Ethical considerations of phone-based interviews from three studies of COVID-19 impact in Bihar, India.

Phone-based interviews present a range of ethical challenges, including how to ensure informed consent and privacy and maintain confidentiality. Our paper presents conceptual and practical ethical considerations taken into account across three telephone studies on the impact of COVID-19 conducted following India's nationwide lockdown imposed in March 2020. Two studies captured COVID-19 response impact on primary-level Reproductive Maternal Neonatal and Child Health (RMNCH) services and on provider wellness, respectively. The third study focused on how the gendered experience of COVID-19 and the state's response to control transmission impacted women's lives, focusing on health services, livelihood, entitlements and social change, by interviewing individual women. The ethical challenges as well as the advantages of digital data collection are presented with recommendations for low-resource settings. Ethical considerations included the above challenges as well as avoiding posing unreasonable time burden on the respondents, framing questions with a gendered lens, considering emotional states given contagion concerns and economic uncertainties, and redressing pandemic-induced distress. Using scripted Hindi was challenging in consent-taking, as was protecting household respondents' privacy and confidentiality during lockdown. Unanticipated positive ethical implications of using a telephone approach included providing respondents privacy and catharsis, respondents choosing convenient interview times and affording health providers more privacy than institutional inperson interviews. Internalising empathy, respect and appreciative enquiry are key to establishing rapport in the absence of prior relationships. Institutional Review Board (IRB) time limits on call duration need to be flexible to allow for 'active listening' and empathetic enquiry in surveys on the impact of COVID-19.

Readiness of public health facilities to provide quality maternal and newborn care across the state of Bihar, India: a cross-sectional study of district hospitals and primary health centres.

INTRODUCTION: Poor access to quality healthcare is one of the most important reasons of high maternal and neonatal mortality in India, particularly in poorer states like Bihar. India has implemented initiatives to promote institutional maternal deliveries. It is important to ensure that health facilities are adequately equipped and staffed to provide quality care for mothers and newborns. METHODS: We conducted a cross-sectional study of 190 primary health centres (PHCs) and 36 district hospitals (DHs) across all districts in Bihar to assess the readiness of facilities to provide quality maternal and neonatal care. Infrastructure, equipment and supplies and staffing were assessed using the WHO service availability and readiness assessment and Indian public health standard guidelines. Additionally, we used household survey data to assess the quality of care reported by mothers delivering at study facilities. RESULTS: PHCs and DHs were found to have 61% and 67% of the mandated structural components to provide maternal and neonatal care, on average, respectively. DHs were, on average, slightly better equipped in terms of infrastructure, equipment and supplies by comparison to PHCs. DHs were found to be inadequately prepared to provide neonatal care. Lack of recommended handwashing stations and bins at both DHs and PHCs suggested low levels of hygiene. Only half of the essential drugs were available in both DHs and PHCs. While no association was revealed between structural capacity and patient-reported quality of care, adequacy of staffing was positively associated with the quality of care in DHs. CONCLUSION: Examining all DHs and a representative sample of PHCs in Bihar, this study revealed the gaps in structural components that need to be filled to provide quality care to mothers and newborns. Access to quality care is essential if progress in reducing maternal and neonatal mortality is to be achieved in this high-burden state.

Strategies for developing sustainable health research capacity in low and middle-income countries: a prospective, qualitative study investigating the barriers and enablers to locally led clinical trial conduct in Ethiopia, Cameroon and Sri Lanka.

OBJECTIVES: In 2013, the WHO stated that unless low-income and middle-income countries (LMICs) become producers of research, health goals would be hard to achieve. Among the capacities required to build a local evidence base, ability to conduct clinical trials is important. There is no evidence-based guidance for the best ways to develop locally led trial capacity. This research aims to identify the barriers and enablers to locally led clinical trial conduct in LMICs and determine strategies for their sustainable development. DESIGN: Prospective, multiple case study design consisting of interviews (n=34), focus group discussions (n=13) and process mapping exercises (n=10). SETTING: Case studies took place in Ethiopia (2011), Cameroon (2012) and Sri Lanka (2013). PARTICIPANTS: Local health researchers with previous experiences of clinical trials or stakeholders with an interest in trials were purposively selected through registration searches and snowball sampling (n=100). PRIMARY AND SECONDARY OUTCOME MEASURES: Discussion notes and transcripts were analysed using thematic coding analysis. Key themes and mechanisms were identified. RESULTS: Institutions and individuals were variably successful at conducting trials, but there were strong commonalities in the barriers and enablers across all levels and functions of the research systems. Transferable mechanisms were summarised into the necessary conditions for trial undertaking, which included: awareness of research, motivation, knowledge and technical skills, leadership capabilities, forming collaborations, inclusive trial operations, policy relevance and uptake and macro and institutional strengthening. CONCLUSIONS: Barriers and enablers to locally led trial undertaking exist at all levels and functions of LMIC research systems. Establishing the necessary conditions to facilitate this research will require multiple, coordinated interventions that seek to resolve them in a systemic manner. The strategies presented in the discussion provide an evidence-based framework for a self-sustaining capacity development approach. This represents an important contribution to the literature that will be relevant for research funders, users and producers.

Health research capacity development in low and middle income countries: reality or rhetoric? A systematic meta-narrative review of the qualitative literature.

OBJECTIVES: Locally led health research in low and middle income countries (LMICs) is critical for overcoming global health challenges. Yet, despite over 25 years of international efforts, health research capacity in LMICs remains insufficient and development attempts continue to be fragmented. The aim of this systematic review is to identify and critically examine the main approaches and trends in health research capacity development and consolidate key thinking to identify a more coherent approach. METHODS: This review includes academic and grey literature published between January 2000 and July 2013. Using a predetermined search strategy, we systematically searched PubMed, hand-searched Google Scholar and checked reference lists. This process yielded 1668 papers. 240 papers were selected based on a priori criteria. A modified version of meta-narrative synthesis was used to analyse the papers. RESULTS: 3 key narratives were identified: the effect of power relations on capacity development; demand for stronger links between research, policy and practice and the importance of a systems approach. Capacity development was delivered through 4 main modalities: vertical research projects, centres of excellence, North-South partnerships and networks; all were controversial, and each had their strengths and weaknesses. A plurality of development strategies was employed to address specific barriers to health research. However, lack of empirical research and monitoring and evaluation meant that their effectiveness was unclear and learning was weak. CONCLUSIONS: There has been steady progress in LMIC health research capacity, but major barriers to research persist and more empirical evidence on development strategies is required. Despite an evolution in development thinking, international actors continue to use outdated development models that are recognised as ineffective. To realise newer development thinking, research capacity outcomes need to be equally valued as research outputs. While some development actors are now adopting this dedicated capacity development approach, they are in the minority.

Understanding the investigators: a qualitative study investigating the barriers and enablers to the implementation of local investigator-initiated clinical trials in Ethiopia.

OBJECTIVES: Clinical trials provide 'gold standard' evidence for policy, but insufficient locally relevant trials are conducted in low-income and middle-income countries. Local investigator-initiated trials could generate highly relevant data for national governments, but information is lacking on how to facilitate them. We aimed to identify barriers and enablers to investigator-initiated trials in Ethiopia to inform and direct capacity strengthening initiatives. DESIGN: Exploratory, qualitative study comprising of in-depth interviews (n=7) and focus group discussions (n=3). SETTING: Fieldwork took place in Ethiopia during March 2011. PARTICIPANTS: Local health researchers with previous experiences of clinical trials or stakeholders with an interest in trials were recruited through snowball sampling (n=20). OUTCOME MEASURES: Detailed discussion notes were analysed using thematic coding analysis and key themes were identified. RESULTS: All participants perceived investigator-initiated trials as important for generating local evidence. System and organisational barriers included: limited funding allocation, weak regulatory and administrative systems, few learning opportunities, limited human and material capacity and poor incentives for conducting research. Operational hurdles were symptomatic of these barriers. Lack of awareness, confidence and motivation to undertake trials were important individual barriers. Training, knowledge sharing and experience exchange were key enablers to trial conduct and collaboration was unanimously regarded as important for improving capacity. CONCLUSIONS: Barriers to trial conduct were found at individual, operational, organisational and system levels. These findings indicate that to increase locally led trial conduct in Ethiopia, system wide changes are needed to create a more receptive and enabling research environment. Crucially, the creation of research networks between potential trial groups could provide much needed practical collaborative support through sharing of financial and project management burdens, knowledge and resources. These findings could have important implications for capacity-strengthening initiatives but further research is needed before the results can be generalised more widely.

Effects of hydroxychloroquine on immune activation and disease progression among HIV-infected patients not receiving antiretroviral therapy: a randomized controlled trial.

CONTEXT: Therapies to decrease immune activation might be of benefit in slowing HIV disease progression. OBJECTIVE: To determine whether hydroxychloroquine decreases immune activation and slows CD4 cell decline. DESIGN, SETTING, AND PATIENTS: Randomized, double-blind, placebo-controlled trial performed at 10 HIV outpatient clinics in the United Kingdom between June 2008 and February 2011. The 83 patients enrolled had asymptomatic HIV infection, were not taking antiretroviral therapy, and had CD4 cell counts greater than 400 cells/µL. INTERVENTION: Hydroxychloroquine, 400 mg, or matching placebo once daily for 48 weeks. MAIN OUTCOME MEASURES: The primary outcome measure was change in the proportion of activated CD8 cells (measured by the expression of CD38 and HLA-DR surface markers), with CD4 cell count and HIV viral load as secondary outcomes. Analysis was by intention to treat using mixed linear models. RESULTS: There was no significant difference in CD8 cell activation between the 2 groups (-4.8% and -4.2% in the hydroxychloroquine and placebo groups, respectively, at week 48; difference, -0.6%; 95% CI, -4.8% to 3.6%; P = .80). Decline in CD4 cell count was greater in the hydroxychloroquine than placebo group (-85 cells/µL vs -23 cells/µL at week 48; difference, -62 cells/µL; 95% CI, -115 to -8; P = .03). Viral load increased in the hydroxychloroquine group compared with placebo (0.61 log10 copies/mL vs 0.23 log10 copies/mL at week 48; difference, 0.38 log10 copies/mL; 95% CI, 0.13 to 0.63; P = .003). Antiretroviral therapy was started in 9 patients in the hydroxychloroquine group and 1 in the placebo group. Trial medication was well tolerated, but more patients reported influenza-like illness in the hydroxychloroquine group compared with the placebo group (29% vs 10%; P = .03). CONCLUSION: Among HIV-infected patients not taking antiretroviral therapy, the use of hydroxychloroquine compared with placebo did not reduce CD8 cell activation but did result in a greater decline in CD4 cell count and increased viral replication. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN30019040.