Expedited Partner Therapy in the Management of


Sexually Transmitted Diseases


Review and Guidance


U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 

PUBLIC HEALTH SERVICE 

Centers for Disease Control and Prevention 

National Center for HIV, STD, and TB Prevention 
EXPEDITED PARTNER THERAPY IN THE MANAGEMENT OF SEXUALLY

TRANSMITTED DISEASES 

Contributors: 

H. Hunter Handsfield, M.D. 1, 2

Matthew Hogben, Ph.D. 1

Julia A. Schillinger, M.D., M.Sc. 1

Matthew R. Golden, M.D., M.P.H. 2, 3

Patricia Kissinger, Ph.D. 4

P. Frederick Sparling, M.D. 5

1

Division of STD Prevention, Centers for Disease Control and Prevention 

2

Department of Medicine and Center for AIDS and STD, University of Washington 

3

Public Health - Seattle & King County STD Program 

4

Tulane University Health Sciences Center, School of Public Health and Tropical Medicine 

5

School of Medicine, University of North Carolina at Chapel Hill 

Suggested Citation: 

Centers for Disease Control and Prevention. Expedited partner therapy in the management 

of sexually transmitted diseases. Atlanta, GA: US Department of Health and Human 

Services, 2006. 
PREFACE

This report was prepared at the direction of John M. Douglas, Jr., M.D., Director, Division 

of STD Prevention, NCHSTP, CDC. It summarizes the available literature on expedited 

partner therapy (EPT) for the management of the partners of persons with STD and 

interprets the results. It also incorporates perspectives gained from two expert 

consultations, one that predominantly addressed the scientific evidence related to EPT and a 

second that emphasized operational issues that will affect implementation of EPT. The 

report serves as background on EPT and provides the evidence in support of anticipated 

guidelines for the selective use of EPT. It is intended as a reference document for use by 

CDC and by public health agencies, other organizations, interested individuals, and other 

partners in the public and private sector. 

2 
TABLE OF CONTENTS 

Executive Summary 4 

Introduction 7 

Current Practices 9

Research in Expedited Partner Therapy 11 

Implementation Issues 18 

Discussion 25

Conclusions 32

Guidance 34

References 35

Tables and Figures 39 

3 
EXECUTIVE SUMMARY 

Overview 

Expedited partner therapy (EPT) is the practice of treating the sex partners of persons with 

sexually transmitted diseases (STD) without an intervening medical evaluation or 

professional prevention counseling. The usual implementation of EPT is through patientdelivered partner therapy (PDPT), although other methods may be employed. The available 

literature and selected unpublished studies were systematically reviewed, and this report 

provides background for the development of guidance on use of EPT as an option for 

partner management for selected STDs and patients. 

Evidence 

For STDs other than syphilis, partner management based on patient referral or provider 

referral has had only modest success in assuring partner treatment, largely attributable to 

limitations of available financial and personnel resources. EPT is believed to have been 

widely employed in women with trichomoniasis. Recent surveys document occasional use 

by many primary care providers in the management of patients with gonorrhea and 

chlamydial infection, and consistent use by a few. A retrospective case control study and 

two process-oriented analyses suggested that EPT holds promise as a partner management 

option. These studies contributed to CDC decisions to fund 4 randomized controlled trials 

(RCTs) designed to compare EPT with standard partner management approaches in men 

and women with gonorrhea, chlamydial infection, or trichomoniasis; and to assess 

behavioral predictors of treatment and reinfection. 

Persistent or Recurrent Infection 

The first RCT of EPT followed 1,787 women in 6 cities after treatment for chlamydial 

infection. Recurrent infection was documented at follow-up visits 1 months and 4 months 

later in 12% of women randomized to EPT and 15% of those managed by patient referral 

(odds ratio [OR] 0.80, 95% confidence interval [CI] 0.62-1.05). The second RCT enrolled 

2,751 men and women with gonorrhea or chlamydial infection from both public and private 

care settings in a single metropolitan area. Persistent or recurrent infection with either 

disease was found in 9.9% of subjects randomized to EPT and 13.0% of those who had 

standard patient-referral or provider-referral of their partners (OR 0.76, 95% CI 0.59-0.98). 

EPT was more effective in preventing gonorrhea at follow-up (OR 0.32, 95% CI 0.13-0.77) 

than chlamydial infection (OR 0.82, 95% CI 0.62-1.07). Chlamydial infection was present 

at follow-up in 7.6% of women who denied all sex since treatment, suggesting that a higher 

than expected rate of treatment failure accounted for some infections at follow-up. In the 

third available RCT, 977 men with symptomatic urethritis (principally gonorrhea and 

chlamydial infection) were randomized to EPT, patient referral, or patient referral enhanced 

by written education materials. Follow-up testing for gonorrhea and chlamydial infection 

4-8 weeks later was accomplished in 37.5% of patients. Persistent or recurrent infection 

was found in 43% of subjects in the patient referral group (referent), 14% of men 

randomized to enhanced patient referral (OR 0.22, 95% CI 0.11-0.44, P<0.001), and 23% of 

men randomized to EPT (OR 0.38, 95% CI 0.19-0.74, P<0.001). For trichomoniasis, in an 

as yet unpublished RCT of 463 women randomized to the same interventions as the male 

4 
urethritis trial, with 80% follow-up, the prevalences of infection 3-7 weeks later were not 

significantly different for patient referral (6%), enhanced patient referral (9%), or EPT 

(9%). 

Behavioral Outcomes 

The 4 available RCTs evaluated the association of EPT with index cases’ reports of success 

in partner notification, confidence that their partners were treated, and sexual behaviors 

likely to predict reinfection. In 2 trials that enrolled male index cases, men randomized to 

EPT were equally or more likely to notify their partners than those randomized to the 

control strategies. Female index cases with chlamydial infection or gonorrhea who were 

randomized to EPT had either equivalent success or enhanced success in notifying partners 

compared with women randomized to standard partner management. In all 3 trials of 

gonorrhea or chlamydial infection, EPT was associated with at least equivalent and 

typically increased confidence by both male and female index cases that their partners had 

received treatment, including direct observation that their partners took medication. Two 

trials that addressed both gonorrhea and chlamydial infection found EPT to be associated 

with significantly reduced rates of sex with untreated partners at follow-up. The 

trichomoniasis trial showed general equivalence of EPT with desirable behavioral outcomes 

compared with standard patient referral. 

Cost Effectiveness 

Preliminary economic analyses suggest that EPT is a cost-saving and cost effective partner 

management strategy. 

Limitations 

The data available to support EPT for chlamydial infection were derived in larger and 

geographically more diverse samples of patients than those for gonorrhea. Nevertheless, 

the evidence in favor of EPT, as measured by the rate of persistent or recurrent infection at 

follow-up, is stronger for gonorrhea than for chlamydial infection, perhaps due to a higher 

than expected rate of persistent chlamydial infection in women. This finding confounds the 

assessment of EPT in women with chlamydial infection. Assuring the treatment of infected 

men’s female partners is a high priority to prevent ongoing transmission and community 

spread. 

As for all RCTs, the extent to which the results of the available trials can be safely 

generalized to other populations and settings is not certain. Owing to modest sample sizes 

in some disease-specific patient groups, and varying effect sizes, not all outcomes of 

interest have been shown to be statistically significant. For example, further data are 

desirable on the use of EPT in male index cases. The available data do not support the 

routine use of EPT in the management of trichomoniasis, and no published data support the 

use of EPT for chlamydial infection or gonorrhea in men who have sex with men (MSM). 

Although substantial numbers of adolescents were included in the available trials, there is 

little experience in patients <18 years old. 

5 
Issues in Implementation of EPT 

Among several pragmatic issues that will influence implementation of EPT as an STD 

prevention strategy, a dominant one is the possibility of undetected STD in partners. The 

potential for undiagnosed pelvic inflammatory disease (PID) is of concern when EPT is 

used to treat the female partners of men with gonorrhea or chlamydial infection. Therefore, 

EPT intended for female partners should be accompanied by warnings about the symptoms 

of PID and advice that women seek medical attention in addition to accepting treatment. 

Undiagnosed gonorrhea and chlamydial infection are common in the partners of women 

with trichomoniasis, and undiagnosed HIV infection and other morbidities have been found 

in many partners of STD-infected MSM. 

The legality of EPT is uncertain in some states and overt statutory impediments exist in 

others; the practice is clearly legal only in a few states. The medicolegal ramifications may 

be uncertain in the event of adverse outcomes in the recipients of EPT. Other barriers 

include direct and indirect costs, including limitations on third-party insurance coverage; 

missed opportunities for prevention counseling of partners; risks of allergic reactions and 

other adverse drug effects; administrative barriers; privacy issues; and the attitudes and 

beliefs of health care providers and agencies about the practice. 

Conclusions 

Both clinical and behavioral outcomes of the available studies indicate that EPT is a useful 

option to facilitate partner management among heterosexual men and women with 

chlamydial infection or gonorrhea. The evidence indicates that EPT should be available to 

clinicians as an option for partner management, although ongoing evaluation will be needed 

to define when and how EPT can be best utilized. EPT represents an additional strategy for 

partner management that does not replace other strategies, such as standard patient referral 

or provider-assisted referral, when available. Along with medication, EPT should be 

accompanied by information that advises recipients to seek personal health care in addition 

to EPT. This is particularly important when EPT is provided to male patients for their 

female partners, and for male partners with symptoms. Existing data suggest that EPT has 

a limited role in partner management for trichomoniasis. No data support its use in the 

routine management of syphilis, and there is no experience with EPT for gonorrhea or 

chlamydial infection among MSM. 

6 
INTRODUCTION 

Assuring treatment of infected persons’ sex partners has been a central component of 

prevention and control of bacterial STDs in the United States for six decades, since the 

concept was introduced in the United States by Thomas Parran and systematic efforts were 

implemented for the prevention of syphilis under Parran’s leadership of the U.S. Public 

Health Service in the 1940s.1

 In general, treatment has been recommended for all partners 

sexually exposed to the infected index case within a specified time interval in order to 

prevent morbidity in the partners and curtail transmission. Usually treatment was preceded 

by clinical evaluation, diagnostic testing, and education or formal counseling, and 

attendance at traditional clinical facilities was required. Initially developed as a strategy for 

control of syphilis, such partner management came to be widely recommended for 

gonorrhea, chlamydial infection and, most recently, human immunodeficiency virus (HIV) 

infection.2,3 

Several strategies have been employed to facilitate clinical assessment and treatment of 

partners, as indicated in the Centers for Disease Control and Prevention’s Program 

Operations Guidelines.2

 With provider referral, partners are directly contacted, usually by 

telephone or in person, by the index patient’s health care provider or by a disease 

intervention specialist (DIS) or other outreach worker on behalf of the provider. Under 

patient referral, also called self referral, the index patient assumes primary responsibility to 

notify and refer his or her partners at risk. These approaches may be combined. For 

example, conditional referral, also called contract referral, describes patient referral 

supplemented by provider referral, such as a telephone reminder, for partners who do not 

respond within a specified time. The term dual referral also has been used, particularly in 

the context of HIV partner management, to describe joint referral by the patient and a 

public health professional.3

 Patient referral also can be supplemented by various 

mechanisms to assist the index patient in notifying his or her partners; for example, card 

referral means providing patients with appointment cards to deliver to partners. 

Despite extensive use, the contribution of partner management to overall STD prevention 

and control has been difficult to ascertain. Success has been evaluated largely by analysis 

of process indicators, such as numbers of partners elicited and the number brought to 

treatment. By these measures, provider referral strategies generally have been most 

effective.4-6 Provider referral is widely considered to have contributed significantly to 

control of syphilis, with a 1990s trial providing estimates of process effectiveness,7

 but the 

efficacy of traditional partner management in assuring treatment of the partners of persons 

with gonorrhea or chlamydial infection remains problematical and their contribution to 

prevention and control uncertain. Social network approaches for management of the 

partners of persons with syphilis or HIV infection have shown substantial promise in 

retrospective evaluations,8,9 but have not been studied for chlamydial infection, and may be 

too costly for routine use in most settings. A single prospective evaluation of network 

techniques to enhance interviews and analyze data uncovered more syphilis cases than 

would have resulted from contacting only the sex partners of infected persons.10 

Most STD cases in the United States are diagnosed and treated in the private sector by 

primary care providers,11 but the available data on partner management are dominated by 

analyses in patients attending STD clinics or other public health clinics who often may not 

7 
be representative of most infected persons. Except for syphilis, most health departments 

make little direct effort in partner management for persons with STDs treated in the private 

sector.12,13 The Institute of Medicine described STD partner management in the United 

States as inadequate, inefficient, and in need of redesign.14 

Anecdotal reports have long suggested that some clinicians selectively arrange for 

treatment of partners without referral or examination, typically by providing the index 

patient medication for his or her partner(s) or by writing a prescription to be delivered by 

the patient to the partner. This practice is generally believed to have been particularly 

widely used for the treatment of the male partners of women with vaginal trichomoniasis.* 

Nevertheless, public health and prevention experts have typically insisted that treatment for 

partners of persons with gonorrhea, chlamydial infection or syphilis be administered only 

through direct clinical intervention. However, as the inadequacy of resources for provider 

referral and the modest success rate of patient referral in assuring notification and treatment 

of partners became apparent, streamlined approaches to partner management became the 

subject of increasing attention. 

This document reviews the evidence for use of expedited partner therapy (EPT), defined as 

treatment of partners without an intervening personal assessment by a health care provider. 

EPT may be implemented by any of several methods. The usual method in many settings, 

and the one used predominantly to date, is patient-delivered partner therapy (PDPT), 

wherein clinicians provide their patients with drugs intended for the partners, prescribe 

extra doses of medication in the index patients’ names, or write prescriptions in the 

partners’ names. Other potential means to achieve EPT include non-prescriptive 

arrangements with cooperating pharmacies, retrieval of medication by partners at public 

health clinics or other venues, or delivery of medication to partners in non-clinical settings 

by public health workers. 

* There are several possible reasons that the practice gained currency for trichomoniasis in particular. 

For many years trichomoniasis probably was not widely understood by many clinicians to be an 

STD, despite the conflict of that perception with the practice itself. Until the 1980s, gonorrhea 

typically required penicillin by injection and chlamydial infection was virtually unknown, so that 

trichomoniasis was the only commonly diagnosed STD that could be managed with single doses or 

short courses of oral antibiotic. Further, some clinicians may have believed that local or state health 

departments would assure treatment of the partners of patients with reportable STDs, but not 

trichomoniasis. 

8 
CURRENT PRACTICES 

Traditional Partner Management 

To estimate the scope of attempted provider referral for common STDs by public health 

departments, Golden et al. surveyed 78 metropolitan health departments that collectively 

represented the 50 cities in the United States with the highest rates of at least one reportable 

bacterial STD (gonorrhea, chlamydial infection, syphilis) and the 50 metropolitan areas 

with the highest reported rates of AIDS.12,13 Sixty health departments (77%) submitted 

usable responses. Of 8,492 cases of infectious syphilis reported to these health 

departments, in 7,583 cases (89%) public health authorities attempted to assure treatment of 

the patients’ sex partners. By contrast, the responding health departments attempted to 

identify and contact the partners of 17% of 139,287 reported cases of gonorrhea and 12% of 

228,210 persons with chlamydial infection. When partner management was attempted for 

persons with gonorrhea or chlamydial infection, patient referral was the predominant model 

employed. Forty-one health departments (68%) made no attempt to notify or contact the 

partners of patients treated for gonorrhea outside public health clinics, and 46 (77%) made 

no such attempt for the partners of persons with chlamydial infection. The survey 

respondents cited lack of sufficient personnel and other resources as the dominant reason 

for low partner management coverage.12 

Most health care providers advise their patients with STD to notify their sex partners. St. 

Lawrence et al. reported on the practices of a national probability sample of 4,223 

physicians in 5 specialties that report most STD morbidity in the United States (general or 

family practice, internal medicine, pediatrics, gynecology-obstetrics, emergency 

medicine).15 Eighty-eight percent of the respondents were in private practice and the 

survey had a 70% response rate. Almost 82% of respondents reported that they advised 

their infected patients to notify partners of exposure to gonorrhea or chlamydial infection 

and 9-11% collected partner information to send to a health department; only 4% attempted 

provider referral. In another analysis of the same national probability sample, Hogben et 

al.16 found that most physicians in the U.S. were willing to report STD cases to their local 

health departments, but most respondents believed that provider referral is no more useful 

than patient referral in assuring partner treatment and were less supportive of provider 

referral by health departments than of other partner management strategies. Among 150 

private sector providers in King County, Washington who had reported >1 case of 

chlamydial infection in the preceding year, 135 (90%) said they told their patients that their 

sex partners required treatment, and 72 (95%) of 76 patients acknowledged that they had 

been so informed.17 Twenty-six providers (17%) were confident that all partners at risk had 

been treated. 

Thus, patient referral is the dominant mechanism employed in the U.S. to assure treatment 

of the partners of persons with chlamydial infection or gonorrhea. The proportion of 

partners who actually receive treatment or other direct clinical services is difficult to 

ascertain. Table 1 summarizes the results of 7 studies conducted in the United States and 

western Europe that reported the success of various patient referral strategies conducted by 

public health personnel to achieve treatment of partners exposed to gonorrhea or chlamydial 

infection.18-24 One study reported that 29% of partners were successfully treated; the 

9 
remaining studies reported success rates from 49% to 59%. The proportion of partners who 

respond to patient referral as practiced by most providers, without the involvement of 

public health personnel, is unknown. However, the available data suggest that roughly half 

of all partners of persons with gonorrhea or chlamydial infection receive treatment. 

Expedited Partner Therapy 

Emerging data indicate that many providers in the United States selectively employ EPT for 

gonorrhea and chlamydial infection and that some do so routinely. Hogben et al.25 analyzed 

the responses of the national sample of physicians described above15 to questions about the 

providers’ partner management practices (Figure 1). Among 2,538 physicians who 

reported treating at least one patient for chlamydial infection in the preceding 12 months, 

56% had managed at least one partner by PDPT and 15% “usually” or “always” did so. 

The results were similar for gonorrhea, with 50% of providers reporting use of PDPT and 

11% reporting PDPT as their usual or universal approach to partner management. The 

investigators estimated that PDPT had been employed in the management of 9% to 15% of 

the respondents’ patients with gonorrhea and 13% to 20% of those with chlamydial 

infection. 

Four geographically limited surveys also have addressed the practice of EPT. Among 111 

Connecticut and Rhode Island physicians, 48% indicated favorable attitudes toward PDPT, 

50% had employed the practice, and 6% reported using PDPT “frequently”.26 Of 150 

providers surveyed in King County, Washington, 57% had employed EPT for chlamydial 

infection in the preceding year and 21% reported doing so at least half the time, although 

only 5% of the providers had done so for their most recently diagnosed cases.17 In a 

stratified random sample of 708 physicians and 805 nurse practitioners in California 

undertaken soon after legislation was adopted to legalize EPT for chlamydial infection, 

EPT was reported substantially more frequently than in the preceding studies; about half the 

respondents reported “usually” or “always” using EPT for their patients with chlamydial 

infection, primarily by providing index patients with prescriptions for their partners.27 

Finally, according to preliminary analysis of a survey of providers in New York City,28 

approximately half the respondents had ever used PDPT and 27% reported doing so 

“frequently.” In the New York survey, an atypically high proportion of providers (24%) 

reported that they directly contacted their patients’ partners (provider referral).28 

Collectively, the national survey and two of the regional ones suggest that roughly half of 

U.S. clinicians who treat STD cases use EPT selectively and that 5% to 10% do so 

frequently or as their standard approach to partner management. EPT may be used more 

frequently in California than elsewhere, perhaps because the survey was conducted amid 

publicity about recent legalization of the practice for chlamydial infection. New York City 

providers apparently use EPT more frequently than in most regions but less frequently than 

those in California. 

10 
RESEARCH IN EXPEDITED PARTNER THERAPY 

Preliminary Studies 

The first published study with data on EPT was a retrospective analysis of the prevalence of 

Chlamydia trachomatis within 12 weeks of treatment for chlamydial infection in Swedish 

women (Figure 2).29 Among 372 women in whom no effort was made to identify or treat 

partners, 38 (10.2%) had recurrent or persistent infection. Infection was present in 84 

(8.4%) of 997 women told to refer their partners without further follow-up (patient referral), 

and in 31 (4.5%) of 645 women who were told to refer partners followed by reminders 

when partners failed to appear (conditional referral). Among 167 women managed with 

PDPT, 3 (1.8%) had persistent or recurrent infection. Although the partner management 

strategies were not randomly assigned and provider selection probably influenced the 

results, this report offered the first evidence that EPT might hold promise for partner 

management in women with chlamydial infection. 

Kissinger et al. analyzed reinfection rates in 256 women with chlamydial infection treated 

at an urban STD clinic, of whom 178 were re-tested a mean of 17.7 + 7.7 months later.30 

The annualized rate of reinfection was 12% among 43 women managed with PDPT, 

compared with 22% of 135 managed by card-enhanced patient referral (odds ratio [OR] 

0.37, 95% confidence interval [CI] 0.15-0.97, P <0.05). In Uganda, Nuwaha et al. 

undertook a randomized controlled trial (RCT) of PDPT compared with card-enhanced 

patient referral in STD clinic patients given syndromic management for urethral or vaginal 

discharge.31 After 2 weeks follow-up, index patients managed with PDPT reported that 176 

(74%) of 237 identified partners had received treatment, whereas 79 (34%) of the 234 

partners identified by control patients attended the clinic to be treated. Although the 

investigators reported these outcomes as significant in favor of PDPT (OR 2.44, 95% CI 

1.95-3.07), the differences in ascertainment of partner therapy—index case report vs. 

partner attendance at a clinic—make comparison difficult and the validity of the outcome 

uncertain. 

Randomized Controlled Trials: Biomedical Outcomes 

Four RCTs comparing EPT with traditional partner referral strategies, funded wholly or in 

part by CDC, have been conducted in the United States among patients with gonorrhea, 

chlamydial infection or trichomoniasis.32-35 The prevalences of persistent or recurrent 

infection in index cases at follow-up are summarized in Table 2. 

Multicenter Study of Chlamydial Infection in Women 

Schillinger et al.32 conducted a trial of PDPT compared with patient referral in women with 

uncomplicated chlamydial infection from 1996 to 2000 in 6 metropolitan areas, including 

San Francisco, California; Seattle, Washington; New Orleans, Louisiana; Birmingham, 

Alabama; Indianapolis, Indiana; and urban southern California (Long Beach, Torrance and 

Los Angeles). Patients were diagnosed in family planning, teen health, primary care, and 

STD clinics, and emergency departments. Initial chlamydial infections were diagnosed by 

various tests in routine use at the participating clinics, and follow-up infections were 

11 
determined by nucleic acid amplification tests (NAAT) (specifically, ligase chain reaction 

[LCR] or polymerase chain reaction [PCR]) testing of urine specimens. A total of 1,787 

eligible subjects were randomly assigned either to partner management by PDPT with 

single doses of 1.0 g azithromycin (for up to 4 partners) or to patient referral. In both 

groups the subjects were counseled to tell their partners about exposure and to encourage 

the partners to seek treatment. Those in the PDPT arm were provided with packets for 

delivery to their partners that contained powdered azithromycin, instructions on drug 

reconstitution and administration, advice about possible adverse effects and to abstain from 

sexual intercourse until 7 days after treatment, and a fact sheet about chlamydial infection. 

Control subjects, but not those in the PDPT arm, were provided with a list of clinics where 

their partners could obtain cost-free care. 

Follow-up visits were scheduled 1 month and 4 months after enrollment. At least 1 followup visit was completed >3 weeks after treatment in 728 (82%) of 887 patients assigned to 

PDPT and 726 (81%) of 900 controls.32 The control and intervention groups were similar 

demographically and in several behavioral measures. Women found to be infected at the 

first follow-up visit were not followed thereafter. At the first follow-up visit, C. 

trachomatis was identified in 37 women (5.1%) in the PDPT group and 54 (7.4%) of those 

in the patient referral arm. Among women who were chlamydia-negative at the first 

follow-up and were followed again a median of 13 weeks after treatment, C. trachomatis 

was identified in 50 (11.1%) of 450 women in the PDPT arm and 54 (12.2%) of 443 

controls. Thus, the cumulative prevalences of persistent or recurrent infection were 87 

(12.0%) of women in the PDPT arm and 108 (14.9%) of controls (OR 0.80, 95% CI 0.62-

1.05, P = 0.102). (The analysis assumed that women who tested negative at 1 month and 

were not followed further remained uninfected.) This effect remained after adjusting for 

patient age and study center, and the risk of reinfection was not correlated with compliance 

with the intervention within each study arm. Among women who reported a new sex 

partner after treatment and before follow-up, those the PDPT arm were more likely to be 

reinfected than women in the patient referral arm. 

Gonorrhea and Chlamydial Infection in Men and Women, King County, Washington 

From 1998 to 2003, Golden et al.33 contacted 7,723 patients with reported gonorrhea or 

chlamydial infection (among 26,656 reported cases). After excluding 2,471 persons who 

declined study participation and 2,501 who believed all partners at risk had already been 

treated, the investigators randomized 2,751 subjects to EPT (N = 1,376) or standard partner 

management (N = 1,375). Nineteen percent of enrolled subjects were diagnosed in public 

STD clinics, 23% in other public health clinics, 13% in community or family planning 

clinics, 12% in hospital emergency departments, and 33% by other clinicians in the private 

sector. Statistically significant differences between participants and those who declined 

participation were found in age (mean 23.2 and 25.2 years old, respectively, P<0.001), 

gender (74% and 64% female, P<0.001), diagnosis with gonorrhea without chlamydial 

infection (13% and 18%, P<0.001), diagnosis in emergency departments (10% and 6%, 

P<0.001), and diagnosis in family planning or community clinics (16% and 18%, P = 

0.009). 

For patients with gonorrhea, EPT consisted of cefixime 400 mg plus azithromycin 1.0 g; 

azithromycin alone was administered for chlamydial infection. The medications were 

delivered in “partner packs” that contained drug and written materials with instructions on 

12 
drug administration, warnings about possible side effects and allergic reactions, fact sheets 

about gonorrhea and/or chlamydial infection, and a list of clinics where cost-free STD care 

was available. In the EPT arm, index patients enrolled in the STD clinic who were able and 

willing to contact their partners were given partner packs for up to 3 partners. Participants 

randomized to EPT who were enrolled by telephone retrieved partner packs at pharmacies 

that had agreed to collaborate in the project. When index patients were unable or unwilling 

to contact their partners, study personnel contacted the partners and arranged for the 

partners to retrieve partner packs from the cooperating pharmacies. The standard arm was 

patient referral for subjects who were willing and able to contact their partners and provider 

referral by study personnel for others. Index patients or study personnel advised the 

partners to attend the STD clinic or to visit their own health care providers for treatment, 

and were provided written materials as in the EPT arm, without the medication-specific 

information. Index patients in both study arms were followed for interview and for urine 

NAAT testing for C. trachomatis and Neisseria gonorrhoeae by NAAT (LCR or 

transcription mediated amplification [TMA]). There were no significant differences 

between study arms in the distribution of gonorrhea or chlamydial infection, gender, age, 

race, ethnicity, type of health care facility where the diagnosis was made, symptoms, 

number of sex partners, or frequency of condom use in the 60 days before enrollment. 

The prevalences of persistent or recurrent infection at follow-up are summarized in Figure 

3. Follow-up 3-19 weeks after enrollment was 68% in each arm. The protocol-defined 

primary outcome of persistent or recurrent infection with either N. gonorrhoeae or C. 

trachomatis was found in 92 (9.9%) of 929 patients in the EPT group and 121 (13.0%) of 

931 controls (OR 0.76, 95% CI 0.59-0.98, P = 0.04). The reduction in persistent or 

recurrent infection was greater for gonorrhea (OR 0.32, 95% CI 0.13-0.77, P <0.01) than 

for chlamydial infection (OR 0.82, 95% CI 0.62-1.07, P = 0.17). Table 3 summarizes the 

prevalence of infection at follow-up separately for men and women and for each infection. 

EPT remained independently associated with a lower prevalence of infection with either 

organism at follow-up (OR 0.7, 95% CI 0.6-1.0) after adjustment for gonorrhea versus 

chlamydial infection, index patient age, the clinical setting where the diagnosis was made, 

race/ethnicity, resumption of sex following treatment, and number of partners with whom 

index patients had unprotected sex since treatment (Table 4). (Factors associated with the 

outcome on univariate analysis but which were believed to be in the causal pathway for the 

effects of EPT, such as the index cases’ belief that all partners at risk had been treated, were 

excluded from the final multivariate model.) 

Golden et al offered 4 hypotheses to explain the weaker association with chlamydial 

infection than gonorrhea at follow-up.33 Three of these (differences between patients with 

gonorrhea or chlamydial infection in successful delivery of therapy to partners; differences 

in resumption of sex with untreated partners; and differences in receipt of antibiotic therapy 

in addition to the initial treatment) were not supported by data from the index case 

interviews at follow-up. The fourth hypothesis was that chlamydial infections in women 

may persist following therapy more frequently than do gonococcal infections. Among 

women with chlamydial infection, 289 (21.8%) of 1,328 who returned for follow-up denied 

sex with any partner since treatment, as did 38 (18.9%) of 201 women with gonorrhea who 

were followed. C. trachomatis was identified at follow-up in 22 (7.6%) of the 289 subjects 

who denied sexual exposure since treatment, whereas N. gonorrhoeae was found in 1 (3%) 

13 
of the 38 female gonorrhea patients who denied sex after treatment (Figure 4). None of 87 

men who denied sex after treatment was infected with either organism. 

Urethritis in Men, New Orleans 

From December 2001 to March 2004, Kissinger et al.34 enrolled 977 male STD clinic 

patients with symptomatic urethritis into a 3-arm RCT of PDPT, patient referral, or bookletenhanced partner referral (BEPR), i.e. patient referral supplemented with a booklet that 

provided information about gonorrhea and chlamydial infection. Patients were enrolled on 

the day of presentation, before the diagnosis was bacteriologically confirmed, and the EPT 

regimen for all patients was azithromycin 1.0 g plus either cefixime 400 mg or 

ciprofloxacin 500 mg. Subsequent diagnostic testing documented gonorrhea alone at 

enrollment in 54.5% of subjects, chlamydial infection alone in 15.0%, and both infections 

in 5.9%; neither infection was found in the remaining 25%. Seven hundred seventy men 

(79%) returned for follow-up 2-8 weeks after enrollment, but testing for N. gonorrhoeae 

and C. trachomatis was available for only 289 men (37.5%), attributed by the authors to 

multiple factors, including patients’ fears that testing for illicit drugs would be conducted 

on urine. The subjects tested were similar to those not tested in all demographic and 

behavioral characteristics measured at baseline and in the proportion who had sex with a 

new partner since treatment (14% of those who permitted testing and 13% of those who did 

not). Follow-up tests were permitted by 43% of men randomized to BEPR compared with 

33% of those managed with EPT or standard partner referral (P <0.05). Testing at follow-up 

was accomplished by the strand displacement NAAT of urine in 242 subjects, and in 47 

men by non-amplified DNA probe test on urethral swab specimens. 

The results are summarized in Table 2. For subjects with either chlamydial infection, 

gonorrhea or both, infection was present at follow-up in 35 (43%) of 82 men in the patient 

referral arm (referent), 20 (23%) of 87 managed with PDPT (adjusted OR 0.38, 95% CI 

0.19-0.74), and 16 (14%) of 112 in the BEPR arm (adjusted OR 0.22, 95% CI 0.11-0.44). 

Compared with patient referral, the reduction in infection prevalence at follow-up in the 

PDPT arm was similar for gonorrhea (OR 0.34, 95% CI 0.13-0.86) and chlamydial 

infection (OR 0.46, 95% CI 0.13-0.87). Using an intention-to-treat mode, reinfection rates 

for subjects in both the PDPT and BEPR conditions remained significantly lower than in 

the control condition. In an analytic model in which all untested men were assumed to be 

uninfected at follow-up, the prevalences of persistent infection were 5.8% for PDPT, 4.6% 

for BEPR, and 12.3% for subjects managed with standard patient referral (P<0.01).34 

Trichomoniasis in Women, New Orleans 

From 2001 to 2004, Kissinger et al.35 conducted a trial of PDPT in 463 women with vaginal 

trichomoniasis in an STD clinic. PDPT with single doses of metronidazole 2.0 g was 

compared with patient referral and BEPR, as described above. Infection at baseline and 

follow-up was diagnosed by culture of Trichomonas vaginalis. The prevalences of 

infection at follow-up are summarized in Table 2. Among 376 women followed 3-7 weeks 

after enrollment, persistent or recurrent trichomoniasis was documented in 8 (6%) of 126 

women in the patient referral group (referent), 12 (9%) of 128 patients randomized to 

PDPT, and 11 (9%) of 122 in the BEPR arm (P = 0.6). The results were not substantially 

different when controlled for several demographic and behavioral variables. The 

investigators hypothesized that the absence of measurable differences in treatment 

14 
outcomes may reflect a higher-than-expected treatment failure with single-dose 

metronidazole in index patients, partners, or both. In addition, the 73% compliance rate for 

the patient referral (control) arm was substantially higher than expected, requiring a larger 

than anticipated sample size to document possible differences. 

Randomized Controlled Trials: Behavioral Outcomes 

The 4 RCTs32-35 included self-reported behavioral outcomes derived from interviewing 

subjects who returned for follow-up, and many measures were similar across these studies 

in both design and procedure. Because of these similarities, and because desirable 

behaviors of patients and partners are common to all three STDs studied (gonorrhea, 

chlamydial infection, trichomoniasis), the results in three domains—partner notification 

behaviors, patients’ perceptions that their partners were treated, and sexual behaviors 

following treatment—were combined. 

Partner Notification 

In 3 RCTs,33-35 index patients were directly asked at follow-up whether they had notified 

their partners. In the other trial, Schillinger et al.32 asked trial participants whether they 

complied with the intervention, which required women in both arms to notify their partners 

that they had been exposed and recommend they be evaluated and treated, and for women 

in the PDPT arm to deliver medication to their partners. The results from all 4 trials are 

summarized in Table 5. For PDPT, 505 (85%) of 591 women responded affirmatively, 

compared with 431 (75%) of 576 controls (P<0.01). In the New Orleans urethritis trial,34 

participants were directly asked whether they notified their partners: 500 (71%) of 705 men 

randomized to PDPT reported that they did so, compared with 280 (48%) of 579 in the 

patient referral arm (P<0.001) and 375 (53%) of 707 men managed with booklet-enhanced 

partner referral (BEPR) (P<0.001). 

In the King County study33 and the New Orleans trichomoniasis trial,35 the rates of reported 

partner notification were virtually identical for EPT and standard partner management: 

77% of 1,335 EPT patients versus 78% of 1,403 controls in King County; and 90% of 176 

for EPT versus 88% of 173 patients in the patient referral arm in New Orleans (Table 5). 

The rate was 84% of 172 New Orleans women in the BEPR group. None of the observed 

differences was statistically significant. The especially high rates of partner notification 

observed in New Orleans (84 – 90%) may have resulted from enhanced counseling in all 

trial conditions; all participants received expanded instructions and education about the 

importance of notification that were not routine in the authors’ clinic. 

Partner Treatment 

The participants in all 4 RCTs were asked if they believed their partners were treated, and 

in two trials they were asked whether they observed their partners take medication (Table 

6). Among women with a single partner at enrollment in the 6-city trial, 518 (86%) of 602 

subjects in the PDPT arm thought it “very likely” that their partners took the medication, 

compared with 392 (57%) of 681 women in the patient referral arm who stated it was “very 

likely” that the partners had been treated (P<0.001). In King County,33 816 (64%) of 1,268 

participants in the EPT group and 732 (52%) of 1,354 persons randomized to standard 

management reported that their partners “very likely” were treated (P<0.001); and 519 

15 
(61%) of 850 EPT patients versus 435 (49%) of 888 controls reported that all partners at 

risk had been treated (P<0.001). 

In the New Orleans urethritis trial34 the subjects managed with PDPT reported compliance 

with the intervention for 70% of their partners, compared with 48% of the partners of men 

in the patient referral arm (P<0.001) and 58% of those in the BEPR arm (P<0.01). The 

index cases in the PDPT arm reported that 56% of their partners said they took medication, 

compared with 34% for patient referral and (P<0.001) and 44% for BEPR (P<0.01).34 

Among women with trichomoniasis studied in New Orleans,35 the patients randomized to 

PDPT observed 63% of their partners take the drug, compared with 18% for patient referral 

(P<0.001) and 20% in the BEPR arm (P<0.001). However, in the same trial women 

randomized to PDPT were no more likely than those in the standard management group to 

report that their partners said they took medication (77% vs. 70%, P = NS). Women in the 

BEPR condition reported that only 58% of their partners said they took their medications 

(P<0.01 compared with PDPT).35 

Sexual Behavior Following Treatment 

Schillinger et al.32 asked their study subjects whether they had acquired new sex partners 

between treatment and follow-up; 167 (23%) of 728 women in the PDPT arm had done so, 

compared with 201 (28%) of 726 randomized to patient referral (P<0.05) (Table 7). In the 

King County study,33 51 (5.8%) of 886 participants randomized to EPT had sex following 

treatment with >1 partner who had neither been treated nor tested and found to be negative 

for STDs, compared with 110 (12.2%) of 902 controls (OR 0.5, 95% CI 0.3-0.6, P<0.01) 

(Table 7). 

Although the two New Orleans trials studied the same interventions, significantly different 

sexual behavior outcomes were observed for men with urethritis and women with 

trichomoniasis (Table 7).34,35 Men managed with PDPT reported unprotected sex before 

partner treatment with 28% of their partners, compared with 37% of partners of men in the 

patient referral arm (P<0.05), and 35% of partners of men in the BEPR arm (P = NS).34 

Among women with trichomoniasis, the comparable outcomes were 8% for PDPT, versus 

5% for the patient referral arm (P = NS) and 6% for BEPR (P = NS).35 After treatment, 

29% of men managed with PDPT reported unprotected sex during the follow-up period 

with their partners, compared with 34% of men in the patient referral arm and 37% of men 

in the BEPR arm (P = NS). By contrast, 26% of women with trichomoniasis randomized to 

PDPT reported unprotected sex during follow-up with their partners, versus 13% of women 

managed with patient referral (P<0.01) and 16% of women managed with BEPR (P<0.05). 

Randomized Controlled Trials: Cost Effectiveness 

A retrospective cost effectiveness analysis36 was conducted based on the results of the 6-

city trial.32 Providing PDPT for all partners, which was the most effective method of 

treating the male partners of women enrolled in the study, was the model that resulted in the 

fewest number of cases of PID in the index women. When the costs of averted sequelae 

were considered, PDPT was cost-saving compared either to standard patient referral, or to a 

modeled strategy of selective PDPT in which medication was assumed to be provided for 

delivery to only those partners women believed unlikely to seek care. When considering 

16 
only program costs, i.e. excluding the costs of sequelae, PDPT was slightly more expensive 

than either patient referral or the selective PDPT strategy, because an individual clinic or 

program typically does not realize the cost savings that result from preventing sequelae. 

The program cost of PDPT per index patient was higher per index patient ($32) than the 

alternative of standard patient referral ($28) or the modeled option of selective EPT ($28). 

However, because treatment rates were higher, EPT was less costly per infected partner 

treated ($82 versus $137 and $130, respectively). EPT was cost-saving compared to the 

alternatives when costs of averted sequelae were included in the analysis.36 

Cost effectiveness analyses37 were incorporated prospectively into the King County and 

New Orleans trials of EPT for chlamydial infection and gonorrhea.32,33 Literature estimates 

were used for the costs of sequelae, the proportions of other partners likely to be infected, 

and the costs of unobserved patient visits to health care providers. Cost effectiveness was 

analyzed from programmatic and health care systems perspectives. In the King County 

trial.33 Personnel costs were derived from prospective records of the time spent by study 

personnel in contacting providers, patients and pharmacies, and for related administrative 

work; these variables were designed to mimic those anticipated in implementation of 

partner management in a typical health department. EPT was found to be cost-saving 

compared to standard partner management as practiced in the trial (patient referral or 

provider referral, depending on the subjects’ willingness and ability to personally contact 

their partners), and remained cost-saving whether or not the costs of sequelae averted were 

included in the analysis. Because public health personnel or resources are not involved in 

partner management for most patients with gonorrhea or chlamydial infection treated in 

U.S. health departments,12 the analysis was repeated without these expenditures. The 

programmatic cost of EPT was $200 more per additional infected partner treated than for 

standard patient referral or provider referral. When the costs of sequelae averted were 

included in the analysis, EPT was cost-saving compared to the low-cost referral model that 

had been adjusted for public health expenditures for male index patients, but not for female 

index patients. In any particular program, the latter figure would be highly sensitive to the 

proportion of patients managed by patient referral, provider referral, conditional referral, or 

other mechanisms.37 

In the New Orleans urethritis trial,34 the program cost of EPT per index patient ($60) was 

found to be lower than the equivalent costs for standard patient referral ($81) or bookletenhanced partner referral (BEPR) ($79).37 The cost per infected partner treated was $86 for 

EPT, compared with $193 for standard referral and $176 for BEPR. The difference was 

primarily the result of reduced numbers of health care visits by partners managed by EPT. 

EPT remained substantially less costly than the control interventions after adjustment for 

the costs of averted sequelae.37 

17 
IMPLEMENTATION ISSUES 

Numerous practical issues will influence implementation of EPT and its priority compared 

with traditional partner management strategies. Except where indicated, this discussion 

addresses EPT for chlamydial infection and gonorrhea. 

Special Populations 

The 4 available RCTs and other evaluation studies are largely limited to heterosexual adult 

men and women, whereas EPT may be used for other populations diagnosed with STD, 

such as men who have sex with men (MSM), pregnant women, and adolescents. No data 

are known to exist on EPT for gonorrhea or chlamydial infection among MSM. The rates 

of syphilis, gonorrhea and probably of chlamydial infection in MSM are substantially 

higher than in most heterosexual populations and have been rising rapidly in all 

industrialized countries.38 All partner management strategies have variable success in this 

population because of high rates of partner change and anonymous partnerships, which 

would challenge the efficacy of EPT. Further, it is likely that high prevalences of comorbidities, including HIV infection, other STDs, substance use, and psychological 

impairment favor traditional partner management over EPT in MSM. 

Pregnant women were not separately analyzed in the available trials of EPT. Because of 

potential adverse effects of gonococcal or chlamydial infection on the course of pregnancy 

and neonatal health, preventing reinfection may be a higher priority than in nonpregnant 

women. On the other hand, most pregnant women have ready access to health care and 

many are highly motivated to protect the health of the fetus, factors that are likely to 

enhance the success of traditional partner management and might reduce the role of EPT. 

Improved partner management is a high priority among heterosexual adolescents,39,40 

among whom the rates of gonorrhea and chlamydial infection in females outstrip those of 

all other age groups.41 Recent data on partner notification in teens assessed dispositional 

correlates of success, such as self-efficacy and relationship quality.24 No studies have 

explicitly addressed EPT in predominantly adolescent populations. Slightly over half the 

patients in the 6-city RCT of women with chlamydial infection were aged 14-19 years, and 

the results were not materially different than in the study population as a whole, with 

prevalences of infection at follow-up of 13% of in the EPT arm and 17% of controls (P = 

0.09).32 However, few subjects were <16 years old, and useful data are lacking on the 

efficacy of EPT in young teens. 

Other Sexually Transmitted Diseases 

In many settings, EPT may be a consideration in partner management for STDs other than 

those studied to date. Partners of patients with NGU, MPC, or PID often are treated before 

the results of diagnostic tests are available, and some providers likely will use EPT without 

knowledge of microbiologic etiology. The utility of partner treatment in reducing 

morbidity in partners or preventing reinfection has not been established for nonchlamydial 

NGU or MPC. Uncertainty about how to manage partners is an important reason clinicians 

are encouraged to test all patients with NGU, MPC, or PID for N. gonorrhoeae and C. 

18 
trachomatis. Syphilis requires injection therapy with benzathine penicillin G, precluding 

PDPT and most other EPT strategies. Azithromycin may have promise as a single-dose or 

two-dose oral option for treatment of persons with infectious syphilis and their partners,42,43 

and was transiently used by some health departments as PDPT for MSM with syphilis.44 

However, high and rising rates of azithromycin-resistant strains of Treponema pallidum and 

substantial rates of treatment failure following azithromycin therapy preclude EPT with 

azithromycin unless and until expanded research establishes the safety and efficacy of such 

treatment.45,46 It seems likely that some providers now use EPT in the management of some 

patients with scabies, pediculosis pubis, and perhaps genital herpes or other STDs, but no 

data are known to exist on these practices. 

STD Co-morbidity in Partners 

If partners receiving EPT do not seek evaluation, EPT may incur missed opportunities for 

diagnosis and therapy of STDs that would be detected by personal evaluation of the 

partners. Stekler et al.47 reviewed the medical records of 4 urban STD clinics (Baltimore, 

Birmingham, Denver and Seattle) to determine the prevalence of STDs in persons named as 

partners of persons who gave their reason for clinic attendance as sexual contact with 

persons who had gonorrhea, chlamydial infection, NGU or trichomoniasis (Table 8). The 

STD contact histories were self-reported, without corroboration by record review or by 

other methods. Among 8,623 patients, 28 (0.3%) had infectious syphilis; 24 of these were 

in a single clinic (Baltimore), where the 1.1% prevalence of syphilis was substantially 

higher than in the other clinics. Infectious syphilis was present in 8 (1.7%) of 473 MSM. 

Among female partners of men with gonorrhea, chlamydial infection or NGU, acute PID 

and trichomoniasis were diagnosed in 3.8% in 4.9%, respectively. Previously undiagnosed 

HIV infection was present in 19 (0.4%) of 4,716 heterosexual men and women and 13 (6%) 

of 207 MSM. Among 785 male partners of women with trichomoniasis, 81 men (10.3%) 

had gonorrhea or chlamydial infection; in Birmingham the prevalence was 15%. 

STD contact was self-reported, and the clinics’ databases do not systematically record 

patients’ histories of contact with multiple STDs, factors that limit the interpretation of this 

study. Another important limitation is that patients who attend STD clinics as partners of 

persons diagnosed with STD probably are not representative of partners who do not seek 

care, or partners who seek care in venues other than STD clinics. 

Effects on Bacterial Ecology and Antimicrobial Resistance 

The recipients of EPT have indications for antimicrobial therapy. Nevertheless, a 

substantial increase in relatively unsupervised antibiotic usage might raise concerns about 

the effects on bacterial ecology and antimicrobial resistance. However, the incremental 

effect of EPT on overall antibiotic use likely would be small. For example, about 55 

million prescriptions for azithromycin and other macrolide antibiotics are written in the US 

annually.48 Even if azithromycin could be successfully administered through EPT and 

other means to one sex partner for each of 3 million estimated annual cases of incident 

chlamydial infection, the increment in macrolide prescriptions would approximate 5%; the 

actual increment in macrolide use would be much smaller. Similar considerations apply to 

19 
single-dose treatment with fluoroquinolones and cephalosporins. Use of doxycycline 

probably carries a greater risk of adverse ecological outcomes than the other options, 

because unused medication from multiple-dose regimens undoubtedly increases the 

potential for unsupervised later use. 

Adverse Effects of Drugs 

Drug toxicity and allergic reactions in partners treated without direct medical supervision 

are potential problems for all drugs likely to be used for EPT in managing patients with 

chlamydial infection, gonorrhea or trichomoniasis. Less serious but more frequent adverse 

outcomes consist primarily of transient gastrointestinal intolerance. Delivery of dual 

therapy active against both gonorrhea and chlamydial infection increases the risk of adverse 

reactions and drug intolerance. Doxycycline and the fluoroquinolones carry theoretical 

risks for adverse effects in pregnant women or the fetus, but the actual frequencies of fetal 

and pregnancy-related morbidity are low. Metronidazole carries risks of gastrointestinal 

intolerance, allergic reactions, and disulfiram-like reactions in association with alcohol 

ingestion. The potential for reducing the frequency of adverse effects represents a 

particular advantage of EPT strategies that depend on delivery of drug by pharmacies, 

whether by written prescription or other means.49 

Missed Opportunities for Prevention Counseling 

Compared with personal evaluation in a health care setting, treatment by EPT represents a 

missed opportunity for professional counseling of patients’ sex partners, and there is broad 

consensus that partners who are willing and able to attend for personal care should be 

encouraged to do so. However, few data are available to judge the prevention efficacy of 

such counseling, especially when provided by typical primary care providers, or to 

document that its prevention benefit outweighs that which might accrue through 

educational literature that might accompany EPT or counseling by a pharmacist; or the 

relative efficacies, on a population level, of such counseling compared with overall 

enhanced partner treatment. McCree et al. encouraged pharmacists to embrace counseling 

and educational responsibilities related to EPT, as an initial interface between sex partners 

and the health care system.49 One facet of pharmacy-based counseling would be to 

encourage recipients of EPT to seek medical evaluation. An expanded role of pharmacies 

in STD partner management is consistent with increasing involvement by pharmacists in 

preventive medicine through blood pressure monitoring, immunization, provision of 

emergency contraception, and other initiatives. 

Legal Status of EPT 

Providing a prescriptive drug to a patient with whom the clinician lacks an established 

provider-patient relationship is not legal in some states, and elsewhere may be incorrectly 

perceived by providers as illegal. Golden et al. surveyed the directors of medical practice 

boards and pharmacy boards in 2003 in order to assess the legal status of EPT in the 50 

states.50 Usable responses were received from either or both sources from 47 states. In 4 

states (Washington, California, Colorado, Tennessee), both respondents stated that EPT is 

20 
legal. The practice was classified by both respondents as illegal in 30 states, but many of 

the respondents expressed uncertainty and stated that the issue had never been directly 

addressed in their states. The medical and pharmacy board representatives in 3 states 

(Arizona, Oregon and North Carolina) gave conflicting responses. In 42 states where EPT 

was not known to be legal, most respondents expressed uncertainty as to whether 

enforcement action would be taken against providers who pursued the practice.50 

Medicolegal Concerns 

The risk of litigation in the event of adverse outcomes may be elevated (or perceived by 

practitioners to be elevated) when a practice has uncertain legal status or is outside formally 

accepted community practice standards. Guidance from authoritative bodies may help 

determine community standards of care and thereby influence the assessment of 

medicolegal impediments to EPT. 

Funding 

When clinicians simply integrate EPT into their existing practices, the primary increased 

cost may be that of drug therapy per se, which often will be absorbed by index cases or 

their partners. The importance of this obstacle will vary widely between patients and in 

various settings. Increasingly comprehensive programs by public health departments, 

health maintenance organizations, or other agencies will incur additional costs, including 

expenses incurred in counseling index patients, purchasing drugs, development of 

educational literature, packaging drugs and counseling aids, administrative expenses 

incurred by arrangements with pharmacies, personnel time when medications are delivered 

to patients by public health workers, and others. The cost effectiveness studies undertaken 

in connection with 3 RCTs of EPT had promising outcomes, suggesting that 

institutionalized EPT in health department settings likely is cost-saving and probably is a 

cost effective partner management strategy.36,37 The expenses of EPT may be modest in 

relation to the total costs incurred in diagnosis and management of patients with treatable 

STDs, and in relation to the potential to prevent complications and curtail the spread of 

infection.37 Nevertheless, even small incremental costs may cause difficulties for underfunded public health departments, especially those that now expend few resources on 

partner management for STDs other than syphilis and HIV infection. 

The same cost effectiveness considerations are relevant to patients treated in 

institutionalized settings other than health departments, such as health maintenance 

organizations and managed care plans. Partner management strategies that reduce risk of 

persistent or recurrent gonorrhea and chlamydial infection may influence some such 

agencies and health insurers to finance EPT for their enrollees’ sex partners. Others 

undoubtedly will demur for logistical and administrative reasons or because of medicolegal 

considerations, in particular perceived liability for adverse effects in non-enrolled patients. 

Further, there are regulatory impediments to use of patients’ third party coverage for partner 

treatment. 

21 
Privacy 

Pharmacy laws or policies may require that identifying information be recorded for persons 

receiving prescription drugs. At the same time, stipulations of the Health Information 

Portability and Accountability Act (HIPAA), as well as historic concerns for patient 

confidentiality, may preclude documenting a partner’s identity in an index patient’s medical 

record. To surmount this obstacle, some programs have established pharmacy records that 

are separate from patient records. Recent legislation in Tennessee permits EPT for 

unnamed partners, presumably facilitating recording of all necessary information in index 

patients’ medical or pharmacy records. In many jurisdictions providers and health care 

agencies are likely to require guidance on implementation of EPT while guarding the 

privacy of both index patients and partners and to comply with HIPAA. 

Drug Delivery and Packaging 

PDPT, either of medications per se or of prescriptions, undoubtedly will be the usual 

mechanism for EPT, especially in the private sector. Acceptance of PDPT for chlamydial 

infection in San Francisco initially was low,51 but qualitative research among recipients of 

PDPT with azithromycin for syphilis in the same setting revealed that professionalappearing (and therefore more costly) packaging enhanced patient acceptance.44 However, 

some patients will be unwilling or unable to assist in contacting or treating one or more 

partners, and optimal use of EPT may depend on partners retrieving drug at pharmacies, 

health department clinics, or other facilities, or delivery of medications DIS or other 

outreach workers. There is broad consensus that EPT should be accompanied by written 

materials that include descriptions of the STD of concern, symptoms of infection, advice 

that personal evaluation is preferable to self-treatment, sources of STD-related health care, 

and information about potential adverse effects and allergic reactions. In some settings, 

packaging and delivery of drugs and accompanying materials may carry significant 

administrative and financial costs. 

Providers’ and Health Agencies’ Attitudes and Beliefs 

It is likely that multilayered attitudinal differences have long existed between most public 

health agencies’ recommendations, some providers’ practices, and providers’ beliefs about 

the appropriateness or utility of EPT. Historically, public health experts and agencies have 

overtly or tacitly condemned EPT, yet some providers employed it frequently and at least 

half did so sporadically for chlamydial infection or gonorrhea.25-28 These attitudes and 

beliefs undoubtedly will influence the acceptance and implementation of EPT. There are 

other precedents for EPT-like uses of anti-infective drugs for prevention of communicable 

diseases, as when antibiotics are distributed to persons exposed to invasive meningococcal 

disease; when entire families are treated for pediculosis or pinworm infestation diagnosed 

in one member of the household; and when patients and employees of extended health care 

facilities are treated after diagnosis of a single case of scabies. Nevertheless, some 

providers may not view these practices as precedents for EPT for STDs. The California 

experience suggests that many providers who employ EPT for gonorrhea or chlamydial 

infection do so despite believing it to be suboptimal health care.27 Endorsement of EPT by 

22 
professional societies and organizations may be anticipated in the future, perhaps 

facilitating provider acceptance. 

Administrative Barriers and Organization of EPT 

Although EPT is presently in use by some providers at little apparent administrative cost, 

substantial barriers may exist at the institutional level. To reach large numbers of persons 

diagnosed with gonorrhea or chlamydial infection, the King County trial of EPT33 depended 

on substantial cooperation and coordination between public health and the private sector, 

involving the health department, numerous health care providers and clinics, the local 

medical society, and pharmacies.23 This collaboration itself has been cited as a useful 

outcome of the study.52 A demonstration project designed to implement a similar system 

statewide, and to assess the impact of routine use of EPT on gonorrhea on the incidence and 

prevalence of infection at a population level, will soon be underway in the state of 

Washington (Golden MR, personal communication). 

Provider Education 

Few public health agencies currently employ EPT, and there is great variability in the 

frequency of use by private health care providers.17,25-27 It is likely that most providers have 

not systematically considered the advantages, disadvantages, costs, and barriers associated 

with various partner management strategies for particular STDs and in various populations 

at risk. These facts imply a need for a concerted and focused effort to educate providers on 

all partner management strategies. 

Interaction with Other Partner Management Strategies 

The resources available and index patient willingness to bring or refer his or her partners 

for personal evaluation and the availability and expected effectiveness of provider referral 

will influence implementation of EPT. Some patients will be willing and able to refer their 

partners for traditional care, with confidence the partners will comply, and in other settings 

effective provider referral may be available. EPT may have a lesser role in partner 

management in such settings. Most health departments have insufficient resources to 

attempt to provide partner services for persons with gonorrhea, but 6 jurisdictions (each 

with <2,500 annual cases of gonorrhea) of 60 surveyed reported that they attempted to 

initiate partner services for >80% of persons with gonorrhea.12 Data are generally not 

available from those jurisdictions to judge overall effectiveness of partner management, but 

EPT may have a lesser role for gonorrhea management in those settings than others. 

Similar data are not available for chlamydial infection. 

Retesting for Chlamydial Infection and Gonorrhea 

Retesting of women, also called rescreening, is emerging as an important strategy for 

control of chlamydial infection.53-55 Some providers might believe that enhanced assurance 

that partners received treatment reduces the need for retesting, but the results of 3 RCTs of 

23 
EPT reviewed in this report reconfirm the importance of retesting women following 

treatment of chlamydial infection, regardless of the partner management strategy employed, 

and highlight its probable importance for men with chlamydial infection and both men and 

women following treatment of gonorrhea.32-34 

24 
DISCUSSION 

Summary and Interpretation of the Randomized Controlled Trials 

Persistent and Recurrent Infection Following EPT 

In 4 RCTs, the frequency of persistent and recurrent infection following EPT compared to 

standard partner management was assessed among persons with gonorrhea, chlamydial 

infection, or trichomoniasis. The effects were largely consistent across the trials, but varied 

according to disease and gender. In two RCTs that evaluated men with gonorrhea or 

chlamydial infection to assess treatment of their female partners,33,34 EPT was associated 

with reduced rates of reinfection compared with patient referral and/or provider referral. 

However, the combined sample size of males available for biomedical follow-up is modest. 

In the King County trial,33 this information is available for 157 men with gonorrhea and 267 

men with chlamydial infection. In New Orleans,34 persistent or recurrent infection was 

measured in 289 men with either infection. 

In women, the association of EPT with a reduced prevalence of infection at follow-up was 

weaker for chlamydial infection32,33 than gonorrhea.33 In the King County trial, 7.6% of 

female index cases with chlamydial infection who were treated with azithromycin and 

denied all sexual exposure after treatment nevertheless were infected at follow-up.33 By 

contrast, among patients who denied sex following treatment, only one woman had 

gonorrhea at follow-up and no man had either infection. Analysis of the determinants of 

persistent or recurrent chlamydial infection in 5 of the centers (and most of the same 

clinics) where the 6-city trial32 was subsequently conducted also suggested a higher than 

expected rate of persistent infection in women who denied sexual reexposure.53 Thus, the 

apparent efficacy of both EPT and the control strategies in preventing reinfection with C. 

trachomatis may have been reduced by a higher-than-expected rate of persistent infection at 

follow-up. Highly sensitive NAATs were used to detect chlamydial infection in the EPT 

trials32-35 and the 5-city cohort study of reinfection that preceded it,53 whereas culture was 

employed in most published studies designed to determine the efficacy of azithromycin 

against C. trachomatis.

56 In addition, the therapeutic trials typically followed patients at 3-

6 weeks,56 compared with 6-20 weeks follow-up in the EPT-related studies.32-35,53 Other 

evidence also suggests that persistent C. trachomatis following treatment with azithromycin 

may be more common than previously believed.57 

The single available RCT of EPT for trichomoniasis in women did not demonstrate a 

significant difference in the prevalence of persistent or recurrent infection compared with 

either standard or booklet-enhanced patient referral, and mixed results were observed for 

desirable behavioral outcomes.35 The trial is limited in its generalizability because the 

population studied, almost exclusively minority patients of low socioeconomic status in a 

southern, inner city STD clinic, is poorly representative of many women with 

trichomoniasis. Further, the control subjects displayed an unexpectedly high success rate of 

73% in referring their partners for treatment, perhaps challenging the ability of the study to 

document differences in outcomes between the study arms. Finally, higher than expected 

rates of persistent or recurrent infection might have contributed to the outcome. The 

recommended 2.0 g metronidazole regimen used in the trial cures 90-95% of cases,58,59 

25 
compared with >96% cure rates for the recommended gonorrhea and chlamydial regimens. 

No studies have assessed the efficacy of metronidazole using maximally sensitive tests of 

cure such as PCR for T. vaginalis,

60 raising the possibility that the actual cure rate is <90% 

in men, women, or both. Tinidazole may be more effective than metronidazole.59,61 

Behavioral Outcomes Associated with EPT 

All 4 RCTs reviewed incorporated assessment of behavioral outcomes in addition to the 

primary outcome of persistent or recurrent infection.32-35 Across the 4 trials, according to 

interviews of the index cases at follow-up, EPT resulted in higher or equivalent frequencies 

of partner notification and partner treatment. In 3 of the trials,32-34 EPT was associated with 

lower frequencies of behaviors that would risk reinfection, including sexual re-exposure to 

untreated partners and unprotected sex with new partners. In the trichomoniasis RCT, 

however, EPT was associated with a greater likelihood of unprotected sex compared with 

standard management.35 The generally favorable outcomes associated with EPT were 

based on self-report by subjects who might have overtly or unwittingly provided desirable 

responses, but there is no particular reason to believe that this potential bias was 

systematically associated with EPT compared with the control strategies. Some of the 

behavioral outcomes, such as patients’ reports that they observed their partners ingest the 

medication and reduced frequency of post-therapeutic sex with untreated partners, 

undoubtedly are involved in the causal pathway for reduced prevalence of infection at 

follow-up. These findings give promise that behavioral outcomes may serve as surrogate 

markers for partner treatment success in less costly future studies that do not rely on 

prolonged follow-up to measure persistent or recurrent infection. 

Generalizability 

With rare exceptions, all RCTs raise questions of generalizability: to what extent are the 

patient populations, interventions and outcomes pertinent to settings other than those 

represented in the trials? The geographic distribution of the patients studied by Schillinger 

et al is an important strength of the 6-city trial, especially since PDPT was associated with 

similarly reduced rates of recurrent or persistent infection in 5 of the 6 study centers and 

across most subgroups analyzed.32 Data are not available on the proportion of potentially 

eligible subjects who were enrolled, how those persons compared with those not enrolled, 

and how the study population compares with other women infected with C. trachomatis. 

Golden et al.33 enrolled subjects diagnosed at a broad and well-documented range of 

clinical settings, with predominant representation from private practices and other nonpublic clinics, and carefully characterized the study population, demonstrating substantial 

comparability to subjects who declined participation or were ineligible. However, the trial 

was undertaken in a single metropolitan area that may not be representative of many 

jurisdictions where EPT might be employed. For example, although racial and ethnic 

minorities were well represented in relation to the population of King County, the numbers 

and population proportions of minorities were small in comparison to those in many 

geographic areas. 

The design of both trials necessarily excluded subjects whose partners already had received 

treatment, i.e. patients in whom partner management (probably almost exclusively through 

patient referral) already was successful. This is a particular issue for the King County trial, 

in which about half the potential subjects were excluded because the index cases believed 

26 
all partners at risk had been treated. Thus, the study population probably was biased toward 

a subset of patients less likely than others to facilitate partner treatment, which might have 

reduced the apparent efficacy of both EPT and the control strategies. It is likely that fewer 

patients enrolled in the 6-city trial32 had an opportunity to inform and arrange for treatment 

of their partners before enrollment, but the available data do not permit definitive 

assessment of this possibility. 

The New Orleans trials of EPT for urethritis in men34 and trichomoniasis in women35 

enrolled most patients at the time of diagnosis, before any effort had been made to assure 

referral and treatment of the subjects’ partners. In this respect, the studies may more 

accurately reflect the implementation of EPT in settings where index case treatment and 

partner management are undertaken simultaneously, such as public STD clinics. However, 

both New Orleans patient populations were composed almost entirely of African Americans 

attending an inner city STD clinic. These patients may be more socioeconomically 

disadvantaged than many patients who may be offered EPT, especially in the private sector. 

The failure of many male subjects in New Orleans to provide urine specimens at follow-up, 

ostensibly because of fears that the specimens would be tested for illicit drugs, may have 

introduced undetected biases in the analysis of persistent or recurrent infection, and further 

may suggest particularly high rates of substance use that might challenge the 

generalizability of the findings. 

The 4 RCTs also had limited power to draw conclusions about efficacy for some 

combinations of disease, gender, and patient characteristics. The available data do not 

permit definitive evaluation of disease-specific or gender-specific EPT outcomes in relation 

to potentially important confounders, such as age, socioeconomic status, education, clinical 

setting, and a variety of sexual behaviors. On the other hand, the consistency of both 

biological and behavioral outcomes for chlamydial infection and gonorrhea across 3 trials, 

despite substantial differences in population and study design, provides a measure of 

assurance that the results are robust and broadly applicable. 

Implementation Issues 

Of the numerous issues pertinent to systematic implementation of EPT as a partner 

management strategy, the potential for missed morbidity in partners, the legal status of 

EPT, and concerns about adverse effects of antibiotics probably are the dominant potential 

obstacles in most settings. 

Missed Morbidity 

There is particular concern that EPT in male index cases might foster underdiagnosis and 

undertreatment of complicated infections in their female partners, especially if women with 

overt or incipient PID forego medical evaluation. Stekler et al.47 found that PID was 

diagnosed in almost 4% of women who gave their reason for attending STD clinics as 

exposure to men with STD, including but not limited to men with gonorrhea or chlamydial 

infection. The clinics in the study use clinical criteria for PID similar to those recommended 

by CDC for presumptive treatment, which are designed to maximize sensitivity and are 

relatively nonspecific.54 Therefore, the analysis might have overestimated the prevalence 

of symptomatic PID. However, it is not known whether a higher or lower proportion of 

27 
women who attend STD clinics as contacts of infected men may have complications 

compared with women who have not yet sought clinical services. Thus, special caution is 

warranted in use of EPT in men for delivery to their female partners. On the other hand, the 

potential for missed PID is partly balanced (and may be exceeded) by an overall reduction 

in PID and its complications that might accrue from improved overall partner management. 

Similar but less urgent considerations apply to symptomatic male recipients of EPT, who 

should be encouraged to seek care in addition to (or instead of) accepting treatment. 

High prevalences of STD co-morbidity also can be expected in women with trichomoniasis 

and their partners,47,62 contributing to caution in use of EPT for trichomoniasis. The reverse 

observation, a high likelihood of undiagnosed trichomoniasis in the partners of persons with 

gonorrhea or chlamydial infection,62 is less relevant to the use of EPT or other partner 

management strategies. Sensitive diagnostic tests for T. vaginalis, such as PCR, are not yet 

widely available, and most cases of trichomoniasis in partners (and many cases in index 

patients with gonorrhea or chlamydial infection) will not be diagnosed regardless of the 

partner management strategy employed. Stekler et al also found a 6% prevalence of 

undiagnosed HIV infection in MSM who gave STD exposure as their reason for visiting 

STD clinics,47 a significant issue in considering use of EPT in this population. Finally, no 

data are available on the prevalence of non-STD morbidities in partners, such as substance 

abuse and mental health problems, although it is not clear that other partner management 

strategies are any more effective in detecting or preventing them. 

Legal Issues 

The legal status of EPT, whether real or perceived, will affect implementation. Some 

clinicians apparently use EPT without obvious inhibition based on legal status,25 but most 

public health departments and many health care institutions, such as health maintenance 

organizations and managed care plans, will be constrained from formal institution of EPT 

until the legal status of EPT has been addressed in their jurisdictions. Health officers in 

most or all states possess statutory powers to protect and maintain the public’s health, and 

in some states these powers may override laws or policies that apparently conflict with 

EPT. In others, administrative or judicial rulings may nullify apparent legal barriers, as 

occurred in the state of Washington (Klopfenstein L, personal communication). However, 

new legislation may be necessary to establish the legality of EPT, as undertaken recently in 

California and Tennessee63,64 and currently under consideration elsewhere. Pharmacy laws 

may also influence the utilization of EPT. For example, legislation to regulate or curtail 

online access to prescription drugs may unwittingly place limits on EPT. 

Adverse Effects of Antimicrobial Therapy 

Although individualized use of EPT for selected STDs apparently has been common for 

many years, systematic use as a public health recommendation represents a new paradigm 

for STD prevention. The risk of serious adverse intolerance, toxicity, or allergic reactions 

is low for the regimens recommended for treatment of gonorrhea and chlamydial infections, 

and for the drugs that might be contemplated for treatment of other STDs. However, even 

low risk may influence the acceptance of EPT as a routine procedure by some providers, 

health maintenance organizations, and public health agencies, largely because of the 

possible medicolegal implications of adverse events. Development and implementation of 

guidelines by public health agencies, professional societies, and health care institutions 

28 
should influence community standards of clinical care and help to reduce such risks or 

providers’ perceptions of the risks. The success of EPT as an STD prevention strategy also 

will depend in part on the development and implementation of methods to reduce the risk of 

adverse effects. Therefore, EPT should routinely be accompanied by information that 

warns potentially allergic recipients to defer treatment and seek medical attention, and 

advises partners of the potential side effects of therapy and sources of care in the event of 

adverse events. At the same time, the likely population-level benefits of improved STD 

partner management dictate that the risk of adverse events should not in itself preclude use 

of EPT. 

Research Agenda 

Review of the available data on EPT revealed numerous gaps in knowledge that must be 

filled to optimize recommendations and implementation of EPT as a routine partner 

management strategy. The following list is not comprehensive, and the sequence does not 

denote priority. Each of the implementation issues implies one or more research needs, as 

do all the limitations of the existing data cited above. 

Therapeutic Efficacy of Regimens Employed for EPT 

Systematic research is indicated to confirm and explain the observation of higher-thanexpected rates of persistent C. trachomatis infection in women. Studies should include 

extended follow-up of treated patients, treatment with alternate antibiotics, variable 

regimens of azithromycin and perhaps doxycycline, and associated laboratory-based 

research. Research also is indicated to elucidate the possible contribution of suboptimal 

efficacy of single-dose treatment recommendations for trichomoniasis as a factor that may 

have contributed to the apparent failure of EPT in one trial to modify the frequency of 

persistent or recurrent infection. Scant data document the efficacy of single-dose 

metronidazole against trichomoniasis in men, and no studies of therapeutic efficacy in men 

have used sensitive diagnostic methods, such as PCR, to document cure. Knowledge of the 

efficacy of the regimens recommended for uncomplicated gonorrhea and chlamydial 

infection against subclinical or incipient PID would inform strategies to help prevent PID 

and its complications in the female recipients of EPT. 

Organization and Systems for EPT 

EPT will continue to be employed by individual practitioners and clinics, but optimal use to 

maximize prevention efficacy will require coordinated, systematic approaches involving the 

public health sector, private sector clinicians and agencies, pharmacies, health insurers, and 

community-based organizations. Organization of such collaborative efforts is the logical 

domain of state and local health departments. Research is indicated into systematic 

approaches and organization, including expanded cost effectiveness research. Such a study 

is soon to be initiated in Washington State (Golden MR, personal communication). 

Therapeutic Compliance 

Research is indicated on compliance with various models of EPT, including patient delivery 

of drugs, patient delivery of prescriptions, treatment by public health personnel away from 

clinical facilities, pharmacy-facilitated treatment and, for each of these circumstances, the 

influence of direct observation of treatment by the index patient, pharmacist or other 

29 
provider. Although most EPT probably will be accomplished primarily with single-dose 

regimens, compliance with multiple-dose regimens (e.g., doxycycline for chlamydial 

infection) also is of interest. 

EPT for Trichomoniasis 

Despite the challenges to successful and safe EPT in partner management for women with 

trichomoniasis, it is likely that many providers will continue to employ the practice, and 

further research on the efficacy of EPT is a high priority. Studies should include 

confirmation of the efficacy of single-dose and short-course therapy with metronidazole or 

tinidazole in women with vaginal trichomoniasis, as well as assessment of co-morbidities, 

and should be conducted in broadly representative populations. Expanded information is 

needed on the efficacy of single-dose metronidazole or tinidazole against T. vaginalis 

infection or carriage in men. 

EPT for Etiologically Undefined STDs 

Study is indicated on use of EPT for partners of patients with NGU, MPC, PID and perhaps 

scabies and pediculosis pubis. An important component will include qualitative research 

among health care providers and patients about the role and implementation of EPT in 

persons with NGU or cervicitis in the absence of diagnostic tests for N. gonorrhoeae and C. 

trachomatis, or while awaiting the results of such tests. In some settings, studies are 

indicated for use of EPT in chancroid, although this presently is a low priority in the U.S. 

Behavioral Research and Surrogate Markers of EPT Success 

Substantial behavioral research is indicated to enhance the efficacy and evaluate the 

performance of EPT as a partner management strategy. Currently available data 

demonstrate the value of behavioral outcomes and suggest that behavioral markers, perhaps 

especially those in the causal pathway that results in reduced prevalence of infection at 

follow-up, might serve as surrogates for prediction of rates of index case reinfection, 

facilitating the design of future trials with shorter follow-up and at considerably less 

expense than studies dependent on biomedical outcomes. Future behavioral research also 

should address the association of various partner management strategies with resumption of 

sex with treated versus untreated partners, with new partners, and with condom use. 

Additional Populations 

The high rates and potentially serious consequences of gonorrhea and chlamydial infection 

in teens <18 years old, pregnant women, and MSM dictate the need for studies of EPT 

implementation and outcomes in these populations. Studies among MSM may be a 

particularly high priority, in view of resurgent sexual risks and STD rates and the poor 

outcomes of standard partner management practices. Research in MSM should incorporate 

methods to assess the prevalence of previously undiagnosed HIV infection in the recipients 

of EPT and the response to accompanying advice to seek health care, including HIV testing 

and counseling. 

STD Co-morbidity in Recipients of EPT 

The available data on co-morbidity in the sex partners of infected patients were derived 

from retrospective analysis of patients attending STD clinics with self-described STD 

exposures. Studies of partners who are offered EPT are indicated to determine the 

30 
prevalences of the index STD, other STDs, and other co-morbidities. A particularly high 

priority is to elucidate the prevalence of overt PID, and ideally of subclinical salpingitis, in 

female recipients of EPT for chlamydial infection or gonorrhea. Information also is 

desirable on non-STD co-morbidities, such as substance abuse and psychological 

impairment. 

Development of Patient Education Materials and Counseling Strategies 

Systematic research is needed on the formulation and context of written materials to 

accompany EPT, counseling strategies to enhance communication between index cases 

with their partners, and the roles of ancillary health personnel and agencies, such as 

pharmacies and community based organizations. Such research should emphasize not only 

the development of such counseling and educational materials, but the recipients’ 

immediate and long-term behavioral responses to them. 

Effect of EPT on Health Care-seeking Behavior 

Studies are indicated to determine the compliance of intended recipients of EPT with 

treatment and to accompanying advice to seek health care. There should be particular 

emphasis on women, especially those with symptoms consistent with salpingitis, but such 

knowledge is needed for the entire range of intended recipients, including heterosexual 

men, MSM, teens, and women with and without symptoms of complicated infection. 

Health Care Providers’ Perceptions, Beliefs, and Attitudes 

Although several recent surveys document considerable use of EPT by some providers, no 

systematic data have addressed the determinants of providers’ decisions about EPT or other 

partner management strategies. Similarly, providers’ beliefs about what partner services 

are and are not offered by their local or state health departments might influence their 

utilization of EPT and the development of local policies, strategies, and options. 

Other Research Issues 

Most of the EPT implementation issues carry their own implications for research. For 

example, the only available data on the legality of EPT is based on the personal opinions of 

survey respondents, and refinement is desirable. The frequency of adverse drug effects in 

recipients of EPT may be worthy of formal study. Systematic understanding of the 

attitudes and responses of health insurers would facilitate implementation. Assessment of 

programs’ responses to the cost of EPT, and other experiences in implementation, will 

inform program development in other jurisdictions. Further research is needed to determine 

optimal packaging of drugs and counseling materials, and qualitative research is indicated 

to assess providers’ and health agencies’ attitudes, beliefs and practices with respect to EPT 

in particular and STD partner management in general. 

31 
CONCLUSIONS 

Three RCTs available for analysis and other supporting data indicate that EPT is a useful 

option to facilitate partner management in heterosexual men and women with chlamydial 

infection or gonorrhea. This support derives from documented prevention of persistent or 

recurrent infection one month to 4 months after treatment, and from favorable associations 

of EPT with the study subjects’ reported success in notifying their partners, beliefs that 

their partners were treated, and reductions in post-treatment sexual behaviors that risk 

reinfection. Reducing reinfection is particularly important in women because of the risk of 

PID and its sequelae, and serious outcomes of chlamydial infection and gonorrhea are 

uncommon in men. Thus, from a clinical perspective, preventing reinfection may be less 

important in men than women. However, at a population level men generally are more 

efficient STD transmitters than women, and preventing recurrent infections in men may be 

important in reducing continued transmission in the community. 

Ongoing assessment will be needed to evaluate all partner management strategies. 

However, the available evidence indicates that EPT is at least equivalent in efficacy to 

standard partner management for gonorrhea and chlamydial infection; that traditional 

partner management by public health agencies and health care providers for these STDs is 

limited in scope; and that the benefits of EPT outweigh the risks. Therefore, EPT should be 

available to clinicians as an option for partner management for gonorrhea and chlamydial 

infection. EPT represents an additional strategy for partner management of persons with 

gonorrhea or chlamydial infection that does not replace other strategies such as standard 

patient referral and provider-assisted partner referral, when available. Along with 

medication, recipients of EPT should also receive written advice (and, when possible, 

personal counseling, such as by a pharmacist) that clinical evaluation is desirable in 

addition to EPT. This is particularly important when EPT is provided for female partners 

and for male partners with symptoms. EPT also should be accompanied by information 

warning recipients not to accept treatment if allergic to the drug or to related compounds, 

and about common side effects and the appropriate responses to them. 

At present, recommendations to employ EPT are not feasible in many settings because of 

pragmatic issues in implementation, including the uncertain legal status of EPT in some 

states. The legal and other barriers to implementation of EPT will need to be addressed and 

resolved at the local or state level by collaboration between individuals, local and state 

health departments, and other organizations interested in STD prevention. Substantial 

operational research is indicated to optimize the use of EPT. 

The available data do not support routine employment of EPT in the management of 

women with trichomoniasis, despite its historically frequent use. However, only a single 

trial of modest size and uncertain generalizability has been conducted. Drug intolerance 

may be more frequent in treating trichomoniasis than with the regimens used for gonorrhea 

or chlamydial infection, and STD co-morbidities are especially prevalent in persons with 

trichomoniasis, further challenging the utility of EPT. Therefore, pending additional data, 

EPT should be used with caution in managing women with trichomoniasis, but it should 

remain an option when treatment of partners cannot otherwise be assured. 

No data support the use of EPT in the routine management of syphilis, which typically 

requires injection therapy and for which direct assistance with partner management is 

32 
generally available from local or state public health departments. No available data address 

the efficacy or role of EPT in the management of any STD in MSM, many of whose 

partners are likely to have undiagnosed HIV infection or other STDs. Experience also is 

lacking in the use of EPT in the management of patients with etiologically undefined 

clinical syndromes such as NGU, MPC, and PID. 

The available RCTs reinforce existing recommendations for retesting women with 

chlamydial infection approximately 3 months after treatment, and provide support for 

extension of routine retesting to men following chlamydial infection and to both men and 

women with gonorrhea. 

33 
GUIDANCE FOR USE OF EXPEDITED PARTNER THERAPY

EPT is at least equivalent to patient referral in preventing persistent or recurrent gonorrhea 

or chlamydial infection in heterosexual men and women, and in its association with several 

desirable behavioral outcomes. These conclusions support the following recommendations: 

• Gonorrhea and chlamydial infection in women: EPT can be used to treat 

partners as an option when other management strategies are impractical or 

unsuccessful. Symptomatic male partners should be encouraged to seek medical 

attention, in addition to accepting therapy by EPT, through counseling of the index 

case, written materials, and/or personal counseling by a pharmacist or other 

personnel. 

• Gonorrhea and chlamydial infection in men: EPT can be used to treat partners as 

an option when other management strategies are impractical or unsuccessful. 

Female recipients of EPT should be strongly encouraged to seek medical attention, 

in addition to accepting therapy. This should be accomplished through written 

materials that accompany medication, by counseling of the index case and, when 

practical, through personal counseling by a pharmacist or other personnel. It is 

particularly important that female recipients of EPT who have symptoms that 

suggest acute PID, such as abdominal or pelvic pain, seek medical attention. 

• Gonorrhea and chlamydial infection in men who have sex with men: EPT 

should not be considered a routine partner management strategy, because data are 

lacking on the efficacy in this population, and because of a high risk of comorbidity, especially undiagnosed HIV infection, in partners. EPT should only be 

used selectively, and with caution, when other partner management strategies are 

impractical or unsuccessful. 

• Women with trichomoniasis: EPT is not recommended for routine use in the 

management of women with trichomoniasis, because of a high risk of STD comorbidity in partners, especially gonorrhea and chlamydial infection. EPT should 

only be used selectively, and with caution, when other partner management 

strategies are impractical or unsuccessful. 

• Syphilis: EPT is not recommended for routine use in the management of patients 

with infectious syphilis. 

34 
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38 
Table 1 

Outcomes of Partner Notification for Gonorrhea and Chlamydial Infection by Patient 

Referral 

Location (year) Number Index 

Patients Studied 

STI % Partners 

Treated 

PN procedures and outcome 

ascertainment 

Colorado Springs 

(1977)18 

93 GC 54 All patients received a routine followup call. Partner treatment status based 

on confirmed treatment in STD clinic 

Colorado Springs 

(1985)19 

975 GC 29 “Perfunctory” PN interviewing 

performed with no follow-up. Partner 

treatment status based on confirmed 

treatment or evaluation 

London (1994)20 254 CT 53 Index patients had ocular CT infection. 

Treatment status based on confirmed 

treatment. 

Amsterdam (1997)21 440 GC/CT 49 Patients given referral cards. Partner 

treatment status based on confirmed 

treatment in STD clinic or elsewhere 

Houston (2000)22 54 GC/CT 55 Partner treatment status based on index 

patient report. Percentage reflects any 

partner having been treated 

Seattle (2001)23 698 GC/CT 51 Partner treatment status based on index 

patient report 

Indianapolis 

(2002)24 

241 GC/CT/N 

GU/TV 

59 Partner notification status based on 

index patient report (treatment outcome 

not reported) 

GC=gonorrhea, CT=C. trachomatis, NGU=nongonococcal urethritis, TV=trichomoniasis. 

39 
Table 2 

Randomized Controlled Trials in the United States: Persistent/Recurrent Infection 

Trial Setting and Study 

Population 

Study Design Intervention and Control Persisten

CDC Project 455, B2 • Multi-center (6 cities) • Uncomplicated CT • PDPT to maximum 4 • Control 

Schillinger et al. Sex 

Transm Dis 2003;30:49-56 

• 1996- 2000 • N=1,787, 81% followed • Women age 14-34 • Primary care, FP, teen, 

(without GC) 

• 1.0g azithromycin DOT • 21 days – 3 months • Urine PCR/LCR 

partners 

• Control = patient-referral 

(verbal and written) 

• EPT 

OR = 

2 

STD, ED 

Seattle 

Golden et al. NEJM 

2005;.352:676-685. 

• Seattle-King Co., WA • 1998 - 2003 • N=2,751, 68% follow-up • Male 23%, Female 77%, 

age >14 yr (mean 23 yr) 

• All reporting sites: STD, 

FP, private, ED 

• Uncomplicated CT 

(N=2162), GC (450), or 

both (139) 

• AZM 1.0 g + CFX 400 

mg for CT, GC 

• Follow-up 3-19 wk • Urine NAAT (LCR or 

TMA) 

• Patient or partner pick-up 

of drug at 1 of 12 pharmacies 

• Control = patient-referral • DIS assistance (both 

arms) if patient unable/unwilling to contact partner 

• Control • EPT 

RR = 

See supplemCT/GC outc

New Orleans Urethritis 

Trial 

Kissinger et al. Clin Inf 

Dis 2005;41:623-9. 

• New Orleans, LA • 2002 - 2004 • N=629, 80% behavioral 

FU, 30% biological FU 

• Male age >16, median 24 

• Symptomatic urethritis 

(61% GC, 21% CT, 6% both) 

• AZM 1.0 g + CFX 

400mg or cipro 500 mg 

• PDPT • Control = patient-referral 

with brief counseling 

• Third arm “Booklet 

Referral” 

• Control • EPT • Booklet EPT v cont

yr • GenProbe(enrollment) OR = 0.38 

• STD clinic Urine PCR (follow-up) BEPR v co

OR = 0.22 

40 
New Orleans 

Trichomoniasis Trial 

Kissinger et al. Sex 

Transm Dis In press. 

• New Orleans, LA • 2001 – 2004 • N=282, 87% behavioral 

FU, 80% biological 

• Women age 16-44 yr • STD clinic 

• Trichomonal vaginitis 

• Metronidazole 2.0 g • Follow-up 21-56 d • Wet mount at 

enrollment, culture (InPouch) at follow-up 

• PDPT to maximum 4 

partners 

• Control = patient-referral 

with brief counseling 

• Third arm “Booklet 

Referral” 

• Control = • EPT = 11• Booklet = EPT v contOR = 1.58 BEPR v coOR = 1.47 

41 
_______________________________________________________________ 

_______________________________________________________________ 

Table 3 

Persistent or Recurrent Gonorrhea and Chlamydial Infection in the Seattle RCT 

Index Case Dx EPT (%) Standard (%) RR (95% CI) 

GC or CT 92/929 (10) 121/931 (13) 0.76 (0.59 – 0.98) 

Male 13/194 (7) 24/202 (12) 0.56 (0.30 – 1.08) 

Female 79/735 (11) 97/729 (13) 0.81 (0.61 – 1.07) 

Gonorrhea 6/179 (3) 19/179 (11) 0.32 (0.13 – 0.77) 

Male 3/72 (4) 8/85 (9) 0.44 (0.12 – 1.61) 

Female 3/107 (3) 11/94 (12) 0.25 (0.07 – 0.83) 

Chlamydial Inf. 86/797 (11) 105/798 (13) 0.82 (0.62 – 1.07) 

Male 10/132 (8) 17/135 (13) 0.60 (0.29 – 1.27) 

Female 76/665 (11) 88/663 (13) 0.86 (0.65 – 1.15) 

Note. Table is a reproduction from Golden et al. NEJM 2005;352:676-685, with 

permission from the New England Journal of Medicine. 

42 
Table 4 

Demographic, clinical and behavioral factors associated with persistent or 

recurrent gonorrhea or chlamydial infection 

Persistent or Unadjusted RR Adjusted RR 

recurrent STI* 

N (%) 

Age: 

< 20 109 (15) 0.7 (0.6-0.8) 0.8 (0.7-0.9) 

 20-24 68 (11) per category change per category change 

 24-29 22 (9) 

30+ 14 (6) 

Gender: 

Male 37 (9) 0.8 (0.6-1.1) 

 Female 176 (12) 

Initial diagnosis: 

 Gonorrhea only 15 (6) 1.0 1.0 

 Chlamydial infection only 175 (12) 2.1 (1.2-3.4) 1.7 (0.9-2.9) 

 Both gonorrhea & 23 (24) 4.3 (2.4-7.9) 3.4 (1.8-6.4) 

 chlamydial infection 

Source of STI diagnosis: 

STD clinic 33 (10) 1.1 (0.7-1.6) 

Other public health clinic 73 (17) 1.8 (1.3-2.5) 1.4 (1.1-1.9) 

 Emergency room 22 (11) 1.2 (0.8-2.0) 

 Community Clinic 27 (11) 1.2 (0.8-1.8) 

Other 58 (9) 1.0 

Race/ethnicity: 

White 93 (11) 0.9 (0.7-1.2) 

Black race 75 (12) 1.1 (0.8-1.4) 

 Native American / 10 (9) 0.8 (0.4-1.5) 

 Alaskan Native 

Asian / Hawaiian / 34 (14) 1.3 (0.9-1.8) 

Pacific Islander 

Other race 12 (13) 1.2 (0.7-1.2) 

Hispanic 13 (7) 0.6 (0.4-1.1) 0.5 (0.3-1.0) 

Number of sex partners at 

baseline (last 60 days) 

0-1 126 (11) 1.0 

2 56 (12) 1.1 (0.8-1.5) 

3+ 31 (16) 1.5 (0.9-1.9) 

Any sex since treatment 

Yes 182 (13) 2.2 (1.5-3.4) 1.9 (1.1-3.2) 

No 22 (6) 

43 
New sex partner since 

treatment** 

Yes 70 (14) 1.2 (0.9-1.6) 

No 112 (12) 

Number of sex partners since 

treatment with whom condom 

not used for all vaginal sex 

0 66 (8) 1.7 (1.4-2.2) 1.5 (1.2-2.0) 

1 122 (14) per category change per category change 

2+ 14 (20) 

Reexposure to sex partner 

patient believes had other 

partners 

Yes 73 (14) 1.4 (1.1-1.8) 

No 130 (10) 

Sex with any partner not 

believed to be “very likely” 

treated or tested STI negative 

Yes 40 (25) 2.6 (1.9-3.5) † 

No 156 (10) 

All partners “very likely” 

treated or tested STI negative 

Yes 87 (9) 0.7 (0.5-0.9) † 

No 106 (14) 

Study arm

 Expedited partner treatment 92 (10) 0.8 (0.6-1.0) 0.7 (0.6-1.0) 

 Standard partner care 121 (13) 

Rates of recurrent chlamydial infection did not differ between index patients treated with 

azithromycin (13%) and those treated with doxycycline (11%) (RR=1.2 95% CI 0.8-1.6). 

* Persistent or recurrent infection defined as chlamydial infection at follow-up in persons originally 

diagnosed with chlamydial infections, gonorrhea in those originally diagnosed with gonorrhea, or 

either infection in those originally diagnosed with both pathogens. 

**Excludes those with no sex partners since treatment 

†Variable statistically significant in multivariate model. Inclusion in model results in study randomization 

assignment not being significantly associated with persistent or recurrent infection. These variables were not 

included in the final multivariate model because of their role in the presumed causal pathway between the 

trial’s intervention and the outcome of persistent or recurrent STI. RRs for multivariate model generated via 

generalized linear model with binary outcomes and log link 

Note. Table is a reproduction from Golden et al. NEJM 2005;352;676-685, with permission from the New 

England Journal of Medicine. 

44 
__________________________________________________________________________________________

___________________________________________________________________________________________________

Table 5 

Variations in Sex Partner Notification as a Function of EPT versus Control Condition among R

Notification Behavior EPT Control RR (95% 6-city trial 

Talked to partner and delivered fact sheet (and medications in EPT) 85% 75% 1.14 (1.0

Seattle trial 

Notified partner of exposure or knew of negative test 77% 78% 0.92 (0.7

New Orleans (urethritis)1 

Talked to partner about infection 71% 48% -- 

Gave intervention to partner 70% 48% -- 

New Orleans (trichomoniasis)1 

Talked to partner about infection 90% 88% -- Gave intervention to partner 82% 88% -- 

1Percentages for this study are based on proportion of partnerships, not proportion of cases. Significance levels 

45 
________________________________________________________________________________________________ 

_________________________________________________________________________________________________ 

Table 6 

Variations in Sex Partner Treatment as a Function of EPT versus Control Condition 

Treatment Behavior EPT Control RR (95% CI) 6-city trial 

Reported “very likely” partner took medication1 86% 57% 1.50 (1.40 – 1.59) 

Seattle trial 

Reported all partners “very likely treated” or tested negative 61% 49% 1.25 (1.14 – 1.36) Reported partner “very likely” treated or tested negative 64% 52% 1.19 (1.12 – 1.27) 

New Orleans (urethritis)2 

Reported seeing patient take medication 48% 26% -- Partner reported taking medication 56% 34% -- Checked partner was treated 64% 42% -- 

New Orleans (trichomoniasis)2 

Reported seeing patient take medication 63% 18% -- Partner reported taking medication 77% 70% -- Checked partner was treated 78% 76% -- 

1Analysis limited to women with one partner. 2Percentages for this study are based on proportion of partnerships, not prop

Significance levels are based on GEE. 

46 
___________________________________________________________________________________________________

___________________________________________________________________________________________________

Table 7 

Variations in Sexual Behaviors as a Function of EPT versus Control Condition 

Sexual Behavior EPT Control RR (95% CI) 6-city trial 

Reported acquisition of new sex partner 23% 28% 0.83 (0.69 – 0.99

Seattle trial 

Reported sex with an untreated partner 6% 12% 0.47 (0.34 – 0.65

New Orleans (urethritis) 

Reported unprotected sex before partner took medication1 8% 13% 0.63 (0.40 – 0.99

Reported unprotected sex with any partner 29% 34% 0.85 (0.66 – 1.10

New Orleans (trichomoniasis) 

Reported unprotected sex before partner took medication1 8% 5% 1.55 (0.62 – 3.88

Reported unprotected sex with any partner 26% 13% 1.99 (1.20 – 3.34

1Percentages for this analysis are based on proportion of partnerships, not proportion of cases. Significance levels are base

size is a prevalence odds ratio, not a relative risk. 

47 
_____________________________________________________________ 

-- 

_____________________________________________________________ 

Table 8 

STD in Contacts to GC, CT, NGU, or MPC in Seattle, Baltimore, Birmingham and Denver 

STD Women Heterosex. men MSM 

(N = 2507) (N = 3511) (N = 460) 

GC (non-GC 

contacts only) 3.9% 3.1% 6.1% 

PID 3.7% n/a n/a 

New HIV 0 0.2% 5.5% 

Early syphilis 0.1% 0 0.4% 

Trichomoniasis 4.9% n/a n/a 

GC/CT (partners 

of women with TV) 10.3% --

Note. Data drawn from Stekler et al. Clin Inf Dis 2005;40:787-793. 

48 
Figure 1 

Percentages of Physicians Giving Patients Medications to Take to Sex Partners in a 

National Survey 

44 

34 

8 9 

6 

50 

31 

7 7 

4 

0 

10 

20 

30 

40 

50 

60 

1 2 3 4 5 

% 

CT infections 

GC infections 

Note. Data drawn from Hogben, et al. Sex Transm Dis 2005;32:101-105. 

1 = Never; 2 = Sometimes; 3 = About half the time; 4 = Usually; 5 = Always. 

49 
Figure 2 

Chlamydial Reinfection Rates In Sweden By Partner Management Strategy According to 

Retrospective Chart Review, 1979 – 1980 and 1983 – 1984

12

10

8

% 6

4

2

0

10.2 

8.4 

4.8 

1.8 

Reinfection rates 

1 2 3 4

Note. Data are drawn from Ramstedt, et al. Int J STD AIDS 1991;2:116-118. 

1 = No partner management (N = 372); 2 = Patient couseled to refer partner(s) (N = 997); 3 

= Patient counseled to refer partner(s), compliance monitored (N = 645); 4 = Patientdelivered partner therapy (N = 167). 

50 
Figure 3 

Infection Rates at Follow-up in Seattle Randomized, Controlled Trial of Expedited Partner 

Therapy 

10.6 

13.2 13 

3.4 

10.8 

9.9 

0 

2 

4 

6 

8 

10 

12 

14 

1 2 3 

% Standard care 

Expedited care 

Note. Data are drawn from Golden, et al. NEJM 2005;352:676-685. 

1 = GC infections only, P = .02 (N = 358); 2 = CT infections only, P = .17 (N = 1595); 3 = 

GC or CT infections, P = .04 (N = 1860). 

51 
Figure 4 

Differential Infection at Follow-up Among Women Who Reported any Sex Since Treatment 

in Seattle Randomized, Controlled Trial of Expedited Partner Therapy 

0 

5.9 

2.6 

7 

10.2 

7.6 

0 

2 

4 

6 

8 

10 

12 

1 2 3 

% 

Gonorrhea 

Chlamydial 

infection 

Note. Data are drawn from Golden, et al. NEJM 2005;352:676-685. 

1 = Expedited care; 2 = Standard care; 3 = Total. 

52