Nearly all HIV-infected children require antiretroviral (ARV) therapy, regardless of when they first contracted the disease or when symptoms appear. Children respond differently to treatment regimens than adults, and they must be monitored carefully due to considerable variation in side effects, toxicity, and metabolic responses to medication. Children (depending on age and maturity level) as well as their parents must understand the importance of adherence to ARV therapy regimens and the dire need to contact providers should unexpected problems arise, to re-evaluate the child’s status.

Criteria for appropriate management differ according to whether the patient is deemed clinically stable, clinically unstable, or has no other therapeutic options.

• If the pediatric patient is assessed as clinically stable:
  • Appropriate management requires that the pediatric patient’s viral load or CD4 count be monitored in the four-month review period
  • Pediatric patients are deemed clinically stable if their case meets at least one of the following criteria:
    • Viral load is undetectable
    • Viral load has dropped by at least one log since the last four-month review period
    • Viral load has increased by less than 1 log from the lowest value in the last 12 months on that regimen
    • CD4 count is the same or higher during review period
    • Note by treating physician indicates the patient is deemed clinically stable.

• If the pediatric patient is deemed clinically unstable:
  • One of four management options need to be documented:
    • Regimen was changed and a viral load assay performed within 8 weeks of decision
    • Justification was documented not to change therapy, along with a viral load assay within 8 weeks of decision        
      • Common justifications include:
        • Intercurrent illness
        • Recent vaccination
        • Documented adherence intervention
        • Viral load reordered
        • Resistance testing ordered
        • Note from treating physician indicating the patient is deemed clinically/immunologically stable
    • Documentation that patient decides not to take medication and viral load assay performed within four months
    • Documented decision to discontinue therapy and clinical follow-up plan noted in record within four months

• Pediatric patients are deemed clinically unstable if their case meets at least one of the following criteria:
  • Viral load has increased by more than one log and absolute value is over 1,000
  • Transition in CD4 percent from above 25 percent to below 25 percent, or above 15 percent to below 15 percent
  • Downward change in immunologic class (1 to 2, or 2 to 3)
  • Opportunistic infection (OI) or AIDS-defining condition in the last four month review period (new or recurrent)
  • Note from treating physician indicating that the patient is deemed clinically unstable

• If the pediatric patient meets the unstable criteria above but has no other therapeutic options available, then the viral load should be monitored every four months.

Formula:  The total number of pediatric patients (birth to 13 years) on ARV therapy who are appropriately managed during a four month period, divided by the total number of pediatric patients who are on ARV therapy during that same four month period.  (Appropriately-managed pediatric patients are divided into two categories: stable or unstable, and these categories should be graphed separately to maximize performance information.) Multiply by 100 to calculate percent.

For further explanation of this indicator and/or criteria for exclusions, please view indicator definitions produced by the National HIVQUAL Project.

Increase the total percentage of pediatric patients on ARV therapy who are appropriately managed (whether clinically stable or unstable) to 100 percent within six months.

Assess all pediatric patients monthly or at the frequency established by your quality improvement effort.  Identify your sample (pediatric patients, birth to 13 years, who are eligible or on ARV therapy), determine if each pediatric patient is clinically stable or unstable—the input of an experienced clinical practitioner is advised—and conduct clinical assessments of pediatric patients’ medical records to determine whether pediatric patients are appropriately managed.

Patients who are clinically stable:

Add the total number of pediatric patients, birth to 13 years, who are clinically stable and who were managed appropriately during the past four months. Divide by the total number of patients who are clinically stable and were on ARV therapy during that same four-month period. Multiply by 100 to calculate percent.

Patients who are clinically unstable:

Add the total number of pediatric patients, birth to 13 years, who are clinically unstable and who were managed appropriately during the past four months. Divide by the total number of patients who are clinically unstable and were on ARV therapy during that same four-month period. Multiply by 100 to calculate percent.

Both groups (stable and unstable) combined:

Add the total number of pediatric patients, birth to 13 years (whether clinically stable or unstable), who were managed appropriately during the past four months. Divide by the total number of pediatric patients who were on ARV therapy during the same four-month period. Multiply by 100 to calculate percent.

Graph each category (stable, unstable, and both groups combined) as a separate data series on the same graph to provide the most detailed performance information (see sample graph below).

The National HIVQUAL Project’s Minimum Sample Table will help you determine the number of records in your sample. Research Randomizer can generate a random number series to help you select which records to review.