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  5. Performance Measure: Neonatal Zidovudine Prophylaxis

Performance Measure: Neonatal Zidovudine Prophylaxis

National Quality Forum #: None

Description: Percentage of infants1 born to women with HIV infection and were prescribed Zidovudine (ZDV) prophylaxis2 for HIV within 12 hours of birth during the measurement year

Numerator: Number of infants born to women with HIV infection and were prescribed ZDV prophylaxis within 12 hours of birth during the measurement year

Denominator: Number of infants who:

  • Were born to women with HIV infection during the measurement year
  • Had a visit with a provider with prescribing privileges3 in an HIV setting 4 during the measurement year

Patient Exclusions: None

Data Elements:

  1. Was the infant born to a woman with HIV infection during the measurement year? (Y/N)
    1. If yes, was the infant seen by a provider with prescribing privileges in an HIV setting during the measurement year? (Y/N)
      1. If yes, was ZDV prophylaxis prescribed within 12 hours of (Y/N)
        1. If yes, list the date.

Data Sources:

  • Electronic medical record/electronic health record
  • CAREWare, Lab Tracker, or other electronic data base
  • Medical record data abstraction by grantee of a sample of records
  • Billing records

National goals, targets, or benchmarks for comparison

The HIV Quality Measures (HIVQM) Module is a tool within the Ryan White HIV/AIDS Services Report portal. It allows recipients to enter aggregate data specific to HRSA HAB Performance Measures. The HIVQM Module allows recipients to conduct point-in-time benchmarking across Ryan White HIV/AIDS Programs that use the module.

Outcome measures for consideration

Rate of perinatal transmission

Basis for selection

Zidovudine (ZDV) was shown in the PACTG 076 study to effectively reduce perinatal HIV transmission and is recommended for all neonates born to mothers with HIV infection. "In the Pediatric AIDS Clinical Trials Group (PACTG) 076 study, ZDV alone reduced the incidence of perinatal HIV transmission by 66%, and ZDV is recommended as prophylaxis for neonates whose mothers received ART that resulted in consistent viral suppression during pregnancy."5

"All newborns with perinatal exposure to HIV should receive antiretroviral (ARV) drugs during the neonatal period to reduce the risk of perinatal HIV transmission, with the selection of the appropriate ARV regimen guided by the level of transmission risk. HIV transmission can occur in utero, intrapartum, or during breastfeeding.

Maternal viral load is the most important risk factor for HIV transmission to a newborn. Newborns are at an increased risk for HIV acquisition when their mothers did not receive antiretroviral therapy (ART) during pregnancy, started antepartum treatment late in pregnancy, or when antepartum treatment does not result in viral suppression (defined as at least two consecutive tests with HIV RNA levels <50 copies/mL obtained at least 4 weeks apart). Higher maternal viral load, especially in late pregnancy, correlates with higher risk of transmission. There is a spectrum of transmission risk that depends on these and other maternal and infant factors, including mode of delivery, gestational age at delivery and maternal health status."6

Department of Health and Human Services Clinical Practice Guidelines

  • "All newborns who were exposed perinatally to HIV should receive postpartum antiretroviral (ARV) drugs to reduce the risk of perinatal transmission of HIV (AI).
  • Newborn ARV regimens administered at doses that are appropriate for the infant's gestational age should be initiated as close to the time of birth as possible, preferably within 6 hours of delivery (AII).
  • A 4-week zidovudine (ZDV) ARV prophylaxis regimen can be used in newborns whose mothers received ART during pregnancy and had viral suppression near delivery (defined as a confirmed HIV RNA level <50 copies/mL) and for whom there are no concerns related to maternal adherence (BII).
  • Providers with questions about ARV management of perinatal HIV exposure should consult the National Perinatal HIV Hotline (1-888-448-8765), which provides free clinical consultation on all aspects of perinatal HIV, including newborn care (AIII)." 6

Use in other federal programs

None

References/notes

1 "Infants" includes all patients aged 12 months and younger.

2 From the U.S. Department of Health and Human Services Clinical Practice Guidelines: The Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission Panel recommends a "4-week neonatal ZDV prophylaxis regimen for full-term infants if the mother has achieved viral suppression on ART during pregnancy (defined as a confirmed HIV RNA level <50 copies/mL) at or after 36 weeks, and there are no concerns related to maternal adherence. Dosing recommendations for ZDV are available for premature newborns, and an intravenous preparation of ZDV is available. Table 7 shows recommended neonatal ZDV dosing based on gestational age and birthweight" (E-20).

3 A "provider with prescribing privileges" is a health care professional who is certified in his/her jurisdiction to prescribe medications.

4 An HIV care setting is one that receives Ryan White HIV/AIDS Program funding to provide HIV care.

5 Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission. Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States (PDF - 5 MB). Department of Health and Human Services. Available online. Accessed February 2023. G-10

6 Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs During Pregnancy with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States (PDF - 5 MB). Department of Health and Human Services. Available online. Accessed February 2023. G-2.

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