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Partner Management for Gonococcal and Chlamydial Infection

Expansion of Public Health Services to the Private Sector and Expedited Sex Partner Treatment Through a Partnership With Commercial Pharmacies

Golden, Matthew R. MD, MPH*†; Whittington, W. L. H. BS*; Handsfield, H. Hunter MD*†; Malinski, Cheryl BS*†; Clark, Agnes BS*†; Hughes, James P. PhD*; Gorbach, Pamina M. MHS, DrPH*; Holmes, King K. MD, PhD*

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Abstract

PARTNER NOTIFICATION and treatment (PN) have been components of US sexually transmitted disease (STD) control efforts since the 1930s. 1 Despite this long history, only 53% of public health departments provide PN services for patients diagnosed with gonorrhea or chlamydial infection, 2,3 and most PN programs are thought to concentrate these services on patients seen in STD clinics, which may be as few as 10% of all cases. 4

The continuing shift of STD care in the United States from STD clinics to private healthcare providers calls for closer integration of health departments’ STD control activities and services provided through the private sector. 5,6 In a survey of private healthcare providers and their patients with chlamydial infection in King County, Washington, 85% of clinicians supported routine notification by the health department of their chlamydia patients’ sex partners, and 22% of patients interviewed more than a month after treatment stated they had not notified all of their partners. 7

Recent trends in the epidemiology of gonorrhea and chlamydial infection may provide an impetus for intensifying partner notification efforts. Regional prevalences of chlamydial infection have now stabilized at unacceptably high levels, and declines in gonorrhea incidence observed through the 1990s have leveled off and may be reversing. 8 Because the prevalence of these infections has decreased, the cost per case detected by screening programs has increased. In this context, renewed emphasis on PN merits consideration.

The current US PN system cannot form the basis for an intensified PN effort without significant changes. 6 Most large US health department PN programs employ disease intervention specialists (DIS) to notify partners and ensure their treatment. Without an enormous increase in funding, this system will not be able to meet the need for greatly expanded PN services. Evaluating the US PN system, the National Institute of Medicine concluded: “the current methods of partner notification utilized by public health STD clinics in the United States are extremely resource intensive, inefficient and in need of redesign.”6

In 1998 we began evaluating a new approach to PN in King County (KC), Washington. We expanded the provision of public health PN services for gonorrhea and chlamydial infection to private sector patients and initiated a trial in which randomly selected patients and partners are offered expedited partner treatment through commercial pharmacies. In this paper, we present preliminary results from this ongoing trial. We describe a new system of expanded and expedited PN, and present data on criteria that might be used to more efficiently target public health PN services.

Methods

Study Population

The study population was composed of nonincarcerated, English-speaking women and heterosexual men 14 years of age or older diagnosed with gonorrhea or genital chlamydial infection and reported to Public Health–Seattle & King County (PHSKC) between September 29, 1998 and July 31, 1999. To minimize the impact of index patient reinfection prior to randomization on the trial’s outcome, potential subjects were excluded from the study if they could not be contacted within 14 days of their treatment. Further exclusion criteria included residence outside of KC (n = 352), enrollment in a separate ongoing study of partner notification (n = 134), homelessness that precluded follow-up (n = 93), previous enrollment in the study (n = 118), STD diagnosis as part of evaluation for sexual assault (n = 49), and intoxication or psychosis precluding informed consent (n = 13). As the study proceeded, new clinical sites were added until all large clinical sites in KC eventually agreed to participate in the trial; 958 infected persons were excluded because they were patients at clinical sites not yet participating in the study when they were treated.

Case Ascertainment, Clinician Approval, and Informed Consent

Cases of gonorrhea and chlamydial infection were identified through laboratory-based case reporting (60%), provider-initiated case reports (36%), and on-site case ascertainment (4%). After receiving a case report, study staff, working as agents of PHSKC, contacted clinicians to solicit their permission to contact their patients regarding partner notification. (Although clinician approval for public health staff to contact STD patients is not required by law, by tradition PHSKC does not contact such persons without the clinician’s knowledge and consent.) Prior to initiating the study, physicians (internists, family doctors, and obstetrician/gynecologists) who were members of the King County Medical Society were sent a letter from PHSKC informing them about the change in PN procedures and the present study, and requesting their permission to contact all of their patients with gonorrhea or chlamydial infection in the future. In addition, providers contacted about individual patients were asked to give the study permission to contact all future patients. As of July 2000, 746 individual providers, 8 emergency rooms, and 9 private sector clinics had given blanket permission to contact their patients.

After obtaining clinician permission, study staff attempted to contact infected persons by telephone. When telephone contact was not successful, letters were sent to the patients asking them to contact study personnel. At one community clinic and at the public health STD clinic, some subjects were enrolled on site and interviews were conducted in person. When contacted, patients were read a scripted description of the study and verbal informed consent was solicited. Those who agreed to participate in the study were interviewed about each of their sex partners in the 60 days preceding the date of diagnosis. Patients who denied sex with any person during the 60 days preceding their diagnosis were questioned about their most recent partner. Subjects with at least one untreated partner about whom they had sufficient information to facilitate notification were randomly assigned to receive either standard or expedited partner care. Infected persons evaluated as contacts of someone with gonorrhea or chlamydial infection and those who believed that all of their partners were already treated were interviewed but not randomized.

The University of Washington Institutional Review Board approved study procedures. The Washington State Pharmacy Board approved all pharmacy procedures.

Partner Treatment Strategies

Expedited Management.

All patients were asked if they were able and willing to contact each of their untreated partners. Subjects randomly assigned to expedited partner care received a “partner pack” to give to each partner they were able and willing to contact themselves. Partner packs for partners of subjects with gonorrhea contained single doses of cefixime 400 mg and azithromycin 1.0 gm; those for partners of persons with chlamydial infection contained only azithromycin. In addition to antimicrobials, each partner pack contained condoms, instructions on taking medication, a pamphlet about STD prevention, and instructions advising partners to seek medical care and informing partners that such care is available at the Public Health STD clinic at no cost. Study personnel offered to contact those partners who patients were unable or unwilling to contact themselves. When contacted, these partners were offered an opportunity to obtain a partner pack.

Standard Management.

Patients assigned to standard partner care were advised to notify those partners whom they were able and willing to contact themselves, and were informed that cost-free STD care is available at the Public Health STD clinic. Study personnel offered to directly contact partners whom patients were unable or unwilling to contact themselves. When contacted, partners were informed that they should seek care either at the STD clinic or from their own medical provider, but neither treatment nor diagnostic tests were otherwise offered.

Medication Distribution

Twelve commercial pharmacies in KC agreed to participate in the study and to distribute partner packs. Pharmacies were chosen to ensure wide geographic access to treatment with a concentration in the areas reporting the highest number of cases of gonorrhea and chlamydial infection in 1997. Study personnel telephoned prescriptions to the pharmacies and maintained pharmacy stocks of partner packs. To determine if patients or partners picked up medication prescribed for the partners, pharmacies were called one week and two weeks after medications were prescribed. If index patients or partners had not picked up the prescription, study staff gave them a reminder call. Only one reminder was given after the initial interview. Partners who at index patient request were notified directly by the study were initially reminded only once to obtain medications; however, this study procedure was changed in 2000 to dictate multiple reminder calls either until patients had obtained their prescribed medication or until further efforts were deemed futile. Patients and partners who preferred not to receive medication through a pharmacy were offered the options of obtaining a partner pack at the Public Health STD clinic, or having medication delivered to their home or work by mail or by study staff. Interviewers gave partner packs to subjects interviewed in person. Early in the study, subjects were also asked if they would prefer to receive a prescription to give to their partner(s). Because of low patient interest in this option, it was abandoned.

Statistical Methods

The chi-square test was used to test for the presence of univariate associations between categorical variables, and the t test to compare the means of continuous variables between two groups. Logistic regression was used for multivariate analyses. Statistically significant variables on univariate tests of association were placed in multivariate models. Only variables founds to be statistically significant were included in the final multivariate models. All statistical procedures were performed using the SAS system.

Results

Between September 29, 1998 and July 31, 2000, 8868 cases of gonorrhea or genital chlamydial infection were diagnosed and reported to PHSKC. Of these cases, 80% (7121/8868) occurred among nonincarcerated, English-speaking heterosexuals age 14 or older, and 6433 of these were reported to PHSKC within 14 days of treatment (Figure 1). An additional 1717 persons had other exclusions (see Methods section) and ineligibility information was incomplete on 196 cases, leaving 4520 persons who were potentially eligible for enrollment in the study. Study staff successfully contacted the treating clinicians regarding 3972 (88%) of these cases, and clinicians gave the study permission to contact 3613 (91%) of their patients. Of the 359 patients whose providers refused permission to allow their patients to be contacted, 159 (44%) were diagnosed in one of 6 school-based teen clinics.

Fig. 1
Fig. 1:
Study enrollment and exclusions.

Study staff successfully contacted 2531 (70%) of the 3613 potentially eligible patients whose providers agreed to health department contact, and 1693 (67%) agreed to participate in the study. Compared with nonparticipants, study participants were younger, more often female, more frequently white, less frequently infected with Neisseria gonorrhoeae and less often treated by private sector clinicians (Table 1). Patients treated in the private sector were more likely than public health patients to be excluded from the study because they were not reported to the health department or reached by study personnel within 14 days of their treatment (52% vs. 29%, P < 0.0001).

Table 1
Table 1:
Characteristics of Nonincarcerated Heterosexuals Over Age 13 Diagnosed With Genital Chlamydial Infection or Gonorrhea in King County, Washington, and Potentially Eligible for Enrollment in a Study of Partner Notification

At time of study interview, 1095/1693 (65%) of participants had partners they believed had not yet been treated. Subjects interviewed at longer intervals after their treatment were less likely to report untreated partners, and the percentage of index patients with untreated partners began to plateau approximately 7 days after index patient treatment. Index patients reporting more than one sex partner in the 60 days preceding treatment or who reported that they did not anticipate having sex with a partner again in the future were significantly more likely to have untreated partners when contacted for study interview (Figure 2). On multivariate analysis, other factors associated with having untreated partners included: female gender, infection with Neisseria gonorrhoeae, and diagnosis in an emergency department or public health facility (Table 2). The belief that it was “very likely” that a sex partner in the preceding 60 days was the patient’s source of infection and African American race in the index patient were associated with having untreated partners on univariate but not multivariate analysis.

Fig. 2
Fig. 2:
Proportion of persons with gonorrhea or chlamydial infection with untreated partners at time of interview for partner notification (n = 1692). * Risk factors: > 1 sex partner in preceding 60 days or subject does not anticipate having sex with a partner again.
Table 2
Table 2:
Characteristics of Persons With Gonorrhea or Chlamydial Infection With and Without Untreated Sex Partners at Time of Interview Regarding Partner Notification

A total of 922 study participants were assigned to receive expedited or standard partner care; of these, 831 (90%) stated they would notify at least one partner themselves and 116 (13%) requested assistance to notify at least one partner. On multivariate analysis, factors associated with the index patient requesting assistance notifying partners included not anticipating having sex with a partner again (odds ratio [OR] 3.3, 95% CI 2.0–5.4), the belief that an acknowledged partner had given the subject gonorrhea or chlamydial infection (OR 2.8, 95% 95% CI 1.7–4.9), and having more than one sex partner in the 60 days preceding treatment (OR 1.4, 95% CI 1.0–2.2). Age, race, gender, and type of diagnosing facility were not independently associated with subjects’ requesting assistance notifying a sex partner.

Of the 1693 patients interviewed for the study, 828 (49%) reported multiple sex partners and/or a partner who the patient did not anticipate having sex with again. One or both of these two risk factors were present in 248 of the 354 persons interviewed 7 or more days after treatment who acknowledged at least one sex partner they believed was untreated (sensitivity = 70%). Of the 116 study subjects who requested assistance notifying a partner, 95 had one or both risk factors (sensitivity = 82%).

Participants provided some information about 1321 (94%) of the 1400 partners who they believed remained untreated at time of interview. Figure 3 presents data on how these partners were managed. Study participants stated that they would notify or deliver treatment to 1105 (84%) of their 1321 untreated partners and asked study staff to notify 117 (9%) of the partners. Subjects stated they could not or would not contact their remaining 99 partners. In the expedited arm of the study, 346 (76%) of 458 study subjects stated they would deliver medication to at least one partner. Among the 266 subjects who arranged to obtain medication for a partner from a commercial pharmacy, 223 (84%) successfully did so. Subjects with more than one sex partner or a partner they did not anticipate having sex with again were significantly less likely to obtain medication after agreeing to do so (81% vs. 94%, P < 0.001, chi-square).

Fig. 3
Fig. 3:
Sex partner management among 922 patients randomized to standard or expedited partner treatment.

Study personnel successfully contacted 98 (84%) of the 117 partners for whom patients requested assistance with notification. Of the 58 partners of expedited care patients who remained untreated when contacted by study staff, 35 (60%) agreed to pick up medication at a pharmacy, and 25 (71%) did so. An additional 11 partners had medication delivered or mailed to them.

Discussion

The Institute of Medicine report on STDs—The Hidden Epidemic: Confronting the Sexually Transmitted Diseases–challenged public health officials to develop a new STD prevention and control system. Part of that challenge was to develop an improved PN system for bacterial STD. 6 Optimally, we believe that public health PN services should concentrate efforts on those most important in the spread of disease and on those most in need of assistance, including patients seen outside of STD clinics, while maximizing efficiency by relying on patients to notify partners whenever possible. With these principles in mind, we began the process of evaluating and redesigning the PN system in KC.

Our findings demonstrate that expanded public health PN services are acceptable both to clinicians and patients. As anticipated, most patients preferred to notify partners themselves. In the context of a randomized trial, we offered patients the opportunity to receive free medication to give to their sex partner(s). The majority of patients (76%) accepted that offer. While we cannot be certain that patients actually delivered medication to their partners, the fact that 84% of study participants picked up medication after agreeing to do so suggests that most took the responsibility seriously.

Only 7% of all patients we contacted, 13% of patients with untreated partners at time of study interview, asked for assistance notifying a partner. While this is a small proportion, other studies have also found that only a relatively small minority of patients with STD desire assistance in notifying partners. In a nonrandomized trial comparing two approaches to partner notification for gonorrhea, Potterat found that 86% of patients themselves referred untreated partners for care after a brief interview and a single telephone reminder. 9 The fact that only a small proportion of people with gonorrhea or chlamydial infection request assistance notifying their partners, the finding that almost half of patients denied having untreated partners when contacted, and the very high costs associated with the universal provision of PN services by public health departments all emphasize the need to target the populations least likely to notify partners themselves.

We were able to identify two specific criteria—having more than 1 sex partner in the 60 days preceding treatment and having a partner with whom the patient does not expect to have sex in the future—that characterized 70% of all persons with untreated partners 7 or more days after treatment and 83% of persons who accepted assistance with PN. Previous studies among patients with gonorrhea and chlamydial infections in the Netherlands, 10,11 qualitative studies in Seattle and Uganda, 12,13 and our preliminary work among private sector clinicians in Seattle 7 have all emphasized that patients frequently do not notify nonregular partners. The fact that the same risk factors were associated with having untreated partners, the desire for assistance notifying partners, and the failure to pick up medication from a pharmacy to help assure the treatment of a partner suggests the need to intensify the effort directed at people with these risks in order to increase the proportion that will accept assistance with PN. Restricting public health partner notification services to those persons with these risk factors would diminish the overall population requiring public health services by over 50%. Future studies should examine the feasibility and utility of using selective criteria to target PN services.

Of note, patients treated in STD clinics were no more likely than private sector patients to request assistance notifying sex partners and were only slightly more likely to have untreated partners when interviewed. In fact, half of patients seen outside public health clinics and interviewed 7 or more days following their treatment still had untreated partners, and the proportion of patients with untreated partners remained remarkably stable after the first week following patient treatment. These findings demonstrate that the current concentration of public health PN services on STD clinic patients not only neglects the estimated 90% of persons currently receiving care outside of STD clinics, 4 but also does not focus on the patients most in need of assistance.

This study has several limitations. First, as shown in Table 1, the study population differed significantly from the larger population of people diagnosed with gonorrhea or chlamydial infection during the study period. In large part, this reflects constraints imposed by our randomized trial, many of which would not necessarily affect broad application of our approach outside of a research study. Study participants were younger, more often white, and less frequently treated in the private sector. This may have biased the findings presented here. However, the study enrolled substantial numbers of people from all demographic groups and no demographic variable was found to be associated with PN outcomes. A strength of the study is that the population was composed primarily of people diagnosed and treated in the private sector, the predominant source of care for patients with STD but one seldom included in research studies. Second, we relied on participant reports to ascertain whether partners had been treated. Some patients almost certainly incorrectly told interviewers that their partners were treated leading us to overestimate the proportion of partners treated at time of study interview. Despite this, most patients acknowledged having untreated partners at time of study interview and the risk factors we identified for unsuccessful partner notification are consistent with previous studies. 7,10,11,13 Third, we relied on process outcomes to assess our PN system. Optimally, the assessment of public health interventions would be based on their impact on disease incidence or prevalence. Retrospective observational studies have suggested that giving patients medication to give to their partners can decrease reinfection rates. 14,15 Our randomized trial is ongoing and will assess the impact of expedited treatment on index patient reinfection.

In conclusion, to date, this ongoing study has demonstrated that: (1) public health PN services for gonorrhea and chlamydial infection can be provided to patients treated by clinicians in the private sector; (2) most patients are willing to deliver medication to their partners; (3) partner treatment can be provided through a collaboration with commercial pharmacies; and (4) a definable population of patients treated in the private sector probably requires assistance notifying their sex partners. Future studies should define the efficacy of expedited partner treatment and the feasibility of targeting PN services to defined high-risk groups.

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