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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.

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Presentation on theme: "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."— Presentation transcript:

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) Tobacco1,026,667 Influenza84,000 AIDS37,170 Cervical Cancer10,667 West Nile Virus524 Anthrax (Bioterrorism)5 Smallpox0

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 *Incidence estimates based on Weinstock, et al., HBV and HIV incidence estimates include sexually acquired cases only. Genital herpes incidence estimates include HSV-2 only. Estimated lifetime cost per case, number of new cases among persons aged years, and total direct medical costs of major STDs--US, 2000 (Chesson. Persp Sex Reprod Hlth 2004) STD Average lifetime cost per case Number of new cases in 2000* Total direct medical cost HIV $199,800 15,000 $3.0 billion HPV $ million $2.9 billion Genital herpes $417 (women) $511 (men) 640,000 $292.7 million HBV $779 7,500 $5.8 million Chlamydia $244 (women) $20 (men) 1.5 million $248.4 million Gonorrhea $266(women) $53 (men) 431,000 $77.0 million Trichomoniasis $ million $34.2 million Syphilis $444 8,200 $3.6 million TOTAL 9.1 million $6.5 billion

8 Estimates of the Burden of STD in the US (1996 & 2000) STD Chlamydia3 million2.8 million Gonorrhea650,000718,000 Syphilis70,00037,000 Hepatitis B 77,000 81,000 HIV 20,00030,000 Trichomoniasis5 million7.4 million HSV-21 million1.6 million HPV5.5 million6.2 million TOTAL15.3 million18.9 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) AAPannually-all young sexually active F ACOGroutinely-all young sexually active F, other high-risk F ACPMannually-all young (< 25) sexually active F, pregnant F, other high-risk AMAannually-all young sexually active F Can TFPHCall young (<25) sexually active F, pregnant F, other high-risk CDCannually-all young (< 25) sexually active F, pregnant F, other high-risk USPSTFroutinely-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 yr old women tested in family planning clinics, 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 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 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 ClinicSTD 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 HEDIS Effectiveness of Care Measurements Adolescent immunization Advising smokers to quit Breast cancer screening Cervical cancer screening Childhood immunization (2 yo) Chlamydia screening yo yo % 65% 73% 72% 64% 19% 16% Care Measures % 68% 75% 81% 69% 27% 25% % 64% 55% 60% 56% 37% 38% % 64% 56% 62% 58% 41% 42% CommercialMedicaid

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) Prevalence in Women Prevalence in Men High PID cost Low PID cost 1.0%2.0% 6.0% 2.0%3.5% 10.0% 3.0%5.0% 13.0% 4.0%6.5% 15.5% 5.0%8.0% 18.5% 6.0%9.5% >20.0%

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  g/mL. Susceptibility to ciprofloxacin was first measured in GISP in 1990.

25 Prevalence of QRNG by sexual orientation, excluding Hawaii and California, GISP MSMHeterosexuals % (0/447)0.03% (1/3936) % (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 Progress on Syphilis Elimination ( ) Total Women White Black Hispanic Congenital Syphilis Black:White P&S Syphilis Rate Ratio P&S Syphilis ,556 3, , ,078 44:1 7,007 3, , :1 6,617 2, , :1 5,979 2, , :1 6,130 1, , :1 6,862 1, , : ,082 1, :1

28 Rate (per 100,000 males/females) Male:Female Rate Ratio Rate (per 100,000 males/females) Male:Female Rate Ratio Male Female Male Female Male Female Male:Female Rate Ratio Primary/secondary syphilis, by year and sex: reported rates and male:female rate ratios – United States,

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 Year Total Cases M Cases F CasesM:F Case Ratio MSM Cases* (%) Non-MSM Cases † 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, ,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 Findings from syphilis outbreak investigations, 2001 CharacteristicMiamiNew York CityLos Angeles 111 ** 50No. of cases Median age, yrs % 32% 22% 27% 10% 59% Race/ethnicity White Black Hispanic % 14% 59% 44% 111 Known HIV+ 41% 32% 22% White Black Hispanic * 41% 32% 22% White Black Hispanic White Black Hispanic *January through June 2001 only **Primary & secondary syphilis only *January through June 2001 only **Primary & secondary syphilis only *January through June 2001 only **Primary & secondary syphilis only *January through June 2001 only **Primary & secondary syphilis only *January through June 2001 only **Primary & secondary syphilis only 34 43%53%

31 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 Francisco44% provided no names Los Angeles 67% had some anonymous partners Had some anonymous or unable to locate partners Types of Partnerships of MSM with Primary and Secondary Syphilis: Preliminary Experience in 8 Large U.S. Cities

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

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

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, % Race, sex years years years years  40 years Overall Black, Male Female Nonblack Male Female 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) Percentage with Infection Placebo Valaciclovir 500 mg once daily 500 mg once daily 3.8% (28/741) 1.9% (14/743) P=0.039 RR: 0.50 (95% CI: 0.26, 0.94) 50% Reduction

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 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 Indications for HPV Testing in Cervical Cancer Screening

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 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) % --No. HPV 16- CIN %

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….

51 STD/HIV Prevention: the ABCs A = Abstinence B = Be Faithful C = Condoms

52 Sexual Behavior Among High School Students 1991 & 2001 (Youth Risk Behavior Surveillance, MMWR 2002; 51) Behavior Ever sex Sex before age 13 >4 lifetime partners Responsible sexual behavior* Condom use at last sex *never sex, no sex in past 3 months, or sex with condom at last sex % % % % 7% 14% 86% 58%

53 Attitudes of American Teens and Their Parents about Teen Pregnancy (2003 annual survey, National Campaign to Prevent Teen Pregnancy) Almost all adults (94%) and teens (92%) believe important that society give a strong message that teens delay sex until after high school Most adults (71%) and teens (59%) think teens shouldn’t be sexually active but that those who are should have access to birth control Most adults (75%) and teens (60%) wish that teens were getting information about both abstinence and prevention -Most adults (68%) and teens (77%) think that such a message is “clear” not “mixed” Most teens (88%) think it would be easier to postpone sexual activity if they could have more open conversations about sexual activity with their parents (more influential than friends, clergy, sex educators, media)

54 NIH Workshop Summary on Effectiveness of Male Latex Condoms (July 2001) STD transmitted by genital secretions –HIV: evidence of effectiveness strongest –GC-M: consistent evidence –GC-F, CT, Trichomoniasis: insufficient evidence GUD (HSV, syphilis, chancroid): insufficient evidence HPV: no epidemiologic evidence that condom use reduced the risk of HPV infection but might afford some protection for disease (GW in men, cervical neoplasia in women) Most studies limited by methodologic design problems; thus, absence of definitive conclusions reflected inadequacies of the evidence available & should not be interpreted as proof of the adequacy or inadequacy of the condom to reduce the risk of other STD

55 The Condom Forgiveness Factor (Cates, STD 2000; 29: 350)

56 The Expanded ABCs of STD Prevention Abstinence (Awareness) For those who choose to be sexually active Being faithful (selective) Condoms (contraception) Diagnosis (screening, RX) For all Education (empowerment) Vaccines

57 Beyond the ABCs: Diagnosis and Vaccine Essentials Detection –Annual Chlamydia screening for F < 25 –Regular Pap smear screening for F > 21 –Pregnant women –Men who have sex with men Vaccines –Current: HBV—all adolescents, high-risk adults –Future: HPV--?? All adolescent F

58 CDC Report to Congress on Prevention of Genital HPV Infections (January 2004): Recommendations Individual level –Surest way to prevent infection is Abstinence –For those who choose to be sexually active, strategies include Being monogamous with an uninfected partner (though infection status hard to determine) Reducing # of partners and riskier partners Condoms—can’t be recommended as primary strategy to prevent HPV infection but may reduce risk of cervical cancer –Detection of pre-neoplastic changes by Pap test remains key strategy to prevent cervical cancer –Vaccine will be important (but will not replace other strategies)

59 Issues for STD prevention: penultimate thoughts Keeping STD prevention on the radar screen of public health and the public at large in the face of competing issues (bioterrorism, SARS, West Nile, obesity, etc) Getting our issues on the screen of “private health” Integration of our messages: –The full alphabet of prevention –Is it time to more closely embrace the concept of sexual health?

60 Sexual Health: Surgeon General’s Call to Action (July 2001) Surgeon General’s Call to Action (July 2001) –Focuses on the need to promote sexual health and responsible sexual behavior across the lifespan –Primary goal is stimulate respectful, thoughtful, and mature discussion in our communities and in our home about sexuality. –It is necessary to find common ground—balancing diversity of opinion with the best available scientific evidence—to improve the health of our nation –While sexuality may be difficult to discuss for some…we cannot afford consequences of continued or selective silence

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