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      Introduction of Syphilis Point-of-Care Tests, from Pilot Study to National Programme Implementation in Zambia: A Qualitative Study of Healthcare Workers’ Perspectives on Testing, Training and Quality Assurance

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          Abstract

          Syphilis affects 1.4 million pregnant women globally each year. Maternal syphilis causes congenital syphilis in over half of affected pregnancies, leading to early foetal loss, pregnancy complications, stillbirth and neonatal death. Syphilis is under-diagnosed in pregnant women. Point-of-care rapid syphilis tests (RST) allow for same-day treatment and address logistical barriers to testing encountered with standard Rapid Plasma Reagin testing. Recent literature emphasises successful introduction of new health technologies requires healthcare worker (HCW) acceptance, effective training, quality monitoring and robust health systems. Following a successful pilot, the Zambian Ministry of Health (MoH) adopted RST into policy, integrating them into prevention of mother-to-child transmission of HIV clinics in four underserved Zambian districts. We compare HCW experiences, including challenges encountered in scaling up from a highly supported NGO-led pilot to a large-scale MoH-led national programme. Questionnaires were administered through structured interviews of 16 HCWs in two pilot districts and 24 HCWs in two different rollout districts. Supplementary data were gathered via stakeholder interviews, clinic registers and supervisory visits. Using a conceptual framework adapted from health technology literature, we explored RST acceptance and usability. Quantitative data were analysed using descriptive statistics. Key themes in qualitative data were explored using template analysis. Overall, HCWs accepted RST as learnable, suitable, effective tools to improve antenatal services, which were usable in diverse clinical settings. Changes in training, supervision and quality monitoring models between pilot and rollout may have influenced rollout HCW acceptance and compromised testing quality. While quality monitoring was integrated into national policy and training, implementation was limited during rollout despite financial support and mentorship. We illustrate that new health technology pilot research can rapidly translate into policy change and scale-up. However, training, supervision and quality assurance models should be reviewed and strengthened as rollout of the Zambian RST programme continues.

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          Most cited references37

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          Rapid tests for sexually transmitted infections (STIs): the way forward.

          In the developing world, laboratory services for sexually transmitted infections (STIs) are either not available, or where limited services are available, patients may not be able to pay for or physically access those services. Despite the existence of national policy for antenatal screening to prevent congenital syphilis and substantial evidence that antenatal screening is cost-effective, implementation of syphilis screening programmes remains unacceptably low because of lack of screening tools that can be used in primary health care settings. The World Health Organization Sexually Transmitted Diseases Diagnostics Initiative (SDI) has developed the ASSURED criteria as a benchmark to decide if tests address disease control needs: Affordable, Sensitive, Specific, User-friendly, Rapid and robust, Equipment-free and Deliverable to end-users. Rapid syphilis tests that can be used with whole blood approach the ASSURED criteria and can now be deployed in areas where no previous screening has been possible. Although rapid tests for chlamydia and gonorrhoea lack sensitivity, more tests are in development. The way forward for STI diagnostics requires a continuing quest for ASSURED tests, the development of a road map for test introduction, sustainable programmes for quality assurance, and the creation of a robust infrastructure linked to HIV prevention that ensures sustainability of STI control efforts that includes viral STIs.
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            Point-of-Care Tests to Strengthen Health Systems and Save Newborn Lives: The Case of Syphilis

            Rosanna Peeling and colleagues describe their experience of introducing point-of-care testing to screen for syphilis in pregnant women living in low- and middle-income countries.
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              Prevalence of malaria and sexually transmitted and reproductive tract infections in pregnancy in sub-Saharan Africa: a systematic review.

              Malaria and sexually transmitted infections/reproductive tract infections (STIs/RTIs) in pregnancy are direct and indirect causes of stillbirth, prematurity, low birth weight, and maternal and neonatal morbidity and mortality. To conduct a systematic review and meta-analysis of malaria and STI/RTI prevalence estimates among pregnant women attending antenatal care facilities in sub-Saharan Africa. PubMed, MEDLINE, EMBASE, the World Health Organization International Clinical Trials Registry, and reference lists were searched for studies reporting malaria, syphilis, Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis, or bacterial vaginosis among pregnant women attending antenatal care facilities in sub-Saharan Africa. Included studies were conducted in 1990-2011 with open enrollment. Studies from South Africa, where malaria is no longer endemic, were excluded. Point prevalence estimates were corrected for diagnostic precision. A random-effects model meta-analysis was applied to produce pooled prevalence estimates. A total of 171 studies met inclusion criteria, providing 307 point prevalence estimates for malaria or STIs/RTIs and including a total of 340 904 women. The pooled prevalence estimates (with 95% CIs and number of women with positive diagnosis) among studies in 1990-2011 in East and Southern Africa were as follows: syphilis, 4.5% (3.9%-5.1%; n = 8346 positive diagnoses), N gonorrhoeae, 3.7% (2.8%-4.6%; n = 626), C trachomatis, 6.9% (5.1%-8.6%; n = 350), T vaginalis, 29.1% (20.9%-37.2%; n = 5502), bacterial vaginosis, 50.8% (43.3%-58.4%; n = 4280), peripheral malaria, 32.0% (25.9%-38.0%; n = 11 688), and placental malaria, 25.8% (19.7%-31.9%; n = 1388). West and Central Africa prevalence estimates were as follows: syphilis, 3.5% (1.8%-5.2%; n = 851), N gonorrhoeae, 2.7% (1.7%-3.7%; n = 73), C trachomatis, 6.1% (4.0%-8.3%; n = 357), T vaginalis, 17.8% (12.4%-23.1%; n = 822), bacterial vaginosis, 37.6% (18.0%-57.2%; n = 1208), peripheral malaria, 38.2% (32.3%-44.1%; n = 12 242), and placental malaria, 39.9% (34.2%-45.7%; n = 4658). The dual prevalence of malaria and STIs/RTIs in pregnancy among women who attend antenatal care facilities in sub-Saharan Africa is considerable, with the combined prevalence of curable STIs/RTIs being equal to, if not greater than, malaria.
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                Author and article information

                Contributors
                Role: Academic Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                1 June 2015
                2015
                : 10
                : 6
                : e0127728
                Affiliations
                [1 ]Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, United Kingdom
                [2 ]Elizabeth Glaser Pediatric AIDS Foundation, Washington, District of Columbia, United States of America
                [3 ]Department of Social & Environmental Health, London School of Hygiene and Tropical Medicine, London, United Kingdom
                [4 ]Department of Epidemiology and Biostatistics, George Washington University, Washington, District of Columbia, United States of America
                [5 ]Elizabeth Glaser Pediatric AIDS Foundation, Lusaka, Zambia
                [6 ]Office of Population and Reproductive Health, United States Agency for International Development, Washington, District of Columbia, United States of America
                [7 ]HIV/AIDS STI Programme, Ministry of Health, Lusaka, Zambia
                [8 ]Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, United Kingdom
                Johns Hopkins University, UNITED STATES
                Author notes

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

                Conceived and designed the experiments: EMA MMG JR SS KDS TS FTP RWP DM. Performed the experiments: EMA ATN GTM. Analyzed the data: EMA MMG JR. Contributed reagents/materials/analysis tools: EMA MMG KDS. Wrote the paper: EMA MMG KDS FTP JR.

                [¤a]

                Current address: Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America

                [¤b]

                Current Address: ICAP program, Mailman School of Public Health, Columbia University, New York, United States of America

                Article
                PONE-D-14-42899
                10.1371/journal.pone.0127728
                4452097
                26030741
                e45e7584-071d-4f88-9434-b7af7c733140

                This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication

                History
                : 2 October 2014
                : 20 April 2015
                Page count
                Figures: 3, Tables: 2, Pages: 18
                Funding
                Funding for the pilot study was from UNICEF/UNDP/World Bank/World Health Organization Special Programme for Research and Training in Tropical Diseases through a grant from the Bill & Melinda Gates Foundation (grant no. OPP 47697). The authors received no specific funding for the rollout evaluation. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
                Research Article
                Custom metadata
                All relevant data are available in the paper and its Supporting Information files.

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