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Expedited Partner Therapy EPT: To Be or Not To BE? Charlotte A. Gaydos, MS, MPH, DrPH Professor Division of Infectious Diseases Johns Hopkins University Baltimore, Maryland, USA North American Region of IUSTI Global IUSTI Meeting Melbourne, Australia 14-17 October 2012 Introduction •EPT or Expedited Partner Therapy is the treatment of sex partners exposed to a treatable STI without a clinical evaluation from a health care provider. The intervention is also called Patient-Delivered Partner Therapy (PDPT). •Controversial •Should/How can we integrate it into practice? •Pros and cons and legal issues. •Can advocacy move this treatment method into practice? Objective • Review EPT practice in the United States as a partner treatment option Overview • Expedited Partner Therapy: • basics & national perspective • Research and evaluation history – what we know (and what we don’t know) • Issues to consider while making policy on EPT: • Inclusion and exclusion of populations and infections • Note on antibiotic resistance (gonorrhea) • CDC Guidance and Resources EPT definition and core elements •Overview: practice of treating the sex partner of individuals with an STI without intervening medical evaluation or professional counseling Implementation is through patient • Core elements An infection that is treatable via oral medication A recognizable point of origin in which medications or prescriptions can be disbursed A mechanism through which therapy can be brought to sex partners of infected people * CDC. Expedited partner therapy in the control of sexually transmitted diseases. 2006 Case • Suzie Green, age 17, has been diagnosed with chlamydia in your clinic. She is devastated and wants her treatment right away. When Dr. Black informs her that she could get reinfected again if her partner does not get treated, she states she is afraid that her boyfriend Joey, age 18, will never go to a clinic to get treated, since he does not have any symptoms. Suzie asks Dr. Black if she can’t just give her medicine for Joey too, as she is sure that he would take it. Dr. Black thinks this is a good idea. Can Dr. Black give her EPT for Joey in your state legally? • What can Dr. Black do to find out if this is legal in her state? • If not, or if the area is “gray”, what can Dr. Black do to advance legislative efforts to make this practice legal? How does she identify stakeholders or coalitions to help? How does she set the “wheels into motion”? Who else should she enlist to help her in this effort? • How does she find research that can inform policy through advocacy efforts? Methods •Models of EPT have been studied and implemented in the United States since 2001. Strategy relies on clinicians giving either medications or prescriptions to index patients for his/her sex partner(s) •Object is to reduce infection rates and reinfection rates • Numerous national organizations and professional societies have endorsed EPT CDC (2006), American Bar Association American Medical Association Society for Adolescent Health and Medicine American Academy of Pediatrics American Congress of OB and GYN •Barriers exist such as state laws, pharmacy laws, and reimbursement practices. EPT in the context of partner notification and treatment • Provider referral with expedited partner therapy • “Field-delivered therapy.” The public health investigator seeks the partners of infected persons, notifies them, makes referrals for evaluation and care and brings therapy to the partners • Patient referral with expedited partner therapy • “Patient-delivered partner therapy.” (PDPT) The patient accepts and is entrusted with the task of notification and referral for services and brings therapy to his or her partner(s). Why EPT Approach to Partner Services? • Chlamydia screening recommendations have been in place for 18 years How successful has this been? What are the next steps for program improvement? Chlamydia Prevalence Among Women Aged 14-25 Years, NHANES, U.S., 1999– 2008 8 No change in prevalence over 10 years Prevalence 6 4 2 0 1999-2000 Datta et al, STD 2012 2001-2002 2003-2004 2005-2006 2007-2008 Chlamydia Prevalence • • Data suggest PID rates and prevalence in some populations decreasing Have not seen dramatic, continuing declines in chlamydia infection with control efforts • So what are the next steps? • Clearly room for improvement in screening coverage In many settings, coverage of eligible women low • Very few women are getting screened every year • But is expanding screening enough? How important are other strategies, such as EPT, better partner notification strategies, and treatment? Modeling: Effect of prevention strategies on chlamydia • Three strategies optimally reduced prevalence Increasing screening of women from 20% to 65% (25% partner treatment) Increasing partner treatment from 25% to 55% (20% screening coverage) Increasing screening coverage from 20% to 35% and partner treatment from 25% to 40% • Combined approach may be more effective and best use of resources Partner treatment interrupts transmission and is a critical component of chlamydia prevention Kretzschmar M, Satterwhite C, Leichliter J, Berman S. Effects of screening and partner notification on chlamydia prevalence in the U.S.: A modeling study. Partner treatment strategies • Traditional patient referral • Patient informs partner; up to partner to access treatment • Provider-assisted referral • Provider or public health staff contacts partner for treatment • Usually impractical for chlamydia and gonorrhea due to low staffing vs. very large number of cases • Expedited partner therapy (EPT) • Patient-delivered partner therapy (PDPT) • Field-delivered partner therapy • • “BYOP” – bring your own partner Web-based PN strategies One size does not fit all: A combination of strategies may be needed and may vary by clinical setting Results from 5 EPT RCTs Sample Outcome Re-infection Proportion of partners treated (EPT vs. (EPT vs. patient referrapatient referral Schillinger, females, CT RR 0.80 -2003 (N=1,454) (0.62-1.05) Kissinger, males, CT/GC OR 0.38 55.8% vs. 35.0 2005 (N=977) (0.19-0.74) (p=.001) Golden, males & femaleRR 0.76 RR 1.2 2005 CT/GC (0.59-0.98) (1.1-1.3) (N=1,833) Kissinger, females, RR 1.48 76.5% vs. 70.4 2006 trich (0.62-3.49) (p=0.36)* (N=463) Cameron, females, CT HR 1.32 42% vs. 34% 2009 (N=215) (0.50-3.56) (p=0.28)* * Per index patients' reports EPT can reduce repeat infections Trelle et al, BMJ 2007 EPT can increase partners treated Trelle et al, BMJ 2007 Trichomonas vaginalis A Randomized Controlled Trial of Partner Notification Methods for Prevention of Trichomoniasis in Women Jane R. Schwebke, MD, and Renee A. Desmond, PHD Background: Trichomoniasis is associated with adverse pregnancy outcomes and increased risk for human immunodeficiency virus. Methods: Women were randomized to self-referral of partners (PR), partner-delivered therapy (PDPT), or public health disease intervention (DIS) locating partners and delivering medication in the field, Test-ofcure visits were conducted at 5 to 9 days after enrollment. Repeat infections at 1 and 3 months of follow-up were the measure of effectiveness. Trichomonas vaginalis Results: A total of 484 women were randomized. Initial cure rates were 95.3%. At the 1- and 3-month follow-up visits, there was no significant difference in repeat infection rates when PDPT or DIS were compared to the reference of PR. However, when PDPT was compared to DIS or PR/DIS combined, at 1 month the PDPT group had a lower repeat infection rate (5.8 vs. 15% and 5.8 vs. 12.5%, respectively). Of these, 80% of women randomized to PDPT reported delivering medication and 89% thought it likely that partners took the medication. No serious adverse events were reported. Conclusions: PDPT for trichomoniasis was well accepted and safe. Rates of repeat infection in women in this intervention were lower than those in the DIS arm and DIS/PR arm combined although when compared directly to PR there was no significant difference EPT in an Urban Family Planning Clinic • • • • • 466 women infected with chlamydia and treated; 2004-5 in New York City EPT given to 323 (69.3%) 40% returned for retest at 3 months (4.8% reinfection rate) 74% retested within 1 yr. (reinfection rate 11.4% ) Patients who received EPT were as likely to be reinfected at 3 mo, as those not receiving EPT (O.R. 1.6, (95% CI 0.2-13.7) Kerns et al. STD 38:722-726, 2011 Concurrent Patient-partner Treatment in Pregnancy (BYOP) • 45 pregnant women w/ CT or GC received CPPT (cohort of 241) • 196 women treated and counseled on patient referred treatment strategy • CPPT shortened median time to cure (neg TOC) to 4.4 wk vs. 5.1 wk in patient referral • No repeat chlamydia infections in CPPT vs.19 18.1% in patient referral group Mmeje et al. STD 39:665-670, 2012 Patient preference for treating partner(s) of patients with a Chlamydia infection by sex (n 2693) and age (n 2677). Howard et al STD 2011;38:148-149 PDPT indicates patient delivered partner therapy Patient-reported percentage of partners treated, by partner management strategy and partner type, 8 family planning clinics, California 2005-06 BYOP PDPT Patient referral None 100 Partners Treated (%) 90 89 83 80 70 60 57 60 44 50 40 38 30 17 20 5 10 0 Steady partner (n=551) BYOP = “bring your own partner” Non-steady partner (n=404) Yu Y, Frasure J, Bolan G, et al. STD Prev Conf, Chicago 2008. Expedited Partner Therapy Legal Status August 2012 www.cdc.gov/std/ept. CDC and EPT • CDC has endorsed EPT as a useful component of comprehensive partner services • To prevent re-infection and curtail further transmission • May be the most practical, cost effective strategy to increase partner treatment for chlamydia/gonorrhea • To date, CDC’s efforts have focused primarily on encouraging EPT where legal and developing tools to support EPT implementation • Now we need to focus more on how to improve implementation of EPT and other partner services, including provider uptake Goal is to increase number of partners treated, quickly and efficiently, not just to “increase EPT”! Cost Effectiveness of EPT Gift STD 38: 1067,2011 Cost differences per index patient in terms of the cost for EPT minus the cost for SR for 10,000 iterations of the Monte Carlo simulation for Seattle. The cost difference per index patient is graphed versus the proportion of the index patient’s partners who receive care from the same payer as the index. Gift STD 38: 1067,2011 Negative values indicate that EPT is less costly .Trend lines for men (solid line) and women (dotted line). The points at which they cross the x-axis are the points at which the costs for EPT and SR are equal. Cost differences per index patient in terms of the cost for EPT minus the cost for SR for 10,000 iterations of the Monte Carlo simulation for New Orleans CDC Guidance • 2006 Review and Guidance document: Expedited Partner Therapy in the Management of Sexually Transmitted Diseases • http://www.cdc.gov/std/ept/default.htm • 2008 Recommendations for Integrated Partner Services • http://www.cdc.gov/nchhstp/partners/ • 2010 STD Treatment Guidelines • http://www.cdc.gov/std/treatment/ Clinical Guidance • • EPT: “…does not replace other interventions…” Consider EPT for heterosexual men and women with uncomplicated gonorrhea or chlamydial infection • With written instructions and demonstrable counseling • • • More caution for trichomoniasis (weaker efficacy in 2006 RCT) More caution for men who have sex with men (MSM) - fewer data, higher HIV comorbidity Last resort for syphilis Dear Colleague letter, May 2005; EPT report, 2006 (p34). Both at www.cdc.gov/std/ept. GC Antibiotic Resistance • 1930s – Sulfonamides • 1940s – Penicillins • 1970/80s – Tetracyclines • 2000 – Fluoroquinolones • 2000 – Reduced susceptibility to cephalosporins • 2009 – Ceftriaxone-resistant isolate identified in Japan Programmatic Guidance • Treat partners according to CDC treatment guidelines • For STDs for which single-dose oral therapy is feasible [i.e., (gonorrhea) and chlamydial infection], consider PDPT for partners who will not be notified via provider referral • Programs should be sure that all appropriate parties are consulted to ensure that any EPT strategy in the jurisdiction is medically and legally sound * CDC. Recommendations for partner services programs for HIV infection, syphilis, gonorrhea, and chlamydial infection. MMWR 2008. (pp. 37-9). PDPT, Notification and Treatment Ratios 100 90.3 Percentage 80 73.2 60 40 20 0 Per 100 Cases Notification Ratio Treatment Ratio Notification and Treatment Ratios for All Methods of Partner Notification 100 Percentage 80 60 Provider Referral Patient Referral PDPT 40 20 0 Per 100 Cases Notification Ratio Treatment Ratio Discussion: Maximum Prevention Impact as a Program Goal • What implications do these data have for the mix of partner notification interventions in STD prevention programs? Consider the costs associated with each approach Consider the ease of implementing each approach Consider the feasibility of increasing the efficacy of each approach Are the approaches independent of each other? • For prevention programs, this is a resource allocation question as well as an effectiveness question EPT Recommendations: 2010 Treatment Guidelines • Heterosexual patients with chlamydia (or gonorrhea): • If partners are unlikely to seek care, PDPT, a form of EPT, can be offered • PDPT packages should include treatment instructions, medication warnings, general health counseling, and statement advising partners to seek personal medical evaluation • • Nongonococcal urethritis (NGU) and mucopurulent cervicitis (MPC): EPT and patient referral are alternative approaches to treating partners MSM: EPT not routinely recommended Summary •In the United States, controversy exists as to its effectiveness and its legal status •EPT is permissible in 32 states and Baltimore, MD •EPT is potentially allowable in 11 states, the District of Columbia, and Puerto Rico •EPT is likely prohibited in 7 states •Using EPT has the added benefit of saving resources for health departments and clinicians EPT has traditionally been evaluated for CT/GC •Five clinical trials have demonstrated an overall relative risk of 0.73 in preventing reinfection rates Conclusion Overcoming barriers to the routine use of EPT will be of key importance to more extensive and effective use (To be) Combining EPT with other Partner Notification and prevention tools may provide the best results (To be better) Gonorrhea resistance & changes in CDC oral Rx guidelines will impact EPT for GC (Not to be) More widespread use of EPT with quality evaluation has the potential to prevent reinfections and eventually lower infections prevalences of chlamydia (To be) EPT To Be? Or EPT Not To Be? • Chlamydia: To Be • Gonorrhea: Not to Be Acknowledgments •Matthew Hogben •Rachel Gorwitz Resources: www.cdc.gov/std/ept Resources for those seeking to make policy around EPT National Center for HIV/AIDS, Viral Hepatitis, STD & TB Prevention Division of STD Prevention Expedited Partner Therapy Use of sexually transmitted infections research and its translation to inform policy makers Should/How can we integrate it into practice Pros and cons and legal issues. Can advocacy move this treatment method into practice? EPT implementation and coverage • • Where EPT is legal, how much is it being used? Data are limited, but suggest overall coverage still low outside of isolated settings Many providers have used EPT in past, but few do so frequently Source: Kissinger and Hogben, Curr Inf Dis Rep 2011. What we expected: Gonorrhea Rates, United States, 1941–2010 Rate (per 100,000 population) 500 400 300 200 100 0 1941 1946 1951 1956 1961 1966 1971 1976 Year 1981 1986 1991 1996 2001 2006 What we observed: Chlamydia Rates, United States, 1990–2010 Rate (per 100,000 population) 750 Men Women Total 625 500 375 250 125 0 1990 1992 1994 1996 1998 2000 2002 2004 2006 Year NOTE: As of January 2000, all 50 states and the District of Columbia have regulations that require the reporting of chlamydia cases. 2008 2010