Dataset Information

Study protocol: an open-label individually randomised controlled trial to assess the efficacy of artemether-lumefantrine prophylaxis for malaria among forest goers in Cambodia.

ABSTRACT:

Introduction

In the Greater Mekong Subregion, adults are at highest risk for malaria. The most relevant disease vectors bite during daytime and outdoors which makes forest work a high-risk activity for malaria. The absence of effective vector control strategies and limited periods of exposure during forest visits suggest that chemoprophylaxis could be an appropriate strategy to protect forest goers against malaria.

Methods and analysis

The protocol describes an open-label randomised controlled trial of artemether-lumefantrine (AL) versus multivitamin as prophylaxis against malaria among forest goers aged 16-65 years in rural northeast Cambodia. The primary objective is to compare the efficacy of the artemisinin combination therapy AL versus a multivitamin preparation as defined by the 28-day PCR parasite positivity rate and incidence of confirmed clinical malaria of any species. The sample size is 2200 patient-episodes of duration 1 month in each arm. The duration of follow-up and prophylaxis for each participant is 1, 2 or 3 consecutive 28-day periods, followed by a further 28 days of post-exposure prophylaxis, depending on whether they continue to visit the forest. Analysis will be done both by intention to treat and per protocol.

Ethics and dissemination

All participants will provide written, informed consent. Ethical approval was obtained from the Oxford Tropical Research Ethics Committee and the Cambodia National Ethics Committee for Health Research. Results will be disseminated by peer-reviewed open access publication together with open data.

Trial registration number

NCT04041973; Pre-result.

SUBMITTER: Maude RJ

PROVIDER: S-EPMC8264911 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundCountries in the Greater Mekong sub-region (GMS) aim to eliminate all forms of malaria by 2030. In Cambodia and Vietnam, forest-goers are at an increased risk of malaria. Universal access to prompt diagnosis and treatment is a core malaria intervention. This can only be achieved by understanding the healthcare-seeking behaviour among the most vulnerable groups and eliminating barriers to prompt and effective treatment. This study aimed to explore healthcare-seeking behaviours for febrile illness among populations at risk for malaria in Cambodia and Vietnam.MethodsIn 2019, researchers from Population Services International (PSI) conducted a population-based survey of forest-goers in Cambodia and Vietnam using respondent-driven sampling (RDS) In Cambodia two operational districts, Oral and Phnom Srouch in Kampong Speu Province were included in the study. In Vietnam, communes located within 15 km of the forest edge in Binh Phuoc and Gia Lai Provinces were selected. Adults who had spent at least one night per week or four nights per month in the forest over the previous three months were eligible for the study.ResultsSome 75% of forest-goers in Cambodia and 65% in Vietnam sought treatment for illness outside the home. In Cambodia, 39% sought treatment from the private sector, 32% from community health workers, and 24% from public health facilities. In Vietnam, 62% sought care from community facilities, 29.3% from the private sector, and 6.9% went to a public facility. Among forest-goers who sought care, 33% in Cambodia and 52% in Vietnam did so within 24 h.ConclusionsThis study is consistent with others that show that early diagnosis and treatment of malaria remains an obstacle to malaria elimination. This study also demonstrates that there are gaps in timeliness of care seeking among forest-goers. The findings from this study around provider preference and delays in treatment-seeking can be used to strengthen the design and targeting of malaria interventions and social and behaviour change strategies to accelerate malaria elimination in Cambodia and Vietnam.

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