Between 2004 and 2012, over 159 million HTC sessions were provided with PEPFAR support using HIV rapid tests (RT). Working towards the elimination of new HIV infections under PEPFAR's Combination HIV Prevention strategy will require increasing access to and uptake of HTC and emphasizing efforts to ensure the accuracy of HIV testing. In support of these efforts, the Laboratory, HTC and PMTCT TWGs collectively proposed an HIV Rapid Testing Quality Improvement Initiative (RTQII), which has been approved by Ambassador Goosby. The RTQII aims to ensure the quality of HIV rapid testing and expand upon current in-country HIV rapid testing quality improvement work. The RTQII is comprised of the following five key action areas:
Policy Engagement: Create an enabling framework for policy development
Human Resource: Increase cadres of qualified testers through training and certification
Proficiency Testing Programs: Increase uptake and coverage and demonstrate impact
Post Market Surveillance: Monitor the quality of new kit lots
All seven selected countries, like all PEPFAR-supported ones, are presently implementing to some extent the different focused areas identified by this Initiative. However, because of inadequate engagements at national levels, insufficient resource allocations, coverage and consistency in rolling out quality assurance has been challenging. To this end, the RTQII will help synergize and leverage existing country resources and ensure long-term sustainability of the quality of HIV testing.
The RTQII indicators are developed to help monitor the implementation of activities and to demonstrate progress in strengthening country capacity to improve the quality of HIV testing. These indicators will help assess processes, outcomes and impact. They may not satisfy every country need and may not be designed to provide information on all aspect of the HTC program in country‐specific settings. However, they can be adapted at the country‐level to assess the impact of overall efforts geared toward improving the quality of HIV testing.
These indicators have been developed collectively by PEPFAR interagency technical working groups (Laboratory, HTC and PMTCT).
1.0 POLICY ENGAGEMENT: Sustainably improving the quality of HIV rapid testing will require high-level policy engagement with MOH. These indicators will help assess the level of MOH commitment for sustainable quality testing and integration of quality of HIV testing in programmatic areas
In-country engagement involving all key stakeholders on quality assurance/quality improvement efforts for rapid testing?
Formation or strengthening of in-country inter-program TWG for rapid test quality assurance
Formation of an active Interagency Task Team to support the initiative.
Implementing a national strategic plan for RT QII? Existence of national coordinating mechanism, chaired by the ministry of health, to oversee and plan the development of the RTQI policy and strategy?
Current status of national policy and guidance for rapid testing quality improvement consistent with WHO guidance (e.g. not started yet, planning, development, complete, implementation, need for revision).
2.0 HUMAN RESOURCE DEVELOPMENT: Currently, HTC training curricula lacks hands-on practical components related to QA, resources for refresher training (for trainers or testers), or strategies to assess the impact of training on testing accuracy. Without common standards and rigorous oversight, the quality of testing sites and testers is variable and largely unknown. The indicators below will assess the national program’s capacity to implement a rapid testing quality improvement initiative.
Number of individuals trained using national standardized training curricula
Number of training workshops conducted using the national standardized training curricula
Number of individuals certified or re-certified by national certification program for rapid testing
Number of individuals of certified or re-certified by international certification program for rapid testing
3. PROFICIENCY TESTING: PT programs have been shown to improve the quality of testing. ILB/CDC developed dried tube specimens (DTS) for implementing PT program at HTC sites. Currently, DTS has been transferred to more than 50 countries; however, their use and implementation has been partial and variable and PT data is not being analyzed sufficiently to adequately address issues and provide corrective actions to sites with poor performance. The indicators below aim to assess the uptake and coverage of the PT program as well as the performance of sites overtime
Percentage of sites enrolled in DTS PT program (Note: Specify Total number of sites enrolled in DTS PT program/ total number of sites conducting RT)
Disaggregation + timeframe (past 3 or 6 months)
Percentage of sites with PT results in each round. (Note:Specify Total number of sites participating in each round / Total number of sites enrolled in each PT round).
Percentage of sites with satisfactory PT results in each round. (Note: Specify Total number of sites with satisfactory PT results / Total number of sites participating in each PT round).
Percentage of sites that received corrective actions and feedback. (number of sites that received corrective actions / total number of sites with poor performance during that PT round)
Percentage of sites with improved PT performance following corrective actions. (Note: Specify Total number of sites with improved PT performance / Total number of sites that received corrective actions in the previous PT round)
4. STANDARDIZED LOGBOOK: Current practices at most HTC sites include HIV testing registers that capture varying and incomplete information and are therefore inadequate for QA purposes. Therefore, ILB/CDC developed a Standardized Logbook that incorporates pertinent QA information. However, the logbook adoption process has been suboptimal or where it has been adopted, capacity to centrally collect and analyze data is inadequate. The indicators below will assess the uptake of logbook and its impact on the overall testing performance.
Percentage of sites using standardized logbook across programs (Number of sites using the standardized logbook / Total number of sites offering HTC services).
Percentage of sites reporting logbook stock out? (Note: Specify Total number of sites reporting stock out of logbook / Total number of sites expected to use the logbook. Proposed reporting period: last 3 months)
Percentage of sites with consistent agreement rate between Test 1 and Test 2 (>98%)? (Note: Specify Total number sites with high agreement rate / Total number of sites that reported monthly logbook data. Proposed reporting period: last 3 months).
Percentage of staff trained to use the logbook (number of staff trained to use the logbook/total number of staff offering RT services)
Lab, PMTCT, HTC, C&T
Percentage of logbook used at all levels and across programs (number of staff trained using the logbook/total number of staff to use, the logbook data
Percentage of test sites that received corrective actions and feedback. (number of sites that received corrective actions / total number of sites with poor agreement rate)
Percentage of districts or regions with capacity and resources to manage and analyze logbook data for monitoring and improving the quality of RT (Total number of district or regions with capacity and resources to manage and analyze logbook data for monitoring and improving the quality of RT/total number of districts and regions)
5. NEW LOT VERIFICATION AND POST MARKET SURVEILLANCE: Post-marketing surveillance for HIV tests (RT-PMS) is a critical process for monitoring the quality of test kits procured and used within a given market, program or country. Implementation of post-marketing surveillance for rapid test kits within HIV programming is extremely limited. Given the current limited capacity to perform lot-release testing nationally, the RTQII is an opportunity to strengthen NRL capacity for new lot release and PMS. The indicators below will assess the NRL’s ability to perform PMS.
Number of NRLs or regional labs with capacity to perform new lot verification
Percentage of new lots evaluated for use in the country through the NLV/PMS (Note: Specify Total number of new lots (segregate by test kit) evaluated through PMS/ Total number of new lots entering the country regardless of procurement mechanism or donor. Proposed reporting period: last 3 months).
6.0 SITE ASSESSMENT INDICATORS: Monitoring the overall impact of this initiative at the site level will be indicative of a successful program. Two sets of indicators have been defined to monitor the progress and the impact.
6.a. Site level RTQII M&E Indicators: To evaluate the progress and the overall impact of RTQII at site level, a set of indicators have been set to monitor implementation progress of four of the five components at the site level.
Measurement of site level MOH support for implementation of quality assurance activities and support for supply chain for HIV RTs and testing. Calculated using site assessment report by averaging Support from the MOH during reporting period (reporting period: past 3-6 months).
Measurement of site level implementation of training and certification for HIV rapid testers inclusive of hands-on training and re-training with certification process. Calculated using site assessment report by averaging HR Development – Training and Certification during reporting period (reporting period: past 3-6 months).
Measurement of site engagement in dried tube specimen (DTS)-based proficiency testing and quality control specimens, as part of routine HIV RT testing and for training purpose. Calculated using site assessment report by averaging Proficiency Testing and QC using DTS during reporting period (reporting period: past 3-6 months).
Measurement of site level implementation of standard logbook for HIV Testing. Calculated using site assessment report by averaging Use of Standardized Logbook during reporting period (reporting period: past 3-6 months).
6.B. SPI-RT Indicators: To assist ministries of health and national programs, a stepwise process for improving the quality of HIV rapid testing (SPI-RT) checklist has been developed. This checklist provides guidance on quality assurance (QA) practices for sites using HIV Rapid Test to diagnose HIV infection. Working through the SPI–RT checklist format in a step-by-step manner will enable heads of testing sites and facilities to recognize quality gaps and shortcomings identify areas for improvement and ultimately achieve national certification requirements. The certification program can help improve the accuracy and reliability of HIV and help maintain testing personnel performance and competency. This checklist sets minimum standards for all HIV testing sites and provides guidelines and requirements to certify testing sites.
Percentage of sites certified in RT (Number of sites certified in RT / total number of sites conducting RT) by setting type (PMTCT, L&D, TB, VMMC, stand-alone VCT, other)"