Feasibility, Acceptability and Costs of a Multiple First-lines Artemisinin-based Combination Therapies

NCT04265573 | Completed DMC

• 1 other identifier: MFTs-ACTs-BF (PO17/01110)
• Study Type: observational
• Target: 150,000
• Locations: 1 country
• Sites: 1

Brief Summary

A simultaneous deployment of multiple first line therapies (MFT) for uncomplicated malaria using artemisisin based combination therapies as showed by theoretical models, may extend the useful therapeutic life of the current Artemisinin-based combination thérapies (ACTs) by reducing drug pressure and slowing the spread of resistance without putting life at risk. We therefore hypothesized that a simultaneous deployment of three ACTs targeting three segments of the population is feasible, acceptable and can achieve high coverage rate if potential barriers are well identified, well addressed and the key implementers are well-trained and adequately supported. To test this hypothesis, a quasi-experimental study will be conducted.

Conditions

Malaria

Keywords

Uncomplicated malaria; Multiple First-lines Therapies; Artemisinin-based Combination Therapy; Acceptability; Feasability; Costs

Outcome Measures

Primary Outcomes (1)

• Number of favourable and unfavourable opinions from various profiles of informants about the MFT pilot program.

  Data will be collected through qualitative surveys (FGDs; IDIs) and quantitative households surveys (KAP questionnaire) from various profiles of informants.

  From the formative phase to the end of drugs deployment: 18 months duration.

Secondary Outcomes (28)

• Proportion of community resources people with favourable opinions to the MFTs pilot program.

  From the formative phase to the end of drugs deployment: 18 months duration.

• Proportion of community resources people with unfavourable opinions to the MFTs pilot program.

  From the formative phase to the end of drugs deployment: 18 months duration.

• Average number of monitoring visits performed per annum

  Through the MFTs deployment phase: 12 months of duration.

• Average number of monitoring visits on which drugs stores have stock out of any dose of study ACTs per annum.

  Through the MFTs deployment phase: 12 months of duration.

• Average number of monitoring visits on which health facilities have stock out of mRDTs per annum.

  Through the MFTs deployment phase: 12 months of duration.

Study Arms (3)

Children under-five

Uncomplicated malaria case in this group will be managed using Pyronaridine-Artesunate at health facility level. This drug is registered in Burkina Faso for routine medical care for uncomplicated malaria case.

Individuals five years of age and above

Uncomplicated malaria case in this group will be managed using Dihydoartemisinin-Piperaquine health facility level. This drug is registered in Burkina Faso for routine medical care for uncomplicated malaria case.

Pregnant women

Uncomplicated malaria case in this group will be managed using Artemether-Lumefantrin health facility level. This drug is registered in Burkina Faso for routine medical care for uncomplicated malaria case.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target populations for the deployment of the MFTs for uncomplicated malaria are: children less than five years of age, pregnant women, individuals five years of age and above.

You may qualify if:

• Household survey
• Caregivers, adults, pregnant women
• Signed consent form

Sponsors & Collaborators

• Groupe de Recherche Action en Sante: lead
• Medicines for Malaria Venture: collaborator
• National Malaria Control Programme (NMCP), Burkina Faso: collaborator
• Institut de Recherche en Sciences de la Sante, Burkina Faso: collaborator

Study Sites (1)

Groupe de Recherche Action en Santé

Ouagadougou, Burkina Faso

Location

Related Publications (4)

• Boni MF, White NJ, Baird JK. The Community As the Patient in Malaria-Endemic Areas: Preempting Drug Resistance with Multiple First-Line Therapies. PLoS Med. 2016 Mar 29;13(3):e1001984. doi: 10.1371/journal.pmed.1001984. eCollection 2016 Mar.

  PMID: 27022739 RESULT

• Boni MF, Smith DL, Laxminarayan R. Benefits of using multiple first-line therapies against malaria. Proc Natl Acad Sci U S A. 2008 Sep 16;105(37):14216-21. doi: 10.1073/pnas.0804628105. Epub 2008 Sep 9.

  PMID: 18780786 RESULT

• Kabore JMT, Siribie M, Hien D, Soulama I, Barry N, Nombre Y, Dianda F, Baguiya A, Tiono AB, Burri C, Tchouatieu AM, Sirima SB. Attitudes, practices, and determinants of community care-seeking behaviours for fever/malaria episodes in the context of the implementation of multiple first-line therapies for uncomplicated malaria in the health district of Kaya, Burkina Faso. Malar J. 2022 May 30;21(1):155. doi: 10.1186/s12936-022-04180-z.

  PMID: 35637506 DERIVED

• Siribie M, Tchouatieu AM, Soulama I, Kabore JMT, Nombre Y, Hien D, Kiba Koumare A, Barry N, Baguiya A, Hema A, Dianda F, Savadogo Y, Kouanda S, Tiono AB, Sirima SB. 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.

  PMID: 33589447 DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Mohamadou Siribié, MD, PhD

  Groupe de Recherche Action en Sante

  PRINCIPAL INVESTIGATOR

• André-Marie Tchouatieu, MD

  Medicine for Malaria Venture (MMV)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: February 11, 2020
• Study Start: November 10, 2018
• Primary Completion: December 1, 2020
• Study Completion: February 25, 2021
• Last Updated: March 25, 2022

Record last verified: 2020-02

Locations

BU (1)