Protocol for a quasi-experimental study to assess the feasibility, acceptability and costs of multiple first-lines artemisinin-based combination therapies for uncomplicated malaria in the Kaya health district, Burkina Faso

BMJ Open. 2021 Feb 15;11(2):e040220. doi: 10.1136/bmjopen-2020-040220.

Abstract

Introduction: As demonstrated in mathematical models, the simultaneous deployment of multiple first-line therapies (MFT) for uncomplicated malaria, using artemisinin-based combination therapies (ACTs), may extend the useful therapeutic life of the current ACTs. This is possible by reducing drug pressure and slowing the spread of resistance without putting patients' life at risk. We hypothesised that a simultaneous deployment of three different ACTs is feasible, acceptable and can achieve high coverage rate if potential barriers are properly identified and addressed.

Methods and analysis: We plan to conduct a quasi-experimental study in the Kaya health district in Burkina Faso. We will investigate a simultaneous deployment of three ACTs, artemether-lumefantrine, pyronaridine-artesunate, dihydroartesinin-piperaquine, targeting three segments of the population: pregnant women, children under five and individuals aged five years and above. The study will include four overlapping phases: the formative phase, the MFT deployment phase, the monitoring and evaluation phase and the post-evaluation phase. The formative phase will help generate baseline information and develop MFT deployment tools. It will be followed by the MFT deployment phase in the study area. The monitoring and evaluation phase will be conducted as the deployment of MFT progresses. Cross-sectional surveys including desk reviews as well as qualitative and quantitative research methods will be used to assess the study outcomes. Quantitatives study outcomes will be measured using univariate, bivariate and multivariate analysis, including logistic regression and interrupted time series analysis approach. Content analysis will be performed on the qualitative data.

Ethics and dissemination: The Health Research Ethics Committee in Burkina Faso approved the study (Clearance no. 2018-8-113). Study findings will be disseminated through feedback meetings with local communities, national workshops, oral presentations at congresses, seminars and publications in peer-reviewed scientific journals.

Trial registration number: NCT04265573.

Keywords: chemotherapy; epidemiology; public health; tropical medicine.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Amodiaquine / therapeutic use
  • Antimalarials* / therapeutic use
  • Artemether / therapeutic use
  • Artemether, Lumefantrine Drug Combination / therapeutic use
  • Artemisinins* / therapeutic use
  • Burkina Faso
  • Child
  • Child, Preschool
  • Cross-Sectional Studies
  • Drug Combinations
  • Feasibility Studies
  • Female
  • Humans
  • Malaria* / drug therapy
  • Malaria, Falciparum* / drug therapy
  • Pregnancy

Substances

  • Antimalarials
  • Artemether, Lumefantrine Drug Combination
  • Artemisinins
  • Drug Combinations
  • Amodiaquine
  • Artemether

Associated data

  • ClinicalTrials.gov/NCT04265573