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Transcript
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