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Item Neurodevelopmental assessment of HIV-exposed uninfected and early-treated HIV-infected children: study protocol(BioMed Central, 2018-04) Strehlau, Renate; van Aswegen, Tamryn; Potterton, JoanneObjective: Sub-Saharan Africa has the highest prevalence of children at risk of not achieving their developmental potential, attributable largely to the human immunodefciency virus (HIV) pandemic coupled with negative environmental factors. Childhood developmental stimulation programmes can mitigate adverse outcomes. Methods: Neonates testing HIV positive at birth will be initiated on antiretroviral treatment (ART) and receive an ageappropriate stimulation program, updated at 3 monthly intervals through the frst year of life. Neurodevelopment at 12 months of age will be assessed using the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III). Outcomes will be compared with HIV-infected and HIV-exposed uninfected children (HEU) not having received the stimulatory intervention. Associations between neurodevelopmental outcomes, environmental factors, and parental stress will be investigated. The study will take place at a single site in Johannesburg, South Africa. This non-randomised controlled intervention study, with a single non-blinded comparative intervention group, aims to investigate whether an early childhood stimulation programme used in conjunction with ART initiated at birth can positively impact neurodevelopmental outcomes at 1 year of age in children infected with HIV.Item The effect of a ketogenic diet versus a high-carbohydrate, low-fat diet on sleep, cognition, thyroid function, and cardiovascular health independent of weight loss: study protocol for a randomized controlled trial(BMC, 2018-01) Iacovides, Stella; Meiring, Rebecca M.Background: Many physiological health benefits observed after following a ketogenic diet (KD) can be attributed to the associated weight loss. The KD has become more prominent as a popular health choice, not only in obese/ overweight individuals, but also in healthy adults. The study aims to determine the effects of a KD, independent of weight loss, on various aspects of physiological health including: sleep, thyroid function, cognition, and cardiometabolic health. The study will also aim to determine whether a change in basal metabolic rate may be associated with any changes observed. Methods: Twenty healthy men and women between 18 and 50 years of age will take part in this study. In a randomized controlled, cross-over design, participants will follow two isocaloric diets: a high-carbohydrate, low-fat diet (55% CHO, 20% fat, 25% protein) and a KD (15% CHO, 60% fat, 25% protein). Each dietary intervention will last for a minimum of 3 weeks, with a 1-week washout period in between. Before and after each diet, participants will be assessed for sleep quality, cognitive function, thyroid function, and basal metabolic rate. A blood sample will also be taken for the measurement of cardio-metabolic and immune markers. Discussion: The present study will help in understanding the potential effects of a KD on aspects of physiological health in healthy adults, without the confounding factor of weight loss. The study aims to fill a significant void in the academic literature with regards to the benefits and/or risks of a KD in a healthy population, but will also explore whether diet-related metabolic changes may be responsible for the changes observed in physiological health.Item Feeding children with autism in South Africa: the teachers’ perspectives(AOSIS Publishing, 2024-02) Adams, Skye N.; Matsimela, NthabisengBackground: Over 80% of children diagnosed with autism spectrum disorders (autism) exhibit disruptive behaviours during mealtimes, highlighting the need for personalised care. In South Africa, teachers often take on the responsibility of feeding due to resource constraints and the time children spend at school. Moreover, children with autism have unique and individualised feeding requirements, which many teachers may not have the necessary training or skills to address adequately. Objectives: To explore the ways in which teachers of autistic children manage feeding difficulties in the classroom. Method: A qualitative research design was employed using semi-structured interviews. Eight teachers were interviewed on feeding autistic children between the ages of 3 years - 9 years in Johannesburg, South Africa. Data were transcribed and analysed using thematic analysis. Results: The findings revealed that teachers encountered distinct challenges when it came to feeding autistic children in the classroom, particularly concerning the management of associated feeding difficulties. Teachers employed several strategies to encourage eating in the classroom setting including: (1) bolus modification, (2) behaviour modelling, (3) positive reinforcement and (4) offering choices and alternatives. Conclusion: The study concludes the need for specialised support and training for teachers to address the individualised feeding needs of children with autism. Implementing targeted interventions and providing resources for teachers could enhance their abilities to effectively support children with autism during mealtimes and promote a more inclusive classroom environment. Contribution: This study highlighted the importance of including the teacher in the multidisciplinary team when managing the feeding challenges in children with autism.Item Exploring quality of life post sudden onset hearing loss: a convergent parallel approach(AOSIS Publishing, 2024-02) Ntlhakana, Liepollo; Hamid, SabeehahBackground: Sudden onset hearing loss (SOHL) is rare and presents differently to individuals; hence, it is complex to diagnose. The impact on the quality of life (QoL) varies for individuals and their support structure. However, the exploration of research designs is warranted. Objectives: This study explored the lived experiences of adults post-SOHL diagnosis and the impact on the QoL. Facilitators of emotional and social aspects of counselling provided by audiologists post-SOHL diagnosis were established. Method: This was a convergent parallel research study. Data were collected from the two primary participants and three secondary participants, face-to-face and telephonically. The Hearing Handicap Inventory for Adults (HHIA) screening tool and the semi-structured interviews were used for data collection. The data sets were analysed independently, viz. descriptive analysis and thematic analysis, to confirm the impact on the QoL post-SOHL diagnosis. Results: The HHIA scores obtained were 84% and 50% for P1 and P2, respectively. Key themes that emerged from the interviews revealed that communication difficulties mostly impacted the QoL, which in turn influenced their mental and social well-being. Aural rehabilitation was perceived as ineffective support, thus the inability to reduce the impact on the QoL post-SOHL diagnosis. Conclusion: The integrated findings indicated the impact on the QoL post-SOHL diagnosis. Convergent parallel methods should be considered by researchers to understand rare auditory pathologies and their impact on the QoL. Contribution: Person-centred care (PCC) and family-centred care (FCC) are facilitators of counselling that audiologists can employ as QoL management strategies post-SOHL diagnosis.Item The assessment and aetiology of drug-induced ischaemic priapism(Springer Nature, 2024-12) Moodley, Divyen; Badenhorst, Anja; Choonara, Yahya; Adam, AhmedIschaemic priapism is a urological emergency characterised by a prolonged, painful erection unrelated to sexual stimulation. While several aetiological factors contribute to this condition, the pharmacological causes have gained significant attention in recent years. This narrative review aims to comprehensively assess ischaemic priapism, specifically focusing on its pharmacological aetiology. We propose an approach and assessment strategy to the numerous factors associated with pharmacologically induced ischaemic priapism. By enhancing our understanding of the harmacological causes of this condition, healthcare professionals can improve patient management and reduce the long-term complications associated with ischaemic priapism.Item Mobile Technology use in clinical research examining challenges and implivations for health promotion in South Africa: mixed methods study(JMIR Publications, 2024) Norris, Shane A.; Mabetha, Khuthala; Soepnel, Larske M.; Mabena, Gugulethu; Motlhathedi, Molebogeng; Nyathi, Lukhanyo; Draper, Catherine E.Background: The use of mobile technologies in fostering health promotion and healthy behaviors is becoming an increasingly common phenomenon in global health programs. Although mobile technologies have been effective in health promotion initiatives and follow-up research in higher-income countries and concerns have been raised within clinical practice and research in low- and middle-income settings, there is a lack of literature that has qualitatively explored the challenges that participants experience in terms of being contactable through mobile technologies. Objective: This study aims to explore the challenges that participants experience in terms of being contactable through mobile technologies in a trial conducted in Soweto, South Africa. Methods: A convergent parallel mixed methods research design was used. In the quantitative phase, 363 young women in the age cohorts 18 to 28 years were contacted telephonically between August 2019 and January 2022 to have a session delivered to them or to be booked for a session. Call attempts initiated by the study team were restricted to only 1 call attempt, and participants who were reached at the first call attempt were classified as contactable (189/363, 52.1%), whereas those whom the study team failed to contact were classified as hard to reach (174/363, 47.9%). Two outcomes of interest in the quantitative phase were "contactability of the participants" and "participants' mobile number changes," and these outcomes were analyzed at a univariate and bivariate level using descriptive statistics and a 2-way contingency table. In the qualitative phase, a subsample of young women (20 who were part of the trial for ≥12 months) participated in in-depth interviews and were recruited using a convenience sampling method. A reflexive thematic analysis approach was used to analyze the data using MAXQDA software (version 20; VERBI GmbH). Results: Of the 363 trial participants, 174 (47.9%) were hard to reach telephonically, whereas approximately 189 (52.1%) were easy to reach telephonically. Most participants (133/243, 54.7%) who were contactable did not change their mobile number. The highest percentage of mobile number changes was observed among participants who were hard to reach, with three-quarters of the participants (12/16, 75%) being reported to have changed their mobile number ≥2 times. Eight themes were generated following the analysis of the transcripts, which provided an in-depth account of the reasons why some participants were hard to reach. These included mobile technical issues, coverage issues, lack of ownership of personal cell phones, and unregistered number. Conclusions: Remote data collection remains an important tool in public health research. It could, thus, serve as a hugely beneficial mechanism in connecting with participants while actively leveraging the established relationships with participants or community-based organizations to deliver health promotion and practice.Item Molecular and phenotypic characteristics of RSV infections in infants during two nirsevimab randomized clinical trials(Nature Research, 2023) Madhi, Shabir A.; Ahani, Bahar; Tuffy, Kevin M.; Aksyuk, Anastasia A.; Wilkins, Deidre; Abram, Michael E.; Dagan, Ron; Domachowske, Joseph B.; Guest, Johnathan D.; Ji, Hong; Kushnir, Anna; Leach, Amanda; Mankad, Vaishali S.; Simões, Eric A. F.; Sparklin, Benjamin; Speer, Scott D.; Stanley, Ann Marie; Tabor, David E.; Hamrén, Ulrika Wählby; Kelly, Elizabeth J.; Villafana, TonyaNirsevimab is a monoclonal antibody that binds to the respiratory syncytial virus (RSV) fusion protein. During the Phase 2b (NCT02878330) and MELODY (NCT03979313) clinical trials, infants received one dose of nirsevimab or placebo before their first RSV season. In this pre-specified analysis, isolates from RSV infections were subtyped, sequenced and analyzed for nirsevimab binding site substitutions; subsequently, recombinant RSVs were engineered for microneutralization susceptibility testing. Here we show that the frequency of infections caused by subtypes A and B is similar across and within the two trials. In addition, RSV A had one and RSV B had 10 fusion protein substitutions occurring at >5% frequency. Notably, RSV B binding site substitutions were rare, except for the highly prevalent I206M:Q209R, which increases nirsevimab susceptibility; RSV B isolates from two participants had binding site substitutions that reduce nirsevimab susceptibility. Overall, >99% of isolates from the Phase 2b and MELODY trials retained susceptibility to nirsevimab.Item Comparable safety and non‑inferior immunogenicity of the SARS‑CoV‑2 mRNA vaccine candidate PTX‑COVID19‑B and BNT162b2 in a phase 2 randomized, observer‑blinded study(Nature Research, 2024) Madhi, Shabir A.; Tran, Richard; Martin‑Orozco, Natalia; Panicker, Rajesh Krishnan Gopalakrishna; Pastrak, Aleksandra; Reiter, Lawrence; Grefrath, Johann; Zidel, Bian; Ostrowski, Mario; Gommerman, Jennifer; Cooper, CurtisIn the aftermath of the COVID-19 pandemic, the evolution of the SARS-CoV-2 into a seasonal pathogen along with the emergence of new variants, underscores the need for dynamic and adaptable responses, emphasizing the importance of sustained vaccination strategies. This observer-blind, double-dummy, randomized immunobridging phase 2 study (NCT05175742) aimed to compare the immunogenicity induced by two doses of 40 μg PTX-COVID19-B vaccine candidate administered 28 days apart, with the response induced by two doses of 30 µg Pfzer-BioNTech COVID-19 vaccine (BNT162b2), administered 21 days apart, in Nucleocapsid-protein seronegative adults 18–64 years of age. Both vaccines were administrated via intramuscular injection in the deltoid muscle. Two weeks after the second dose, the neutralizing antibody (NAb) geometric mean titer ratio and seroconversion rate met the non-inferiority criteria, successfully achieving the primary immunogenicity endpoints of the study. PTX-COVID19-B demonstrated similar safety and tolerability profle to BNT162b2 vaccine. The lowest NAb response was observed in subjects with low-to-undetectable NAb at baseline or no reported breakthrough infection. Conversely, participants who experienced breakthrough infections during the study exhibited higher NAb titers. This study also shows induction of cell-mediated immune (CMI) responses by PTX-COVID19-B. In conclusion, the vaccine candidate PTX-COVID19-B demonstrated favourable safety profle along with immunogenicity similar to the active comparator BNT162b2 vaccine.Item Predictors of switch to and early outcomes on third-line antiretroviral therapy at a large public-sector clinic in Johannesburg, South Africa(BMC, 2018) Evans, Denise; Hirasen, Kamban; Berhanu, Rebecca; Malete, Given; Ive, Prudence; Spencer, David; Badal‑Faesen, Sharlaa; Sanne, Ian M.; Fox, Matthew P.Background: While efficacy data exist, there are limited data on the outcomes of patients on third-line antiretroviral therapy (ART) in sub-Saharan Africa in actual practice. Being able to identify predictors of switch to third-line ART will be essential for planning for future need. We identify predictors of switch to third-line ART among patients with significant viraemia on a protease inhibitor (PI)-based second-line ART regimen. Additionally, we describe characteristics of all patients on third-line at a large public sector HIV clinic and present their early outcomes. Methods: Retrospective analysis of adults (≥ 18 years) on a PI-based second-line ART regimen at Themba Lethu Clinic, Johannesburg, South Africa as of 01 August 2012, when third-line treatment became available in South Africa, with significant viraemia on second-line ART (defined as at least one viral load ≥ 1000 copies/mL on second-line ART after 01 August 2012) to identify predictors of switch to third-line (determined by genotype resistance testing). Third line ART was defined as a regimen containing etravirine, raltegravir or ritonavir boosted darunavir, between August 2012 and January 2016. To assess predictors of switch to third-line ART we used Cox proportional hazards regression among those with significant viraemia on second-line ART after 01 August 2012. Then among all patients on third-line ART we describe viral load suppression, defined as a viral load < 400 copies/mL, after starting third-line ART. Results: Among 719 patients in care and on second-line ART as of August 2012 (with at least one viral load ≥ 1000 copies/mL after 01 August 2012), 36 (5.0% over a median time of 54 months) switched to third-line. Time on second-line therapy (≥ 96 vs. < 96 weeks) (adjusted Hazard Ratio (aHR): 2.53 95% CI 1.03–6.22) and never reaching virologic suppression while on second-line ART (aHR: 3.37 95% CI 1.47–7.73) were identified as predictors of switch. In a separate cohort of patients on third-line ART, 78.3% (47/60) and 83.3% (35/42) of those in care and with a viral load suppressed their viral load at 6 and 12 months, respectively. Conclusions: Our results show that the need for third-line is low (5%), but that patients’ who switch to third-line ART have good early treatment outcomes and are able to suppress their viral load. Adherence counselling and resistance testing should be prioritized for patients that are at risk of failure, in particular those who never suppress on second line and those who have been on PI-based regimen for extended periods.Item Bone mineral density in midlife long-term users of hormonal contraception in South Africa: relationship with obesity and menopausal status(BMC, 2018-04) Beksinska, Mags E.; Smit, Jenni A.; Kleinschmidt, ImmoBackground: In South Africa, hormonal contraception is widely used in women over the age of 40 years. One of these methods and the most commonly used is depot-medroxyprogesterone acetate (DMPA) which has been found to have a negative effect on bone mass. Limited information is available on the effect of norethisterone enanthate (NET-EN) on bone mass, and combined oral contraceptives (COCs) have not been found to be associated with loss of bone mass. The aim of this study was to investigate bone mineral density (BMD) in pre and perimenopausal women (40–49 years) in relation to use of DMPA, NET-EN and COCs for at least 12 months preceding recruitment into the study and review associations with body mass index (BMI) and menopausal status. Methods: One hundred and twenty seven users of DMPA, 102 NET-EN users and 106 COC users were compared to 161 nonuser controls. Menopausal status was assessed, BMI and forearm BMD was measured at the distal radius using dual X-ray absorptiometry. Comparison analysis was conducted at baseline and 2.5 years. Results: There was no significant difference in BMD between the four contraceptive user groups (p = 0.26) with and without adjustment for age at baseline or at 2.5 years (p = 0.52). The BMD was found to be significantly associated with BMI (p = < 0.0001) with an increase of one unit of BMI translating to an increase of 0.0044 g/cm2 in radius BMD. Follicle stimulating hormone (FSH) level ≥ 25.8 mIU/mL was associated with a decrease of 0.017 g/cm2 in radius BMD relative to women with FSH < 25.8 mIU/mL. Significant interaction between FSH and BMI in their effect on BMD was observed (p = .006). Conclusion: This study found no evidence that long-term use of DMPA, NET-EN and COCs affects forearm BMD in this population at baseline or after 2.5 years of follow-up. This study also reports the complex relationship and significant interaction between FSH and BMI in their effect on BMD. BMD research in older women needs to ensure that women are assessed for menopausal status and BMI.