Seroprevalence of HSV-2 in Suburban Primary Care Offices

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 common21.9 of the United
  States population age gt12 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

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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 groups18 - 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

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Methods

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

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Methods

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

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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

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Study Sample Gender and Age

• Total sample N5452
• Per the study design, sample was distributed
  nearly equally
• among males and females, and
• among the four age groupings

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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

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Study Sample Demographics

• Married 57.3
• Employed full- or part-time 79.6
• Some college, tech/prof., 73.6 or more
  education
• gt 60,000 in total household income 44.9
• Private/employer provided insurance 81.8

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RESULTS
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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)

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HSV-2 Seroprevalence byGender and Age
24
Seroprevalence Rates by Race/Ethnicity
25
Seroprevalence Rates byMarital Status
26
Other Demographic Variables
27
Seroprevalence Rates by Highest Educational Level
Attained
28
Seroprevalence Rates by Total Household Income in
2001
29
Seroprevalence Rates by Region
30
Behavioral Variables
31
HSV-2 Seroprevalence Rates by Age at First
Intercourse
32
HSV-2 Seroprevalence by Gender and Lifetime No.
of Sex Partners
33
History of Genital Herpes
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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

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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

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Multivariate AnalysisPredictors 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
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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.

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Limitations (contd) HerpesSelect 2 May Have
Overestimated Prevalence by 1-2 (Absolute)
Versus Gold Standard (Western Blot)
Per HerpesSelect 2 package Insert
Sensitivity.96.1, Specificity97
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Conclusions and Recommendations
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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

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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
QA
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

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Backup/Optional slides
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NHANES III vs. HS240024 HSV-2 Seroprevalence

• 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

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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

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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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Inclusion / Exclusion Criteria

• Male or female
• 18 - 59 years of age
• Able to read and comprehend English in order to
  complete the Risk Assessment Questionnaire
• Must be visiting their physicians office due to
  illness or injury, annual physical examination,
  etc. for any reason except explicitly to enroll
• Must be willing and able to provide written
  informed consent and comply with the protocol

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Assessments / Procedures

• Demographic information obtained
• Completion of Risk Assessment Questionnaire for
  subsequent analysis of data
• Field Interviewers to interact with subjects
  office staff to coordinate RAQ blood sample
  collection
• Determination of HSV-2 antibody status via
  collection of subject blood sample and analysis
  by central lab (FOCUS HerpeSelect 2 ELISA IgG
  kit)
• Educational material regarding genital herpes
  offered to all subjects

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Assessments / Procedures

• Questionnaire administered in an area conducive
  to privacy for the patient
• Duplicate random numbers applied to each
  subjects blood sample questionnaire, thus
  linking the blood sample to the RAQ
• Identity of the subject will not be compromised
  no subject names on questionnaire or blood sample
• Conduct of study is not to interfere with patient
  care
• One venipuncture if at all possible

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Risk Assessment Questionnaire

• 8 demographic questions
• 21 questions (symptoms/sexual behavior-attitudes)
• 14 optional questions (knowledge/beliefs re
  STDs)
• Self-administered via ACASI technology (Audio
  Computer-Assisted Self-Interviewing)

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How to Reach Me

• Douglas T. Fleming, MD
• Senior Researcher
• Mathematica Policy Research, Inc.
• PO Box 2393
• 600 Alexander Park
• Princeton, NJ 08543
• Tel. [phone]
• Fax [phone]
• DFleming_at_Mathematica-MPR.com
• Our Web site www.mathematica-mpr.com