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      Scaling up HIV viral load – lessons from the large‐scale implementation of HIV early infant diagnosis and CD4 testing

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          Abstract

          Introduction

          The scale‐up of effective HIV viral load (VL) testing is an urgent public health priority. Implementation of testing is supported by the availability of accurate, nucleic acid based laboratory and point‐of‐care (POC) VL technologies and strong WHO guidance recommending routine testing to identify treatment failure. However, test implementation faces challenges related to the developing health systems in many low‐resource countries. The purpose of this commentary is to review the challenges and solutions from the large‐scale implementation of other diagnostic tests, namely nucleic‐acid based early infant HIV diagnosis ( EID) and CD4 testing, and identify key lessons to inform the scale‐up of VL.

          Discussion

          Experience with EID and CD4 testing provides many key lessons to inform VL implementation and may enable more effective and rapid scale‐up. The primary lessons from earlier implementation efforts are to strengthen linkage to clinical care after testing, and to improve the efficiency of testing. Opportunities to improve linkage include data systems to support the follow‐up of patients through the cascade of care and test delivery, rapid sample referral networks, and POC tests. Opportunities to increase testing efficiency include improvements to procurement and supply chain practices, well connected tiered laboratory networks with rational deployment of test capacity across different levels of health services, routine resource mapping and mobilization to ensure adequate resources for testing programs, and improved operational and quality management of testing services. If applied to VL testing programs, these approaches could help improve the impact of VL on ART failure management and patient outcomes, reduce overall costs and help ensure the sustainable access to reduced pricing for test commodities, as well as improve supportive health systems such as efficient, and more rigorous quality assurance. These lessons draw from traditional laboratory practices as well as fields such as logistics, operations management and business.

          Conclusions

          The lessons and innovations from large‐scale EID and CD4 programs described here can be adapted to inform more effective scale‐up approaches for VL. They demonstrate that an integrated approach to health system strengthening focusing on key levers for test access such as data systems, supply efficiencies and network management. They also highlight the challenges with implementation and the need for more innovative approaches and effective partnerships to achieve equitable and cost‐effective test access.

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          Most cited references36

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          Effect of point-of-care CD4 cell count tests on retention of patients and rates of antiretroviral therapy initiation in primary health clinics: an observational cohort study.

          Loss to follow-up of HIV-positive patients before initiation of antiretroviral therapy can exceed 50% in low-income settings and is a challenge to the scale-up of treatment. We implemented point-of-care counting of CD4 cells in Mozambique and assessed the effect on loss to follow-up before immunological staging and treatment initiation. In this observational cohort study, data for enrolment into HIV management and initiation of antiretroviral therapy were extracted retrospectively from patients' records at four primary health clinics providing HIV treatment and point-of-care CD4 services. Loss to follow-up and the duration of each preparatory step before treatment initiation were measured and compared with baseline data from before the introduction of point-of-care CD4 testing. After the introduction of point-of-care CD4 the proportion of patients lost to follow-up before completion of CD4 staging dropped from 57% (278 of 492) to 21% (92 of 437) (adjusted odds ratio [OR] 0·2, 95% CI 0·15-0·27). Total loss to follow-up before initiation of antiretroviral treatment fell from 64% (314 of 492) to 33% (142 of 437) (OR 0·27, 95% CI 0·21-0·36) and the proportion of enrolled patients initiating antiretroviral therapy increased from 12% (57 of 492) to 22% (94 of 437) (OR 2·05, 95% CI 1·42-2·96). The median time from enrolment to antiretroviral therapy initiation reduced from 48 days to 20 days (p<0·0001), primarily because of a reduction in the median time taken to complete CD4 staging, which decreased from 32 days to 3 days (p<0·0001). Loss to follow-up between staging and antiretroviral therapy initiation did not change significantly (OR 0·84, 95% CI 0·49-1·45). Point-of-care CD4 testing enabled clinics to stage patients rapidly on-site after enrolment, which reduced opportunities for pretreatment loss to follow-up. As a result, more patients were identified as eligible for and initiated antiretroviral treatment. Point-of-care testing might therefore be an effective intervention to reduce pretreatment loss to follow-up. Absolute Return for Kids and UNITAID. Copyright © 2011 Elsevier Ltd. All rights reserved.
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            Scale-up of Routine Viral Load Testing in Resource-Poor Settings: Current and Future Implementation Challenges

            Cost and complexity have hindered implementation to date of viral load testing in resource-limited settings. If rapid and timely scale-up is to become a reality, numerous factors will need to be addressed, including health and laboratory system strengthening, pricing, and multiple programmatic and funding challenges.
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              Progress with Scale-Up of HIV Viral Load Monitoring - Seven Sub-Saharan African Countries, January 2015-June 2016.

              The World Health Organization (WHO) recommends viral load testing as the preferred method for monitoring the clinical response of patients with human immunodeficiency virus (HIV) infection to antiretroviral therapy (ART) (1). Viral load monitoring of patients on ART helps ensure early diagnosis and confirmation of ART failure and enables clinicians to take an appropriate course of action for patient management. When viral suppression is achieved and maintained, HIV transmission is substantially decreased, as is HIV-associated morbidity and mortality (2). CDC and other U.S. government agencies and international partners are supporting multiple countries in sub-Saharan Africa to provide viral load testing of persons with HIV who are on ART. 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. By June 2016, based on the target numbers for viral load testing set by each country, adequate equipment capacity existed in all but one country. During 2015, two countries tested >85% of patients on ART (Namibia [91%] and South Africa [87%]); four countries tested 80% among those patients who received a viral load test in all countries except Côte d'Ivoire. Sustained country commitment and a coordinated global effort is needed to reach the goal for viral load monitoring of all persons with HIV on ART.
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                Author and article information

                Contributors
                tpeter@clintonhealthaccess.org
                Journal
                J Int AIDS Soc
                J Int AIDS Soc
                10.1002/(ISSN)1758-2652
                JIA2
                Journal of the International AIDS Society
                John Wiley and Sons Inc. (Hoboken )
                1758-2652
                12 November 2017
                November 2017
                : 20
                : Suppl Suppl 7 , Reaching the Third 90: Taking Routine Viral Load Monitoring to Scale ( doiID: 10.1111/jia2.2017.20.issue-S7 )
                : e25008
                Affiliations
                [ 1 ] Clinton Health Access Initiative Gaborone Botswana
                [ 2 ] United States Centers for Disease Control Addis Ababa Ethiopia
                [ 3 ] Foundation for Innovative New Diagnostics Geneva Switzerland
                [ 4 ] African Society for Laboratory Medicine Addid Ababa Ethiopia
                [ 5 ] ICAP University of Columbia New York USA
                [ 6 ] World Health Organization Geneva Switzerland
                [ 7 ] UNICEF New York USA
                [ 8 ] Institut Nacional Da Saude Maputo Mozambique
                Author notes
                [*] [* ] Corresponding author: Trevor Peter, Plot 2503, Extension 9, Gaborone, Botswana. Tel: +267 3933176 ( tpeter@ 123456clintonhealth.access.org )
                Article
                JIA225008
                10.1002/jia2.25008
                5978645
                29130601
                4bcd8ac9-7815-4205-8dbc-2fd8d6a2cf10
                © 2017 The Authors. Journal of the International AIDS Society published by John Wiley & sons Ltd on behalf of the International AIDS Society.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

                History
                : 06 April 2017
                : 21 August 2017
                Page count
                Figures: 0, Tables: 1, Pages: 7, Words: 6032
                Funding
                Funded by: UNITAID
                Funded by: PEPFAR
                Categories
                Commentary
                Commentary
                Custom metadata
                2.0
                jia225008
                November 2017
                Converter:WILEY_ML3GV2_TO_NLMPMC version:version=5.4.0 mode:remove_FC converted:31.05.2018

                Infectious disease & Microbiology
                hiv,viral load,early infant diagnosis,eid,cd4 implementation
                Infectious disease & Microbiology
                hiv, viral load, early infant diagnosis, eid, cd4 implementation

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