Presentation on theme: "Expedited Partner Therapy (EPT) for Gonorrhea & Chlamydial Infection"— Presentation transcript:
1 Expedited Partner Therapy (EPT) for Gonorrhea & Chlamydial Infection Matthew R. Golden MD, MPHCenter for AIDS & STD, University of WAPublic Health – Seattle & King County
2 Overview Background on development of EPT Overview of data from randomized trialsBarriers to EPTCommunity-level scale-up
3 Gonorrhea — Rates: United States, 1941–2006 and the Healthy People 2010 target Note: The Healthy People 2010 target for gonorrhea is 19.0 cases per 100,000 population.
4 Chlamydia — Rates: Total and by sex: United States, 1987–2006 Note: As of January 2000, all 50 states and the District of Columbia had regulations requiring the reporting of chlamydia cases.
5 Chlamydia in Minnesota Rate per 100,000 by Year of Diagnosis, 1992-2007
6 Figure 35. Nonspecific urethritis — Initial visits to physicians’ offices by men: United States, 1966–2000
7 Adjusted chlamydia prevalence in Infertility Prevention Project (IPP) clinics & gonorrhea incidence,Y axis for chlamydia prevalence on left side, for gonorrhea incidence on right sideChlamydia in yellow, gonorrhea in redR2=0.95
8 Chlamydia — Positivity Rates by Age and Gender MIPP† Clinics, 2002-2007 † The Minnesota Infertility Prevention Project (MIPP) is a project funded by the CDC to provide STD testing and treatment to uninsured men and women ages Participating clinics include STD, family planning, adolescent, and community clinics.
9 Pelvic inflammatory disease — Hospitalizations of women 15 to 44 years of age: United States, 1980–2003
10 Pelvic inflammatory disease — Initial visits to physicians’ offices by women 15 to 44 years of age: United States, 1980–2004Note: The relative standard error for these estimates ranges from 19% to 30%.SOURCE: National Disease and Therapeutic Index (IMS Health)
11 Ectopic pregnancy — Hospitalizations of women 15 to 44 years of age: United States, 1980–2003
12 Racial Disparities in a Probability Sample of American Adolescents JAMA 2004:291:2229ChlamydiaGonorrheaRisk Ratio
13 Gonorrhea Rates by Race/Ethnicity Minnesota, 1997-2007 * Persons of Hispanic ethnicity can be of any race.
14 Gonorrhea & Chlamydia in the U.S. Circa 2008 Gonorrhea rates are very low relative to the sChlamydia probably dropped with the introduction of screeningMajor morbidity from gonorrhea and chlamydia is way downBurden of disease is now probably roughly stableDramatic racial disparities persistAdditional progress will require new approaches
15 Strategies to Improve the Control of Bacterial STD Primary prevention – behavior changePrimary & secondary prevention - Case-finding & treatmentIncrease screeningRescreening – retest those with an STD at 3 monthsImprove partner treatment
16 Partner NotificationProcess of notifying the sex partners of persons with an STD and assuring their treatmentPublic health authorities developed partner notification programs in the 1940s for syphilisPublic health advisors interview people with STD and notify their partnersGrowth in the 1960s and 70s and assumed some responsibility for gonorrheaContraction in the 1980s – tentative response to HIV, no response to chlamydia
17 PN: Data from mathematical models Source: Am J Epi 2001;153:90
18 Percent Interviewed for PN Percentage of Cases of STD/HIV Interviewed for PN in High STD/HIV Morbidity Areas of U.S., & 2006Percent Interviewed for PNSources: STD 2003:30:490, STD 2004;31:709, unpublished
19 Could We Provide DIS Services To Everyone with a Reportable STD? ~ 1.5 million cases of HIV, syphilis, gonorrhea, and chlamydia reported annually in U.S.~2800 Disease Intervention Specialists (DIS) to provide services to 75% of cases~ $200 million annually for DISCDC STD budget = $108 million in 2007
20 Chlamydia partner notification practices among private sector providers in King County (n=150) PercentTold patient to notify partnersKnows all partners treatedGave patient medication for partnersSource: STD 1999;26:543-7.
21 Outcomes of partner notification for gonorrhea and chlamydial infection by patient referral % partners evaluated51%62%68%53%40%65%49%City (yr)Colorado 1977Colorado 1985Canada 1992London 1994Amsterdam 1997Seattle 2001Indianapolis 2002France 2002Number93336837254440698241145STDGCCTGC/CTGC/CT/NGU/TVAny STD
22 Expedited Partner Therapy (EPT) Global term for process of treating partners without their mandatory prior examinationPatient delivered partner therapy (PDPT) – index patient gives meds to partnersMost common form of EPT
23 Pt delivered prescription Proportion of women “reinfected” with Chlamydia trachomatis based on partner notification practices: Swedish observational dataPercentNo PNPt. referralConditional referralPt delivered prescriptionSource: Int. J STD & AIDS 1991;2:116
24 Proportion of patients with chlamydial infection to whom physicians give medications for their sex partnersPercentNeverSometimesHalfUsuallyAlwaysSource: Sex Trans Dis 2005;32:101N=2,538 CT N=1,873 GC
25 3 RCTs of Expedited Partner Therapy (EPT) StudyPopulationInterventionOutcomeFollow-upMulti-city CT in ♀11787 Women screened CT+ – mostly FP clinicsPatient-delivered partner therapy (PDPT)Partner treated*Infection at 1& 4 months90% 1 month55% 3-4monthsSeattle CT/GC2Population-based2751 Men & WomenAll offered assistance1) PDPT2) Partners contactedby hlth. dept. offereddirect RxInfection at 3-4 months68% at weeksNew Orleans urethritis3977 STD clinic patients2 Interventions1) Informational booklet2) PDPT- Partner treated*- Infection at 1-2 months85% Interview30% specimenScotland CT303 Women in STD, FP and Abortion clinics2) Mailed specimenPartner treatedInfection w/in 12 months65%* Partner treatment per participant report in all studies except ScotlandSources: Schillinger et al Sex Transm Dis 2003;30:491, Golden et al NEJM 1992;352:6762, Kissinger et al Clin Inf Dis 2005;41:6233, Cameron ST et al, Num Reprod 20094
26 Partner treatment per index patient report PercentP=.001Source: NEJM 2005;352:676
27 Infection during follow-up among 1860 persons completing the randomized trial PercentN=358N=1595N=1860Source: NEJM 2005;352:676
28 Impact of PDPT on Index Patient GC/CT Reinfection in 4 Randomized Controlled Trials 3.560.190.540.741.320.380.760.80.590.620.981.050.1110Log Odds RatioCT in women (CDC multi city trial)GC or CT in men or women (Seattle)Urethritis in men (New Orleans)CT in women (Scotland)
29 New Orleans urethritis PDPT 86% 64% 56% 94% Control 57% 52% 34% 78% Impact of PDPT on Index Patient Report that Partner was Treated in 4 Randomized Controlled TrialsStudyMulti-city CT in ♀Seattle CT/GCNew Orleans urethritisScottish CT in ♀*PDPT86%64%56%94%Control57%52%34%78%P-value0.0010.02* Outcome is all partners contacted, not treated
30 Subgroup Analysis: Reinfection Partner Study PercentRelative risks associated with receipt of standard careSources: Golden et al NEJM 1992;352:6762 (unpublished data)
31 Subgroup Analysis: Percentage of Partners Treated Relative risks associated with receipt of EPTSources: Golden et al NEJM 1992;352:6762 (unpublished data)
32 CDC & Professional Activities Related to EPT Date5/052/066/068/0610/62008CDC Dear Colleague LetterExpedited Partner Therapy Review & Guidance DocumentAmerican Medical Assoc. Statement on EPTLegal Status EPT EvaluationSTD Treatment GuidelinesCDC EPT WebsiteNew Partner Notification GuidelinesAm. Acad. Pediatrics Supports EPT
33 Barriers Is this legal, and what is my liability? Is this an acceptable standard of medical care?Will EPT promote antimicrobial resistance?Is this ethical?
34 Legal Status of EPT in the United States WAMEMTNDMNORNYIDWISDMIWYPAIANEOHILINUTWVNVCOVACAKSMOKYNCTNOKSCARAZNMMSGAALTXLAAKFLHIEPT PermissibleEPT ProhibitedEPT legal status uncertainEPT newly legalSource: Adapted from Hodge JG. AJPH 2008;98:236EPT under consideration
35 Legal Issues in MN“Nothing in this chapter prohibits a licensed practitioner from issuing a prescription or dispensing a legend drug in accordance with the Expedited Partner Therapy in the Management of STD guidance document issued by the US CDC.”CDC recommends that EPT when other management options are impractical or unsuccessful
36 Legal Issues Information to provide with EPT Name of original patient sufficient in MNInformation about medications & STDAdvice about complications and need for care (e.g. PID)Where to seek care
37 Information in MNMN Dept Health has information sheets on their website that can be distributed with medications
38 Liability You can always be sued Are you acting in a manner that is consistent with standards of care in your community?Can you be sued for not providing EPT?
39 Is EPT a Good Standard of Care? A complete evaluation of all partners would be bestAre we missing concurrent diagnoses?Are we placing partners at significant risk of adverse drug reactions?
40 Men who Have Sex with Men STD diagnoses in persons presenting as contacts to gonorrhea, chlamydia or NGU/MPC Seattle, Baltimore, Birmingham and DenverWomen(n=2507)3.9%3.7%<0.1%Heterosexual Men(n=3511)3.1%NA0.2%Men who Have Sex with Men(n=460)6.1%NA5.5%0.4%Gonorrhea*PIDNew HIVEarly Syphilis* GC excludes contacts to GC.Source: CID 2005;40:787
41 Adverse Drug Reactions Anaphylaxis to macrolides is very rarePCNAnaphylaxis with cephalosporins is rare ( %)~10% of people report having a PCN allergyCross reactivity to 3rd gen cephalosporins 1-3%Only avertable reactions are those occurring in persons with a known allergy who take meds despite written warningsNo cases anaphylaxis to date in CA and WA
42 Antimicrobial Resistance No known chlamydial resistance to azithroCephalosporin resistant GC very uncommon is U.S.Some evidence rising MICs in JapanStandard of care is to treat contacts to GC & chlamydia without awaiting test resultsEPT primarily increases antimicrobial use by increasing appropriate treatment of partnersIn 2005, 55 million prescriptions for Azithro; 3 million cases of chlamydia in U.S.
43 Ethics Respect for Patient Autonomy Beneficence Nonmaleficence Justice Insofar as RCTs show decreased reinfection in index cases given EPT, EPT is a superior standard of careIs EPT better for the partner? Can partners make an informed decision?
44 EPT Guidelines CDC CA MN WA Heterosexual GC & CT “Can be used as an option when other management strategies are impractical or unsuccessful.”Partners who are “unable or unlikely to seek timely treatment”Most appropriate for partners who are unable or unlikely to seek prompt clinical services.Give if partner treatment “not otherwise assured”MSMGC & CTShould not be considered a routine partner management strategyNo different recommendation – acknowledges potential riskNot recommended as routineMSM should be referred to health Dept.TrichomonasNot addressed
45 California State EPT Program Guidelines promulgated and published(Sex Transm Dis 2007, epub)Paying for EPTMedicare waiver to pay for PDPT deniedState bulk purchasing medication for PDPT for Infertility Prevention Program clinicsCDC funded evaluation in family planning clinics
46 CA Family Planning Clinic Evaluation: Association of Treatment Outcome with Management Strategy by Relationship TypePartner Notification Method EmployedPercentage Partners Treated, by Index Case ReportSource: Yu CDC STD Prevention Conference
47 Source: Yu. 2007 CDC STD Prevention Conference Association of Treatment Outcome with Management Strategy by Relationship TypePartnerManagementStrategySteady Partner(n=551)Non-steady Partner(n=404)OR (95%)*OR (95%CI)*BYOP3.6 ( )3.5 ( )PDPT2.8 ( )6.0 ( )Patient referral1.4 ( )2.0 ( )None1.0*OR adjusted for patient’s age and race/ethnicitySource: Yu CDC STD Prevention Conference
48 Steps in Developing and Implementing A New Public Health Intervention Evaluate Existing System & Literature on AlternativesDesign InterventionConsider Feasibility for Wide-Spread ImplementationIndividual Level Randomized Controlled TrialsCost-Effectiveness Analysis (relative CEA)Re-Design Intervention for Scale-upModel Population-Level ImpactCommunity-Level RCT
49 Scheme of PN Barriers & Interventions Index patient diagnosed & treatedPartner NotifiedPartner TreatedBARRIERSDoesn’t know partner(s)Doesn’t like partner(s)Can’t reach partner(s)Afraid of partner(s)Access to care(clinic hrs, transportation)Partner asymptomatic - not concernedINTERVENTIONDIS Pt Delivered Rx
50 Proportion of Patients with Untreated Partners at Time of Study Interview Percent with untreated partnerDays Between Treatment & InterviewSource: STD 2001;28:658Risk factors: > 1 sex partner 60 days or pt does not anticipate sex with partner in future
52 Association of PN Plan on Case Report Form with PN Outcomes PercentSource: Golden et al. Sex Transm Dis 2007;epub* Limited to persons contacted >7 days after treatment
53 Percentage of Persons with Gonorrhea or Chlamydia in King County Given PDPT by Their Diagnosing ProviderPercentUse of PDPT remained significantly greater in the (OR 3.2, 95% CI ) compared to after adjusting for diagnosing site, gender, GC vs. CT, and the presence of case report risk factors for PN failure
54 Estimated Percentage of Persons Assuring the Treatment of All of their Sex Partners Among All Cases* of Gonorrhea or Chlamydial Infection in King CountyPercentNo InterventionIntervention without Direct Public Health AssistanceIntervention Including Direct Public Health Intervention* Nonincarcerated heterosexuals
55 Assessment of Community-Wide EPT: Simulation Model 50% → 60% partners treated15 realisations, thick line is median. Includes annual Ct screening of 25% of women aged <26.10% increase in partner treatment results in a ~25% reduction in CT prevalence at 2 years, and a ~50% reduction in 4 years
56 Chlamydia Positivity in Women Tested in IPP Clinics in King County and WA State Outside of King County,Percent infectedPHSKC Institutes Free EPT and Case-Report Based Partner Notification TriageEPT RCT BeginsPHSKC Recommends EPTTime
57 WA State EPT Community-Level Randomized Trial Stepped-wedge community-level randomized trialUnit of randomization = health jurisdiction (n=24)Timing of program institution is randomly assigned as “steps”Every ~6 months - 1st step 9/07, 2nd step 5/08, 3rd step 12/08InterventionCase-report based triage of cases for assisted partner notificationFree PDPT distributed via large clinics & commercial pharmaciesCase report form has prescriptions preprinted for faxingOutcome = Prevalence of chlamydia in sentinel clinics (IPP), reportedincidence of gonorrhea in women
58 Cases with at Least One Partner Treated via EPT from the Diagnosing Provider, WA State EPT Community-Level Trial Waves 1 and 2Wave 2 Intervention BeginsWave 1 Intervention BeginsPercent
59 Preliminary Outcomes: Wave 1 Communities, WA State EPT, Proportion of Partners Notified and Treated PercentOutcomes restricted to persons interviewed >7 days post treatment. Adjusted for demographic factors.
60 ConclusionsExpedited partner therapy (EPT) decreases reinfection rates and increases the proportion of partners treated per index patient reportEPT is legal in MN, but requires that you dispense information for partnersEPT can be introduced into a diverse large communities and appears to have a population-level effect on the proportion of all partners treatedThe population-level of effect of EPT on the occurrence of STD or STD associated morbidity, like that of other STD interventions, has yet to be proven