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Completed

NCT Number: NCT04265573

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe de Recherche Action en Santé

Ouagadougou, Burkina Faso

About this study

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

  • 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.

  • 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.

  • 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.

  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Household survey

  • Caregivers, adults, pregnant women
  • Signed consent form

Exclusion criteria

-

Treatment and study plan

Primary outcomes

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

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

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

Secondary outcomes

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

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

    Data will be collected at community level through qualitative surveys (FGDs; IDIs) from various profiles of informants.

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

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

    Data will be collected at community level through qualitative surveys (FGDs; IDIs) from various profiles of informants.

  3. Average number of monitoring visits performed per annum

    Time frame: Through the MFTs deployment phase: 12 months of duration.

    Data will be obtained though the health facility- based surveys.

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

    Time frame: Through the MFTs deployment phase: 12 months of duration.

    Data will be obtained though the health facility- based surveys.

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

    Time frame: Through the MFTs deployment phase: 12 months of duration.

    Data will be obtained though the health facility- based surveys.

  6. Proportion of febrile episode seen at health facility level.

    Time frame: Through the MFTs deployment phase: 12 months of duration

    Data will be obtained through health facility- based surveys using registers of Health Facilities (HF).

  7. Proportion of febrile episode seen at health facility level (HFL) within 24 hours

    Time frame: Through the MFTs deployment phase: 12 months of duration

    Data will be obtained through health facility- based surveys using registers of HF.

  8. Proportion of febrile episode seen at HFL within 24 hours and tested for parasitemia.

    Time frame: Through the MFTs deployment phase: 12 months of duration.

    Malaria diagnosis will done using malaria rapid diagnosis test (mRDT). Data will be obtained through health facility- based surveys using registers of HF.

  9. Proportion of febrile episode seen at HFL within 24 hours with positive diagnostic test who were given ACT according to the MFTs strategy

    Time frame: Through the MFTs deployment phase: 12 months of duration.

    Malaria diagnosis will done using malaria rapid diagnosis test (mRDT). Data will be obtained through health facility- based surveys using registers of HF.

  10. Proportion of febrile episode seen at HFL within 24 hours with negative diagnostic test who did not received any antimalarial.

    Time frame: Through the MFTs deployment phase: 12 months of duration.

    Malaria diagnosis will done using malaria rapid diagnosis test (mRDT). Data will be obtained through health facility- based surveys using registers of HF.

  11. Proportion of febrile episode seen at HFL within 24 hours with negative diagnostic test who received an ACT.

    Time frame: Through the MFTs deployment phase: 12 months of duration.

    Malaria diagnosis will done using malaria rapid diagnosis test (mRDT). Data will be obtained through health facility- based surveys using registers of HF.

  12. Proportion of febrile episodes treated with ACTs adhering to ACT treatment schedule (timing and doses) by HWs according to MFTs strategy

    Time frame: During MFTs deployment phase at peak malaria season: 6 months of duration.

    Household surveys (data will be collected in the community level through the KAP questionnaire).

  13. Cost per additional febrile episode receiving prompt treatment or confirmed negative diagnosis

    Time frame: Through the MFTs deployment phase: 12 months of duration.

    Data will be obtained using the cost data collection forms through health facility- based surveys.

  14. Cost per additional inappropriate antimalarial treatment avoided.

    Time frame: Through the MFTs deployment phase: 12 months of duration.

    Data will be obtained using the cost data collection forms through health facility- based surveys.

  15. The cost per additional febrile episode appropriate managed for malaria with confirmed diagnosis

    Time frame: Through the MFTs deployment phase: 12 months of duration

    Data will be obtained using the cost data collection forms through health facility- based surveys.

  16. The total cost per capita of intervention (provider perspective)

    Time frame: Through the MFTs deployment phase: 12 months of duration

    Data will be obtained using the cost data collection forms through health facility- based surveys.

  17. The total cost per capita of intervention (societal perspective)

    Time frame: Through the MFTs deployment phase: 12 months of duration

    Data will be obtained using the cost data collection forms through household surveys (costing questionnaire administered at community level).

  18. Cost to the HWs to participate to the MFTs strategy.

    Time frame: Through the MFTs deployment phase: 12 months of duration.

    Data will be obtained using the cost data collection forms through at health facilities level.

  19. Proportion of episode of uncomplicated fever seen by HWs tested for malaria parasitemia.

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

    Data will be obtained through the health facility- based surveys (data collected at health facilities level using the registers of HF).

  20. Proportion of uncomplicated fever episodes/malaria seen by HW, tested positive and treated with correct dose of ACT according to MFTs pilot program

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

    Data will be obtained through the health facility- based surveys (data collected at health facilities level using the registers of HF).

  21. Proportion of febrile episodes treated with ACTs according to MFTs pilot programme by HWs provided with appropriate dosing advice

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

    Data will be obtained through the health facility- based surveys (data collected at health facilities level using the registers of HF).

  22. Proportion of uncomplicated febrile episodes/malaria seen by HWs provided with advice on danger signs.

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

    Data will be obtained through the health facility- based surveys (data collected at health facilities level using the registers of HF).

  23. Incidence of uncomplicated febrile episode/malaria within 4 weeks preceding the surveys

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

    Household surveys before and during the MFTs deployment using KAP questionnaire administered at the community level.

  24. Proportion of uncomplicated febrile episode/malaria seen at health facility level before and during the MFTs deployment in the study area.

    Time frame: Through the MFTs deployment phase: 12 months of duration.

    Data will be obtained through the health facility- based surveys (data collected at the health facility level using the registers of HF).

  25. Mortality rate related to febrile episode/malaria before and during the pilot MFTs deployment.

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

    Data will be collected through the Health and demographic surveillance system mortality data and health facility- based surveys (data collected at the health facility level using the registers of HF).

  26. Proportion of individuals with fever in the last four weeks for whom advice or treatment was sought

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

    Household surveys using KAP questionnaire administered at the community level

  27. Proportion of individuals with fever in the last four week who sought treatment at HFL within 24 hours

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

    Household surveys using KAP questionnaire administered at the community level.

  28. Source of advice or care for those suffering from fever in the last four weeks

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

    Household survey using KAP questionnaire administered at the community level.

Sponsors and collaborators

Lead sponsor

Groupe de Recherche Action en Sante

Other

Collaborators

  • Institut de Recherche en Sciences de la Sante, Burkina Faso
  • Medicines for Malaria Venture
  • National Malaria Control Program

Registry information

Official study title

Feasibility, Acceptability and Costs of a Strategy Deploying Multiple First-lines Artemisinin-based Combination Therapies for Uncomplicated Malaria: a Pilot Programme in the Health District of Kaya, Burkina Faso

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Feb 11, 2020
Registry last updated
Mar 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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