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Epidemiologic Basis of STD Control: Introduction and STD Surveillance Jonathan Zenilman, MD Johns Hopkins University Section A Background on STDs STDs: Background 15 million cases annually in the U.S. Predominantly adolescents and young adults Major cause of Morbidity and Mortality in developed and developing countries Other issues—women’s health, child health, association with HIV Stigma 4 Sexual Health Sexual health is a state of physical, emotional, mental, and social wellbeing in relation to sexuality; it is not merely the absence of disease, dysfunction, or infirmity. Sexual health needs a positive and respectful approach to sexuality and sexual relationships, and the possibility of having pleasurable and safe sexual experiences that are free of coercion,discrimination, and violence. For sexual health to be attained and maintained, the sexual rights of all individuals must be respected, protected, and satisfied. 5 Overview of Complications of STDs 6 Combined Frequency of Infection of Four Curable STIs: Gonorrhea, Chlamydia, Syphilis, and Trichomonas Source: Figure 3. Glasier A, et al. Sexual and reproductive health: a matter of life and death. Lancet 2006;368(9547):1595-1607. Copyright © 2006 Elsevier Ltd. All Rights Reserved. 7 Events and Outcomes: Costs and Morbidity of Sexual Behavior Unintended pregnancy Low birth weight infants Terminations STD direct costs-medical (PID) Long-term STD costs (ectopics, infertility) Emotional and economic costs Potentiated HIV risk (three to six times the risk) 8 The IOM Report of 1997: The Hidden Epidemic “Despite the tremendous health and economic burden of STDs, the scope and impact of the STD epidemic are underappreciated and the STD epidemic is largely hidden from public discourse. Public awareness and knowledge regarding STDs are dangerously low, but there has not been a comprehensive national public education campaign to address this deficiency.” 9 Section B STD Surveillance: General Principles Assessment Systematically collect, assemble, analyze, and make available information on the health of the community, including statistics on health status, community health needs, and epidemiological and other studies of health problems Source: Institute of Medicine, 1988 11 Disease Surveillance: Objectives Determine trends of incidence and prevalence Provide strategic direction to disease prevention and medical care programs Provide baseline data for evaluation Identify “sentinel” events for public health action 12 Disease Reporting Issues: STDs Public/private biases Classification of contacts Case definitions—syndromic treatment Resource availability Funding stream Timeliness 13 STD Surveillance Challenges Identify the appropriate outcomes/measurements Prevalent vs. incident disease Do you have to count every case? Clinical/syndromic case definitions Variable needs in different areas 14 Incubation Periods Gonorrhea—days Chlamydia—weeks HPV—three to six months HIV—three to six weeks Syphilis—three to six weeks Trichomonas—days 15 Incident STDs Typically bacterial infections which are curable Short incubation period Often symptomatic Susceptible to reinfection after treatment Examples—gonorrhea, syphilis, chancroid 16 Estimated Burden of STIs in Society Source: Figure 4. Glasier A, et al. Sexual and reproductive health: a matter of life and death. Lancet 2006;368(9547):1595-1607. Copyright © 2006 Elsevier Ltd. All Rights Reserved. 17 “Prevalent” STDs Usually chronic viral infections Incident infection difficult to detect Cross-sectional studies identify prevalent disease, usually with specific serology assays Often long latency period Examples—HIV, herpes simplex, CMV 18 HSV-2 Seroprevalence in the United States Prevalence (%) 25 20 15 10 5 0 1978 1990 2000 AW-245 8-13-1996. Source: Fleming, P. (1997), NEJM; CDC National Meeting, 2004 19 Prevalent Infections: The Control Challenge Strategy based on prevalent data Time trajectory often not known Evaluation of interventions is methodologically difficult Use of surrogate (e.g., behavioral) markers for evaluation 20 Section C Syphilis—STD Reflecting Social Trends Primary and Secondary Syphilis Rates: U.S., 1970–2004 and the Healthy People 2010 Target Rate (per 100,000 population) 25 P&S Syphilis 2010 Target 20 15 10 5 0 1970 73 76 79 82 85 88 91 94 Note: The Healthy People 2010 target for P&S syphilis is 0.2 case per 100,000 population 97 2000 03 22 Primary and Secondary Syphilis (Rates by Race/ Ethnicity): U.S., 1962–2005 Figure 32. STD Surveillance 2005. CDC 23 Syphilis in the U.S.: 1940s 24 Syphilis in the U.S.: 1940s 25 Primary and Secondary Syphilis (Rates by State): U.S. and Outlying Areas, 1998 0.8 0.0 0.1 0.0 0.2 0.2 0.2 1.2 0.1 0.2 0.2 0.5 0.9 0.3 4.1 3.6 0.5 3.0 0.8 3.7 1.2 0.2 2.0 2.2 2.7 9.7 10.6 4.3 7.2 Guam 0.0 9.6 6.3 4.4 2.3 9.9 0.2 VT NH MA RI CT NJ DE MD 0.8 0.2 0.9 0.7 2.2 2.0 Rate per 100,0 population <=4 4.1-8 >8 0.3 Puerto Rico 4.6 Note: The total rate of primary and secondary syphilis for the United States and outlying areas (including Guam, Puerto Rico and Virgin Islands) was 2.6 per 100,000 population. The Healthy People year 2000 objective is 4.0 per 100,000 population. STD Surveillence 2002. CDC Virgin Is. 6.4 26 Primary and Secondary Syphilis (Rates by State): U.S. and Outlying Areas, 2005 Figure 29. STD Surveillance 2005. CDC 27 Primary and Secondary Syphilis (Cases by Reporting Source and Sex): U.S.,1996–2005 Figure 31. STD Surveillance 2005. CDC 28 Primary and Secondary Syphilis (Male-to-Female Rate Ratios): U.S., 1981–2004 Male-Female rate ratio 10:1 8:1 6:1 4:1 2:1 0 1981 83 STD Surveillance 2004. CDC 85 87 89 91 93 95 97 99 2001 03 29 Incidence of Total Syphilis in 2005 by Province Numbers in parentheses show number of provinces in band Figure 4. Chen et al. Syphilis in China: results of a national surveillance programme. Lancet 2007;369:132-138 30 Section D GIS as an Applied Tool GIS Application: The Baltimore Syphilis Epidemic In 1997-1999 there was a large syphilis epidemic in Baltimore GIS mapping was used to describe the outbreak The outbreak was characterized by endemic and “spread” areas 32 Pathways of STD “Every time someone in Baltimore comes to a public clinic for treatment of syphilis or gonorrhea, John Zenilman plugs his or her address into his computer, so that the case shows up as a little black star on a map of the city. It's rather like a medical version of the maps police departments put up on their walls, with pins marking where crimes have occurred. On Zenilman's map the neighborhoods of East and West Baltimore, on either side of the downtown core, tend to be thick with black stars. From those two spots, the cases radiate outward along the two central roadways that happen to cut through both neighborhoods. In the summer, when the incidence of sexually transmitted disease is highest, the clusters of black stars on the roads leading out of East and West Baltimore become thick with cases. The disease is on the move. But in the winter months, the map changes. When the weather turns cold, and the people of East and West Baltimore are much more likely to stay at home, away from the bars and clubs and street corners where sexual transactions are made, the stars in each neighborhood fade away.” 33 Reported Primary and Secondary Syphilis Rates by Year: 1995-2004 (Projection) 100.0 90.0 Rate per 100,000 80.0 70.0 60.0 50.0 Baltimore US 40.0 30.0 20.0 10.0 0.0 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004* * Projected 2004 rate; 2003 and 2004 U.S. are rates unavailable Source: Baltimore City Health Department, STD Surveillance Unit (July, 2004) 34 1994 35 1995 36 1996 37 1997 38 1998 39 1999 40 2000 41 2001 42 2002 43 Gonorrhea (Rates by Race and Ethnicity): U.S., 1981– 2002 and the Healthy People 2010 Objective Rate (per 100,000 population) 2,500 White Black Hispanic Asian/Pac Isl Am Ind/AK Nat 2010 Objective 2,000 1,500 1,000 500 0 1981 83 85 87 89 91 93 95 97 99 2001 44 Gonorrhea (Rates by State): U.S. and Outlying Areas, 2005 Figure 29. STD Surveillance 2005. CDC 45 Defining Population Based STD Prevalence in Baltimore Health department reports are biased towards symptomatic disease cases seeking care Private sector/public sector reporting bias Development of new nucleic acid based tests (NAATS)—Gaydos, Quinn; facilitate population assessments 46 Geographic Distribution of STDs STDs are not equally distributed across neighborhoods Studies in Colorado Springs, Dade County, North Carolina, Miami, San Francisco, and Baltimore show similar findings Development of mapping and GIS tools have facilitated this area of study Most governments now have active GIS units 47 Gonorrhea Rate Categories by Census Block Group in Baltimore, MD, 1995–1998 = GC 5,000-1,039 per 100,000 = GC 1,038–167 per 100,000 = GC 166-0 per 100,000 48 Gonorrhea Rate Per 100,000 by Census Block Group in Baltimore, MD, 1994–1999 49 Prevalence of STDs in Baltimore? What is the true population prevalence of STDs in Baltimore? Charles F. Turner; Susan M. Rogers; Heather G. Miller; William C. Miller; James N. Gribble; James R. Chromy; Peter A. Leone; Phillip C. Cooley; Thomas C. Quinn; Jonathan M. Zenilman. Untreated Gonococcal and Chlamydial Infection in a Probability Sample of Adults. JAMA 2002 287: 726-733 OBJECTIVE: To estimate the overall prevalence of untreated gonococcal and chlamydial infections and to describe patterns of infection within specific demographic subgroups of the young adult population in Baltimore, Md. 50 Probability Sample of Baltimore City Adults 1,014 adults 18-35 Probability sample of residences from tax rolls Random selection within household 45 minute survey + LCR testing Crude response rate—71% Oversamples—white CTs with high STDs, males in black CTs 51 Weighted Estimates (Standard Error) of GC/CT Prevalence in Baltimore, 1997-1998 Disease Chlamydia Gender Black White Female 6.4 (2.2) 0 Male 1.1 (0.7) 2.4 (1.3) Female 9.3 (3.3) 1.3 (0.5) Male 5.3 (2.0) 1.3 (0.5) Gonorrhea Source: Turner C, et al. Untreated Gonococcal and Chlamydial Infection in a Probability Sample of Adults. JAMA 2002 287: 726-733 52 Citywide Estimates: Gonorrhea 4,566 cases reported in 1998 (2.6% prevalence) Survey self reported estimate: 4,708 (2.7%) - 5,231 (3.0%) NAAT-positive at time of survey—9,241 persons infected (5.3%) 53 Policy Conclusions An estimated 7.5-8.3% of the population 18-35 has untreated GC or CT Nearly all infections were asymptomatic Prevalence is greater than three times that estimated from Baltimore City Health Department statistics Baltimore likely represents a “best case” for STD surveillance data reporting RTI colleagues funded for second surveillance study 54 Section E Chlamydia Surveillance Issues “Cross-Over STDs” Chlamydia and trichomonas − Both curable − May be asymptomatic for prolonged periods of time − Have epidemiological characteristics of incident and prevalent infection − There are large surveillance and control programs in place for chlamydia due to large scale support for testing 56 Chlamydia (Rates by Sex): United States, 1984–2003 Rate (per 100,000 population) 500 400 300 Men Women 200 100 0 1984 86 88 Source: STD Surveillance 2003. CDC. 90 92 94 96 98 2000 02 57 Chlamydia (Rates by County): United States (2003) Rate per 100,000 population <=150.0 (N= 1,498) 150.1-300.0 (N= 939) >300.0 Source: STD Surveillance 2003. CDC. (N= 703) 58 Outcome Measurements: Disease Acute − Gonorrhea/chlamydia − Pelvic inflammatory disease − HPV Chronic − Infertility − Ectopic pregnancy − Cervical cancer − (HIV) 59 Section F STD Surveillance-Operational Issues Sources of Surveillance STD Data Health department data Community surveys National databases Hospital databases Payor data (Medicaid, etc.) 61 Pelvic Inflammatory Disease: Hospitalization of Women 15 to 44 Years of Age: U.S., 1996–2004 Note: The relative standard error for these estimates of the total number of acute unspecified PID cases range from 8% to 11%. 62 STD Surveillance Data Flow Provider County or City Health Dept State Health Dept Lab ESS MMWR Other Publications CDC Data Warehouse 63 Reporting Structure of China’s Nationwide STD Surveillance System 64 STD Behavioral Surveillance New issue Need for baseline data Identification of high risk groups for intervention Validity/reliability issues Objective—assess intervention effectiveness and secular behavioral trends 65 Sources of Behavioral Surveillance Data Qualitative surveys Population-specific—STD clinics, jails Cross sectional − Telephone surveys (BRFSS) − Face to face surveys (NHANES) − ACasi 66 Bias Issues Population selection − YRBSS − Population specific − Response differential Phone surveys have major selection issues because of technology Ascertainment bias Reporting bias 67 Sexual Behavior Events Age of sexual debut Numbers of partners—serial/concurrent Condom use patterns HIV risk profiles Other co-morbidities − Drug use, economic impact, commercial sex, travel 68 Structural Influences on Behavior and STI Risk Status of women Migration (internal and external) Gender ratio (e.g., China, Baltimore) Age at marriage Religious/social norms External stress (e.g. war, conflict) Economic issues (Macro and Micro) Public health efforts − Behavioral − Clinical 69 Condom Use at Last Sex: GSS 70 60 50 40 Regular Casual/New 30 20 10 0 1996 1998 2000 2002 Source: Adapted from Anderson JE, et al. Changes in HIV-Related Preventive Behavior in the US Population: Data From National Surveys, 1987–2002 (2003), JAIDS; 34: 195-202 70 Male Condom Use at Last Sex with a Non-Regular (Non-Marital, Non-Cohabiting) Partner 71 Percentage of High School Students Currently Sexually Active* by Sex and Race/Ethnicity** (2005) 100 Percent 80 60 47.4 40 33.9 34.6 33.3 32.0 Total Female Male White 35.0 20 0 Black Hispanic * Had sexual intercourse with ≥ 1 persons during the 3 months preceding the survey ** B > W, H Source: National Youth Risk Behavior Survey (2005). CDC 72 Percentage of High School Students Who Were Currently Sexually Active* (1991–2005) 100 Percent 80 60 40 37.5 37.5 37.9 1991 1993 1995 34.8 36.3 1997 1999 33.4 34.3 33.91 2001 2003 2005 20 0 * Had sexual intercourse with ≥ 1 persons during the three months preceding the survey 1 Significant linear decrease, P < .05 Source: National Youth Risk Behavior Surveys (1991–2005). CDC 73 High School Students Who Used a Condom During Last Sexual Intercourse* by Sex** and Race/Ethnicity*** (2005) 100 80 70.0 Percent 62.8 68.9 62.6 57.7 55.9 60 40 20 0 Total Female Male White Black Hispanic * Among the 33.9% of students nationwide who had sexual intercourse with one or more persons during the three months preceding the survey ** M > F *** B > W > H Source: National Youth Risk Behavior Survey (2005). CDC. 74 Percentage of High School Students Who Used a Condom During Last Sexual Intercourse* (1991–2005) 100 Percent 80 60 52.8 54.4 1993 1995 56.8 58.0 57.9 1997 1999 2001 63.0 62.81 2003 2005 46.2 40 20 0 1991 * Among students who had sexual intercourse with one or more persons during the three months preceding the survey 1 Significant linear increase, P < .05 Source: National Youth Risk Behavior Surveys, 1991–2005. CDC. 75 Section G STD Surveillance-Specific Populations STD Surveillance-Specific Populations: Determining Disease Prevalence Population-based survey methods − Statistical (NHANES) vs. convenience samples (GISP) New diagnostic methods for clinical and population-based surveys − Urine STD diagnostics—LCR/PCR − Oral HIV tests Serial serological surveys 77 National Surveys: STD/HIV as Outcomes Not part of surveys until 1988 Surveys since have included mostly STD self-report Biological measures in NHANES (HSV, RPRs), NSAM (urine for GC, chlamydia) Recent advances include urine tests for GC, chlamydia, saliva HIV tests, self-administered vaginal swabs 78 Military STD Surveillance Issues At-risk population Mobile population Universal health care access Interaction with communities Interaction with other servicemen/women 79 Surveillance and Managed Care Movement of traditional STD populations into managed care (Medicaid) Role of public health laboratories MCO model often not oriented to disease surveillance Syndromic patient management 80 Antimicrobial Resistance Surveillance A need for standardized susceptibility determinations (MIC from culture) Developed multicenter approach in 1986 Adopted in EU, Asia, Australia Collect behavioral and biological data 81 Principles of GISP Standardized lab procedures including Q/A Standardized reagents Resistance definitions and clinical action thresholds Systematic collection of isolates (first 25 males in participating clinics) 82 Laboratory-Based Surveillance Resistance tracking Plasmid or subtype analysis Confirmation of clinical algorithms Confirmation of surveillance definitions 83 Gonococcal Isolate Surveillance Project (GISP): Location of Participating Clinics and Regional Laboratories: U.S., 2003 Seattle Portland Minneapolis Salt Lake City Chicago Cleveland Denver San Francisco Las Vegas Detroit Philadelphia Baltimore Cincinnati St.Louis Los Angeles Long Beach Orange Co. Albuquerque San Diego Phoenix Greensboro Oklahoma City Birmingham Atlanta Dallas New Orleans Anchorage Tripler AMC Honolulu Gonococcal Isolate Surveillance Project (GISP). CDC. STD Clinics Clinics and Regional Labs Miami 84 GISP: Neisseria Gonorrhea Isolates with Resistance or Intermediate Resistance to Ciprofloxacin, 1990–2003 Percent 7.5 Resistance 6.0 Intermediate resistance 4.5 3.0 1.5 0.0 1990 91 92 93 94 95 96 97 98 99 2000 01 Note: Resistant isolates have ciprofloxacin MICs ≥ μg/ml. Isolates with intermediate resistance have ciprofloxacin MICs of 0.125–0.5 μg/ml. Susceptibility to ciprofloxacin was first measured in GISP in 1990. GISP 2004 Surveillance Supplement. CDC. 02 03 85 Conclusions Trend analysis is critical for effective STD surveillance Focused/sentinel STD surveillance approaches are cheaper and easier New diagnostic test technology facilitates field activities Core group approaches may be warranted 86