7 research outputs found

    Assessing Compliance to the World Health Organization Schedule for Antenatal Care in Swaziland : a retrospective analysis

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    Dissertation (MPH)--University of Pretoria, 2014.In 2001, the World Health Organization (WHO) proposed to developing countries a different approach to antenatal care (ANC) service delivery called the “Goal-oriented” or “focused ANC” (FANC) approach. Since then, a number of countries have adopted this approach and Swaziland is one of the countries. Fundamentally, this model helps in reducing the number of ANC visits women need to make during pregnancy, placing more emphasis on birth planning, emergency preparedness and identification, prevention and management of life threatening complications during pregnancy, labour and delivery. Swaziland like many African states has encountered several challenges in implementing this approach. About 97 percent of pregnant women visit health facilities during pregnancy, close to 80 percent make at least four ANC visits (Swaziland Demographic and Health Survey 2006/7) but the challenge is the country does not have empirical evidence on compliance to the WHO focused approach. To assess compliance with the Focused ANC approach among women in Swaziland, a retrospective desk review of ANC records was be undertaken in 17 ANC facilities identified as ANC sentinel sites. The review used records of pregnant women attending ANC from 2010 to 2012. The primary objective was to assess compliance with the WHO FANC approach, using data from 2010-2012. The limitation of the study approach is that only existing information collected for patient monitoring was used, therefore additional information that would have been necessary for the analysis was unfortunately unavailable. There was no contact made with the women during data collection process. Epi-info was used for electronic data capturing. Data was then imported to STATA version 12 for analysis. A p-value of 0.05 was considered for statistical significance. The total sample size used was 1264 records. Descriptive statistics were generated to compare demographic information. Compliance was estimated by combining the four visits made by each woman and comparing visits with the WHO schedule for visits. Fishers exact test was used to test for probable demographic and health factors associated with compliance. The multivariate logistic regression model was used to estimate the coefficients for ANC compliance according to demographic and health factors and to control for potential confounders. Ethical clearance to conduct the study was sought from the Ministry of Health Scientific and Ethics Committee in Swaziland as well as the University of Pretoria. Permission to access data was also sought from the Strategic Information Department in the Ministry of Health. Results from this study will be used as a baseline since no other study on compliance has been done in Swaziland. The results will also be used to inform future FANC implementation as Swaziland has already reviewed the focused ANC guidelines. On the other hand, WHO is reviewing the focused ANC guidelines which will be shared with countries for adaption. This study has come just at an opportune time as results can also be used to inform the finalization of the new FANC guidelines at the global level. The findings will be presented at the University of Pretoria School of Health Systems and Public Health seminar and also at a national stakeholders’ meeting, as well as local and international conferences. Findings will also be published in the WHO Bulletin. The study found that women in Swaziland did not comply with the Focused ANC schedule. Overall compliance was 0.87% (CI: 04-1.4). There was however an observed improvement in compliance over the years, where women who presented for ANC in 2012 were four (4) times more compliant than those who presented in 2010 (OR: 3.8). These findings are presented as a journal article in partial fulfilment of the requirements for the award of a Master’s degree in Public Health at the University of Pretoria. Miss. Nomsa Mulima is the first author and Professor Andy Beke and SAS Shade Ajayi Steve Olorunju are the second and third authors respectively.tm2015School of Health Systems and Public Health (SHSPH)MPHUnrestricte

    ''Factors Inhibting Effective Teaching of Physical education: A Case Study of Selected Basic schools in Mbala District, Zambia''

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    This study was set to find out the factors inhibiting the effective teaching of physical education in some Basic schools. It was conducted in ten (10) selected urban and rural basic schools of Mbala district. The data were collected using questionnaires for the teachers, pupils, school managers and standards officers. Also face to face interviews for physical education teachers and school managers were conducted. The sample size consisted of 174 respondents made up of one hundred and fifty (150) pupils, ten (10) physical education teachers, ten school managers and four standards officers from the District Education Board Secretary's Office. The findings of the study revealed that physical education was being taught in all the sampled schools and that two periods per week were allocated.All the teacher respondents were trained to teach physical education despite the problem of understaffing.Further results revealed that physical education equipment and materials were none existent in schools except for balls hence the number of pupils who got involved in physical education activities was relatively small while the majority merely watched without getting the benefit. On the other hand the perception of both teachers and pupils towards the teaching of physical education was positive and that school managers and standards officers had taken proactive role in supporting the teaching of physical education. In view of the findings the author made a number of recommendations such as: • That the government beefs up the training of physical education teachers to help solve the prevailing problems. • That the government should consider providing different types of equipment to schools and in increased numbers where need be and • That the Ministry of Education should ensure that all schools have physical education facilities such as play grounds, gymnasiums and swimming pools so as to allow the majority of the pupils to get involved

    ''Factors inhibiting effective teaching of Physical Education: A case study of selected Basic Schools in Mbala, Zambia.

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    This study was set to find out the factors inhibiting the effective teaching of physical education in some Basic schools. It was conducted in ten (10) selected urban and rural basic schools of Mbala district. The data were collected using questionnaires for the teachers, pupils, school managers and standards officers. Also face to face interviews for physical education teachers and school managers were conducted. The sample size consisted of 174 respondents made up of one hundred and fifty (150) pupils, ten (10) physical education teachers, ten school managers and four standards officers from the District Education Board Secretary's Office. The findings of the study revealed that physical education was being taught in all the sampled schools and that two periods per week were allocated. nAll the teacher respondents were trained to teach physical education despite the problem of under-staffing. Further results revealed that physical education equipment and materials were none existent in schools except for balls hence the number of pupils who got involved in physical education activities was relatively small while the majority merely watched without getting the benefit. On the other hand the perception of both teachers and pupils towards the teaching of physical education was positive and that school managers and standards officers had taken proactive role in supporting the teaching of physical education. In view of the findings the author made a number of recommendations such as:That the government beefs up the training of physical education teachers to help solve theprevailing problems.• That the government should consider providing different types of equipment to schools and in increased numbers where need be and• That the Ministry of Education should ensure that all schools have physical education facilities such as play grounds, gymnasiums and swimming pools so as to allow the majority of the pupils to get involved

    Effect of dolutegravir on folate, vitamin B12 and mean corpuscular volume levels among children and adolescents with HIV: a sub‐study of the ODYSSEY randomized controlled trial

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    Introduction: Dolutegravir-based antiretroviral therapy (ART) is the preferred antiretroviral treatment for children and adolescents living with HIV. A large surveillance study in Botswana previously raised concerns about an association between preconception dolutegravir and neural tube defects. Before these concerns were subsequently resolved, we set up a sub-study to look at the effect of dolutegravir on levels of folate and vitamin B12 in children and adolescents within the randomized ODYSSEY trial, as folate and vitamin B12 are known to play a crucial role in neural tube development.Methods: We conducted the sub-study among Ugandan ODYSSEY participants and compared folate and vitamin B12 between children randomized to dolutegravir-based ART (DTG) and non-dolutegravir-based standard-of-care treatment (SOC). Plasma folate was measured at enrolment and week 4 on stored samples; in addition, plasma and red blood cell (RBC) folate and vitamin B12 were assayed at week >= 96 in prospectively collected samples. RBC mean corpuscular volume (MCV) was measured 24-weekly in all ODYSSEY participants. Samples analysed in the sub-study were collected between September 2016 and October 2020.Results: A total of 229 children aged >= 6 years were included in the sub-study with median age at trial enrolment of 12.3 (interquartile range [IQR] 9.0, 14.7) years, and CD4 count of 501 (IQR 228, 695); 112 (49%) children were male. Most participants (225/229, 98%) had plasma folate results at enrolment and 214 (93%) children had results available for RBC folate, vitamin B12 and plasma folate at week >= 96. MCV results were analysed on 679 children aged >= 6 years enrolled in ODYSSEY. At week 4, mean plasma folate was significantly higher in the dolutegravir arm than in SOC (difference [DTG-SOC] 1.6 ng/ml, 95% CI 0.8, 2.3; p= 96 (2.7 ng/ml, 95% CI 1.7, 3.7; p= 96 weeks was also higher in the DTG arm (difference 73 ng/ml, 95% CI 3, 143; p = 0.041). There was no difference in the treatment arms for vitamin B12 levels at >= 96 weeks or change in MCV through trial follow-up.Conclusions: Plasma and RBC folate levels were higher in children and adolescents receiving dolutegravir-based ART than on other ART regimens. Further studies are needed to clarify the mechanisms of these interactions and the clinical implications of increased blood folate levels

    Effect of dolutegravir on folate, vitamin B12 and mean corpuscular volume levels among children and adolescents with HIV: a sub‐study of the ODYSSEY randomized controlled trial

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    INTRODUCTION: Dolutegravir-based antiretroviral therapy (ART) is the preferred antiretroviral treatment for children and adolescents living with HIV. A large surveillance study in Botswana previously raised concerns about an association between pre-conception dolutegravir and neural tube defects. Before these concerns were subsequently resolved, we set up a sub-study to look at the effect of dolutegravir on levels of folate and vitamin B12 in children and adolescents within the randomized ODYSSEY trial, as folate and vitamin B12 are known to play a crucial role in neural tube development. METHODS: We conducted the sub-study among Ugandan ODYSSEY participants and compared folate and vitamin B12 between children randomized to dolutegravir-based ART (DTG) and non-dolutegravir-based standard-of-care treatment (SOC). Plasma folate was measured at enrolment and week 4 on stored samples; in addition, plasma and red blood cell (RBC) folate and vitamin B12 were assayed at week ≥96 in prospectively collected samples. RBC mean corpuscular volume (MCV) was measured 24-weekly in all ODYSSEY participants. Samples analysed in the sub-study were collected between September 2016 and October 2020. RESULTS: A total of 229 children aged ≥6 years were included in the sub-study with median age at trial enrolment of 12.3 (interquartile range [IQR] 9.0, 14.7) years, and CD4 count of 501 (IQR 228, 695); 112 (49%) children were male. Most participants (225/229, 98%) had plasma folate results at enrolment and 214 (93%) children had results available for RBC folate, vitamin B12 and plasma folate at week ≥96. MCV results were analysed on 679 children aged ≥6 years enrolled in ODYSSEY. At week 4, mean plasma folate was significantly higher in the dolutegravir arm than in SOC (difference [DTG-SOC] 1.6 ng/ml, 95% CI 0.8, 2.3; p<0.001), and this difference persisted to week ≥96 (2.7 ng/ml, 95% CI 1.7, 3.7; p<0.001). Mean RBC folate at ≥96 weeks was also higher in the DTG arm (difference 73 ng/ml, 95% CI 3, 143; p = 0.041). There was no difference in the treatment arms for vitamin B12 levels at ≥96 weeks or change in MCV through trial follow-up. CONCLUSIONS: Plasma and RBC folate levels were higher in children and adolescents receiving dolutegravir-based ART than on other ART regimens. Further studies are needed to clarify the mechanisms of these interactions and the clinical implications of increased blood folate levels

    Dolutegravir twice-daily dosing in children with HIV-associated tuberculosis: a pharmacokinetic and safety study within the open-label, multicentre, randomised, non-inferiority ODYSSEY trial

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    Background: Children with HIV-associated tuberculosis (TB) have few antiretroviral therapy (ART) options. We aimed to evaluate the safety and pharmacokinetics of dolutegravir twice-daily dosing in children receiving rifampicin for HIV-associated TB. Methods: We nested a two-period, fixed-order pharmacokinetic substudy within the open-label, multicentre, randomised, controlled, non-inferiority ODYSSEY trial at research centres in South Africa, Uganda, and Zimbabwe. Children (aged 4 weeks to <18 years) with HIV-associated TB who were receiving rifampicin and twice-daily dolutegravir were eligible for inclusion. We did a 12-h pharmacokinetic profile on rifampicin and twice-daily dolutegravir and a 24-h profile on once-daily dolutegravir. Geometric mean ratios for trough plasma concentration (Ctrough), area under the plasma concentration time curve from 0 h to 24 h after dosing (AUC0–24 h), and maximum plasma concentration (Cmax) were used to compare dolutegravir concentrations between substudy days. We assessed rifampicin Cmax on the first substudy day. All children within ODYSSEY with HIV-associated TB who received rifampicin and twice-daily dolutegravir were included in the safety analysis. We described adverse events reported from starting twice-daily dolutegravir to 30 days after returning to once-daily dolutegravir. This trial is registered with ClinicalTrials.gov (NCT02259127), EudraCT (2014–002632-14), and the ISRCTN registry (ISRCTN91737921). Findings: Between Sept 20, 2016, and June 28, 2021, 37 children with HIV-associated TB (median age 11·9 years [range 0·4–17·6], 19 [51%] were female and 18 [49%] were male, 36 [97%] in Africa and one [3%] in Thailand) received rifampicin with twice-daily dolutegravir and were included in the safety analysis. 20 (54%) of 37 children enrolled in the pharmacokinetic substudy, 14 of whom contributed at least one evaluable pharmacokinetic curve for dolutegravir, including 12 who had within-participant comparisons. Geometric mean ratios for rifampicin and twice-daily dolutegravir versus once-daily dolutegravir were 1·51 (90% CI 1·08–2·11) for Ctrough, 1·23 (0·99–1·53) for AUC0–24 h, and 0·94 (0·76–1·16) for Cmax. Individual dolutegravir Ctrough concentrations were higher than the 90% effective concentration (ie, 0·32 mg/L) in all children receiving rifampicin and twice-daily dolutegravir. Of 18 children with evaluable rifampicin concentrations, 15 (83%) had a Cmax of less than the optimal target concentration of 8 mg/L. Rifampicin geometric mean Cmax was 5·1 mg/L (coefficient of variation 71%). During a median follow-up of 31 weeks (IQR 30–40), 15 grade 3 or higher adverse events occurred among 11 (30%) of 37 children, ten serious adverse events occurred among eight (22%) children, including two deaths (one tuberculosis-related death, one death due to traumatic injury); no adverse events, including deaths, were considered related to dolutegravir. Interpretation: Twice-daily dolutegravir was shown to be safe and sufficient to overcome the rifampicin enzyme-inducing effect in children, and could provide a practical ART option for children with HIV-associated TB

    Neuropsychiatric manifestations and sleep disturbances with dolutegravir-based antiretroviral therapy versus standard of care in children and adolescents: a secondary analysis of the ODYSSEY trial

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    BACKGROUND: Cohort studies in adults with HIV showed that dolutegravir was associated with neuropsychiatric adverse events and sleep problems, yet data are scarce in children and adolescents. We aimed to evaluate neuropsychiatric manifestations in children and adolescents treated with dolutegravir-based treatment versus alternative antiretroviral therapy. METHODS: This is a secondary analysis of ODYSSEY, an open-label, multicentre, randomised, non-inferiority trial, in which adolescents and children initiating first-line or second-line antiretroviral therapy were randomly assigned 1:1 to dolutegravir-based treatment or standard-of-care treatment. We assessed neuropsychiatric adverse events (reported by clinicians) and responses to the mood and sleep questionnaires (reported by the participant or their carer) in both groups. We compared the proportions of patients with neuropsychiatric adverse events (neurological, psychiatric, and total), time to first neuropsychiatric adverse event, and participant-reported responses to questionnaires capturing issues with mood, suicidal thoughts, and sleep problems. FINDINGS: Between Sept 20, 2016, and June 22, 2018, 707 participants were enrolled, of whom 345 (49%) were female and 362 (51%) were male, and 623 (88%) were Black-African. Of 707 participants, 350 (50%) were randomly assigned to dolutegravir-based antiretroviral therapy and 357 (50%) to non-dolutegravir-based standard-of-care. 311 (44%) of 707 participants started first-line antiretroviral therapy (ODYSSEY-A; 145 [92%] of 157 participants had efavirenz-based therapy in the standard-of-care group), and 396 (56%) of 707 started second-line therapy (ODYSSEY-B; 195 [98%] of 200 had protease inhibitor-based therapy in the standard-of-care group). During follow-up (median 142 weeks, IQR 124–159), 23 participants had 31 neuropsychiatric adverse events (15 in the dolutegravir group and eight in the standard-of-care group; difference in proportion of participants with ≥1 event p=0·13). 11 participants had one or more neurological events (six and five; p=0·74) and 14 participants had one or more psychiatric events (ten and four; p=0·097). Among 14 participants with psychiatric events, eight participants in the dolutegravir group and four in standard-of-care group had suicidal ideation or behaviour. More participants in the dolutegravir group than the standard-of-care group reported symptoms of self-harm (eight vs one; p=0·025), life not worth living (17 vs five; p=0·0091), or suicidal thoughts (13 vs none; p=0·0006) at one or more follow-up visits. Most reports were transient. There were no differences by treatment group in low mood or feeling sad, problems concentrating, feeling worried or feeling angry or aggressive, sleep problems, or sleep quality. INTERPRETATION: The numbers of neuropsychiatric adverse events and reported neuropsychiatric symptoms were low. However, numerically more participants had psychiatric events and reported suicidality ideation in the dolutegravir group than the standard-of-care group. These differences should be interpreted with caution in an open-label trial. Clinicians and policy makers should consider including suicidality screening of children or adolescents receiving dolutegravir
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