1. HIV Testing In Vermont Update 2007 Cathleen Harris, MD Fletcher Allen Health Care

2. Proposed Revisions to VT Guidelines VT Department of Health draft proposal under external review at this time VT Department of Health draft proposal under external review at this time “Recommended Revisions to VT Guidelines for Universal HIV Counseling and Voluntary Testing for Pregnant Women” “Recommended Revisions to VT Guidelines for Universal HIV Counseling and Voluntary Testing for Pregnant Women” Updates original guidelines written in 1999 Updates original guidelines written in 1999

3. Proposed Revisions to VT Guidelines Preconception Care: Preconception Care: Health care providers should provide HIV counseling and offer testing to women before they become pregnant or as early in pregnancy as possible Health care providers should provide HIV counseling and offer testing to women before they become pregnant or as early in pregnancy as possible Pregnancy: Pregnancy: Principles per CDC “Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health Care Settings” Principles per CDC “Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health Care Settings” MMWR 2006; 55 (no. RR-14) MMWR 2006; 55 (no. RR-14)

4. Proposed Revisions to VT Guidelines HIV testing recommended for ALL pregnant patients HIV testing recommended for ALL pregnant patients Patient will receive an HIV test as part of routine prenatal lab tests unless she declines Patient will receive an HIV test as part of routine prenatal lab tests unless she declines HIV testing must be voluntary and without coercion. HIV testing must be voluntary and without coercion. Patient should not be tested without her knowledge Patient should not be tested without her knowledge Women should receive oral or written information about HIV infection, meaning of HIV test results, and interventions to reduce transmission Women should receive oral or written information about HIV infection, meaning of HIV test results, and interventions to reduce transmission NO additional process or written documentation of informed consent is required beyond what is required for other prenatal lab tests NO additional process or written documentation of informed consent is required beyond what is required for other prenatal lab tests

5. Proposed Revisions to VT Guidelines If HIV testing is declined, it should be documented in the medical record If HIV testing is declined, it should be documented in the medical record Discuss and address reasons for declining Discuss and address reasons for declining Discuss lack of perceived risk, fear of HIV, DV, etc. Discuss lack of perceived risk, fear of HIV, DV, etc. Inform of importance of retesting with each pregnancy Inform of importance of retesting with each pregnancy Resolve logistical reasons for not testing Resolve logistical reasons for not testing Some women may accept at a later date Some women may accept at a later date Especially if concerns are discussed Especially if concerns are discussed Some women may continue to decline Some women may continue to decline Their decision should be respected Their decision should be respected This should be documented in the medical record This should be documented in the medical record

6. Proposed Revisions to VT Guidelines Timing of HIV Testing Timing of HIV Testing Preconception or as early in pregnancy as possible Preconception or as early in pregnancy as possible Women who decline testing early in prenatal care should be encouraged to test at a later visit Women who decline testing early in prenatal care should be encouraged to test at a later visit Recommend 2 nd test in the third trimester if: Recommend 2 nd test in the third trimester if: High risk for acquiring HIV infection: High risk for acquiring HIV infection: IDU, partner IDU, exchange sex for drugs, partner of HIV-infected person, new or more than one partner IDU, partner IDU, exchange sex for drugs, partner of HIV-infected person, new or more than one partner Signs or symptoms consistent with acute HIV (different test) Signs or symptoms consistent with acute HIV (different test) Counsel women regarding risk reduction if factors present Counsel women regarding risk reduction if factors present

7. Proposed Revisions to VT Guidelines Hospitals should use internal QA measures to determine the percentage of pregnant women screened for HIV Hospitals should use internal QA measures to determine the percentage of pregnant women screened for HIV Consider including this information on L and D intake/database record Consider including this information on L and D intake/database record OBNet does record and track this information and can be used for this purpose OBNet does record and track this information and can be used for this purpose

8. Proposed Revisions to VT Guidelines Individual hospitals should determine whether a rapid testing program is appropriate for the facility Individual hospitals should determine whether a rapid testing program is appropriate for the facility “Phase in” of rapid testing programs in VT? “Phase in” of rapid testing programs in VT? Issues to consider include: Issues to consider include: How often testing will be performed How often testing will be performed Infrastructure needed: test kit, protocol, ARV meds, follow- up care Infrastructure needed: test kit, protocol, ARV meds, follow- up care Coordination between departments, providers, hospitals Coordination between departments, providers, hospitals Refer to CDC Guide & Model Protocol regarding steps to start a program Refer to CDC Guide & Model Protocol regarding steps to start a program www.cdc.gov/hiv/topics/testing/resources/guidelines/pdf/Labor& DeliveryRapidTesting.pdf www.cdc.gov/hiv/topics/testing/resources/guidelines/pdf/Labor& DeliveryRapidTesting.pdf

9. Proposed Revisions to VT Guidelines HIV testing during labor: HIV testing during labor: Hospitals with rapid testing: Hospitals with rapid testing: Screen with rapid test if undocumented (unless declines) Screen with rapid test if undocumented (unless declines) Give ARV prophylaxis if reactive rapid test Give ARV prophylaxis if reactive rapid test Initiate ARV for infant while awaiting confirmatory test Initiate ARV for infant while awaiting confirmatory test Hospitals without rapid testing: Hospitals without rapid testing: Screen with traditional test if unknown (unless declines) Screen with traditional test if unknown (unless declines) Appropriate ARV treatment and follow-up care for mother and infant Appropriate ARV treatment and follow-up care for mother and infant

10. Proposed Revisions to VT Guidelines HIV Testing in Postpartum/Newborn: HIV Testing in Postpartum/Newborn: Hospitals with rapid testing: Hospitals with rapid testing: Screen immediately PP if unknown (unless declines) Screen immediately PP if unknown (unless declines) If mother status unknown PP, recommend rapid testing of newborn ASAP If mother status unknown PP, recommend rapid testing of newborn ASAP If foster care, inform person authorized to give legal consent regarding recommending rapid HIV test If foster care, inform person authorized to give legal consent regarding recommending rapid HIV test Hospitals without rapid testing: Hospitals without rapid testing: Screen immediately PP with traditional test Screen immediately PP with traditional test If mother status unknown PP, antibody or virologic testing of newborn ASAP recommended If mother status unknown PP, antibody or virologic testing of newborn ASAP recommended

11. Progress toward rapid testing at Fletcher Allen HealthCare Rapid HIV testing program endorsement by Labor and Delivery Operations Committee obtained Rapid HIV testing program endorsement by Labor and Delivery Operations Committee obtained Key individuals participating in program: Key individuals participating in program: Mary Clairmont—Nurse Manager, Labor and Delivery Mary Clairmont—Nurse Manager, Labor and Delivery Cathleen Harris—OB/MFM Cathleen Harris—OB/MFM Bill Raszka—Peds ID Bill Raszka—Peds ID Jack Long—Nursery/Peds QA Jack Long—Nursery/Peds QA Dan Gibson—Laboratory Dan Gibson—Laboratory Karen McBride—Pharmacy Director Karen McBride—Pharmacy Director Deana Chase—Social Work Deana Chase—Social Work

12. Progress toward rapid testing at Fletcher Allen HealthCare Program components to be presented for approval to L and D Operations Committee Program components to be presented for approval to L and D Operations Committee May 2007 May 2007 Items: Lab & pharmacy procedures, OB care plans, Peds Care plans, SW crisis plan and resource list, legal policies regarding consent/minors Items: Lab & pharmacy procedures, OB care plans, Peds Care plans, SW crisis plan and resource list, legal policies regarding consent/minors Letter describing program will be sent to OB and nursery providers prior to start date Letter describing program will be sent to OB and nursery providers prior to start date Written materials will be available on L and D and in nursery for all procedures/resources Written materials will be available on L and D and in nursery for all procedures/resources

13. Progress toward rapid testing at Fletcher Allen HealthCare Laboratory— Laboratory— Already has established a protocol for rapid testing and confirmatory testing Already has established a protocol for rapid testing and confirmatory testing Able to provide service 24-hr testing with turnaround under 40 minutes Able to provide service 24-hr testing with turnaround under 40 minutes Using Uni-Gold Recombigen assay Using Uni-Gold Recombigen assay Verbal consent allowed with provider responsibility for documenting in medical record Verbal consent allowed with provider responsibility for documenting in medical record

14. Progress toward rapid testing at Fletcher Allen HealthCare OB Care Plan OB Care Plan Specify candidates for testing Specify candidates for testing Standardized information sheet for patients/script for verbal consent Standardized information sheet for patients/script for verbal consent How to order rapid test properly How to order rapid test properly Patient care plan based on results: NEG, POS, invalid Patient care plan based on results: NEG, POS, invalid Ped/Nursery Care Plan Ped/Nursery Care Plan Social work Care Plan Social work Care Plan Crisis mgmt Crisis mgmt Hospital and community resources Hospital and community resources Employee safety/PEP policies--in place Employee safety/PEP policies--in place Pharmacy plan—May 2 meeting for ARV selection/protocol Pharmacy plan—May 2 meeting for ARV selection/protocol QA plan to assess staff knowledge/performance QA plan to assess staff knowledge/performance

15. Progress toward rapid testing at Fletcher Allen HealthCare In-service education sessions targeted for June 2007 In-service education sessions targeted for June 2007 Leaders may include representatives from OB/Peds/Nursing/Lab/Pharmacy Leaders may include representatives from OB/Peds/Nursing/Lab/Pharmacy Content to include: Content to include: HIV and pregnancy review HIV and pregnancy review Rapid HIV testing principles Rapid HIV testing principles Intrapartum ARV prophylaxis Intrapartum ARV prophylaxis Overview of program and protocols Overview of program and protocols Target audiences: Target audiences: Labor and delivery staff Labor and delivery staff OB providers—OB/MFM/FP/CNM OB providers—OB/MFM/FP/CNM Nursery personnel Nursery personnel