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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: 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]