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

Groupe de Recherche Action en Sante

Status: Completed

Conditions: Malaria

Study type: Observational

Funder types: Other

Identifiers

NCT04265573

MFTs-ACTs-BF (PO17/01110)

Details and patient eligibility

About

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.

Full description

The study will be conducted through four overlapping phases: formative research phase, the MFTs deployment phase, the evaluation phase and the post-evaluation phase.

1. Formative research phase

   1.1 Objective

   Generate baseline information and to develop intervention tools for the pilot implementation of MFTs for uncomplicated malaria in the study area.

   1.2 Design

   Cross-sectional surveys using desk reviews, qualitative and quantitative research methods:

   • Individual in-depth Interviews
   • Focus group discussions
   • Household surveys for the assessment of malaria-related morbidity and mortality at community level as well as the healthcare system utilisation
   • Health facility-based surveys for malaria morbidity and mortality, antimalarial drugs and malaria rapid diagnostic tests availability.

   1.3 Duration

   Six months from obtaining the approval of the ethics committee for health research.

2. MFTs deployment phase

   2.1 Objective

   Implement the MFTs for uncomplicated malaria in the health district of Kaya that is feasible, acceptable and achieve high coverage rate.

   2.2 Drugs deployment

   Study ACTs and respective target populations:

   • Artesunate-Pyronaridine for children less than five years of age
   • Artemether-Lumefantrine for pregnant women
   • Dihydroartemisinin-Piperaquine for individuals five years of age and above

   NB: Community case management of malaria using Artemether-Lumefantrine as per National Malaria Control Program recommendation.

   2.3 Duration

   Twelve months including low and high malaria transmission seasons in the study area.

3. Monitoring and evaluation phase

   3.1 Objectives

   Assess the feasibility, the acceptability, the cost and the effects of the pilot MFTs pilot programme for uncomplicated malaria in the health district of Kaya.

   3.2 Design

   Cross-sectional surveys using desk review, qualitative and quantitative research methods:

   • Individual in-depth Interviews
   • Focus group discussions
   • Household surveys for the assessment of malaria-related morbidity and mortality at community level as well as the healthcare system utilisation
   • Health facility-based surveys for malaria-related morbidity and mortality, the availability and use of antimalarial drugs and malaria rapid diagnostic tests.
   • Costs assessments.

   3.3 Duration

   Four months.

4. Post-evaluation phase

4.1 Objectives

Communicating and disseminating the findings of the pilot implementation of multiple first-lines artemisinin-based combination therapies for uncomplicated malaria in the health district of Kaya, Burkina Faso;

4.2 Methodology

• Feedback meetings for reporting to local communities
• National workshop aiming at reporting the programme findings
• Final report to be submitted to the donor
• Oral presentations of findings at congresses, conferences, seminars and publication of findings in peer-reviewed scientific journals

Enrollment: 150,000 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Household survey

• Caregivers, adults, pregnant women
• Signed consent form

Exclusion criteria

Trial design

150,000 participants in 3 patient groups

Children under-five

Description:

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

Description:

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

Description:

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.