1. We have the Guidelines… what else do we need to do?

2. Getting to ZERO Disseminate the current Guidelines Focus education on anyone caring for pregnant women and infants < 2 years of age (Obstetrics, Family Practice, Internists, Pediatricians, case managers, statewide perinatal nurses, peer navigators) Create Local / Community Perinatal Prevention Teams Representatives for all the stakeholders in the community Intensify education for Labor & Delivery teams  Rapid Testing protocols and performance measures Management of HIV + deliveries - Optimize Options 10 Steps in L & D for a Healthy HIV Negative infant

3. Getting to ZERO Intensify education for pediatricians in newborn nurseries to optimize management of HIV exposed infants in the “highest risk” situations Facilitate communication amongst the Perinatal Prevention Team including EMR, and data transfer Create Statewide Performance Measures for Prevention – based on the guidelines Earlier notification to the state DOH of a “high risk” perinatal exposure for assistance and tracking

4. Getting to ZERO Utilize the Perinatal Prevention Program at USF Center for HIV Education and Research www.usfcenter.org/perinatal www.usfcenter.org/perinatal Work with the Florida/Caribbean AIDS Education Training Center (F/CAETC) www.fcaetc.org National Perinatal HIV “Hotline” 888-448-8765

5. Getting to ZERO Distribute educational materials from Perinatal Prevention Program www.usfcenter.org/perinatal Review systems practices and performance in any facility where an HIV infected infant is born – provide training and technical assistance

6. Possible Interventions Preconceptual Opportunities Interventions Discordant couple - Woman HIV negative - Man HIV positive Recommend and Support Disclosure Reproductive Options (Ask/invite partner into the discussion) Pre-conceptual consultation Serial testing for a negative partner Treatment as Prevention Pre-Exposure Prophylaxis Problem solve effective therapy 10 Actions for a Healthy Baby HIV + couple – one or the other or both

7. Possible Interventions Missed Opportunities In Pregnancy Interventions Unplanned pregnancyReproductive Options (going forward) Prenatal consultation Review / support disclosure Problem solve effective therapy 10 Actions for a Healthy Baby Non-adherence to Rx Non-disclosure Lost to follow-upTOPWA Use of Peer Navigators and Case Managers Plan for Follow-up and lost to follow-up DOH Intervention – financial incentives, DOT, hospitalization, incarceration Substance use Mental illness High risk behaviors during pregnancy (HIV negative mothers) Closer Follow-up with TOPWA, case managers, etc. Serial testing throughout pregnancy, 3 rd Trimester, at delivery and at 6 weeks post-partum 10 Actions for a Healthy Baby

8. Possible Interventions Missed Opportunities Interventions Newly Diagnosed during Pregnancy Pregnancy Options  Prenatal consultation (with a pediatrician) Review / support disclosure Problem solve effective therapy Expedient Initiation of ARVs Create a “Pregnancy Plan” 10 Actions for a Healthy Baby Non-adherence to ARVs during Pregnancy Identify Reasons for Non-Adherence Review / support disclosure Prenatal consultation (with a pediatrician) Problem solve effective therapy Review “Pregnancy Plan” and “10 Actions” Closer initial follow-up for support + success

10. Possible Interventions Potential Missed Opportunities Interventions Primary HIV Infection during Pregnancy Pregnancy Options  Prenatal consultation Review / support disclosure Problem solve effective therapy Urgent Initiation of ARVs Create a “Pregnancy Plan” Involve Local Perinatal Coordinator Utilize a Peer Navigator 10 Actions for a Healthy Baby Lack of Prenatal Care 3 rd Trimester Diagnosis HIV Perform Confirmation Testing Complete initial HIV Evaluation Immediate initiation of ARV Rx (without confirmation or genotype results) Alert the Perinatal Prevention Team

11. Possible Interventions at Delivery Missed OpportunitiesInterventions Lack of Prenatal Care Unknown HIV Status at delivery Rapid Testing  Act on + Results Perform Confirmation Testing – HIV Evaluation Create management plan for delivery and infant Immediate Initiation of ARV Rx (without confirmation) (Consider 4 drug regimen – adding raltegravir) Begin IV Zidovudine for the mother Consider “High Risk” Empiric Treatment (ARVs for infant – Functional Cure) No 3 rd Trimester Testing Previously Negative Assessed as “High Risk” Situation for Mother

12. Possible Interventions at Delivery OpportunityInterventions Evidence of Inadequate or Ineffective Rx High Viral Load + / - other risks (Low CD4, STI, Drug abuse, etc.) Initiate Therapy to Stop Labor & Delay Delivery Create management plan for delivery and infant Re-initiation of ARV Rx (Consider 4 drug regimen – adding raltegravir) Begin IV Zidovudine for the mother Consider “High Risk” Empiric Treatment for Infant (Functional Cure) Premature Labor (<37 weeks GA) Inadequate Prenatal Care Known HIV + but No Recent VLs or CD4s Initiate Therapy to Stop Labor & Delay Delivery Create management plan for delivery and infant Immediate Initiation/continuation of ARV Rx (Consider adding raltegravir) Begin IV Zidovudine for the mother Consider “High Risk” Empiric Treatment for Infant (Functional Cure)

13. 10 Action Steps for Mothers for a Healthy Baby 1.Know your HIV Status  CD4 counts, Viral Loads, etc. 2.Start Prenatal Care early  Take your ARVs as directed 3.Take care of yourself  eating, vitamins, exercise, rest 4.Avoid exposures  No alcohol or drugs, Stop smoking, Cut down on caffeine 5.Disclose your status & Create support for yourself + baby 6.Make the steps into your “Pregnancy Plan” 7.Ask for a Prenatal consultation – including no breastfeeding, no pre-mastication of baby’s foods, medications and testing for the baby 8.Plan the Delivery – medications, delivery location, option of a cesarean section, IV Zidovudine 9.Give the medications for your baby as directed 10.Follow-up care for you and your baby after the birth

14. 10 Action Steps During Pregnancy for a Healthy Baby 1.Review HIV status (viral loads, CD4 counts, STIs, etc.) 2.Review health of pregnancy status (previous pregnancies, deliveries, additional health concerns and healthy steps) 3.Provide Understanding and Support for Disclosure 4.Create a pregnancy plan with the mother (family) 5.Problem solve effective therapy 6.Initiate an ARV regimen per the guidelines 7.Confirm adequate response to ARVs in 2-4 weeks 8.Monitor adherence and response at least every 3 months and at least in each trimester (especially at 34-36 weeks) 9.Create a delivery plan based on all the data – review it serially 10.Implement the delivery plan and follow-up for mother and infant

15. 10 Action Steps in Labor & Delivery for a Healthy Baby 1.Assess labor progression and delivery imminence 2.Confirm HIV status (1 st and 3 rd trimester testing) or Do Rapid Testing 3.Review [if HIV +] the ARV regimen, viral loads, CD4 counts, STIs, etc. 4.Clarify health of pregnancy (previous pregnancies, deliveries, additional health concerns in this pregnancy and healthy steps by the mother) 5.Create a plan for a safe delivery ( continue ARV regimen, arrest labor, IV zidovudine, cesarean section, other interventions) 6.Involve the pediatrician as indicated 7.Implement the safe delivery plan 8.Optimize maternal post-partum care (delivery completion, continuation of ARVs, indicated testing and vaccinations, follow-up) 9.Confirm interventions for the infant (testing, ARV regimen, Proscribe breastfeeding and pre-mastication of infant foods, follow-up) 10.Connect the mother and infant to local perinatal coordinator

16. Pregnancy Plan Set the dates for Prenatal Care Review all your options Ask about the perinatal coordinator and a pediatrician Understand and document your medications lab results / dates – CD4, Viral Loads Go over the decision-making about a Cesarean section Understand the important signs for delivery Bleeding Rupture of membranes Labor pains Changes in temperature, blood pressure, edema, etc. Communicating your health status with the Delivery Room staff Plan for your Baby’s needs – medications, No breastfeeding, follow-up and testing for HIV, No pre-mastication of food What to do after delivery for your health and your infant’s health

17. Functional Cure for Infants Recognize the “High Risk” for infection early Discuss the risk and present a plan (before, during and after delivery as possible) Initiate “Empiric Treatment” for HIV Infection within hours of delivery (2 hours – 36 hours) Current approved medications  Lamivudine, Emtricitabine, Zidovudine, Nevirapine, Stavudine Potential additional future ARVs  Darunavir (approved for > 3 years, + liquid) Raltegravir (approved for > 2 years, (-) liquid) Lopinavir/ritonavir (approved for > 4 weeks, + liquid) Tipranavir (approved for > 2 years, + liquid) Ritonavir (approved for > 4 weeks, + liquid)

18. Perinatal HIV Transmission Prevention: Getting to ZERO 1. Take the GUIDELINES to the trenches 2. Create Community Perinatal Prevention Teams 3. Facilitate Communication – EMRs and data 4. Develop Performance Measures for Prevention Testing in 1 st & 3 rd trimester (HIV Ag/Ab tests, or viral loads / CD4 counts) Rapid testing at delivery (as needed) Implementation of appropriate delivery plans Initiate pediatric interventions per the guidelines

19. Perinatal HIV Transmission Prevention: Getting to ZERO 4. Apply Performance Measures across the state 5. Empower and support women 6. Make Perinatal Prevention everyone’s priority 8. Review systems practices and performance in any facility where an HIV infected infant is born  Provide training and technical assistance

20. Special Thanks Yvette Rivero, BS, MPH, Perinatal Prevention Director HIV/AIDS Surveillance and Prevention Florida Department of Health in Broward County Scott Mickley, HIV/AIDS Surveillance Coordinator Florida Department of Health in Escambia County for their assistance with scheduling the chart reviews

21. Special Thanks Rashida Marshall, BS, Statewide Perinatal Coordinator Florida Department of Health Marlene LaLota, MPH, Program Administrator HIV/AIDS Prevention Program, Florida Department of Health for their data, organizational assistance, and the broad participation of the Florida Department of Health

22. Special Thanks Sheryl Carney, BA, RN, Florida/Caribbean AETC South East Program Coordinator Perinatal Nurse Educator, University of Miami Miller School of Medicine Clara Leach, RN, BSN, Program Manager Perinatal HIV Prevention Program University of South Florida, Center for HIV Education and Research For their zeal for this topic and heroic organizational efforts