All Viral Load Testing

Viral load monitoring is the key to measuring HIV treatment success and achievement of the third 90. The goal of antiretroviral therapy (ART) is viral suppression—viral load that is so low that it cannot be detected by viral load tests. Achieving the third of UNAIDS' 90-90-90 targets means that, by 2020, 73% of all people living with HIV will have suppressed viral loads. This collection of resources and tools helps you find what you need to scale up viral load testing.

New! Meeting Report: Regional Workshop on HIV Viral Load Scale-Up

African Society for Laboratory Medicine, 2018.

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

New! Does U=U for Breastfeeding Mothers and Infants? Breastfeeding by Mothers on Effective Treatment for HIV Infection in High-Income Settings

Waitt C. et al., (2018). Lancet. DOI: 10.1016/S2352-3018(18)30098-5.

This article summarizes existing evidence on the transmission of HIV through breastfeeding, differences in HIV dynamics and viral load between breastmilk and plasma, and the effects of antiretroviral therapy on infants. At present, insufficient evidence exists to make clear recommendations for the required frequency of clinical and virological monitoring for mother and infant in a breastfeeding relationship or for the action to be taken in the event of viral rebound. This article proposes a roadmap for collaborative research to provide the missing evidence required to enable mothers who wish to breastfeed to make a fully informed choice. A summary of this discussion is available here.

New! [Collection] Viral Load Monitoring Scale-Up Update in Uganda—Data Updates

PEPFAR Uganda & MOH Uganda Central Public Health Laboratories (CPHL), 2018.

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.
    View Online

  • 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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Key Considerations for Introducing New HIV Point-of-Care Diagnostic Technologies in National Health Systems

UNICEF, ASLM, CDC, CHAI, OGAC, EGPAF, LSHTM, ICAP, MSF, NHLS, USAID, and WHO, 2018.

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.

CROI 2018 Poster—Compliance to Guidelines for Routine Viral Load Testing in Resource Limited Settings

Castelnuovo B., et al., 2018 (CROI Abstract Number 1130).

This CROI 2018 poster describes an evaluation of the compliance to the World Health Organization guidelines in implementing viral load testing and managing patients according to guidelines in a large urban clinic in Uganda.

Ghana Laboratory Viral Load Testing Expansion Plan (2017-2020)

Ghana Health Service / NACP / CDC / APHL, 2017.

This viral load (VL) scale up plan describes the current status of VL testing in Ghana, including a SWOT analysis; VL testing program targets and projections as well as program needs. Objectives and strategies addressed include program management, equipment, supply chain management, human resources, specimen referral and result transmission, quality assurance, laboratory information management, and monitoring and evaluation. The document provides a phased approach with a detailed workplan on how to address each of these areas.

Public Health & HIV Viral Load Suppression

UNAIDS, 2017.

This 2017 UNAIDS briefer summarizes key messages including the growing scientific consensus that people living with HIV who are taking effective antiretroviral therapy and whose virus is suppressed to undetectable levels will not transmit HIV sexually.

Realizing the Potential of Routine Viral Load Testing in Sub-Saharan Africa

El-Sadr W.M., et al. JIAS (2017), 20(S7): e25010. doi:10.1002/jia2.25010.

Viral load (VL) measurement is a critical tool to assess the impact of HIV treatment efforts, but though VL measurement is a laboratory assay, the challenge of VL scale-up is not for laboratorians only. The experience of early infant diagnosis (EID) scale-up highlights the importance of conceptualizing VL testing as a continuum; a series of steps, each critical for achieving the ultimate goal—swift and appropriate clinical management to maximize the chance of sustained viral suppression. This editorial describes the VL continuum and recommends that programs utilize viral suppression as the indicator of programmatic effectiveness.

Scaling Up HIV Viral Load—Lessons from the Large-Scale Implementation of HIV Early Infant Diagnosis and CD4 Testing

Peter T. et al. JIAS (2017), 20(S7): e25008. doi:10.1002/jia2.25008.

To inform the scale-up of viral load testing, this commentary reviews the challenges and solutions from the large-scale implementation of other diagnostic tests including nucleic-acid based early infant HIV diagnosis (EID) and CD4 testing, and identifies key lessons. The lessons and innovations from large-scale EID and CD4 programs demonstrate the importance of an integrated approach to health system strengthening focusing on data systems, supply efficiencies, and network management as well as need for more innovative approaches and effective partnerships to achieve equitable and cost-effective test access.

Cost-Effectiveness of Routine Viral Load Monitoring in Low- and Middle-Income Countries: A Systematic Review

Barnabas R.V. et al. JIAS (2017), 20(S7): e25006. doi:10.1002/jia2.25006.

Viral load (VL) testing represents a substantial cost in resource-constrained health care systems. This systematic review identified 18 studies that evaluated the cost-effectiveness of VL monitoring in HIV treatment programs. The review identified three key factors that make it more likely for VL monitoring to be cost-effective: 1) Use of effective, lower-cost approaches to VL monitoring (e.g. use of dried blood spots); 2) Ensuring the pathway to health improvement is established and that VL results are acted upon; and 3) VL results are used to simplify HIV care in patients with viral suppression (i.e. differentiated care, with fewer clinic visits and longer prescriptions).

Point-of-Care Resources from the 9th IAS Conference on HIV Science (IAS 2017)

African Society for Laboratory Medicine, 2017.

A summary of two IAS 2017 sessions: Integrating Diagnostic Services at Point-of-Care (POC) and Bringing the Test to the Patient: Results from the Early Routine Use of POC HIV Testing in Resource-Limited Settings as well as links to POC-related IAS 2017 abstracts.

Point of Care HIV Diagnostics: Bringing Faster Results for Early and More Effective Treatment

Unitaid, CHAI, UNICEF, ASLM, 2017.

Unitaid, in partnership with ASLM, CHAI, and UNICEF, launched the Point of Care (POC) diagnostics project “Accelerating Access and Integration of Innovative POC Diagnostics for HIV in National Diagnostics Programmes.” This technical brief summarizes early results from the initial phases of the project that have demonstrated the potential of POC diagnostic technologies to accelerate access to testing, and earlier and more effective treatment.

WHO: What’s New in Treatment Monitoring: Viral Load and CD4 Testing—Information Note

World Health Organization, 2017.

Monitoring of individuals on ART is important to ensure treatment efficacy and improved health outcomes. This information note highlights key facts on viral load and CD4 testing for treatment monitoring based on the 2016 WHO Consolidated Guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. It provides definitions of virological failure, immunological failure, and clinical failure for adults, adolescents, and children and provides the viral load testing strategy.

USAID ASSIST Project Uganda Viral Load Resources

USAID ASSIST Project, 2017.

This package of viral load (VL) resources includes two case studies describing the USAID ASSIST Project’s work in northern Uganda to increase access to VL monitoring, as well as a change package summarizing activities with examples of innovative changes that can be implemented in order to improve VL testing.

HIV Viral Load Scale-Up: Multiple Interventions to Meet the HIV Treatment Cascade

Carmona S. et al. (2017). Current Opinion in HIV & AIDS: March 2017 Vol 12. 10.1097/COH.0000000000000352

This review concludes that viral load scale-up cannot be attained simply by increasing testing capacity at a laboratory or by placing POCT at multiple sites. Effective scale-up will need a multisector approach that will stimulate demand through appropriate use of viral load, and will require coordination of funders and implementing partners, Ministries of Health commitment, and continued operational research to ensure that scale-up efforts are cost-effective, impactful, and specifically directed at achieving the 90-90-90 targets by 2020.

Early Antiretroviral Therapy Initiation: Access and Equity of Viral Load Testing for HIV Treatment Monitoring

Peter T, et al. (2017). Lancet Infect Dis 2017;17: e26–29. http://dx.doi.org/10.1016/S1473-3099(16)30212-2

This publication offers a framework for a concerted and harmonized implementation strategy that enables a rapid and cost effective scale-up of viral load testing for HIV treatment monitoring.

Field Evaluation of Dried Blood Spots for HIV-1 Viral Load Monitoring in Adults and Children Receiving ART in Kenya: Implications for Scale-up in Resource-Limited Settings

Schmitz, ME et al. (2017). J Acquir Immune Defic Syndr 2017;74:399–406).

This study carried out in Kenya evaluates the accuracy of dried blood spot (DBS) viral load testing, under field conditions, as a practical alternative to plasma samples in determining virologic failure (VF).

Viral Load Monitoring and the Last 90—VL Snapshot: An Inventory of Facility and Laboratory Capacity and Needs for Viral Load Monitoring

OPHID, 2016.

This report describes a 2016 baseline assessment conducted in 22 districts in Zimbabwe to describe the availability of viral load (VL) monitoring in each district and the functionality of equipment. This assessment also documents the human resources available and identifies bottlenecks and barriers to effective and efficient use of VL monitoring.

Country Posters—Reaching the Third 90: Implementing High Quality Viral Load Monitoring at Scale

MOH / PEPFAR / USAID, 2016.

This set of posters from Reaching the Third 90: Implementing High Quality Viral Load Monitoring at Scale—a PEPFAR-supported meeting convened in 2016 to advance the scale-up of viral load (VL) services in sub-Saharan Africa—describe country experiences implementing routine VL monitoring. Posters from Kenya, Lesotho, Malawi, Mozambique, Swaziland, Tanzania, Uganda, Zambia, and Zimbabwe are included.

Reaching the Third 90: Implementing High Quality Viral Load Monitoring at Scale—Meeting Report

ICAP—Columbia University, 2016.

This report summarizes a PEPFAR-supported meeting convened to advance the scale-up of viral load services in sub-Saharan Africa. The meeting focused on deeper understanding of the barriers to and facilitators of VL scale up, with a focus on practical implementation challenges, as well as key lessons learned, resources and best practices; new and enhanced partnerships and communities of practice focused on surmounting health systems barriers to the scale-up of high-quality VL services; a framework for monitoring and evaluating VL services; a priority agenda for implementing research; case studies and key lessons learned to inform further VL scale-up; rapid implementation and scale-up of VL measurement and monitoring in priority countries; and design and implementation of QI collaborative to support VL monitoring.

Reaching the Third 90: Implementing High Quality VL Monitoring at Scale— Key Strategic Decisions for Countries Designing & Scaling-up VL Services

ICAP—Columbia University, 2016.

This table provides a snapshot of 21 key strategic decisions for country consideration when designing and scaling up viral load services with common options that can be explored and brief country examples.

Scale-up of Routine Viral Load Testing in Resource-Poor Settings: Current and Future Implementation Challenges

Roberts T. et al. (2016) Clin Infect Dis. 2016 Apr 15; 62(8): 1043–1048. doi: 10.1093/cid/ciw001.

This article describes current barriers to viral load testing in resource-limited settings concluding that effective scale-up can be achieved through health system and laboratory system strengthening and test price reductions, as well as tackling multiple programmatic and funding challenges.

AIDS 2016—WHO Viral Load Guidance

World Health Organization, 2016

In this AIDS 2016 presentation, WHO shared key recommendations from the 2016 Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection, including that viral load is recommended as the preferred approach to diagnose and confirm treatment failure. DBS specimens, using venous or capillary whole blood, can be used to determine HIV VL and using a failure threshold of 1,000 copies/ml. WHO also recommended that VL should be measured at 6 months, 12 months, and then every 12 months after ART initiation.

Progress with Scale-Up of HIV Viral Load Monitoring — Seven Sub-Saharan African Countries, January 2015–June 2016

Lecher S, et al. (2016). MMWR 2015; 65, 47: 1332–1335.

This report examines current capacity for viral load testing based on equipment provided by manufacturers and progress with viral load monitoring of patients on ART in seven sub-Saharan countries (Côte d’Ivoire, Kenya, Malawi, Namibia, South Africa, Tanzania, and Uganda) during January 2015–June 2016.

Building Demand and Preparing for Second-line Switching

Ministry of Health Kenya, (2016).

In this AIDS 2016 presentation Kenya emphasized the importance of physician engagement to ensure that HIV viral load results are used in clinical decision-making and the critical role of data in managing a rapidly growing testing program.

Fact Sheet: HIV Treatment and Care—What’s New in Monitoring

World Health Organization (WHO), (2016).

Monitoring of individuals on ART is important to ensure treatment efficacy and improved health outcomes. This fact sheet highlights key facts on viral load for monitoring treatment; definitions of clinical, immunological and virological failure; monitoring for drug resistance; stopping the use of CD4 where viral load is available; settings with limited access to viral load testing; and appropriate use of CD4 testing as viral load access increases.

HIV Viral Load Supply Chain Management and Workforce Development During Scale-up

Ministry of Health Malawi, (2016).

In this AIDS 2016 presentation Malawi shared their solutions for building sample transportation networks, improving supply-chain management, and increasing human resources capacity, while more than doubling HIV viral load testing volumes.

Scaling-Up Access to HIV Viral Load Testing: Viral Load Scale-up and Decentralized Testing Experience in Botswana

Ministry of Health Botswana, (2016).

This AIDS 2016 presentation highlights how Botswana’s decentralized testing model provides an example of how “taking the services closer to the people, rather than people coming to the services” can increase access, when supported by strong partnerships.

The Need for Routine Viral Load Testing

Joint United Nations Programme on HIV/AIDS (UNAIDS), (2016).

This brief question and answer guide to viral load testing emphasizes that greatly expanded access to routine viral load testing will be a game-changer in the global response to AIDS. Routine viral load tests improve treatment quality and individual health outcomes for people living with HIV, contribute to prevention, and potentially reduce resource needs for costly second- and third-line HIV medicines. Greatly expanded access to routine viral load testing will be a game-changer in the global response to AIDS. Routine viral load tests improve treatment quality and individual health outcomes for people living with HIV, contribute to prevention, and potentially reduce resource needs for costly second- and third-line HIV medicines.

Viral Load Scale-Up Experience in Uganda

Ministry of Health Uganda, (2016).

In this AIDS 2016 presentation Uganda presented on how they used a centralized model, developing a single laboratory capable of processing over 1.2M samples per year. The program has maintained a turnaround time of under two weeks, while increasing the number samples processed by more than 200,000 in a year’s time.

Xpert® MTB/RIF test Rollout and Implementation Plan

United Republic of Tanzania Ministry of Health and Social Welfare National Tuberculosis and Leprosy Programme, (2016).

The overall objective of this implementation plan is to define the strategy for implementation of the Xpert MTB/RIF test for rapid detection of TB and rifampicin (RIF) resistance in Tanzania, within the context of the National Tuberculosis and Leprosy Programme (NTLP) strategic plan and other national health guidelines. It is intended to serve as the main guiding document for national, regional and local programme managers, clinicians, coordinators, laboratory staff and other health workers; national and regional reference laboratories; local and international implementing partners; and donors involved in TB control.

Zimbabwe National Viral Load Scale up Plan (2015-2018)

Zimbabwe Ministry of Health, 2015.

This document describes a three-phase scale-up plan for viral load testing in Zimbabwe. The plan has three main objectives: to provide a road map to guide VL testing scale-up from 3% to 70% by the end of 2017 and 90% by 2018; to establish collaboration and coordination between government and partners as they scale up VL testing; and to support resource mobilization. It describes considerations including laboratory infrastructure, equipment, service, and maintenance; sample type and transportation; procurement and supply chain management; data management and results transmission; PLHIV education and adherence counselling and support; human resources, training, and mentorship; quality assurance; program management; and monitoring and evaluation.

Malawi Ministry of Health HIV Viral Load Scale Up Strategic and Implementation Plan (2015-2018)

Malawi Ministry of Health, 2015.

This document provides an overview of the scale-up efforts undertaken by the Malawi Ministry of Health during the first phases of scale-up of routine viral load monitoring. It outlines the strategic and implementation plan required to ensure that the continued scale-up of VL services is efficient and effective. It includes planning for sample transportation, product selection, supply chain management, and monitoring and evaluation. Appendices include Malawi's VL testing algorithm, estimated testing and HR needs, the EID/VL requisition form, and a stock management worksheet.

Tanzania National HIV Viral Load Testing Guidelines

MOH Tanzania, 2015.

This HIV Viral Load Guideline and Scale up Plan provides direction on viral load monitoring and the plans to scale it up in Tanzania. It was developed to provide high quality, effective, and standardized HIV viral load testing to monitor patients on ART. It includes the clinical laboratory procedure for viral load testing from the pre-examination phase at the sample collection point and the testing laboratory, to the examination phase—including quality control, to the post-examination phase at the testing laboratory. It also covers the national scale-up plan related to infrastructure, procurement and maintenance, supply chain management, and the sample referral system.

Tanzania National Operational Plan for Scaling up HIV Viral Load

MOH Tanzania, 2015.

This National Operational Plan for Scaling up HIV Viral Testing provides guidance to support effective and efficient scale up of HIV viral load testing for monitoring ART clients in Tanzania. The Operational Plan includes the HIV viral load monitoring implementation strategy; information on forecasting, financing, and mapping the HIV viral load network; the viral load testing hub system in Tanzania; human resources considerations; and information on the information management system and monitoring and evaluation.

Directriz de Implementação da Carga Viral de HIV em Moçambique

MOH (MISAU) Mozambique, 2015.

Implementation Guidelines for HIV Viral Load in Mozambique. This Ministry of Health (MISAU) document describes the clinical, laboratory, and programmatic protocol(s) and algorithm(s) for implementation of viral load testing in two phases.

Diagnostics Access Initiative to Achieve the 90-90-90 Treatment Target

Joint United Nations Programme on HIV/AIDS (UNAIDS), (2015).

The aim of the Diagnostics Access Initiative is to leverage improved, accessible, affordable and optimally used diagnostic technologies and strategies to ensure achievement of a bold new HIV treatment target for 2020.

HIV/AIDS Diagnostics Technology Landscape. 5th Edition

UNITAID, (2015).

This report reviews the current technology landscape for HIV diagnostics, including: (i) the algorithms and tests required in HIV care and treatment, both before and after ART initiation; (ii) the diagnostic platforms used and price points for testing; and (iii) the intended uses and appropriate settings for testing. With this information as background, the report then reviews the current technologies and diagnostic platforms in three key testing areas: CD4 and viral load (VL) testing for adults and children as well as EID, including EID run on VL platforms—all of which have traditionally been available only through centralized, high-infrastructure laboratory platforms, even for resource-limited settings. The report also describes the POC and near-POC platforms on the market and in the development pipeline, and considers the implications of the landscape, including what efficiencies might be achieved with respect to test algorithms, the cost of testing and decentralized service delivery.

Tanzania National Operational Plan for Scaling Up HIV Viral Load Testing & Tanzania National HIV Viral Load Testing Guideline to Support HIV and AIDS Prevention, Care and Treatment

United Republic of Tanzania Ministry of Health & Social Welfare National AIDS Control Program, (2015).

These national guidelines support the effective and efficient scaling up of the utilization of HIV viral load testing for monitoring ART clients in Tanzania.

Technical and Operational Considerations for Implementing HIV Viral Load Testing Interim Technical Update

World Health Organization (WHO), (2014).

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.

Viral Load Monitoring in African HIV Treatment Programmes

African Society for Laboratory Management (ASLM), (2013).

With the continued need for rapid scale-up of ART and an increasing emphasis on viral load for ART monitoring, there is an urgent need to expand viral load testing capacity within Africa. The ASLM “Viral Load Monitoring in African HIV Treatment Programmes” meeting brought together leading clinicians, policy makers, industry leaders and laboratory scientists to share their collective expertise and experience of best practice and innovation. This report outlines the key findings of the meeting and provides recommendations to help countries move forward with the implementation of expanded viral load monitoring programs.

New! Integrated Management of HIV, HCV, TB and Other Co-Infections

Unitaid & WHO, 2018.

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.

Key Considerations for Introducing New HIV Point-of-Care Diagnostic Technologies in National Health Systems

UNICEF, ASLM, CDC, CHAI, OGAC, EGPAF, LSHTM, ICAP, MSF, NHLS, USAID, and WHO, 2018.

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.

HIV Point-of-Care Diagnostics Toolkit

UNICEF, CHAI, ASLM, EGPAF, CDC, WHO, Unitaid, 2018.

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.

[Collection ] India Viral Load Testing Guidance

India National AIDS Control Organsation (NACO), 2018.

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.

Multidisease Testing for HIV and TB Using the Genexpert Platform: A Feasibility Study in Rural Zimbabwe

Ndlovu Z, et al. 2018. PLoS ONE 13(3): e0193577. DOI: 10.1371/journal.pone.0193577.

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.

Scale-up of Kenya’s National HIV Viral Load Program: Findings and Lessons Learned

Mwau M., et al. 2018. PLoS ONE 13(1): e0190659.

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.

HIV Point-of-Care (Nucleic Acid Tests) Landscape in Africa

African Society for Laboratory Medicine (ASLM), 2017.

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.

Testing Platform Cost Model

HE2RO (Wits Health Consortium), 2017.

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.

ATLAS Tool: Assessment Tool for Laboratory Services (2017 Update)

GHSC-PSM (2017 Update) / USAID | DELIVER PROJECT (2006).

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.

ICAP Approach to Implementation of Routine Viral Load Monitoring

ICAP, 2017.

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.

Zimbabwe Treat All Toolkit—Viral Load Guidance & Tools

MOHCC Zimbabwe & OPHID, 2017.

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:

Point-of-Care Diagnostics: Extending the Laboratory Network to Reach the Last Mile

Drain P.K. and Rousseau C. (2017). Curr Opin HIV AIDS. 2017 Mar; 12(2): 175–181. DOI: 10.1097/COH.0000000000000351.

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.

Viral Load Scale-up: Increasing Access to Viral Load Testing for People Living with HIV in Sub-Saharan Africa

Association of Public Health Laboratories (APHL), 2017.

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.

Report: Putting HIV and HCV to the Test: A Product Guide for Point-of-Care CD4 Tests and Laboratory-based and Point-of-Care HIV and HCV Viral Load Tests—3rd Ed

Médecins Sans Frontières (MSF), 2017.

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.

National Guidelines in 55 Low and Middle-Income Countries for CD4 and Viral Load Testing

Médecins Sans Frontières (MSF), 2017.

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.

Evaluation of the Performance of Abbott m2000 and Roche COBAS Ampliprep / COBAS Taqman Assays for HIV-1 Viral Load Determination Using Dried Blood Spots and Dried Plasma Spots in Kenya

Zeh C, et al. PLOS ONE 12(6): e0179316. https://doi.org/10.1371/journal.pone.0179316. (2017)

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.

Specimen Origin, Type and Testing Laboratory are Linked to Longer Turnaround Times for HIV Viral Load Testing in Malawi

Minchella PA, et al. (2017). PLOS ONE 12(2): e0173009. doi.org/10.1371/journal.pone.0173009

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.

Implementing Quality Assurance for Laboratory-Based and Point-of-Care HIV Testing in Nigeria

Abubakar A. et al. Afr J Lab Med. 2016, 5(2): 455. doi:10.4102/ajlm.v5i2.455.

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.

[Updated Version 1.1] Standard Operating Procedures on VL Monitoring for ICAP Clinical Staff and Health Care Worker

ICAP—Columbia University, 2016.

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.

Kenya MOH Viral Load Tools

Kenya Ministry of Health, 2016.

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.

Improving Laboratory Efficiencies to Scale-Up HIV Viral Load Testing

Alemnji G, Onyebujoh P, and Nkengasong JN. (2016). Curr Opin HIV AIDS 2016, 11:000–000. DOI:10.1097/COH.0000000000000346.

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.

Availability and Use of HIV Monitoring and Early Infant Diagnosis Technologies in WHO Member States in 2011–2013: Analysis of Annual Surveys at the Facility Level

Habiyambere V, Ford N, Low-Beer D, Nkengasong J, Sands A, Pérez González M, et al. (2016). PLoS Med 13(8): e1002088. doi:10.1371/journal.pmed.1002088.

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.

Clinician and Laboratorian Training Tool

CDC, USAID, WHO, CHAI, ASLM, MSF, Global Fund, (2016).

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.

HIV Viral Load and Early Infant Diagnosis Scorecard

CDC, USAID, WHO, CHAI, ASLM, MSF, Global Fund, (2016).

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

Making Viral Load Routine: Successes and Challenges in the Implementation of Routine HIV Viral Load Monitoring, the Viral Load Lab

Médecins Sans Frontières (MSF), (2016).

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.

Making Viral Load Routine: The Viral Load Lab

Médecins Sans Frontières (MSF), (2016).

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.

Point-of-Care EID and VL Products: What’s in the Pipeline?

Clinton Health Access Initiative (CHAI), (2016).

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.

Progress in Harmonizing Tiered HIV Laboratory Systems: Challenges and Opportunities in 8 African Countries

Williams J, Umaru F, Edgil D, Kuritsky J. Glob Health Sci Pract. 2016; 4(3):467-480. http://dx.doi.org/10.9745/GHSP-D-16-00004.

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.

WHO Manual for Organizing a National External Quality Assessment Programme for Health Laboratories and Other Testing Sites

WHO, (2016).

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.

Building Laboratory Capacity to Support HIV Care in Nigeria: Harvard/APIN PEPFAR, 2004–2012

Hamel DJ, et al. (2015). Afr J Lab Med. 2015; 4(1): 190. doi: 10.4102/ajlm.v4i1.190

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.

Tanzania MOHSW HIV Viral Load Tools

MOH Tanzania, 2015

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.

Putting HIV and HCV to the Test: A Product Guide for Point-of-Care CD4 and Laboratory-Based and Point-of-Care Virological HIV and HCV Tests

Médecins Sans Frontières (MSF), (2015).

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.

Seminário sobre uso de Carga Viral para Avaliação de Pacientes HIV+ em Moçambique

MOH (MISAU) Mozambique, 2014

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.

Laboratory Challenges to Viral Load Implementation in Resource-Limited Settings

African Society for Laboratory Medicine, (2014).

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.

Programming of Laboratory Investments with a Focus on Viral Load Testing

Global Fund, (2014).

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 Laboratory Product Quantification Tool

Opian Health Information Technology Solutions.

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.

New! Meeting Report: Regional Workshop on HIV Viral Load Scale-Up

African Society for Laboratory Medicine, 2018.

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

New! GLI Guide to TB Specimen Referral Systems and Integrated Networks

Global Laboratory Initiative (GLI)—Stop TB Partnership, 2018.

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.

Key Considerations for Introducing New HIV Point-of-Care Diagnostic Technologies in National Health Systems

UNICEF, ASLM, CDC, CHAI, OGAC, EGPAF, LSHTM, ICAP, MSF, NHLS, USAID, and WHO, 2018.

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.

HIV Point-of-Care Diagnostics Toolkit

UNICEF, CHAI, ASLM, EGPAF, CDC, WHO, Unitaid, 2018.

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.

[Collection ] India Viral Load Testing Guidance

India National AIDS Control Organsation (NACO), 2018.

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.

CROI 2018 Poster—Sustainable Viral Load Monitoring Scale-Up: Geospatial Optmization Model for Zambia

Nichols B.E., et al., 2018 (CROI Abstract Number 1141).

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.

ICAP Approach to Implementation of Routine Viral Load Monitoring

ICAP, 2017.

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.

Costs of HIV Viral Load and Early Infant Diagnosis: Forecasting Tool & Manual for Application

Health Finance & Governance (HFG) Project, 2017.

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.

Costs of HIV Viral Load and Early Infant Diagnosis Testing in Kenya

Health Finance & Governance (HFG) Project, 2017.

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.

Guidance for Procurement of In Vitro Diagnostics and Related Laboratory Items and Equipment

World Health Organization, 2017.

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.

Briefing on Guidance for Procurement of In Vitro Diagnostics and Related Laboratory Items and Equipment

World Health Organization/USAID, 2017.

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.

Laboratory Procurement and Supply Chain Considerations

USAID, 2017.

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.

HIV Viral Load and Early Infant Diagnosis Selection and Procurement Information Tool

The Global Fund, 2017.

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.

Economic Evaluation of Viral Load Testing and Early Infant Diagnosis in Rural Zimbabwe

Medecins Sans Frontieres, 2016.

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.

Kenya MOH Viral Load Tools

Kenya Ministry of Health, 2016.

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.

Improved Specimen-Referral System and Increased Access to Quality Laboratory Services in Ethiopia: The Role of the Public-Private Partnership

Kebede Y, et al. (2016). J Infect Dis. 213(Suppl 2): S59–S64. doi: 10.1093/infdis/jiv576

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.

The 90 90 90 Strategy to End the HIV Pandemic by 2030: Can the Supply Chain Handle It?

Jamieson D and SE Kellerman. (2016). J Int AIDS Soc. 19(1): 20917. doi: 10.7448/IAS.19.1.20917

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.

Viral Load Specimen Referral Network Report—Zambia

John Snow, Inc., 2016

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.

Combined Global Demand Forecasts for Antiretroviral Medicines and HIV Diagnostics in Low- and Middle-Income Countries from 2015 to 2020

World Health Organization (WHO), (2016).

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.

Global Access Initiative FAQ Document

Roche, (2016).

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.

Guidance for Developing a Specimen Transport and Referral System for Viral Load and Infant Virologic HIV Diagnosis Testing Networks

CDC, USAID, WHO, CHAI, ASLM, MSF, Global Fund, (2016).

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.

Improving Health Outcomes Through Strategic Sourcing of ARVs and Viral Load Technologies

Global Fund, (2016).

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.

List of Prequalified In Vitro Diagnostic Products

World Health Organization (WHO), (July 2016).

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.

Scaling-Up Viral Load Testing: Procurement and Supply Chain Considerations

USAID, (2016).

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.

Abbott Agreement Global Fund

Abbott, (2015).

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.

Costing Model for CD4 and Viral Load Transition and User Guide

SCMS, CHAI, USAID, PEPFAR, WHO, (2015).

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.

EID/VL POC Technology Performance Characteristics (2015)

UNICEF, (2015).

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

Work Plan Template for Xpert MTB/RIF® Implementation and Scale-up

FIND, (2015).

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.

Xpert MTB/RIF Implementation Manual—Technical and Operational "How-To": Practical Considerations

WHO, (2014).

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 for People Living with HIV

WHO, (2014).

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.

GeneXpert for TB Diagnosis: Planned and Purposeful Implementation

Piatek AS, van Cleeff M, Alexander H, Coggin WL, Rehr M, van Kampen S, et al. . Glob Health Sci Pract. 2013;1(1):18-23. http://dx.doi.org/10.9745/GHSP-D-12-00004.

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.

Location, Location: Connecting People Faster to HIV Services

UNAIDS, (2013).

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.

Manual for Procurement of Diagnostics and Related Laboratory Items and Equipment

World Health Organization (WHO), (2013).

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.

New! Video: Collection of Dried Blood Spot (DBS) specimen for Viral Load (VL) Testing

CDC, 2018.

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.

New! A Targeted Approach for Routine Viral Load Monitoring in Malawian Adults on Antiretroviral Therapy

Mungwira, R.G. et al. (2018). Tropical Medicine 23:5. DOI : 10.1111/tmi.13047.

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.

Scale-up of Kenya’s National HIV Viral Load Program: Findings and Lessons Learned

Mwau M., et al. 2018. PLoS ONE 13(1): e0190659.

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.

Pregnant and Breastfeeding Women: A Priority Population for HIV Viral Load Monitoring

PLOS One, 2017.

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.

Virological Response and Resistance among HIV-Infected Children Receiving Long-Term Antiretroviral Therapy without Virological Monitoring in Uganda and Zimbabwe: Observational Analyses within the Randomised ARROW Trial

Szubert A.J. et al. (2017). PLoS Med 14(11): e1002432. DOI: 10.1371/journal.pmed.1002432.

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.

Community-Driven Demand Creation for the Use of Routine Viral Load Testing: A Model to Scale Up Routine Viral Load Testing

Killingo B.M. et al. JIAS (2017), 20(S7): e25009. doi:10.1002/jia2.25009.

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.

Selecting a Viral Load Threshold for Routine Monitoring in Resource-Limited Settings: Optimizing Individual Health and Population Impact

Ellman T.M. et al. JIAS (2017), 20(S7): e25007. doi:10.1002/jia2.25007.

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.

Optimal Timing of Viral Load Monitoring During Pregnancy to Predict Viraemia at Delivery in HIV-Infected Women Initiating ART in South Africa: A Simulation Study

Lesosky M. et al. JIAS (2017), 20(S7): e25000. doi:10.1002/jia2.25000.

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.

Routine Viral Load Monitoring in HIV-Infected Infants and Children in Low- and Middle-Income Countries: Challenges and Opportunities

Arpadi S.M. et al. JIAS (2017), 20(S7): e2500. doi:10.1002/jia2.25001.

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 Case for Viral Load Testing in Adolescents in Resource-Limited Settings

Marcus R, et al. JIAS (2017), 20(S7): e25002. doi:10.1002/jia2.25002.

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.

HIV Viral Load Monitoring Among Key Populations in Low- and Middle-Income Countries: Challenges and Opportunities

Schwartz S.R. et al. JIAS (2017), 20(S7): e25003. doi:10.1002/jia2.25003.

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.

ICAP Viral Load Toolkit—Training Materials

ICAP—Columbia University, 2017.

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.

New! Quality Improvement of the Viral Load Programme in Mopani District, Limpopo Province

Anova Health Institute, 2016.

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.

Viral Load Monitoring and Enhanced Adherence Counseling Flipcharts

ICAP—Columbia University.

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.

Kenya MOH Viral Load Tools

Kenya Ministry of Health, 2016.

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.

ICAP Sample Viral Load Tools

ICAP—Columbia University.

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.

ICAP Viral Load Toolkit – Tools

ICAP—Columbia University.

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.

[Updated Version 1.1] Standard Operating Procedures on VL Monitoring for ICAP Clinical Staff and Health Care Worker

ICAP—Columbia University, 2016.

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.

On the Front Line of HIV Virological Monitoring: Barriers and Facilitators from a Provider Perspective in Resource-Limited Settings

Rutstein SE, et al. (2016) AIDS Care. 2016 Jan; 28(1): 1–10. doi: 10.1080/09540121.2015.1058896.

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.

Be Healthy—Know Your Viral Load Website

International Treatment Preparedness Coalition. (2015)

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.

Clinician and Laboratorian Training Tool

CDC, USAID, WHO, CHAI, ASLM, MSF, Global Fund, (2016).

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.

Making Viral Load Routine: Programmatic Strategies

Médecins Sans Frontières (MSF), (2016).

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.

Making Viral Load Routine: A Focus on Programmatic Strategies Presentation

ICAP, (2016).

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

Making Viral Load Routine: Successes and Challenges in the Implementation of Routine HIV Viral Load Monitoring, Programmatic Strategies

Médecins Sans Frontières (MSF), (2016).

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.

Viral Load Scale-Up Clinical Facility Readiness Assessment

CDC, USAID, WHO, CHAI, ASLM, MSF, Global Fund, (2016).

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.

Tanzania MOHSW HIV Viral Load Tools

MOH Tanzania, 2015

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.

Seminário sobre uso de Carga Viral para Avaliação de Pacientes HIV+ em Moçambique

MOH (MISAU) Mozambique, 2014

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.

Technical and Operational Considerations for Implementing HIV Viral Load Testing—Interim Technical Update

World Health Organization (WHO), (2014).

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.

Viral Load Toolkit: An Implementer’s Guide to Introducing HIV Viral Load Monitoring

Médecins Sans Frontières (MSF), (2013).

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.

New! Meeting Report: Regional Workshop on HIV Viral Load Scale-Up

African Society for Laboratory Medicine, 2018.

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

New! [Collection] Viral Load Monitoring Scale-Up Update in Uganda—Data Updates

PEPFAR Uganda & MOH Uganda Central Public Health Laboratories (CPHL), 2018.

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.
    View Online

  • 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.
    View Online

  • 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.
    View Online

  • 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.
    View Online

New! GLI Guide to TB Specimen Referral Systems and Integrated Networks

Global Laboratory Initiative (GLI)—Stop TB Partnership, 2018.

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.

Supporting Quality Data Systems: Lessons Learned from Early Implementation of Routine Viral Load Monitoring at a Large Clinic in Lilongwe, Malawi

Gibb J. et al. (2017). J Clin Res HIV AIDS Prev. 3(1): 10.14302/issn.2324-7339.jcrhap-17-1468.

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.

Returning HIV-1 Viral Load Results to Participant-Selected Health Facilities in National Population-Based HIV Impact Assessment (PHIA) Household Surveys in Three Sub-Saharan African Countries, 2015 to 2016

Saito S. et al. JIAS (2017), 20(S7): e25004. doi:10.1002/jia2.25004.

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.

Nigeria Viral Load Dashboard

Federal Ministry of Health Nigeria.

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).

Better Monitoring HIV Treatment Adherence in South Africa: Using Existing Data in New Ways to Guide Improvements

World Bank, 2016.

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.

Kenya Viral Load Dashboard

MOH Kenya National AIDS & STI Control Programme (NASCOP)

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.

Malawi Viral Load Dashboard

MOH Malawi 2010-2017

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.

Uganda Viral Load Dashboard

MOH Uganda Central Public Health Laboratories 2014-2017

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.

Monitoring and Evaluation Framework for Viral Load Scale-up and Implementation

CDC, USAID, WHO, CHAI, ASLM, MSF, Global Fund, (2016).

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.

Monitoring, Evaluation, and Reporting (MER 2.0) Indicator Reference Guide

The United States President’s Emergency Plan for AIDS Relief (PEPFAR), (2016).

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.

Viral Load Dashboard Generation and Programmatic Use for Quality Improvement

CDC, (2016).

This presentation summarizes viral load dashboards for monitoring and evaluation.