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      Evaluating quality management systems for HIV rapid testing services in primary healthcare clinics in rural KwaZulu-Natal, South Africa

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      1 , 2 , 3 , 4 , 5 , 1 , *
      PLoS ONE
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          Abstract

          Introduction

          Rapid HIV tests have improved access to HIV diagnosis and treatment by providing quick and convenient testing in rural clinics and resource-limited settings. In this study, we evaluated the quality management system for voluntary and provider-initiated point-of-care HIV testing in primary healthcare (PHC) clinics in rural KwaZulu-Natal (KZN), South Africa.

          Material and methods

          We conducted a quality assessment audit in eleven PHC clinics that offer voluntary HIV testing and counselling in rural KZN, South Africa from August 2015 to October 2016. All the participating clinics were purposively selected from the province-wide survey of diagnostic services. We completed an on-site monitoring checklist, adopted from the WHO guidelines for assuring accuracy and reliability of HIV rapid tests, to assess the quality management system for HIV rapid testing at each clinic. To determine clinic’s compliance to WHO quality standards for HIV rapid testing the following quality measure was used, a 3-point scale (high, moderate and poor). A high score was defined as a percentage rating of 90 to 100%, moderate was defined as a percentage rating of 70 to 90%, and poor was defined as a percentage rating of less than 70%. Clinic audit scores were summarized and compared. We employed Pearson pair wise correlation coefficient to determine correlations between clinics audit scores and clinic and clinics characteristics. Linear regression model was computed to estimate statistical significance of the correlates. Correlations were reported as significant at p ≤0.05.

          Results

          Nine out of 11 audited rural PHC clinics are located outside 20Km of the nearest town and hospital. Majority (18.2%) of the audited rural PHC clinics reported that HIV rapid test was performed by HIV lay counsellors. Overall, ten clinics were rated moderate, in terms of their compliance to the stipulated WHO guidelines. Audit results showed that rural PHC clinics’ average rating score for compliance to the WHO guidelines ranged between 64.4% (CI: 44%– 84%) and 89.2% (CI: 74%– 100%).Ten out of eleven of the clinics were rated as moderate (70–89%). All clinic have scored highest for the following audit component: equipment; process control and specimen management; and facility ad safety, with 100%. Clinics obtained the lowest scores for the assessment audit component followed by process improvement and organisation, with 40.9% (CI: 15.7–66.1%), 45.5% (CI: 10.4–80.5%) and 56.8% (CI: 31.8 81.8%), respectively. A statistically significant correlation was observed between the following: category of staff performing the HIV rapid tests in the audited clinics and service and satisfactory audit component; weekly average number of patients using the audited PHC clinics and service and satisfactory audit component; number of HIV lay counsellors in the audited clinics and quality control audit component with p<0.05.

          Discussion

          In the small audit of primary healthcare clinics located within the rural part of KwaZulu-Natal, results revealed an overall moderate rating of the quality management system for rapid HIV testing. Improvements in the organisation, quality control, process improvement and assessment components could enable a higher quality assurance rating for rural HIV testing in KwaZulu-Natal.

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          Most cited references32

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          HIV Infection and AIDS in Sub-Saharan Africa: Current Status, Challenges and Opportunities

          Global trends in HIV infection demonstrate an overall increase in HIV prevalence and substantial declines in AIDS related deaths largely attributable to the survival benefits of antiretroviral treatment. Sub-Saharan Africa carries a disproportionate burden of HIV, accounting for more than 70% of the global burden of infection. Success in HIV prevention in sub-Saharan Africa has the potential to impact on the global burden of HIV. Notwithstanding substantial progress in scaling up antiretroviral therapy (ART), sub-Saharan Africa accounted for 74% of the 1.5 million AIDS related deaths in 2013. Of the estimated 6000 new infections that occur globally each day, two out of three are in sub-Saharan Africa with young women continuing to bear a disproportionate burden. Adolescent girls and young women aged 15-24 years have up to eight fold higher rates of HIV infection compared to their male peers. There remains a gap in women initiated HIV prevention technologies especially for women who are unable to negotiate the current HIV prevention options of abstinence, behavior change, condoms and medical male circumcision or early treatment initiation in their relationships. The possibility of an AIDS free generation cannot be realized unless we are able to prevent HIV infection in young women. This review will focus on the epidemiology of HIV infection in sub-Saharan Africa, key drivers of the continued high incidence, mortality rates and priorities for altering current epidemic trajectory in the region. Strategies for optimizing the use of existing and increasingly limited resources are included.
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            Laboratory medicine in Africa: a barrier to effective health care.

            Providing health care in sub-Saharan Africa is a complex problem. Recent reports call for more resources to assist in the prevention and treatment of infectious diseases that affect this population, but policy makers, clinicians, and the public frequently fail to understand that diagnosis is essential to the prevention and treatment of disease. Access to reliable diagnostic testing is severely limited in this region, and misdiagnosis commonly occurs. Understandably, allocation of resources to diagnostic laboratory testing has not been a priority for resource-limited health care systems, but unreliable and inaccurate laboratory diagnostic testing leads to unnecessary expenditures in a region already plagued by resource shortages, promotes the perception that laboratory testing is unhelpful, and compromises patient care. We explore the barriers to implementing consistent testing within this region and illustrate the need for a more comprehensive approach to the diagnosis of infectious diseases, with an emphasis on making laboratory testing a higher priority.
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              Diagnostic point-of-care tests in resource-limited settings.

              The aim of diagnostic point-of-care testing is to minimise the time to obtain a test result, thereby allowing clinicians and patients to make a quick clinical decision. Because point-of-care tests are used in resource-limited settings, the benefits need to outweigh the costs. To optimise point-of-care testing in resource-limited settings, diagnostic tests need rigorous assessments focused on relevant clinical outcomes and operational costs, which differ from assessments of conventional diagnostic tests. We reviewed published studies on point-of-care testing in resource-limited settings, and found no clearly defined metric for the clinical usefulness of point-of-care testing. Therefore, we propose a framework for the assessment of point-of-care tests, and suggest and define the term test efficacy to describe the ability of a diagnostic test to support a clinical decision within its operational context. We also propose revised criteria for an ideal diagnostic point-of-care test in resource-limited settings. Through systematic assessments, comparisons between centralised testing and novel point-of-care technologies can be more formalised, and health officials can better establish which point-of-care technologies represent valuable additions to their clinical programmes. Copyright © 2014 Elsevier Ltd. All rights reserved.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Writing – original draft
                Role: ConceptualizationRole: Funding acquisitionRole: ValidationRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: SupervisionRole: ValidationRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                22 August 2017
                2017
                : 12
                : 8
                : e0183044
                Affiliations
                [1 ] Discipline of Public Health Medicine, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa
                [2 ] International Clinical Research Center, Department of Global Health, University of Washington, Seattle, Washington, United States of America
                [3 ] Division of Infectious Diseases, Department of Medicine, University of Washington, Seattle, Washington, United States of America
                [4 ] Department of Epidemiology, University of Washington, Seattle, Washington, United States of America
                [5 ] Department of Surgery, Massachusetts General Hospital, Boston, Massachusetts, United States of America
                Waseda University, JAPAN
                Author notes

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

                Author information
                http://orcid.org/0000-0002-4193-2416
                Article
                PONE-D-17-16220
                10.1371/journal.pone.0183044
                5567898
                28829801
                bfecafc7-31b6-4a74-8a69-8ee27f7d4db8
                © 2017 Jaya 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.

                History
                : 27 April 2017
                : 30 July 2017
                Page count
                Figures: 4, Tables: 2, Pages: 17
                Funding
                Funded by: College of Health Sciences, University of KwaZulu-Natal
                Award Recipient :
                Funded by: South African Centre for Epidemiological Modelling and Analysis
                Award Recipient :
                Funded by: African Population Health Research Centre
                Award Recipient :
                Funded by: National Institute of Allergy and Infectious Disease of the National Institutes of Health
                Award ID: K23 AI108293
                Award Recipient :
                We would also like to thank the following institutions: College of Health Sciences, University of KwaZulu-Natal; South African Centre for Epidemiological Modelling and Analysis as well as the African Population Health Research Centre; and National Institute of Allergy and Infectious Disease of the National Institutes of Health (K23 AI108293) for their support and enabling access to resources used in conducting this study. We also like to thank the KZN Language institute for editorial assistance.
                Categories
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                Microbial Pathogens
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                Custom metadata
                Data from this study are the property of the University of KwaZulu-Natal and can be made publicly available. All interested readers can access the data set from the senior author Tivani Mashamba-Thompson via this email address Mashamba-Thompson@ 123456ukzn.ac.za and University of KwaZulu-Natal Biomedical Research Ethics Committee (BREC) from the following contacts: The Chairperson BIOMEDICAL RESEARCH ETHICS ADMINISTRATION Research Office, Westville Campus, Govan Mbeki Building University of KwaZulu-Natal P/Bag X54001, Durban, 4000 KwaZulu-Natal, South Africa Tel.: +27 31 260 4769 Fax: +27 31 260 4609 Email: BREC@ 123456ukzn.ac.za .

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