2015 indicator reference guide viral load suppression at 12 months
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This document provides guidance on the indicator "Percentage of ART patients with a viral load result documented in the medical record within the past 12 months". It aims to monitor the proportion of patients on antiretroviral therapy (ART) who receive routine viral load testing to determine treatment effectiveness. The numerator is the number of ART patients with a documented viral load result in their medical record from the past 12 months. The denominator is the number of ART patients whose medical records were reviewed who have been on treatment for at least 6 months. Achieving high rates of routine viral load testing is important for sustaining treatment outcomes and reducing transmission at scale.
2015 indicator reference guide viral load suppression at 12 months
- 1. Treatment March 2015 ARV Services Indicator code: TX_VIRAL 1 Percentage of ART patients with a viral load result documented in the medical record within the past 12 months Purpose: ART is viewed by the scientific community and PEPFAR not only as essential for decreasing morbidity and mortality, but also as a highly effective approach to prevent HIV transmission. The ultimate desired outcome of ART is an undetectable viral load (usually defined as a viral load <1000 copies/ml). An unsuppressed viral load can be indicative of suboptimal treatment adherence, and can lead to the development and spread of drug resistance. In line with 2013 WHO guidelines that delineate viral load as the preferred ART monitoring test, PEPFAR countries are currently working to scale-up the use of routine viral load testing. This indicator monitors the proportion of adult and pediatric patients on ART who have received a viral load test within the recommended testing interval (i.e., 12 months). To ensure that the viral load testing can be used by providers for clinical patient management, documentation of the result on the patient’s medical record is required. This will be a key indicator for monitoring the scale-up of routine viral load testing and return of results to the facility level. NGI Mapping: N/A – this is a new indicator PEPFAR Support Target/Result Type: Both Direct Service Delivery (DSD) and Technical Assistance-Service Delivery Improvement (TA-SDI) targets and results should be reported to HQ. Numerator: 1 Number of adult and pediatric ART patients with a viral load result documented in the patient medical record within the past 12 months. Denominator: 1 Number of adults and children on ART for at least 6 months whose medical records were reviewed. Disaggregation(s): 1 Age/Sex: <1 Male, <1 Female, 1-4 Male, 1-4 Female, 5-14 Male, 5-14 Female, 15-19 Male, 15-19 Female, 20+ Male, 20+ Female 1 Result category: Undetectable (<1000 copies/ml); Detectable (>1000 copies/ml) Data Source: ART patient charts or ART registers/databases Data Collection Frequency: Viral load results should be collected and documented continuously at the facility level as part of routine service delivery and aggregated in time for PEPFAR reporting cycles.. Data should be reviewed regularly for the purposes of program management, to monitor progress towards achieving targets, and to identify and correct any data quality issues. Method of Measurement: Data collection for this indicator will be done through a sampling methodology. The USG and site teams should determine the appropriate number of patient charts that will be randomly selected for review. A suggested sample size is 10% of the current patients on ART for least 6 months, with a minimum of 20 and a maximum of 50. Explanation of Numerator: Data for the numerator should be generated by counting the number of patients with charts reviewed who have a viral load result documented in the medical record within the last 12 months. Review of the medical record is required to determine whether any viral load result is present. If yes, review of the time period of the result is necessary to determine if the viral load was collected within the past 12 months.
- 2. The numerator requires that adult and child patients must be alive and on ART for at least 6 months (as most national guidelines recommend the first viral load 6 months after ART initiation). The numerator does not require patients to have been on ART continuously. Patients may be included in the numerator if they have missed an appointment or drug pick-up or temporarily stopped treatment as long as they are still taking ART. On the contrary, those patients who have died, stopped treatment, or been lost to follow-up should not be sampled, and therefore, will not be included in the numerator. Explanation of Denominator: The denominator is the number of sampled adults and children who have been on ART at least 6 months (excluding those who have died, stopped ART, or been lost to follow-up) with charts reviewed. Interpretation: The indicator determines the proportion of adult or pediatric ART patients who have received a viral load test within the appropriate interval. Assessing the ability of ART sites to provide routine viral load testing for ART patients is critical to achieving widespread scale-up of viral load monitoring and thus measure virologic suppression. This information could also contribute to quality improvement activities designed to maximize rates of viral load testing and use of results for clinical and programmatic decision-making. The programmatic implications of the results include, but are not limited to: Support for the scheduled use of viral load testing as part of routine monitoring and supervision functions within the national ART program Modification of laboratory procedures and algorithms for return of viral load testing results to the facility level Targeted assistance for countries with lags in scale-up of routine viral load testing Increasing ART coverage in resource-limited settings in the absence of routine viral load monitoring is raising concerns about the development of resistance to first-line ART regimens, long-term individual patient outcomes, and increased risk of transmission of HIV, including drug-resistant HIV. To sustain the progress made in reducing morbidity and mortality from HIV through ART, it is important that HIV-infected patients continue to have access to safe, tolerable, and potent ARVs. To accomplish this, the use of viral load testing to monitor HIV treatment will need to be expanded. Increasing the availability of viral load monitoring remains a challenge in most PEPFAR-supported countries. Wherever possible, PEPFAR should assist the country in expanding the capacity for VL testing through activities such as procurement of reagents and/or platforms and support for transportation systems for processing and shipment of specimens. PEPFAR Support: DSD: Individuals will be counted as receiving direct service delivery support from PEPFAR when BOTH of the below conditions are met: Provision of key staff or commodities AND frequent, at least quarterly, support to improve the quality of services. TA-SDI: Individuals will be counted as supported through TA-SDI when the point of service delivery receives support from PEPFAR that meets the second criterion only: Frequent, at least quarterly support to improve the quality of services. 1. PEPFAR is directly interacting with the patient or beneficiary in response to their health (physical, psychological, etc.) care needs by providing key staff and/or essential commodities for routine service delivery. For PLHIV receiving ART/VL testing, this can include ongoing procurement of critical
- 3. commodities, such as for viral load testing or ARVs, or funding for salaries of HCW who deliver HIV treatment or laboratory services. Staff who are responsible for the completeness and quality of routine patient records (paper or electronic) can be counted here; however, staff who exclusively fulfill MOH and donor reporting requirements cannot be counted. AND/OR 2. PEPFAR provides an established presence at and/or routinized, frequent (at least quarterly) support to those services to those individuals at the point of service delivery. For ART/VL services, this ongoing support for service delivery improvement can include: clinical mentoring and supportive supervision of staff at ART sites, support for quality improvement activities, patient tracking system support, routine support of ART M&E and reporting, commodities consumption forecasting and supply management. Additional References: Three interlinked patient monitoring systems for HIV care/ART, MCH/PMTCT (including malaria prevention during pregnancy), and TB/HIV: standardized minimum data set and illustrative tools. World Health Organization 2009. WHO updated HIV Drug Resistance Early Warning Indicators and targets – 2012. http://www.who.int/hiv/pub/meetingreports/ewi_meeting_report/en/index.html). Refer to the PEPFAR Adult Treatment TWG with further inquiries.