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The Real World of STD Prevention

Guidance on Expedited Partner Therapy

A Content Analysis of Informational Materials for Providers, Pharmacists, Patients, and Partners

Carman-McClanahan, Michelle MPH; McCool-Myers, Megan PhD, MPH

Author Information
doi: 10.1097/OLQ.0000000000001099

Prevalence rates of sexually transmitted infections (STIs) have steadily increased in the United States in recent years, yet the Centers for Disease Control and Prevention (CDC) states that these rates may in fact be considerably higher because of the underdiagnosis of STIs.1 Undiagnosed or recurrent STIs can result in deleterious reproductive health complications, particularly for women.2 Lack of partner treatment is one factor contributing to recurrent reinfections and rising STI rates.3

In 2006, the CDC endorsed expedited partner therapy (EPT) as an evidence-based practice to prevent chlamydial reinfection in index patients and lower barriers to treatment for partners.4 With EPT, health care practitioners can provide patients with antibiotics or a prescription for antibiotics for sexual partners, without requiring prior evaluation of said partners.4 As of April 2019, EPT was permissible in 43 states and the District of Columbia, potentially allowable in 5 states and Puerto Rico, and prohibited in 2 states.5

Despite widespread legislation/policies in support of EPT, the practice remains underused in many parts of the United States because of barriers on the path toward implementation.6,7 First, providers may be unfamiliar with EPT and/or with EPT protocols at their place of work8; they may also have concerns about possible allergic reactions in the partner, having not previously evaluated the partner.9 Second, pharmacists may reject legal prescriptions for EPT if they are unaware of state legislation.10 Although patients express that they are willing to deliver EPT to a partner,11,12 they may be anxious about initiating a conversation with their partners, as a positive test result for an STI can be associated with shame, stigma, or infidelity.13,14 Finally, partners who wish to fill the EPT prescription could encounter delays in treatment due to logistics, costs, and/or being denied the medication by a pharmacist.7,15

Some of these hurdles could perhaps be lowered through adequate information on EPT for each stakeholder group. State health departments release guidance on EPT for providers, but it is unclear if additional guidance is available for other participants in the EPT continuum, that is, pharmacists, patients, and partners.6,15 Furthermore, there are no established examples for the content, design, or readability of EPT informational materials.12 The primary objective of this study was to conduct a review of state/territory health department websites in the United States to ascertain the availability, readability, design, and content of EPT informational materials. The secondary objective was to score and identify top-ranking EPT informational materials, which could serve as examples for other settings.

MATERIALS AND METHODS

Between April and May 2019, a review using content analysis was conducted to examine the availability, readability, design, content, and overall utility of EPT informational materials found on health department websites in US states/territories, which permit/allow EPT (as of April 2019).5 Expedited partner therapy legislation and policies vary. Although the CDC offers overarching guidance for EPT,4,16 each health department can create rules and regulations to guide the provision of EPT in that state/territory. Furthermore, local jurisdictions and health systems may develop their own protocols based off state guidelines. This analysis chose to focus on information across state/territory health departments to provide a top-level overview of the availability and quality of materials.

Search Strategy

State and territorial health departments websites were included in the search if EPT was indicated to be permissible or potentially allowable according to the CDC as of April 2019 (n = 50).5 Health departments were excluded from the search if EPT was prohibited (n = 2). The research team first searched the health department websites to find informational material about EPT using the terms “expedited partner therapy,” “EPT,” “partner-delivered patient therapy,” and “PDPT.” In addition, search terms were entered into any website-specific search fields, if available. Google searches were also used for each state/territory to ensure that all documents related to EPT had been captured. Inclusion criteria for the informational materials were as follows: (1) it included the terms “expedited partner therapy,” “EPT,” “patient-delivered partner therapy,” or “PDPT”; (2) it focused on the treatment of chlamydia; (3) it was intended for 1 of the 4 target audiences (providers, pharmacists, index patients, sex partners); and (4) it was downloadable. This analysis focused only on chlamydia for 2 reasons: (1) this indication is included in all EPT legislation/policy, and (2) the CDC recommendation for treatment of gonorrhea (single intramuscular administration of ceftriaxone 250 mg) is not conducive to EPT delivery.17

Evaluation Procedures

Two raters (M.C.-M. and M.M.-M.) assessed each document independently. To achieve the primary objective, each document was evaluated in 3 domains: readability, design, and content; separate tools were used for each of the 3 domains. For the secondary objective of this study, scores for each of these domains were then summed to create an overall document rank. Documents were evaluated and analyzed separately depending on if they were intended for health professionals (providers and pharmacists) or for index patients and sex partners.

Readability

Readable (Added Bytes Ltd, Sussex, United Kingdom) software was used to electronically calculate the readability of EPT informational materials. The Flesch Kincaid Grade Level,18 Gunning Fog Score,19 and SMOG Index20 readability tools were used to assess the grade level of each document before an average grade level was calculated. Numeric scores correspond with grade levels in the United States with scores higher than 12.0 indicating collegiate levels and those higher than 16.0 indicating graduate levels. Readable analytics also provided a proprietary readability rating for each of the documents. The Readable rating system scores documents from A to E, with A being the best score; ratings were converted to a numeric value based on an academic 4.0 grading scale (4.0 = A) for use in subsequent analyses.

Design

The Medication Information Design Assessment Scale (MIDAS) was used to quantify the extent to which each document met various design characteristics.21 The criteria for MIDAS include attributes such as font size, line spacing, margins, headings, and the use of bullet points. The scoring system assigned 1 point for the presence of each attribute for a maximum score of 13 points.

Content

A literature scan and consultation with colleagues at the CDC revealed that no tool currently existed for assessing the content of EPT materials. Therefore, the research team developed 2 content analysis tools based on the CDC Clear Communication Index (the Index)22 and CDC guidance on and recommendations for EPT.4,16 After pilot testing, the 2 content tools were reviewed by an EPT expert at the CDC and revised. The final Medical Provider and Pharmacist Content Tool comprised 25 items; the final Index Patient and Sex Partner Content Tool comprised 20 items. The scoring system assigned 1 point for the presence of each item for maximum scores of 25 and 20, respectively. Each rater calculated individual scores for each document, which were then averaged to create a final content score. The 2 content tools can be found in Appendices A (Supplementary Digital Content, http://links.lww.com/OLQ/A435) and B (Supplementary Digital Content, http://links.lww.com/OLQ/A435).

Document Ranking

Documents were ranked in each of the 3 domains. An overall document rank was calculated based on the following formula: Readable score (max 4 points) + MIDAS score (max 13 points) + Content score (either 20 or 25 max points) = Overall document score.

Documents were then ranked by the highest overall score for patients and partners and for medical providers and pharmacists, with potential maximum scores of 37 and 42, respectively.

Analysis

Data analysis was performed using IBM SPSS Statistics V26 (Armonk, NY). Both raters evaluated the documents separately before meeting to discuss discrepancies in the implementation of the 2 instruments. Interrater reliability was assessed with percent agreement for each item of each tool. The strength of the correlation between raters' total scores for each tool was calculated using the Pearson correlation.23

RESULTS

Search Results

Of the 50 states/territories where EPT is permissible or potentially allowable, 64.0% (n = 32) had downloadable, chlamydia-focused EPT informational materials available on their health department website. A total of 82 documents were collected from 32 health department websites. Fifteen (30.0%) states/territories where EPT is permissible or potentially allowable had no eligible materials regarding EPT available on their website. Three (6.0%) states (AR, ID, KS) had web references for EPT but did not have downloadable informational materials and were not included in the analysis. Figure 1 shows the number of EPT documents identified on health department websites, ranging from 0 to 7, with a mean (SD) of 1.62 (1.91) documents.

Figure 1
Figure 1:
Expedited partner therapy informational materials collected by state.

Document Characteristics

The initial search resulted in the collection of 82 downloadable documents that met the inclusion criteria. After reviewing the documents, 2 were excluded from the final sample because they were not informational materials but had met the initial search criteria. During document analysis, reviewers identified 4 additional index patient and sex partner documents embedded in larger medical provider guidance as appendices. These were then isolated from their parent documents and analyzed separately by both reviewers. In total, 84 informational documents from health department websites were included in the final analysis (Fig. 2).

Figure 2
Figure 2:
Flow chart of included informational materials on expedited partner therapy.

These documents had 4 distinct primary intended audiences: medical providers (51.2%; n = 43), sex partners (35.7%; n = 30), pharmacists (7.1%; n = 6), and index patients (4.8%; n = 4). One document was written for both index patients and sex partners (1.2%; n = 1). Only 2 states (MI, NY) offered documents for all 4 target populations; 6 (AZ, MA, MD, ME, NH, WI) had documents for 3 of the 4 target populations.

The mean (SD) page length for this sample was 4.73 (7.91) pages, with a minimum of 1 page and a maximum of 54 pages. The documents came in a variety of formats, with directions (n = 33), fact sheets (n = 28), and implementation guides (n = 21) being the most common. Of these documents, only 64.3% included a publication and/or revision date. A list of all included documents in this analysis, their characteristics, and detailed results for the 3 domains can be found in Appendices C (Supplementary Digital Content, http://links.lww.com/OLQ/A435) and D (Supplementary Digital Content, http://links.lww.com/OLQ/A435).

Readability

The average (SD) reading level for all documents was 11.27 (1.75). The average (SD) reading level of documents designed for index patients and sex partners (n = 34) was 9.90 (1.12), whereas the average (SD) reading level for medical providers and pharmacists (n = 49) was 12.24 (1.44). According to the proprietary Readable grading system, texts intended for the general public should be rated B or higher. Of the documents, 56.0% (n = 47) scored a B or higher, 33.3% (n = 28) scored a C, and 10.7% (n = 9) scored a D or below.

Design

The mean (SD) MIDAS score of the sample was 9.57 (0.97) points of a possible 13. Scores ranged from 7.0 to 11.5. Most documents met the criteria for appropriate font size (n = 82; 97.6%), line spacing (n = 81; 96.4%), margins (n = 77; 91.7%), headings (n = 74; 88.1%), and the use of bullet points (n = 70; 83.3%). However, few documents (n = 11; 13.1%) provided relevant pictures or illustrations, and only 2 documents (2.4%) were formatted with short line lengths (<40 characters per line).

Appendix E (Supplementary Digital Content, http://links.lww.com/OLQ/A435) shows that interrater agreement for each item of the MIDAS fell between 90.5% and 100.0% agreement (mean agreement for all 13 items, 95.33%). Pearson correlation revealed a strong relationship between the raters' total MIDAS scores (r = 0.769, P < 0.01; 95% confidence interval [CI], 0.653–0.843).

Content

Medical Provider and Pharmacist Content

For the 49 documents for providers and pharmacists, the mean (SD) content score was 12.51 (5.52) points of 25. Average scores ranged from 1.0 to 22.5. Topics most commonly addressed in the documents were as follows: a definition of EPT (n = 48; 92.3%), a statement on the legal status of EPT (n = 41; 78.8%), and instruction to provide written materials for patient/partner (n = 41; 78.8%) (Table 1). The documents failed to include content on STI prevention strategies for patient/partner (n = 8; 15.4%), care for adolescent populations (n = 8; 15.4%), and the long-term effects of chlamydia (n = 9; 17.3%). Only 8 documents (15.4%) specifically referenced EPT for adolescent populations. When referenced, adolescents were most often described as a high-risk population with numerous barriers to STI treatment, making EPT an appropriate treatment option for them.

TABLE 1
TABLE 1:
Documents Fulfilling the Content Criteria for EPT Information

Appendix E (Supplementary Digital Content, http://links.lww.com/OLQ/A435) presents the interrater agreement for the provider/pharmacist content tool, which ranged from 82.0% to 100.0% agreement per item (mean agreement for all 25 items, 93.44%). Pearson correlation revealed a strong relationship between raters' total scores (r = 0.975, P < 0.01; 95% CI, 0.960–0.985).

Index Patient and Sex Partner Content

For the 34 documents for patients and partners, the mean (SD) content score was 10.73 (2.90) of 20 possible points. Average scores ranged from 2.0 to 15.0. Topics covered by most documents were as follows: directions to abstain from sex for 7 days after treatment (n = 34; 89.5%), the reason for receiving EPT/risk of exposure (n = 31; 81.6%), the asymptomatic nature of chlamydia (n = 30; 78.9%), and the treatment protocol (n = 30; 78.9%). The documents failed to provide information on how to tell a partner about EPT (n = 0; 0.0%), how to tell a partner about the STI diagnosis (n = 3; 7.9%), what to do if the partner refuses medicine or testing (n = 3; 7.9%), the risk of intimate partner violence (n = 3; 7.9%), how much it costs to fill the EPT prescription (n = 4; 10.5%), or what to expect when filling the prescription at the pharmacy (n = 5; 13.2%) (Table 1).

Although nearly all documents informed patients to abstain from sex for 7 days after treatment, follow-up and preventive care were not sufficiently addressed. Less than half of the documents (n = 17; 44.7%) reminded patients to seek retesting after 3 months. Twenty-two documents (57.9%) presented at least 1 STI prevention strategy; 12 did not offer any. The most commonly recommended strategy was condoms (n = 22), followed by abstinence (n = 16) and limiting partners (n = 14).

Appendix E (Supplementary Digital Content, http://links.lww.com/OLQ/A435) shows the results of the interrater reliability for the patient/partner content tool. Percentage agreement spanned from 80.0% to 100.0% per item (mean agreement for all 20 items, 93.86%). Pearson correlation revealed a strong relationship between raters' total scores (r = 0.951, P < 0.01; 95% CI, 0.908–0.975).

Document Ranking

Total scores for readability, design, and content were calculated, and the top-scoring documents for providers and pharmacists and for patients and partners were identified (Table 2). The highest score for the provider and pharmacist assessment was 36.0 of 42; this document was an implementation guide from Maryland for providers (MD_1). The highest score for the patient and partner assessment was 29.5 of 37; these were directions for patients, issued again by the State of Maryland (MD_4).

TABLE 2
TABLE 2:
Highest-Ranking State-Issued Informational Materials for EPT

The 4 documents scoring in the top 10% overall for the provider/pharmacist assessment were all written for medical providers. The documents were implementation guides from MD, NY, WI, and CA, which had been published/revised in the last 6 years. Page length varied from 7 to 33. The low Readable scores suggest that these materials targeted an audience with a higher-than-average reading level.

Of the 4 documents scoring in the top 10% overall for the patient/partner assessment, 2 were written for index patients (MD, ME) and 2 were written for partners (NY, MD). These documents were published or revised within the last 4 years. Compared with documents written for medical providers, these had higher Readable scores, indicating lower-than-average reading levels, and higher MIDAS scores. Documents scoring in the top 10% for each evaluation area are listed in Appendix F (Supplementary Digital Content, http://links.lww.com/OLQ/A435).

DISCUSSION

The goal of this study was to critically examine EPT informational materials available on health department websites to ascertain their availability, readability, design, content, and overall utility. Expedited partner therapy is permissible/potentially allowable in nearly all 50 states, yet one-third of states/territories did not have any downloadable EPT information. Although several states offered more than one document on EPT, only 2 states had information for all 4 of the audiences integral to successful EPT implementation: providers, pharmacists, patients, and partners. Through this systematic evaluation and assessment, 8 documents from MD, NY, WI, ME, and CA were ranked highly; these could serve as example resources for other EPT programs.

Documents were written for audiences all along the EPT continuum15; however, little information was designed for patients or pharmacists. Involving index patients in shared responsibility for the management of sexual partners has been shown to improve outcomes in STI reduction,24 yet only 4 states offered documents specifically for patients. The CDC guidelines state that EPT should be accompanied by written materials.4 Therefore, state health departments should look to the materials issued by MD and ME (Table 2) to create high-quality patient education materials that providers can give to patients. Pharmacists also play a key role in EPT implementation because they are responsible for filling the prescription. Only 7.1% of the documents targeted pharmacists. Furthermore, of the 8 documents that were ranked highly for their quality, none of these documents addressed pharmacists, revealing a critical gap in the EPT continuum. Low awareness of EPT legislation and practices may lead pharmacists to reject a valid EPT prescription.10,25 To ensure that partners can access the EPT medication, which has been prescribed to them, it is imperative that pharmacists receive adequate education on EPT provision within their state.

Most materials for patients and partners were written at a ninth-grade reading level or higher, far exceeding that of the average American. Although most adults read between eighth- and ninth-grade levels, approximately 90 million adults have fair to poor literacy, with 21% to 23% reading at or below a fifth-grade level.26 Health literacy experts recommend patient information be written at a sixth-grade reading level; it should also be short and clear, and include illustrations to increase comprehension.27,28 The results from MIDAS revealed limited use of relevant pictures as well as long line lengths in the text. Furthermore, many documents lacked publication and revision dates, putting the recency of the information into question. Health literacy affects an individual's ability to access care29; therefore, up-to-date materials with excellent readability and design are needed.

This content analysis provided an important baseline understanding of information contained in EPT materials as well as the evident gaps. For providers and pharmacists, less than 50% of documents discussed liability and prescription instructions. Concerns about liability in the case of an adverse event in the partner have been identified as a significant barrier to practicing EPT.9,30,31 Expedited partner therapy guidance for providers and pharmacists should underline the state-specific liability clauses, as well as the absence of any reported adverse event in nearly 20 years of EPT practice.7,16

Because of the lack of clear guidance on EPT in health care settings, providers may not know which patients to offer EPT; provider documents in this analysis seldom outlined inclusion/exclusion criteria. Adolescents and young adults report the highest rates of chlamydial infection.1 Simultaneously, this high-risk population experiences multiple barriers to accessing STI prevention services including lack of insurance or inability to pay, lack of transportation, discomfort with facilities and services designed for adults, and concerns about confidentiality.32,33 Expedited partner therapy provides a means to potentially overcome these barriers to STI treatment; plus, several studies have shown that adolescents and young adults demonstrate high willingness to give their partners EPT medication/prescription, if offered.11,34,35 Provider information should highlight the importance of offering EPT to adolescents and young adults to lower the threshold to treatment for this high-risk population.

For patients and partners, there was a distinct lack of content describing the practical steps of accessing EPT: cost and pharmacy encounter. Cost will vary according to an individual's insurance, and pharmacies are highly heterogenous; still, basic instructions would help the individual navigate the system and avoid delays in accessing treatment.12,15 Furthermore, information on how to tell sex partners about EPT/STI diagnosis and how to manage negative reactions in the partner was missing. Role-playing and sample disclosure scripts have been recommended as tools to support with these complex conversations.14 Documents should also include a contact number if assistance is needed, for example, alternative strategies for partner notification and treatment.14 Partner communication is an essential component of EPT acceptance and STI treatment; counseling, in combination with written information, should be leveraged to aid patient-partner interaction.

Three limitations warrant discussion. First, the search only included state/territory health department websites. Documents published by county/local health departments, organizations, or health systems may have provided additional insights or higher-quality materials. Second, although the novel content tools demonstrated high interrater agreement and reliability, it is clear that the content assessment could have been approached from an alternative angle, which would have yielded different results. The content tools are included in the Appendix (Supplementary Digital Content, http://links.lww.com/OLQ/A435) to ensure transparency and to allow other researchers to refine these tools further in future research. Third, printed materials (whether online or as brochures/flyers) are only one type of media for accessing information and may not be the most effective method for each of the audiences addressed in this study. Future research in EPT should explore end-users' needs for accessing information and novel solutions for information transfer.

Previous studies indicate the effectiveness of EPT as an evidence-based practice to prevent chlamydial reinfection in index patients and lower barriers to treatment for partners; however, it remains underused because of the many challenges along the path to implementation. This systematic evaluation of the readability, design, and content of EPT informational materials contributes to the portfolio of tools that could be used to advance EPT implementation. Still, the findings also underline that high-quality informational materials for key target populations along the EPT continuum are still needed. Public health professionals must take readability, design, and content into consideration when developing informational materials for target populations. Rather than reinvent the wheel, however, EPT programs in the United States could use the top-ranking resources identified in this study and adapt them to their own setting.

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