This ICAP synopsis of a cluster-randomized controlled trial describes an evaluation of the effect of point-of-care (POC) early infant HIV testing on rates of antiretroviral therapy (ART) initiation and retention in care among HIV-positive infants who presented for early infant diagnosis at health facilities in Mozambique. Full synopsis is also available in French.

In this observational study, point-of-care (POC) early infant diagnosis (EID) technologies were introduced into routine services at seven health facilities in Malawi. Antiretroviral therapy initiation rates were significantly improved with the implementation of same-day POC EID testing compared with referred, longer-turnaround laboratory-based testing.

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

This toolkit provides practical tools and training materials to guide health care workers in providing clinical care and testing to HIV-exposed infants (HEIs), including infant virologic testing.
View Online

• Care of the HIV-Exposed Infant Flipchart
  CDC, 2018.
  This clinical job aid addresses the importance of maternal health and antiretroviral therapy adherence, as well as care and testing for the HIV-exposed infant until the infant’s final HIV diagnosis after the end of breastfeeding.
  View Online

• Job Aid: Collection of Dried Blood Spots (DBS) from Infants for PCR Testing
  CDC, 2018.
  This clinical job aid provides health care workers with information on how to collect specimens for early infant diagnosis on dried blood spots, as well as drying and packaging for transport.
  View Online

• Job Aid: Guide for Receiving and Storing Dried Blood Spots (DBS) for Molecular Testing at Reference Laboratories
  CDC, 2018.
  This job aid provides information for laboratorians about how to receive, process, and store dried blood spot specimens collected for early infant diagnosis, viral load, or drug resistance testing.
  View Online

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

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

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

This implementation study analyzed the performance of point-of-care (POC) versus laboratory early infant diagnosis testing assessing acceptability and implementation issues.

Short message service (SMS) and general packet radio service (GPRS) printers allow test results to be transmitted immediately to health facilities on completion of early infant diagnosis (EID) testing in the laboratory. This systematic review and meta-analysis assessed the benefit of using SMS/GPRS printers to increase the efficiency of EID test result delivery compared to traditional courier paper-based results delivery.

This retrospective analysis was conducted of HIV-exposed infants enrolled in 15 Kenyan hospital early infant diagnosis (EID) programs and in three laboratories using the HITSystem, an eHealth intervention that alerts staff when services are overdue or results are delayed. The authors assessed mean and median TAT from when a sample was: 1) obtained to when it was shipped to the laboratory; 2) shipped to when it was received at the laboratory, 3) received to when a result was posted; and 4) the total time from obtaining the sample to posting the result.

This retrospective study evaluated early infant diagnosis (EID) turnaround times in Lesotho and found that the major contributor to delays in turnaround time in the EID cascade was the time from receipt of specimen at the central laboratory to return of results to district laboratory, followed by the time for transfer of specimens from health center to district laboratory hub. Although HIV-exposed infants are brought to the clinic at an average of seven weeks of life to have their 6-weeks DNA-PCR EID test, it took over two months for caregivers to get the results back. The study concluded that the main bottleneck in the EID cascade in Lesotho was the central laboratory.

This webinar highlighted a study to evaluate the performance and benefit of point-of-care (POC) early infant diagnosis (EID) testing of HIV-exposed newborns at birth in Mozambique. The study aimed to determine the sensitivity, specificity, and predictive values of POC EID at birth compared with laboratory-based EID testing at birth, and the proportion of HIV-infected infants diagnosed by testing at birth and 4-6 weeks compared by testing only at 4–6 weeks.

This study, supported by the National Institutes of Health, PEPFAR/USAID, and UNICEF, describes the prevalence and outcomes of diagnostic challenges associated with HIV-1 PCR testing at birth in South Africa. While the majority of neonates with a positive HIV-1 PCR test at birth were confirmed to be HIV-1 infected, indeterminate results were associated with uncertainty and diagnostic delay. The authors conclude that the clinical requirements and social consequences of managing an infant with an indeterminate HIV-1 result make it critical that a timely and unequivocal diagnosis is established by the clinician and effectively communicated to the primary caregiver.

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

This Excel sheet provides supplementary material for the 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 guidelines on the use of infant diagnostic and HIV testing in pregnant women across 55 low- and middle-income countries, and the extent of implementation, sourced from the International Association of Providers of AIDS Care (IAPAC) database. It includes timing of early infant diagnosis for HIV-exposed infants within two months of birth and frequency of HIV testing in pregnant and breastfeeding women.

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.

This package of Kenya MOH tools includes an early infant diagnosis (DNA-PCR) laboratory requisition form and a viral load/EID rejection form for laboratory staff.

In this AIDS 2016 presentation, pooled data from an independent field evaluation in six countries conducted under the EID Consortium demonstrated that point-of-care EID devices perform well compared with conventional EID platforms. For specimens from HIV-exposed infants <18 months, the Alere Q HIV ½ Detect had a sensitivity of 99.07% and specificity of 99.94% and the Cepheid GeneXpert had a sensitivity of 96.88% and specificity of 99.92%.

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

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

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.

This presentation describes the procedure for collection of a dried blood spot (DBS) specimen from an infant below 18 months of age for performing HIV-1 PCR testing in India.

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.

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

In 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.

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

This package of MOH Uganda PMTCT tools includes the Exposed Infant Clinical Chart, the DBS Dispatch Form, the Exposed Infant Register, the HIV Care Patient Appointment Book, and the Daily Activity Register for Serological Tests and Viral Load.

This manual is a training and reference guide for laboratorians providing early infant diagnostic services. As infants retain maternal antibodies to HIV for many months after birth, a diagnostic test based on viral material is necessary for definitive diagnosis of infant HIV infection until 18 months of age. The recommended viral method for early infant diagnosis programs is PCR (polymerase chain reaction) amplification of HIV-1 DNA from peripheral blood mononuclear cells from dried blood spots (DBS). Specific considerations for PCR services are addressed in this guide, including: necessary laboratory infrastructure, equipment, supplies, standard operating procedures, quality assurance measures, and appropriate reporting of test results.

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

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

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

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

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

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

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

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

A global procurement consortium has been formed to ensure uninterrupted provision of timely, high-quality early infant diagnosis and viral load test results in countries most in need. The consortium aims to catalyze demand for and uptake of POC technologies, and ensure sustainability of the market, by applying strategies such as: pooling test volumes across purchasers; sharing market intelligence; providing advanced procurement forecasts to manufacturers; agreeing on procurement principles and negotiation targets; jointly negotiating prices as well as service and maintenance terms; and coordinating the placement of orders. From October 2016 to July 2017, EGPAF monitored procurement indicators for POC EID devices and tests kits ordered for eight project countries: Cameroon, Côte d’Ivoire, Kenya, Lesotho, Mozambique, Rwanda, Swaziland, and Zimbabwe. This issue brief presents early results.

A consortium working across more than 13 African countries to improve the market for point-of-care early infant diagnosis (POC EID) technologies is collaborating to facilitate long-term price reductions in POC EID and increase access. These organizations are working with The Global Fund to leverage their volumes and harmonize contracts and ensure that The Global Fund grantees will be able to procure these technologies under the same negotiated terms through a most favored customer clause. This EGPAF issue brief provides a comparison between the advertised prices, total cost of ownership, and cost of goods analysis for POC EID cartridges as well as an analysis of the service and maintenance provisions of the two current quality-assurance systems for POC EID with suggested areas to improve access.

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

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

This 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.

This AIDS 2016 presentation describes Global Fund efforts to provide a range of credible, cost-effective, competitive options with more transparent pricing and contracting—accessible to all—and highlights the online Viral Load and EID Selection and Procurement Tool. A table with suppliers (July 2016) and their testing products and regulatory status is included.

This ASLM 2016 presentation describes a stepwise approach to site and platform selection and site preparation towards readiness for point-of-care EID introduction in nine countries.

This ASLM 2016 poster discusses site selection for platform placement to integrate point-of-care technologies into national EID networks. Early infant diagnosis data from 7,979 heath facilities across all nine UNITAID POC EID project countries was evaluated for EID demand.

This ASLM 2016 poster presents site mapping and an innovative model of hub/spoke as an approach to optimizing the EID network in Lesotho.

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.

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

This 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 early infant diagnosis tests is expected to rise from about 800,000 in 2014 to 1.8 million by 2020. The growth in demand will be driven by changes in the testing guidelines to include testing at birth, the introduction of point-of-care early infant diagnosis testing and additional partner funding. The full need under 90–90–90 would be even larger: about 2.8 million tests in 2020.

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

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

This presentation provides a country example of introducing POC EID technologies from a pilot in Malawi including lessons learned on key barriers to viral load scale up.

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

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

This ICASA 2015 presentation emphasizes that with conventional EID, many test results are never received by the infant or caregiver and outlines POC HIV EID (and viral load) products— available and pipeline—and next stage POC technologies.

Early diagnosis and treatment are critical to prevent morbidity and mortality in HIV-infected children; however, early infant HIV testing rates remain low in most high HIV-burden countries. This paper describes the available evidence on the health outcomes of HIV-exposed infants (HEI), defines a comprehensive care package for HEI that extends beyond early HIV testing, and describes successful examples of integrated services for HEI.

Family testing is an index case finding strategy through which HIV-infected patients are systematically screened to identify family members with unknown HIV status. By specifically targeting a high-risk population, family testing is a pragmatic, high-yield, and efficient approach to identify previously undiagnosed HIV-infected children and link them to care before they become symptomatic. This article reviews the evidence base for family testing, describes its challenges, and provides guidance and sample tools for program managers aiming to integrate family testing into existing health systems.

This study identified maternal characteristics that help target birth testing of high‐risk infants. This practice can identify the large majority of in utero HIV transmissions and allows early antiretroviral therapy initiation for these infants. Birth testing has been shown to be feasible, acceptable, and affordable, but due to limited resources, a targeted approach may be the best initial method for implementation.

This CDC video—available in English, French, and Portuguese—reviews the skills needed to collect high quality dried blood spot (DBS) samples. It demonstrates how to: (1) Gather the supplies required for DBS collection; (2) Collect DBS samples on perforated cards; (3) Dry, package, and store (if necessary) DBS samples properly; (4) How to tell the difference between valid and invalid DBS; and (5) Ensure that all DBS cards are properly labeled and that specimen logs are kept accurately.

This toolkit provides practical tools and training materials to guide health care workers in providing clinical care and testing to HIV-exposed infants (HEIs), including infant virologic testing.
View Online

• Care of the HIV-Exposed Infant Flipchart
  CDC, 2018.
  This clinical job aid addresses the importance of maternal health and antiretroviral therapy adherence, as well as care and testing for the HIV-exposed infant until the infant’s final HIV diagnosis after the end of breastfeeding.
  View Online

• Job Aid: Collection of Dried Blood Spots (DBS) from Infants for PCR Testing
  CDC, 2018.
  This clinical job aid provides health care workers with information on how to collect specimens for early infant diagnosis on dried blood spots, as well as drying and packaging for transport.
  View Online

• Job Aid: Guide for Receiving and Storing Dried Blood Spots (DBS) for Molecular Testing at Reference Laboratories
  CDC, 2018.
  This job aid provides information for laboratorians about how to receive, process, and store dried blood spot specimens collected for early infant diagnosis, viral load, or drug resistance testing.
  View Online

This study assessed HIV prevalence in infants and children receiving care at various service entry points in primary health facilities in Uganda. Expanding routine early infant diagnosis screening beyond the traditional PMTCT setting to nutrition and inpatient entry points can increase the identification of HIV‐infected infants and help HIV care programs significantly expand testing to improve access to EID and pediatric treatment.

This Ministry of Health and Child Care (MOHCC) job aid presents the infant risk assessment and ARV prophylaxis algorithm for HIV-exposed infants in Zimbabwe including infant dosing for NVP and AZT as well as cotrimoxazole.

This systematic review summarizes interventions that demonstrate statistically significant improvements in service uptake and retention of HIV-positive pregnant and breastfeeding women and their infants along the PMTCT cascade including uptake of early infant diagnostic testing and retention of mothers and infants.

This study evaluated the use of mobile phones in Zambia to improve the process of early infant diagnosis. The feasibility of using mobile phones to notify mothers of the availability of test results either directly, or through their local rural health center, was assessed. In addition, the performance of a national short message service (SMS) reporting system to deliver test results from the central laboratory to the clinic was evaluated during the first two years of implementation.

This study described point-of-care testing (POCT) for HIV-exposed newborns and compares outcomes to universal laboratory-based testing (LABT) in South Africa. Mothers whose infants received POCT received their results in 96 percent of cases, while only 53 percent of mothers whose infants received LABT received their results. Infants diagnosed via POCT initiated treatment earlier than infants diagnosed via LABT (one day versus six days). The study concluded that POCT is accurate, increases the likelihood of the mother receiving the result, reduces waiting time, and decreases time to ART initiation.

Find this study and others on global HIV prevention issues in the AIDSFree Prevention Update.

This package of Guinea Ministry of Health tools tracks women and exposed infants in PMTCT (PTME in French) under the National Program for Health Care and Prevention of STI / HIV / AIDS (PNPCSP in French). It includes the PMTCT Card, PMTCT Register, Exposed Infant Follow-up Card, Exposed Infant Register, and Monthly Report on PMTCT Activities.

This webinar provided a global update on the HIV epidemic in women and children and PMTCT, a primer on diagnosing HIV infection in infants, a summary of EID implementation, and an overview of birth testing considerations and controversies.

This technical update emphasizes that improved case finding of HIV-infected infants, children, and adolescents through implementation of routine, systematic HIV testing and counseling (HTC) approaches is urgently needed to maximize pediatric treatment coverage and reduce rates of infant and child mortality attributable to HIV and AIDS.

Algorithm for establishing the presence of HIV infection in HIV-exposed infants and children less than 18 months of age in resource-limited settings.

This implementation guide for program managers provides on overview of infant diagnosis for program managers. It covers the basics of setting up early infant diagnosis services, including choice of a test and an appropriate testing algorithm, clinical staff training needs, required laboratory infrastructure, and program evaluation.

This 5-module training curriculum on early infant diagnosis and infant follow-up is intended for midwives, nurses, doctors, and other healthcare staff. Following the training, staff members will be able to identify infants in need of testing, counsel caregivers before testing, and provide appropriate follow-up care for HIV-exposed and HIV-infected infants and young children. They will also learn how to collect, handle, and send dried blood spot (DBS) specimens for early infant diagnosis. The fifth module is an interactive group exercise that evaluates and reinforces skills gained from the training.

Children and AIDS is the online information portal and community for the HIV/AIDS programme of the United Nations Children's Fund (UNICEF). Through technical support, education, advocacy and a range of other efforts, UNICEF seeks to ensure that all babies, children, adolescents and their mothers can access life-saving HIV prevention, treatment, care and support.

Large differences remain between the estimated number of children living with HIV (CLHIV) and those identified through national HIV programs. This study—pooling data from modeled, survey, and routine program data—evaluated the number of CLHIV and those on treatment in Lesotho, Malawi, Swaziland, Tanzania, Uganda, Zambia, and Zimbabwe. The study concluded that many children are still not being identified and treated—there is need to expand comprehensive early infant diagnosis (EID) and strengthen the linkage between diagnosis and treatment.

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

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

This Nigeria Federal Ministry of Health dashboard presents a summary of monthly early infant diagnosis trends including total infants tested, positivity rate, average age of testing, and reasons for PCR testing— presented for PMTCT and for rapid and infant testing.

Since 2015, EGPAF, through funding and support from Unitaid, has been working to integrate point-of-care early infant diagnosis (POC EID) into the current EID system in nine high-prevalence countries: Cameroon, Côte d’Ivoire, Kenya, Lesotho, Mozambique, Rwanda, Swaziland, Zambia, and Zimbabwe. To understand the effect of POC EID, EGPAF is conducting a pre- and post-intervention evaluation. Pre-intervention, baseline data from infants tested using conventional, laboratory-based EID was collected prior to introducing POC technology. Baseline data was compared with POC EID data on key service delivery indicators. Pilot findings from six intervention countries are summarized in this EGPAF issue brief.

Since 2015, EGPAF, through funding and support from Unitaid, has been working to integrate point-of-care early infant diagnosis (POC EID) into the current EID system in nine high-prevalence countries: Cameroon, Côte d’Ivoire, Kenya, Lesotho, Mozambique, Rwanda, Swaziland, Zambia, and Zimbabwe. To understand the effect of POC EID, EGPAF is conducting a pre- and post-intervention evaluation. Pre-intervention, baseline data from infants tested using conventional, laboratory-based EID was collected prior to introducing POC technology. Baseline data was compared with POC EID data on key service delivery indicators. Pilot findings from six intervention countries are summarized in this EGPAF interactive data visualization dashboard.

This article provides an overview of major achievements in M&E across Global Plan countries and highlights key challenges and innovative country-driven solutions using PMTCT program data, the authors also identify outstanding challenges and potential ways forward.

This package of Guinea Ministry of Health tools tracks women and exposed infants in PMTCT (PTME in French) under the National Program for Health Care and Prevention of STI / HIV / AIDS (PNPCSP in French). It includes the PMTCT Card, PMTCT Register, Exposed Infant Follow-up Card, Exposed Infant Register, and Monthly Report on PMTCT Activities.

This Tanzania Ministry of Health online dashboard provides a snapshot of early infant diagnosis testing and outcomes trends—including total samples tested, rejected, total positives, and results by age—as well as regional statistics.

This MOH Kenya dashboard presents a summary of monthly early infant diagnosis testing trends including outcomes, with disaggregation by age, county, entry point, mother's prophylaxis, and infant prophylaxis, as well as HIV-exposed infant follow-up. Lab performance statistics for early infant diagnosis, including specimen rejection rate trends and turnaround times, are also presented.

This MOH Malawi national online dashboard presents a summary of monthly EID tests, national lab test statistics, national lab turnaround times, EID results by age of testing, and reason for sample collection with filters by district and facility as well as a summary of EID sample submitting sites statistics by district.

This MOH Uganda online dashboard summarizes key EID metrics including total tests, HIV-positive infants, positivity rate, and initiation rate with filters for date, region, districts, and facility levels.

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.

The IATT Option B/B+ M&E Framework contains 3 sections that provides guidance on: routine monitoring of lifelong care and treatment for pregnant and breastfeeding women living with HIV and their children which outlines the core indicators and key questions for all MNCH and HIV Care and Treatment facilities; enhanced monitoring to assess program quality and identify issues needing targeted intervention; and conducting evaluations and operational research to assess outcomes and effectiveness of national programs. Using this framework, stakeholders can review, adapt and update current monitoring systems and continuously evaluate programs, maximizing the potential impact of lifelong treatment programs to improve health outcomes and prevent HIV infections for women, their children and their families.