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Diseases without Borders: Best Practices for Sexually Transmitted Diseases Care and Prevention Linda Creegan, MS, FNP California STD/HIV Prevention Training.

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Presentation on theme: "Diseases without Borders: Best Practices for Sexually Transmitted Diseases Care and Prevention Linda Creegan, MS, FNP California STD/HIV Prevention Training."— Presentation transcript:

1 Diseases without Borders: Best Practices for Sexually Transmitted Diseases Care and Prevention Linda Creegan, MS, FNP California STD/HIV Prevention Training Center Border Conference El Centro, CA June 2014

2 I do not have any financial arrangements or affiliations with commercial sponsors which have direct interest in the subject matter:

3 S EXUALLY T RANSMITTED D ISEASES Chlamydia Gonorrhea Syphilis HIV / AIDS Hepatitis B Hepatitis C Chancroid Trichomonas Granuloma inguinale LGV M. genitalium HPV Genital herpes Lice Scabies BV? Others…..

4 Complications of STDs Infection PIDInfertility Ectopic pregnancy Chronic pain CancerPerinatal Congenital infection Low birth weight Stillbirth HIV Brain/organ damage o Chlamydia o Gonorrhea o HPV o Hepatitis B o Trichomona s o HSV o Syphilis o Chlamydia o Gonorrhea o HPV o Hepatitis B o Trichomona s o HSV o Syphilis

5 CA STD Data and Statistics


7 Priority Populations Teens & young people Pregnant women Gay/Bi men (MSM) People of color

8 Testing in STD Care Testing applications Case finding –Asymptomatic (screening) –Symptomatic (diagnostic) Follow-up Guide treatment (HIV resistance testing) Surveillance Types of tests Culture (susceptibility testing) Serologic tests (antibodies in the blood) Molecular-based tests (NAAT) Combo tests –CT/GC –HIV/syphilis –Non-treponemal and treponemal

9 Testing Approaches In clinic –Clinician-collected –Self-collected Outside the clinic –Collected at lab –Field-based program –Home testing

10 Provide Those Free Sexual Health Services! Essential Health Benefits related to STD/HIV prevention and care Must be included in all health plans at no cost-sharing to patient –Annual Wellness visit –STD and HIV screening –STD and HIV care –HPV and Hep B Immunizations –Risk Reduction counseling –Pap smears

11 1. Ask three essential sexual history questions  WHO are your partners?  WHAT are your sexual and drug use practices?  HOW do you try to prevent STDs/HIV? Risk assessment important since many STDs are asymptomatic

12 2. Screen for Chlamydia and Gonorrhea  ALL sexually active adolescent and young women ≤ 25 years  Pregnant women  Men who have sex with men (MSM)  Persons living with HIV  Others according to risk CDC 2010 STD Tx Guidelines.

13 Why screen? Highly prevalent Frequently asymptomatic Reduces transmission Prevents complications HEDIS measure: chlamydia screening in females under 25 years old Standard of care

14 Sexually Active adolescents & up to age 25 Routine chlamydia and gonorrhea screening Others STDs and HIV based on risk Women over 25 years of age STD/HIV testing based on risk Pregnant women Chlamydia Gonorrhea (<25 years of age or risk) HIV Syphilis serology HepB sAg Hep C (if high risk) Sexually Active adolescents & up to age 25 Routine chlamydia and gonorrhea screening Others STDs and HIV based on risk Women over 25 years of age STD/HIV testing based on risk Pregnant women Chlamydia Gonorrhea (<25 years of age or risk) HIV Syphilis serology HepB sAg Hep C (if high risk) CDC 2010 STD Tx Guidelines

15 NationalCalifornia Estimated Chlamydia Screening Coverage (HEDIS), Females Age 15–24, USA and California, 1999–2010 Rev. 4/2012 Source:National Committee on Quality Assurance; California DHCS Division of Medi-Cal Managed Care; Kaiser Permanente Northern CA; California DPH Office of Family Planning

16 Who is falling through the cracks?  Visits that do not require an exam Pregnancy test only Emergency contraception Contraception method follow-up Refills Depo-provera injection

17 A pelvic exams is not necessary to obtain a chlamydia test Noninvasive samples –Urine –Self-collected vaginal swabs Nucleic acid amplification tests (NAATs) u Highest sensitivity

18 Major conclusions NAATs recommended for detection of genital tract infections in men and women – with and without symptoms Optimal specimen types are: First catch urine for men Self collected vaginal swabs from women NAATs recommended for: detection of rectal and oropharyngeal infections

19 CT Test Volume & Prevalence among Females by Age *Quest Diagnostics/Unilab: West Hills/Tarzana, Sacramento, San Jose What about Women over age 25? 50% Test Volume CA FPACT Data, 2006

20 Which women over age 25 should be screened? Based on risk: –Infection with CT or GC in past 2 years –> 1 sex partner in past 12 months –New partner in past 3 months –Belief that a partner in the past 12 months may have had other sex partners at the same time Other indications: –Pregnancy –Contact to STD –New STD diagnosis CA CT Screening Guidelines Draft; Howard et al. Over 20. In prep.

21 STI Screening Recommendations: HIV-positive Men & Women STIAnatomic Site ChlamydiaGenital, rectal if exposed GonorrheaGenital, rectal & oral if exposed SyphilisSerology TrichomoniasisWomen only HSV-2Serology Hep B sAgSerology Hep CSerology Primary Care Guidelines for the Management of Persons Infected with HIV: 2009 Update by the HIVMA of the IDSA. Clin Infect Dis 2009;49, 651-681. * Screen at least annually; repeat screening every 3-6 months as indicated by risk. MSM- Consider anal Pap screening Women-Cervical Pap screening; Consider anal Pap if hx of dysplasia. *

22 STD Screening for MSM HIV Syphilis Urethral GC and CT Rectal GC and CT (if RAI) Pharyngeal GC (if oral sex) HSV-2 serology (consider) Hepatitis B (HBsAg) Anal Pap (consider for HIV+) HIV Syphilis Urethral GC and CT Rectal GC and CT (if RAI) Pharyngeal GC (if oral sex) HSV-2 serology (consider) Hepatitis B (HBsAg) Anal Pap (consider for HIV+) * At least annually, more frequent (3-6 months) if at high risk (multiple/anonymous partners, drug use, high risk partners) CDC 2010 STD Tx Guidelines *

23 Majority of Rectal Infections in MSM are Asymptomatic Chlamydia n=316 Gonorrhea n=264 Chlamydia n=315 Gonorrhea n=364 Rectal Infections Urethral Infections Asymptomatic Symptomatic Kent, CK et al, Clin Infect Dis July 2005 86% 84% 42% 10%

24 Proportion of CT and GC infections MISSED among 3398 asymptomatic MSM if screening only urine/urethral sites, San Francisco, 2008-2009 ChlamydiaGonorrhea Marcus et al, STD Oct 2011; 38: 922-4

25 Chlamydia and Gonorrhea NAA Testing …not FDA-cleared for rectal or pharyngeal specimens but now the preferred testing method over culture Validation procedures can be done by labs to allow use of a non-FDA-cleared test or application Quest & LabCorp currently provide GC/CT NAAT for rectal/pharyngeal specimens

26 NAAT Laboratory Ordering and Billing Codes *CDC does not endorse these laboratories, however, they represent the largest laboratories nationally. There may be other private laboratories that have verified rectal and pharyngeal testing with NAATs. Many PHLs have also verified rectal and pharyngeal testing. For information on specimen collection and transportation, clinicians should contact the local reference laboratory representative. Bolan, CDC webinar March 2011

27 Case Scenario 22 year old female Asymptomatic, no prior STDs STD Screening done on intake No known drug allergies GC positive CT negative

28 What regimen would you use to treat Gonorrhea? A.Ceftriaxone 250 mg IM B.Azithromycin 2 gm PO C. Ceftriaxone 250 mg IM plus azithromycin 1 gm PO D. Ceftriaxone 125 mg IM plus azithromycin 1gm PO

29 Development of GC Resistance 1930s-1970s1980s1990s2000s2010s 1945: Penicillin first used widely for TX 1936: Sulfanilamides introduced as TX 1989: Penicillin no longer recommended for TX by CDC 1976: Pen-R NG first identified in US (in CA) 1986: GISP started by CDC 2007: Fluoroquinolones no longer recommended for TX by CDC 1991: QRNG first identified in US (in HI) 2002: Fluoroquinolones no longer recommended for TX by CA 2010: Dual TX recommended for TX by CDC 2001: First cephalosporin TX failures in Japan

30 Who is most likely to be affected by cephalosporin-resistant GC? Men who have sex with men California 30

31 Gonorrhea Treatment: Uncomplicated Genital/Rectal/Pharyngeal Infections Ceftriaxone 250 mg IM in a single dose Azithromycin 1 g orally ** or Doxycycline 100 mg BID x 7 days PLUS* * Regardless of CT test result MMWR Weekly August 10, 2012 MMWR updates CDC 2010 Guidelines **Azithromycin preferred as 2 nd antimicrobial 3. Use Current Treatment for Gonorrhea

32 Do you have ceftriaxone and azithromycin available onsite? 1.Yes 2.No

33 ALTERNATIVE CEPHALOSPORINS:  Cefixime 400 mg orally once PLUS  Dual treatment with azithromycin 1 g (preferred) or doxycycline 100 mg BID x 7 days, regardless of CT test result IN CASE OF SEVERE ALLERGY:  Azithromycin 2 g orally once (Caution: GI intolerance, emerging resistance) Gonorrhea Treatment Alternatives Anogenital Infections MMWR 2012 / 61(31);590-594 Proposed in case of allergy: gentamicin 240 mg IM + azithromycin 2g orally or gemifloxacin 320 mg orally + azithromycin 2g orally

34 Test of Cure Current TOC recommendation: Test of cure in 1 week for anyone treated w/ alternative regimens –Routine TOC poses implementation challenges –No data on TOC positivity rates in absence of symptoms Proposed: Limit TOC only to pharyngeal GC treated with alternative regimen, may extend interval to 14 days

35 How to slow the spread of A-R Gonorrhea New antibiotics Multiple antibiotics Surveillance –Rapid response plans –Resistance testing of isolates

36 Suspected GC Treatment Failure What should I do? CDPH Recommendations CULTURE: if GC culture not available on-site, call CA STD Control Branch for resources 510 620 3400 REPEAT TREATMENT: Ceftriaxone 500 mg IM PLUS Azithromycin 2 g orally in a single dose* REPORT: To your local health department within 24 hours; call STD Control Branch if consult desired TREAT PARTNERS: All partners in last 60 days should be treated with CTX 500 mg + AZ 2g TEST OF CURE (TOC): Patient returns in 1 week for TOC with culture (if culture not avail, with NAAT) * If reinfection suspected instead of treatment failure, OK to repeat treatment with CTX 250 + AZ 1g

37 4. Ensure Partner Management Patient referral Ask patient to notify partner and ensure treatment Suggest patient bring partner to clinic for concurrent treatment (“BYOP”) Internet-based anonymous notification Expedited partner treatment (EPT) Patient-delivered partner treatment (PDPT) Health department field-delivered treatment Pharmacy-based Provider or clinic-based referral Health department referral

38 Legal Status of EPT in the U.S. PERMISSIBLE 32 states UNCERTAIN 11 states PROHIBITED 7 states CDC EPT Legal Status Updated August 2012

39 Online Partner Referral Patients use website to notify partners - anonymous - free - referrals for testing

40 Nadine 28 y/o non-pregnant female treated for CT. When should you schedule her follow-up? A.1 week for a TOC B.3 weeks for a TOC C.3 months for a test for reinfection D.1 year for her annual exam E.Not sure

41 Retesting Recommendations:  Retest all women and men with CT or GC 3 months after treatment* “Opportunistic” testing  Retest whenever possible, 1-12 mo *CDC 2010 STD Tx Guidelines, 5. Retest for CT and GC at three months following treatment

42 Repeat Chlamydial Infection is Common Hosenfeld C, et al. Sex Transm Dis. 2009 Aug;36(8):478-89 Typical Screening Prevalence Retesting Prevalence

43 Repeat Infection is Dangerous Repeat CT infection leads to higher risk of complications: PID, ectopic pregnancy, infertility Most infections are asymptomatic Hillis SD, et al. (1997). Am J Obstet Gynecol 176(1 Pt 1): 103-7. Relative Risk

44 Chlamydia Care Continuum: Family PACT females age ≤25 years (N=686,327) Source: Family PACT Annual Report FY 11-12 78% 92% 60% 59% Total Est Cases Cases detected Cases treated Pt returns 1-6 mo. retested Pos at Restest

45 Getting clients back in for retesting: Counseling at treatment visit Written materials Advance appointments Traditional reminder systems (telephone and postcards) Text message and/or email reminders Downer SR et al Aust Health Rev 2006;30:389; Leong KC et al. Fam Pract 2006; 23:699.

46 Appointment and STI Retest Reminders For more information:

47 6. Recommend the HPV Vaccine PopulationACIP Recommendation GenderAge Females11-12 (as young as 9) Routine vaccination with either HPV4 or HPV2 13-26Routine catch-up vaccination either HPV4 or HPV2* Males11-12 (as young as 9) Routine vaccination w HPV4 13-21Routine catch-up vaccination HPV4 22-26Permissive recommendation HPV 4 MSM & HIV+ Males 22-26Routine catch-up vaccination HPV 4 MMWR, May 28 2010; 59(20):626-629, 630-632 MMWR, December 23 2011; 60(50);1705-1708 * Irrespective of history of abnormal Pap, HPV, genital warts

48 The HPV Family Dermal HPVs Common skin warts (~60 types) Mucosal HPVs (~40 types) “High-risk” Cancer types “Low-risk” Wart types

49 Incidence of Cervical HPV Detection in Women from the Time of Sexual Debut Collins et al. Br J Obstet Gynecol 2002;109:96 Time since first intercourse (months) 0% 10% 20% 30% 40% 50% 60% 70% 0612182430364248 Cervical HPV Detection

50 Clearance of HPV Infections Over 2 Years Adapted from Brown et al. JID 2005:191;182 Time from HPV infection (months) Percent HPV Infected

51 Low Risk Mucosal HPVs TYPESMost common: 6, 11 Others: 40, 42, 43, 44, 54, etc DISEASESGenital and oral warts Respiratory papillomatosis Low grade cervical Pap abnormalities

52 Anogenital Warts Source: DOIA Website, 2000

53 HPV Vaccine Efficacy in Preventing Precancer and Warts HPV DiseaseHPV 4HPV 2 FEMALESCIN 2+98% Genital Warts100%--- VIN/VaIN 2+100%--- MALESGenital warts90%--- AIN78%--- Future II Study Group. N Engl J Med 2007;356(19):1915-27 Garland SM et al. NEJM 2007;356(19):1928-43 Paavonen et al. Lancet. 2009;374(9686):301-14 Giuliano et al. NEJM 2011; 364:401-11 Palefsky et al. NEJM 2011; 365:1576-85. CIN = Cervical Intraepithelial Neoplasia AIN = Anal Intraepithelial Neoplasia VIN = Vulvar Intraepithelial Neoplasia VaIN = Vaginal Intraepithelial Neoplasia

54 ACIP Recommendations : Administration, Precautions and Contraindications Synchronized dosing: 3-dose schedule, second dose at 1-2 months after first dose, third dose 6 months after first dose Minimum intervals: –Minimum time b/w 1 st & 2 nd = 4 wks –Minimum time b/w 2 nd & 3 rd = 12 wks –Minimum time b/w 1 st & 3 rd = 24 wks If schedule is interrupted, the series does not need to be restarted HPV vaccines can be given simultaneously/before/after other vaccines If possible, the same product should be used for all doses in the series No change in cervical cancer screening recommendations MMWR, May 28, 2010; 59(20):626-629, 630-632

55 ACIP Recommendations : Administration, Precautions and Contraindications Pregnancy: HPV vaccines are not recommended for use in pregnant women; however pregnancy testing is not needed before vaccination. Any exposure to vaccine during pregnancy should be reported to the appropriate vaccine pregnancy registry: Pregnancy Registry: 800-986-8999 (Merck) or 888- 452-9622 (GSK vaccine) Contraindications: allergy to vaccine component, severe illness Quadrivalent HPV vaccine contains yeast antigens Bivalent HPV vaccine in prefilled syringes contraindicated for persons with anaphylactic latex allergy  Adverse reactions should be reported to VAERS: or 800-822-7967 MMWR, May 28, 2010; 59(20):626-629, 630-632

56 Vaccine Funding Programs Vaccines for Children Program Up to age 18, Medicaid eligible, uninsured or underinsured Receiving immunizations through a Federally Qualified Health Center or Rural Health Clinic, or Native American or Alaska Native Merck Vaccine Assistance Program Age ≥ 19, low income, and no health insurance coverage Phone number 1-800-293-3881 (8a-8p EST) Merck Dose Replacement Program Vaccine doses provided but not reimbursed GSK Vaccines Access Program Age 19-25, income eligible, and no heath insurance

57 HPV Vaccine Uptake, Girls Ages 13-17 National Immunization Survey, 2007-2010 MMWR 2008 / 57(40):1100-3; MMWR 2009 / 58(36):997-1001; MMWR 2010 / 59(32):1018-23; MMWR 2011 / 60(33):1117-1123 37% 25% 44% 49%

58 Challenges in Managing Vaginitis Patient factors –Self-treatment may preclude diagnosis –Clients seek help from multiple providers Provider factors –Under-utilization of available tests –Insensitive clinic-based tests –Dependent on provider skill s 7. Offer Management for Recurrent/Persistent Vaginitis

59 Bacterial Vaginosis Decrease in lactobacilli Polymicrobial overgrowth Enzymes degrade the protective effects of cervical mucus and immune factors Photo: Seattle PTC



62 Bev….. “I have BV again!”  Recurrence rates a s high as 30% at 3 months and 80% at 9 months  Etiology unclear  Resistance?  Re-infection?  Unrecognized trigger?  Failure of lactobacilli to recolonize? Management  Confirm diagnosis  Condoms  No douching  Intermittent metronidazole gel (twice a week intravaginally)

63 Recurrent BV: Success with Suppressive Treatment Clinical 26/51 (51%)33/44 (75%).02 Gram Stain 17/45 (38%)17/35 (49%).33 Clinical 13/51 (26%)26/44 (59%) <.001 Gram Stain 8/45 (18%)14/35 (40%).03 Recurrence MTNZPlaceboP value Prophylactic phase (4 mo) Observation phase (3 mo) Sobel JD et al, Am J ObGyn. May 2006

64 Candice…….  Majority of women have no predisposing or underlying conditions  Non-albicans more common  Pathogenesis is unclear  Deficient host response?  Overactive host response?  Relapse/reinfection? Photos; Mosby STD Atlas 1997 and Seattle STD/HIV PTC  Initial Treatment  Longer regimen of topical therapy (7-10 d)  Fluconazole (100 mg, 150 mg, or 200 mg) p.o. every 3rd d x 3  Maintenance Regimens  Fluconazole (100 mg, 150 mg, 200 mg) qw x 6 m OR if not feasible  Topical antifungals used intermittently

65 Trixie….. First treatment failure, re-treat with:  Metronidazole 500 mg PO BID x 7 days If repeat failure, treat with:  Metronidazole 2 g PO x 5 days  Tinidazole 2 g PO x 5 days Susceptibility testing: send isolate to CDC CDC Consult & T. vaginalis susceptibility (404-718-4141)

66 Diagnostic tests for Trichomonas Sekisui Diagnostics –CLIA-waived –Results in 10 minutes –83% sensitive compared to culture BioMed Diagnostics –Needs incubator –Read at 3 and 5 days Gen-Probe APTIMA Trichomonas vaginalis Assay Same specimen types as for other APTIMA tests Close to 100% sensitive; Slightly less sensitive using urine Over 99% specific

67 Trich in HIV + Women Screen on entry to care Retest at 3 months after treatment Consider metronidazole 500 mg p.o. bid x 7d instead of stat dose

68 OH, NO!! She’s allergic to metronidazole!

69 Treatment Options with “Azole” Allergy Consult with specialist –Metronidazole desensitization Helms et al, Am J Obstet Gynecol 2008 Perlman et al, Am J Obstet Gynecol, 1996 Kurohara et al, j Allergy Clin Immunol, 1991 Paramomycin vaginal inserts –not as effective

70 8. Encourage Good Old Condoms!

71 Openers for a Conversation about Condoms Tell me about your experience with condoms. Some men take condoms almost for granted, and other men really dislike them. What about you? How willing have you found guys to be about using condoms?

72 Making the Change Goal: to improve patient care by improving medical practice What can you do on your own? What can you realistically influence? What can you advocate for?

73 THANK YOU!!!! Questions?

74 A bit more info…..

75 Online STD Resources CDC Treatment Guidelines California STD/HIV Prevention Training Center California Department of Public Health STD Control Branch

76 California Laws and Regulations

77 STD Reporting to Public Health Which diseases? –Syphilis  within 1 day –HIV/AIDS –Chlamydia, including LGV –Gonorrhea –Chancroid –Pelvic Inflammatory Disease (PID) By whom? –Provider and Laboratory To whom? The jurisdiction where patient resides How? CMR to be completed by the provider Within 7 days

78 Partner Management Provider Responsibility The clinician should: – Attempt to determine the source of infection – Determine the intimate and sexual contacts of the infected patient – Make an effort with patient to bring in those contacts for exam and treatment Persons determined as source of infection but not under treatment within 10 days of infection should be reported to the health officer EPT is allowable for CT, GC, and trichomoniasis CCR Title 17 §2636

79 Minor’s Rights to STD Care in California Minors age 12 and above are able to consent to STD and reproductive health care without parental permission As of January 1, 2012, minors may also consent to medical care related to prevention of STD (e.g., HPV vaccine) Minors have a right to confidentiality Parents are not liable for costs of STD care Reporting requirements for non-consensual (and “unlawful”) sexual activity CA Family Code §6926

80 Transmission of HSV-2 to Susceptible Partners is Reduced with Once-Daily Suppression Corey et al, NEJM 2004; 350(1):11-20. Control Group (N=741) Valacyclovir Group (N=743) 1484 heterosexual couples randomized to 500 mg of valacyclovir vs placebo once daily for 8 months Monthly serum samples collected from susceptible partners Valacyclovir group showed decreased transmission lower frequency of shedding fewer copies of HSV-2 DNA when shedding occurred

81 Gardasil or Cervarix: Which is better? BOTH HPV Vaccines: Effective in preventing 16/18-related cervical dysplasia Good safety profile High cost –Gardasil advantages: Protects against 6/11-related genital warts Licensed for males Indications vulvar/vaginal dysplasia –Cervarix advantages: Higher titer levels May give greater cross-protection against other oncogenic HPV types Effectiveness data for preventing persistent re-infection

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