Introcaso, Camille E. MD*; Rogers, Meighan E. MPH†; Abbott, Sharon A. PhD‡; Gorwitz, Rachel J. MD, MPH*; Markowitz, Lauri E. MD*; Schillinger, Julia A. MD, MSc*†
Effective management of sexually transmitted diseases (STDs) includes appropriate patient testing and treatment, as well as services for patients’ sex partners.1 Studies have demonstrated the safety and efficacy of expedited partner therapy (EPT) for gonococcal or chlamydial infection in the form of patient-delivered partner therapy, a practice in which a patient is given either medication or a prescription to deliver to his or her sex partners without those partners having a medical evaluation.2 Expedited partner therapy has been shown to have similar or higher efficacy at preventing reinfection among patients with chlamydial infection than asking patients to refer their partners for treatment.3,4 In 2006, the Centers for Disease Control and Prevention (CDC) recommended EPT as an option for partner treatment for women and heterosexual men with gonococcal or chlamydial infection.2
In New York State (NYS), legislation permitting EPT for chlamydial infection was passed in 2009, regulations adopted in 2010, and health care provider guidelines were finalized in 2011.5–7 New York State law allows EPT to be dispensed as either medication or prescription for presumptive or laboratory-confirmed chlamydial infection in a patient without gonorrhea or syphilis coinfection, requires that educational materials accompany EPT, and protects health care and pharmacy personnel from liability related to EPT. A 2005 survey of New York City (NYC) providers demonstrated that EPT was used frequently even before its legalization.8
Sexually transmitted disease services are provided in a variety of health care settings, including federally qualified health centers (FQHCs). Federally qualified health centers began in the 1960s to provide health care to the underserved9 and have a mandate to provide high-quality primary care to those who have difficulty accessing the traditional health care system because of their inability to pay or other barriers. In 2011, FQHCs cared for an estimated 20.2 million people nationally and 1.4 million people in NYS.10,11 The Affordable Health Care Act of 2010 provided significant increases in FQHC funding, and with the expansion of Medicaid, the number of FQHC patients is expected to increase.12
In NYC in 2011, 12.8% (8,309/64,966) of chlamydia cases reported citywide were diagnosed by FQHCs, compared with 10.2% of chlamydia cases that were diagnosed in the city’s 9 STD clinics (unpublished program data, NYC). Our objectives were to describe EPT and other STD management practices among FQHCs in NYC and to identify opportunities to improve EPT provision and STD services for FQHC patients.
Federally qualified health centers are often organized into a governing organization, or “entity,” that operates 1 or more clinical “sites.” We administered one survey to medical directors of FQHCs at the entity level and a second survey to clinicians at FQHC sites. Our goal was to assess entity and site policies and practices surrounding EPT for chlamydial infections and other STD management issues. In both surveys, we defined EPT as health care professionals providing treatment for partners of patients with Chlamydia trachomatis infection without first examining partners and doing so through having patients deliver medication or a prescription to their partners. The entity survey asked for the annual number of patients seen across the entity’s sites, whether the entity had a written EPT policy, if the policy permitted or prohibited EPT, and other policy specifics. New York State law requires prescriptions be written in the name of the person for whom medication is intended; the EPT law/regulations additionally require that prescriptions for EPT have “EPT” written in the body of the prescription, but allow for EPT prescriptions to be written and filled without a patient name, if a partner’s name is not available. Electronic health records (EHRs) usually restrict prescribing to patients who have a file in the EHR. Because we anticipated that EHR systems might limit providers’ capacity to prescribe EPT, the entity survey included questions about EHR use. Finally, the entity survey was used to identify sites serving the greatest numbers of reproductive health/family planning, HIV-positive, or adolescent patients, or any school-based health clinics (SBHCs) located in a high school, for participation in the site-level survey.
The site survey asked about patient population, whether or not the site had a site-based written policy regarding EPT, whether or not it provided EPT, specifics of how EPT was provided, and if they were aware of any adverse events related to EPT. Sites were asked about use of other partner management strategies: encouraging patients to refer partners or bring partners to clinic, health care providers’ offices contacting partners, and specifically clinic staff’s use of the Internet to contact partners. As another measure of partner services, sites were asked if they provided emergency contraception to male patients or to female patients for future use.
Entity Survey Administration
Using a database generated from the US Health Resources and Services Administration Web site (http://www.hrsa.gov/index.html) on March 5, 2012, we identified a total of 31 FQHC entities in NYC. Using telephone calls and online searches, we collected contact information for entity medical directors. One entity had closed and one was determined to be a subsidiary of another entity, leaving 29 entities invited to take the survey. Initial survey invitations were sent in May 2012. Invited participants were given up to 3 e-mail or telephone reminders. Upon receipt of completed surveys, we sent respondents a $75 gift card.
Site Survey Administration
Twenty-five sites were “named” by their parent entities as having the greatest numbers of reproductive health/family planning, HIV-positive, or adolescent patients, or as being a SBHC located in a high school. Entities were asked to give contact information for the provider most knowledgeable about reproductive health care or STD management. Each of these providers was e-mailed an invitation to the survey in May or June 2012, with up to 3 reminders. Upon receipt of a completed survey, we sent respondents a $50 gift card.
To ensure representation of a diverse range of FQHCs, additional sites were invited to participate. The same Health Resources and Services Administration database used to identify entities listed 368 FQHC sites in NYC. The site list was de-duplicated, and sites were excluded from the sample if they were no longer operating, did not provide medical services (ie, only nonmedical services to homeless persons or mental health services), lacked contact information for at least 1 provider, had previously been identified as a named site, or were an SBHC serving preadolescent children. During the exclusion process, we placed telephone calls to each site requesting contact information for the provider most knowledgeable regarding reproductive health and/or the diagnosis and treatment of STDs at that site.
After exclusions, 1 provider from each of the 47 remaining sites was invited to participate. When combined with the named sample, 72 sites were invited to participate in the survey. Each site was assigned to a clinic type based on its patient population; reproductive health/family planning, HIV, adolescent, or SBHC.
Sites and entities were linked through the entity name. Frequencies for answers to the surveys were calculated, and bivariate analyses were performed to identify characteristics associated with entities having a written policy for EPT use and with sites providing EPT using SAS survey procedures (SAS 9.2 software, SAS Institute Inc, Cary, NC).
This survey was a program evaluation within the scope of public health practice and was exempt from institutional review board review. At the time of the survey, EPT was legal for chlamydial infection in NYS and recommended by the CDC.2
Twenty-two entities (22/29; 76%) responded to the survey. Together these entities reported visits by 1,240,800 patients per year. Half the entities (55%) reported that they have a written policy permitting EPT (Table 1). No entities reported a written policy prohibiting EPT. Among 10 entities without a written policy, 7 reported that a written policy was not necessary because EPT is legal in NYS. The second most common reason for not having a written policy, reported by 4, was limitations related to the EHR. One entity, representing 9000 patients per year, reported that it had no policy because it did not wish to endorse EPT. Almost all the entities (21/22; 96%), representing 1,207,800 patients per year, reported that their organizations uses an EHR.
Among those entities with written policies permitting EPT, 92% reported that the policy allows for and encourages EPT (Table 2). In addition to female patients, most entities’ policies allow for EPT to be dispensed to male patients with female partners, adolescents, and male patients with male partners.
Most entities (18/22; 82%) reported having a written policy to conduct annual chlamydia screening for sexually active female patients aged 15 to 25 years. More than half (12/22; 54%) of entities reported a written policy to rescreen female patients with chlamydia or gonorrhea 3 to 4 months after initial infection. Most (17/22; 77%) entities also reported a written policy to conduct sexual health assessments. There was no relationship between having written policy for annual chlamydia screening for female patients, rescreening for female patients with chlamydia or gonorrhea, or sexual health assessments and having a written policy permitting EPT (data not shown).
Of 25 named sites invited to participate, 20 (80%) responded to the survey. Of the 47 additionally selected sites selected sites invited to participate, 31 (66%) responded to the survey. The overall response rate was 70% (51/72).
Among the 51 responding sites, 80%, representing approximately 90,000 patient visits per year, provide EPT (Table 3). Expedited partner therapy was provided by 86% of sites whose parent entities have a written EPT policy and 70% of sites whose parent entities did not have a written EPT policy (difference not statistically significant). All sites with their own site-based EPT policy provide EPT. All of the HIV clinics and most clinics of all types provide EPT. All sites with an on-site pharmacy provide EPT, whereas 76% of those without an on-site pharmacy provide EPT (difference not statistically significant). There were no differences in the provision of EPT between the sites that do and do not use paper prescriptions. When asked about additional partner management strategies, few clinics reported active contacting of partners (Table 3).
Among the 41 sites that provide EPT, variation exists in EPT practices. More than half (22/41; 54%) of sites reported using EPT for laboratory-confirmed chlamydial infection “usually (50%–90% of the time)” or “almost always (>90% of the time).” However, EPT use for cases treated presumptively is less frequent: EPT is offered at the time of presumptive treatment (without awaiting laboratory confirmation) by only 27% (11/41) of sites; 44% (18/41) of sites invite presumptively treated patients to return to clinic to get EPT if/when a positive test result becomes available; and an additional 27% of sites do not offer EPT to presumptively treated patients at any point during care. All sites providing EPT offer it to female patients; most of these sites also provide EPT to male patients with female partners (38/41; 93%), adolescents (36/41; 88%), and male patients with male partners (29/41; 71%). Only 5% (2/41) of sites restrict the number of partners who can receive EPT (1 site restricts to 2 partners or less, and 1 site restricts to 6 partners or less). Expedited partner therapy is provided only by prescription by 58% (24/41) of sites, by both dispensed medication and prescription by 34% (14/41) of sites, and only by dispensed medication by 7% (3/41) of sites. Expedited partner therapy provision and the number of partners for whom EPT is provided are most commonly recorded in the notes section of the patient record. Approximately one third of sites (13/41; 32%) reported not providing educational materials with EPT. No sites were aware of any problem or adverse event (defined as possible allergies in a partner, missed coinfections, patient misuse of prescription, concerns about drug resistance, etc) after a partner’s receipt of EPT.
Ten sites (10/51; 20%), representing 117,960 patient visits per year, do not provide EPT. The most frequent reason for not providing EPT, reported by 6 sites, was “clinical concerns,” including possible allergies in a partner, missed coinfections, patient misuse of prescription, and drug resistance. Other reported reasons included the following: limitations related to the EHR (4 sites), ethical concerns (3 sites), and fear of liability (2 sites), financial barriers (2 sites), and not being aware EPT was legal in NYS (2 sites).
When sites were stratified by clinic type or by the percentage of site patients aged 15 to 19 years, there were few differences across these groups in how EPT was provided. Some practice differences were noted between HIV clinics and other clinic types. Specifically, none of the 4 HIV clinics provided EPT to male patients with male partners or provided EPT at the time of presumptive diagnosis of chlamydia, whereas most or some of the sites of all other clinic types did so (data not shown).
We conducted surveys of FQHC parent entities and clinical sites in NYC to characterize EPT and other STD management policies and practices. We found that most FQHCs have written policies in place supporting the use of EPT and that 80% of clinical sites practice EPT regardless of whether they or their entity has a written EPT policy. Given the number of patients with chlamydial infection seen in FQHCs in NYC each year, regular and appropriate use of EPT in this setting might reduce incidence of reinfection and possibly transmission of chlamydia in the community.
We also found modest rates of sites reporting EPT provision for presumptively diagnosed chlamydia. Almost half of FQHC entities reported having a written policy that allows provision of EPT to patients who are presumptively treated for chlamydia while waiting for test results; however, in practice at the site level, only 27% of sites offered EPT at the time of presumptive treatment. Providing EPT at the time of presumptive treatment could result in unnecessary treatment for unexposed partners (if the original patient tests negative for chlamydia). However, if EPT is not provided at the time of presumptive treatment, finding a convenient and effective strategy to provide these patients with EPT is challenging. Determining whether to provide EPT to presumptively treated patients requires weighing the risks of overuse of EPT and the risks of missed opportunities to treat partners.
Our findings show that FQHCs practicing EPT depart from current CDC and NYS guidelines. Almost three quarters of sites who provide EPT do so for male patients with male partners. Guidelines of CDC and NYS do not recommend EPT for men who have sex with men (MSM) because of the lack of studies supporting the efficacy of the practice among MSM and higher risk of STD/HIV coinfection in partners to MSM. The risk of a partner not being treated for known chlamydia exposure needs to be weighed against a missed opportunity to diagnose an STD/HIV coinfection (if, eg, receipt of EPT makes a partner less likely to present for medical evaluation).
New York State law requires that educational materials accompany EPT; however, 32% of sites reported that they do not provide educational materials with EPT. The lack of educational materials accompanying EPT might contribute to fewer partners taking the medication prescribed or result in partners who have other symptoms taking the medication without a visit to a provider for further evaluation. Not providing educational materials may reflect a lack of knowledge of the specific law and regulations or sites’ unfounded presumption that pharmacies are providing these educational materials; both the NYS Department of Health13 and the NYC Department of Health and Mental Hygiene14 have EPT patient and partner materials in English and Spanish available for download and reproduction on their Web sites.
Finally, we identified 2 potential barriers to EPT provision; (1) most sites reported providing EPT through prescriptions, and little information exists concerning the effectiveness of EPT through patient-delivered prescriptions requiring payment, and (2) some entities and sites cited limitations in EPT provision related to EHRs. When EPT is dispensed by prescription, a series of actions must be taken for the medication to reach the intended recipient: (1) the prescription must be delivered to a pharmacy; (2) the pharmacy has to fill the prescription; and (3) the original patient or sex partner must pick up and pay for the dispensed medication (or present insurance or drug plan coverage). Whether these steps are taken when EPT is dispensed by prescription in NYC is largely unknown. Almost all sites reported that they provided EPT using prescriptions, and 58% reported that they provided EPT exclusively as prescriptions, so if the use of prescriptions for EPT results in lower rates of sex partner treatment, EPT would not be as effective as it was in published trials. Electronic health records were also identified as a barrier to providing EPT. With increasing use of EHRs and electronic prescribing, prescribing a medication to a person who is not registered in a provider’s EHR system is challenging. Forty percent of entities without a written EPT policy and 40% of the sites not providing EPT named EHR limitations as a reason. However, 81% of sites that only use electronic prescribing also provide EPT, so some sites have devised systems to make their EHRs and/or electronic prescribing system work.
Our analyses have several limitations. First, although we sampled most FQHC entities, our results may not be generalizable to all NYC FQHCs. Differences may exist between the entities and sites that responded to the survey and those that did not and between the sites with available provider contact information and those without. Second, because some entities had sites that provided services other than medical care, such as dental or mental health care (as reflected in the high number of sites that were excluded), it is likely that the annual number of patients seen by those entities reflects some patients who were only accessing these other services, not medical or STD services. Third, although we directed the survey to the providers most knowledgeable of reproductive health and/or STD management practices, it is possible that the answers given did not accurately reflect policy or practice. Fourth, because we sampled multiple sites for a given entity and prevalence measures were not weighted, entities with a larger number of sites responding to the survey may bias measures of the prevalence of site-level practices.
Findings from this analysis are being provided to the entities and sites who responded to the surveys for their consideration and program evaluation. Future analyses that monitor outcomes, such as the number of chlamydial infections diagnosed and the number of patients offered and accepting EPT, would allow direct measurement of the impact of FQHC policies and practices. As the US health care system changes, FQHCs will increasingly provide STD management.12 Expedited partner therapy for chlamydia is endorsed at a national level and legal in NYS. Although NYC FQHCs commonly provide EPT, opportunities for improvement exist. These opportunities include increasing the number of sites providing EPT; increasing the distribution of educational materials with EPT; gaining a better understanding of whether, and how, prescriptions for EPT are presented to a pharmacy and how payment for the medication is handled; and enabling the electronic generation of prescriptions for EPT. These improvements might reduce chlamydial reinfections among FQHC patients.