North Dakota Expedited Partner Therapy Guidelines Julie Wagendorf, M.S. North Dakota Department of Health (701) April 12, 2012 HIV/AIDS/STD/TB /Hepatitis Symposium

Overview Context and Background Expedited partner therapy (EPT) definition and principles Evidence of EPT efficacy and effectiveness NDDoH EPT Guidance: Implementation of EPT as a strategic option 2

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Historical PN “Contact tracing” ▫Even in the absence of therapy, useful for interrupting transmission (1930s) ▫In conjunction with therapy, rapid drop in syphilis (1940s and 1950s) ▫Conducted largely by trained public health staff 4 Seems to work for syphilis between

Partner Referral Approaches Self referral or patient referral (Chlamydia) ▫Patient is intended to notify partners of exposure (with varying levels of provider encouragement) Provider referral (NDDoH field staff refer all GC and syphilis partners; only prioritized Chlamydia cases) ▫A public health professional elicits partners’ identifying information and contacts and notifies partners Contract or conditional referral ▫Patient gets initial chance to contact and notify partners, but professional will do so if patients do not (within a specified time frame) BYOP 5

CT/GC Partner Management Options: 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

Definition and Principles Questions so far?

Expedited Partner Therapy Core elements ▫A STD that is treatable via oral medication ▫A point of origin in which medications or prescriptions can be disbursed ▫A mechanism through which can be brought to sex partners of infected people 8 CDC. Expedited partner therapy. 2006

Legal Status of EPT by Jurisdiction, U.S. 9

ND Administrative Rules Changes Effective January 2009 Board of Pharmacy: Board of Nursing: Board of Medical Examiners:

Selecting Appropriate Patients Patients with partners who are unable or unlikely to seek prompt clinical services Partner lacks a primary care provider Partner faces significant barriers to accessing clinical services Partner is unwilling to seek care 11

When EPT is not appropriate Patients co-infected with STDs that are not covered by EPT medications Cases of suspected child abuse Sexual assault or abuse Any situation in which the patient’s safety is in doubt 12

Options for EPT Partner Delivered Partner Therapy (PDPT) Partner Delivered Prescriptions Field Delivered/Directly Observed Therapy (FDT/DOT) – Last resort ▫Any gonorrhea case ▫Prioritized chlamydia  re-infections  pregnant females – partners who are pregnant should seek care as soon as possible. EPT for should be a last resort 13

EPT Referral Strategies Basic Strategy (1) Patient referral or self referral ▫Patient is intended to notify partners of exposure (with varying levels of provider encouragement) (2) Provider referral ▫Provider (meaning public health staff as default) is intended to notify partners of exposure EPT “addition” (1) PDPT or pharmacy based ▫Patient carries prescription or medication for partner along with instructions (2) Field-delivered therapy ▫Provider notifies and delivers prescription or medication (plus instructions, etc.) 14

Efficacy and Effectiveness Questions so far?

16 Dear Colleague letter May 11, 2005 “CDC has concluded that EPT is a useful option to facilitate partner management, particularly for treatment of male partners of women with chlamydial infection or gonorrhea.”

August 2011 “The American College of Obstetricians and Gynecologists supports expedited partner therapy in the management of gonorrhea and chlamydial infections when the partner is unlikely or unable to otherwise receive in-person evaluation and appropriate treatment. “ “Clinicians practicing in states where expedited partner therapy is legal should use it for eligible patients. “ 17

Expedited Partner Therapy: Should gonorrhea be included? “Neisseria gonorrhoeae with Reduced Susceptibility to Azithromycin - San Diego County, California, 2009” MMWR, May 13, 2011 Cephalosporin Susceptibility Among Neisseria gonorrhoeae Isolates --- United States, 2000— 2010, MMWR, July 8, 2011 / 60(26);

3 Changes to Gonorrhea Treatment in Ceftriaxone IM preferred over oral cephalosporins 2.Ceftriaxone dose increased to 250 mg 3.Dual treatment for chlamydia regardless of test result CDC 2010 STD Treatment Guidelines

Gonorrhea Treatment Uncomplicated Genital/Rectal Infections Ceftriaxone 250 mg IM in a single dose Cefixime 400 mg orally in a single dose Azithromycin 1 g orally or Doxycycline 100 mg BID x 7 days OR, if not an option: PLUS* * Regardless of CT test result CDC 2010 STD Treatment Guidelines

Gonorrhea Treatment Oropharyngeal Infections Ceftriaxone 250 mg IM in a single dose Azithromycin 1 g orally or Doxycycline 100 mg BID x 7 days PLUS CDC 2010 STD Treatment Guidelines

Gonorrhea Treatment using EPT Cefixime 400 mg orally in a single dose Azithromycin 1 g orally PLUS* * Regardless of CT test result CDC 2010 STD Treatment Guidelines

Potential risks of EPT for GC  Pharyngeal infections may not resolve  Infections caused by isolates resistant to oral cephalosporins may remain untreated  Use of oral cephalosporins may contribute to the emergence of antimicrobial resistance

Pharyngeal infection counseling Cefixime 400 mg plus azithromycin 1 g used for EPT are not as effective for treating pharyngeal GC infection compared with an injection EPT medication may not cure pharyngeal GC Partners at risk (hx of performing oral sex on a man) should be seen by a medical provider 24

Treatment Efficacy for Uncomplicated Anogenital Gonorrhea DRUG AND DOSEEFFICACYLower 95% CI Ceftriaxone 250 mg IM99%>95% Ceftriaxone 125 mg IM 99%98% Cefixime 400 mg PO98%95% Cefpodoxime 400 mg PO 97%94% Cefuroxime 1 g PO96%94% Azithromycin 2 g PO99%97% Azithromycin 1 g PO98%96% Moran JS, Levine WC. Clin Infect Dis 1995;20 Suppl 1:S47–S65. Newman LM, Moran JS, Workowski KA. Clin Infect Dis 2007;44 Suppl 3:S84–101.

Treatment Efficacy for Pharyngeal Gonorrhea DRUG AND DOSEEFFICACYLower 95% CI Ceftriaxone 250 mg IM99%94% Ceftriaxone 125 mg IM94%86% Cefixime 400 mg PO92%75% Azithro 2 g PO96%76%* Cefixime 400 mg PLUS Azithro 1 g PO 100%92%** Moran JS, Levine WC. Clin Infect Dis 1995;20 Suppl 1:S47–S65. Newman LM, Moran JS, Workowski KA. Clin Infect Dis 2007;44 Suppl 3:S84–101. * Dan M, Poch F, Amitai Z, STD, 2006;33 (8); small sample size N=21. ** L. Newman, unpublished data; small samploe size N=36.

Which statement do you most strongly agree with? 1. EPT should NEVER be used to treat partners exposed to GC. 2. EPT for GC is acceptable if used SELECTIVELY for partners who would not otherwise be treated. 3. EPT for GC is safe and effective and should be ROUTINELY OFFERED to patients diagnosed with GC. 4. I am UNDECIDED about whether EPT should be used to treat partners exposed to GC.

Affirmative Position: EPT for GC should be available* as a tool to treat partners of GC+ patients when other treatment options are not feasible or effective. * i.e., EPT should not be first line strategy

Establishing Efficacy: Key Outcomes Effect on clinically relevant outcomes establishes EPT efficacy ▫Index patient re-infection rates ▫Treatment rates ▫Patient and partner behaviors These are the same outcomes by which one would judge any PN intervention or program 29

Golden M, et al. N Engl J Med 2005 Feb 17;352(7): GONORRHEA P=.02 CHLAMYDIA P=.17 Randomized Trials: EPT Impact on GC and CT Re-Infection Rates

Implementation Questions so far?

CDC Guidance 32 From the 2006 Review and Guidance See also: 2010 STD Treatment Guidelines Recommendations for Integrated Partner Services

33 North Dakota Department of Health Expedited Partner Therapy of Chlamydia trachomatis and Neisseria gonorrhoeae: Interim Guidance for Medical Providers in North Dakota Revised April

Guidance for Use of EPT Heterosexual males and females ▫Gonorrhea and chlamydial infection ▫Accompany with written instructions  How to take meds, allergies, seek evaluation Men who have sex with men – not recommended for EPT ▫More caution (fewer data, more HIV comorbidity, risk for syphilis) 34

EPT Tool Kit STD self-interview form Drug fact sheets Disease fact sheets Referral cards Important Medical Information booklet 35

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37 Referral Contact Card ____You have test positive ____Your sex partner has tested positive For ____________________(Disease) at ____________(Facility) on ______(Date). This is a sexually-transmitted disease, and can be serious if left untreated. A confidential exam and treatment are available on a walk-in basis at: xxxxx Photo identification required Please call xxxx for clinic hours and information For appointment, call xxxx

Barriers to coverage: What gets in the way? Who pays? Information about the partner is second hand Documentation Provider liability 38

Barriers to EPT cited in the field A diagnosed pt may refuse to deliver meds or a prescription to a partner because s/he: ▫Does not know or has no locating info ▫Does not like the partner ▫Is afraid of the partner 39

Concerns Raised about EPT PATIENTS Missed opportunities for diagnosis of HIV/STD Complicated infections undertreated Adverse effects of drugs (allergy, toxicity) Drug exposure to fetuses PROVIDERS Misuse or waste of drugs Misuse by providers as 1 st line strategy Medicolegal risks PUBLIC HEALTH Cost and funding challenges Drug delivery and packaging

Why we need EPT options for partners exposed to CT and GC  Non-treatment of partners exposed to CT/GC leads to personal and public health problems  Partner treatment is inadequate and alternatives to current methods are needed  EPT is a safe and effective alternative  Benefits outweigh potential harms and harms can be mitigated

Contact information Julie Wagendorf ▫(701)