How to Work With Less Leveraging Your Resources for Perinatal Hepatitis B and HIV Prevention

1. How to Work With LessLeveraging Your Resources for Perinatal Hepatitis B and HIV Prevention Hollie Malamud-Price, M.P.H. Ryan White Treatment Modernization Act Maternal and Child Coordinator Division of Health, Wellness, and Disease Control HIV/AIDS Prevention and Intervention Section

2. What Are We Talking about Today • Basic Epidemiology of Mother-to-Child Transmission • Preventing Mother-to-Child Transmission (PMTCT) • Puzzle of Collaboration • What We Did in Michigan • Challenges • Lessons Learned • Resources

3. Women and HIV  Fastest-growing group of persons with new HIV diagnosis (30% of U.S. infections in 2001)  6,000 to 7,000 HIV-positive women deliver annually  40% of HIV-infected infants born to mothers with unknown status  As of 2003: 5,000 cumulative deaths from perinatally acquired AIDS in U.S. Ann Intern Med. 2005;143:38-54.

4. Women and HIV, cont…  For women of all races and ethnicities, the largest number of HIV/AIDS diagnoses during recent years was for women aged 15–39  High-risk heterosexual contact was the source of 80% of these newly diagnosed infections  Women with AIDS made up an increasing part of the epidemic. • In 1992, women accounted for an estimated 14% of adults and adolescents living with AIDS in the 50 states and the District of Columbia • By the end of 2005, this proportion had grown to 23% http://www.cdc.gov/hiv/topics/women/resources/factsheets/women.htm#3

5. Mother-to-Child Transmission • Perinatal HIV transmission is the most common route of HIV infection in children • It is now the source of almost all AIDS cases in children in the United States • Most of the children with AIDS are members of minority races/ethnicities • Many of these infections involve women who were not tested early enough in pregnancy or who did not receive prevention services CDC. HIV/AIDS Surveillance Report, 2005. Vol. 17. Rev. ed. Atlanta: US Department of Health and Human Services, CDC; 2007:1–54.

6. Mother-to-Child Transmission Rates of perinatal HIV Transmission of < 2% are possible with: • Early identification of maternal HIV infection • 3 part (antenatal, peripartum and neonatal) antiretroviral regimen • Pre-labor cesarean section if a maternal viral load of <1000 copies/ml is not achieved Approximately 144-236 infants per year acquire HIV infection via MTCT in the U.S. ~40% of their mothers not tested until birth or later

7. Perinatal Prevention Cascade Prevention Opportunities Missed Opportunities HIV positive woman or woman who does not know hr status Primary HIV prevention for women Pre-conception counseling and care BecomePregnant Prevention of unintended pregnancy No Prenatal Care Accessible, affordable, welcoming prenatal care Universal prenatal HIV testing (routine, opt-out) Re-offering testing to those who decline Second test in third trimester L&D rapid testing for women with unknown HIV status No HIV Test Inadequate ARV Prophylaxis Providing ARV prophylaxis to all eligible. Support for adherence to ARV ARV prophylaxis of exposed newborns Child Infected Despite Treatment Comprehensiveservices for mother and infant

8. Remaining Obstacles to Eradicating Perinatal HIV in the U.S.  Increase of HIV infection among women of child-bearing age  Delayed or lack of prenatal care  Women seen in antenatal care but not offered voluntary counseling/testing due to perceived low risk  Poor adherence to antiretroviral medications  Lack of full implementation of routine, universal prenatal HIV counseling and testing Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States; November 2, 2007

10. Tyrosinemia: 1 in >300,000 Maple-syrup urine disease: 1 in 175,000 Homocystinuria: 1 in 100,000 Galactosemia: 1 in 60,000 Phenylketonuria: 1 in 14,000 Hypothyroidism: 1 in 4,000 Perinatal HIV exposure, US 1 in 670 Perinatal HIV infection, US 1 in 2,680 to 1in 33,500 (according to interventions) Prevalence of Diseases Screened for in Newborns

11. Women and Hepatitis B • 24, 000 births to hepatitis B surface antigen (HBsAg) positive women annually • Without appropriate prophylaxis at birth 90% of exposed infants will become infected • CDC estimates 600 births to HBsAg positive women in MI • Approximately 300 are identified • <50% identified in Michigan and nationally

12. Identified and Expected Births to HBsAg-Positive Mothers, US, 1993-2003 23,827 19,043 48% 41% Source: National Immunization Program, CDC

13. Hepatitis B Birth Dose • Infants born to HBsAg-positive women and a completed vaccine series • With HBIG and hepB at birth • 80 - 95% protection • With hepB only started at birth • 70 - 95% protection Source: MMWR 2006; 55(RR-16)

14. Advisory Committee on Immunization Practices (ACIP) Hep B Recommendations • 1991 – Universal program implemented • First dose at birth or 1-2 mo for infants born to HBsAg-negative moms • 2002 – Preference to give first hepB at birth • 2005 - First hepB vaccine should be given at birth www.cdc.gov/ncidod/diseases/hepatitis/b/acip.htm

15. Risk Factors for Acute Hepatitis B U. S., 2006 Heterosexual (39%)* Injecting Drug Use (16%) Household Contacts; Health Care, and Travel (5%) MSM (24%) Unknown (16%) * Includes sexual contact with acute cases, carriers, and multiple partners. Source: MMWR 2006; 55(RR-16):6-7

16. Michigan’s Public Health Code 333.5123 • Requires pregnant women to be tested for HIV, syphilis, and/or hepatitis B at initial prenatal care visit, at the time of labor and delivery, and/or immediate post partum if the mother’s status is unknown or undocumented • The Michigan Department of Community Health (MDCH) also recommends retesting for HIV and for HBsAg for hep B high risk negative women in the third trimester

17. Public Health Code, cont. • Informed consent is required for both HIV and hep B testing • HIV testing requires a signed consent form • HIV providerscan use the MDCH counseling and testing booklet or a consent form of their choice • A general consent form for services is OK

18. USPHS Guidelines for HIV Screening • 1995: USPHS recommends that all pregnant women be counseled for HIV and encouraged to be tested • 2001: USPHS strengthens recommendation for routine testing of all pregnant women • Simplification of testing process so that pretest counseling is not a barrier • More flexible consent process to allow for various type of informed consent • Routine retesting in 3rd trimester for facilities serving high HIV prevalence (i.e., >.5%) communities

19. HIV Infection Ideal Disease for Screening • HIV serious health disorder that can be diagnosed in an asymptomatic state • HIV can be detected by reliable, inexpensive, and noninvasive screening test • Infected patients have YOLG if treatment initiated early • Cost of screening reasonably in relation to anticipated benefit MMWR 2006; 55 (NO RR-14) 1-17

20. 2006 CDC Releases Revised Recommendations on HIV Testing • All pregnant women in the United States should be screened for HIV infection • Transmission continues to occur among women who lack pnc or who were not offered voluntary HIV counseling and testing during pregnancy • Data confirm that testing rates are higher when HIV tests are included in the standard panel of screening tests for all pregnant women MMWR 2006; 55 (NO RR-14) 1-17

21. CDC Recommendations on Maternal Hepatitis Screening • Screen all pregnant women prenatally for HBsAg • At time of delivery • Review maternal HBsAg status • Record results on both labor and delivery record and on infant’s delivery summary sheet • Perform HBsAg testing STAT on women who: • Do not have a documented HBsAg test result • Tested HBsAg-negative prenatally and are at risk for hepatitis B virus (HBV) infection

22. Perinatal Cost Savings • Universal prenatal screening is cost savings in the U.S. • Repeat testing in 3rd trimester is cost-effective in areas of elevated HIV incidence among women of child-bearing age • The discounted lifetime treatment cost for perinatally-infected children • $113,476 for 9 years of survival • $228,155 for 25 years of survival • As years of survival increase for HIV-infected children, the lifetime costs are also likely to increase Sansom, et al. JAIDS 41: 4, April 2006

23. Who is Responsible for Perinatal Hepatitis B and HIV Prevention?

24. Puzzle of Collaboration Entering into Prenatal Care Reporting Obstetrical Provider Pregnant Woman L and D Knowing the woman’s HIV and Hep B status Obstetrician Providing Testing Infection Control/ Infectious Disease Provider Treatment Test Results Being Returned

25. What Did Michigan Do? Perinatal Hep B and HIV Coordinators met one another! Partnered and leveraged resources! Looked at what each program had done Made plans to move forward

26. What Did Michigan Do? Developed a survey that was sent to all of Michigan’s 91 birthing hospitals and 500nprenatal care providers Direct telephone follow-up with each birthing hospital

27. Example of Questions Asked  HIV Policies • Does your facility have written policies (WP) and standing orders (SO) to: • 1. Do HIV testing upon admission to L&D if results are unknown or undocumented for HIV? • 2. Repeat testing for (-) but high risk pregnant women for HIV? • 3. Do rapid (20 min–hrs) HIV testing? • How long does it take to get the results to the L&D staff? ____ • 4. Do expedited (24-48 hrs) HIV testing? How long does expedited testing take? _________ • 5. Do standard Elisa (3+ days) testing?

28. Example of Questions Asked  HBV Policies • Does your facility have written policies (WP) and standing orders (SO) to: • 1. Test for HBsAg upon admission to L&D if results are unknown or undocumented? • 2. Repeat HBsAg testing for (-) but high risk pregnant women? • 3. Do STAT HBsAg testing? • 4. Offer hepatitis B immune globulin (HBIG) and hepatitis B vaccine to infants born to HBsAg positive women? • 5. Offer hepatitis B vaccine to all newborns?

29. Survey Results-HIV • 40 (44%) has written policies and standing orders (WP/SO) to offer HIV testing to women upon admission to labor and delivery (L and D) with an unknown or undocumented HIV status. • Of the 40 hospitals, 28 (70%) have WP/SO to offer rapid testing (RT) in L and D. • Of the 40 hospitals, that have WP/SO to offer HIV testing to women upon admission to L and D with an unknown or undocumented HIV status, 12 (30%) replied that is unknown and/or do not offer RT in L and D.

30. Survey Results-Hep B • Have written policies and standing orders to: • 81 (89%) test women STAT upon admission to L & D if no result is available for HBsAg • 9 (10%) offer repeat testing for HBsAg negative but high risk pregnant women • 87 (96%) give HBIG and hepatitis B vaccine within 12 hours to infants born to HBsAg positive women • 86 (95%) give hepatitis B vaccine to all newborns

31. Current Activities  Reviewing a sample of birth hospital charts over the next five years.  All hospitals receive a report on performance.  To date 18 hospitals have had record reviews.

32. Next Steps  Disseminate chart review data as it is available to state working group  Determine what hospitals need immediate technical assistance  Provide TA as much as possible based on limited staff time and resources

33. Challenges  Limited staff time and resources.  Not funded to do perinatal HIV prevention by CDC or HRSA  Lack of state perinatal regions/networks to assist in working with birthing hospitals to promote perinatal Hep B/HIV prevention.

34. Over Coming Challenges  Recognize your limitations  Recognize what you can do  Leverage your resources-figure out where you can collaborate!  Know one another and build relationships

35. Lessons Learned  Baby Steps are O.K.  Be patient with the process.  Beg, borrow, and steal-use materials from national organizations to support your work-CDC, ACOG, etc.  Partner with other public health programs to spread the word-family planning, WIC, etc.

36. Resources

37. National Resources-HIV • CDC National Prevention Information Network (NPIN)P.O. Box 6003,Rockville, MD 20849-6003Phone: 1-800-458-5231TTY: 1-800-243-7012FAX: 1-888-282-7681In English, en EspañolMonday through Friday, 9 a.m. to 8 p.m. Eastern Time www.cdcnpin.orginfo@cdcnpin.org Receive technical assistance and publication distribution for organizations and professionals working in HIV/AIDS, STD, and TB prevention

38. National Resources-HIV • National Perinatal HIV Consultation and Referral Service (Perinatal Hotline)1-888-448-876524 Hours/Daywww.ucsf.edu/hivcntr/Hotlines/Perinatal.html The Perinatal Hotline provides around-the-clock advice on indications and interpretations of standard and rapid HIV testing in pregnancy as well as consultation on antiretroviral use in pregnancy, labor and delivery, and the postpartum period. The Perinatal HIV Consultation and Referral Service also links HIV-infected pregnant women with appropriate health care.

39. National Resources-HIV • http://aidsinfo.nih.gov/contentfiles/PerinatalGL.pdf • www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm • http://www.cdc.gov/hiv/topics/perinatal/1test2lives/default.htm • www.cdc.gov/hiv/projects/perinatal • www.cdc.gov/hepatitis • www.cdc.gov/hiv/rapid_testing • AIDS Info www.aidsinfo.nih.gov 1.800.448.0440 Resources on HIV/AIDS Treatment and Clinical Trials

40. National Resources-Hep B • www.cdc.gov/hepatitis • www.hbvadvocate.org • www.hivandhepatitis.com • www.hblist.org

41. Contact Information Hollie Malamud-Price. M.P.H.3056 W. Grand Blvd Suite 3-150 Detroit, MI 48202 313.456.4362 malamudh@michigan.gov