EXPEDITED PARTNER THERAPY (EPT) IN THE TREATMENT OF CHLAMYDIA Jean Ann Davison, DNP, FNP-BC Clinical Assistant Professor at UNC-Chapel Hill & Hannah E. Schrum, MSN, FNP-BC Chlamydia trachomatis Chlamydia is a common sexually transmitted disease (STD) caused by infection with Chlamydia trachomatis bacteria. Very prevalent, often asymptomatic, but can present as Chlamydia Cervicitis in Women Source: St. Louis STD/HIV Prevention Training Center 1
Urethritis and Proctitis in Both Men and Women, often times dx as: Nongonococcal Urethritis (NGU) in men Source: Diepgen TL, Yihune G et al. Dermatology Online Atlas Why Focus on Chlamydia? More than one million new cases annually Responsible for causing cervicitis, urethritis, proctitis, lymphogranuloma venereum (LGV), and pelvic inflammatory disease Direct and indirect cost of chlamydial infections run into billions of dollars Potential to transmit to newborn during delivery Conjunctivitis, pneumonia Objectives for this presentation 1. Discuss the incidence and prevalence of chlamydia in terms of age and gender. 2. Explain the causes, risk factors and consequences of chlamydia infection. 3. Perform a sexual history, risk assessment and counseling for safe sex practices. 4. Reference current screening, diagnostic test and treatment guidelines. 5. Utilize treatment strategies such as expedited partner therapy (EPT) using pharmacology guidelines to decrease the incidence and prevalence of chlamydia 2
Incidence and Prevalence of Chlamydia Chlamydia is the most commonly reported STD in the US effecting an estimated 1 in 15 sexually active females ages 14-19 y.o. Often picked up during the USPSTF recommended screening of asymptomatic females (Centers for Disease Control and Prevention [CDC] 2014). Because males are not screened or routinely tested with the approved nucleic acid amplification tests (NAATs), their incidence and prevalence is often under reported. Chlamydia Rates in U.S. Women In 2011, there were 1,412,791 new cases of chlamydia reported Incidence and Prevalence of Chlamydia Prevalence of genital Chlamydia trachomatis* infection among persons aged 14 39 years, Prevalence among sexually active young women aged 14 24 years was 4.7% Male N = 4,181 prevalence = 1.4% Female N = 4,149 prevalence = 2.0% MMWR Sept. 26, 2014 http://www.cdc.gov/mmwr/pdf/wk/mm6338.pdf 3
Chlamydia Rates: Gender and Race Chlamydia Rates in US Incidence and Prevalence of Chlamydia MMWR Sept. 26, 2014 http://www.cdc.gov/mmwr/pdf/wk/mm6338.pdf 4
Risk Factors for Chlamydia Highest Prevalence with Unprotected Sex Sexually active young women (aged 14 24 years was 4.7%) Education less than High School or GED (2.7% compared to 1.1% if > high school). No. of sex partners in last year ( > 1 = 3.2% compared to 1 = 1.4%) Other characteristics: single > married; low income > higher income African American> Hispanic>White MMWR Sept. 26, 2014 http://www.cdc.gov/mmwr/pdf/wk/mm6338.pdf Consequences Chlamydial infection is a significant contributor to pelvic inflammatory disease (PID) in women, tubal factor infertility, ectopic pregnancy, and chronic pelvic pain. In Men: urethritis, proctitis Chlamydial infection can cause pneumonia and opthalmia neonatorum in newborns born to mothers who have untreated chlamydia. $$$$ Costs billions of dollars each year CDC, 2012a Sexual History & Risk Assessment The single most important rule is: To be non-judgmental Explain why you need to know certain data Find opening questions to sensitive topics Acknowledge your own discomfort Be culturally competent LISTEN 5
Sexual History, Risk Assessment and Counseling for Safe Sex Practices CDC recommends The five P s : Partners Practices Protection from STDs Past history of STDs Prevention of pregnancy These are the areas that you should openly discuss with all your patients. Physical exam should include: Observation of general appearance Inspection of skin and hair Inspection of the oropharynx Inspection of lymph nodes Inspection of genitalia Rectal exam when indicated. (Consider testing for other sexually transmitted infections Gonorrhea, syphilis and HIV based on history and risk factors) *Remember more than one infection may be present, more than one site infection and infection may be present without any symptoms. (The pocket reference guide for clinical evaluation and treatment of clients with sexually transmitted infections Laura Bachmann, 2011) Screening, Diagnostic Tests and Treatment Guidelines. Consider this case study: A 40 year old male presents with dysuria and states he had unprotected sexual intercourse with a new female partner two weeks ago. She told him she was diagnosed, and treated, for chlamydia one year ago. He states he would like to be screened for chlamydia. 6
USPSTF Sexual Behavioral Counseling and Screening Guidelines Sexually transmitted infections counseling Chlamydia screening: The USPSTF recommends intensive behavioral counseling for all sexually active adolescents and for adults who are at increased risk for sexually transmitted infections. The USPSTF recommends screening for chlamydia in sexually active women age 24 years younger and in older women who are at increased risk for infection. women Laboratory Tests for Chlamydia Tissue culture had been the standard Specificity approaching 100% Sensitivity ranges from 60% to 90% Non-amplified tests Enzyme Immunoassay (EIA), e.g. Chlamydiazyme sensitivity and specificity of 85% and 97% respectively useful for high volume screening false positives Nucleic Acid Hybridization (NA Probe), e.g. Gen-Probe Pace-2 sensitivities ranging from 75% to 100%; specificities greater than 95% detects chlamydial ribosomal RNA able to detect gonorrhea and chlamydia from one swab need for large amounts of sample DNA Laboratory Tests for Chlamydia (continued) DNA amplification assays polymerase chain reaction (PCR) ligase chain reaction (LCR) Sensitivities with PCR and LCR 95% and 85-98% respectively; specificity approaches 100% LCR ability to detect chlamydia in first void urine 7
2014 NAAT Testing; Preferred For Men 2014 NAAT Testing Some Health Departments Still test for Nongonococcal Urethritis NGU Etiology: 20-40% C. trachomatis 20-30% genital mycoplasmas (Ureaplasma urealyticum, Mycoplasma genitalium) Occasional Trichomonas vaginalis, HSV Unknown in ~50% cases Sx: Mild dysuria, mucoid discharge Dx: Urethral smear 5 PMNs (usually 15)/OI field Urine microscopic 10 PMNs/HPF Leukocyte esterase (+) 8
Case Study: A 40 year old male presents with dysuria and states he had unprotected sexual intercourse with a new female partner two weeks ago. She told him she was diagnosed, and treated, for chlamydia one year ago. He states he would like to be screened for chlamydia. You respond: 1. The USPSTF only recommends women be screened for chlamydia, so I will only do a urine analysis to test for a urinary tract infection. 2. Since you have been exposed to a partner who had a past history of chlamydia, I will treat you prophylactically with the appropriate antibiotic. 3. Because of your age, your urinary symptoms are most likely due to BPH, so I will do a prostate exam. 4. Because you are symptomatic, I would like to offer you a diagnostic test for GC and chlamydia. Case Study A twenty year old female tests positive for chlamydia during her routine pregnancy screening. She tells you her husband works construction, often out of town and leaves the house at 7am and returns in the evening. How would you handle his follow up/treatment? CDC 2010 Treatment Guidelines. Recommended Regimens Azithromycin 1 g orally in a single dose OR Doxycycline 100 mg orally twice a day for 7 days Alternative Regimens Erythromycin base 500 mg orally four times a day for 7 days OR Erythromycin ethylsuccinate 800 mg orally four times a day for 7 days OR Levofloxacin 500 mg orally once daily for 7 days OR Ofloxacin 300 mg orally twice a day for 7 days * Note must abstain from sexual intercourse for one week after treatment and partner should be treated at same time. 9
CDC 2010 Guidelines for Pregnancy Recommended Regimens Azithromycin 1 g orally in a single dose OR Amoxicillin 500 mg orally three a day for 7 days Alternative Regimens Erythromycin base 500 mg orally four times a day for 7 days OR 250mg po qid x 14 days Erythromycin ethylsuccinate 800 mg orally four times a day for 7 days OR 400mg po qid x 14 days * Note must abstain from sexual intercourse for one week after treatment and partner should be treated at same time. For pregnant women a test of cure is recommended at 3 weeks after tx. Treatment Strategies such as Expedited Partner Therapy (EPT) CDC guidelines for Management of Sex Partners Patients should be instructed to refer their sex partners for evaluation, testing, and treatment if they had sexual contact with the patient during the 60 days preceding onset of the patient s symptoms or chlamydia diagnosis. Although the exposure intervals defined for the identification of at-risk sex partners are based on limited evaluation, the most recent sex partner should be evaluated and treated, even if the time of the last sexual contact was >60 days before symptom onset or diagnosis. Expedited Partner Therapy (EPT) Among heterosexual patients, if concerns exist that sex partners who are referred to evaluation and treatment will not seek these services (or if other management strategies are impractical or unsuccessful), patient delivery of antibiotic therapy to their partners can be considered (see Partner Management). Compared with standard partner referral, this approach, which involves delivering a prescription or the medication itself, has been associated with a trend toward a decrease in rates of persistent or recurrent chlamydia (68,69,71). http://www.cdc.gov/std/treatment/2010/chlamydialinfections.htm 10
Expedited Partner Therapy (EPT) Patients must also inform their partners of their infection and provide them with written materials about the importance of seeking evaluation for any symptoms suggestive of complications (e.g., testicular pain in men and pelvic or abdominal pain in women). Patient-delivered partner therapy is not routinely recommended for MSM because of a high risk for coexisting infections, especially undiagnosed HIV infection, in their partners. http://www.cdc.gov/std/treatment/2010/chlamydialinfections.htm What is Expedited partner therapy? Expedited partner therapy (EPT) refers to the quick and efficient treatment of the sexual partners of patients diagnosed with Chlamydia trachomatis or Neisseria gonorrhea. EPT is referred to as patient-delivered partner therapy (PDPT) when patients deliver medicines or prescriptions to their sexual partners. Literature Review 11
Althaus, C.L., et al. (2010) The impact of screening programs is improved with a longer duration of the asymptomatic period of chlamydia. Batteiger, B.E., et al. (2010) Most of the repeated chlamydial infections were due to re-infections, but treatment failures also contributed to repeated infections. Cameron, S.T., et al. (2010) 87% of patients surveyed reported that they were satisfied with the treatment of chlamydia by the use of EPT at the pharmacy. Cameron, S.T., et al. (2009) Postal testing kits and patient-delivered partner therapy were not found to be effective treatment options as compared to patient referral treatment for chlamydia. Davis, C.F., et al. (2009) County health officials opinions regarding legalization of PDPT: For : 45% Against : 45% Undecided : 10% Estcourt, C., et al. (2012) The proportion of contactable partners was significantly higher if either of the two EPT options (hotline or pharmacy) were chosen. 12
Gift, T.L., et al. (2011) EPT was less costly from a societal or systemwide standpoint and allowed for treatment of significantly more patients than standard referral Golden, M.R., et al. (2005) The treatment of partners who received EPT resulted in a 15% reduction of chlamydial infection, and 73% reduction of gonorrhea at follow up as compared to patients who received standard referral treatment. Golden, M.R., et al. (2007) The percentage of cases where all of the partners of patients infected with gonorrhea and/or Chlamydia were treated, increased from 39% to 65% when the partner notification system was implemented. Gursahaney, P.R., et al. (2011) Success rate of patient-initiated partner notification: 77.3%. Patients who preferred standard referral as opposed to expedited partner therapy: 54.5%. Heijne, J.C.M., et al. (2010) The mathematical model developed for the study is more accurate than previous models because it accounts for reinfection. Jones, H.E., et al. (2011) The medical chart audit conducted by the researchers found that documentation of partner management was often missing or incomplete, and only 36% of patients seen for a post-treatment visit were tested for reinfection of chlamydia. 13
Kretzschmar, M., et al. (2012) Increasing screening coverage from 35% to 65% resulted in incremental decreases in chlamydia positivity. Increasing the partner notification rate also resulted in incremental decreases in chlamydia positivity. Increasing the partner notification and treatment rate significantly reduced reinfection rates. McBride, K., et al. (2009) Instructional materials on PDPT influenced patients willingness to deliver and receive PDPT. McClean, H., et al. (2008) In chart audits, the following percentages of occurrences were observed: Follow-up by phone or text: 43% Follow-up in clinics: 39% Advice provided about partner notification: 91%, Documentation of partner notification outcome: 75%, Documentation of treatment status of sexual contacts: 60%. McNulty, A., et al. (2008) 137 secondary contacts (21.9% of n) were identified as secondary contacts. Patient-delivered partner therapy to the index case alone may miss a potential 3-10% of secondary contacts. Mercer, C.H., et al. (2007) Patient attendance at a walk-in clinic for treatment of sexually transmitted infections was associated with a significant reduction in patient delay and provider delay. 14
Melvin, L., S.T., et al. (2009) Women 67% of women preferred PDPT for partners 57% of women would prefer PDPT for themselves. 3% of women preferred postal testing kits (PTK) Men 70% of men would choose Patient Referral (PN) for partners. 53% would prefer Patient Referral (PN) for themselves. 9% of men preferred PTK Mmeje, O. & Coleman, J.S. (2012) Concurrent patient-partner treatment (CPPT) was compared with patient referral. Results: Median time to cure: CPPT: 4.4 weeks Patient Referral: 5.1 weeks Repeat positive chlamydia infections: CPPT: 0% Patient Referral: 19% Roberts, T.E., et al. (2012) Average cost per patient (converted from British pounds): Routine patient notification: $70.05 APT Hotline: $82.23 APT Pharmacy: $80.71 Cost-Consequence Analysis (number and proportion of partners treated): Routine patient notification: 11% APT Hotline: 35% APT Pharmacy: 34% Schillinger, J.A., et al. (2003) Although the risk of re-infection for women who were in the patient-delivered partner treatment group was 20% lower than in the self-referral group, this result was not statistically significant. Shiely, F., et al. (2010) Re-infection risk was lower for patients who received EPT as compared to those who received standard partner referral. 15
Shivasankar, S., & Challenor, R. (2008) Survey results found that 1/3 of health professionals were "strongly opposed" to PDPT. 67% of physicians and 60% of health advisors believed that chlamydia would be the most appropriate infection to treat with PDPT. The majority of health professionals were "cautiously prepared to consider PDPT" The main concern of health professionals was the legal status of PDPT. Sutcliffe, et al. (2009) Overall, patients accepted EPT and felt that it would be a reasonable approach to partner notification. EPT methods which were favored by patients interviewed were: telephone assessment of sex partners, so they could get antibiotics from the clinic to take to their partners; pharmacy-based assessment and treatment; and the ability for sex partners to take sexually transmitted infection test without going to the clinic. Taylor, M.M., (2011) Survey of health providers: Most common concerns with EPT among those surveyed: -Inability to obtain medical and allergy history of partners -Malpractice/liability -Clinic policy of not prescribing medications to non-clinic patients Tuite, A.R., et al. (2012) As compared with "no change" in chlamydia screening, "enhanced" screening was estimated to be highly cost-effective. (Enhanced screening is increased, mathematically modeled, targeted screening.) Yu, Y-Y., (2011) Reported partner services: Concurrent patient-partner treatment: 15% Patient-delivered partner therapy: 19% Patient referral: 55% No partner management: 11% Correlation of patient-partner treatment reports: Patient delivered partner therapy (PDPT): correlation of 80% Concurrent patient-partner treatment: correlation of 79% 16
Case Study A twenty year old female tests positive for chlamydia during her routine pregnancy screening. She tells you her husband works construction, often out of town and leaves the house at 7am and returns in the evening. How would you handle his follow up/treatment? Summary EPT is a proven strategy for: Increasing access to treatment Reducing wait times for partner treatment Increasing rates of partner treatment It has proven to be a popular treatment option for patients and their partners. Recommendations EPT should be included as one of several different options for chlamydial partner treatment to serve those individuals who are unable or unwilling to seek treatment at traditional health clinics. Practitioners who treat STIs should develop a protocol to incorporate EPT into their clinical practice. The safest approach to utilizing EPT would be to conduct screenings of partners which would include a review of their health history and current medications by a trained medical professional. 17
Recommendations In states where EPT is legal, public health authorities should promote awareness of EPT. Where EPT is not legal or where it is unclear if EPT is legal, nurse practitioners should lobby to make EPT a legal option for STI treatment. States should consider developing EPT guidelines. State Boards of Nursing and Pharmacy and state Medical Boards should develop statements in support of EPT as one option to be considered for STI treatment. Research Recommendations More research is needed in high-prevalence areas of the southeastern United States. Efficacy among high-prevalence groups would be especially convincing evidence for expansion of EPT. Incorporate EPT data into routine health department surveillance. Individual clinics considering use of EPT should conduct focus groups and surveys of patients before using EPT in practice. 18
References Agency for Healthcare Research and Quality. (2012). National healthcare quality report, 2011. Retrieved from http://www.ahrq.gov/qual/qrdr11.htm Althaus, C. L., Heijne, J. C. M., Roellin, A., & Low, N. (2010). Transmission dynamics of chlamydia trachomatis affect the impact of screening programmes. Epidemics, 2(3), 123-131. doi:10.1016/j.epidem.2010.04.002 American College of Obstetricians and Gynecologists. (2011). Committee opinion no. 506: Expedited partner therapy in the management of gonorrhea and Chlamydia by obstetriciangynecologists. Obstetrics and Gynecology, 118(3), 761-766. doi:10.1097/aog.0b013e3182310cee Barry, P. M., & Klausner, J. D. (2009). The use of cephalosporins for gonorrhea: The impending problem of resistance. Expert Opinion on Pharmacotherapy, 10(4), 555-577. doi:10.1517/14656560902731993 Batteiger, B. E., Tu, W., Ofner, S., Van Der Pol, B., Stothard, D. R., Orr, D. P.,... Fortenberry, J. D. (2010). Repeated Chlamydia trachomatis genital infections in adolescent women. Journal of Infectious Diseases, 201(1), 42-51. doi:10.1086/648734 Bauer, H. M., Wohlfeiler, D., Klausner, J. D., Guerry, S., Gunn, R. A., Bolan, G., & California STD Controllers Association. (2008). California guidelines for expedited partner therapy for Chlamydia trachomatis and Neisseria gonorrhoeae. Sexually Transmitted Diseases, 35(3), 314-319. doi:10.1097/olq.0b013e31815b0158 Burstein, G. R., Eliscu, A., Ford, K., Hogben, M., Chaffee, T., Straub, D.,... Huppert, J. (2009). Expedited partner therapy for adolescents diagnosed with chlamydia or gonorrhea: A position paper of the society for adolescent medicine. The Journal of Adolescent Health: Official Publication of the Society for Adolescent Medicine, 45(3), 303-309. doi:10.1016/j.jadohealth.2009.05.010 References Cameron, S. T., Glasier, A., Muir, A., Scott, G., Johnstone, A., Quarrell, H.,... Todd, G. (2010). Expedited partner therapy for Chlamydia trachomatis at the community pharmacy. BJOG: An International Journal of Obstetrics and Gynaecology, 117(9), 1074-1079. doi:10.1111/j.1471-0528.2010.02573.x Cameron, S. T., Glasier, A., Scott, G., Young, H., Melvin, L., Johnstone, A., & Elton, R. (2009). Novel interventions to reduce re-infection in women with chlamydia: A randomized controlled trial. Human Reproduction, 24(4), 888-895. doi:10.1093/humrep/den475 Centers for Disease Control and Prevention. (2012a). 2011 Sexually transmitted diseases surveillance, Chlamydia. Retrieved from http://www.cdc.gov/std/stats11/chlamydia.htm Centers for Disease Control and Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Division of STD Prevention. (2012b). Expedited partner therapy. 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L., Kissinger, P., Mohammed, H., Leichliter, J. S., Hogben, M., & Golden, M. R. (2011). The cost and cost-effectiveness of expedited partner therapy compared with standard partner referral for the treatment of Chlamydia or gonorrhea. Sexually Transmitted Diseases, 38(11), 1067-1073. doi:10.1097/olq.0b013e31822e9192 Golden, M. R., & Estcourt, C. S. (2011). Barriers to the implementation of expedited partner therapy. Sexually Transmitted Infections, 87(Suppl 2), ii37-ii38. doi:10.1136/sti.2010.047670 Golden, M. R., Hughes, J. P., Brewer, D. D., Holmes, K. K., Whittington, W. L., Hogben, M.,... Handsfield, H. H. (2007). Evaluation of a population-based program of expedited partner therapy for gonorrhea and chlamydial infection. Sexually Transmitted Diseases, 34(8), 598-603. doi:10.1097/01.olq.0000258319.54316.06 Golden, M. R. (2008). Expedited partner therapy: Moving from research to practice. Sexually Transmitted Diseases, 35(3) doi:10.1097/olo.0b013e318167b0f4 Golden, M. 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