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2004 and Beyond: A Vision of STD Prevention in an Era of Uncertainty

2004 and Beyond: A Vision of STD Prevention in an Era of Uncertainty. John M. Douglas, Jr, MD Director Division of STD Prevention Centers for Disease Control and Prevention. Bioterrorism and Other Microbial Threats to Health. Bioterrorism in Perspective: Estimated

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2004 and Beyond: A Vision of STD Prevention in an Era of Uncertainty

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  1. 2004 and Beyond: A Vision of STD Prevention in an Era of Uncertainty John M. Douglas, Jr, MD Director Division of STD Prevention Centers for Disease Control and Prevention

  2. Bioterrorism and Other Microbial Threats to Health

  3. Bioterrorism in Perspective: Estimated American Death Toll Since 9/11/01* *Through 3/11/04. Estimated for Tobacco, Influenza, AIDS and Cervical Cancer, and actual for West Nile Virus, Anthrax and Smallpox. (F Judson, IOM Presentation)

  4. Health Care and Fiscal Resource Challenges • Growth among the uninsured: 5.8% increase to 43.6 million (Census Bureau, 9/30/03) • Increasingly inefficient health care delivery system • US health administration costs $1059 per capita accounting for 31% of health care costs (vs. $307 and 16.7% in Canada) (Woolhandler. NEJM 2003) • A growing federal debt (Comptroller General 9/17/03) • Current accumulated deficit--$7 trillion ($24,000/person) • U.S. actual liability including anticipated entitlement programs (Veterans, Social Security, Medicare): > $100,000/person • State budget crises: projected 2004 shortfall $68-78 billion (NCSL State Budget Update: April 2003)

  5. Recent Concerns Over STD: the State of the Union Address (January 2004) To encourage right choices, we must be willing to confront the dangers young people face—even when they’re difficult to talk about. Each year, about 3 million teenagers contract STD that can harm them, or kill them, or prevent them from ever becoming parents.

  6. Recent Concern Over STD: New Estimates on Burden of STD (February 2004) USA Today 25 February, 2004

  7. Estimated lifetime cost per case, number of new cases among persons aged 15 - 24 years, and total direct medical cos ts of major STDs -- US , 2000 (Chesson. Persp Sex Reprod Hlth 2004) STD Average Number of new Total direc t lifetime cost cases in 2000 * medical cost per case HIV $199,800 15,000 $3.0 billion HPV $627 4.6 million $2.9 billion Genital herpes $417 (women) 640,000 $292.7 million $511 (men) HBV $779 7 , 5 00 $ 5 .8 million Chlamydia $2 44 (women) 1.5 million $248.4 million $20 (men) Gonorrhea $266 (women) 431,000 $77.0 million $53 (men) Trichomoniasis $18 1. 9 million $3 4 . 2 million Syphilis $444 8,200 $3.6 million TOTAL 9.1 million $6.5 billion *Incidence estimates based on Weinstock, et al., 2004. HBV and HIV incidence estimates include sexually acquired cases only. Genital herpes incidence estimates include HSV-2 only.

  8. Estimates of the Burden of STD in the US (1996 & 2000) STD 1996 2000 Chlamydia 3 million 2.8 million Gonorrhea 650,000 718,000 Syphilis 70,000 37,000 Hepatitis B 77,000 81,000 HIV 20,000 30,000 Trichomoniasis 5 million 7.4 million HSV-2 1 million 1.6 million HPV 5.5 million 6.2 million TOTAL 15.3 million 18.9 million (Cates. STD 1999) (Weinstock. Persp Sex Reprod Hlth 2004)

  9. Issues and Challenges in STD Prevention: Overview • Infertility prevention: what are the next steps? • Syphilis elimination: how to maintain momentum while responding to new populations? • Genital herpes & HPV: the role of STD prevention programs in testing (now) and immunization (future)? • Program challenges • Research translation: how to move new findings to the field • Program evaluation: how do we better evaluate and target program resources • Integration of prevention services (STD, HIV, viral hepatitis, pregnancy prevention): how to operationalize? • Communicating the range of effective prevention strategies

  10. Guidelines for Chlamydia Screening (Peipert NEJM 2003; 349: 25) • AAP annually-all young sexually active F • ACOG routinely-all young sexually active F, other high-risk F • ACPM annually-all young (< 25) sexually active F, pregnant F, other high-risk • AMA annually-all young sexually active F • Can TFPHC all young (<25) sexually active F, pregnant F, other high-risk • CDC annually-all young (< 25) sexually active F, pregnant F, other high-risk • USPSTF routinely-all young (< 25) sexually active F and other high-risk F, pregnant F if < 25 or high-risk

  11. Chlamydia — Rates by sex: United States, 1984–2002

  12. Chlamydia — Trends in positivity in 15-44 yr old women tested in family planning clinics, 1988-02 Note: Trends adjusted for changes in laboratory test method and associated increases in test sensitivity. No data on laboratory test method available for Region VII in 1995 and Regions IV and V in 1996

  13. Gonorrhea — Rates by sex: United States, 1981–2002 and the Healthy People 2010 objective

  14. Pelvic inflammatory disease — Hospitalizations of women 15-44 years of age: United States, 1980–2001 Note: The relative standard error for the estimates of the overall total number of PID cases range from 6% to 15%. SOURCE: National Hospital Discharge Survey (National Center for Health Statistics, CDC)

  15. Pelvic inflammatory disease — Initial visits to physicians’ offices by women 15-44 years of age: United States, 1980–2001 SOURCE: National Disease and Therapeutic Index (IMS America, Ltd.)

  16. Challenges and Options for Chlamydia/Infertility Prevention • Rates of chlamydia prevalence and PID have flattened out • Areas of potential focus • Expand public sector screening (other settings, non-clinical sites—schools, detention, other outreach) into potentially higher prevalence populations • Expand private sector screening • Improve partner management • Improve re-screening of F (to enhance early DX/RX of those re-infected) • Male screening • Resource allocation: retarget resources (from low CT prevalence F, from GC screening)

  17. Chlamydia — Adolescent Women Reproductive Health Monitoring Project chlamydia positivity by venue and project area, 2002 Note: Where data are missing for project areas and venues, no testing or fewer than 50 chlamydia tests were performed at the missing location in 2002.

  18. Reported cases of sexually transmitted disease by sex and reporting source: United States, 2002 Non-STD Clinic STD Clinic C. Trachomatis all PID N. Gonorrhoeae all PID Syphilis P&S EL LL 78% 89% 65% 88% 11% 59% 65% 22% 11% 35% 12% 89% 41% 35%

  19. Adolescent immunization Advising smokers to quit Breast cancer screening Cervical cancer screening Childhood immunization (2 yo) Chlamydia screening 16-20 yo 21-26 yo 1999 30% 65% 73% 72% 64% 19% 16% HEDIS Effectiveness of Care Measurements Commercial Medicaid 2002 50% 68% 75% 81% 69% 27% 25% 2000 29% 64% 55% 60% 56% 37% 38% 2002 43% 64% 56% 62% 58% 41% 42% CareMeasures

  20. Challenges with Partner Management of Chlamydia Cases • Traditional partner referral methods are resource, labor, and time intensive • The volume of partner follow-up for chlamydia is impossible for most programs to manage • Other diseases (HIV and syphilis), and other populations (pregnant women) have a higher priority • There is little coordination of partner management activities with the private sector where most chlamydia cases are identified

  21. Partner-delivered Therapy for CT & GC • Inability to successfully treat partners (usually male) associated with high rates of re-infection (up to 20% of adolescent F with CT) • Partner-delivered therapy found to reduce re-infection rate: by 20% (15% to 12%) (Schillinger et al. STD 2003) and 57% (31% to 14%) (Kissinger. STD Conf 2004) • Therapy delivered through pharmacies via voucher another promising approach (Golden, ISSTDR 2003) • Since legalized in CA in 2001, 50% of providers use this approach (Packel. STD Conf 2004) • Legal issues in many states which will require state-by-state clarification, remediation

  22. Net Program Cost Equivalence of Screening for CT in Men(Gift et al, STD Conf 2004)

  23. Decline in Chlamydia and Gonorrhea 2002 – 2003 After Introduction of STD Clinic Co-pay(Rietmeijer STD Conf 2004) %

  24. Gonococcal Isolate Surveillance Project (GISP) — Percent of Neisseria gonorrhoeae isolates with resistance or intermediate resistance to ciprofloxacin, 1990–2002 Note: Resistant isolates have ciprofloxacin MICs ³ 1 g/mL. Isolates with intermediate resistance have ciprofloxacin MICs of 0.125 - 0.5 g/mL. Susceptibility to ciprofloxacin was first measured in GISP in 1990.

  25. Prevalence of QRNG by sexual orientation, excluding Hawaii and California, GISP MSM Heterosexuals 2001 0% (0/447) 0.03% (1/3936) 2002 1.8% (10/547) 0.2% (8/3740) 2003* 4.6% (20/438) 0.3% (11/3285) * Preliminary data

  26. Crisis in Antibiotic Pipeline • Since 1998 only 8 new antibacterial drugs • 2003—only 2 new antibacterial drugs • 2002—0/89 new drugs an antibacterial • Profit margin much lower than in medications for chronic, ongoing conditions (diabetes, hypercholesterolemia, impotence) • Public policy intervention may be needed analagous to vaccines ( tax credits, patent extensions, market exclusivity, etc)

  27. Total Women White Black Hispanic Congenital Syphilis Black:White P&S Syphilis Rate Ratio Progress on Syphilis Elimination(1997-2003) 1997-2003 2003 1997 1998 1999 2000 2001 2002 P&S Syphilis 7,082 1,230 230 817 159 285 5:1 8,556 3,895 453 3,255 145 1,078 44:1 7,007 3,096 400 2,524 138 840 34:1 6,617 2,777 428 2,163 139 575 30:1 5,979 2,445 385 1,864 162 554 24:1 6,130 1,967 249 1,527 146 497 16:1 6,862 1,594 217 1,195 147 412 8:1 -17 -68 -49 -75 +10 -74 -89

  28. Male Male Male Male Female Female Female Female Male:Female Rate Ratio Primary/secondary syphilis, by year and sex: reported rates and male:female rate ratios – United States, 1981-2002 25 25 4 4 20 20 3 3 Rate Ratio Rate Ratio Rate (per 100,000 males/females) Rate (per 100,000 males/females) 15 15 2 2 Male:Female Male:Female 10 10 1 1 5 5 0 0 0 0 1982 1982 1984 1984 1986 1986 1988 1988 1990 1990 1992 1992 1994 1994 1996 1996 1998 1998 2000 2000 2002 2002

  29. Modeling exercise: Estimates of the number of syphilis cases occurring among men who have sex with men (MSM) (Heffelfinger et al, STD Conf 2004) Primary and Secondary Syphilis Total Cases F Cases M:F Case Ratio MSM Cases* (%) Non-MSM Cases M Cases Year 1998 1999 2000 2001 2002 2003† 7,018 6,613 5,973 6,100 6,862 7,081 3,918 3,833 3,528 4,132 5,268 5,851 3,100 2,780 2,445 1,968 1,594 1,230 1.26 1.38 1.44 2.10 3.30 4.76 0 333 441 1,653 3,257 4,302 (0%) (5%) (7%) (27%) (48%) (61%) 7,018 6,280 5,532 4,447 3,605 2,779 *MSM cases=([annual MFCR – 1998 MFCR) x (annual # cases among men) †Preliminary data

  30. *January through June 2001 only *January through June 2001 only *January through June 2001 only *January through June 2001 only *January through June 2001 only **Primary & secondary syphilis only **Primary & secondary syphilis only **Primary & secondary syphilis only **Primary & secondary syphilis only **Primary & secondary syphilis only Findings from syphilis outbreak investigations, 2001 Characteristic Miami New York City Los Angeles * ** No. of cases 50 111 111 171 34 33 35 Median age, yrs Race/ethnicity White White White White 27% 41% 41% 41% 38% Black Black Black Black 10% 32% 32% 32% 14% Hispanic Hispanic Hispanic Hispanic 59% 22% 22% 22% 44% Known HIV+ 43% 53% 59%

  31. Types of Partnerships of MSM with Primary and Secondary Syphilis: Preliminary Experience in 8 Large U.S. Cities Had some anonymous or unable to locate partners New York 74% unable to locate half or more Atlanta Ft. Lauderdale 88% of partners were anonymous Miami 45% provided no names Chicago 60% had some anonymous partners Houston 33% provided no names San Francisco 44% provided no names Los Angeles 67% had some anonymous partners

  32. Number of Cases of Early Syphilis in MSM (% met on internet): preliminary program survey Jan-Jun 2003 2001 2002 West Coast SF LA Seattle (25%) (13%) 50 (14%) 432 (33%) 520 (16%) 58 (18%) 284 (46%) 159 (25%) 38 (28%) East Coast Boston Miami Ft Lauderdale Prince George’s Co., MD South Carolina Philadelphia — 131 (7%) 44 (2%) — 18 (0) 16 (2%) 95 (13%) 206 (5%) 183 (11%) 25 (24%) 27 (11%) 32 (9%) 52 (30%) 119 (9%) 119 (18%) 25 (16%) 31 (0%) 24 (0%) Midwest Columbus, OH Minnesota Kansas Illinois — — — — 39 (0%) — 0 48 (4%) 42 (14%) 45 (14%) 12 (17%) 27 (13%)

  33. Gonococcal Isolate Surveillance Project (GISP) — Percent of gonorrhea cases that occurred among MSM, 1988-2002

  34. STD Control and Prevention in MSM: What Can We Do? • Public health • Screening (outreach settings, on-line) • Social marketing/targeted public awareness regarding signs/symptoms • New approaches to partner services (on-line contact, partner-delivered oral RX) • Providers • Awareness of signs, symptoms to enhance DX, RX • Screening for STD/HIV, risk reduction counseling • Community • Discussion of and mobilization around norms for safer sexual practices

  35. Community Mobilization: Seattle Community Manifesto • To define our (Task Force) demands, values, & vision for a healthy Gay community • To build an HIV responsive community • To promote ideas that will help people feel supported • To help establish healthy Gay community norms • To promote the idea that we should treat each other with value as human beings, instead of as objects • To issue a call to action that "micro-organisms don't care about us, but we can care about ourselves"

  36. Proportion of total cost burden among youth attributable to viral and non-viral STDs (Chesson STD Conf 2004)

  37. Viral STD: the bad news and good news • HSV-2 • Bad: high incidence & prevalence, most infections unrecognized, no curative RX, no vaccine, condoms < 100% effective • Good: most infections minor, safe & effective RX, good diagnostic tests, condoms >> 0% effective, vaccines possible • HPV • Bad: high incidence & ?? prevalence, most infections unrecognized, no curative RX, no vaccine, condoms << 100% effective • Good: most infections minor, good diagnostic tests, vaccines likely • All developments (diagnostics, treatments, vaccines) will have implications for STD control programs

  38. HSV-2 Seroprevalence in NHANES By Age Group (Xu et al)

  39. Percentage of total study population with undiagnosed HSV-2 infection, found only by serologic testing Undiagnosed, % 14-19 years 20-24 years 25-29 years 30-39 years ³40 years Race, sex Overall Black, Male Female Nonblack Male Female 13.8 31.6 4.7 17.4 29.8 55.2 4.1 21.5 38.3 67.1 12.7 28.1 37.2 68.4 21.0 43.1 56.1 82.5 41.3 54.6 34.2 56.4 14.4 29.4 NOTE. Data were calculated from percentage of HSV-2 seroprevalence and percentage of seroprevalent infections remaining undiagnosed and represent the potential yield, in the setting of sexually transmitted-disease clinics, of serologic screening to detect clinically undiagnosed HSV-2 infection. Gottlieb JID 2002

  40. Use of Serologic Tests for Prevention of Genital HSV • Currently most helpful for symptomatic patients or their partners • Pending issues • specificity in various populations and need for confirmatory tests • impact in pregnancy • impact of counseling and prevention benefit of knowledge of asymptomatic HSV-2 • role of genital HSV-1

  41. Efficacy of Oral Valacyclovir in Prevention of HSV-2 Transmission (Corey. NEJM 2004) P=0.039 RR: 0.50 (95% CI: 0.26, 0.94) 3.8% (28/741) 50% Reduction Percentage with Infection 1.9% (14/743) Placebo Valaciclovir 500 mg once daily

  42. HPV DNA Testing • Hybrid Capture-II: microtiter-based solution hybridization assay commercially available in U.S. since late 1990s • Designed to detect • 5 low-risk types (6/11/42/43/44) • 13 high-risk types (16/18/31/33/35/39/45/51/52/56/58/59/68) [types found in 99% of HPV+ cervical cancers]

  43. Indications for HPV Testing in Cervical Cancer Screening Triage of mildly abnormal Pap tests (ASC-US) • Women with high-risk HPV types: undergo immediate colposcopy • Women without HPV: repeat Pap in 12 months • Women not tested for HPV: repeat Pap 4-6 mos. Adjunct to primary screening (Pap + HPV DNA test) for women >30 • Normal Pap/HPV negative: rescreen in >3 years • Normal Pap/HPV positive: recommendations (evolving since most become HPV- in 6 months and risk of CIN 2/3 is > 5%)—best approach may to repeat Pap and HPV in 6-12 months • Colposcopy if either + • Rescreen in 3 yrs if both negative

  44. HPV Tests in Cervical Cancer Screening: Pro and Con • Potential advantages of HPV testing • Can reduce number of colposcopies • Can reduce number of Paps • Decreases repeat Paps for followup of ASCUS • Lengthens screening interval to > 3 years for women > 30 (ACS, ACOG) • Potential disadvantages of HPV testing: • Cost of HPV test • Psychosocial impact--counseling of unsuspecting HPV+ women potentially complex • Could increase number of colposcopies

  45. Randomized Controlled Trial of HPV 16 Vaccine (Koutsky et al. NEJM 2002; 347: 1645) • 1533 women 16-23 yrs old, < 6 life SP, HPV 16 negative (PCR - baseline & 7 mos; seronegative baseline) • Vaccine 0, 1, 6 months; FU every 6 mos after 3rd dose for 3.5 yrs. • Among vaccinees, 99.7% seroconverted; GMT 58 X higher than women with natural infection • Outcome (HPV 16 infection/100py risk): Vaccine Placebo Efficacy rate --Persistent HPV infection 0 3.8% 100% --Transient or persistent 0.6% 6.3% 91% --No. HPV 16+ CIN (1 or 2) 0 9 100% --No. HPV 16- CIN 22 22 0%

  46. Cross-cutting Challenges to STD Prevention Programs • Translation of research findings to program • Evaluation of program activities • Integration of services

  47. Translating Research to Program: Program Needs • Up-to-date information on new research studies • Methods for interpreting research results in a program context • Information about implementing STD interventions in a non-research setting • Demonstration studies to verify applicability • Assessment of cost burden and efficiency • Methods for scale-up for large and small programs • Technical assistance in implementing new intervention strategies • Training in how to use local surveillance data to guide strategy development • Assistance in interpreting and applying CDC guidance & recommendations • STD treatment guidelines (eg, new RX recommendations, microbicides) • Partner management (eg, patient-delivered therapy) • Laboratory guidelines • Guidelines for areas with evolving data (screening for GC, syphilis, HSV-2) • Sufficient resources and assistance in choosing among competing strategies

  48. Evaluation and Improvement of STD Prevention Programs • STD programs have huge challenges • Multiple STI to consider • High incidence and prevalence • Relatively low public, provider interest • We need to get smarter about how effectively our resources are used both to improve what we do, convey to the public and policy makers our value, and to make difficult choices when we have to • Will involve partnership between prevention programs at all levels (local, state, federal)

  49. Integration of Prevention Programs for STD, HIV, and Viral Hepatitis • Major public health problems with overlapping routes of transmission • National programs exist for prevention of STDs and HIV/AIDS, with inter-programmatic collaboration and integration increasing • Integrated prevention activities for viral hepatitis in existing public health settings now underway in STD clinics, HIV counseling sites, drug RX clinics, correctional care • Resurgence of risk behavior in MSM is creating opportunities at all levels for integration

  50. March 2004 Dear Colleague Letter Dear Colleague: Men who have sex with men (MSM) are at increased risk for multiple sexually transmitted diseases (STDs) including human immunodeficiency virus (HIV) infection/Acquired Immunodeficiency Syndrome (AIDS), syphilis, gonorrhea, chlamydia, hepatitis B virus (HBV) and hepatitis A virus (HAV). Numerous recent reports document a resurgence in unsafe sexual practices among MSM that appear to be associated with increased rates of STDs….

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