The prevalence of herpes simplex virus type 1 (HSV-1) and Type 2 (HSV-2) among those aged 14 to 49 years in the United States is estimated to be 57.7% for HSV-1 and 17% for HSV-2.1 Among sexually transmitted disease (STD) clinic attendees, the rates are higher.2 Type-specific serological assays for HSV have been commercially available since 1999, making possible confirmation of clinical diagnoses and screening. Misdiagnosis of genital herpes through history and clinical examination is common, and laboratory testing is currently recommended to confirm a diagnosis.3 The value of HSV screening (i.e., testing among persons without symptoms) is controversial, and most professional organizations do not recommend HSV screening in the general population.4,5 However, many specialists believe serological screening should be conducted among persons at high-risk including individuals with multiple sex partners or human immunodeficiency virus(HIV) infection, and all men who have sex with men at risk for HIV.3 The Centers for Disease Control and Prevention (CDC) recommend that both virologic and type-specific serologic tests for HSV be available in clinical settings providing care for patients with STDs or those at risk for STDs.3
Despite this recommendation, little is known about the availability of HSV testing or the specific testing strategies used in public health clinics in the United States. This study was designed to assess whether many of the largest STD clinics in the United States offer virologic and serologic tests for HSV. Although many terms are used to describe the 2 categories of tests, for clarification within this manuscript, swab tests, (polymerase chain reaction or culture) will be included in an overall “virologic test” category. The terms blood, serum, and antibody tests will be termed “serologic tests.”
MATERIALS AND METHODS
A survey was designed to measure the availability, type, and circumstances surrounding the use of HSV tests in clinics. It was subsequently pilot-tested among staff selected from the overall sample of public health clinics (n = 10). The survey was shortened (from 24 questions to 7 questions) as a result of the initial findings (many of the questions were too detailed and staff did not know the answers) and feedback (it took too long). A data collection form was used; each question had several possible response categories and a final “other” option, which allowed for an open-ended response.
A list of the 5 largest cities in each state was obtained. Then, the largest public STD clinic in each of those cities (or county, if appropriate) was selected for inclusion. A call was made to each clinic, and the interviewer asked to speak with the medical or clinic manager. If the clinic manager or medical director was not present or not available to answer questions, the interviewer asked to speak with a physician, nurse practitioner, or registered nurse who saw patients in the clinic. If none of these people were available, messages were left with a request for a return call. As data were collected, they were entered into Survey Monkey and subsequently imported into SPSS (SPSS Inc, Chicago, IL) for analysis. Descriptive statistics were conducted. Bivariate analyses using Pearson chi square tests were conducted to assess the relationship between geographic location and testing availability. A P ≥ 0.05 was considered statistically significant. One nurse practitioner, the first author of this article (T.W.), conducted all of the interviews between November 2008 and January 2009. Interviewers included a clinical research coordinator and a nurse practitioner. According to the Office of Human Subjects Research, the Federal Regulation 46.101 (b)5 for the Protection of Human Subjects indicates that both study phases were exempt from IRB review because the questions were entirely about clinic services offered.6
Interviews were conducted with a provider from each of 230 clinics—5 from each state with the following exceptions: 4 clinics each from Delaware, Idaho, Kansas, Massachusetts, Maine, New Mexico, and Utah; 3 from Nevada, and 1 each from Hawaii, Rhode Island, Washington DC, and Puerto Rico. When fewer than 5 clinics per state were interviewed, it was because the state did not have 5 public STD clinics that the researchers could identify. Additionally, Washington DC and Puerto Rico each had 1 clinic included. Due to extensive follow-up, the response rate was 100%. Of these, 53 (23%) were from Western states, 59 (26%) from the Midwest, 83 (36%) from the South, 34 (15%) from the Northeast, and 1 from Puerto Rico (<1%).
Table 1 presents results of this study. Slightly over one-third of the clinics surveyed reported either no testing available for HSV (37%) or only virologic testing available for HSV (36%). Less than one-quarter reported both serologic and virologic testing. Of the clinics which had virologic testing available, 39% reported that typing could be done and 2% reported that it could not be done. Over one-third of the study respondents in clinics with virologic testing were unsure if typing was available. Clinics in the western and northeastern regions were significantly more likely to offer any type of HSV testing, serological testing, or both serologic and virologic tests compared to the southern and Midwestern states (Table 2). Most clinics without virological tests referred patients for testing/evaluation (81%), but over one-third diagnosed by clinical examinations only. When serology was available, nearly all the clinic staff reported offering antibody tests when a patient requested one (92%) and/or when a patient had symptoms (84%).
A majority of respondents from clinics without virology were unsure why it was unavailable (68%), and almost one-third said that it was due to the financial limitations (32%). Although one-third of the clinics reported diagnosing by clinical examination alone, only 2 (2%) responded that the reason for the lack of virologic tests was because clinical examination is enough. A majority of providers in clinics without serological tests were unsure why it was unavailable, 46% cited financial limitations and less than 2% were unsure of what to do with the results, thought the test is unreliable or that a clinical examination alone was adequate.
To our knowledge, this is one of the few studies to document the availability of HSV testing in public, US STD clinics. A striking finding was that only 23% of the 230 largest STD clinics met the CDC recommendations to have available both serologic and virologic tests for HSV. A substantial portion of the clinics (37%) offered no testing for genital herpes (i.e., neither virologic nor serologic). As a result, the ability and techniques to diagnose HSV varied widely by site and ranged from diagnosing by clinical examination only or referring to other providers to offering serological testing as a routine to all patients.
There were significant regional differences in the availability of tests for HSV. States from the western and northeast regions were significantly more likely to offer any type of HSV testing than the southern and Midwestern States. Reasons for these differences are unknown but may include political and financial support for STD clinic services, knowledge of implications of HSV, community attitudes about the importance of STD testing, and patient demand. It is clear from these data that access to CDC recommended tests varies depending on where an individual lives.
Of concern is the finding that in the absence of virologic or serological testing, many clinics are diagnosing HSV based on clinical examination only. Diagnosis of genital herpes by clinical examination is both insensitive and nonspecific.4 It is not unlikely therefore, that many patients seen in these clinics are being misdiagnosed. There is an immediate need for guidelines for HSV diagnosis in the absence of testing technology.
There are several important limitations to this study. First, data on the position or training of a particular respondent were not collected. Many providers lacked knowledge about why testing was not available in their clinic, and even whether their clinics had virologic tests that could differentiate between HSV-1 and HSV-2. Participants in this evaluation consisted of clinic managers, medical directors, nurse practitioners, or registered nurses who cae for STD clinic patients. It may be that providers of care are not decision makers and are simply unaware of how the administrative personnel decide which tests to incorporate into a clinic. Had the interviewer spoken directly with a clinic manager every time, more information may have been obtained about the specific reasons for not testing. However, it is a concern that so many were unfamiliar with the reasons behind decisions related to the availability of tests and diagnostic procedures. It is also a concern that patients calling for information about HSV testing may be left without answers or misinformed. Another limitation of the study is that questions addressed availability of testing only, not whether tests were actually used. It is likely that even in the minority of clinics with available testing, actual usage may be suboptimal and thus, real access to these tests is even lower than suggested by the results.
The state of HSV testing in large public health clinics in the United States is not consistent with CDC recommendations. Though the reasons for the lack of test availability are not completely clear, it appears to have following 3 main components: (1) funding, (2) lack of time and knowledge to do herpes counseling for those who test positive, and (3) questions about the true benefits of identifying those infected with HSV-2. The funding issue, which was also identified in a study by Fife et al,7 can be addressed in a few different ways. Rapid in-office testing for HSV-2 is available for CLIA certified, moderate complexity laboratories (which is required to do Gram stains, routinely performed in STD clinics) for about $15. The reagents used in enzyme-linked immunosorbent assay HSV-2 test estimate about $4, assuming a state public health laboratory already owns a plate reader. Patients could be routinely offered HSV-2 testing for an additional fee, something many Planned Parenthood clinics already do routinely. The second issue can be addressed by offering simple and well done reading materials and videos about herpes to watch at home as an initial strategy. Accurate web site addresses can be given for further guidance. For those who need more information still, appointments can be set up for counseling with a specific clinician in the office who is knowledgeable about herpes and interested in doing this kind of counseling. Referrals can be made to local therapists who specialize in chronic illnesses. The third issue is most difficult. If clinicians see no benefit in identifying those with herpes, they will not be eager to make this diagnosis. Although the public health value of HSV screening is controversial, the importance of access to and testing for HSV diagnosis in clinics providing STD services is certain. The data presented here make clear that on this issue alone clinics are lagging far behind national guidelines. In addition, given the potential implications of HSV infection for particular groups of patients (HIV infected, pregnant women, high-risk individuals),8,9 an ability to access testing for this most common STD seems more than reasonable.
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6.NIH Regulations and Ethical Guidelines, Title 45 CFR Part, Code of Federal Regulations, Title 45 Public Welfare, Department of Health and Human Services, Part 46: Protection of Human Subjects. 2007. Available at: http://ohsr.od.nih.gov/guidelines/45cfr46.html
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