1. Chlamydia among males: What do we know? Who should we screen? Charlotte Kent, PhD Chief, Health Services Research & Evaluation Branch Division of STD Prevention NCHHSTP Region I IPP Meeting November 12, 2009

2. Outline Intro Epidemiology Heterosexual Men –Priority populations of men to screen –Cost-effectiveness of screening men vs women –Who pays for male screening? –Male CT Screening Consultation Recommendations Men who have sex with men (MSM) –Prevalence of CT –Role of rectal infections in HIV transmission

3. Epidemiology of CT in males

4. Chlamydia — Rates: Total and by sex: United States, 1988–2007 Note: As of January 2000, all 50 states and the District of Columbia had regulations requiring the reporting of chlamydia cases.

5. Trends in chlamydia rates by gender, with male/female ratio, San Francisco, 2004-2008.

6. Chlamydia — Age- and sex-specific rates: United States, 2007

7. Chlamydia positivity among persons 14-39 years, 1999-2002 SD Datta. Ann Intern Med 2007 Age (years)FemalesMales 14-194.6 (3.7-5.8)2.3 (1.5-3.5) 20-291.9 (1.0-3.4)3.2 (2.4-4.3) 30-391.9 (1.0-3.5)0.7 (1.9-5.0)

8. Chlamydia positivity among persons 14-39 years, 1999-2002 SD Datta. Ann Intern Med 2007 Race/ ethnicity FemalesMales White1.5 (0.8-2.8)1.5 (0.9-2.4) Black7.2 (5.7-9.2)5.3 (3.8-7.5) Mexican American 3.1 (2.0-4.8)3.1 (1.9-5.0)

9. Heterosexual Men

10. Which populations to target?

11. Population Data on Male CT AddHealth, 2001-2002 –18-26 years, 3.7% National Job Training Program, 2003-2004 –16-19 years, 8.0% –20-24 years, 8.8% MSM Prevalence Monitoring Project, 2005 –15-80 years, 6.0% urethral infections Satterwhite CL. STD 2008.

12. Chlamydia trachomatis positivity rates among men tested in selected venues in the United States: a review of the recent literature Rietmeijer CA et al. STD 2008 CT rates high in certain venues, particularly corrections But, depends on demographic composition of the target population & location Conduct pilot programs to assess CT+ & feasibility and cost in target venues

13. Chlamydia — Positivity by age group & sex, adult corrections facilities, 2007

14. Prevalence of chlamydia among females and males in youth and adult detention by age group: San Francisco, 2003 – 2005 (N=16,399) N tested 1,0923,0652,0886,4706393,046 12–1718–2526–30 Years Barry P et al. STI 2007

15. Number of chlamydial infections detected in youth and adult detention by sex and age group: San Francisco, 2003 – 2005 N tested 1,0923,0652,0886,4706393,046 12–1718–2526–30 Years Barry P et al. STI 2007

16. Reported chlamydia among males by provider type: New York City, 2004 − 2005 Pathela P et al. STD 2009

17. Impact of Jail Screening on Community Chlamydia Rates: San Francisco Barry P et al. STD 2009

18. Female Chlamydia Rates & Jail Testing Density by Neighborhood, San Francisco 2004 Female Chlamydia Rate Per 100,000 Population 750 to1,800 500 to749 250 to499 0 to249 Jail Testing Density Per 1,000 Population 200 to334 100 to199 50 to99 3 to49 Barry P et al. STD 2009

19. Race/Ethnicity of Persons Tested in Jails by Sex, 1997–2004 Males 18–30 years N=29,167 Females 18–35 years N=10,863

20. Chlamydia Positivity among Females Aged 15–25 Years by Clinic and Year, San Francisco p<0.001 Barry P et al. STD 2009

21. Rate & predictors of repeat CT infection among men Dunne EF et al. STD 2008 Men 15-35 years with CT from 3 cities: Baltimore, Denver & San Francisco Repeat infection in 13% of men (similar proportion as in women) Predictors of repeat infection –History of STD –Venue (corrections & adolescent primary care) Incidence of repeat infection supports rescreening of men within 3 months

22. The program cost and cost- effectiveness of screening men for chlamydia to prevent pelvic inflammatory disease in women: findings from a large-scale US study T Gift 1, C Gaydos 2, C Kent 3, J Marrazzo 4, C Rietmeijer 5, J Schillinger 1, E Dunne 1 1 Centers for Disease Control and Prevention, Atlanta; 2 Johns Hopkins University, Baltimore; 3 San Francisco Department of Public Health, San Francisco; 4 University of Washington School of Medicine, Seattle; 5 Denver Public Health, Denver STD Supplement, November 2008

23. Modeling Male CT Screening Cost-effectiveness model: –Dynamic, compartment-based –Societal-perspective costs –Used data from study & literature –Assumed population of 100,000 aged 14-39 years, evenly divided between men & women –Assumed 35% of women screened at baseline 17,500 per year –Assumed male screening program would screen 1% of men annually 500 per year

24. Data Sources Much data came from a CDC-funded study –4 cities, conducted 2001-2003 –23,000 men screened in a variety of venues Corrections (adult and juvenile) CBOs Primary care School-based clinics, health fairs Drug treatment centers –Data included: CT positivity, symptoms, treatment rates Partner numbers, partner notification (PN) outcomes Cost of screening, PN

25. Data Sources, Cont. Two sexual activity groups (high & low) –Based on: Laumann EO, et al. 1994 Garnett GP, et al. Phil Trans R Soc Lond B Biol Sci 1999; 354:787-797 Group% of population Rate of partner change per year Men Low950.90 Men High513.30 Women Low980.88 Women High233.26

26. Model Details Women screened have same CT prevalence as the general US population (2.5%) * Screened men had higher rates of partner change and higher prevalence than general population –17% from high group (vs. 5% in general pop.) –CT prevalence: 4.9% vs. 2.1% overall PN data (effectiveness, etc.) drawn from study for men, modeled for women Time horizon: 5 years * Datta SD, et al. Ann Intern Med 2007; 147:89-96.

27. Model Details, Cont. Model assessed use of additional fund to either: –Screen 500 men annually –Increase the female screening budget by an equivalent amount (510 women annually) Model converts outcomes of acute infection, PID, and epididymitis to QALYs Model compares cost and QALYs for the two alternatives

28. QALYs QALY = Quality-adjusted life year Values health state from 1 (perfect health) to 0 (dead) Enables different health outcomes to be compared Value of health state multiplied by the time spent in the health state shows the impact of disease –For example, chronic pelvic pain: 0.36 health state loss for 5 years = 1.8 QALYs lost (undiscounted)

29. Cost and QALY Comparison between Screening Men and Expanded Screening of Women Discounted QALYs Saved (Men vs. Women) Discounted Societal Cost ($, Men vs. Women) X Axis Shows Chlamydia Positivity in Screened Men

30. Discounted QALYs Saved (Men vs. Women) Discounted Societal Cost ($, Men vs. Women) Discounted QALYs Saved from Screening Men – Expanded Screening of Women X Axis Shows Chlamydia Positivity in Screened Men Cost and QALY Comparison between Screening Men and Expanded Screening of Women

31. Discounted QALYs Saved (Men vs. Women) Discounted Societal Cost ($, Men vs. Women) Discounted QALYs Saved from Screening Men – Expanded Screening of Women When Dotted Line is above the X Axis, Screening Men Saves More QALYs than Expanded Screening of Women X Axis Shows Chlamydia Positivity in Screened Men Cost and QALY Comparison between Screening Men and Expanded Screening of Women

32. Discounted QALYs Saved (Men vs. Women) Discounted Societal Cost ($, Men vs. Women) Discounted Net Societal Cost for Screening Men – Expanded Screening of Women X Axis Shows Chlamydia Positivity in Screened Men Cost and QALY Comparison between Screening Men and Expanded Screening of Women

33. Discounted QALYs Saved (Men vs. Women) Discounted Societal Cost ($, Men vs. Women) Discounted Net Societal Cost for Screening Men – Expanded Screening of Women X Axis Shows Chlamydia Positivity in Screened Men When Solid Line Is below the X Axis, Screening Men Is Less Costly than Expanded Screening of Women Cost and QALY Comparison between Screening Men and Expanded Screening of Women

34. Discounted QALYs Saved (Men vs. Women) Discounted Societal Cost ($, Men vs. Women) Discounted Net Societal Cost for Screening Men – Expanded Screening of Women X Axis Shows Chlamydia Positivity in Screened Men Discounted QALYs Saved from Screening Men – Expanded Screening of Women Screening men becomes both more effective AND less costly than expanded screening of women when the prev- alence > 4.75% (vs. 2.5% for women) Cost and QALY Comparison between Screening Men and Expanded Screening of Women

35. Sensitivity Analysis Multivariate sensitivity analysis revealed that screening high-prevalence men: –Always saved QALYs compared to expanded screening of women –Cost an average of $10,520 per QALY saved over expanded screening of women Interventions costing ≤ $50,000 per QALY typically are considered cost-effective

36. Conclusions Screening men a viable program alternative to expanding screening of women This finding dependent on: –Men available for screening being high-risk –Women available for screening being at less risk Male prevalence was about 2x female prevalence

37. Who pays for male screening? Up to 10% of IPP dollars STD Program dollars Massachusetts health insurance –MA Health Quality partners –Males & females < 25 years National Health Care Reform –Likely not now –Only cover USPTF A & B recommendations United Kingdom does cover male screening

38. Male Chlamydia Screening Consultation Atlanta, Georgia March 28 – 29, 2006 Meeting Report May 22, 2007 http://www.cdc.gov/std/chlamydia/ChlamydiaScreening -males.pdf

39. Male CT Screening Meeting Report Consultants did not consider any recommendations pertaining to whether programs should adopt or expand male Ct screening programs. For state and local programs that have decided to screen, the following guidance is provided to assist with decisions about which populations of males to screen for Ct and how best to screen.

40. Male CT Screening Report Screening Priorities STD clinics Job Corps <30 years of age entering jails

41. Male CT Screening Report Other Priorities Males with Ct infection should be re- screened at 3 months for repeat Ct Urine is the specimen of choice for screening asymptomatic men for Ct NAATs are the test of choice. LET is not recommended for screening males for Ct Pooling of urine specimens should be considered for Ct testing in low prevalence settings to conserve resources Partner services should be offered to partners of males with Ct

42. Gonorrhea and Chlamydia among MSM, Possible Impact on HIV Transmission: Implications for Screening

43. Questions?

44. Prevalence of selected STDs among MSM: San Francisco STD clinic, 2007 STDPrevalence Early Syphilis2% Gonorrhea12% Chlamydia9% San Francisco STD Annual Summary, 2007

45. Copyright ©2008 BMJ Publishing Group Ltd. Scheer, S et al. Sex Transm Infect 2008;84:493-498 Figure 3 New sexually transmitted infection (STI) diagnoses among men who have sex with men (MSM) living with AIDS, male rectal gonorrhoea and primary and secondary syphilis in MSM, San Francisco, 1998-2007.

46. CDC CT & GC screening and diagnostic testing guidelines for MSM – 2002 Rectal GC & CT screening for MSM who have had receptive anal sex. Annual urethral screening for GC & CT among sexually active MSM. Pharyngeal GC screening for MSM with receptive oral-genital exposure. Perform screening regardless of reported condom use for anal sex. Screen every 3-6 mo for MSM at highest risk.

47. Adherence to CDC Guidelines Low perceived need for rectal testing. Availability of rectal cultures inadequate. Most STD clinics do no perform routine rectal CT testing. Most gay men’s health centers do not perform routine GC or CT rectal screening.

48. Prevalence of rectal and urethral CT & GC among MSM, San Francisco STD clinic, 2003-2004 n=6365n=6363 Kent et al. CID 2005

49. Prevalence of rectal chlamydia and gonorrhea* among gay and bisexual men seen in two clinical settings – San Francisco, 2003 n=3300 n=492n=525 Kent et al. CID 2005*NAAT testing by SDA

50. Proportion of asymptomatic rectal chlamydial and gonococcal infections among gay/bisexual men – San Francisco, 2003 ChlamydiaGonorrhea n=316n=264 14%16% 84%86% Kent et al. CID 2005

51. Rectal chlamydia & gonorrhea by HIV serostatus San Francisco STD clinic, 2003-2004 HIV infected at higher risk for rectal infections than HIV negative RR CT = 1.7 (1.4-1.9) RR GC = 1.6 (1.4-1.8) Kent et al. Nat’l HIV Prev Conf 2005 HIV neg 57% HIV pos 43%

52. Bernstein K, JAIDS in press San Francisco STD Clinic, 2003 − 2005

53. Expansion of rectal screening across a variety of settings in San Francisco

54. Instructions for self-collected rectal specimens

55. Rectal Chlamydia Prevalence in 10 settings: San Francisco, 2006 (n=7,935) Overall prevalence – 7.8% with 617 rectal CT infections detected

56. Rectal Infections in 10 Settings in San Francisco, 2006 Rectal GC similar pattern as rectal CT with 7.1% prevalence & 485 infections detected. 1.7% had dual GC & CT infection Overall, 14% had rectal infection –13% among HIV-negative

57. Pharyngeal Screening

58. Prevalence of pharyngeal gonorrhea* at large HIV testing program by gender and sexual orientation – San Francisco, 2001 (N = 4,072) n=2615 n=687n=770 Dilley et al. STD 2003*NAAT testing by LCR

59. Prevalence of pharyngeal chlamydia and gonorrhea* among gay and bisexual men seen in two clinical settings – San Francisco, 2003 n=4658 n=4665n=719n=761 Kent et al. CID 2005*NAAT testing by SDA

60. Rectal n = 318 Urethral n = 315 Proportion of chlamydial infections that would not be identified if only gonorrhea screening performed among gay/bisexual men: San Francisco – 2003 Kent et al. CID 2005

61. Chlamydia n = 574 Gonorrhea n = 785 Proportion of chlamydial and gonococcal infections that would not be identified if only urine/urethral screening performed among gay/bisexual men: San Francisco – 2003 Kent et al. CID 2005

62. Summary MSM Substantial CT among MSM. Rectal infections are more common than urethral infections. About 85% of rectal infections are asymptomatic & would be missed without screening. More than 75% of rectal infections have no concomitant urethral infection.

63. Summary MSM – con’t About 80% of rectal CT infections have no concomitant rectal GC infection. Pharynx is most common site of GC infection. While HIV positive men are at greater risk for rectal infections, the majority of rectal infections are in HIV negative men.

64. Barriers to comprehensive CT/GC screening among MSM Perception of risk low among providers & MSM Lack of availability of non-genital NAATs –LabCorp & Quest have validated –Many PH Labs have validated Non-genital NAATs not FDA-cleared –Insurance will not cover non-FDA cleared tests

65. Recommendations for all male patients Perform STD/HIV risk assessments of all male patients –Gender of partners –Number of partners –Types of sex – oral insertive, oral receptive, anal insertive, anal receptive & vaginal

66. Recommendations MSM Patients Perform routine CT & GC rectal screening & GC pharyngeal screening based on behavior rather than symptoms. Rectal screening & treatment might be an effective bio-medical HIV prevention strategy & needs further study.

67. Questions?

68. Thankyou The findings and conclusions in this presentation have not been formally disseminated by the Centers for Disease Control and Prevention and should not be construed to represent any agency determination or policy.