Lessons from Africa: developing a global human rights framework for tuberculosis control and prevention

Background: Tuberculosis is a highly contagious disease, and there has been a rise in recent years of drug-resistant cases no longer responding to standard treatment. In order to address this threat and contain possible transmission of drug-resistant cases, some countries have taken strong action, including the compulsory detention of non-adherent drug-resistant patients. These measures have been strongly criticized by human rights advocates, and they raise the question of how to legally protect both citizens and the community. Discussion: Following discussions with National Tuberculosis Programs in Africa (the continent with the highest incidence rates of tuberculosis worldwide), we show that of all the countries surveyed, all but one (Swaziland) had either no specific policy addressing tuberculosis, or only general policies regarding public health applicable to tuberculosis. Six countries also reported having policies that address non-adherence to treatment with containment (isolation in health facilities or incarceration), but laws are not adequately enforced. If the international community wants to effectively respond to the threat of tuberculosis transmission, there is a need to go beyond national tuberculosis policies and to implement an international framework for tuberculosis control, inspired by the Framework Convention on Tobacco Control, a key model for future public health treaties that address global burdens of disease. The framework, for which we clarify the conditions and procedures in this piece, would define the rights and responsibilities of the different stakeholders involved: patients, doctors, pharmaceutical firms and public authorities. To facilitate the governance of the national obligations under the Convention, a coordinating body should be set up, under the leadership of the World Health Organization and the Stop TB Partnership. Summary: Successfully implementing policies for tuberculosis that simultaneously address patients’ rights and communities’ wellbeing will have positive implications for those affected by the disease and serve as a basis for other global health conventions to truly ensure the global right to health

Performance of the BD-FACS Presto for CD4 count and hemoglobin measurement in a district hospital and rural laboratory in Ghana

Introduction In Ghana, initiation of Antiretroviral Therapy (ART) is recommended for all patients with an HIV diagnosis, regardless of CD4+ T-cell count. However, measurement of CD4 count remains an important metric for identifying patients with advanced HIV disease, and assessing a person’s overall immune status, which informs the decision to offer opportunistic infection screening and prophylaxis. Access to CD4+ T cell count in rural health facilities remains a major challenge in Ghana and other resource-limited settings. This study aimed to validate the accuracy of the BD FACSPresto near-patient device for measurement of CD4 count and hemoglobin concentration against the FACSCount (CD4) and Sysmex (hemoglobin) diagnostic machines when operated in both a district hospital and rural laboratory, serving a network of health posts in Ashanti Region, Ghana. Methodology In the first phase of the study, patients were recruited from a district hospital, and both venous and capillary blood samples were tested using the FACSCount and Sysmex as reference tests and compared to results of the FACSPresto performed in the clinic laboratory at the district hospital. In the second phase, patients were recruited from both the hospital and from rural health clinics, and samples were tested using the FACSPresto at a rural laboratory. Sensitivity and specificity among samples categorized into different clinically relevant CD4 count ranges were calculated, along with correlation between the Presto and the reference measurements, and mean and relative bias with limits of agreement. Results The FACSPresto was successfully operated in both clinical settings. A total of 59 samples in the first phase and 48 samples in the second phase were included. Positive bias was observed when comparing CD4 count measured by BD FACSPresto to FACSCount in the district hospital (bias = 44, LOA -72,160) and in the rural laboratory setting (bias = 74, LOA -96, 244). In addition, capillary blood samples were shown to give higher measures when compared to venous blood samples from the same participant. All results were statistically significant (p<0.05) apart from hemoglobin measurement in venous blood in the rural laboratory. Correlation coefficients were high for CD4 count measures and lower for hemoglobin measures. Conclusion Overall, the Presto gave higher estimates of CD4 count compared to FACSCount, and hemoglobin measurements were higher than from Sysmex. Samples of capillary blood in turn gave higher results for both measurements compared to venous blood, consistent with previous analyses. These findings should be considered when selecting CD4 count machines for use at the point of care, especially in remote areas where capillary blood sampling may be preferable, but are likely balanced by device’s ease of use, portability, and ability to expand access to services. These results are some of the first to demonstrate the accuracy of the FACSPresto in West Africa and show that this device can be successfully operated in a very rural lab setting and may therefore assist to provide CD4 count and hemoglobin concentration measurement to populations in need

Comparative performance study of three Ebola rapid diagnostic tests in Guinea

Background The 2014/15 Ebola outbreak in West Africa resulted in 11,000 deaths and massive strain on local health systems, and the ongoing outbreak in Democratic Republic of Congo has afflicted more than 3000 people. Accurate, rapid Ebola diagnostics suitable for field deployment would enable prompt identification and effective response to future outbreaks, yet remain largely unavailable. The purpose of this study was to assess the accuracy of three novel rapid diagnostic tests (RDTs): an Ebola, an Ebola-Malaria, and a Fever Panel test that includes Ebola, all from a single manufacturer. Methods We evaluated the three RDTs in 109 Ebola-positive and 96 Ebola-negative stored serum samples collected during the outbreak in Guinea in 2014/15, and tested by real-time polymerase chain reaction (RT-PCR). Sensitivity, specificity, and overall percent agreement were calculated for each RDT using RT-PCR as a reference standard, stratified by Ct value ranges. Results All tests performed with high accuracy on samples with low Ct value (high viral load). The Fever Panel test performed with the highest accuracy, with a sensitivity of 89.9% and specificity of 90.6%. The Ebola and Ebola-Malaria tests performed comparably to each other: sensitivity was 77.1 and 78% respectively, and specificity was 91.7% for the Ebola test and 95.8% for the Ebola-Malaria test. Conclusions This study evaluated the accuracy of three novel rapid diagnostic tests for Ebola. The tests may have significant public health relevance, particularly the Fever Panel test, which detects seven pathogens including Ebola. Given limitations to the study resulting from uncertain sample quality, further evaluation is warranted. All tests performed with highest accuracy on samples with low Ct value (high viral load), and the data presented here suggests that these RDTs may be useful for point-of-care diagnosis of cases in the context of an outbreak. Restrictions to their use in non-severe Ebola cases or for longitudinal monitoring, when viral loads are lower, may be appropriate. Highlighting the challenge in developing and evaluating Ebola RDTs, there were concerns regarding sample integrity and reference testing, and there is a need for additional research to validate these assays

Underreported Threat of Multidrug-Resistant Tuberculosis in Africa

Identification of population-based factors should influence regional and national policy

The effect of an integrated multisector model for achieving the Millennium Development Goals and improving child survival in rural sub-Saharan Africa: a non-randomised controlled assessment

Background Simultaneously addressing multiple Millennium Development Goals (MDGs) has the potential to complement essential health interventions to accelerate gains in child survival. The Millennium Villages project is an integrated multisector approach to rural development operating across diverse sub-Saharan African sites. Our aim was to assess the effects of the project on MDG-related outcomes including child mortality 3 years after implementation and compare these changes to local and national reference data

Institutional and behaviour-change interventions to support COVID-19 public health measures: a review by the Lancet Commission Task Force on public health measures to suppress the pandemic

The Lancet COVID-19 Commission Task Force for Public Health Measures to Suppress the Pandemic was launched to identify critical points for consideration by governments on public health interventions to control coronavirus disease 2019 (COVID-19). Drawing on our review of published studies of data analytics and modelling, evidence synthesis and contextualisation, and behavioural science evidence and theory on public health interventions from a range of sources, we outline evidence for a range of institutional measures and behaviour-change measures. We cite examples of measures adopted by a range of countries, but especially jurisdictions that have, thus far, achieved low numbers of COVID-19 deaths and limited community transmission of severe acute respiratory syndrome coronavirus 2. Finally, we highlight gaps in knowledge where research should be undertaken. As countries consider long-term measures, there is an opportunity to learn, improve the response and prepare for future pandemics.publishedVersio

Global public health security and justice for vaccines and therapeutics in the COVID-19 pandemic.

A Lancet Commission for COVID-19 task force is shaping recommendations to achieve vaccine and therapeutics access, justice, and equity. This includes ensuring safety and effectiveness harmonized through robust systems of global pharmacovigilance and surveillance. Global production requires expanding support for development, manufacture, testing, and distribution of vaccines and therapeutics to low- and middle-income countries (LMICs). Global intellectual property rules must not stand in the way of research, production, technology transfer, or equitable access to essential health tools, and in context of pandemics to achieve increased manufacturing without discouraging innovation. Global governance around product quality requires channelling widely distributed vaccines through WHO prequalification (PQ)/emergency use listing (EUL) mechanisms and greater use of national regulatory authorities. A World Health Assembly (WHA) resolution would facilitate improvements and consistency in quality control and assurances. Global health systems require implementing steps to strengthen national systems for controlling COVID-19 and for influenza vaccinations for adults including pregnant and lactating women. A collaborative research network should strive to establish open access databases for bioinformatic analyses, together with programs directed at human capacity utilization and strengthening. Combating anti-science recognizes the urgency for countermeasures to address a global-wide disinformation movement dominating the internet and infiltrating parliaments and local governments

Global Introduction of New Multidrug-Resistant Tuberculosis Drugs—Balancing Regulation with Urgent Patient Needs

New treatments for multidrug-resistant tuberculosis (MDR TB) are urgently needed. Two new drugs, bedaquiline and delamanid, have recently been released, and several new drugs and treatment regimens are in the pipeline. Misuse of TB drugs is a principal cause of drug resistance. As new drugs and regimens reach the market, the need to make them available to patients must be balanced with regulation of their use so that resistance to the new drugs can be prevented. To foster the rational use of new drugs, we propose 1) expanding/strengthening the capacity for drug susceptibility testing, beginning with countries with a high TB burden; 2) regulating prescribing practices by banning over-the-counter sale of TB drugs and enacting an accreditation system whereby providers must be certified to prescribe new drugs; and 3) decentralizing MDR TB care in rural communities by employing trained community health workers, using promising mobile technologies, and enlisting the aid of civil society organizations