Expedited Partner Therapy for Gonorrhea & Chlamydia

Matthew R. Golden MD, MPHCenter for AIDS & STD, University of WA

Public Health – Seattle & King County

Overview

• Clinical issues and barriers to EPT• Experience with EPT rollout in Washington State

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?

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?

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?

STD diagnoses in persons presenting as contacts to gonorrhea, chlamydia or NGU/MPC

Seattle, Baltimore, Birmingham and Denver

Gonorrhea*

PID

New HIV

Early Syphilis

Women(n=2507)

3.9%

3.7%

0

<0.1%

Heterosexual Men(n=3511)

3.1%

NA

0.2%

0

Men who Have Sex with Men

(n=460)

6.1%

NA

5.5%

0.4%* GC excludes contacts to GC. Source: CID 2005;40:787

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

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.

EthicsRespect for Patient AutonomyBeneficenceNonmaleficenceJustice

• 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?

History of EPT in Washington State

Year

WA State Pharmacy Board Rules that EPT is Legal

1997

King County EPT Randomized Trial 1998-2003

Washington State & Public Health – Seattle & King County Recommend Routine Use of EPT in Heterosexuals

2003

PHSKC makes free medication available to all medical providers for EPT

2004

Start State-wide Community-level Trial of EPT 2007

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

EPT System

• Case-report based triage of DIS services• Widespread access to prepacked medication for EPT

0

20

40

60

80

100

0 2 4 6 8 10 12 14

+ Risk Factor No Risk Factor

Days Between Treatment & Interview

Proportion of Patients with Untreated Partners at Time of Study Interview

Per

cent

with

unt

reat

ed p

artn

er

Source: STD 2001;28:658

Risk factors: > 1 sex partner 60 days or pt does not anticipate sex with partner in future

PN CT & GC: where do we go from here?

WA State EPT Program: Prescription Pad

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

Asotin

5Clark

Whatcom

Clallam

Jefferson

Grays

Harbor

*Wahkiakum

Cowlitz

Mason

Island

San Juan

Skagit

Snohomish

KingKing

Okanogan

ChelanDouglas

Skamania

Klickitat

BentonWalla Walla

Pacific Lewis

Thurston

PierceKittitas

Yakima Franklin

GrantAdams

Lincoln*

Ferry

Stevens

Pend

Oreille

Spokane

Whitman

Columbia*Garfield

*

Kits

ap

Asotin

Wave 1 – 10/07Wave 2 – 6/08Wave 3 – 1/09Wave 4 – 8/09

WA State Local Health Jurisdictions Participating in A Community- Level Trial of EPT

Ferry, Stevens, Pend-Orielle elected not to participate

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: partnernotified, 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

Provider’s Partner Management Plan as Indicated on the Case Report Form (n=26,051)

21%

25%

54%

Health Department Provider All Partners Treated

89% of Forms Completed with a

Partner Management Plan

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%)Patient refused 360 (13%)Language barrier or out of area 141 (5%)Provider refused 120 (4%)Missing 146 (5%)

4304 Partners with Dispositions

Association of PN Plan on Case Report Form with PN Outcomes

22

48

91

29

64

88

60

10

72

0

20

40

60

80

100

Partner Notified at TimeInitial Interview

Partner Supplied PDPT fromClinician

Partner Untreated at TimeInitial Interview

All partners already treated Provider to assure PNHealth dept. assistance requested

Perc

ent

89 56 26

P<.0001 All Comparisons Health Dept. Assistance vs. No Health Dept Assistance

Association of PN Plan on Case Report Form with PN Outcomes

6486

17

25

0

10

20

30

40

50

Partners Supplied PDPT by Health Dept. DIS Assistance Accepted

All partners already treated Provider to assure PN

Health dept. assistance requested

Perc

ent

5 7

P<.0001 All Comparisons Health Dept. Assistance vs. No Health Dept Assistance

Partner Receiving PDPT from the Diagnosing Provider, WA State EPT Community-Level Trial

0

10

20

30

40

50

May-Aug2007

Sep-Dec2007

Jan-Apr2008

May-Aug2008

Sep-Dec2008

Jan-Apri2009

May-Aug2009

Sep-Dec2009

Jan-Apr2010

Wave 1 Wave 2 Wave 3 Wave 4

Intervention Begins

Per

cent

Intervention Begins

Intervention Begins

Intervention Begins

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

Proportion of Partners Treated at Time of Initial Partner Notification Interview, Before and After Program Initiation

4856

0

20

40

60

80

100

Partners Treated

PreinterventionIntervention

Per

cent

p<.0001

Impact of DIS Services Among Persons Referred to Receive Partner Services

72

34

82

66

0

20

40

60

80

100

Notified Treated

Initial InterviewFinal Interview

3/09-3/10

• 1290 partners provided PDPT

• 1147 partners treated after receipt of DIS services

• Cost per partner treated ~$500

• Probably roughly comparable to the cost per case treated via screening

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

Cost-Effectiveness of EPT

Health Care System Costs

QALYs Lost Cost- effectiveness

ratio

Index MenEPT $379 .0272 Cost-savingStandard $445 .0308Index WomenEPT $150 0.004 Cost-savingStandard $186 0.005

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

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

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

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