1. Expedited Partner Therapy for
Gonorrhea & Chlamydia
Matthew R. Golden MD, MPH
Center for AIDS & STD, University of WA
Public Health – Seattle & King County
3. 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?
4. 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?
5. Is EPT a Good Standard of Care?
• A complete evaluation of all partners would
be best
• Are we missing concurrent diagnoses?
• Are we placing partners at significant risk of
adverse drug reactions?
6. STD diagnoses in persons presenting as contacts to
gonorrhea, chlamydia or NGU/MPC
Seattle, Baltimore, Birmingham and Denver
Women Heterosexual Men Men who Have
(n=2507) (n=3511) Sex with Men
(n=460)
Gonorrhea* 3.9% 3.1%
6.1%
PID 3.7% NA
NA
New HIV 0 0.2%
5.5%
Early Syphilis <0.1% 0
0.4%
* GC excludes contacts to GC. Source: CID 2005;40:787
7. Adverse Drug Reactions
• Anaphylaxis to macrolides is very rare
• PCN
– Anaphylaxis with cephalosporins is rare (0.1-0.0001%)
– ~10% of people report having a PCN allergy
– Cross reactivity to 3rd gen cephalosporins 1-3%
– Only avertable reactions are those occurring in persons
with a known allergy who take meds despite written
warnings
• No cases anaphylaxis to date in CA and WA
8. Antimicrobial Resistance
• No known chlamydial resistance to azithro
• Cephalosporin resistant GC
– Some evidence rising MICs in Japan
– No true resistance in U.S., though some isolates have decreased
susceptibility
• Standard of care is to treat contacts to GC & chlamydia
without awaiting test results
– EPT primarily increases antimicrobial use by increasing appropriate
treatment of partners
• In 2005, 55 million prescriptions for Azithro; 3 million cases of
chlamydia in U.S.
9. 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 care
• Is EPT better for the partner? Can partners make
an informed decision?
10. History of EPT in Washington State
Year
WA State Pharmacy Board Rules that EPT is 1997
Legal
King County EPT Randomized Trial 1998-2003
Washington State & Public Health – Seattle & 2003
King County Recommend Routine Use of EPT in
Heterosexuals
PHSKC makes free medication available to all 2004
medical providers for EPT
Start State-wide Community-level Trial of EPT 2007
11. Washington State Community-level Randomized
Trial of EPT
• $2.5 million NIH funded study
• Goal - to define whether an EPT program can decrease the
prevalence of chlamydia and/or the incidence of gonorrhea in
the population
• No intervention to control STD has been shown to do this
• Design – stepped-wedge community-level randomized trial
• Order in which LHJs start intervention randomly assigned
• Comparison of trends in places with and without the
intervention
• Outcome
• CT prevalence in Infertility Prevention Planning clinics
• Reported incidence of gonorrhea
12. EPT System
• Case-report based triage of DIS services
• Widespread access to prepacked
medication for EPT
13. Proportion of Patients with Untreated Partners at Time of
Study Interview
100
Percent with untreated partner
80
60
40
20
+ Risk Factor No Risk Factor
0
0 2 4 6 8 10 12 14
Days Between Treatment & Interview Source: STD
2001;28:658
Risk factors: > 1 sex partner 60 days or pt does not anticipate sex with partner in future
16. PDPT Distribution
• Medication prepackaged to meet
requirements of state pharmacy
board
– Allergy warning, info on STDs,
complications & where to seek
care, condoms
• Stocked in high-volume clinics
and in 157 pharmacies,
statewide
– Pharmacies paid $2-5 dispensing
fee
• Preprinted prescriptions on
case-report form and on faxable
forms
17. WA State Local Health Jurisdictions Participating in A Community-
Level Trial of EPT
Whatcom
Okanogan
San Juan Pend
Ferry
Skagit Oreille
Stevens
Island
Clallam Snohomish
Chelan
Jefferson p Douglas
King Lincoln Spokane
tsa
King *
Ki
Grays Mason
Harbor Kittitas
Grant
Pierce
Adams Whitman
Thurston
Lewis
Pacific
Yakima Franklin
Garfield
Columbia
* Cowlitz
Benton * * Asotin
Asotin
Skamania Walla Walla
Wahkiakum
5
Klickitat
Clark
Wave 1 – 10/07
Wave 2 – 6/08
Wave 3 – 1/09
Ferry, Stevens, Pend-Orielle elected not to participate
Wave 4 – 8/09
18. Evaluation of System
• Random sample of cases defined at time case is entered into
Internet case registry
• Outcomes:
1) Association of provider’s partner notification plan as indicated
on the case report form and
a) Outcomes at time of initial index patient interview: partner
notified, treated, receipt of PDPT from diagnosing provider
b) Acceptance of PDPT or assistance from DIS
2) Use of PDPT by Providers
• Statistics – Associations defined using GEE to adjust for correlated
data
19. Provider’s Partner Management Plan as Indicated on
the Case Report Form (n=26,051)
25% 89% of Forms
Completed with a
Partner
54% Management Plan
21%
Health Department Provider All Partners Treated
20. Process Outcome Evaluation: WA State EPT Trial
31,399 Cases GC/CT in Heterosexuals 1/1/07-12/31/09
6650 (21%) Random Sample
3931 (59%) Interviewed 2719 (41%) Not Interviewed
Not located 1446 (53%)
Late report 506 (19%)
4304 Partners with Dispositions Patient refused 360 (13%)
Language barrier or out of area 141 (5%)
Provider refused 120 (4%)
Missing 146 (5%)
21. Association of PN Plan on Case Report Form with PN Outcomes
All partners already treated Provider to assure PN
Health dept. assistance requested
100
P<.0001 All Comparisons Health Dept.
91 Assistance vs. No Health Dept Assistance
80 88
72
Percent
64
60
48
60
40
89 56 26
20
10 29
22
0
Partner Notified at Time Partner Supplied PDPT from Partner Untreated at Time
Initial Interview Clinician Initial Interview
22. Association of PN Plan on Case Report Form with PN Outcomes
All partners already treated Provider to assure PN
50 Health dept. assistance requested
40 P<.0001 All Comparisons Health Dept.
Percent
Assistance vs. No Health Dept Assistance
30
25
20
5 7 17
10
8
4 6 6
0
Partners Supplied PDPT by Health Dept. DIS Assistance Accepted
24. Medication Delivery
• ~25,000 cases of GC and CT annually in WA State
• ~ 15,000 medication packets distributed per year
• 77% chlamydial infection
• 75% direct to providers – 25% via pharmacies
• 56% of heterosexuals with GC/CT offered PDPT
• 34% of all heterosexual receive PDPT from their provider
• 60% of those not referred to public health
• Total cost of meds including distribution = $105,000/year
25. Proportion of Partners Treated at Time of Initial Partner
Notification Interview, Before and After Program Initiation
100
Preintervention p<.0001
80 Intervention
Percent
60
56
40 48
20
0
Partners Treated
26. Impact of DIS Services Among Persons
Referred to Receive Partner Services
3/09-3/10
100
82
Initial Interview • 1290 partners provided
Final Interview
80 72 PDPT
66
• 1147 partners treated
60
after receipt of DIS
40 34
services
• Cost per partner treated
20 ~$500
0 • Probably roughly
Notified Treated comparable to the cost per
case treated via screening
27. DIS Services
• ~11,000 cases assigned and ~8000 interviews annually
• Driven by high proportion of cases referred by case-
reports to receive DIS services
• 1290 partners received PDPT via DIS
• ~750 partners notified by DIS
• 10-12 DIS state-wide
• Assigned 1000 cases each per year
• Interview 50-60%
• Total cost of DIS = ~$600,000/year
28. Cost-Effectiveness of EPT
Health Care QALYs Lost Cost-
System effectiveness
Costs ratio
Index Men
EPT $379 .0272 Cost-saving
Standard $445 .0308
Index Women
EPT $150 0.004 Cost-saving
Standard $186 0.005
29. EPT is cost saving to the system
~$50 per male index and $20 per female
From payer’s perspective, it is only cost saving if at
least 40% of partners receive care from the payer
30. Tragedy of the Commons
• Each person despoils a common resource because they as an
individual pay little of the cost, and acting conscientiously does not
benefit them
• Two solutions
• Regulation – all insurance companies have to pay
• Pay in common – we buy the meds as a group
31. Summary Community-level EPT Trial
• Ongoing
• Triage via case report form successful in directing DIS
services to those most likely to benefit
• Cost of these services remains high
• Publicly financed free medication can promote
widespread use of PDPT
• Cost of medications, if purchased using 340b pricing, is
relatively modest
32. Conclusion
• Routinely offering patients medication for their partners is
a superior standard of care for the index case
• Most heterosexual patients should be offered PDPT
• Public Health programs should seek to make sure that
provider have the tools to offer their patients PDPT in a
way that is legal and the maximizes the likelihood that
partners receiving information about STD & meds
• Publicly financed partner medication is relatively
inexpensive and can increase PDPT use
• Assures legal compliance
• Highest priority for funding in this area
