title: Evaluating the accessibility and utility of HIV-related point-of-care diagnostics for maternal health in rural South Africa: a study protocol.
abstract: Poor healthcare access is a major barrier to receiving antenatal care and a cause of high maternal mortality in South Africa (SA). 'Point-of-care' (POC) diagnostics is a powerful emerging healthcare approach to improve healthcare access. This study focuses on evaluating the accessibility and utility of POC diagnostics for maternal health in rural SA primary healthcare (PHC) clinics in order to generate a model framework of implementation of POC diagnostics in rural South African clinics.
  
  
  
  We will use several research methods, including a systematic review, quasi-experiments, survey, key informant interviews and audits. We will conduct a systematic review and experimental study to determine the impact of POC diagnostics on maternal health. We will perform a cross-sectional case study of 100 randomly selected rural primary healthcare clinics in KwaZulu-Natal to measure the context and patterns of POC diagnostics access and usage by maternal health providers and patients. We will conduct interviews with relevant key stakeholders to determine the reasons for POC deficiencies regarding accessibility and utility of HIV-related POC diagnostics for maternal health. We will also conduct a vertical audit to investigate all the quality aspects of POC diagnostic services including diagnostic accuracy in a select number of clinics. On the basis of information gathered, we will propose a model framework for improved implementation of POC diagnostics in rural South African public healthcare clinics. Statistical (Stata-13) and thematic (NVIVO) data analysis will be used in this study.
  
  
  
  The study protocol was approved by the Ethics Committee of the University of KwaZulu-Natal (BE 484/14) and the KwaZulu-Natal Department of Health based on the Helsinki Declaration (HRKM 40/15). Findings of this study will be disseminated electronically and in print. They will be presented to conferences related to HIV/AIDS, diagnostics, maternal health and strengthening of health systems.
authors.affiliation: Discipline of Public Health Medicine, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.
authors.forename: T P
authors.initials: TP
authors.lastname: Mashamba-Thompson
authors.affiliation: Department of Global Health, International Clincial Research Center, University of Washington, Seattle, Washington, USA Department of Medicine, Division of Infectious Diseases, University of Washington, Seattle, Washington, USA Department of Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
authors.forename: P K
authors.initials: PK
authors.lastname: Drain
authors.affiliation: Discipline of Public Health Medicine, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.
authors.forename: B
authors.initials: B
authors.lastname: Sartorius
mesh_terms: D003430:Cross-Sectional Studies; D005260:Female; D015658:HIV Infections / Q000175:diagnosis* / Q000453:epidemiology; D006297:Health Services Accessibility / Q000706:statistics & numerical data*; D006801:Humans; D000068097:Maternal Health / Q000592:standards*; D019095:Point-of-Care Systems / Q000706:statistics & numerical data*; D011247:Pregnancy; D011295:Prenatal Care / Q000379:methods*; D011320:Primary Health Care; D012044:Regression Analysis; D012107:Research Design; D012424:Rural Population; D013019:South Africa
keywords: Maternal health outcomes; Point-of-care diagnostics; Primary health care