This UNITAID landscape reviews multi-disease diagnostic platforms currently on the market or in the pipeline. Multi-disease diagnostic platforms hold the potential to streamline and simplify infectious disease diagnosis and management including HIV viral load testing and early infant diagnosis. They could reduce the cost of testing via an integrated network approach, improve the management of co-infections, and increase case-finding of individuals with specific co-infections.

This report describes the key areas that national governments should consider for the introduction and scale-up of point-of-care (POC) diagnostics within national programs as new innovative POC technologies are introduced. It includes considerations and steps for introducing HIV POC technologies including: policy and framework development; strategy and planning; regulations; quality assurance and data management; procurement and supply chain management; implementation; and monitoring and evaluation (M&E). Also available in French.

An extension of Key Considerations for Introducing New HIV Point-of-Care (POC) Diagnostic Technologies in National Health Systems, this Toolkit contains practical tools and guidance to support countries as they introduce POC HIV technologies into existing national diagnostic networks and laboratory systems. It provides a roadmap as countries seek to expand access to quality-assured HIV diagnostics. The toolkit is organized in four modules: (1) Product and Site Selection; (2) Forecasting and Supply Planning; (3) Regulations; and (4) Quality Assurance. Though most links are to documents in English, portions of the site are available in Amharic, French, Portuguese, and Swahili.

In 2018, India implemented routine viral load (VL) testing for all people living with HIV releasing a set of guidance documents to support the scale-up of VL testing to reach the 90-90-90 targets in India—this collection includes National Guidelines for HIV-1 Viral Load Laboratory Testing, National Operational Guidelines for Viral Load Testing, and Guidelines on Quality Monitoring System for Outsourced Viral Load Tests.

• National Guidelines for HIV-1 Viral Load Laboratory Testing

  India National AIDS Control Organsation (NACO), 2018.

  The National Guidelines for HIV-1 Viral Load Laboratory Testing support plans to scale up viral load (VL) testing to reach the 90-90-90 targets in India. This phased scale-up includes the setup of 70 additional VL testing laboratories nationally. These guidelines include laboratory design considerations, a summary of VL technologies, and specimen collection and handling as well as transportation and storage guidance. Quality control and quality assurance requirements are described as well as laboratory safety issues. The guidelines also describe the VL laboratory network to be developed with supply chain management issues and commodities described. Annexes include laboratory registers and reporting forms.

• National Operational Guidelines for Viral Load Testing

  India National AIDS Control Organsation (NACO), 2018.

  These National Operational Guidelines for Viral Load Testing detail how routine viral load testing will be implemented at the facility level in India. They include frequency and interpretation of monitoring, sample collections, storage and transportation, receipt of results, adherence counseling, and reporting requirements. Roles and responsibilities are outlined as well as turnaround time requirements.

• Guidelines on Quality Monitoring System for Outsourced Viral Load Tests

  India National AIDS Control Organsation (NACO), 2018.

  This document provides guidelines and tools for monitoring the quality of outsourced viral load test results in India, defining processes and procedures as well as quality indicators and a monitoring checklist for assuring quality of services. Annexes include reporting forms and checklists for monitoring visits.

This Medecins Sans Frontières study evaluated the operational feasibility of integrated HIV viral load (VL), early infant diagnosis (EID), and tuberculosis (MTB/RIF) testing in new GeneXpert platforms in Zimbabwe. Findings from this study supported that implementation of near point-of-care platforms for integrated multi-disease testing is feasible and will increase access to VL and EID testing to priority populations.

This article describes characteristics of 1,108,356 viral load (VL) tests assessed—including reason for testing, turnaround times, test results, treatment regimens, and socio-demographic information to assess VL program scale-up in Kenya.

Strategic deployment of point-of-care (POC) infant diagnosis is key in getting more infants tested for HIV and initiated on treatment in a timely manner. This ASLM map—updated in November 2017—indicates the POC technologies being utilized by countries in Africa.

This cost model provides a simple tool to determine the cost per test for a testing platform from a provider’s perspective. This tool—developed with USAID funding by the Health Economics and Epidemiology Research Office (HE²RO)—can assist policy makers in answering questions related to the cost per test including viral load testing. The tool includes a user guide, a blank model workbook, and an example model.

This tool was developed to assess laboratory services and logistics—organization, policy, forecasting and procurement, financing, storage, inventory control, system, and laboratory services management information systems. The ATLAS is used to analyze the entire laboratory system—including providing rich information that can guide countries when conducting assessments for their viral load program.

This document describes key considerations for preparing for national implementation and scale-up of routine viral load (VL) monitoring. It outlines VL monitoring principles; implementation considerations; laboratory considerations (including referral network mapping, specimen transport, platform selection, point-of-care VL platforms, and laboratory quality management systems); and monitoring and evaluation.

The Treat All Toolkit consists of a series of tools to help to optimize the operationalization of the HIV test and treat guidelines in line with the Zimbabwe Ministry of Health and Child Care (MOHCC) guidance and tools. The toolkit provides health managers and providers with tips to support optimized implementation of Treat All as part of comprehensive HIV testing, care, and treatment services.

Viral load tools and resources include:

• VL Monitoring Tool
• VL Monitoring Job Aid
• VL Monitoring Patient Pamphlet
• Job Aid—Routine VL Monitoring Algorithm
• Job Aid—How to Prepare a VL DBS Sample from EDTA Algorithm
• Job Aid—Acting on VL Results
• MOHCC Operational & Service Delivery Manual—Differentiated ART Delivery for Clients with High Viral Load
• MOHCC Zimbabwe Enhanced Adherence Session Guidance

This review highlights the obstacles for developing and implementing appropriate strategies for point-of-care (POC) HIV testing assays, including POC viral load testing, to improve clinical services for HIV-infected patients in resource-limited settings.

This brief highlights the viral load scale-up efforts of the Association of Public Health Laboratories (APHL) to implement quality testing services to monitor antiretroviral treatment effectiveness in Zimbabwe, Mozambique, Zambia, Ghana, and Kenya.

This Médecins Sans Frontières (MSF) report is a guide for policymakers, treatment providers, and advocates interested in learning more about diagnostic and monitoring tests for HIV and hepatitis C virus (HCV), including both laboratory-based and point-of-care (POC) virological tests, and POC CD4 tests. HIV diagnostic companies were asked to provide information on the technical specifications of their products; pricing information; volume-based and tiered pricing; maintenance, training and warranty information; and contact information. Data was collected between April and June 2017 and includes technical specifications and pricing information for 22 diagnostic platforms comprising 48 test products.

This Excel sheet provides supplementary material for the MSF report, Putting HIV and HCV to the Test: A Product Guide for Point-of-Care (POC) CD4 Tests and Laboratory-based and POC HIV and HCV Viral Load Tests. It provides updated national recommendations on CD4 and viral load testing, across 55 low- and middle-income countries, sourced from the International Association of Providers of AIDS Care (IAPAC) database, and the extent of implementation. CD4 and viral load testing availability data was derived from Country Progress Reports (2014-2015), PEPFAR COPs, and the MSF Speed-up Scale-up Report, analysis was performed until mid-May 2017. It includes frequency of CD4 testing after ART initiation as well as national recommendations on use of viral load testing for ART monitoring and its availability.

This study evaluated matched dried blood spots (DBS) and dried plasma spots (DPS) against plasma using the Abbott M 2000 and Roche Cobas Ampliprep/Cobas TaqMan (CAP/CTM) quantitative viral load (VL) assays in western Kenya. There was similar performance between matched DBS, DPS, and plasma using the Abbott test, and good correlation for matched DPS and plasma using the CAP/CTM test. The findings suggest that DBS and DPS may be reliably used as alternative specimens to plasma to measure HIV-1 VL using Abbott, and DPS may be reliably used with CAP/CTM in resource-limited settings.

This study analyzed VL testing data collected in Malawi January 2013–March 2016 for two outcomes: greater-than-median pretest phase turnaround time (TAT)—days elapsed from specimen collection to receipt at the laboratory—and greater-than-median test phase turnaround time—days from receipt to testing. Results included that the odds of longer pretest phase TAT were significantly higher for specimen collection districts without laboratories capable of conducting VL tests and longer test phase TAT was significantly associated with use of dried blood spots instead of plasma. The authors conclude that increasing efficiencies, improving quality management systems, and generally strengthening the VL spectrum should be considered essential components of controlling the HIV epidemic.

This article describes the implementation of a quality assurance program for laboratory-based and point-of-care HIV testing in Nigeria. With the support of the US Presidents Emergency Program for AIDS Relief (PEPFAR) program, Nigeria has upgraded its laboratory infrastructure for HIV diagnosis and monitoring including CD4, HIV serology, blood chemistry, hematology, HIV viral load, and early infant diagnosis testing for a total of 566 laboratories.

The purpose of this document is to describe standard operating procedures for viral load (VL) monitoring, including the schedule for VL testing when used for routine monitoring of children, adolescents and adults on ART; interpretation of results; patient management; and specimen collection, preparation and transport. This template document to be adapted for use in various contexts and is one component of a VL monitoring toolkit, to be used in conjunction with ICAP’s VL Monitoring Flipchart and Enhanced Adherence Treatment Plan.

This MOH Kenya package of forms and log books guides clinicians and laboratory staff through the process of tracking viral load samples and results and includes filling instructions.

Though progress is being made in some countries to scale-up viral load, many others still face numerous challenges that may affect scale-up efficiencies: weak demand creation, ineffective supply chain management systems; poor specimen referral systems; inadequate data and quality management systems; and weak laboratory–clinical interface leading to diminished uptake of test results. This review describes different parameters that could be addressed across the viral load testing spectrum aimed at improving efficiencies and utilizing test results for patient management.

This article summarizes a survey of the availability and utilization of technologies for HIV treatment monitoring and EID in WHO Member States. The survey results suggest that major operational changes will need to be implemented, particularly in low- and middle-income countries, if the 90-90-90 targets are to be met.

This training tool is targeted at all cadres including clinicians, counsellors, and laboratorians and contains six modules: (1) Background on viral load monitoring, (2) Implementing the viral load algorithm, (3) Ensuring specimen integrity for viral load testing, (4) Lab quality and efficiency, (5) Patient education, and (6) Enhanced adherence counseling.

This laboratory and clinic-based tool helps define, improve, and measure improvement of efficiencies across the viral load spectrum.

From 2013 to 2016, through an UNITAID-funded initiative, MSF has supported the development on in-country viral load (VL) testing capacity at seven sites in six countries (DRC, Malawi, Mozambique, Swaziland, Uganda, Zimbabwe). The objective of the initiative was to generate and document field experience of scaling up VL testing using a range of available viral load platforms. This report emphasizes that the choice of viral load platform must remain context specific and take into account the ability to prepare and transport specific sample types, the sample throughput and the clinical urgency of the test.

From 2013 to 2016, through an UNITAID-funded initiative, MSF has supported the development on in-country viral load (VL) testing capacity at seven sites in six countries (DRC, Malawi, Mozambique, Swaziland, Uganda, Zimbabwe). The objective of the initiative was to generate and document field experience of scaling up VL testing using a range of available viral load platforms. This report emphasizes that the choice of viral load platform must remain context specific and take into account the ability to prepare and transport specific sample types, the sample throughput and the clinical urgency of the test.

This June 2016 presentation summarizes the point-of-care EID and VL product pipeline, preliminary evidence, regulatory approval, the EID consortium for technical evaluations, and patient impact of POC EID technologies based on pilot indications.

A data-driven laboratory harmonization and standardization approach is one way to create efficiencies and ensure optimal laboratory procurements. Following the 2008 ‘‘Maputo Declaration on Strengthening of Laboratory Systems’’—a call for government leadership in harmonizing tiered laboratory networks and standardizing testing services—several national ministries of health requested that the USG and in-country partners help implement the recommendations by facilitating laboratory harmonization and standardization workshops, with a primary focus on improving HIV laboratory service delivery. Between 2007 and 2015, harmonization and standardization workshops were held in eight African countries. This article reviews progress in the harmonization of laboratory systems in these eight countries.

This manual describes some of the strategic, managerial, financial, technical and scientific aspects to be considered in establishing a national EQA programme for clinical laboratories and other testing services at all health care levels. The manual has been prepared by the World Health Organization (WHO) and partners to fill perceived gaps, and the scope is limited to EQA programmes that deliver proficiency testing. However, it is important to note that other EQA activities as well as internal quality control (process control) measures and other quality elements are an integral part of the quality laboratory management process as defined in ISO 15189:2013.

This article provides an overview of methods for the development and support of a sustainable laboratory infrastructure, while simultaneously developing quality processes through a quality management system model and building upon the existing physical and human capital in a resource-limited setting such as Nigeria.

This package of tools—including standard operating procedures, forms, and job aids—helps health care workers and laboratory staff in Tanzania understand procedures for collecting and preparing samples for viral load testing, tracking samples and results, and providing counselling.

This report is a guide for policymakers, treatment providers and advocates interested in learning more about laboratory-based and point-of-care virological HIV and hepatitis C (HCV), and point-of-care CD4, diagnostic and monitoring tests.

This package of materials is the MOH (MISAU) curriculum on use of viral load to assess HIV-positive patients in Mozambique. It includes a facilitator's guide, participant materials, and two presentations.

This presentation emphasizes that to reach universal viral load access, smarter implementation is needed and provides an overview of challenges that CD4 and EID programs faced and lessons learned. Recommendations developed at a 2013 viral load consultation for clinical strategies, implementation policy, and lab strengthening are also outlined as well as the recommended framework for viral load implementation.

This document developed by the Global Fund to help prepare and/or review robust, prioritized, and costed funding requests; to support grant design; and support grant implementation for investments in laboratory technologies.

ForLab is a standardized, open-source tool with clearly defined requirements, improving programs’ ability to collect and analyze data to accurately forecast commodity needs. ForLab performs long- and short-term forecasts and guides improvements in diagnostic services.

In October 2017, the African Society for Laboratory Medicine (ASLM), in collaboration with CDC, convened a regional meeting on HIV viral load (VL) testing scale-up. The purpose of the meeting was to discuss and evaluate recent progress in HIV VL scale-up efforts, share best practices and new strategies for VL implementation, and launch a new ASLM initiative to support HIV VL scale-up, known as the Laboratory Systems Strengthening Community of Practice (LabCoP).

LabCoP FAQs are available on the ASLM website.

Meeting presentation materials are available for download here: http://bit.ly/2017VLMeetingReport

This guide, developed with USAID support, includes information relevant for tuberculosis (TB) program and laboratory managers, as well as Ministry of Health officials across disease programs interested in establishing integrated solutions for specimen referral. Though TB-focused in name, it offers integration-oriented assessment, design, and monitoring guidance related to improving coordination and efficiency, and is relevant for other programs as well. Country case studies include viral load and early infant diagnosis (EID) in Uganda and EID in Ethiopia.

This report describes the key areas that national governments should consider for the introduction and scale-up of point-of-care (POC) diagnostics within national programs as new innovative POC technologies are introduced. It includes considerations and steps for introducing HIV POC technologies including: policy and framework development; strategy and planning; regulations; quality assurance and data management; procurement and supply chain management; implementation; and monitoring and evaluation (M&E). Also available in French.

An extension of Key Considerations for Introducing New HIV Point-of-Care (POC) Diagnostic Technologies in National Health Systems, this Toolkit contains practical tools and guidance to support countries as they introduce POC HIV technologies into existing national diagnostic networks and laboratory systems. It provides a roadmap as countries seek to expand access to quality-assured HIV diagnostics. The toolkit is organized in four modules: (1) Product and Site Selection; (2) Forecasting and Supply Planning; (3) Regulations; and (4) Quality Assurance. Though most links are to documents in English, portions of the site are available in Amharic, French, Portuguese, and Swahili.

In 2018, India implemented routine viral load (VL) testing for all people living with HIV releasing a set of guidance documents to support the scale-up of VL testing to reach the 90-90-90 targets in India—this collection includes National Guidelines for HIV-1 Viral Load Laboratory Testing, National Operational Guidelines for Viral Load Testing, and Guidelines on Quality Monitoring System for Outsourced Viral Load Tests.

• National Guidelines for HIV-1 Viral Load Laboratory Testing

  India National AIDS Control Organsation (NACO), 2018.

  The National Guidelines for HIV-1 Viral Load Laboratory Testing support plans to scale up viral load (VL) testing to reach the 90-90-90 targets in India. This phased scale-up includes the setup of 70 additional VL testing laboratories nationally. These guidelines include laboratory design considerations, a summary of VL technologies, and specimen collection and handling as well as transportation and storage guidance. Quality control and quality assurance requirements are described as well as laboratory safety issues. The guidelines also describe the VL laboratory network to be developed with supply chain management issues and commodities described. Annexes include laboratory registers and reporting forms.

• National Operational Guidelines for Viral Load Testing

  India National AIDS Control Organsation (NACO), 2018.

  These National Operational Guidelines for Viral Load Testing detail how routine viral load testing will be implemented at the facility level in India. They include frequency and interpretation of monitoring, sample collections, storage and transportation, receipt of results, adherence counseling, and reporting requirements. Roles and responsibilities are outlined as well as turnaround time requirements.

• Guidelines on Quality Monitoring System for Outsourced Viral Load Tests

  India National AIDS Control Organsation (NACO), 2018.

  This document provides guidelines and tools for monitoring the quality of outsourced viral load test results in India, defining processes and procedures as well as quality indicators and a monitoring checklist for assuring quality of services. Annexes include reporting forms and checklists for monitoring visits.

This CROI 2018 poster describes a geospatial optimization model to minimize the cost of a national viral load sample transportation network in Zambia. This model, which can be used in other countries and for other types of samples, has the potential to increase the sustainability of ART programs throughout Africa.

This document describes key considerations for preparing for national implementation and scale-up of routine viral load (VL) monitoring. It outlines VL monitoring principles; implementation considerations; laboratory considerations (including referral network mapping, specimen transport, platform selection, point-of-care VL platforms, and laboratory quality management systems); and monitoring and evaluation.

The Excel-based spreadsheet tool, developed by USAID’s Health Finance and Governance (HFG) project, can be used to estimate the costs and human resource implications of scaling up HIV viral load monitoring and the use of viral load testing for early infant diagnosis (EID). Users can choose between different testing platforms, target populations, and supporting practices, and view outputs accordingly. A manual for application is also available.

The USAID-funded Health Finance and Governance project (HFG) estimated unit costs of HIV viral load (VL) and early infant diagnosis (EID) testing in Kenya using a centralized laboratory network reporting on network utilization and outputs. It also estimates HIV VL and EID testing unit costs under a range of scenarios for two point-of-care (POC) diagnostic platforms being considered for deployment by the Ministry of Health (MOH) and partners. The report aims to help the MOH identify opportunities for cost savings, project resource needs as testing coverage expands, make informed decisions on the placement of POC technologies, and help achieve the 90-90-90 targets in Kenya.

Poorly conducted procurement has a huge programmatic impact if stability of products and allowable shelf life for labile reagents are not foreseen as part of the procurement process. This WHO guidance aims to highlight the necessary factors to consider when procuring in vitro diagnostic medical devices (IVDs) and other laboratory items.

This presentation provides an overview of the 2017 WHO guidance for procurement of in vitro diagnostics (IVD) and related laboratory items and equipment. The overview includes roles and tips for users, procurers of IVDs, manufacturers, and national regulatory authorities.

This 2017 presentation provides an overview of PEPFAR’s viral load/in vitro diagnostic technology scale up strategy—the network approach. It highlights procurement challenges and product selection considerations as well as challenges associated with forecasting and maintenance. The presentation also reviews point-of-care integration considerations and provides recommendations for laboratory procurement.

This Global Fund tool, updated in 2017, provides guidance and clarity for partners procuring HIV viral load and early infant diagnosis technologies—it covers: country scenarios, programming and funding, request for proposal process and outcomes, platform/technology selection, pricing options, and contracting options.

This report assesses the cost of point-of-care (POC) GeneXpert technology for early infant diagnosis (EID) and viral load (VL) compared with conventional platforms in Zimbabwe. Three cost-analyses were conducted based on a retrospective study and simulations: (1) a simple cost analysis of the initial investment (capital cost); (2) a cost-efficiency analysis (cost/ output); and (3) a cost-effectiveness analysis (cost/ outcomes). This report outlines the results—cost of initial investment, running cost per test, simulated costs per test, and cost-effectiveness.

This MOH Kenya package of forms and log books guides clinicians and laboratory staff through the process of tracking viral load samples and results and includes filling instructions.

This study demonstrated how public-private partnerships (PPP) can be used to address key gaps and strengthen laboratory systems. The BD-PEPFAR PPP established standardized, streamlined specimen logistics, using the Ethiopian Postal Service Enterprise to support a laboratory network. Training laboratory and postal service personnel, ensuring an adequate supply of standard specimen transport materials, improving physical specimen logistics, addressing laboratory safety, mentoring facility staff, using geographic information system (GIS) software and geographic positioning system (GPS) devices, and monitoring and evaluating the specimen referral network resulted in increased referring sites and decreased turnaround times for ART-related monitoring. This planned and structured approach to improving specimen referral enhanced access to quality laboratory services.

From a supply chain perspective, each of the “90's” has possible complications and roadblocks towards realizing the promise envisioned by 90-90-90—for example, to monitor those on treatment means an unprecedented scale-up of viral load testing throughout Africa. This article highlights strategies to strengthen the global supply chain system to reach the UNAIDS 90-90-90 targets by 2020. In addition, the article highlights the need for integrated planning, efficient procurement, and supply chain management system.

This assessment aimed to understand the current viral load specimen referral networks in Zambia under the Ministry of Health’s laboratory network and to provide recommendations on a proposed viral load specimen referral network for the Zambian Defence Force (ZDF) Medical Service to implement. The report notes challenges as well as opportunities to improve the system, and in addition looks at equipment availability, transport mechanisms, quality assurance, and coordination among networks, and offers considerations for scale-up.

This report provides projections of the future demand for HIV diagnostics through 2020. These projections are intended to inform advocacy for the scaling up of access to diagnostics, so that the UNAIDS 90–90–90 target for HIV treatment access can be met. The projections will probably also be useful for producers, so that they can plan for adequate supply, and to procurement organizations in planning future funding and long-term purchase plans. Demand for viral load tests is expected to more than triple from nearly 7 million in 2014 to almost 25 million by 2020. The full need for viral load tests would be even higher, at about 30 million in 2020, if all countries adopted the WHO guidelines and reach the 90–90–90 target.

Roche launched the Global Access Program for HIV viral load testing which expands access to diagnostic testing. Through this program, Roche provides special access pricing on the COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test version 2.0 for qualifying organizations in eligible countries. This document provides the pricing agreement for Roche machines and reagents.

This document provides a systematic approach in developing a coordinated, standardized, reliable, efficient, cost-effective, and sustainable specimen transport and referral system to support IVHD and VL testing networks. This document provides technical and programmatic recommendations on the appropriate specimen storage and transportation of specimens for HIV VL and IVHD testing. Along with the national guidelines for specimen storage and transport, these standards should provide guidance on the creation or improvement of specimen referral networks and specimen transport systems. In addition, standard operating procedures (SOPs) targeting drivers and persons responsible for packing of specimens and results return are included in this document.

This report assesses the Global Fund’s use of strategic procurement practices to shape two health product markets i) ARVs, and ii) viral load monitoring and early infant diagnostic testing. The report includes analyses up to the end quarter 3 2015.

This document provides a list of WHO prequalified in-vitro diagnostic products updated in July 2016 including the year prequalified, type of assay, product name and codes, regulatory version, manufacturer/sites, and packaging.

This presentation provides and overview of forecasting and procurement, addressing maintenance challenges, understanding pricing variations, scale-up considerations—including POC integration, and donor and manufacturer engagement.

In June 2015, Abbott was selected by the Global Fund as a panel supplier for HIV-1 Quantitative (VL) assay and HIV-1 Qualitative (EID) assay for an initial 3-year period. This document provides the pricing agreement for Abbott machines and reagents.

This interagency tool allows users to model different scenarios of viral load and CD4 transition based on different testing algorithms and programmatic scale-up rates.

This table illustrates innovative HIV point-of-care (POC) CD4, EID, and Viral Load equipment in 2015 and anticipated for 2016.

The purpose of this document is to provide step-by-step instructions for completing an implementation and scale-up work plan for the Xpert MTB/RIF assay in your country. Completion of this template will yield a clear Xpert MTB/RIF work plan in accordance with national policy and plan requirements of your country. The work plan template is intended to guide the implementation of Xpert MTB/RIF testing in facilities providing clinical services.

In October 2013, WHO issued updated Policy Guidance, providing revised recommendations on using of Xpert MTB/RIF to diagnose pulmonary TB, pediatric TB, extrapulmonary TB and rifampicin resistance. This edition of the Xpert MTB/RIF implementation manual replaces the first edition and takes into consideration the current body of evidence and operational experiences available, in the context of the updated policy recommendations. Expanding the scope of the use of Xpert MTB/RIF and its placement in diagnostic algorithms will have significant implications for operational implementation, and its use should be phased in within the context of national strategic plans for TB.

Xpert MTB/RIF is a fully-automated molecular test for the rapid and simultaneous detection of TB and rifampicin resistance that has the potential to revolutionize and transform TB care and control. It provides accurate results in less than two hours, has minimal biosafety and training requirements, and can be housed in non-conventional laboratories. This fact sheet summarizes WHO recommendations on Xpert MTB/RIF for PLHIV.

In December 2010, WHO endorsed Xpert for the rapid and accurate detection of TB, particularly among PLHIV and people suspected of having MDR-TB. Xpert can improve coordination between HIV and TB programs. This commentary outlines the cost and infrastructure requirements that are key challenges to Xpert implementation—while increased detection of MDR-TB through Xpert could increase the market for second-line anti-TB drugs and drive costs down.

This report discusses important new opportunities to reverse the HIV epidemic in specific locations and among key populations at higher risk of HIV exposure. More and more countries are collecting and analysing data that enable these locations to be identified. Data collection is expanding, and new methods are being used to identify where localized epidemics may be emerging, where specific populations are carrying the highest burden of disease and where vital HIV services are deficient or absent. These data are being combined in innovative ways, including with geographical information, to produce more detailed and vivid understandings of the HIV epidemic, all the way to the district and subdistrict levels. This makes it possible to focus HIV programmes more precisely and effectively and to offer or adapt services to reach greater numbers of people in need.

This manual provides information on procurement processes specific to HIV and related diagnostics, laboratory items and equipment. The intended audience includes procurement officers, HIV programme managers and end-users of diagnostics, staff in United Nations (UN) agencies and non-governmental organizations (NGOs) who are responsible for the selection, use and procurement of diagnostics and related laboratory items and equipment.

This CDC video—available in English, French, and Portuguese—reviews the skills needed to collect dried blood spot (DBS) samples for viral load testing. It demonstrates how to: (1) Gather the supplies required for DBS collection; (2) Properly label DBS cards and maintain accurate specimen logs; (3) Collect a DBS sample; (4) Know if a DBS is of good quality; and (5) Dry, package, and (if necessary) store DBS samples properly until time of transport.

This study sought to optimize routine viral load (VL) monitoring through a targeted approach to reduce cost and identify adults at low risk for virologic failure (VF). A VF prediction tool to distinguish clinically stable, low‐risk adults who could be exempted from VL testing is a potential cost‐saving strategy to select clinically stable adults on first‐line antiretroviral therapy (ART) who may be exempted from VL testing at routine VL monitoring milestones in areas with high ART utilization and limited VL testing capacity.

This article describes characteristics of 1,108,356 viral load (VL) tests assessed—including reason for testing, turnaround times, test results, treatment regimens, and socio-demographic information to assess VL program scale-up in Kenya.

Although the importance of routine viral load (VL) monitoring for HIV-infected individuals on ART is widely recognized, there has been minimal attention to VL monitoring in pregnancy and the postpartum period. This article highlights key considerations for VL monitoring in pregnant and breastfeeding women in the context of expanding access to VL monitoring.

Many HIV-infected children on treatment receive either no or infrequent viral load (VL) tests. This study, within the ARROW trial, investigated long-term VL and resistance in HIV-infected children managed without real-time VL monitoring in Uganda and Zimbabwe.

Despite global and national guidelines recommending the use of routine viral load testing, these policies alone have not translated into widespread implementation or sufficiently increased access for people living with HIV (PLHIV). This article describes the Community Demand Creation Model for community-led demand creation for the use of routine VL testing as an example of how treatment education, coupled with small grants to civil society partner organizations, can create the desired outcomes for PLHIV and their communities.

This commentary discusses factors that influence the choice of threshold for viral load (VL) among patients on antiretroviral therapy (ART) in resource-limited settings. The authors note that while treatment experts advocate for the use of the lowest possible VL threshold as the goal of HIV treatment, those with interest in the public health impact of VL monitoring support the use of the 1000 copies/ml threshold as a pragmatic choice. They emphasize that VL scale-up should be coupled with ensuring access for all HIV-positive patients on treatment and with effective utilization of results, irrespective of the VL threshold selected.

While HIV viral load (VL) monitoring is a central tool to evaluate ART effectiveness and transmission risk, there has been little research into VL monitoring in pregnant women. This study explored when and how frequently VL should be monitored in women initiating ART during pregnancy to predict VL at the time of delivery in a simulated South African population. This simulation suggests that pregnant women warrant specialized VL monitoring approaches different from non-pregnant adults, with considerations for gestational age.

This commentary reviews considerations for implementing routine viral load (VL) monitoring programs for HIV-infected infants and children living in low- and middle-income countries including frequency of monitoring, blood specimen type, and adherence challenges, where specific approaches tailored for infants and children may differ from those for adult patients.

The pediatric HIV epidemic is maturing, with increasing numbers of children living into adolescence and young adulthood due to the scale-up of antiretroviral therapy (ART), and HIV-infected children with slow disease progression presenting to health services for the first time in adolescence. This review discusses the rationale for priorizing viral load (VL) monitoring among adolescents and the associated challenges. Since adolescents have disproportionately high rates of virological failure, the authors conclude that targeting this age group for VL monitoring may increase efficiency in identifying treatment failure and determining regimen choices, as well as provide valuable lessons to inform broader scale-up.

Key populations bear a disproportionate HIV burden and have substantial unmet treatment needs. Viral load (VL) data can be used as an advocacy tool to demonstrate differences in service delivery and to promote allocation of resources to disproportionately affected key populations and communities with suboptimal health outcomes. However, efforts must be taken so that routine VL monitoring among marginalized populations does not cause inadvertent harm. The authors of this commentary conclude that opportunities for expanded VL monitoring could and should benefit all those affected by HIV, including key populations and that increasing routinization of VL monitoring can be a tool to advance HIV treatment equity.

This training curriculum is intended to build the capacity of health workers to conduct viral load monitoring and enhanced adherence counseling, using the tools included in this package. The curriculum contains eight modules. A brief facilitator’s guide is provided for each module, along with slides to guide the training. Speaker notes are in the notes section for each PowerPoint slide and interactive activities and case studies are included. Materials are available in Word and PowerPoint allowing them to be revised to meet specific country/context needs.

This case study describes a pilot project carried out in Limpopo Province, South Africa, to improve viral load (VL) completion rates. A strategy of using color-coded stickers for tracking when patients needed VL monitoring led to improved VL completion at 6 and 12 months of the pilot. It is a simple and low-cost quality improvement intervention to improve VL completion, requiring minimal training.

These flipcharts help health workers provide information about viral load (VL) monitoring to patients and to explain the meaning of VL results. They guide the provision of enhanced adherence counseling to patients with elevated VL. There are three versions of the flipchart: one for adult (non-pregnant nor breastfeeding) patients, one for adolescent patients, and one for infants and children. Each is available in English, French, Portuguese, and Swahili, and PowerPoint versions are provided to facilitate adaptation.

This MOH Kenya package of forms and log books guides clinicians and laboratory staff through the process of tracking viral load samples and results and includes filling instructions.

English- and Portuguese-language country examples of tools to support the implementation of viral load (VL) monitoring from Angola, Mozambique, and Swaziland. Includes (from Angola): SOPs and tools for M&E of VL implementation; Health Facility Laboratory Specimen Register; High VL Register: High VL Patient Monitoring Form; Site Readiness Assessment Checklist; National Readiness Assessment; VL Clinical Training Slides; (from Mozambique): Patient Follow-Up Register; and VL Collection Register; and (from Swaziland): High Viral Load Register; Site Readiness Assessment; and Lab Requisition Form.

These French, Portuguese, and Swahili tools were developed by ICAP to support the implementation of viral load (VL) monitoring and enhanced adherence counseling including an Enhanced Adherence Plan Tool; National VL Scale-Up Assessment Checklist; and VL Scale-Up Facility Readiness Assessment Checklist. Current HIV Viral Load Scale up Tools are available in English on the ASLM website.

The purpose of this document is to describe standard operating procedures for viral load (VL) monitoring, including the schedule for VL testing when used for routine monitoring of children, adolescents and adults on ART; interpretation of results; patient management; and specimen collection, preparation and transport. This template document to be adapted for use in various contexts and is one component of a VL monitoring toolkit, to be used in conjunction with ICAP’s VL Monitoring Flipchart and Enhanced Adherence Treatment Plan.

ART providers are critical to effective scale-up of viral load (VL) monitoring. This article explored provider-perceived barriers and facilitators of VL monitoring interviewing providers engaged in a public health evaluation of dried blood spots for VL monitoring in Malawi. Results from the study provide insight into provider perceptions of VL monitoring and indicate the importance of policies responsive to individual and environmental challenges of VL monitoring program implementation. Findings may inform scale-up by helping policymakers identify strategies to improve feasibility and sustainability of VL monitoring.

The Be Healthy—Know Your Viral Load campaign aims to inform people living with HIV about the value of viral load tests; mobilize people to demand routine viral load testing; and urge governments to make sure the tests are routinely available, accessible and affordable.

This training tool is targeted at all cadres including clinicians, counsellors, and laboratorians and contains six modules: (1) Background on viral load monitoring, (2) Implementing the viral load algorithm, (3) Ensuring specimen integrity for viral load testing, (4) Lab quality and efficiency, (5) Patient education, and (6) Enhanced adherence counseling.

From 2013 to 2016, through an UNITAID-funded initiative, MSF has supported the development on in-country viral load (VL) testing capacity at seven sites in six countries (DRC, Malawi, Mozambique, Swaziland, Uganda, Zimbabwe). The objective of the initiative was to generate and document field experience of scaling up VL testing using a range of available viral load platforms. This report emphasizes that the choice of viral load platform must remain context specific and take into account the ability to prepare and transport specific sample types, the sample throughput and the clinical urgency of the test.

This presentation describes operational strategies for scale up of viral load monitoring.

This report examines the outcome of the viral load cascade from coverage of routine viral load testing through to an appropriate switch to second line ART. To address the leaks in the viral load cascade four essential programmatic investments were identified to make viral load routine: (1) Strengthening of health systems to identify those in need of viral load and enhanced adherence counselling (EAC) (2) ensuring a dedicated health care worker can provide psychosocial support for those with high viral load (3) creating demand for viral load testing through patient education and engagement of civil society, and (4) the decentralisation and task shifting of second line ART provision.

This tool gathers situational analysis information regarding the facility’s readiness to provide routine VL monitoring for patients on ART, assesses clinical systems in place for implementation of routine viral load (VL) testing and interpretation, and serves as scorecard for monitoring and documenting improvements.

This package of tools—including standard operating procedures, forms, and job aids—helps health care workers and laboratory staff in Tanzania understand procedures for collecting and preparing samples for viral load testing, tracking samples and results, and providing counselling.

This package of materials is the MOH (MISAU) curriculum on use of viral load to assess HIV-positive patients in Mozambique. It includes a facilitator's guide, participant materials, and two presentations.

This publication provides high-level guidance on implementing and scaling up HIV viral load testing programs for health ministries and implementation partners, using a three-phased approach: (1) planning; (2) scale-up; and (3) sustainability. This publication is intended to serve as a reference point for countries, whether they are commencing implementation or scaling up existing viral load testing capacity. Thoughtful consideration and planning of all areas covered in this publication will assist in developing a robust and sustainable HIV viral load testing network.

This toolkit is designed to provide implementers with a set of tools to aid in implementation of VL monitoring including aspects related to sample preparation, activities for clinical and counselling staff, and education and empowerment of the patients themselves. The tools and algorithms form a basis for implementation, but will need to be adapted to the local context. A training pack for clinicians and counsellors is also attached in Annexes 4 and 5 that incorporate these key components.

This study used a mathematical model to determine whether antiretroviral therapy (ART) as prevention is more effective if viral load (VL) is routinely monitored and patients lost to follow-up (LTFU) traced. In this modeling, VL monitoring and tracing lost patients reduced new infections, but only minimally. The authors conclude that interventions designed to keep patients in care without interruptions could be beneficial.

In October 2017, the African Society for Laboratory Medicine (ASLM), in collaboration with CDC, convened a regional meeting on HIV viral load (VL) testing scale-up. The purpose of the meeting was to discuss and evaluate recent progress in HIV VL scale-up efforts, share best practices and new strategies for VL implementation, and launch a new ASLM initiative to support HIV VL scale-up, known as the Laboratory Systems Strengthening Community of Practice (LabCoP).

LabCoP FAQs are available on the ASLM website.

Meeting presentation materials are available for download here: http://bit.ly/2017VLMeetingReport

This package of materials includes a summary of viral load monitoring approaches, outcomes, and next steps in Uganda as well as presentations from the March 2018 PEPFAR Uganda Integrated Viral Load/Early Infant Diagnosis & Tuberculosis Data Review Meeting.

• Viral Load Monitoring: The Last Mile in Realising the Continuum of Response for HIV Care and Treatment
  Uganda M&E Technical Support Program, 2018.
  The Uganda M&E Technical Support Program (METS) with funding from PEPFAR has supported the Ministry of Health Central Public Health Laboratories to scale up viral load (VL) monitoring to over 80% of people living with HIV on antiretroviral therapy between 2016 and 2017 with the use of a VL dashboard, support for curriculum development, capacity building trainings, and continuous quality improvement initiatives. This article summarizes VL monitoring approaches, outcomes, and next steps in Uganda.
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• Presentation: Integrated VL/EID & TB Data Review—March 2018
  PEPFAR Uganda & MOH Uganda Central Public Health Laboratories (CPHL), 2018.
  This presentation from the March 2018 PEPFAR Uganda Integrated Viral Load (VL)/Early Infant Diagnosis (EID) & Tuberculosis (TB) Data Review Meeting reviews progress in national VL monitoring, EID, and TB. It introduces key activities including the ‘HIV Situation Room’—an interactive software platform to centralize real-time service delivery data to improve tracking and programming.
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• Presentation: PEPFAR PMTCT-EID FY18 Q1 Performance—Summary of Key EID Indicators
  PEPFAR Uganda, 2018.
  This presentation from the March 2018 PEPFAR Uganda Integrated Viral Load (VL)/Early Infant Diagnosis (EID) & Tuberculosis (TB) Data Review Meeting reviews implementing partner EID performance and approaches to scale-up and quality improvement.
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• Presentation: Progress in Scale up of VL/EID & TB Monitoring for Moroto & Kotido
  USAID RHITES-E Project, 2018.
  This presentation from the March 2018 PEPFAR Uganda Integrated Viral Load (VL)/Early Infant Diagnosis (EID) & Tuberculosis (TB) Data Review Meeting reviews VL coverage trends and suppression rates, successful VL scale-up efforts, as well as challenges and recommendations in Moroto and Kotido districts. The presentation also covers EID and TB trends and challenges.
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This guide, developed with USAID support, includes information relevant for tuberculosis (TB) program and laboratory managers, as well as Ministry of Health officials across disease programs interested in establishing integrated solutions for specimen referral. Though TB-focused in name, it offers integration-oriented assessment, design, and monitoring guidance related to improving coordination and efficiency, and is relevant for other programs as well. Country case studies include viral load and early infant diagnosis (EID) in Uganda and EID in Ethiopia.

This PEPFAR-funded study describes a quality improvement assessment of a viral load (VL) program with a focus on the accuracy of data collected from patients as well as adherence to Malawi HIV Guidelines in regard to response to elevated viral loads. Data was collected from three parallel medical record systems to investigate the proportion of patients with a repeat VL and whether the sociodemographic and clinical data matched in the data systems.

Logistical complexities of returning laboratory test results to participants have precluded most population-based HIV surveys conducted in sub-Saharan Africa from doing so. For HIV-positive participants, this presents a missed opportunity for engagement into clinical care and improvement in health outcomes. The Population-based HIV Impact Assessment (PHIA) surveys, which measure HIV incidence and the prevalence of viral load (VL) suppression in selected African countries, are returning VL results to health facilities (specified by each HIV positive participant) within eight weeks of collection. The PHIA Project surveys described in Zimbabwe, Malawi, and Zambia demonstrated that returning VL results in the context of a national population-based survey is feasible, but requires establishing specimen and data management systems to allow for tracking each participant result to ensure timely return as specified in the survey protocols.

This Nigeria Federal Ministry of Health dashboard presents a summary of monthly viral load trends including numbers tested, results, rejection rate, coverage, and indication for VL testing (baseline, repeat, immunological failure, confirmation, routine, or clinical failure).

The policy brief demonstrates how big data analytics methods can be used to link various fragmented data platforms to form one consolidated information hub to improve decision making in critical viral load scale up areas. It also gives practical policy recommendations on the gaps identified.

This MOH Kenya dashboard presents a summary of monthly viral load testing trends including outcomes, with disaggregation by age, gender, and county as well as regimen, facility type, and implementing partner outcomes. Lab performance statistics for national viral load testing, including sample type, reason for testing and turnaround times, are also presented.

This MOH Malawi national online dashboard presents a summary of monthly viral load tests, lab statistics, test outcomes, turnaround times, sample type, and results. The dashboard also presents suppression rates by district.

This MOH Uganda online dashboard summarizes key viral load metrics including samples received, suppression rate, rejection rate, and percentage on first line regimen with filters for date, districts, gender, regimen, and line with a summary of key indicators and treatment indication.

This framework presents key considerations and examples of tools to assist countries in developing a national viral load monitoring and evaluation plan. Section 1 describes the process of assessing M&E data systems and tools and understanding how data flows to and from facilities, sample transport networks and laboratories. Section 2 outlines a set of indicators that M&E systems are encouraged to collect in order to measure key program and patient outcomes along the VL testing cascade. Section 2 also includes a discussion on how to monitor patients who are not virally suppressed and suggests tools for longitudinally following cohorts of non-suppressed patients. Section 3 provides methods for evaluating viral load implementation plans and examples of evaluation questions.

This updated indicator reference guide emphasizes that PEPFAR's focus on impact in individuals and communities is the driving force for an effective framework that not only monitors outputs from the program but also key outcomes.

This presentation summarizes viral load dashboards for monitoring and evaluation.