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Seroprevalence of HSV-2 in Suburban Primary Care Offices

Seroprevalence of HSV-2 in Suburban Primary Care Offices. Douglas T. Fleming, MD. Acknowledgements. Authors: P. Leone, A. Gilsenan, L. Li, S. Justus

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Seroprevalence of HSV-2 in Suburban Primary Care Offices

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  1. Seroprevalence of HSV-2 in Suburban Primary Care Offices Douglas T. Fleming, MD

  2. Acknowledgements • Authors: P. Leone, A. Gilsenan, L. Li, S. Justus • Staff from the following organizations: RTI Health Solutions, Quest Diagnostics Clinical Trials, American Social Health Association, and GlaxoSmithKline • Investigators, staff and patients from the 36 study sites

  3. Background • HSV-2 infection is common:21.9% of the United States population age >=12 in the early 1990s • In the same study, only ~9% of seropositives reported that they had “ever had genital herpes” Fleming D, et al; New England Journal of Medicine, vol. 337, no. 16, October 1997, pp. 1105-11

  4. Background (continued) • The great majority of HSV-2 seropositive people experience outbreaks – most unrecognized – with symptoms or viral shedding or both • Genital herpes can cause devastating disease in neonates and immunosuppressed people, and appears to facilitate HIV transmission Wald A, et al; N Engl J Med, vol. 342, no. 12, March 2000, pp. 844-50 Fleming D and Wasserheit J; Sexually Transmitted Infections, vol. 75, no. 1, February 1999, pp. 3-17.

  5. Background (continued) • Many primary care physicians believe that the HSV-2 seroprevalence rates in national surveys do not apply to their patient populations, and that very few of their patients have genital herpes • Anecdotal evidence suggests that this belief is especially strong in more affluent suburban areas

  6. Objectives • Provide HSV-2 seroprevalence estimates from a sample of adults attending PCP offices in suburban areas of 6 U.S. communities • Describe the demographic and behavioral correlates of genital herpes in this population

  7. Methods • Weighted HSV-2 seroprevalence study • Target sample size: 5,400 • Adults 18 - 59 years of age • Not known to be pregnant

  8. Methods 6 U.S. suburban communities

  9. Methods • In each of the six metropolitan areas, sampling design began with relatively affluent U.S. Census Tracts, defined as those with above-median values for • Home ownership • Household income • Housing value

  10. Methods • Within the group of these census tracts in each metropolitan area, six PCP offices were sampled • Between 21 and 76 eligible PCP offices were contacted in each metropolitan area in order to recruit the six participating offices. Little information was available on non-participating offices. • Total clinic sample: 36 PCP offices

  11. Methods • 150 subjects per PCP office • 2 Genders: 75 male / 75 female • 4 Age groups:18 - 29, 30 -39, 40 - 49, 50 – 59 • Total: 8 cells (=2 x 4) • For weighting purposes, field interviewers counted patients in each cell visiting each office over a 2-week period

  12. Methods • Patients were recruited during a normal clinic visit • Clinic Staff provided information card to all eligible patients upon check-in, and referred interested subjects to an on-site field interviewer • Field interviewers screened subjects, obtained informed consent, and coordinated collection of data

  13. Methods Subjects ….. • Provided a blood sample for HSV-2 serology testing, and • Filled out a questionnaire

  14. Methods Type-specific HSV-2 serology • FOCUS HerpeSelect 2 ELISA IgG kit • Processed at central laboratory

  15. Methods • All subject-specific results (HSV-2 Ab) undisclosed to PCP, clinic staff, or study sponsor • HSV-2 Ab results & counseling services were available to subjects via a toll-free anonymous call to the American Social Health Association

  16. Methods • Patients filled out a risk assessment questionnaire using Audio Computer-Assisted Self-Interviewing (ACASI) • Included questions on demographics, sexual behaviors, knowledge and beliefs, and symptoms

  17. Methods • Results were weighted to the estimated total sample of patients entering physicians’ offices in suburban areas within the selected cities • Analyzed in SUDAAN

  18. Study Sample: Gender and Age • Total sample: N=5452 • Per the study design, sample was distributed nearly equally • among males and females, and • among the four age groupings

  19. Study Sample: Race/Ethnicity • Caucasian 75.0% • African-American 14.2% • Asian 2.8% • Hispanic 4.3% • American Indian 0.7% • Mixed Race or Other 2.9% [Self-reported by respondents: “Please select the one category that most closely applies to you”]

  20. Study Sample: Demographics • Married 57.3% • Employed full- or part-time 79.6% • Some college, tech/prof., 73.6% or more education • > $60,000 in total household income 44.9% • Private/employer provided insurance 81.8%

  21. RESULTS

  22. HSV-2 Seroprevalence Rates • Overall 25.5% (20.2-30.8) • Gender Male 22.0% (17.3-26.7) Female 28.3% (22.0-34.6) • Age group 18-29 13.4% (9.3-17.5) 30-39 25.2% (18.3-32.1) 40-49 31.2% (27.5-34.9) 50-59 28.0% (20.2-35.8)

  23. HSV-2 Seroprevalence (%) Age Group (Year) HSV-2 Seroprevalence byGender and Age

  24. HSV-2 Seroprevalence (%) Race / Ethnicity Seroprevalence Rates by Race/Ethnicity

  25. HSV-2 Seroprevalence (%) Marital Status Seroprevalence Rates byMarital Status

  26. Other Demographic Variables

  27. HSV-2 Seroprevalence (%) Educational Level Seroprevalence Rates by Highest Educational Level Attained

  28. HSV-2 Seroprevalence (%) Household Income Seroprevalence Rates by Total Household Income in 2001

  29. HSV-2 Seroprevalence (%) Region Seroprevalence Rates by Region

  30. Behavioral Variables

  31. HSV-2 Seroprevalence (%) Age First Intercourse HSV-2 Seroprevalence Rates by Age at First Intercourse

  32. HSV-2 Seroprevalence (%) Lifetime No. Sex Partners *age-adjusted to US population HSV-2 Seroprevalence by Gender and Lifetime No. of Sex Partners*

  33. History of Genital Herpes

  34. History of Genital Herpes • “Have you ever been told you have Genital Herpes?” Percent that answered “Yes”: Overall 4.3% Males 3.4% Females 5.1%

  35. History of Genital Herpes • Percent of HSV-2-seropositives with a known history of genital herpes: Overall 11.9% Males 11.6% Females 12.1%

  36. Multivariate Analysis:Predictors of HSV-2 Serostatus

  37. Predictors of HSV-2 Serostatus X Gender Age Race/Ethnicity Marital Education Income Region Age at First Intercourse Lifetime # Partners X X X

  38. Limitations • Non-random factors may have operated in determining the sample of (1) physician offices, and (2) patients who volunteered • Little is known about non-participants (partly because of HIPAA regulations) • However…. • There is no a priori reason to suspect bias • Interviewers anecdotally reported high interest rates in all groups.

  39. Limitations (cont’d) HerpesSelect 2 May Have Overestimated Prevalence by 1-2% (Absolute) Versus Gold Standard (Western Blot) Per HerpesSelect 2 package Insert: Sensitivity.=96.1%, Specificity=97%

  40. Conclusions and Recommendations

  41. Conclusions • Among patients visiting their primary care physicians in these relatively affluent suburban areas, HSV-2 infection was .. • common (25.5%), but • largely unrecognized (herpes history in 11% of seropositives)

  42. Conclusions • Especially strong independent predictors of HSV-2 seroprevalence were • Age • Race/ethnicity • Lifetime number of sexual partners • Marked regional differences in HSV-2 seroprevalence were no longer significant after adjustment for other predictors

  43. Recommendations • Improve appreciation of the high prevalence of HSV-2 infection, even in populations often considered at “low risk” • Improve recognition of genital herpes by clinicians, since • Few seropositives were aware of their infection, despite access to health care • Once a person with GH is able to recognize outbreaks, he or she can take steps that may help avoid infecting partners or neonates

  44. Future Directions Analyses of the dataset are ongoing. Themes to explore include: • Predictors of a known history of genital herpes among HSV-2 seropositives • Relationship of HSV-2 serostatus to recent history of nonspecific symptoms such as dysuria, genital itch, and discharge.

  45. Q&A

  46. Acknowledgements • Authors: D. Fleming, P. Leone, A. Gilsenan, L. Li, S. Justus • Staff from the following organizations: RTI Health Solutions, Quest Diagnostics Clinical Trials, American Social Health Association, and GlaxoSmithKline • Investigators, staff and patients from the 36 study sites

  47. Backup/Optional slides

  48. Overall Caucasian Afr.-Americans NHANES III Both: 21.9 17.6 45.9Male: 17.8 14.9 34.7Female: 25.6 20.2 55.1 HS240024Both: 25.5 20.6 52.4Male: 22.0 18.2 42.6Female: 28.3 22.6 59.4 NHANES III vs. HS240024% HSV-2 Seroprevalence

  49. Subject Disposition Total screened 5,732Ineligible 107Refusal 111 Enrolled 5,514Interviewed - no blood specimen 37Problems with blood specimen 25 Population for prevalence estimates 5,452Provide blood specimen 19 Population for risk modeling 5,433

  50. Why Subjects Did Not Participate... • Ineligible: out of age range • Ineligible: language barrier • Ineligible: age/gender cell full • Ineligible: pregnant woman • Refusal: no reason given • Refusal: no time • Refusal: not interested • Refusal: too sensitive/personal • Refusal: due to venipuncture required

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