Lived experiences of frontline healthcare providers offering maternal and newborn services amidst the novel corona virus disease 19 pandemic in Uganda: A qualitative study.

BACKGROUND: The COVID-19 pandemic has brought many health systems in low resource settings to their knees. The pandemic has had crippling effects on the already strained health systems in provision of maternal and newborn healthcare. With the travel restrictions, social distancing associated with the containment of theCOVID-19 pandemic, healthcare providers could be faced with challenges of accessing their work stations, and risked burnout as they offered maternal and newborn services. This study sought to understand the experiences and perceptions of healthcare providers at the frontline during the first phase of the lockdown as they offered maternal and newborn health care services in both public and private health facilities in Uganda with the aim of streamlining patient care in face of the current COVID-19 pandemic and in future disasters. METHODS: Between June 2020 and December 2020, 25 in-depth interviews were conducted among healthcare providers of different cadres in eight Public, Private-Not-for Profit and Private Health facilities in Kampala, Uganda. The interview guide primarily explored the lived experiences of healthcare providers as they offered maternal and newborn healthcare services during the COVID-19 pandemic. All of the in depth interviews were audio recorded and transcribed verbatim. Themes and subthemes were identified using both inductive thematic and phenomenological approaches. RESULTS: The content analysis of the in depth interviews revealed that the facilitators of maternal and newborn care service delivery among the healthcare providers during the COVID-19 pandemic included; salary bonuses, the passion to serve their patients, availability of accommodation during the pandemic, transportation to and from the health facilities by the health facilities, teamwork, fear of losing their jobs and fear of litigation if something went wrong with the mothers or their babies. The barriers to their service delivery included; lack of transport means to access their work stations, fear of contracting COVID-19 and transmitting it to their family members, salary cuts, loss of jobs especially in the private health facilities, closure of the non-essential services to combat high patient numbers, inadequate supply of Personal Protective equipment (PPE), being put in isolation or quarantine for two weeks which meant no earning, brutality from the security personnel during curfew hours and burnout from long hours of work and high patient turnovers. CONCLUSION: The COVID-19 Pandemic has led to a decline in quality of maternal and newborn service delivery by the healthcare providers as evidenced by shorter consultation time and failure to keep appointments to attend to patients. Challenges with transport, fears of losing jobs and fear of contracting COVID-19 with the limited access to personal protective equipment affected majority of the participants. The healthcare providers in Uganda despite the limitations imposed by the COVID-19 pandemic are driven by the inherent passion to serve their patients. Availability of accommodation and transport at the health facilities, provision of PPE, bonuses and inter professional teamwork are critical motivators that needed to be tapped to drive teams during the current and future pandemics

Lived experiences of frontline healthcare providers offering maternal and newborn services amidst the novel corona virus disease 19 pandemic in Uganda: A qualitative study.

BACKGROUND: The COVID-19 pandemic has brought many health systems in low resource settings to their knees. The pandemic has had crippling effects on the already strained health systems in provision of maternal and newborn healthcare. With the travel restrictions, social distancing associated with the containment of theCOVID-19 pandemic, healthcare providers could be faced with challenges of accessing their work stations, and risked burnout as they offered maternal and newborn services. This study sought to understand the experiences and perceptions of healthcare providers at the frontline during the first phase of the lockdown as they offered maternal and newborn health care services in both public and private health facilities in Uganda with the aim of streamlining patient care in face of the current COVID-19 pandemic and in future disasters. METHODS: Between June 2020 and December 2020, 25 in-depth interviews were conducted among healthcare providers of different cadres in eight Public, Private-Not-for Profit and Private Health facilities in Kampala, Uganda. The interview guide primarily explored the lived experiences of healthcare providers as they offered maternal and newborn healthcare services during the COVID-19 pandemic. All of the in depth interviews were audio recorded and transcribed verbatim. Themes and subthemes were identified using both inductive thematic and phenomenological approaches. RESULTS: The content analysis of the in depth interviews revealed that the facilitators of maternal and newborn care service delivery among the healthcare providers during the COVID-19 pandemic included; salary bonuses, the passion to serve their patients, availability of accommodation during the pandemic, transportation to and from the health facilities by the health facilities, teamwork, fear of losing their jobs and fear of litigation if something went wrong with the mothers or their babies. The barriers to their service delivery included; lack of transport means to access their work stations, fear of contracting COVID-19 and transmitting it to their family members, salary cuts, loss of jobs especially in the private health facilities, closure of the non-essential services to combat high patient numbers, inadequate supply of Personal Protective equipment (PPE), being put in isolation or quarantine for two weeks which meant no earning, brutality from the security personnel during curfew hours and burnout from long hours of work and high patient turnovers. CONCLUSION: The COVID-19 Pandemic has led to a decline in quality of maternal and newborn service delivery by the healthcare providers as evidenced by shorter consultation time and failure to keep appointments to attend to patients. Challenges with transport, fears of losing jobs and fear of contracting COVID-19 with the limited access to personal protective equipment affected majority of the participants. The healthcare providers in Uganda despite the limitations imposed by the COVID-19 pandemic are driven by the inherent passion to serve their patients. Availability of accommodation and transport at the health facilities, provision of PPE, bonuses and inter professional teamwork are critical motivators that needed to be tapped to drive teams during the current and future pandemics

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

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

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

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

Impact of mode of delivery on pregnancy outcomes in women with premature rupture of membranes after 28 weeks of gestation in a low-resource setting: A prospective cohort study.

BACKGROUND:Despite the high prevalence of premature rupture of membranes (PROM) in low-resource settings, the preferred mode of delivery remains unclear. We compared the perinatal mortality in a prospective cohort of women with PROM after 28 weeks following vaginal or caesarean delivery at Mulago Hospital with the aim of adopting evidence based practice and improving patient care. METHODS:Between November 2015 and May 2016, 1455 women with PROM after 28 weeks of gestation and their newborns were prospectively followed from admission to discharge at Mulago Hospital. The primary outcome was perinatal mortality. Secondary neonatal outcomes included sepsis and admission to the Special Care Unit. Maternal outcomes included maternal deaths and complications. Outcomes were compared between women who had vaginal vs. caesarean delivery using multivariable logistic regression. All statistical tests were 2-sided with the level of statistical significance set at p < 0.05. RESULTS:The incidence of PROM was 12.1%. The perinatal mortality following PROM was 65 per 1000 live births. Of the 1425 women with PROM, 991 (69.5%) had vaginal delivery and 434 (30.5%) underwent Caesarean section. There was no statistical difference in perinatal mortality by the mode of delivery (vaginal vs. caesarean) in PROM (p = 0.12). The risk factors for perinatal mortality included chorioamnionitis, failure to administer corticosteroids in preterm PROM, gestational age (28-33 weeks), duration of drainage of liquor (24-48 hours), and presence of maternal complications. Caesarean delivery was associated with increased maternal postpartum infections, admission to the Special Care Unit and maternal death. CONCLUSION:In low resource settings, vaginal delivery is the preferred mode of delivery for PROM after 28 weeks gestation. It is associated with lesser maternal and perinatal morbidity when compared to caesarean delivery

Comparison of maternal and neonatal outcomes between vaginal and caesarean section at Mulago Hospital.

<p>Comparison of maternal and neonatal outcomes between vaginal and caesarean section at Mulago Hospital.</p

Maternal and neonatal characteristics associated with perinatal death.

<p>Maternal and neonatal characteristics associated with perinatal death.</p

Fetal conditions leading to the 324 Special Care Unit admissions as per the different modes of delivery at Mulago Hospital.

<p>Fig 1 shows that Prematurity was the leading condition for the admission followed by asphyxia. Congenital anomalies contributed the least to the admission. RDS is Respiratory Distress Syndrome.</p

Baseline characteristics of 1425 participants with PROM at Mulago Hospital, Kampala.

<p>Baseline characteristics of 1425 participants with PROM at Mulago Hospital, Kampala.</p