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Trials (2018) 19:271 https://doi.org/10.1186/s13063-018-2604-9
Based on the findings of this trial, we will examine the potential use and scale up of iSupport for caregiver distress in India. This style of online self-help programs could be expande
...
d to other regions or countries or to other suitable caregiver groups
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PLOS ONE | https://doi.org/10.1371/journal.pone.0192068 March 9, 2018
Dziva Chikwari et al. Implementation Science (2018) 13:70 https://doi.org/10.1186/s13012-018-0762-5
The conduct of COVID-19 vaccine trials in the context of a candidate vaccine being issued with Emergency Use Designation raises challenging ethical questions, including in relation to the use of placebo controls and unblinding of trial participants
...
in current and future COVID-19 vaccine trials. This policy brief was developed by the WHO Access to COVID-19 Tools (ACT) Accelerator Ethics & Governance Working Group, to provide guidance for researchers, sponsors, regulators, research ethics committees, and policy-makers, on these and related issues.
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Published:February 02, 2021DOI:https://doi.org/10.1016/S0140-6736(21)00234-8
Soil-transmitted helminths (STH) affect 1.45 billion people worldwide, and high intensity infections are associated with anemia, undernutrition and impaired cognition, particularly among children. Mathematical models suggest it may be possible to interrupt the transmission of STH in a community by e
...
xpanding mass drug administration (MDA) from targeted high-risk groups (primarily school-aged children and women of child-bearing age) to all community members with high coverage. The DeWorm3 Project will test the feasibility of this approach to interrupting the transmission of STH using a series of cluster randomized trials in Benin, India and Malawi. Each study area (population 80,000) will be divided into 40 clusters and randomized to community-wide or standard-of-care targeted MDA for three years. Two years following the final round of MDA, prevalence of STH will be compared between arms and transmission interruption assessed in each cluster. The DeWorm3 trials will provide stakeholders with information regarding the potential to switch from STH control to a more ambitious and sustainable strategy.
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Background: Community health worker (CHW) programmes are a valuable component of primary care in resource-poor settings. The evidence supporting their effectiveness generally shows improvements in disease-specific outcomes relative to the absence of a CHW programme. In this study, we evaluated expan
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ding an existing HIV and tuberculosis (TB) disease-specific CHW programme into a polyvalent, household-based model that subsequently included non-communicable diseases (NCDs), malnutrition and TB screening, as well as family planning and antenatal care (ANC).
Methods: We conducted a stepped-wedge cluster randomised controlled trial in Neno District, Malawi. Six clusters of approximately 20 000 residents were formed from the catchment areas of 11 healthcare facilities. The intervention roll-out was staggered every 3 months over 18 months, with CHWs receiving a 5-day foundational training for their new tasks and assigned 20–40 households for monthly (or more frequent) visits.
Findings: The intervention resulted in a decrease of approximately 20% in the rate of patients defaulting from chronic NCD care each month (−0.8 percentage points (pp) (95% credible interval: −2.5 to 0.5)) while maintaining the already low default rates for HIV patients (0.0 pp, 95% CI: −0.6 to 0.5). First trimester ANC attendance increased by approximately 30% (6.5pp (−0.3, 15.8)) and paediatric malnutrition case finding declined by 10% (−0.6 per 1000 (95% CI −2.5 to 0.8)). There were no changes in TB programme outcomes, potentially due to data challenges.
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The Lancet, Early Online Publication, 11 July 2014
doi:10.1016/S0140-6736(14)60934-X
*Free registration is required to view this article
The Lancet. Published Online December 22, 2016 http://dx.doi.org/10.1016/S0140-6736(16)32621-6. Open Access
PLOS ONE | https://doi.org/10.1371/journal.pone.0196239 April 23, 2018
Surgical site infection (SSI) is the most common postoperative complication worldwide. WHO guidelines to prevent SSI recommend alcoholic chlorhexidine skin preparation and fascial closure using triclosan-coated sutures, but called for assessment of both interventions in low-resource settings. This s
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tudy aimed to test both interventions in low-income and middle-income countries.
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The Lancet Vol.400 (2022) p.17-67-1776. Published:October 31, 2022DOI:https://doi.org/10.1016/S0140-6736(22)01884-0.
Surgical site infection (SSI) is the most common complication of surgery around the world: ChEETAh trial finds routinely changing g
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loves and instruments for wound closure could prevent as many as one in eight SSIs in abdominal surgery
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This was a Phase 3, multi-center, randomized, open-label, parallel-group, active control study where 273 male and female patients with first stage Trypanosoma brucei gambiense HAT were treated at six sites: one trypanosomiasis reference center in Angola, one hospital in South Sudan, and four hospita
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ls in the Democratic Republic of the Congo between August 2005 and September 2009 to support the registration of pafuramidine for treatment of first stage HAT in collaboration with the United States Food and Drug Administration. Patients were treated with either 100 mg of pafuramidine orally twice a day for 10 days or 4 mg/kg pentamidine intramuscularly once daily for 7 days to assess the efficacy and safety of pafuramidine versus pentamidine. Pregnant and lactating women as well as adolescents were included.
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Lancet Infectious Disease Volume 24, Issue 4p386-394April 2024
Lancet 2024; 403: 533–44
R21/Matrix-M was well tolerated and offered high efficacy against clinical malaria in African children. This
low-cost, high-efficacy vaccine is already licensed by several African countries, and recently received a WHO policy
recommendation and prequalification, offerin
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g large-scale supply to help reduce the great burden of malaria in sub-
Saharan Africa.
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This version of Field Trials of Health Interventions includes seven new chapters on conducting systematic literature reviews, trial
governance, preliminary studies and pilot testing, budgeting and accounting, intervention costing and economic analy
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sis, and Phase IV studies. Before new interventions are released into disease control programmes, it is essential that they are carefully evaluated in ‘field trials’. These may be complex and expensive undertakings, requiring the follow-up of hundreds, or thousands, of individuals, often for long periods. This manual was designed to provide guidance on the practical issues in great detail
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Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE)
Researchers are devising a clinical-trial protocol to test three medicines in Africa's latest outbreak
Nature doi: 10.1038/d41586-018-06132-7
