Assessing training needs in health research ethics: a case study from the University of Zambia School of Medicine.

In many settings, and perhaps especially in low-middle income countries, training institutions do not adequately prepare their students for the ethical challenges that confront them in professional life. We conducted a survey to assess the training needs in research ethics among the faculty at the University of Zambia, School of Medicine (UNZASoM) using a structured questionnaire distributed to faculty members in January 2015. The study was approved by the University of Zambia Biomedical Research Ethics Committee. Seventy-five faculty members of various ranks completed the questionnaire. It was found that 31% of the faculty had not received any research ethics training. Of those who had received training, most of them had received it through short workshops of five days or less (57.4%, n = 31), while only 27.7% received ethics training as a component of an academic degree and 22.2% obtained it through electronic web-based courses. While most faculty (70.7%) reported being well-prepared to guide their students in developing a research methods section of a research protocol, only 25.3% felt they were well-prepared to guide on ethical considerations. This study has demonstrated gaps in research ethics training among faculty members at UNZASoM. Mandatory instruction in research ethics among faculty and students is recommended.

Prevalence of iodine deficiency among pregnant women in Gwembe and Sinazongwe districts of Southern Province, Zambia: a cross-sectional study.

BACKGROUND: Maternal iodine deficiency is one of the common causes of morbidity and mortality during pregnancy. Maternal iodine deficiency during pregnancy is associated with a number of adverse outcomes such as abortion, stillbirth, congenital anomalies, perinatal mortality and irreversible mental retardation. A study conducted in Zambia among pregnant women in 2013 on the prevalence of iodine deficiency showed that iodine deficiency was not a public health concern. The previous study used Urine Iodine concentration (UIC) as a marker of iodine deficiency among the pregnant women. Our study was conducted to assess the prevalence of iodine deficiency among pregnant women in Gwembe and Sinazongwe districts of Southern Province, Zambia, using urine iodine concentration and goitre presence by manual palpation. METHODS: We carried out a community based, cross sectional study in rural areas of Gwembe and Sinazongwe districts between April 2016 to March 2018. Data were collected from 412 pregnant women by a multistage cluster sampling technique. The presence of a goitre was examined by manual palpation and urinary iodine concentration was determined by the Ultra Violet Method using PerkinElmer Labda UV Spectrometer equipment made in Jena Germany (Model 107,745). As part of the existing baseline data, we used results of a 2013 countrywide study (n = 489) for household salt iodine content which showed a greater than 40 ppm at 76.2%, between 15 and 40 ppm at 19.21% and less than 15 ppm at 4.59%. Statistical analysis was done using Stata version 14.0. The outputs of analysis are presented as median and Interquartile range (IQR) as the urine data were not normally distributed. Further, the categorical and independent variables were presented as proportions (percentages) to describe the distribution and trends in the target sample population. RESULTS: The median Urine Iodine concentration (UIC) of the pregnant women was 150 µg/L (Interquartile Range (IQR): 100-200 µg/L). Based on the UIC, There were 49% pregnant women who had inadequate iodine intake with urine iodine concentration of less than 150 µg/L, 34.0% had UIC of 150-249 µg/L indicating adequate iodine intake, 13.0% with UIC of 250-499 µg/L indicating more than adequate iodine intake, and 5.0% with UIC of above 500 µg/L indicating excessive iodine intake. To determine whether the women had access to iodized salt, we used baseline data from 2013 Zambia national survey for iodine concentration in household salt samples as being an average of 40 ppm, which also showed that 95.41% households consumed adequately iodized salt (≥15 ppm). The prevalence of goitre in our study was very low at 0.02% among the pregnant women of all ages who participated in the study (18-49 years). CONCLUSION: Iodine deficiency was still not a public health concern among the pregnant women of Gwembe and Sinazongwe districts of Southern Province in Zambia. Goitre prevalence has remained very low in this study area. The UIC and goitre observations were consistent with the Zambia National Food and Nutrition Commission findings in 2013 report. However, our study showed more pregnant women with insufficient than adequate iodine status indicating the risk of developing IDD is still high in this region. It also reinforces the argument that strengthening of the existing salt iodization program is needed in order to make a homogenous iodated salt available to the communities. The National Food and Nutrition Commission of Zambia needs to find innovative ways of sensitizing people about the adverse effects of IDDs and how these could be prevented. It is recommended that iodine supplementation be introduced as part of the package of Antenatal clinic care for all pregnant women.

Perceptions on the feasibility of decentralizing phlebotomy services in community anti-retroviral therapy group model in Lusaka, Zambia.

BACKGROUND: The focus of the community anti-retroviral therapy Group model is on drug refill, adherence and support groups. However, laboratory services are completely neglected in this model, and stable patient still have to go to the clinic for blood draws after drugs refills from the community. Due to the introduction of new ART drugs, the guidelines now recommend the use of viral loads to guide decision in switching all patients from NNRTI to dolutegravir based first line ART regimens. But the national viral load testing coverage stands at 37% and and falls short of meeting the global UNAIDS and phlebotomy delivery system is congested. The purpose of this study was to identify the perceptions in decentralizing phlebotomy services into the community anti-retroviral therapy Group model. METHOD: A qualitative case study design was used. Data were collected through ten Focused group discussions among community anti-retroviral therapy Group members, community and health care workers at anti-retroviral therapy clinics and in-depth interviews with five key informants. Data were managed with the help of Nvivo version 10 and analyzed using thematic method. RESULTS: Positive perceptions were identified as those which contributed to decongesting phlebotomy rooms, reduced missing phlebotomy appointments, work Load, and lost results. Improved quality of phlebotomy service delivery and testing coverage, innovative access to laboratory services and encouraged patient's accountability. The negative perceptions were compromised sample integrity, inability to perform prevention control and patients less contact with clinicians. CONCLUSION: The study has demonstrated that decentralizing phlebotomy services within the CAG model has greater potential to improve the quality of services delivery for patients. In addition, it has perceived threats on the quality of specimen collected, patient's safety, and health care.

Challenges for health care providers, parents and patients who face a child hood cancer diagnosis in Zambia.

BACKGROUND: Zambia is experiencing high prevalence of childhood cancer. However, very few children access and complete treatment for cancer. This study aimed to document the challenges for health care providers, parents and patients who face a child hood cancer diagnosis in Zambia, and their coping strategies. METHODS: This was an exploratory health facility-based qualitative study that was conducted at a Paediatric oncology ward at referral hospital in Zambia. In-depth individual interviews conducted with fifteen (15) caregivers and seven (7) key informants were analysed using thematic analysis. RESULTS: Several challenges related to managing the childhood cancer diagnosis were recorded. Individual and family challenges were inadequate knowledge on childhood cancer, lack of finances to meet treatment and transport costs as well as long period of hospitalisation that affected women's ability to perform multiple responsibilities. Whereas challenges at community level were inadequate support to address emotional and physical distress and social stigmatisation experienced by caregivers. Health systems issues included inadequate specialised health workers, poor communication among health workers, limited space and beds as well as insufficient supplies such as blood. Cultural related factors were the belief that cancer is a product of witchcraft as well as religious beliefs regarding the role of faith healing in childhood cancer treatment. Coping strategies used by parents/ caregivers included praying to God, material support from organisations and church as well as delaying having another child. CONCLUSION: Addressing the challenges for health care providers, parents and patients who face a childhood cancer diagnosis may require adopting a systems or an ecological approach that allows developing strategies that simultaneously address challenges related to the individual, family, community, health system and cultural aspects.

Rapid assessment of institutional research ethics capacity: a case study from Zambia / Evaluación rápida de la capacidad institucional de investigación ética: un estudio de caso en Zambia / Avaliação rápida da capacidade institucional de ética em pesquisa: um estudo de caso na Zâmbia

Abstract: Recently, there has been a remarkable increase in biomedical research being conducted in low and middle-income countries. This increase has brought attention to the need for high quality research ethics systems within these countries and a greater focus on research ethics training. Though most programs tend to concentrate on training individuals, less attention has focused on institutions as the target of such training. In this paper we demonstrate a rapid approach to evaluating institutional research capacity. The method adapts the Octagon Model, which evaluates institutional research ethics using eight domains: basic values and identity, organization of activities, implementation, relevance, proper skills, financing and administration, target groups, and working environment. The framework was applied to the University of Zambia in order to conduct a baseline assessment of university research ethics capacity. Internal and external assessments were conducted. The domains of working environment and proper skills scored highest, while relevance, target groups and identity scored lower. Consistent with previous work, a systems approach to evaluating institutional research development capacity can provide a rapid assessment of an institutional bioethics program. This case study reveals the strengths and weaknesses of the university's research ethics program and provides a framework for future capacity growth.

Resumen: Recientemente, ha habido un notable aumento en la investigación biomédica en países de ingresos bajos y medianos. Este aumento ha llamado la atención sobre la necesidad de sistemas éticos de investigación de alta calidad en estos países y un mayor enfoque en la formación en ética de la investigación. Aunque la mayoría de los programas tienden a concentrarse en la formación de los individuos, menos atención se ha centrado en las instituciones como objetivo de dicha formación. En este trabajo se demuestra un enfoque rápido para evaluar la capacidad de investigación institucional. El método adapta el modelo Octagon, que evalúa la ética institucional de la investigación utilizando ocho dominios: valores básicos e identidad, organización de actividades, implementación, relevancia, habilidades adecuadas, financiamiento y administración, grupos objetivo y ambiente de trabajo. El marco se aplicó a la Universidad de Zambia, con el fin de realizar una evaluación inicial de la capacidad de ética de la investigación universitaria. Se realizaron evaluaciones internas y externas. Los ámbitos del entorno de trabajo y de las competencias apropiadas obtuvieron el puntaje más alto, mientras que la relevancia, los grupos objetivo y la identidad obtuvieron calificaciones más bajas. De acuerdo con trabajos previos, un enfoque sistémico para evaluar la capacidad de desarrollo institucional de la investigación puede proporcionar una evaluación rápida de un programa institucional de bioética. Este estudio de caso revela las fortalezas y debilidades del programa de ética de la investigación de la universidad y proporciona un marco para el futuro crecimiento de la capacidad.

Resumo: Recentemente, tem havido um notável aumento na investigação biomédica em países de renda baixa e média. Este aumento tem chamado a atenção para a necessidade de sistemas éticos de pesquisa de alta qualidade nesses países e um maior foco na formação em ética em pesquisa. Embora a maioria dos programas tende a se concentrar na formação dos indivíduos, menos atenção centrou-se em instituições como objetivo dessa formação. Este trabalho demonstra uma aproximação rápida para avaliar a capacidade de pesquisa institucional. O método adapta o modelo Octagon, que avalia a ética institucional de pesquisa usando oito domínios: valores básicos e identidade, organização das atividades, implementação, pertinência, competências adequadas, financiamento e administração, os grupos-alvo e ambiente de trabalho. O quadro foi aplicado para a Universidade da Zâmbia, a fim de fazer uma primeira avaliação da capacidade de ética em pesquisa universitária. Foram realizadas avaliações internas e externas. Os campos do ambiente trabalho e competências adequadas, obtiveram a maior pontuação, enquanto a relevância, grupos-alvo e identidade obtiveram qualificações inferiores. De acordo com trabalhos anteriores, uma abordagem sistêmica para avaliar a capacidade dedesenvolvimento institucional de pesquisa pode fornecer uma avaliação rápida de um programa institucional de bioética. Este estudo de caso revela os pontos fortes e pontos fracos do programa de ética em pesquisa da Universidade e fornece uma estrutura para o crescimento futuro da capacidade.

'Rumours' and clinical trials: a retrospective examination of a paediatric malnutrition study in Zambia, southern Africa.

BACKGROUND: Many public health researchers conducting studies in resource-constrained settings have experienced negative 'rumours' about their work; in some cases they have been reported to create serious challenges and derail studies. However, what may appear superficially as 'gossip' or 'rumours' can also be regarded and understood as metaphors which represent local concerns. For researchers unaccustomed to having concerns expressed from participants in this manner, possible reactions can be to be unduly perturbed or conversely dismissive.This paper represents a retrospective examination of a malnutrition study conducted by an international team of researchers in Zambia, Southern Africa. The fears of mothers whose children were involved in the study and some of the concerns which were expressed as rumours are also presented. This paper argues that there is an underlying logic to these anxieties and to dismiss them simply as 'rumours' or 'gossip' would be to overlook the historic and socio-economic factors which have contributed to their production. METHODS: Qualitative interviews were conducted with the mothers whose children were involved in the study and with the research nurses. Twenty five face-to-face interviews and 2 focus group discussions (FGDs) were conducted with mothers. In addition, face-to-face interviews were conducted with research nurses participating in the trial. RESULTS: A prominent anxiety expressed as rumours by the mothers whose children were involved in the study was that recruitment into the trial was an indicator that the child was HIV-infected. Other anxieties included that the trial was a disguise for witchcraft or Satanism and that the children's body parts would be removed and sold. In addition, the liquid, milk-based food given to the children to improve their nutrition was suspected of being insufficiently nutritious, thus worsening their condition.The form which these anxieties took, such as rumours related to the stealing of body parts and other anxieties about a stigmatised condition, provide an insight into the historical, socio-economic and cultural influences in such settings. CONCLUSIONS: Employing strategies to understand local concerns should accompany research aims to achieve optimal success. The concerns raised by the participants we interviewed are not unique to this study. They are produced in countries where the historic, socio-economic and cultural settings communicate anxieties in this format. By examining this study we have shown that by contextualizing these 'rumours', the concerns they express can be constructively addressed and in turn result in the successful conduct of research aims.

Barriers to initiation of antiretroviral treatment in rural and urban areas of Zambia: a cross-sectional study of cost, stigma, and perceptions about ART.

BACKGROUND: While the number of HIV-positive patients on antiretroviral therapy (ART) in resource-limited settings has increased dramatically, some patients eligible for treatment do not initiate ART even when it is available to them. Understanding why patients opt out of care, or are unable to opt in, is important to achieving the goal of universal access. METHODS: We conducted a cross-sectional survey among 400 patients on ART (those who were able to access care) and 400 patients accessing home-based care (HBC), but who had not initiated ART (either they were not able to, or chose not to, access care) in two rural and two urban sites in Zambia to identify barriers to and facilitators of ART uptake. RESULTS: HBC patients were 50% more likely to report that it would be very difficult to get to the ART clinic than those on ART (RR: 1.48; 95% CI: 1.21-1.82). Stigma was common in all areas, with 54% of HBC patients, but only 15% of ART patients, being afraid to go to the clinic (RR: 3.61; 95% CI: 3.12-4.18). Cost barriers differed by location: urban HBC patients were three times more likely to report needing to pay to travel to the clinic than those on ART (RR: 2.84; 95% CI: 2.02-3.98) and 10 times more likely to believe they would need to pay a fee at the clinic (RR: 9.50; 95% CI: 2.24-40.3). In rural areas, HBC subjects were more likely to report needing to pay non-transport costs to attend the clinic than those on ART (RR: 4.52; 95% CI: 1.91-10.7). HBC patients were twice as likely as ART patients to report not having enough food to take ART being a concern (27% vs. 13%, RR: 2.03; 95% CI: 1.71-2.41), regardless of location and gender. CONCLUSIONS: Patients in home-based care for HIV/AIDS who never initiated ART perceived greater financial and logistical barriers to seeking HIV care and had more negative perceptions about the benefits of the treatment. Future efforts to expand access to antiretroviral care should consider ways to reduce these barriers in order to encourage more of those medically eligible for antiretrovirals to initiate care.