These guidance articles are peer reviewed and provided to give research teams high quality and trustworthy information on how to conduct a task or resolve an issue in the design, conduct or reporting of a clinical trial. Articles are accompanied by resources, such as a template or example documents. These are free for you to download and adapt for your study. Please acknowledge www.globalhealthtrials.org if you use these.
What did we know before this research?The border between Thailand and Cambodia is the world’s epicenter of cases of multi-drug resistant Plasmodium falciparum , the most dangerous malaria species. Recently, cases of resistance to artemisinin have been documented in the region and triggered efforst to contain further spread.
What we did we know before this research?In Africa it’s common practice to overdiagnose malaria, which means that very often patients are given ACT drugs simply because they present fever. Not only this leads to the waste of expensive drugs, but it also means that patients don’t receive treatment for their actual illness.
Evidence shows that in many African regions, including Ghana, malaria is massively over-diagnosed. This means that patients who are not diagnosed with malaria by tests that identify malaria parasites in the blood are still considered to have the disease and therefore receive anti-malarial treatment.
The World Health Organization recommends artemisinin-based combination therapy (ACT) as the first-line treatment for malaria. This consists of combining two drugs: artemisinin (which derives from the artemisia plant) and a partner drug (one of existing antimalarials). If taken alone rather than combined, they are considered monotherapies and are less effective.
Scientific title: Interactions between the antimalarial combination artemether/lumefantrine and antiretroviral therapy including nevirapine or lopinavir/ritonavir in HIV-infected adults What did we know before this research?Several African countries are heavily affected by both HIV/AIDS and malaria. The World Health Organization and ministries of health in most endemic countries recommend the use of artemisinin-based combination therapy (ACT) for malaria and antiretroviral combination treatments (ART) for HIV/AIDS, and such treatments have become increasingly available.
Scientific title: Determining sub-national intervention coverage and malaria impact estimates in young children and older age groups using a continuous Malaria Indicator Survey in Chikhwawa district, Malawi What did we know before this research?In areas where malaria transmission rates are moderate to high, the progress of malaria control is mainly evaluated using national household surveys such as Malaria Indicator Surveys (MIS), Demographic Health Surveys (DHS) or UNICEF Multiple Indicator Cluster Surveys (MICS). These are then complemented by data from Health Management Information Systems (HMIS).
Scientific title: Qualitative study on antimalarial drug use in the context of perceptions of ACTs and intra-household decision making in the Chikhwawa district of Malawi What did we know before this research?There are very effective antimalarial drugs available , but it is a challenge to ensure that they reach those that need them and that they are used appropriately.
What did we know before this research?International efforts to increase the use of artemisinin-based combination therapy (ACT) over the past decade have been based on the argument that this will lead to fewer malaria deaths. It has also been assumed that these drugs are safe even if used repeatedly. While there is no evidence to suggest concern, this has not been demonstrated directly in children under five years of age living in those areas.
In many malaria-endemic countries HIV/AIDS continues to spread, therefore an increasing number of patients need treatment for both infections at the same time. The WHO and ministries of health in many endemic countries recommend the use of artemisinin-based combination therapy (ACT) for malaria and antiretroviral combination treatments (ART) for HIV/AIDS. Such treatments have become increasingly available and research is being conducted into the clinical implications of taking ACT and ART concomitantly.
In many malaria-endemic countries HIV/AIDS continues to spread, therefore an increasing number of patients need treatment for both infections at the same time. The World Health Organization and ministries of health in many endemic countries recommend the use of artemisinin-based combination therapy (ACT) for malaria and antiretroviral combination treatments (ART) for HIV/AIDS. Such treatments have become increasingly available.
It is common practice in Africa to overdiagnose malaria, meaning that very often patients are given ACT drugs simply because they present fever. Given the high price of this type of medication, this approach becomes unsustainable. At the same time, it means that patients don’t receive treatment for their actual illness.
What did we know before this research?In sub-Saharan Africa it is common to overdiagnose and overtreat malaria, which means that patients who are not formally diagnosed with malaria are still considered to have the disease and therefore receive anti-malarial treatment. This leads to the waste of expensive drugs and increases the risk of developing drug resistance.
Scientific title: Infectious disease aetiologies of uncomplicated febrile illness in children <5 years of age in rural Zanzibar. As a result, Zanzibar has turned into a low transmission area with a decline of P. falciparum malaria among children with fever from approximately 30% to 1%, as well as a significant reduction of the crude child mortality.
Scientific title: Effectiveness of Malaria Rapid Diagnostic Tests in fever patients attending primary health care facilities in Zanzibar. Over the past decade, Zanzibar has adopted artemisinin-based combination therapy (ACT), long lasting insecticide treated nets and indoor residual spraying
Strategies for expanding access to quality malaria diagnosis in south-central Asia where malaria incidence is lowby ACTConsortium
Scientific title: An examination of ACT strategy in south-central Asia on P. falciparum malaria in a context where P. vivax is the major species. With the exception of Sub-Saharan Africa, most areas that are endemic for malaria have a combination of two species: Plasmodium falciparum and P. vivax. P. vivax is often the dominant species, accounting for a greater proportion of malaria cases.
Scientific title: A cost-effectiveness analysis of provider and community interventions to improve the treatment of uncomplicated malaria in Nigeria. Private-sector providers are a major source of malaria treatment in Nigeria, and many patients in Enugu state seek treatment at pharmacies and drug stores as well as public health centres.
Training manuals from REACT study in Cameroon. REACT Cameroon designed six training modules to support the introduction of malaria rapid diagnostic tests (RDTs). The manuals were used to train health workers at government and mission hospitals and health centres. The six modules are presented in two manuals
Cost-effectiveness of interventions to support the introduction of malaria rapid diagnostic tests in Cameroonby ACTConsortium
Scientific title: A cost-effectiveness analysis of provider interventions to improve health worker practice in providing treatment for uncomplicated malaria in Cameroon. Testing patients before prescribing medication is important, and should ensure patients receive the most appropriate treatment. This is important because unnecessary and inappropriate treatment has costs –incurred by patients, but also governments and donors working to control malaria.
Scientific title: IMPACT 2: Monitoring Interventions to Improve ACT Access and Targeting. It is generally agreed that artemisinin-based combination therapies (ACT) are the best treatment for malaria, but it is less clear how it should be deployed by national programmes.
Evaluation of the referral system implemented in registered drug shops, and impact on the public health systems in Uganda. Most malaria deaths occur within 48 hours after the first symptoms appear. In rural areas, where access to health centres is poor, home-based management of malaria can reduce mortality caused by the disease by up to 50%. This approach provides training to members of the community who are then able to give effective treatment near the patients’ home.
Introducing rapid diagnostic tests (RDTs) into the public and private health sectors in Uganda: a randomised trial to evaluate impact on antimalarial drug use. This study examines whether it is feasible and cost-effective to introduce RDTs into drug shops in Uganda in order to promote a rational and correct use of ACT drugs when managing cases of malaria.
This study evaluates whether the use of rapid diagnostic tests by community medicine distributors – with the aim to improve diagnosis and treatment of malaria in the community – is feasible, well accepted and cost-effective. This cluster randomized trial compares two approaches.
The PROCESS project is a complementary evaluation study that runs alongside the PRIME trial, which aimed to improve health centre management, fever case management and patient centred services at Ugandan health centres.
In Uganda and elsewhere, poor health services may limit appropriate management of fever cases and delivery of good quality care. Ultimately, this could contribute to the lack of progress on malaria control. In the formative research that preceded our intervention, we identified barriers and aspirations for quality health care. We used these results, together with evidence from studies elsewhere and the inputs of local stakeholders, to identify the most feasible interventions with the greatest potential for impact on health outcomes.
The TACT training manuals and patient leaflet were designed to support the use of malaria rapid diagnostic tests (RDTs). Here we provide Trainer/Trainee manuals in English and French, and visual patient information sheets in English, French and Swahili.
The Artemisinin-based Combination Therapy (ACT) Consortium Drug Quality programme collected and analysed the quality of over 10,000 artemisinin-based drugs from six malaria endemic countries. Report available in English, Spanish and French.
Guidance for non-economist audience to understand economic evaluations of health care interventions from the ACT consortium.
Fetal Growth Standards for ultrasound measurements of head circumference (HC), bi-parietal diameter (BPD), occipito-frontal diameter (OFD), femur length (FL) and abdominal circumference (AC) are now available for download. For information about how to perform these measurements, or for other information on standards in ultrasound imaging, please see the ultrasound training toolkit.
Practical chart for health practitioners to use to assess newborn size (weight, length, head circumference) at birth against global standards. This version of the chart is being piloted within the University of Oxford hospital network, and plans to pilot in the INTERGROWTH-21st study sites and in Boston area hospitals are developing quickly. Practitioners can download and use this version of the chart freely. To connect with the INTERGROWTH-21st team regarding your experience with piloting this chart, or to request modifications to the chart (e.g. language; different institutional logo), please contact email@example.com.
The last decade has witnessed a substantial increase of multi-centre, public health-oriented clinical trials in poor countries. However, non-commercial research groups have less staff and financial resources than traditional commercial sponsors, so the trial teams have to be creative to comply with Good Clinical Practices (GCP) requirements. This article hopes to feed the reflection on the methodological and ethical aspects of clinical trials carried out in developing countries by North-South collaborative research groups.
This paper, recently published on the Italian Journal of Tropical Medicine(Vol 15, N 1-4, 2010), reports on a debate that took place during the 6thEuropean Conference of Tropical Medicine in 2009, on some topics of greatinterest for GlobalHealthTrials.org: is there a global standard for clinicalresearch? Should standards be adapted in developing countries? How toencourage research while preventing the exploitation of vulnerableindividuals or groups? Five "debate questions" where addressed by ProfessorNick White and by Dr. Lumuli Mbonile, and discussed with the moderator(Raffaella Ravinetto) and the audience.
Clinical trial governance encompasses sponsorship, contracts, finance, confidentiality, trial insurance and professional indemnity and scientific and ethical review. You can find guidance and template documents relating to all of these topics throughout GlobalHealthTrials.org or you can contribute your own material to help others.