3. Electronic Theses and Dissertations (ETDs) - All submissions
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Item Enrollers’ perceptions of communication during informed consent at a South African tuberculosis research site(2018) Nolle, SamanthaThe informed consent process (ICP) in clinical trials is an interaction of communication: one in which important information should be adequately conveyed by the enroller and sufficiently understood by the potential participant. However, barriers to effective communication are often encountered during the process and result in participants’ comprehension of information being compromised. This study aimed to use qualitative methods to explore the reported experiences of thirteen enrollers involved in the ICP pre- and post- the implementation of a communication training programme in a Human Immunodeficiency Virus (HIV) and tuberculosis (TB) research study in Rustenburg, South Africa. The communication training programme aimed to improve communication processes during the ICP and enhance participant comprehension of information. This study used journaling and FGDs as data collection methods. Inductive thematic analysis was used to explore the reported experiences of enrollers during the ICP, and to identify perceived barriers and facilitators to communication during these interactions. Findings revealed language-, procedure- and participant-related facilitators and barriers. Furthermore, communication and language strategies employed by enrollers to overcome reported barriers were discussed. Several strategies paralleled the communication and language skills taught during the communication skills training. Many of these strategies were found to facilitate communication processes within the enroller-participant interaction, improve understandings of the informed consent form (ICF) and obtain proper informed consent. These findings confirm that enrolment is a complex process impacted by many variables. Keywords: informed consent, communication, enrollers, clinical researchItem The pharmacokinetics and pharmacodynamics of kanamycin and capreomycin in patients with drug resistant-tuberculosis and the relationship between hearing levels: a feasibility study(2018) Hollander, CaraIndividuals respond differently to medication as a result of their genetic inheritance. These differences can result in the under- or over-dosing of medication, which may affect the efficacy or in the case of aminoglycosides (kanamycin) and polypeptides (capreomycin), result in toxicity. In South Africa, administration of the standardised Drug Resistant -Tuberculosis (DR-TB) medication regimen is simplified across four weight bands. These bands accommodate the formulations available in the country while complying with international requirements for minimum, maximum and average dose per kilogram. There is a dearth of information on the ideal concentration, pharmacokinetics, and pharmacodynamics of kanamycin (KM) and capreomycin (CM) in patients with DR-TB and relationship of this on hearing levels. Thus, this study aimed to establish the feasibility of investigating the pharmacokinetics and pharmacodynamics of kanamycin and capreomycin in patients with DR-TB and the relationship between hearing levels. This feasibility study employed a prospective, cross-sectional, exploratory, descriptive and case series research design. A total of 22 participants (mean age 33.78 years, ±7.3) participated in this multi-site study at Helen Joseph (HJH) and South Rand Hospitals (SRH). The majority of the paryicpants were females (68%, n=15). Participants underwent audiological (otoscopy, tympanometry, ultra high frequency DPOAEs, ultra high frequency pure tone audiometry) and pharmacological assessments at baseline and every two weeks for the first three months of treatment. Creatinine clearance was measured, and the overall outcome of treatment was evaluated in relation to the pharmacokinetics. Results revealed high-frequency hearing loss with both kanamycin and capreomycin, specifically in the ultra-high frequencies (9kHz to 16kHz). Clinically significant ultra-high frequency loss noted was with pure tone audiometry from week four after the initiation of treatment, and from week six in the high frequencies (6kHz to 8kHz). Pharmacokinetic measurements showed erratic levels of kanamycin and capreomycin, with considerable differences among individuals, specifically with the peak readings. Mean peak levels for kanamycin were within the target range yet were subtherapeutic for the capreomycin participants. Kanamycin also correlated to more reduced kidney function when compared to capreomycin. Participants’ culture converted within the first two months from baseline, however, long-term culture results are unknown. Trough levels were also below 10 μg/ml and not within a toxic range, despite the hearing loss detected. This research identified many challenges with regard to establishing the feasibility of investigating the pharmacokinetics and pharmacodynamics of kanamycin and capreomycin in patients with DR-TB and the relationship between hearing levels. Participant enrolment was poor, with high attrition. This study also highlighted the need for a standardised ototoxicity monitoring protocol designed for this population which led to the development of ‘Ototcalc’: an ototoxicity calculator in the form of a mobile application designed to assist healthcare professionals in the classification of significant ototoxicity as well as with management recommendations. With the considerations identified in this study to further enhance the feasibility, the pharmacokinetics and pharmacodynamics of kanamycin and capreomycin are recommended for further exploration in relation to toxicity and efficacy with a larger sample, combined with the use of ‘Otocalc’.Item A longitudinal study of migration and it relation to AIDS/TB mortality in rural South Africa(2017) Afolabi, Sulaimon AtolagbeBackground: In exploring the relationship between migration and HIV/AIDS, a focus of earlier studies was on the role of the mobile population in the geographical spread of the disease. There has been a shift in this perception and the focus now is on the implications of being a migrant. A body of literature has developed on the risk of migrants contracting HIV, but only a few studies have examined the AIDS/TB mortality risk as a consequence of migration, with the results showing that migrants have higher chance of dying of AIDS/TB compared to their non-migrant counterparts. However, these studies mainly looked at the impact of migration on mortality due to AIDS/TB and did not make provision for the presence of other causes of death. Therefore, this study is geared towards investigating migration as it relates to death caused by AIDS/TB, longitudinally, and in the presence of other causes such as non communicable diseases, other infectious diseases, and external causes of death, in rural South Africa. Specifically, the study addressed the following questions: (i) What is the risk of dying from AIDS/TB among migrants in rural South Africa in the presence of other causes of death? (ii) How does this relationship compare with the relationship between migration and other causes of death? (3) What are possible predictors of the relationship between migration and AIDS/TB in the presence of other causes of death? Method: This research project is part of a longitudinal study of the inhabitants of the Agincourt sub-district, situated in the rural north-eastern part of South Africa. The study utilises the Agincourt Health and Demographic Surveillance System data spanning 12 years, starting from 1st January, 2000 to 31st December, 2011. The main target group for the study is individuals aged 20 to 69 years at the date of analysis. The selected individuals are divided into the following categories: (i) the return migrants who returned after spending a period of time outside the study area; (ii) the in-migrants who moved into the study location for the first time, and (iii) the permanent residents (non migrants). A six month residence threshold period is used to distinguish participants from ordinary visitors. The migration status categorical variable was further expanded from three to five categories with in-migrant and return migrant categories being split to accommodate short and long-term durations of exposure. In the year 2000, the baseline year, a total of 25,621 individuals who met the entry criteria were recruited into the study. For data analysis, a Fine and Gray model is used, which is a variant of a Cox proportional hazard model, to estimate the competing risk of dying among the selected participants by sex. The causes of death (CoD) variable was categorised into the following broad categories: “AIDS/TB”, “Non Communicable Disease”, “External cause” and “Other infectious disease”, with indeterminate causes coded as missing. The five categories of migration serve as the independent variable, with permanent residence acting as the reference group, while the broad Cause of Death categories are the main dependent variables. Other dependent variables are: period, nationality, education and socio-economic status. Results: This first set of results aims to address the question on the risk of AIDS/TB mortality among migrants in rural South Africa in the presence of other causes of death. The findings are that male and female short-term return migrants have significantly higher relative risk of dying of AIDS/TB death when compared to their non-migrants counterparts with sub-hazard ratio (SHR) of 4.87 (95% CI 4.17-5.72; P<0.001) and 5.44 (95% CI 4.64-6.38; P<0.001)) reported for both gender group respectively. For male and female long-term return migrants, their SHR was 1.80 (95% CI 1.43-2.26; P<0.001) and 2.06 (95% CI 1.57-2.70; P<0.001) respectively. The results did not reveal significant results for the in-migrants. The second set of results aims to address the second research question, which is, how does the relationship between migration and mortality caused by AIDS/TB in rural South Africa in the context of other causes of death compare with the relationship between migration and causes different from AIDS/TB. The results show that Short-term return migrants have higher mortality than non-migrants, whatever the four causes of mortality. For instance, the competing risk of death due to AIDS/TB for short-term return migrants compared to non-migrants showed a lower SHR for external cause of death, namely 8.78 (95% CI 5.86-13.16; P<0.05) vis-à-vis non-migrants. This implies that the difference in the relative risk of mortality between migrants and non migrants is even higher for external causes than for AIDS/TB. The same is applicable to the risk of death from other infectious diseases for females, which has a SHR of 4.97 (95% CI 2.50-9.89; P<0.05) in the competing risk model. The relative risk of death due to AIDS/TB for male is 4.87 (95% CI 4.14-5.72 P<0.001) while that of female is 5.44 (95% CI 4.64-6.38; P<0.001); respectively. With regards to the question on the possible predictors of the relationship between migration and AIDS/TB in the presence of other causes of death, it is shown that period is one of the predictors of the relationship between migration and AIDS/TB mortality. And, it is relevant to the study participants who died as a result of AIDS/TB, NCDs and other infectious diseases. In general, the risk dwindles in the latter period when the antiretroviral drugs become available for AIDS/TB. Nationality is also a determinant of the relationship and it is applicable to those who lost their lives due AIDS/TB (female only), NCDs and other infections (female). In all, the Mozambican nationals are less likely to die in comparison with the South Africans. Educational status is a predictor and it relevance cuts across virtually all the causes of death. The dominant pattern that is revealed in this context is that the higher the level of education, the lower the risk of death due to any of the causes. The predictive impact of SES can only be felt among the respondents whose death was due to AIDS/TB and NCDs (female only). Conclusion: With circular labour migration in South Africa showing no evidence of declining and with the attendant mortality risks due to AIDS/TB and other causes, and needs to be carefully considered - in policies aiming to control mortality in South Africa. Disease-induced migration creates burdens not only for the left-behind families in terms of their means of livelihood through loss of remittances, but also for the burden on health care facilities in the rural area. With short-term labour migrants being a high risk group, the success of intervention programmes addressing the problem of HIV infection and the resultant mortality implication, such as ‘treatment as prevention’ programmes, can only be guaranteed by recognising the risks incumbent on this group of people and the influence of the larger communities.Item Non-European tuberculosis in South Africa(2014-08-14) Rossiter, Nicholas A.