Nakuru County Council

Moral injury among healthcare workers is well recognised in extreme conditions such as the COVID-19 pandemic1 2 or critical care settings,3 but its impact on research personnel has received far less attention.4Exposure to moral injury is not part of standard training for research coordinators or investigators.This commentary reflects experiences from an ongoing clinical trial across multiple lowand middle-income countries (LMICs) in sub-Saharan Africa and offers 13 practical approaches by which to build ethical resilience and help mitigate moral injury.

Abstract Rationale: We explored the impact of a multicenter, randomized controlled trial (RCT) on clinical care in five hospitals in Sub-Saharan Africa from the perspective of study staff and hospital clinicians. Describing these impacts will facilitate improved research design and increased equity in clinical research. Methods: We conducted a qualitative analysis of the Building Respiratory Support in East Africa Through High-Flow versus Standard Flow Oxygen Evaluation (BREATHE) trial, an RCT comparing high-flow oxygen with usual care across four public and one faith-based hospital in Kenya, Malawi, and Rwanda (ClinicalTrials.gov, NCT05754034). Guided by the Consolidated Framework for Implementation Research (CFIR), we performed a rapid inductive analysis of 50 staff meetings and 9 clinician interviews to identify trial-related facilitators of and barriers to quality care. Results: We identified several facilitators of improved clinical practice from the perspective of trial staff and clinicians. Patients in both arms received increased monitoring, diagnostics (lung ultrasound), and emotional support from study staff, a significant benefit in settings with low clinician-to-patient ratios. Trial-related monitoring helped identify existing clinical gaps. Leadership at some sites were eager to incorporate aspects of trial protocols, such as oxygen titration guidelines, into hospital-wide practice. Trial staff conducted educational sessions for clinical staff, which were well-attended and appreciated. Many felt the trial fostered a culture of academic inquiry and cross-site networking for future clinical trials, for which planning is already underway. One clinician suggested further locally-driven research “would be very good because we can use the effective data which is local..the real population and the real conditions.” Negative impacts (barriers) were also identified. Early in enrollment, adapting to trial activities was burdensome for busy clinicians. Patients were worried about randomization and parallel care pathways. Later, clinicians expressed concern about a vacuum of knowledge and resources that may occur when the trial concludes-"If they left them [HFO devices] without training they cannot benefit us.” These are preliminary results pending further interviews with clinical staff, patients, and caregivers. Conclusion: CFIR-guided analysis of a multicenter RCT in sub-Saharan Africa uncovered impacts of RCT implementation at participating hospitals including increased monitoring and support for patients, identification of care gaps, education for clinical staff, and fostering a culture of inquiry, but also extra clinician burden, patient concerns around randomization, and worries about reduced resources after trial completion. Future researchers should consider these factors during study design and implementation to account for the impact of research on clinical practice.

Abstract Rationale: Although most critical care and pulmonary research is conducted in high-income countries, the barriers and facilitators of randomized controlled trials (RCTs) in resource-constrained settings are poorly characterized. Understanding RCT implementation in these settings can facilitate future studies and ultimately improve equity and generalizability of research. Methods: We analyzed qualitative data from Building Respiratory support in East Africa Through High flow versus standard flow oxygen Evaluation (BREATHE), an RCT comparing clinical outcomes of high-flow oxygen therapy to standard care at resource-constrained, predominantly RCT-inexperienced hospitals in Rwanda, Malawi, and Kenya (ClinicalTrials.govNCT05754034). Employing the Consolidated Framework for Implementation Research (CFIR) and Proctor's Implementation Outcomes Framework, we conducted rapid CFIR-based inductive analysis on 34 weekly staff meetings and 8 clinician interviews to identify barriers, facilitators, and other features of trial implementation. Results: Trial acceptance was facilitated by preexisting trust in local leaders, attentiveness of research assistants, appreciation of increased patient monitoring, education sessions for clinical and study staff, and perception of intervention benefit. Clinicians appreciated receiving the results of diagnostic testing performed by the study, and hospital leadership at one site requested study protocols to adapt for clinical care. Concerns about harm for the intervention were rare. Consent processes were adapted to cultural preferences for extensive family participation, particularly at two sites. Consent was facilitated by language and/or tribe concordance between patient and study staff at three sites. Suspicion of the study intervention occasionally arose surrounding the formal consent process and the switch from hospital device to study device. A government-employed doctors’ strike halted enrollment at one (government) site when few patients were presenting for care, while another (non-government) site was overwhelmed by an influx of critically ill patients, making study enrollment difficult. A public health emergency halted enrollment at two sites when study devices were needed for patients with Marburg virus. Infrastructure challenges included delays in replacing and repairing equipment, as well as adaptations around variable internet connectivity. Both oxygen and electricity interruptions occurred at some sites. Regulatory, data-sharing, and patient protection requirements were substantial, varied by country and over time, and required significant resources to anticipate and manage. These findings are preliminary, pending analysis of additional meetings and interviews. Conclusions: CFIR-guided analysis of BREATHE revealed unique barriers and facilitators to implementation relating to acceptability, environment, consent, communication, critical incidents, infrastructure, and regulatory oversight. These insights could streamline future RCTs in East Africa and other resource-constrained contexts.

Routine HIV viral load testing is important for evaluating HIV treatment outcomes, but conventional viral load testing has many barriers including expensive laboratory equipment and lengthy results return times to patients. A point-of-care viral load testing technology, such as GeneXpert HIV-1 quantification assay, could reduce these barriers by decreasing cost and turnaround time, however real-world performance is limited. We conducted a secondary analysis using 900 samples collected from participants in two studies to examine the performance of GeneXpert as point-of-care viral load compared to standard-of-care testing (which was conducted with two centralized laboratories using traditional HIV-1 RNA PCR quantification assays). The two studies, Opt4Kids (n = 704 participants) and Opt4Mamas (n = 820 participants), were conducted in western Kenya from 2019–2021 to evaluate the effectiveness of a combined intervention strategy, which included point-of-care viral load testing. Paired viral load results were compared using four different thresholds for virological non-suppression, namely ≥50, ≥200, ≥400, ≥1000 copies/ml. At a threshold of ≥1000 copies/mL, paired samples collected on the same day: demonstrated sensitivities of 90.0% (95% confidence interval [CI] 68.3, 98.8) and 66.7% (9.4, 99.2), specificities of 98.4% (95.5, 99.7) and 100% (96.5, 100), and percent agreements of 97.7% (94.6, 99.2) and 99.1% (95.0, 100) in Opt4Kids and Opt4Mamas studies, respectively. When lower viral load thresholds were used and the paired samples were collected an increasing number of days apart, sensitivity, specificity, and percent agreement generally decreased. While specificity and percent agreement were uniformly high, sensitivity was lower than expected. Non-specificity of the standard of care testing may have been responsible for the sensitivity values. Nonetheless, our results demonstrate that GeneXpert may be used reliably to monitor HIV treatment in low- and middle- income countries to attain UNAID’s 95-95-95 HIV goals.

BackgroundTungiasis is a highly neglected tropical skin disease caused by the sand flea, Tunga penetrans, the female of which burrows into the skin, causing pain and itching. The disease occurs throughout South America and sub-Saharan Africa but there are few systematic data on national disease burdens. The tungiasis research community is keen to develop survey methods to fill this gap. Here we used a school-based, thorough examination method to determine the prevalence and risk factors for tungiasis in Kenya.MethodsWe conducted the first nationally representative survey of tungiasis, including nine counties covering the major ecological zones of Kenya. A stratified multistage random sampling was used to select 22 primary schools from each of the nine counties and to select up to 114 pupils aged 8 to 14 years in each school. Pupils were examined thoroughly for tungiasis. Two surveys were conducted, the first between May and July 2021 and the second between October 2021 and April 2023 when pupils were also interviewed for risk factors. Mixed effect logistic regression models were used to test associations of independent variables with tungiasis using the school as a random effect.ResultsThe overall prevalence of tungiasis in the first survey was 1.35% [95% confidence interval (CI): 1.15–1.59%], and 0.89% in the second survey. The prevalence ranged from 0.08% (95% CI: 0.01–0.59%) in Taita Taveta county to 3.24% (95% CI: 2.35–4.44%) in Kajiado county. Tungiasis infection was associated with county of residence, male sex [adjusted odds ratio (aOR) = 2.01, 95% CI: 1.52–2.67], and lower age (aOR = 0.81, 95% CI: 0.75–0.88). For the first time we demonstrate an association with attending public schools rather than private schools (aOR = 5.62, 95% CI: 1.20–26.22) and lower socioeconomic status (aOR = 0.10, 95% CI: 0.03–0.33). Using a rapid screening method of the top of feet only, would have missed 62.9% of all cases, 78.9% of mild cases and 20.0% of severe cases.ConclusionsTungiasis is widely but heterogeneously distributed across Kenya. School-based surveys offer an efficient strategy for mapping tungiasis distribution.Graphical

Data used in this study was collected daily between January 2011 and April 2016 from four fish landing beaches along the shores of Lake Naivasha; Central, Karagita, Kamere and Tarambete beaches. The results revealed that the total landings of Nile tilapia Oreochromis niloticus has been gradually increasing from a 0% in 2011 to 42.7% (206.923 tons) of the total landings between January and April 2016 (422.613 tons) with projections of it surpassing carp by December 2016. These findings corroborate regular field observations which indicate that fishermen are abandoning carp fisheries, opting for Nile tilapia due to its high demand and increased market returns. Between January and April 2016, Nile tilapia had an average price per kg of KShs 147.52 compared to carp’s KShs 122.93. The study therefore concludes that the re-introduction of O. niloticus in 2011 has achieved its main objectives of food security and improving livelihoods since the fish has completely established itself and is now the key driver of Lake Naivasha fishery.