Tivani P. Mashamba-Thompson

Evaluating the accessibility and utility of HIV-related point-of-care diagnostics for maternal health in rural South Africa: a study protocol

Introduction 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. Method and analyses 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. Ethics and dissemination 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.

Impact of point-of-care diagnostics on maternal outcomes in HIV-infected women: systematic review and meta-analysis protocol

Introduction Studies indicate substandard diagnostic care, delayed and missed diagnosis as some of the contributing factors to maternal mortality. The clinical impact of point-of-care (POC) diagnostics has been shown in the monitoring and treatment of a variety of infectious diseases, including HIV/AIDS and tuberculosis. The objective of this systematic review is to investigate the impact of POC diagnostics on maternal outcomes for HIV-infected women. Methods We will conduct a systematic review to evaluate the impact of POC diagnostics for improving desired healthcare outcomes for HIV-infected women. The search strategy will involve electronic databases including: Cochrane Infectious Disease Group Specialised Register; Cochrane Central Register of Control Trials, published in The Cochrane Library; PubMed; EBSCOhost and LILACS. The studies will be mapped in 2 stages: stage 1 will map studies descriptively by focus and method; stage 2 will involve additional inclusion criteria, quality assessment and data extraction undertaken by 2 reviewers in parallel. Evidence will be synthesised using relevant systematic research tools: meta-analysis and subgroup analysis will be conducted using RevMan and Stata 13 will be used for meta-regressions. We will follow recommendations described in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and the Cochrane Handbook for Intervention Reviews. Ethics and dissemination We anticipate finding a large number of studies on POC diagnostic interventions on maternal outcomes in HIV-infected women, which, once summarised, will be useful to guide future diagnostic interventions. The protocol for the systematic review has been registered in PROSPERO. The study will be disseminated electronically and in print. It will also be presented to conferences related to HIV/AIDS, POC diagnostics and maternal health. Trial registration number PROSPERO CRD42014015439.

Point-of-Care Diagnostics for Improving Maternal Health in South Africa

Improving maternal health is a global priority, particularly in high HIV-endemic, resource-limited settings. Failure to use health care facilities due to poor access is one of the main causes of maternal deaths in South Africa. “Point-of-care” (POC) diagnostics are an innovative healthcare approach to improve healthcare access and health outcomes in remote and resource-limited settings. In this review, POC testing is defined as a diagnostic test that is carried out near patients and leads to rapid clinical decisions. We review the current and emerging POC diagnostics for maternal health, with a specific focus on the World Health Organization (WHO) quality-ASSURED (Affordability, Sensitivity, Specificity, User friendly, Rapid and robust, Equipment free and Delivered) criteria for an ideal point-of-care test in resource-limited settings. The performance of POC diagnostics, barriers and challenges related to implementing POC diagnostics for maternal health in rural and resource-limited settings are reviewed. Innovative strategies for overcoming these barriers are recommended to achieve substantial progress on improving maternal health outcomes in these settings.

Effect of Point-of-care Diagnostics on Maternal Outcomes in Human Immunodeficiency Virus–infected Women: Systematic Review and Meta-analysis

Introduction The World Health Organization advocates for increased accessibility of human immunodeficiency virus (HIV)–related point-of-care (POC) diagnostics in settings that lack laboratory infrastructure. The aim of this study was to assess the effect of POC diagnostics on maternal health outcomes in HIV-infected women. Methods A systematic literature review used the following multiple data sources: Cochrane Infectious Disease Group Specialized Register, Cochrane Central Register of Control Trials, published in The Cochrane Library, PubMed, Elton B. Stephens Co Host, and Latin American and Caribbean Health Sciences Literature from January 2000 to October 2015. References of included studies were hand-searched. Randomized controlled trials and observational studies examining health outcomes of HIV-infected women were eligible for inclusion in this review. The Cochrane Risk of Bias tool was used for bias assessment of the included studies. Preferred reporting items for systematic reviews and meta-analyses guidelines were used for reporting. Results Of 695 studies identified, 6 retrievable studies (5 cross-sectional studies and 1 case-control study) met the inclusion criteria and were included in this study. These studies examined a total of 167 HIV-infected women in different study settings. No studies reported evidence of CD4 count, viral load, and tuberculosis, and the syphilis POC test effect on HIV-infected women was not found by this study. Included studies reported the effect of various HIV rapid tests across the following 5 maternal outcomes: timely receipt of results with a pooled effect size (ES) of 1.00 (95% confidence interval [CI], 0.98–1.02); enabling partner testing with an ES of 0.95 (95% CI, 0.85–1.04); prevention of mother-to-child transmission of HIV with an ES of 0.86 (95% CI, 0.79–0.93); linkage to antiretroviral treatment with an ES of 0.76 (95 CI, 0.69–0.84); and linkage to HIV care with an ES of 0.50 (95% CI, 0.18–0.82). No studies reported evidence of the effect of POC testing on maternal mortality or maternal and child morbidity of HIV-infected women. Conclusions The review provides an international overview of the effect of HIV POC diagnostics on maternal outcomes in HIV-infected women, showing the evidence that the HIV POC test is significantly associated with decreased mother-to-child transmission of HIV and increased linkage to antiretroviral treatment and HIV care for HIV-infected women. It also revealed a gap in the literature aimed at assessing the effect of POC diagnostics on maternal morbidity and mortality in HIV-infected women. PROSPERO registration number: CRD42014015439

Experiential Bloom's Taxonomy learning framework for point-of-care diagnostics training of primary healthcare workers

The delivery of accessible, affordable and equitable primary healthcare (PHC) is a key focus in many resource-limited settings. One strategy that has been used to improve health access and healthcare equity in rural and resource-limited settings is the use of point-of-care (POC) diagnosticsin PHC clinics. POC testing is defined as: pathology testing performed in a clinical setting at the time of patient consultation, generating a result that is used to make an immediate informed clinical decision that contributes to an improved health outcome for the patient. Although itrelies on clinical, non-laboratory staff and frontline workers, such as nurses, to perform diagnostic testing, POC testing is seen as one of the ways to improve affordability, access and equity in rural areas. A primary advantage of POC diagnostics is that the completion of the test and treatment cycle in the same encounter is conducive to retention in care and patient outcomes.

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

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.

Implementation of Point-of-Care Diagnostics in Rural Primary Healthcare Clinics in South Africa: Perspectives of Key Stakeholders

Introduction: Key stakeholders’ involvement is crucial to the sustainability of quality point-of-care (POC) diagnostics services in low-and-middle income countries. The aim of this study was to explore key stakeholder perceptions on the implementation of POC diagnostics in rural primary healthcare (PHC) clinics in South Africa. Method: We conducted a qualitative study encompassing in-depth interviews with multiple key stakeholders of POC diagnostic services for rural and resource-limited PHC clinics. Interviews were digitally recorded and transcribed verbatim prior to thematic content analysis. Thematic content analysis was conducted using themes guided by the World Health Organisation (WHO) quality-ASSURED (Affordable, Sensitive, Specific, User friendly, Rapid and to enable treatment at first visit and Robust, Equipment free and Delivered to those who need it) criteria for POC diagnostic services in resource-limited settings. Results: 11 key stakeholders participated in the study. All stakeholders perceived the main advantage of POC diagnostics as enabling access to healthcare for rural patients. Stakeholders perceived the current POC diagnostic services to have an ability to meet patients’ needs, but recommended further improvement of the following areas: research on cost-effectiveness; improved quality management systems; development of affordable POC diagnostic and clinic-based monitoring and evaluation. Conclusions: Key stakeholders of POC diagnostics in rural PHC clinics in South Africa highlighted the need to assess affordability and ensure quality assurance of current services before adopting new POC diagnostics and scaling up current POC diagnostics.

Role, structure and effects of medical tourism in Africa: a systematic scoping review protocol

Introduction Some patients travel out of, while others come into Africa for medical care through a growing global phenomenon referred to as medical tourism (MT): the travel in search of medical care that is either unavailable, unaffordable or proscribed at home healthcare systems. While some castigate MT as promoting healthcare inequity, others endorse it as a revenue generator, promising local healthcare system strengthening. Currently, however, the understanding of this component of healthcare in Africa is inadequate. This study seeks to determine the level of knowledge on the role, structure and effect of MT in Africa as it relates to healthcare systems in the region. Methods Conduct a systematic scoping review to outline the role, structure and effect of MT in Africa. Databases: Academic Search Complete, Business Source Complete. Studies mapped in two stages: (1) mapping the studies based on the relevance of their titles and subject descriptors; (2) applying further inclusion criteria on studies from stage 1. Two reviewers will independently assess study quality and abstract data. Both quantitative and qualitative data analysis will be performed, using STATA V.13 and NVIVO, respectively. Ethics and dissemination The study results will be disseminated by publication in peer-reviewed journals and findings presented at academic and industry conferences related to MT, public health, health systems strengthening and tourism. Discussion MT spurs cutting-edge medical technologies, techniques and best practices in healthcare delivery. The two-tier healthcare landscape in Africa, however, presents an exceptionally unique context in which to situate this study. Much has been written about MT globally, but not much is known about the phenomenon in Africa; hence the appropriateness of this scientific assessment of MT in the region. By elucidating the role, structure and effect of this phenomenon, this study hopes to contribute to health systems strengthening in Africa. PROSPERO registration number CRD42016039745.

Gender-based violence and absent fathers: a scoping review protocol

Introduction Gender-based violence (GBV) and absent fathers are two epidemics that affect women and children in sub-Saharan Africa. However, the understanding of the complex links between GBV and absent fathers is currently inadequate. The aim of the study is to provide an overview of documented evidence that links GBV and absent fathers as well as identifies areas that require systematic review and where more primary research is needed. Methods and analysis The search strategy for this scoping review study will involve electronic databases including: Academic Search Premier, Ingenta, Kluwer Online, PsycARTICLES (EBSCO), PsycINFO (EBSCO), Social Work Abstracts and Sociological Collection. The studies will be mapped in 2 stages: stage 1 will map studies descriptively by focus and method; stage 2 will involve additional inclusion criteria, quality assessment and data extraction undertaken by two reviewers in parallel. A thematic analysis of the studies will be carried out to extract relevant outcomes using NVIVO. Discussion We anticipate finding a large number of studies on GBV diagnostic interventions in sub-Saharan Africa which, once summarised, will be useful to guide future research. The protocol for the scoping review has been registered in PROSPERO. Dissemination The study will be disseminated electronically and in print. It will also be presented to conferences related to GBV, Father Connections and Childrens Health. PROSPERO registration number CRD42015022094.

Mobility and increased risk of HIV acquisition in South Africa: a mixed-method systematic review protocol

BackgroundIn South Africa (home of the largest HIV epidemic globally), there are high levels of mobility. While studies produced in the recent past provide useful perspectives to the mobility-HIV risk linkage, systematic analyses are needed for in-depth understanding of the complex dynamics between mobility and HIV risk. We plan to undertake an evidence-based review of existing literature connecting mobility and increased risky sexual behavior as well as risk of HIV acquisition in South Africa.Methods/designWe will conduct a mixed-method systematic review of peer-reviewed studies published between 2000 and 2015. In particular, we will search for relevant South African studies from the following databases: MEDLINE, EMBASE, Web of Science, and J-STOR databases. Studies explicitly examining HIV and labor migration will be eligible for inclusion, while non-empirical work and other studies on key vulnerable populations such as commercial sex workers (CSW) and men who have sex with men (MSM) will be excluded.DiscussionThe proposed mixed-method systematic review will employ a three-phase sequential approach [i.e., (i) identifying relevant studies through data extraction (validated by use of Distiller-SR data management software), (ii) qualitative synthesis, and (iii) quantitative synthesis including meta-analysis data]. Recurrent ideas and conclusions from syntheses will be compiled into key themes and further processed into categories and sub-themes constituting the primary and secondary outcomes of this study. Synthesis of main findings from different studies examining the subject issue here may uncover important research gaps in this literature, laying a strong foundation for research and development of sustainable localized migrant-specific HIV prevention strategies in South Africa.Systematic review registrationOur protocol was registered with PROSPERO under registration number: CRD 42017055580. (https://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42017055580)