred Doxycycline 100 mg PO bid for 21 days (based on studies of older preparations of tetracyclines) [C-III] Trimethoprim-sulfamethoxazole double strength PO bid for 21 days [C-III] 30 Treatment Recommendations

33 Treatment Recommendations Granuloma Inguinale (continued) Alternatives Ciprofloxacin 750 mg PO bid for 21 days [C-III] Erythromycin 500 mg PO qid for 21 days [C-III] Azithromycin 500 mg PO daily for a minimum of 21 days [C-III] Azithromycin 1 g PO weekly for a minimum of 3 weeks [C-III] Hepatitis B (HBV) For management of a patient with sexual/percutaneous or mucosal exposure to an infected or high risk source refer to algorithm Management of Sexual/ Percutaneous/Mucosal Exposure to Infected HBsAg-Positive Individuals or High Risk Source. For management of a patient with sexual/percutaneous or mucosal exposure to HBV- or low risk source, ensure complete vaccination. Any patient known to have chronic HBV should be referred to an expert for further management. Human Immunodeficiency Virus (HIV) Treatment decisions for those with HIV should be made in collaboration with a colleague experienced in this area. Lymphogranuloma Venereum (LGV) First line Doxycycline 100 mg PO bid for 21 days [B-II] Alternative Erythromycin base 500 mg PO qid for 21 days [C-III]. Erythromycin base may be substituted with equivalent dosages of other formulations. Estolate formulation is contraindicated in pregnancy. Possible Azithromycin 1g PO once weekly for 3 weeks [C-III] Treatment Recommendations 31

34 Treatment Recommendations Pelvic Inflammatory Disease Treatment regimens must provide empiric broad spectrum coverage taking into account the polymicrobial nature of PID. Anaerobic coverage should be considered, but whether elimination of anaerobes from the upper tract is necessary remains to be answered even though anaerobes are detected in the majority of PID cases. For detailed information on recommended parenteral and oral regimens refer to the complete STI guidelines. Pubic Lice/Scabies Pubic Lice Wash the affected area and apply pediculocide formulation (shampoo, cream, lotion) according to package instructions. May repeat in 3 7 days. Permethrin 1% cream [A-I] 0.33% Pyrethrin-piperonyl butoxide shampoo [A-I] Lindane 1% shampoo [A-I]. Contraindicated in children < 2 years of age, in pregnant or lactating women and in patients with extensive dermatitis. Scabies Permethrin 5% cream [A-I] apply from neck down, after 8 14 hours shower Gamma benzene hexachloride (lindane) 1% cream or lotion [A-I] apply from the neck down, after 8 hours shower. Contraindicated in children < 2 years of age, in pregnant or lactating women and in patients with extensive dermatitis. Alternatives (less effective) Crotamiton 10% cream [A-I] apply nightly for 2 nights, wash off 24 hours after last application (available only through Special Access Program [SAP]) Sulphur 5% in petroleum [A-I] apply nightly for 3 nights, wash off 24 hours after last application Note: In pregnancy, permethrin is the only agent that should be used. 32 Treatment Recommendations

35 Treatment Recommendations Pubic Lice/Scabies (continued) For both pubic lice and scabies: Antihistamines or mild topical corticosteroids may be used to control pruritis. Hot water wash or dry-cleaning kills all stages of the organisms on clothes, bedding, as does placing items in a plastic bag for 1 week. Vacuum mattress. Infectious Syphilis (Primary, Secondary, Early Latent <1 year) Preferred Benzathine penicillin G 2.4 million units IM in a single dose [A-II; A-III for HIVinfected individuals] Alternative (for penicillin allergic patients) Doxycycline 100 mg PO bid for 14 days [B-II] Alternative (only in exceptional circumstances) Ceftriaxone 1 g IV or IM daily for 10 days [B-II] Non-infectious Syphilis (Late Latent, Latent of Unkown Duration, Tertiary Syphilis excluding CNS) Preferred Benzathine penicillin G 2.4 million units IM weekly for 3 doses [A-II] Alternative (for penicillin allergic patients) Consider penicillin desensitization (see the complete STI guidelines for more information) Doxycycline 100 mg PO bid for 28 days [B-II] Alternative (only in exceptional circumstances) Ceftriaxone 1 g IV or IM daily for 10 days [C-III] Treatment Recommendations 33

36 Treatment Recommendations Neurosyphilis Preferred Penicillin G 3 4 million units IV every 4 hours (16 24 million units/day) for days [A-II] Alternative (for penicillin allergic patients) Strongly consider penicillin desensitization followed by treatment with penicillin (see the complete STI guidelines for more information) Ceftriaxone 2 g IV/IM per day for days [B-II] Trichomoniasis Metronidazole 2 g PO in a single dose [A-I] Metronidazole 500 mg PO bid for 7 days [A-I] Note: Intravaginal metronidazole gel is not effective. Patients should not drink alcohol during and for 24 hours after therapy with metronidazole because of a possible disulfiram (antabuse) reaction. 34 Treatment Recommendations

37 Partner Notification What is it? A secondary prevention process Sexual and other contacts are: Identified Located Assessed Counselled Screened Treated Crucial to prevent re-infection in the index case and prevent sequelae in undiagnosed and untreated partners Who does it? The patient and/or The physician/health care provider (with the patient s consent) and/or Public health authorities A notification plan including which partners will be notified by whom, is helpful. Partner Notification 35

38 Partner Notification Which contacts/partners should be notified? Infection Trace-back period Who to notify/evaluate Chlamydia Gonorrhea LGV Urethritis Mucopurulent cervicitis PID Epididymitis 60 days Sexual partners Newborns of infected mothers 60 days Sexual partners Primary syphilis 3 months Sexual partners Newborns of infected mothers Secondary syphilis 6 months Early latent syphilis 1 year Late latent syphilis/stage Variable Sexual partners undetermined Newborns of infected mothers Children of maternal case Herpes Current/future Sexual partners Newborns of infected mothers HPV Current/future Sexual partners Chancroid 14 days Sexual partners Trichomoniasis Current Sexual partners HIV Variable Sexual partners Needle-sharing partners Newborns of infected mothers Children of maternal case Hepatitis B Variable Sexual partners Needle-sharing partners Household contacts Newborns of infected mothers Children of maternal case HPV=human papillomavirus LGV=lymphogranuloma venereum PID=pelvic inflammatory disease Note: For more in-depth information on partner notification for HBV and HIV, consult the STI guidelines. 36 Partner Notification

39 Follow-up recommendations Bacterial Vaginosis No follow-up is necessary unless the patient is pregnant or symptoms recur. Candidiasis No follow-up necessary unless symptoms persist or recur. Consider culture and sensitivity of yeast if not responding to appropriate therapy or if infection recurs. Chancroid Repeat diagnostic testing for the detection of H. ducreyi is not routinely indicated if a recommended treatment is given and taken AND symptoms and signs disappear AND there is no re-exposure to an untreated partner. Chlamydia Test of cure for C. trachomatis is not routinely indicated if a recommended treatment is taken AND symptoms and signs disappear AND there is no re-exposure to an untreated partner except: Where compliance is suboptimal If an alternative treatment regimen has been used In all prepubertal children In all pregnant women Test of cure using a NAAT, if needed, should be performed at 3 to 4 weeks after the completion of effective treatment to avoid false-positive results due to the presence of non-viable organisms. Repeat testing in all individuals with C. trachomatis infection is recommended 6 months post-treatment, as reinfection risk is high. Ectoparasites (Pubic Lice/Scabies) Follow up only if clinically necessary. Epididymitis Follow-up should be arranged to evaluate the response to treatment. If a recommended regimen has been given and correctly taken, symptoms and signs have disappeared and there is no re-exposure to an untreated sexual partner, then repeat diagnostic testing for N. gonorrhoeae and C. trachomatis is not routinely recommended. Follow-up Recommendations 37

40 Follow-up recommendations Genital Warts (HPV) Once genital warts are healed, conduct routine follow-up of women with cervical screening, with or without HPV DNA testing, as recommended by provincial/territorial guidelines. Genital Herpes (HSV) Follow-up cultures are not indicated, except when there are unusual recurrent symptoms or to determine in vitro susceptibility when resistance is suspected as a cause of therapeutic failure. Supportive counselling is an important component of managing patients with genital herpes. Gonorrhea Repeat screening of individuals with gonorrhea after 6 months is recommended. Follow-up testing by culture must be completed if any of the following exist: Treatment failure has occurred previously. Antimicrobial resistance to therapy is documented. Compliance is uncertain. There is re-exposure to an untreated partner. There is concern over a false-positive non-culture test result. Infection occurs during pregnancy. PID or disseminated gonococcal infection is diagnosed. Patient is a child. Granuloma Inguinale If the patient is compliant with the prescribed treatment, symptoms resolve and there is no risk of re-exposure to an untreated partner, repeat diagnostic testing is not routinely recommended. Hepatitis B Any patient known to have chronic hepatitis B should be referred to an expert for further management. Human Immunodeficiency Virus (HIV) Consult the full STI guidelines for counselling, management and monitoring recommendations. 38 Follow-up Recommendations

41 Follow-up recommendations Lymphogranuloma Venereum (LGV) Patients should be followed until chlamydial tests are negative (test of cure) and the patient has clinically recovered. Serology should not be used to monitor treatment response, as the duration of antibody response has not been defined. Test of cure should be performed at 3 4 weeks after the completion of effective treatment to avoid false-positive results due to the presence of non-viable organisms (especially if using NAAT). Surgery may be required to repair genital/rectal damage of tertiary LGV. Mucopurulent Cervicitis If treatment is taken as prescribed follow-up is not routinely recommended. Pelvic Inflammatory Disease (PID) Pain and tenderness resulting from acute PID should begin to resolve within 48 to 72 hours of initiating antibiotics. Individuals treated as outpatients need careful follow-up and should be re-evaluated 2 to 3 days after treatment is initiated. If no clinical improvement has occurred, hospital admission for parenteral therapy and observation is required. Following a diagnosis of PID, patients should be informed that they are at risk of both short-term consequences such as Fitz-Hugh-Curtis syndrome (perihepatitis) and tubo-ovarian abscess, and long-term sequelae, including infertility, ectopic pregnancy and chronic pelvic pain. Syphilis NTTs should be monitored until they are seronegative or at a stable low titre (e.g., 1:4 dilutions). See page 41 of this reference tool for a guide to the monitoring of NTTs and adequate serologic response to treatment. Urethritis If treatment is taken and symptoms resolve, follow-up is not routinely recommended. If symptoms persist or recur after completed therapy (1 week after initiation of therapy), the patient should be re-evaluated. Symptoms alone are not sufficient for re-treatment in the absence of laboratory findings or clinical signs. Trichomoniasis No follow-up necessary unless symptoms recur; usually due to re-infection. Follow-up Recommendations 39