Presentation on theme: "California STD/HIV Prevention Training Center"— Presentation transcript:
1 California STD/HIV Prevention Training Center Diseases without Borders: Best Practices for Sexually Transmitted Diseases Care and PreventionLinda Creegan, MS, FNPCalifornia STD/HIV Prevention Training CenterBorder ConferenceEl 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:
7 Priority Populations Teens & young people Pregnant women Gay/Bi men (MSM)People of color
8 Testing in STD Care Testing applications Types of tests Case finding Asymptomatic (screening)Symptomatic (diagnostic)Follow-upGuide treatment (HIV resistance testing)SurveillanceTypes of testsCulture (susceptibility testing)Serologic tests (antibodies in the blood)Molecular-based tests (NAAT)Combo testsCT/GCHIV/syphilisNon-treponemal and treponemal
9 Testing Approaches In clinic Outside the clinic Clinician-collected Self-collectedOutside the clinicCollected at labField-based programHome testing
10 Provide Those Free Sexual Health Services! Essential Health Benefits related to STD/HIV prevention and careMust be included in all health plans at no cost-sharing to patientAnnual Wellness visitSTD and HIV screeningSTD and HIV careHPV and Hep B ImmunizationsRisk Reduction counselingPap smearsEssential health benefits must be included in all insurance packages available in the state insurance exchanges, so these will be benefits that all patients can receive. And of course these are billable services, so when these reproductive health services are provided to patients in your practice, they will be reimbursable.
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?It all begins with a sexual history or risk assessment. A very brief risk assessment can give you a pretty good idea of the level of this patient’s risk for STIs. With all patients, hit just 3 topics as a screenAny current protocol/ practice re: sexual risk assessment? Including self-administered forms that pts fill out? Adolescent and adult history forms both on paper that patients complete and electronic history in EHR.Risk assessment important since many STDs are asymptomatic
12 2. Screen for Chlamydia and Gonorrhea ALL sexually active adolescent and young women ≤ 25 yearsPregnant womenMen who have sex with men (MSM)Persons living with HIVOthers according to riskCDC 2010 STD Tx Guidelines.
13 Why screen? Highly prevalent Frequently asymptomatic Reduces transmissionPrevents complicationsHEDIS measure: chlamydia screening in females under 25 years oldStandard of care
14 STD Screening for Women 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 Estimated Chlamydia Screening Coverage (HEDIS), Females Age 15–24, USA and California, 1999–2010 NationalCaliforniaSource: National Committee on Quality Assurance; California DHCS Division of Medi-Cal Managed Care;Kaiser Permanente Northern CA; California DPH Office of Family PlanningRev. 4/2012
16 Who is falling through the cracks? Visits that do not require an examPregnancy test onlyEmergency contraceptionContraception method follow-upRefillsDepo-provera injectionSo who are we missing, who is falling thru the cracks? Well, women who come for a clinic visit that does not require an exam. CT screening is pretty much routine at annual exams, but many women come for other types of visits which may be the only time we see them for care. And for these women, we’re much less likely to remember to do a CT test.
17 A pelvic exams is not necessary to obtain a chlamydia test Nucleic acid amplification tests (NAATs)Highest sensitivityNoninvasive samplesUrineSelf-collected vaginal swabsA pelvic exam isn’t necessary to obtain the sample for a CT test. NAAT tests using urine or vaginal swab samples are in widespread use now. So the urine we get for that pregnancy test can be sent for a CT test as well.
18 Major conclusionsNAATs recommended for detection of genital tract infections in men andwomen – with and without symptomsOptimal specimen types are:First catch urine for menSelf collected vaginal swabs from womenNAATs recommended for: detection of rectal and oropharyngeal infections
19 CT Test Volume & Prevalence among Females by Age What about Women over age 25?CT Test Volume & Prevalence among Females by Age50% Test VolumeThis slide graphically depicts the problem we face in CA – namely the over-screening that is occurring within the low prevalence population of FP women over age 25.This graph shows 2006 CT test volume and prevalence data by age group for women tested for CT via CA’s F-PACT program (F-PACT, or “Family PACT”, is a CA entitlement program which provides comprehensive reproductive health care to low income female and male residents of the state).The red line in this graph represents a CT prevalence of 3%, the state’s cost-effective cut-off for universal screening, which was chosen based on research of the 1) literature, 2) statewide surveillance data, and 3) our current level of resources in CA.. CT prevalence drops below this line in the groups of women age 25 and older. Yet, the CT test volume remains quite high across these older age groups, with 50% of all Family-PACT chlamydia testing occurring in the population of women over age 25.This practice of screening older adult women with a CT prevalence lower than the cost-effective level is not an effective use of the limited resources we have in CA.CA FPACT Data, 2006*Quest Diagnostics/Unilab: West Hills/Tarzana, Sacramento, San Jose
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 monthsNew partner in past 3 monthsBelief that a partner in the past 12 months may have had other sex partners at the same timeOther indications:PregnancyContact to STD New STD diagnosisCA CT Screening Guidelines Draft;Howard et al. Over 20. In prep.
21 STI Screening Recommendations: HIV-positive Men & Women Anatomic SiteChlamydiaGenital, rectal if exposedGonorrheaGenital, rectal & oral if exposedSyphilisSerologyTrichomoniasisWomen onlyHSV-2Hep B sAgHep C** Screen at least annually; repeat screening every 3-6 months as indicated by risk.MSM- Consider anal Pap screeningWomen-Cervical Pap screening; Consider anal Pap if hx of dysplasia.Primary Care Guidelines for the Management of Persons Infected with HIV: 2009 Update by the HIVMA of the IDSA. Clin Infect Dis 2009;49,
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+)** 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 86%84%ChlamydiaGonorrhean=316n=264AsymptomaticUrethral InfectionsSymptomatic10%42%ChlamydiaGonorrhean=315n=364Kent, CK et al, Clin Infect Dis July 2005
24 Proportion of CT and GC infections MISSED among 3398 asymptomatic MSM if screening only urine/urethral sites, San Francisco,ChlamydiaGonorrheaMarcus 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 cultureValidation procedures can be done by labs to allow use of a non-FDA-cleared test or applicationQuest & LabCorp currently provide GC/CT NAAT for rectal/pharyngeal specimens
26 NAAT Laboratory Ordering and Billing Codes For information on specimen collection and transportation, clinicians should contact the local reference laboratory representative.*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.Bolan, CDC webinar March 2011
27 Case Scenario 22 year old female Asymptomatic, no prior STDs STD Screening done on intakeNo known drug allergiesGC positiveCT negative
28 What regimen would you use to treat Gonorrhea? Ceftriaxone 250 mg IMAzithromycin 2 gm POCeftriaxone 250 mg IM plus azithromycin 1 gm POCeftriaxone 125 mg IM plus azithromycin 1gm PO
29 Development of GC Resistance 1930s-1970s1980s1990s2000s2010s1976: Pen-R NG first identified in US (in CA)2002: Fluoroquinolones no longer recommendedfor TX by CA1945: Penicillin first used widely for TX2001: First cephalosporin TX failures in Japan1986: GISP started by CDC1991: QRNGfirst identifiedin US (in HI)2010: Dual TXrecommendedfor TX by CDC1936: Sulfanilamides introduced as TX1989: Penicillin no longer recommended for TX by CDC2007: Fluoroquinolones no longer recommended for TX by CDC
30 Who is most likely to be affected by cephalosporin-resistant GC? Men who have sex with menCalifornia30
31 3. Use Current Treatment for Gonorrhea [Insert Lecture Name Here]3. Use Current Treatment for GonorrheaGonorrhea Treatment: Uncomplicated Genital/Rectal/Pharyngeal InfectionsAzithromycin 1 g orally **or Doxycycline 100 mg BID x 7 daysCeftriaxone 250 mg IM in a single dosePLUS** Regardless of CT test result**Azithromycin preferredas 2nd antimicrobialMMWR Weekly August 10, 2012MMWR updates CDC 2010 GuidelinesSlide 31
32 Do you have ceftriaxone and azithromycin available onsite? YesNo
33 Gonorrhea Treatment Alternatives Anogenital Infections ALTERNATIVE CEPHALOSPORINS:Cefixime 400 mg orally oncePLUSDual treatment with azithromycin 1 g (preferred) or doxycycline 100 mg BID x 7 days, regardless of CT test resultIN CASE OF SEVERE ALLERGY:Azithromycin 2 g orally once(Caution: GI intolerance, emerging resistance)Proposed in case of allergy: gentamicin 240 mg IM + azithromycin 2g orally or gemifloxacin 320 mg orally + azithromycin 2g orallyMMWR / 61(31);
34 Test of CureCurrent TOC recommendation: Test of cure in 1 week for anyone treated w/ alternative regimensRoutine TOC poses implementation challengesNo data on TOC positivity rates in absence of symptomsProposed: 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 antibioticsMultiple antibioticsSurveillanceRapid response plansResistance 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 resourcesREPEAT 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 desiredTREAT PARTNERS: All partners in last 60 days should be treated with CTX 500 mg + AZ 2gTEST 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 AZ 1g
37 4. Ensure Partner Management Patient referralAsk patient to notify partner and ensure treatmentSuggest patient bring partner to clinic for concurrent treatment (“BYOP”)Internet-based anonymous notificationExpedited partner treatment (EPT)Patient-delivered partner treatment (PDPT)Health department field-delivered treatmentPharmacy-basedProvider or clinic-based referralHealth department referral
38 Legal Status of EPT in the U.S. PERMISSIBLE 32 statesUNCERTAIN 11 statesPROHIBITED 7 statesCDC EPT Legal Status Updated August 2012
39 Online Partner Referral Patients use website to notify partners- anonymous- free- referrals for testinginspot.orgsotheycanknow.org
40 Nadine 28 y/o non-pregnant female treated for CT Nadine 28 y/o non-pregnant female treated for CT. When should you schedule her follow-up?1 week for a TOC3 weeks for a TOC3 months for a test for reinfection1 year for her annual examNot sure
41 5. Retest for CT and GC at three months following treatment Retesting Recommendations:Retest all women and men with CT or GC months after treatment*“Opportunistic” testingRetest whenever possible, 1-12 mo*CDC 2010 STD Tx Guidelines,
42 Repeat Chlamydial Infection is Common TypicalScreeningPrevalenceRetestingHosenfeld C, et al. Sex Transm Dis Aug;36(8):478-89
43 Repeat Infection is Dangerous Repeat CT infection leads to higher risk of complications: PID, ectopic pregnancy, infertilityMost infections are asymptomaticRelative RiskHillis SD, et al. (1997). Am J Obstet Gynecol 176(1 Pt 1):
44 Chlamydia Care Continuum: Family PACT females age ≤25 years (N=686,327) Total Est CasesCases detectedCases treated78%92%Pt returns 1-6 mo.retested60%Pos at Restest59%Source: Family PACT Annual Report FY
45 Getting clients back in for retesting: Counseling at treatment visitWritten materialsAdvance appointmentsTraditional reminder systems (telephone and postcards)Text message and/or remindersDowner 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 RecommendationGenderAgeFemales11-12(as young as 9)Routine vaccination with either HPV4 or HPV213-26Routine catch-up vaccination either HPV4 or HPV2*MalesRoutine vaccination w HPV413-21Routine catch-up vaccination HPV422-26Permissive recommendation HPV 4MSM & HIV+ MalesRoutine catch-up vaccination HPV 4Available now? At all of our many clinic sites.b. What funding sources (VFC, various insurance, private pay) VFC and/or coverage for CHDP-approved and managed Medi-Cal programs. Utilization of the Merck program for many of our clients in our community clinic setting when not covered and with insufficient income.c. Any idea of uptake? When offered and covered, the general acceptance, especially when framed as a cancer-preventative vaccine, is encouragingly high, even among children of relatively conservative parents presenting during CHDP physicals, which was not always the case.d. Any problems they have encountered? I am unaware of any problems with stock availability or reported adverse effects other than localized site tenderness* Irrespective of history of abnormal Pap, HPV, genital wartsMMWR, May ; 59(20): ,MMWR , December ; 60(50);
48 The HPV Family Mucosal HPVs (~40 types) Dermal HPVs Common skin warts I’ll start by providing an overview of human papillomavirus family.Currently, there are over 100 types of HPV. These HPVs can be separated into those that infected skin, also called dermal types, that cause common skin warts, and those that infect mucosal tissue, including genital and oral areas. Mucosal HPVs are transmitted through intimate and sexual contact. The genital HPV types can be further subdivided into high-risk types and low-risk types depending on their ability to cause cancer.“Low-risk”Wart types“High-risk”Cancer types
49 Incidence of Cervical HPV Detection in Women from the Time of Sexual Debut 0%10%20%30%40%50%60%70%612182430364248Cervical HPV DetectionCohort study of 242 women with <= 1 lifetime partner followed for 48 months to assess incident HPV infection (PCR)Cervical HPV infection was assessed using highly sensitive PCR tests.By 4 years post sexual debut, over 60% of women were infected with HPV, demonstrating just how common HPV is.The median time from the first sexual experience to HPV detection was only 3 months.Time since first intercourse (months)Collins et al. Br J Obstet Gynecol 2002;109:96
50 Clearance of HPV Infections Over 2 Years Percent HPV InfectedOn this graph you can see how quickly HPV infection goes away on its own without treatment. The line follows the clearance of HPV infections over 2 years.These data are from a study of young women infected with HPV who were tested multiple times for about 24 months. As you can see, by 2 years, 90% of women infected with HPV, completely cleared their infection. The median persistence of any specific HPV type was only about 6 months.HPV infection clears as a result of a healthy immune response which then provides type-specific protection from reinfection for at least 10 years.Time from HPV infection (months)Adapted from Brown et al. JID 2005:191;182
51 Low Risk Mucosal HPVs TYPES Most common: 6, 11 Others: 40, 42, 43, 44, 54, etcDISEASESGenital and oral wartsRespiratory papillomatosisLow grade cervical Pap abnormalitiesThe most common low risk mucosal HPV types are 6 and 11, which account for about 90% of genital warts. These HPVs can cause genital and oral warts, respiratory papillomatosis, an infection of the vocal cords in infants exposed at birth, and low grade cervical abnormalities on Pap tests.I’ll let you know here that the next 2 slides contain graphic pictures of the some of the diseases caused by low risk HPV types.
53 HPV Vaccine Efficacy in Preventing Precancer and Warts HPV DiseaseHPV 4HPV 2FEMALESCIN 2+98%Genital Warts100%---VIN/VaIN 2+MALESGenital warts90%AIN78%CIN = Cervical Intraepithelial Neoplasia AIN = Anal Intraepithelial NeoplasiaVIN = Vulvar Intraepithelial Neoplasia VaIN = Vaginal Intraepithelial NeoplasiaFuture II Study Group. N Engl J Med 2007;356(19):Garland SM et al. NEJM 2007;356(19):Paavonen et al. Lancet. 2009;374(9686):301-14Giuliano et al. NEJM 2011; 364:401-11Palefsky et al. NEJM 2011; 365:
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 doseMinimum intervals:Minimum time b/w 1st & 2nd = 4 wksMinimum time b/w 2nd & 3rd = 12 wksMinimum time b/w 1st & 3rd = 24 wksIf schedule is interrupted, the series does not need to be restartedHPV vaccines can be given simultaneously/before/after other vaccinesIf possible, the same product should be used for all doses in the seriesNo change in cervical cancer screening recommendationsMMWR, May 28, 2010; 59(20): ,
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: (Merck) or (GSK vaccine)Contraindications: allergy to vaccine component, severe illnessQuadrivalent HPV vaccine contains yeast antigensBivalent HPV vaccine in prefilled syringes contraindicated for persons with anaphylactic latex allergy Adverse reactions should be reported to VAERS: orMMWR, May 28, 2010; 59(20): ,
56 Vaccine Funding Programs Vaccines for Children ProgramUp to age 18, Medicaid eligible, uninsured or underinsuredReceiving immunizations through a Federally Qualified Health Center or Rural Health Clinic, orNative American or Alaska NativeMerck Vaccine Assistance ProgramAge ≥ 19, low income, and no health insurance coveragePhone number (8a-8p EST)Merck Dose Replacement ProgramVaccine doses provided but not reimbursedhttps://www.drp4gardasil.com/Site/Home.aspxGSK Vaccines Access ProgramAge 19-25, income eligible, and no heath insurance
58 7. Offer Management for Recurrent/Persistent Vaginitis Challenges in Managing VaginitisPatient factorsSelf-treatment may preclude diagnosisClients seek help from multiple providersProvider factorsUnder-utilization of available testsInsensitive clinic-based testsDependent on provider skills
59 Bacterial Vaginosis Decrease in lactobacilli Polymicrobial overgrowthEnzymes degrade the protective effects of cervical mucus and immune factorsMost common cause of vaginitisSequelaeSAb, PROM, PTL, PTDIncreases susceptibility to HIV, HSV, trichPathogenesis is unclear; Recurrence is commonIs BV an infection?What is the microbial cause?What is the association with sexual activity?Photo: Seattle PTC
62 Bev….. “I have BV again!”Recurrence rates as high as 30% at 3 months and 80% at 9 monthsEtiology unclearResistance?Re-infection?Unrecognized trigger?Failure of lactobacilli to recolonize?ManagementConfirm diagnosisCondomsNo douchingIntermittent metronidazole gel (twice a week intravaginally)
63 Recurrent BV: Success with Suppressive Treatment RecurrenceMTNZPlaceboP valueProphylactic phase (4 mo)Clinical13/51 (26%)26/44 (59%)<.001Gram Stain8/45 (18%)14/35 (40%).03Observation phase (3 mo)Clinical26/51 (51%)33/44 (75%).02Gram Stain17/45 (38%)17/35 (49%).33Sobel JD et al, Am J ObGyn. May 2006
64 Candice…….Majority of women have no predisposing or underlying conditionsNon-albicans more commonPathogenesis is unclearDeficient host response?Overactive host response?Relapse/reinfection?Photos; Mosby STD Atlas 1997 and Seattle STD/HIV PTCInitial TreatmentLonger regimen of topical therapy (7-10 d)Fluconazole (100 mg, 150 mg, or 200 mg) p.o. every 3rd d x 3Maintenance RegimensFluconazole (100 mg, 150 mg, 200 mg) qw x 6 mOR if not feasibleTopical antifungals used intermittently
65 Trixie….. CDC Consult & T. vaginalis susceptibility (404-718-4141) First treatment failure, re-treat with:Metronidazole 500 mg PO BID x 7 daysIf repeat failure, treat with:Metronidazole 2 g PO x 5 daysTinidazole 2 g PO x 5 daysSusceptibility testing: send isolate to CDCCDC Consult & T. vaginalis susceptibility( )
66 Diagnostic tests for Trichomonas BioMed DiagnosticsNeeds incubatorRead at 3 and 5 daysSekisui DiagnosticsCLIA-waivedResults in 10 minutes83% sensitive comparedto cultureGen-Probe APTIMATrichomonas vaginalis AssaySame specimen types as forother APTIMA testsClose to 100% sensitive;Slightly less sensitive using urineOver 99% specific
67 Trich in HIV + Women Screen on entry to care Retest at 3 months after treatmentConsider metronidazole 500 mg p.o. bid x 7d instead of stat dose
69 Treatment Options with “Azole” Allergy Consult with specialistMetronidazole desensitizationHelms et al, Am J Obstet Gynecol 2008Perlman et al, Am J Obstet Gynecol, 1996Kurohara et al, j Allergy Clin Immunol, 1991Paramomycin vaginal insertsnot as effective
70 8. Encourage Good Old Condoms! And last but certainly not least, 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 ChangeGoal: 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?
77 STD Reporting to Public Health Which diseases?Syphilis within 1 dayHIV/AIDSChlamydia, including LGVGonorrheaChancroidPelvic Inflammatory Disease (PID)By whom?Provider and LaboratoryTo whom? The jurisdiction where patient residesHow? CMR to be completed by the providerWithin7 days
78 Partner Management Provider Responsibility The clinician should:Attempt to determine the source of infectionDetermine the intimate and sexual contacts of the infected patientMake an effort with patient to bring in those contacts for exam and treatmentPersons determined as source of infection but not under treatment within 10 days of infection should be reported to the health officerEPT is allowable for CT, GC, and trichomoniasisCCR 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 permissionAs 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 confidentialityParents are not liable for costs of STD careReporting requirements for non-consensual (and “unlawful”) sexual activityCA Family Code §6926
80 Valacyclovir Group (N=743) Transmission of HSV-2 to Susceptible Partners is Reduced with Once-Daily Suppression1484 heterosexual couples randomized to 500 mg of valacyclovir vs placebo once daily for 8 monthsMonthly serum samples collected from susceptible partnersValacyclovir group showeddecreased transmissionlower frequency of sheddingfewer copies of HSV-2 DNA when shedding occurredValacyclovir Group (N=743)Control Group (N=741)Corey et al, NEJM 2004; 350(1):11-20.
81 Gardasil or Cervarix: Which is better? BOTH HPV Vaccines:Effective in preventing 16/18-related cervical dysplasiaGood safety profileHigh costGardasil advantages:Protects against 6/11-related genital wartsLicensed for malesIndications vulvar/vaginal dysplasiaCervarix advantages:Higher titer levelsMay give greater cross-protection against other oncogenic HPV typesEffectiveness data for preventing persistent re-infection