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Background: In South Africa, the prevalence of gestational diabetes (GDM) is growing, concomitant with the dramatically increasing prevalence of overweight/obesity among women. There is an urgent need to develop tailored interventions to support women with GDM to mitigate pregnancy risks and to prevent progression to type 2 diabetes post-partum. The IINDIAGO study aims to develop and evaluate an intervention for disadvantaged GDM women attending three large, public-sector hospitals for antenatal care in Cape Town and Soweto, SA. This paper offers a detailed description of the development of a theory-based behaviour change intervention, prior to its preliminary testing for feasibility and efficacy in the health system. Methods: The Behaviour Change Wheel (BCW) and the COM-B model of behaviour change were used to guide the development of the IINDIAGO intervention. This framework provides a systematic, step-by-step process, starting with a behavioural analysis of the problem and making a diagnosis of what needs to change, and then linking this to intervention functions and behaviour change techniques to bring about the desired result. Findings from primary formative research with women with GDM and healthcare providers were a key source of information for this process. Results: Key objectives of our planned intervention were 1) to address women's evident need for information and psychosocial support by positioning peer counsellors and a diabetes nurse in the GDM antenatal clinic, and 2) to offer accessible and convenient post-partum screening and counselling for sustained behaviour change among women with GDM by integrating follow-up into the routine immunisation programme at the Well Baby clinic. The peer counsellors and the diabetes nurse were trained in patient-centred, motivational counselling methods. Conclusions: This paper offers a rich description and analysis of designing a complex intervention tailored to the challenging contexts of urban South Africa. The BCW was a valuable tool to use in designing our intervention and tailoring its content and format to our target population and local setting. It provided a robust and transparent theoretical foundation on which to develop our intervention, assisted us in making the hypothesised pathways for behaviour change explicit and enabled us to describe the intervention in standardised, precisely defined terms. Using such tools can contribute to improving rigour in the design of behavioural change interventions. Trial registration: First registered on 20/04/2018, Pan African Clinical Trials Registry (PACTR): PACTR201805003336174. [ABSTRACT FROM AUTHOR]

Background: HIV diagnosis in South Africa is based on a point-of-care testing (PoCT) algorithm with paper-based record-keeping. Aggregated testing data are reported routinely. To facilitate improved HIV case-based surveillance, the Western Cape Province implemented a unique pilot intervention to digitise PoCT results, at an individual level, and generate an electronic register using the newly developed Provincial Health Data Centre (PHDC). We describe the intervention (phased) and present an evaluation of the operational feasibility of the intervention. We also offer implementation insights into establishing electronic capture of individual level testing data.Methods: Cross-sectional analyses were conducted on records of all patients attending a local Community Health Centre who had an HIV-PoCT during the study period. Data from the intervention were linked to the PHDC using a unique identifier and compared with aggregate data from the paper-based register. Correlation coefficients were calculated to quantify the correlation between the two monthly datasets. To support an understanding of the findings, the Department of Health project management team generated reflections on the implementation process, which were then grouped thematically into implementation lessons.Results: In total, 11,337 PoCT records were digitised (70% (7954) during Phase I; and 30% (3383) during Phase II). Linkage of forms to the PHDC was 96% in Phase I and 98% in Phase II. Comparison with aggregate data showed high correlation during Phase I, but notable divergence during Phase II. Divergence in Phase II was due to stringent data quality requirements and high clinical staff turnover. Factors supporting implementation success in Phase I included direct oversight of data capturing by a manager with clinical and operational insight. Implementation challenges included operational, health system, and high cost-related issues.Conclusions: We demonstrate that rapid digitisation of HIV PoCT data, without compromising currently collected aggregate data, is operationally feasible, and can contribute to person-level longitudinal HIV case-based surveillance. To take to scale, we will need to improve PoCT platforms and clerical and administrative systems. Although we highlight challenges, we demonstrate that electronic HIV testing registers can successfully replace manual registers and improve efforts to monitor and evaluate HIV testing strategies. [ABSTRACT FROM AUTHOR]

Background: Drug overdoses occur when the amount of drug or combination of drugs consumed is toxic and negatively affects physiological functioning. Opioid overdoses are responsible for the majority of overdose deaths worldwide. Naloxone is a safe, fast-acting opioid antagonist that can reverse an opioid overdose, and as such, it should be a critical component of community-based responses to opioid overdose. However, the burden of drug overdose deaths remains unquantified in South Africa, and both knowledge about and access to naloxone is generally poor. The objective of this study was to describe the experiences of overdose, knowledge of responses to overdose events, and willingness to call emergency medical services in response to overdose among people who use drugs in Cape Town, Durban, and Pretoria (South Africa). Methods: We used convenience sampling to select people who use drugs accessing harm reduction services for this cross-sectional survey from March to July 2019. Participants completed an interviewer-administered survey, assessing selected socio-demographic characteristics, experiences of overdose among respondents and their peers, knowledge about naloxone and comfort in different overdose responses. Data, collected on paper-based tools, were analysed using descriptive statistics and categorised by city. Results: Sixty-six participants participated in the study. The median age was 31, and most (77%) of the respondents were male. Forty-one per cent of the respondents were homeless. Heroin was the most commonly used drug (79%), and 82% of participants used drugs daily. Overall, 38% (25/66) reported overdosing in the past year. Most (76%, 50/66) knew at least one person who had ever experienced an overdose, and a total of 106 overdose events in peers were reported. Most participants (64%, 42/66) had not heard of naloxone, but once described to them, 73% (48/66) felt comfortable to carry it. More than two-thirds (68%, 45/66) felt they would phone for medical assistance if they witnessed an overdose. Conclusion: Drug overdose was common among participants in these cities. Without interventions, high overdose-related morbidity and mortality is likely to occur in these contexts. Increased awareness of actions to undertake in response to an overdose (calling for medical assistance, using naloxone) and access to naloxone are urgently required in these cities. Additional data are needed to better understand the nature of overdose in South Africa to inform policy and responses. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic has posed challenges to the conduct of clinical trials. Strategies for overcoming common challenges to non-COVID-19 trial continuation have been reported, but this literature is limited to pharmacological intervention trials from high-income settings. The purpose of this paper is to expand the literature to include a low- and middle-income country perspective. We describe the challenges posed by COVID-19 for a randomised feasibility trial of a psychological intervention for adolescents in Cape Town, South Africa, and lessons learned when implementing strategies to facilitate trial continuation in this context. We used a Plan-Do-Study-Act cycle method to explore whether our adaptations were having the desired effect on trial accrual and retention. We found that stakeholder engagement, trial coordination and team communication need to be intensified while testing these procedural changes. We learned that strategies found to be effective in high-income countries required significant adaptation to our resource-constrained setting. The detailed documentation of extraneous influences, procedural changes and trial process information was essential to guiding decisions about which adaptations to retain. This information will be used to examine the potential impact of these changes on study outcomes. We hope that these reflections will be helpful to other trialists from low- and middle-income countries grappling with how to minimise the impact of public health emergencies on their research. TRIAL REGISTRATION: The trial is registered with the Pan African Clinical Trials Registry (PACTR20200352214510). Registered 28 February 2020.   https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=9795 . [ABSTRACT FROM AUTHOR]

Background: Nurses' recognition of clinical deterioration is crucial for patient survival. Evidence for the effectiveness of modified early warning scores (MEWS) is derived from large observation studies in developed countries.Methods: We tested the effectiveness of the paper-based Cape Town (CT) MEWS vital signs observation chart and situation-background-assessment-recommendation (SBAR) communication guide. Outcomes were: proportion of appropriate responses to deterioration, differences in recording of clinical parameters and serious adverse events (SAEs) in intervention and control trial arms. Public teaching hospitals for adult patients in Cape Town were randomised to implementation of the CT MEWS/SBAR guide or usual care (observation chart without track-and-trigger information) for 31 days on general medical and surgical wards. Nurses in intervention wards received training, as they had no prior knowledge of early warning systems. Identification and reporting of patient deterioration in intervention and control wards were compared. In the intervention arm, 24 day-shift and 23 night-shift nurses received training. Clinical records were reviewed retrospectively at trial end. Only records of patients who had given signed consent were reviewed.Results: We recruited two of six CT general hospitals. We consented 363 patients and analysed 292 (80.4%) patient records (n = 150, 51.4% intervention, n = 142, 48.6% control arm). Assistance was summoned for fewer patients with abnormal vital signs in the intervention arm (2/45, 4.4% versus (vs) 11/81, 13.6%, OR 0.29 (0.06-1.39)), particularly low systolic blood pressure. There was a significant difference in recording between trial arms for parameters listed on the MEWS chart but omitted from the standard observations chart: oxygen saturation, level of consciousness, pallor/cyanosis, pain, sweating, wound oozing, pedal pulses, glucose concentration, haemoglobin concentration, and "looks unwell". SBAR was used twice. There was no statistically significant difference in SAEs (5/150, 3.3% vs 3/143, 2.1% P = 0.72, OR 1.61 (0.38-6.86)).Conclusions: The revised CT MEWS observations chart improved recording of certain parameters, but did not improve nurses' ability to identify early signs of clinical deterioration and to summon assistance. Recruitment of only two hospitals and exclusion of patients too ill to consent limits generalisation of results. Further work is needed on educational preparation for the CT MEWS/SBAR and its impact on nurses' reporting behaviour.Trial Registration: Pan African Clinical Trials Registry, PACTR201406000838118. Registered on 2 June 2014, www.pactr.org. [ABSTRACT FROM AUTHOR]

Background: Provider-initiated HIV testing and counselling (PITC) increases HIV testing rates in most settings, but its effect on testing rates varies considerably. This paper reports the findings of a process evaluation of a controlled trial of PITC for people with sexually transmitted infections (STI) attending publicly funded clinics in a low-resource setting in South Africa, where the trial results were lower than anticipated compared to the standard Voluntary Counselling and Testing (VCT) approach. Method: This longitudinal study used a variety of qualitative methods, including participant observation of project implementation processes, staff focus groups, patient interviews, and observation of clinical practice. Data were content analysed by identifying the main influences shaping the implementation process. The Normalisation Process Model (NPM) was used as a theoretical framework to analyse implementation processes and explain the trial outcomes. Results: The new PITC intervention became embedded in practice (normalised) during a two-year period (2006 to 2007). Factors that promoted the normalising include strong senior leadership, implementation support, appropriate accountability mechanisms, an intervention design that was responsive to service needs and congruent with professional practice, positive staff and patient perceptions, and a responsive organisational context. Nevertheless, nurses struggled to deploy the intervention efficiently, mainly because of poor sequencing and integration of HIV and STI tasks, a focus on HIV education, tension with a patient-centred communication style, and inadequate training on dealing with the operational challenges. This resulted in longer consultation times, which may account for the low test coverage outcome. Conclusion: Leadership and implementation support, congruent intervention design, and a responsive organisational context strengthened implementation. Poor compatibility with nurse skills on the level of the clinical consultation may have contributed to limiting the size of the trial outcomes. A close fit between the PITC intervention design and clinical practices, as well as appropriate training, are needed to ensure sustainability of the programme. The use of a theory-driven analysis promotes transferability of the results, and the findings are therefore relevant to the implementation of HIV testing and to the design and evaluation of complex interventions in other settings. [ABSTRACT FROM AUTHOR]

Background: Alcohol and other drug (AOD) use among poor Black African and Coloured women in South Africa compounds their sexual risk for HIV. Given South Africa's history of ethnic disparities, ethnic differences in sex risk profiles may exist that should be taken into account when planning HIV risk reduction interventions. This paper aims to describe ethnic differences in AOD use and AOD-related sexual risks for HIV among vulnerable women from Cape Town, South Africa Method: Cross-sectional data on 720 AOD-using women (324 Black African; 396 Coloured) recruited from poor communities in Cape Town were examined for ethnic differences in AOD use and AOD-related sexual risk behavior. Results: Ethnic differences in patterns of AOD use were found; with self-reported drug problems, heavy episodic drinking and methamphetamine use being most prevalent among Coloured women and cannabis use being most likely among Black African women. However, more than half of Black African women reported drug-related problems and more than a third tested positive for recent methamphetamine use. More than a third of women reported being AOD-impaired and having unprotected sex during their last sexual encounter. Coloured women had four-fold greater odds of reporting that their last sexual episode was AOD-impaired and unprotected than Black African women. In addition, close to one in two women reported that their sexual partner was AOD-impaired at last sex, with Coloured women having three-fold greater odds of reporting that their partner was AOD-impaired at last sex than Black African women. Conclusions: Findings support the need to develop and test AOD risk reduction interventions for women from both ethnic groups. In addition, findings point to the need for tailored interventions that target the distinct profiles of AOD use and AOD-related sex risks for HIV among Black African and Coloured women. [ABSTRACT FROM AUTHOR]

Background: All the reported measures of sitting posture, as well as photographs, have one flaw, as these measures are external to the body. These measures use calculations from external bony landmarks to estimate spinal posture, on the understanding that what is being measured externally reflects the shape, health and performance of structures of the underlying spine. Without a comparative measure of the relative position of the structures of the spine, the validity of any external spinal posture measure cannot be established. This paper reports on a study which tests the validity of photographs to measure adolescent sitting posture. Methods: The study was conducted in a laboratory at the Department of Human Biology, University of Cape Town. A random sample of 40 adolescents were recruited from the Cape metropolitan schools, to detect differences of three degrees or more between the repeated measures of upright, normal or slouched posture (photographs) and between the posture photographs and LODOX measures. Eligible participants were healthy male and female subjects aged 15 or 16 years old, in Grade 10, and who were undertaking Computer or Computype studies at their schools. Two posture measurement tools were used in the study, namely: Photographs were taken using the Photographic Posture Analysis Method (PPAM) and Radiographs were taken using the LODOX (LODOX (Pty) Ltd) system. Subjects' posture was assessed in simulated computer workstations. The following angles were measured: the sagittal head angle, cervical angle, protraction/retraction angle, arm angle and the thoracic angle. Results: Data from 39 subjects (19 males, 20 females) was used for analysis (17 15-year-olds (7 boys and 10 girls), 22 16-year-olds (12 boys and 10 girls)). All but one photographic angle showed moderate to good correlation with the LODOX angles (Pearson r values 0.67-0.95) with the exception being the shoulder protraction/ retraction angle Pearson r values. Bland Altman limits of agreement illustrated a slight bias for all angles. The reliability study findings from repeated photographs demonstrated moderate to good correlation of all angles (ICC values 0.78-0.99). Conclusion: The findings of this study suggest that photographs provide valid and reliable indicators of the position of the underlying spine in sitting. Clinically it is important to know whether a patient is showing true progression in relation to a postural intervention. Based on the results of this study, the PPAM can be used in practice as a valid measure of sitting posture. [ABSTRACT FROM AUTHOR]

Background: Low- and middle-income countries often lack the fiscal, infrastructural and human resources to conduct evidence-based research; similar constraints may also hinder the application of good clinical practice guidelines based on research findings from high-income countries. While the context of health organizations is increasingly recognized as an important consideration when such guidelines are implemented, there is a paucity of studies that have considered local contexts of resource-scarcity against recommended clinical guidelines.Methods: This paper sets out to explore the implementation of the NICE Guideline 11 on family interventions when working with persons with intellectual disability and challenging behavior by a group of psychologists employed in a government health facility in Cape Town, South Africa.Results: In the absence of evidence-based South African research, we argue that aspects of the guidelines, in particular those that informed our ethos and conceptual thinking, could be applied by clinical psychologists in a meaningful manner notwithstanding the relative scarcity of resources.Conclusion: We have argued that where guidelines such as the NICE Guidelines do not apply contextually throughout, it remains important to retain the principles behind these guidelines in local contexts. Limitations of this study exist in that the data were drawn only from the clinical experience of authors. Some of the implications for future research in resource-constrained contexts such as ours are discussed. Smaller descriptive, qualitative studies are necessary to explore the contextual limitations and resource strengths that exist in low- and middle-income settings, and these studies should be more systematic than drawing only on the clinical experience of authors, as has been done in this study. [ABSTRACT FROM AUTHOR]