MalariaINDIE-SMCNCT05878366

Understanding and Maximizing the Community Impact of Antimalarial Treatment (INDIE-SMC)

A study testing Seasonal Malaria Chemoprophylaxis (under 5 year old) implemented by the MoH without DOT, Seasonal Malaria Chemoprophylaxis (under 5 years old) with DOT and Seasonal Malaria Chemoprophylaxis (under 10 years old) with DOT in people with Malaria and Malaria,Falciparum, run by London School of Hygiene and Tropical Medicine at 1 site in Burkina Faso.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Seasonal Malaria Chemoprophylaxis (SMC) is a fundamental component of malaria control. The SMC program involves that sulfadoxine-pyrimethamine plus amodiaquine (SPAQ) is given to children below the age of 5 years during the peak transmission season in areas of seasonal malaria transmission. Read more about this study

Who is it for?: Ages 3 months and olderHealthy volunteers can take part
Conditions the study is for: Malaria, Malaria,Falciparum
What is being tested?: Seasonal Malaria Chemoprophylaxis (under 5 year old) implemented by the MoH without DOT, Seasonal Malaria Chemoprophylaxis (under 5 years old) with DOT and Seasonal Malaria Chemoprophylaxis (under 10 years old) with DOT
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,978 participants
Where: 1 siteBurkina Faso
Study dates: 13 Jul 2023to 30 Mar 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 months and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Eligible for chemoprevention for SMC as per the current recommendations
Age 3- 59 months for arms i. and ii.
Age 60 months up to 10 years old for arm iii.
Absence of symptomatic falciparum malaria, defined by fever on enrolment
Absence of other non-P. falciparum species on blood film
No evidence of acute severe or chronic disease
Able and willing to comply with the study protocol and follow-up schedule
Parent or guardian provides written, informed consent on behalf of child

Who cannot join

Symptoms of malaria (axillary fever ≥ 37.5 °C and/or history of fever in the past 48 hours)
Previous reaction to study drugs / known allergy to study drugs
Signs of severe malaria, including hyperparasitemia (defined as asexual parasitemia > 100,000 parasites / µL)
Signs of acute or chronic illness, including hepatitis
The use of other medication (except for paracetamol and/or aspirin)
Presence of severe malnutrition according to WHO's child growth standards

Trial locations and contacts

1 site in 1 country.

Burkina Faso1 site

Groupe de Recherche Action en Santé
Ouagadougou

Other trials in Burkina Faso

About this study

This study involves an Operational evaluation of a modified existing intervention and its implementation are prepared in direct interaction with the Ministry of Health (MoH) to tailor data collection to local needs. The main questions it aims to answer are:

what are the reasons for the continued high infection rates in the SMC-targeted population;
what are the implications for transmission of sub-optimal SMC in children less than 5 years old;
can the impact of SMC be improved by including older age groups that would both expand the population that experiences direct chemoprophylactic benefits and concurrently reduce transmission to the wider community

Researchers will:

Compare SMC effectiveness as implemented by the national malaria control program and SMC implemented in a research context where all doses are directly observed. ii) Quantify the infectious reservoir and the contribution of different age groups to transmission with conventional SMC (<5 years) and extended SMC (<10 years) iii) Determine the impact of drug resistance and drug absorption on SMC efficacy iv) Understand social barriers and enablers interfering with SMC efficacy and how SMC uptake is related to health equity with special attention to gender inequalities.
Quantify SMC efficacy decay under programmatic conditions and key drivers of this decay.

Read the detailed description

Seasonal Malaria Chemoprophylaxis is a well established method of malaria control. Sulfadoxine-pyrimethamine plus amodiaquine (SPAQ) is given to children below the age of 5 years during the peak transmission season in areas of seasonal malaria transmission. Whilst highly effective in controlled research studies, the impact of SMC in terms of reducing infection prevalence is less following operational delivery. It is currently unclear why and what drivers of SMC coverage and uptake play a role. In addition, the relative importance of parasite drug resistance, limited adherence, poor drug absorption and frequent re-infections remain largely unexplored.

Lastly, the World Health Organization has recently widened the scope for SMC to target all vulnerable populations. The Ministry of Health (MoH) in Burkina Faso is considering extending SMC to all children below 10 years of age; the impact of SMC on clinical incidence and parasite prevalence in this population with markedly different immunity is unknown. Moreover, this older age group is known to be highly relevant for onward malaria transmission, making it important to quantify the impact of SMC on the human infectious reservoir for malaria and broader benefits to the community.

The investigators propose a cluster-randomized trial in Saponé Health District, Burkina Faso, with three study arms:

SMC in children under the age of 5 years, implemented by the MoH without directly observed treatment for the full course of SMC ii. SMC in children under the age of 5 years, with directly observed treatment for the full course of SMC iii. SMC in children under the age of 10 years, with directly observed treatment for the full course of SMC The investigators will deliver the different arms of the intervention to 40 clusters of 3 households/compounds (i.e. 120 compounds per arm). The primary endpoint is parasite prevalence at the end of the malaria transmission season, secondary endpoints include the impact of SMC on clinical incidence, gametocyte carriage and potential for onward parasite transmission to mosquitoes. As relevant factors in determining these efficacies, drivers of SMC uptake and treatment adherence will be determined, as well as drug concentrations, parasite resistance markers and transmission of parasites to mosquitoes.

Conditions: Malaria, Malaria,Falciparum
Being tested: Seasonal Malaria Chemoprophylaxis (under 5 year old) implemented by the MoH without DOT, Seasonal Malaria Chemoprophylaxis (under 5 years old) with DOT, Seasonal Malaria Chemoprophylaxis (under 10 years old) with DOT
Keywords: Plasmodium falciparum, Seasonal Malaria Chemoprevention, Antimalarial treatment, Burkina Faso, SP+AQ
Medical subject headings: Malaria, Malaria, Falciparum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Seasonal Malaria Chemoprophylaxis (under 5 year old) implemented by the MoH without DOTOther
Standard approach for SMC strategy used by the Ministry of Health (without directly-observed therapy) and without any interference of the study team. Implemented over 4 rounds, carried out in June-October 2023 with ~30 days between rounds.
Seasonal Malaria Chemoprophylaxis (under 5 years old) with DOTOther
SMC will be implemented with the same number of rounds and the same timing as in active comparator arm but village health workers will visit the participants at home to administer each dose of study treatment (with DOT-directly-observed therapy)
Seasonal Malaria Chemoprophylaxis (under 10 years old) with DOTOther
SMC will be implemented as in arm 2 but age of participants is extended up to 10 years: each dose of study treatment (with DOT-directly-observed therapy) distributed at home by village health workers.

Study groups in NCT05878366
Study group	Role	What they receive
Arm 1	Active comparator	SMC in children under the age of 5 years, implemented by the MoH without directly observed treatment for the full course of SMC Receives: Other: Seasonal Malaria Chemoprophylaxis (under 5 year old) implemented by the MoH without DOT
Arm 2	Experimental	SMC in children under the age of 5 years, with directly observed treatment for the full course of SMC Receives: Other: Seasonal Malaria Chemoprophylaxis (under 5 years old) with DOT
Arm 3	Experimental	SMC in children under the age of 10 years, with directly observed treatment for the full course of SMC Receives: Other: Seasonal Malaria Chemoprophylaxis (under 10 years old) with DOT

What is being measured

The primary outcome is the main question the study is designed to answer.

Parasite prevalence by quantitative PCR (qPCR) at the end of the transmission season in age groups targeted by seasonal malaria chemoprevention.
This endpoint will be compared between arms 1 and 2 (in children aged 3-59 months) and arms 2 and arm 3 (in children aged 3 months-9 years).
Measured: 4 weeks

Secondary outcomes (10)

Parasite prevalence by microscopy at the end of the transmission season in all age groups
This endpoint will compare the parasite prevalence in all age groups between intervention arms.
Measured: 4 weeks
Parasite prevalence by qPCR at the end of the transmission season in all age groups
This endpoint will compare the parasite prevalence in all age groups between intervention arms.
Measured: 4 weeks
Parasite prevalence by microscopy prior to SMC rounds 2, 3 and 4 in SMC-targeted age groups
This endpoint will compare the prevalence by microscopy before SMC rounds (2, 3 and 4) between intervention arms.
Measured: 8 weeks
Rate of re-infection with P. falciparum at weeks 3, 4 and 5 after the last round of SMC, assessed in SMC-targeted age groups
This endpoint will assess the rate of malaria reinfection at different time points after the alst round of SMC between intervention arms
Measured: 10 weeks
Gametocyte prevalence by qRT-PCR at weeks 3, 4 and 5 after the last round of SMC, assessed in SMC-targeted age groups
This endpoint will compare the gametocyte prevalence between intervention arms at different time points after the last round of SMC.
Measured: 10 weeks
Gametocyte prevalence by qRT-PCR at the end of the transmission season in all age groups
This endpoint will compare the gametocyte prevalence between intervention arms in all age groups
Measured: 8 weeks
Plasma levels of AQ and DESAQ after the 4th round of SMC in children aged 3 months-9 years
This endpoint will compare the plasma levels of AQ and DESAQ between intervention arms.
Measured: 6 weeks
Clinical malaria incidence captured during passive-case detection (between arm comparison)
This endpoint will compare the cases of malaria between intervention arms.
Measured: Across study period (6 months)
Parasite prevalence by qPCR at the end of the transmission season compared between arms 1 and combined arms 2 + 3.
This endpoint will assess the prevalence in targeted age groups in combined arms with similar treatment and population
Measured: 4 weeks
Gametocyte prevalence by qRT-PCR at the end of the transmission season in age groups targeted by SMC (comparison between arm1 and 2 (in children aged 3-59 months) and arms 2 and arm 3 (in children aged 5 years-9 years).
This endpoint will assess the gametocyte prevalence and the end of the study between groups and combined similar groups.
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jul 202330 Mar 2024

First posted26 May 2023
Study start13 Jul 2023
Primary completion15 Jan 2024
Study completion30 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for MalariaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: This study involves and Operational evaluation of a modified existing intervention delivered in independent clusters. The project and its implementation are prepared in direct interaction with the Ministry of Health (MoH) to tailor data collection to local needs.
Masking: None (open label)
Enrolment: 2,978 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05878366
Sponsor's protocol ID: 29193
Other IDs: INV-053846
Acronym: INDIE-SMC
Status last verified: Jan 2024
First submitted: 9 May 2023
Last updated: 4 Jul 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: Anonymised individual participant data may be shared on a digital repository or upon reasonable request.

Publications

Yaro JB, Ouedraogo A, Moreno M, Koele S, Sindie SS, Barry A, Soremekun S, Gmeiner M, Lanke K, Byrne I, Ramjith J, Huang L, Marzan F, Badoum ES, Soulama I, Grignard L, Ouedraogo AZ, Sawadogo J, Ouedraogo IN, Hien D, Bradley J, Heine RT, Sirima SB, Bousema T, Drakeley C, Tiono AB. Impact of directly observed treatment and extended age range of seasonal malaria chemoprevention with sulfadoxine-pyrimethamine plus amodiaquine in Burkina Faso: a three-group, open-label, cluster-randomised, controlled trial. Lancet Infect Dis. 2026 Jul 29:S1473-3099(26)00305-1. doi: 10.1016/S1473-3099(26)00305-1. Online ahead of print.
PubMed 42526467
Moreno M, Barry A, Gmeiner M, Yaro JB, Serme SS, Byrne I, Ramjith J, Ouedraogo A, Soulama I, Grignard L, Soremekun S, Koele S, Ter Heine R, Ouedraogo AZ, Sawadogo J, Sanogo E, Ouedraogo IN, Hien D, Sirima SB, Bradley J, Bousema T, Drakeley C, Tiono AB. Understanding and maximising the community impact of seasonal malaria chemoprevention in Burkina Faso (INDIE-SMC): study protocol for a cluster randomised evaluation trial. BMJ Open. 2024 Mar 12;14(3):e081682. doi: 10.1136/bmjopen-2023-081682.
PubMed 38479748

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Understanding and Maximizing the Community Impact of Antimalarial Treatment (INDIE-SMC)
ClinicalTrials.gov ID: NCT05878366
Acronym / sponsor ID: INDIE-SMC / 29193
Conditions: Malaria, Malaria,Falciparum
Keywords: Plasmodium falciparum, Seasonal Malaria Chemoprevention, Antimalarial treatment, Burkina Faso, SP+AQ
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,978 participants (actual)
Lead sponsor: London School of Hygiene and Tropical MedicineUniversity, hospital or other
Collaborators: Groupe de Recherche Action en Sante, Radboud University Medical Center
Study start: 13 Jul 2023 (actual)
Primary completion: 15 Jan 2024 (actual)
Study completion: 30 Mar 2024 (actual)
First posted: 26 May 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

what are the reasons for the continued high infection rates in the SMC-targeted population;
what are the implications for transmission of sub-optimal SMC in children less than 5 years old;
can the impact of SMC be improved by including older age groups that would both expand the population that experiences direct chemoprophylactic benefits and concurrently reduce transmission to the wider community

Researchers will:

Compare SMC effectiveness as implemented by the national malaria control program and SMC implemented in a research context where all doses are directly observed. ii) Quantify the infectious reservoir and the contribution of different age groups to transmission with conventional SMC (<5 years) and extended SMC (<10 years) iii) Determine the impact of drug resistance and drug absorption on SMC efficacy iv) Understand social barriers and enablers interfering with SMC efficacy and how SMC uptake is related to health equity with special attention to gender inequalities.
Quantify SMC efficacy decay under programmatic conditions and key drivers of this decay.

Detailed description

The investigators propose a cluster-randomized trial in Saponé Health District, Burkina Faso, with three study arms:

SMC in children under the age of 5 years, implemented by the MoH without directly observed treatment for the full course of SMC ii. SMC in children under the age of 5 years, with directly observed treatment for the full course of SMC iii. SMC in children under the age of 10 years, with directly observed treatment for the full course of SMC The investigators will deliver the different arms of the intervention to 40 clusters of 3 households/compounds (i.e. 120 compounds per arm). The primary endpoint is parasite prevalence at the end of the malaria transmission season, secondary endpoints include the impact of SMC on clinical incidence, gametocyte carriage and potential for onward parasite transmission to mosquitoes. As relevant factors in determining these efficacies, drivers of SMC uptake and treatment adherence will be determined, as well as drug concentrations, parasite resistance markers and transmission of parasites to mosquitoes.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: This study involves and Operational evaluation of a modified existing intervention delivered in independent clusters. The project and its implementation are prepared in direct interaction with the Ministry of Health (MoH) to tailor data collection to local needs.

Arm	Type	Receives
Arm 1	Active comparator	Other: Seasonal Malaria Chemoprophylaxis (under 5 year old) implemented by the MoH without DOTSMC in children under the age of 5 years, implemented by the MoH without directly observed treatment for the full course of SMC
Arm 2	Experimental	Other: Seasonal Malaria Chemoprophylaxis (under 5 years old) with DOTSMC in children under the age of 5 years, with directly observed treatment for the full course of SMC
Arm 3	Experimental	Other: Seasonal Malaria Chemoprophylaxis (under 10 years old) with DOTSMC in children under the age of 10 years, with directly observed treatment for the full course of SMC

Who may qualify

Ages: 3 months and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (8 listed)

Eligible for chemoprevention for SMC as per the current recommendations
Age 3- 59 months for arms i. and ii.
Age 60 months up to 10 years old for arm iii.
Absence of symptomatic falciparum malaria, defined by fever on enrolment
Absence of other non-P. falciparum species on blood film

Key exclusion criteria (6 listed)

Symptoms of malaria (axillary fever ≥ 37.5 °C and/or history of fever in the past 48 hours)
Previous reaction to study drugs / known allergy to study drugs
Signs of severe malaria, including hyperparasitemia (defined as asexual parasitemia > 100,000 parasites / µL)
Signs of acute or chronic illness, including hepatitis
The use of other medication (except for paracetamol and/or aspirin)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Seasonal Malaria Chemoprophylaxis (under 5 year old) implemented by the MoH without DOTStandard approach for SMC strategy used by the Ministry of Health (without directly-observed therapy) and without any interference of the study team. Implemented over 4 rounds, carried out in June-October 2023 with ~30 days between rounds.	Other	Arm 1
Seasonal Malaria Chemoprophylaxis (under 5 years old) with DOTSMC will be implemented with the same number of rounds and the same timing as in active comparator arm but village health workers will visit the participants at home to administer each dose of study treatment (with DOT-directly-observed therapy)	Other	Arm 2
Seasonal Malaria Chemoprophylaxis (under 10 years old) with DOTSMC will be implemented as in arm 2 but age of participants is extended up to 10 years: each dose of study treatment (with DOT-directly-observed therapy) distributed at home by village health workers.	Other	Arm 3

Primary outcome

Parasite prevalence by quantitative PCR (qPCR) at the end of the transmission season in age groups targeted by seasonal malaria chemoprevention.
Time frame: 4 weeks
This endpoint will be compared between arms 1 and 2 (in children aged 3-59 months) and arms 2 and arm 3 (in children aged 3 months-9 years).

10 secondary outcomes

Parasite prevalence by microscopy at the end of the transmission season in all age groups
Time frame: 4 weeks
Parasite prevalence by qPCR at the end of the transmission season in all age groups
Time frame: 4 weeks
Parasite prevalence by microscopy prior to SMC rounds 2, 3 and 4 in SMC-targeted age groups
Time frame: 8 weeks
Rate of re-infection with P. falciparum at weeks 3, 4 and 5 after the last round of SMC, assessed in SMC-targeted age groups
Time frame: 10 weeks
Gametocyte prevalence by qRT-PCR at weeks 3, 4 and 5 after the last round of SMC, assessed in SMC-targeted age groups
Time frame: 10 weeks
Gametocyte prevalence by qRT-PCR at the end of the transmission season in all age groups
Time frame: 8 weeks
Plasma levels of AQ and DESAQ after the 4th round of SMC in children aged 3 months-9 years
Time frame: 6 weeks
Clinical malaria incidence captured during passive-case detection (between arm comparison)
Time frame: Across study period (6 months)
Parasite prevalence by qPCR at the end of the transmission season compared between arms 1 and combined arms 2 + 3.
Time frame: 4 weeks
Gametocyte prevalence by qRT-PCR at the end of the transmission season in age groups targeted by SMC (comparison between arm1 and 2 (in children aged 3-59 months) and arms 2 and arm 3 (in children aged 5 years-9 years).
Time frame: 4 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
Derived from this study: PubMed 42526467Yaro JB, Ouedraogo A, Moreno M, Koele S, Sindie SS, Barry A, Soremekun S, Gmeiner M, Lanke K, Byrne I, Ramjith J, Huang L, Marzan F, Badoum ES, Soulama I, Grignard L, Ouedraogo AZ, Sawadogo J, Ouedraogo IN, Hien D, Bradley J, Heine RT, Sirima SB, Bousema T, Drakeley C, Tiono AB. Impact of directly observed treatment and extended age range of seasonal malaria chemoprevention with sulfadoxine-pyrimethamine plus amodiaquine in Burkina Faso: a three-group, open-label, cluster-randomised, controlled trial. Lancet Infect Dis. 2026 Jul 29:S1473-3099(26)00305-1. doi: 10.1016/S1473-3099(26)00305-1. Online ahead of print.
Derived from this study: PubMed 38479748Moreno M, Barry A, Gmeiner M, Yaro JB, Serme SS, Byrne I, Ramjith J, Ouedraogo A, Soulama I, Grignard L, Soremekun S, Koele S, Ter Heine R, Ouedraogo AZ, Sawadogo J, Sanogo E, Ouedraogo IN, Hien D, Sirima SB, Bradley J, Bousema T, Drakeley C, Tiono AB. Understanding and maximising the community impact of seasonal malaria chemoprevention in Burkina Faso (INDIE-SMC): study protocol for a cluster randomised evaluation trial. BMJ Open. 2024 Mar 12;14(3):e081682. doi: 10.1136/bmjopen-2023-081682.
Individual participant dataSharing planned: Undecided. Anonymised individual participant data may be shared on a digital repository or upon reasonable request.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alfred Tiono, PhD, MD principal investigator

Groupe de Recherche Action en Sante

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parasite prevalence by quantitative PCR (qPCR) at the end of the transmission season in age groups targeted by seasonal malaria chemoprevention. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05878366, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.