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Understanding and maximising the community impact of seasonal malaria chemoprevention in Burkina Faso (INDIE-SMC): study protocol for a cluster randomised evaluation trial

Por: Moreno · M. · Barry · A. · Gmeiner · M. · Yaro · J. B. · Serme · S. S. · Byrne · I. · Ramjith · J. · Ouedraogo · A. · Soulama · I. · Grignard · L. · Soremekun · S. · Koele · S. · ter Heine · R. · Ouedraogo · A. Z. · Sawadogo · J. · Sanogo · E. · Ouedraogo · I. N. · Hien · D. · Sirima · S. B
Introduction

Seasonal malaria chemoprevention (SMC) involves repeated administrations of sulfadoxine-pyrimethamine plus amodiaquine to children below the age of 5 years during the peak transmission season in areas of seasonal malaria transmission. While highly impactful in reducing Plasmodium falciparum malaria burden in controlled research settings, the impact of SMC on infection prevalence is moderate in real-life settings. It remains unclear what drives this efficacy decay. Recently, the WHO widened the scope for SMC to target all vulnerable populations. The Ministry of Health (MoH) in Burkina Faso is considering extending SMC to children below 10 years old. We aim to assess the impact of SMC on clinical incidence and parasite prevalence and quantify the human infectious reservoir for malaria in this population.

Methods and analysis

We will perform a cluster randomised trial in Saponé Health District, Burkina Faso, with three study arms comprising 62 clusters of three compounds: arm 1 (control): SMC in under 5-year-old children, implemented by the MoH without directly observed treatment (DOT) for the full course of SMC; arm 2 (intervention): SMC in under 5-year-old children, with DOT for the full course of SMC; arm 3 (intervention): SMC in under 10-year-old children, with DOT for the full course of SMC. The primary endpoint is parasite prevalence at the end of the malaria transmission season. Secondary endpoints include the impact of SMC on clinical incidence. Factors affecting SMC uptake, treatment adherence, drug concentrations, parasite resistance markers and transmission of parasites will be determined.

Ethics and dissemination

The London School of Hygiene & Tropical Medicine’s Ethics Committee (29193) and the Burkina Faso National Medical Ethics Committee (Deliberation No 2023-05-104) approved this study. The findings will be presented to the community; disease occurrence data and study outcomes will also be shared with the Burkina Faso MoH. Findings will be published irrespective of their results.

Trial registration number

NCT05878366.

RECITAL: a non-inferiority randomised control trial evaluating a virtual fracture clinic compared with in-person care for people with simple fractures (study protocol)

Por: Teng · M. J. · Zadro · J. R. · Pickles · K. · Copp · T. · Shaw · M. J. · Khoudair · I. · Horsley · M. · Warnock · B. · Hutchings · O. R. · Petchell · J. F. · Ackerman · I. N. · Drayton · A. · Liu · R. · Maher · C. G. · Traeger · A. C.
Introduction

Most simple undisplaced fractures can be managed without surgery by immobilising the limb with a splint, prescribing medication for pain, and providing advice and early rehabilitation. Recent systematic reviews based on retrospective observational studies have reported that virtual fracture clinics can deliver follow-up care that is safe and cost-effective. However, no randomised controlled trial has investigated if a virtual fracture clinic can provide non-inferior physical function outcomes compared with an in-person clinic for patients with simple fractures.

Methods and analysis

312 participants will be recruited from 2 metropolitan hospitals located in Sydney, Australia. Adult patients will be eligible if they have an acute simple fracture that can be managed with a removable splint and is deemed appropriate for follow-up at either the virtual or in-person fracture clinic by an orthopaedic doctor. Patients will not be eligible if they have a complex fracture that requires a cast or surgery. Eligible participants will be randomised to receive their follow-up care either at the virtual or the in-person fracture clinic. Participants at the virtual fracture clinic will be reviewed within 5 days of receiving a referral through video calls with a physiotherapist. Participants at the in-person fracture clinic will be reviewed by an orthopaedic doctor within 7–10 days of receiving a referral. The primary outcome will be the patient’s function measured using the Patient-Specific Functional Scale at 12 weeks. Secondary outcomes will include health-related quality of life, patient-reported experiences, pain, health cost, healthcare utilisation, medication use, adverse events, emergency department representations and surgery.

Ethics and dissemination

The study has been approved by the Sydney Local Health District Ethics Review Committee (RPAH Zone) (X23-0200 and 2023/ETH01038). The trial results will be submitted for publication in a reputable international journal and will be presented at professional conferences.

Trial registration number

ACTRN12623000934640.

How prevalent is COVID-19 vaccine hesitancy in low-income and middle-income countries and what are the key drivers of hesitancy? Results from 53 countries

Por: Dayton Eberwein · J. · Edochie · I. N. · Newhouse · D. · Cojocaru · A. · Bopahbe · G. D. · Kakietek · J. J. · Kim · Y. S. · Montes · J.
Objectives

This study aims to estimate the levels of COVID-19 vaccine hesitancy in 53 low-income and middle-income countries, differences across population groups in hesitancy, and self-reported reasons for being hesitant to take the COVID-19 vaccine.

Methods

This paper presents new evidence on levels and trends of vaccine hesitancy in low-income and middle-income countries based on harmonised high-frequency phone surveys from more than 120 000 respondents in 53 low-income and middle-income countries collected between October 2020 and August 2021. These countries represent a combined 53% of the population of low-income and middle-income countries excluding India and China.

Results

On average across countries, one in five adults reported being hesitant to take the COVID-19 vaccine, with the most cited reasons for hesitancy being concerns about the safety of the vaccine, followed by concerns about its efficacy. Between late 2020 and the first half of 2021, there tended to be little change in hesitancy rates in 11 of the 14 countries with available data, while hesitancy increased in Iraq, Malawi and Uzbekistan. COVID-19 vaccine hesitancy was higher among female, younger adults and less educated respondents, after controlling for selected observable characteristics.

Conclusions

Country estimates of vaccine hesitancy from the high-frequency phone surveys are correlated with but lower than those from earlier studies, which often relied on less representative survey samples. The results suggest that vaccine hesitancy in low-income and middle-income countries, while less prevalent than previously thought, will be an important and enduring obstacle to recovery from the pandemic.

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