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Multidisease testing for HIV and TB using the GeneXpert platform: A feasibility study in rural Zimbabwe

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      Abstract

      Background

      HIV Viral Load and Early Infant Diagnosis technologies in many high burden settings are restricted to centralized laboratory testing, leading to long result turnaround times and patient attrition. GeneXpert (Cepheid, CA, USA) is a polyvalent near point-of-care platform and is widely implemented for Xpert MTB/RIF diagnosis. This study sought to evaluate the operational feasibility of integrated HIV VL, EID and MTB/RIF testing in new GeneXpert platforms.

      Methods

      Whole blood samples were collected from consenting patients due for routine HIV VL testing and DBS samples from infants due for EID testing, at three rural health facilities in Zimbabwe. Sputum samples were collected from all individuals suspected of TB. GeneXpert testing was reserved for all EID, all TB suspects and priority HIV VL at each site. Blood samples were further sent to centralized laboratories for confirmatory testing. GeneXpert polyvalent testing results and patient outcomes, including infrastructural and logistical requirements are reported. The study was conducted over a 10-month period.

      Results

      The fully automated GeneXpert testing device, required minimal training and biosafety considerations. A total of 1,302 HIV VL, 277 EID and 1,581 MTB/RIF samples were tested on a four module GeneXpert platform in each study site. Xpert HIV-1 VL testing was prioritized for patients who presented with advanced HIV disease, pregnant women, adolescents and suspected ART failures patients. On average, the study sites had a GeneXpert utilization rate of 50.4% (Gutu Mission Hospital), 63.5% (Murambinda Mission Hospital) and 17.5% (Chimombe Rural Health Centre) per month. GeneXpert polyvalent testing error rates remained lower than 4% in all sites. Decentralized EID and VL testing on Xpert had shorter overall median TAT (1 day [IQR: 0–4] and 1 day [IQR: 0–1] respectively) compared to centralized testing (17 days [IQR: 13–21] and 26 days [IQR: 23–32] respectively). Among patients with VL >1000 copies/ml (73/640; 11.4%) at GMH health facility, median time to enhanced adherence counselling was 8 days and majority of those with documented outcomes had re-suppressed VL (20/32; 62.5%). Median time to ART initiation among Xpert EID positive infants at GMH was 1 day [IQR: 0–1].

      Conclusion

      Implementation of near point-of-care GeneXpert platform for integrated multi-disease testing within district and sub-district healthcare settings is feasible and will increase access to VL, and EID testing to priority populations. Quality management systems including monitoring of performance indicators, together with regular on-site supervision are crucial, and near-POC test results must be promptly actioned-on by clinicians for patient management.

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      Most cited references 26

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      Mortality of HIV-1-infected patients in the first year of antiretroviral therapy: comparison between low-income and high-income countries.

      Highly active antiretroviral therapy (HAART) is being scaled up in developing countries. We compared baseline characteristics and outcomes during the first year of HAART between HIV-1-infected patients in low-income and high-income settings. 18 HAART programmes in Africa, Asia, and South America (low-income settings) and 12 HIV cohort studies from Europe and North America (high-income settings) provided data for 4810 and 22,217, respectively, treatment-naïve adult patients starting HAART. All patients from high-income settings and 2725 (57%) patients from low-income settings were actively followed-up and included in survival analyses. Compared with high-income countries, patients starting HAART in low-income settings had lower CD4 cell counts (median 108 cells per muL vs 234 cells per muL), were more likely to be female (51%vs 25%), and more likely to start treatment with a non-nucleoside reverse transcriptase inhibitor (NNRTI) (70%vs 23%). At 6 months, the median number of CD4 cells gained (106 cells per muL vs 103 cells per muL) and the percentage of patients reaching HIV-1 RNA levels lower than 500 copies/mL (76%vs 77%) were similar. Mortality was higher in low-income settings (124 deaths during 2236 person-years of follow-up) than in high-income settings (414 deaths during 20,532 person-years). The adjusted hazard ratio (HR) of mortality comparing low-income with high-income settings fell from 4.3 (95% CI 1.6-11.8) during the first month to 1.5 (0.7-3.0) during months 7-12. The provision of treatment free of charge in low-income settings was associated with lower mortality (adjusted HR 0.23; 95% CI 0.08-0.61). Patients starting HAART in resource-poor settings have increased mortality rates in the first months on therapy, compared with those in developed countries. Timely diagnosis and assessment of treatment eligibility, coupled with free provision of HAART, might reduce this excess mortality.
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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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          Emergence of a peak in early infant mortality due to HIV/AIDS in South Africa.

          South Africa has among the highest levels of HIV prevalence in the world. Our objectives are to describe the distribution of South African infant and child mortality by age at fine resolution, to identify any trends over recent time and to examine these trends for HIV-associated and non HIV-associated causes of mortality. A retrospective review of vital registration data was conducted. All registered postneonatal deaths under 1 year of age in South Africa for the period 1997-2002 were analysed by age in months using a generalized linear model with a log link and Poisson family. Postneonatal mortality increased each year over the period 1997-2002. A peak in HIV-related deaths was observed, centred at 2-3 months of age, rising monotonically over time. We interpret the peak in mortality at 2-3 months as an indicator for paediatric AIDS in a South African population with high HIV prevalence and where other causes of death are not sufficiently high to mask HIV effects. Intrauterine and intrapartum infection may contribute to this peak. It is potentially a useful surveillance tool, not requiring an exact cause of death. The findings also illustrate the need for early treatment of mother and child in settings with very high HIV prevalence.
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            Author and article information

            Affiliations
            [1 ] Medecins Sans Frontières, Southern Africa Medical Unit, Cape Town, South Africa
            [2 ] Medecins Sans Frontières, Access Campaign, Geneva, Switzerland
            [3 ] Medecins Sans Frontières, Harare, Zimbabwe
            [4 ] Foundation for Innovative New Diagnostics, Geneva, Switzerland
            [5 ] National Microbiology Reference Laboratory, Ministry of Health and Child Care, Harare, Zimbabwe
            The Ohio State University, UNITED STATES
            Author notes

            Competing Interests: The authors have declared that no competing interests exist.

            Contributors
            ORCID: http://orcid.org/0000-0003-0386-8641, Role: Conceptualization, Role: Data curation, Role: Formal analysis, Role: Methodology, Role: Project administration, Role: Supervision, Role: Writing – original draft, Role: Writing – review & editing
            Role: Conceptualization, Role: Methodology, Role: Writing – review & editing
            Role: Project administration, Role: Writing – review & editing
            Role: Project administration, Role: Writing – review & editing
            Role: Writing – review & editing
            Role: Conceptualization, Role: Methodology, Role: Writing – review & editing
            Role: Conceptualization, Role: Methodology, Role: Writing – review & editing
            Role: Conceptualization, Role: Methodology, Role: Resources, Role: Writing – review & editing
            Role: Writing – review & editing
            Role: Editor
            Journal
            PLoS One
            PLoS ONE
            plos
            plosone
            PLoS ONE
            Public Library of Science (San Francisco, CA USA )
            1932-6203
            2 March 2018
            2018
            : 13
            : 3
            29499042
            5834185
            10.1371/journal.pone.0193577
            PONE-D-17-33012
            (Editor)
            © 2018 Ndlovu et al

            This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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            Figures: 0, Tables: 3, Pages: 13
            Product
            Funding
            Funded by: Foundation for Innovative New Diagnostics
            Foundation for Innovative New Diagnostics (FIND=> https://www.finddx.org/) supported in the acquisition of GeneXpert reagents and Medecins Sans Frontieres (MSF) provided support for aqcusition of GeneXpert platforms. The financial support from FIND went straight to Cepheid (manufactuer of reagents for HIV and TB diagnosis). The opinions expressed herein are those of the authors and do not necessarily reflect the views of Medecins Sans Frontières, National Microbiology Reference Laboratory or Foundation for Innovative New Diagnostics.
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