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

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          Abstract

          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.

          Abstract

          Despite immense progress in antiretroviral therapy (ART) scale-up, many people still lack access to basic standards of care, with our ability to meet the Joint United Nations Programme on HIV/AIDS 90-90-90 treatment targets for HIV/AIDS dependent on dramatic improvements in diagnostics. The World Health Organization recommends routine monitoring of ART effectiveness using viral load (VL) testing at 6 months and every 12 months, to monitor treatment adherence and minimize failure, and will publish its VL toolkit later this year. However, the cost and complexity of VL is preventing scale-up beyond developed countries and there is a lack of awareness among clinicians as to the long-term patient benefits and its role in prolonging the longevity of treatment programs. With developments in this diagnostic field rapidly evolving—including the recent improvements for accurately using dried blood spots and the imminent appearance to the market of point-of-care technologies offering decentralized diagnosis—we describe current barriers to VL testing in resource-limited settings. 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.

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          Viral load monitoring as a tool to reinforce adherence: a systematic review.

          Viral load monitoring has been proposed as a tool to reinforce adherence, but outcomes have never been systematically assessed. A meta-analysis was conducted to systematically analyze the research on viral load monitoring as a tool to reinforce adherence. Viremic resuppression is defined here as a decrease in viral load beneath a particular threshold following viral load levels that have been elevated despite antiretroviral treatment. Six databases were searched for studies published up to November 2012, which reported the use of viral load monitoring as a tool to identify patients in need of adherence support. Three conference abstract sites were reviewed for studies reported in the last 2 years. Randomized and quasi-randomized trials and observational studies, were eligible. No language or geographical restrictions were applied. Six retrospective and 2 prospective observational studies reported data from 8 countries: South Africa, the United States, Thailand, Mali, Burkina Faso, Swaziland, India, and France. Five studies reported on viremic resuppression, with a pooled estimate of 70.5% (95% confidence interval: 56.6% to 84.4%) resuppressed. The remaining 3 studies all reported declines in mean viral load. Delayed onset of routine viral load monitoring was associated with the emergence of drug resistance. The clear trend of resuppression, following viral load testing and adherence support, demonstrates the utility of viral load as a tool to identify patients in need of enhanced adherence support.
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            Outcomes of antiretroviral treatment in programmes with and without routine viral load monitoring in Southern Africa.

            To compare outcomes of antiretroviral therapy (ART) in South Africa, where viral load monitoring is routine, with those in Malawi and Zambia, where monitoring is based on CD4 cell counts. We included 18,706 adult patients starting ART in South Africa and 80,937 patients in Zambia or Malawi. We examined CD4 responses in models for repeated measures and the probability of switching to second-line regimens, mortality and loss to follow-up in multistate models, measuring time from 6 months. In South Africa, 9.8% [95% confidence interval (CI) 9.1-10.5] had switched at 3 years, 1.3% (95% CI 0.9-1.6) remained on failing first-line regimens, 9.2% (95% CI 8.5-9.8) were lost to follow-up and 4.3% (95% CI 3.9-4.8) had died. In Malawi and Zambia, more patients were on a failing first-line regimen [3.7% (95% CI 3.6-3.9], fewer patients had switched [2.1% (95% CI 2.0-2.3)] and more patients were lost to follow-up [15.3% (95% CI 15.0-15.6)] or had died [6.3% (95% CI 6.0-6.5)]. Median CD4 cell counts were lower in South Africa at the start of ART (93 vs. 132 cells/μl; P < 0.001) but higher after 3 years (425 vs. 383 cells/μl; P < 0.001). The hazard ratio comparing South Africa with Malawi and Zambia after adjusting for age, sex, first-line regimen and CD4 cell count was 0.58 (0.50-0.66) for death and 0.53 (0.48-0.58) for loss to follow-up. Over 3 years of ART mortality was lower in South Africa than in Malawi or Zambia. The more favourable outcome in South Africa might be explained by viral load monitoring leading to earlier detection of treatment failure, adherence counselling and timelier switching to second-line ART.
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              Early infant diagnosis of HIV infection in Zambia through mobile phone texting of blood test results

              OBJECTIVE: To see if, in the diagnosis of infant infection with human immunodeficiency virus (HIV) in Zambia, turnaround times could be reduced by using an automated notification system based on mobile phone texting. METHODS: In Zambia's Southern province, dried samples of blood from infants are sent to regional laboratories to be tested for HIV with polymerase chain reaction (PCR). Turnaround times for the postal notification of the results of such tests to 10 health facilities over 19 months were evaluated by retrospective data collection. These baseline data were used to determine how turnaround times were affected by customized software built to deliver the test results automatically and directly from the processing laboratory to the health facility of sample origin via short message service (SMS) texts. SMS system data were collected over a 7.5-month period for all infant dried blood samples used for HIV testing in the 10 study facilities. FINDINGS: Mean turnaround time for result notification to a health facility fell from 44.2 days pre-implementation to 26.7 days post-implementation. The reduction in turnaround time was statistically significant in nine (90%) facilities. The mean time to notification of a caregiver also fell significantly, from 66.8 days pre-implementation to 35.0 days post-implementation. Only 0.5% of the texted reports investigated differed from the corresponding paper reports. CONCLUSION: The texting of the results of infant HIV tests significantly shortened the times between sample collection and results notification to the relevant health facilities and caregivers.
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                Author and article information

                Journal
                Clin Infect Dis
                Clin. Infect. Dis
                cid
                cid
                Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
                Oxford University Press
                1058-4838
                1537-6591
                15 April 2016
                06 January 2016
                06 January 2016
                : 62
                : 8
                : 1043-1048
                Affiliations
                [1 ]Médecins Sans Frontières , Geneva, Switzerland
                [2 ]International Health Unit, Department of Medicine, Section of Infectious Diseases and Immunity, Imperial College London , United Kingdom
                Author notes
                Correspondence: T. Roberts, Médecins Sans Frontières, 78 Rue de Lausanne, Geneva 1202, Switzerland ( dx.teri.roberts@ 123456gmail.com ).
                Article
                ciw001
                10.1093/cid/ciw001
                4803106
                26743094
                d2160d02-3d7c-441f-99d1-bf92f613fe68
                © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence ( http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, contact journals.permissions@ 123456oup.com .

                History
                : 25 September 2015
                : 23 December 2015
                Categories
                HIV/AIDS
                Editor's choice

                Infectious disease & Microbiology
                viral load,virological,resource-limited settings,antiretroviral therapy,monitoring

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