Acceptability and Feasibility of the Plasma Separation Card for an Integrated Model of Care for HBV and HCV Screening Among People Attending HIV Clinics in Cameroon and Uganda.

BACKGROUND: Sub-Saharan African countries have a high burden of viral hepatitis and poor access to screening and care. The aim of this study was to evaluate the feasibility and acceptability of using the plasma separation card (PSC) for viral hepatitis B and C screening among people living with HIV (PLHIV) in Cameroon and Uganda. METHODS: This is a cross-sectional study carried out between 05/2021 and 03/2023 including 192 PLHIV in Cameroon (n = 104) and Uganda (n = 88). Basic sociodemographic variables and whole blood samples were collected. Adequate filling with blood of PSCs was used to determine feasibility together with participant responses to questions on acceptability. A logistic regression model was carried out to assess the relationship between PSC acceptability and factors of interest. RESULTS: 70% of participants reported PSC as an acceptable viral hepatitis screening tool, and it was significantly more accepted in Uganda than Cameroon (100% vs. 43.2%, p < 0.001). Similarly, 75% of PSCs had at least one spot sample filled and were viable for analysis, 99% were correctly filled in Uganda and 53.4% in Cameroon. Reported ease of method performance (aOR: 24.77 95% CI 2.97-206.42, p = 0.003) and reduced collection time (aOR: 3.73 95% CI 1.26-11.04, p = 0.017) were associated with greater odds of PSC acceptance. HBsAg + and anti-HCV + prevalence were 11.1% and 1.0%, respectively. CONCLUSIONS: In spite of country differences, overall, the PSC was reported as a feasible and acceptable viral hepatitis testing method. Acceptability and feasibility of the method must be explored in heterogeneous target communities and qualitative research to better understand country-specific barriers and facilitators should be carried out.

Uptake and effectiveness of a mobile application for real-time reporting and quality assurance of decentralized SARS-CoV-2 testing in Uganda.

Background: Effective management of the COVID-19 pandemic required rapid expansion of diagnosis. The introduction of antigen tests presented an opportunity to decentralize testing, but raised challenges with ensuring accurate and timely reporting of testing data, which is essential to guide the response. Digital solutions can help address this challenge and provide more efficient means of monitoring and quality assurance. Methods: Uganda's existing laboratory investigation form was digitized in the form of an Android-based application, eLIF, which was developed by the Central Public Health Laboratory and implemented in 11 high-volume facilities between December 2021 and May 2022. The app enabled healthcare workers to report testing data via mobile phone or tablet. Uptake of the tool was monitored through a dashboard that enabled real-time visibility into data being transmitted from sites, as well as qualitative insights from site visits and online questionnaires. Results and discussion: A total of 15,351 tests were conducted at the 11 health facilities during the study period. Of these, 65% were reported through eLIF, while 12% were reported through preexisting Excel-based tools. However, 23% of tests were only captured in paper registers and not transmitted to the national database, illustrating the need for increased uptake of digital tools to ensure real-time data reporting. While data captured through eLIF were transmitted to the national database within 0-3 days (min, max), data transmitted through Excel were transmitted in within 0-37 days (min, max), and data for paper-based reporting took up to 3 months. The majority of healthcare workers interviewed in an endpoint questionnaire responded that eLIF improved timeliness of patient management, and reduced reporting time. However, some functions of the app were not successfully implemented, such as providing random selections of samples for external quality assurance and enabling seamless linkage of these data. Challenges arose from broader operational complexities, such as staff workload, frequent task-shifting and unexpected changes to facility workflows, which limited adherence to the envisioned study procedures. Ongoing improvements are needed to adjust to these realities, to strengthen the technology and support to healthcare workers using it, to optimize the impact of this digital intervention.

High burden of pulmonary tuberculosis and missed opportunity to initiate treatment among children in Kampala, Uganda.

Background: There is uncertainty about the actual burden of childhood TB in Uganda, but underestimation is acknowledged. We aimed at determining prevalence, factors associated with PTB among children attending PHC facilities in Kampala. Methods: This was a cross-sectional study of 255 children, with presumed TB, attending six health facilities in Kampala, Uganda, in March 2015. Socio-demographic, clinical, and laboratory data were collected using a questionnaire. TB was diagnosed using "Desk Guide" algorithms. Sputum based on ZN/FM and/or Gene-Xpert. Logistic regression was used to assess associations with outcomes. Results: Overall, prevalence of PTB 13.7 % (2.6 - 24.8). Among HIV-positive, the prevalence of PTB was 41.7%, while among malnourished children, 21.7% and contacts, 89.3%. The factors that influenced PTB included: tobacco smoker at home (OR = 1.6, 95 % CI: 1.07 - 6.86), stunting (OR = 2.2, 95 % CI: 1.01 - 4.15). Only 5.3% of the smear-negative TB children and 81.3% of the smear-positive children were initiated on treatment within a month of diagnosis. Conclusion: Clinical TB among children is underdiagnosed and undertreated. There is a need for more sensitive and specific diagnostic tests, need ways to disseminate and promote uptake of standardized clinical algorithms. Also, contact TB tracing should be strengthened so that such cases can be actively detected even at community level.

Health care users' acceptance of broad consent for storage of biological materials and associated data for research purposes in Uganda.

Background: Implementation of appropriate informed consent has become a cornerstone for the use of biological materials and data from clinical care to use in research. During 2017-2018, the Ugandan National Biorepository has since sought prior informed consent for long-term storage and use of remnant clinical human biological materials, where a shortened informed consent form (ICF) was incorporated on the laboratory investigation form. This project aimed at determining the acceptability rate of broad consent from health care users (HCUs) for storage of biological materials and data for research purposes in Uganda. Methods: A cross-sectional study was conducted at three Primary Health Care Facilities. 500 HCUs above 18 years of age seeking health care at outpatient departments between March to December 2020 were invited to enrol. A shortened experimental ICF for this study was developed and attached to the Laboratory investigation form. Results: Overall the acceptability of broad consent for storage of biological materials and data was 86.2% [95% CI: 82.9%-88.9%]. Compared to participants who perceived that the informed consent information is understandable (OR=0.10, CI [0.03-0.32], participants who either partly or totally disagreed were significantly less likely to perceive information as understandable (OR=0.27, CI [0.15-0.46]. 226 out of 431 respondents that accepted storage of biological materials and data, majority (61.7%) preferred to receive feedback on results of relevance to their health. Conclusion: Acceptance of broad consent for storage of biological materials and data for future research purposes was high among HCUs. A shortened and simplified ICF may trigger discussions between participants and health care workers hence increase research participant understanding of study related materials in biobanking. This in turn could enrich ethically collected biobank resources for future research of public health relevance.

Emergence and spread of a SARS-CoV-2 lineage A variant (A.23.1) with altered spike protein in Uganda.

Here, we report SARS-CoV-2 genomic surveillance from March 2020 until January 2021 in Uganda, a landlocked East African country with a population of approximately 40 million people. We report 322 full SARS-CoV-2 genomes from 39,424 reported SARS-CoV-2 infections, thus representing 0.8% of the reported cases. Phylogenetic analyses of these sequences revealed the emergence of lineage A.23.1 from lineage A.23. Lineage A.23.1 represented 88% of the genomes observed in December 2020, then 100% of the genomes observed in January 2021. The A.23.1 lineage was also reported in 26 other countries. Although the precise changes in A.23.1 differ from those reported in the first three SARS-CoV-2 variants of concern (VOCs), the A.23.1 spike-protein-coding region has changes similar to VOCs including a change at position 613, a change in the furin cleavage site that extends the basic amino acid motif and multiple changes in the immunogenic N-terminal domain. In addition, the A.23.1 lineage has changes in non-spike proteins including nsp6, ORF8 and ORF9 that are also altered in other VOCs. The clinical impact of the A.23.1 variant is not yet clear and it has not been designated as a VOC. However, our findings of emergence and spread of this variant indicate that careful monitoring of this variant, together with assessment of the consequences of the spike protein changes for COVID-19 vaccine performance, are advisable.

Role of a regulatory and governance framework in human biological materials and data sharing in National Biobanks: Case studies from Biobank Integrating Platform, Taiwan and the National Biorepository, Uganda.

Background: In the last decade, Low- and Middle-Income Countries (LMICs) have set up Biobanks to collect human biological materials and associated data for genomic research and public health purposes. Biobanking gives rise to ethical challenges, such as informed consent, benefit sharing, confidentiality, ownership, commercialization and public participation which are harder to navigate in LMIC settings due to disparities in research infrastructure and capacity.  This paper summarizes presentations on Biobank related case studies from two countries, with a focus on challenges in the regulatory and governance framework and suggestions on how to mitigate them.   Methods: Two case studies of Biobanks from LMICs have been used . The case studies were presented at the 2018 Global Forum on Bioethics in Research (GFBR) meeting on the "Ethics of data sharing and Biobanking in health research". Results: The case studies show that an integrated, well-regulated platform for human biological materials and data ensures good quality of human biological materials, saves resources and promotes mutual collaboration of work among researchers. National regulatory bodies are required to generate Biobanking guidelines and policies to facilitate guidance to the rapidly changing landscape of science. Discussion: In general, LMICs have weaker research regulatory infrastructure and governance mechanisms for Biobanks than high-income countries. This has increased the fear of exploitation i.e. unfair distribution of risks and benefits. Establishment of Biobanks and producing effective scientific outcomes based on the Biobanking resources is difficult without a proper legislative, regulatory and governance framework. Conclusion: These two case studies from different LMICs settings show that although in both settings there is strong awareness of the scientific and population health value of Biobanks and strong commitment to their establishment, regulatory and ethical guidance show gaps that need to be addressed.

Risk factors, person, place and time characteristics associated with Hepatitis E Virus outbreak in Napak District, Uganda.

BACKGROUND: Hepatitis E is self-limiting, but can cause death in most at risk groups like pregnant women and those with preexisting acute liver disease. In developing countries it presents as epidemic, in 2014 Hepatitis E Virus (HEV) outbreak was reported in Napak district Uganda. The role of factors in this setting that might have propagated this HEV epidemic, including host, agent, and environmental characteristics, were still not clear. This study was therefore conducted to investigate the risk factors, person, place and time characteristics, associated with the hepatitis E virus (HEV) epidemic in Napak district. METHODS: Review of line lists data for epidemiological description and matched case control study on neighborhood and age in the ratio of 1:2 were used to assess risk factors for HEV outbreak in Napak. Cluster and random sampling were used to obtain a sample size of 332, (111 cases, 221 controls). Possible interaction and confounding was assessed using conditional logistic regression. RESULTS: Over 1359 cases and 30 deaths were reported during 2013/2014 HEV outbreak. The mean age of patients was 29 ± years, 57.9% of cases were females. Overall case Fatality Ratio was 2.2% in general population but 65.2% in pregnant women. More than 94% of the cases were reported in the sub counties of Napak, 5.7% of cases were reported in the outside neighboring districts. The epidemic peaked in January 2014 and gradually subsided by December 2014. Risk factors found to be associated with HEV included drinking untreated water (OR 6.69, 95% CI 3.15-14.16), eating roadside food (OR 6.11, 95% CI 2.85-13.09), reported not cleaning utensils (OR 3.24, 95% CI 1.55-1.76), and being a hunter (OR 1.14, 95% CI 1.03-12.66). CONCLUSION: The results of this study suggest that the virus is transmitted by the feco-oral route through contaminated water. They also suggest that active surveillance and appropriate measures targeting community and routine individual health actions are important to prevent transmission and decrease the deaths.