National Quality Forum #: None
Description: Percentage of infants1 born to women with HIV infection who received recommended virologic diagnostic testing2 for exclusion of HIV infection in the measurement year
Numerator: Number of infants born to women with HIV infection who had at least two virologic diagnostic tests performed at appropriate time points2 by age of six months to definitively exclude HIV infection
Denominator: Number of infants with perinatal HIV exposure who:
- Were 6-12 months of age at any point in the measurement year
- Had a medical visit with a provider with prescribing privileges3 at least once in the measurement year
Patient Exclusions:
- Patients who were newly enrolled after six months of age
- Patients diagnosed with HIV infection
Data Elements:
- Was the patient 6-12 months of age at any point in the measurement year? (Y/N)
- If yes, was the infant born to a woman with HIV infection? (Y/N)
- If yes, was the patient seen by a provider with prescribing privileges during the measurement year? (Y/N)
- If yes, did the infant have documentation of receiving at least two virologic diagnostic tests at recommended time points2 to definitively exclude HIV infection? (Y/N)
- If yes, list dates.
- If yes, did the infant have documentation of receiving at least two virologic diagnostic tests at recommended time points2 to definitively exclude HIV infection? (Y/N)
- If yes, was the patient seen by a provider with prescribing privileges during the measurement year? (Y/N)
- If yes, was the infant born to a woman with HIV infection? (Y/N)
Data Sources:
- Electronic medical record/electronic health record
- CAREWare, Lab Tracker, or other electronic database
- Medical record data abstraction by grantee of the sample 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
- Median age of diagnosis of HIV infection
- Median age of exclusion of HIV infection
- Rate of opportunistic infections among clinic population
Basis for selection
"HIV virologic testing should be performed, at a minimum, at ages 14 to 21 days, 1 to 2 months and 4 to 6 months of age."4
"Pneumocystis jirovecii pneumonia (PCP) prophylaxis is recommended for infants with indeterminate HIV infection starting at 4-6 weeks of life or until they are determined to be definitively or presumptively without HIV infection." Diagnostic testing allows PCP prophylaxis to be avoided or discontinued if HIV infection is presumptively excluded.5
Department of Health and Human Services Clinical Practice Guidelines
- "Virologic assays (e.g., HIV RNA or HIV DNA nucleic acid tests [NATs]) that directly detect HIV must be used to diagnose HIV in infants and children aged <18 months with perinatal and postnatal HIV exposure; HIV antibody tests should not be used (AII).
- Plasma HIV RNA or cell-associated HIV DNA NATs are generally equally recommended (AII). However, the results of plasma HIV RNA NAT or plasma HIV RNA/DNA NAT can be affected by maternal antiretroviral therapy (ART).
- An assay that detects HIV non-B subtype viruses or Group O infections (e.g., an HIV RNA NAT or a dual-target total DNA/RNA test) is recommended for use in infants and children who were born to mothers with known or suspected non-B subtype virus or Group O infections (AII). If a mother of an infant acquired HIV outside of the United States and has had repeated undetectable HIV RNA by standard testing, consultation with a clinical virologist on more sensitive HIV nucleic acid testing may be indicated.
- Virologic diagnostic testing (see Table 3) is recommended for all infants with perinatal HIV exposure at the following ages:
- 14 to 21 days (AII)
- 1 to 2 months (AII)
- 4 to 6 months (AII)
- For infants at higher risk of perinatal HIV transmission, additional virologic diagnostic testing is recommended at birth (AII) and at 2 to 6 weeks after cessation of antiretroviral (ARV) drugs are discontinued (BII).
- For infants with perinatal HIV exposure who are being breastfed, virologic diagnostic testing is recommended at birth, 14 to 21 days, 1 to 2 months, and 4 to 6 months of age (AII). An additional virologic test should be performed between the 1-to-2-month and 4-to-6-month time points if the gap between tests is greater than 3 months. See Infant Feeding for Individuals With HIV in the United States.
- Virologic diagnostic testing should be performed:
- Every 3 months during breastfeeding (BII)
- After cessation of breastfeeding, irrespective of when breastfeeding ends at 4 to 6 weeks, 3 months, and 6 months after cessation (BII)
- Virologic diagnostic testing should be performed:
- A positive virologic test should be confirmed as soon as possible by repeat virologic testing (AII).
- Definitive exclusion of HIV infection in non-breastfed infants is based on two or more negative virologic tests, with one negative test obtained at age ≥1 month (and at least 2 -6 weeks after discontinuation of multi-drug ARV prophylaxis/presumptive HIV therapy) and one at age ≥4 months, or two negative HIV antibody tests from separate specimens that were obtained at age ≥6 months (AII).
- Additional HIV testing (e.g., HIV RNA or HIV DNA NAT, HIV antibody, HIV antigen/antibody) is not needed routinely for non-breastfed infants who meet the criteria for definitive exclusion of HIV and who have had no known or suspected HIV exposure after birth.
- Infants with potential HIV exposure after birth (e.g., from maternal HIV diagnosis during breastfeeding, premasticated feeding, sexual abuse, contaminated blood products, percutaneous exposure) who are aged <18 months require additional testing using HIV RNA/DNA NAT assays to establish their HIV status. Infants aged ≥18 months who have these potential exposures require HIV antigen/antibody testing.
- Age-appropriate HIV testing also is recommended for infants and children with signs and/or symptoms of HIV, even in the absence of documented or suspected HIV exposure.
- For children aged >24 months and for children aged 18 to ≤24 months with non-perinatal HIV exposure only, HIV antibody (or HIV antigen/antibody) tests are recommended for diagnostic testing (AII).
- When acute HIV infection is suspected, additional testing with an HIV NAT may be necessary to diagnose HIV (AII)."4
Use in other federal programs
This measure is linked to an exact or similar indicator(s) within the National HIV/AIDS Strategy (2022-2025).
References/notes
1 For the purposes of this measure "infants" include all patients 6 to 12 months of age.
2 Definitive exclusion of HIV infection in non-breastfed infants is based on two or more negative virologic tests, with one obtained at age ≥1 month and one at age ≥4 months, or two negative HIV antibody tests from separate specimens obtained at age ≥6 months (AII).
3 A "provider with prescribing privileges" is a health care professional who is certified in his/her jurisdiction to prescribe medications.
4 Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection (PDF - 6 MB). Department of Health and Human Services. Available online. Accessed February 2023. C-18 through C-19.
5 Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection (PDF - 6 MB). Department of Health and Human Services. Available online. Accessed August 2022. C-20.