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Malaria, FalciparumAMARETINCT07281443

MDA and Targeted Control Against Plasmodium Carriage in the Sahel

A study testing MDA with DHAp and SLD Primaquine in people with Malaria, Falciparum and Malaria, Asymptomatic Parasitaemia, run by Institut de Recherche pour le Developpement at 1 site in Senegal.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Strategies implemented since 2010 by the Senegalese National Malaria Control Program (NMCP) enabled a reduction of malaria transmission. However, malaria incidence increased again in recent years, especially in the "red zone" of Kedougou, Kolda and Tambacounda regions. Read more about this study

Who is it for?
Ages 3 months to 100 yearsHealthy volunteers can take part
What is being tested?
MDA with DHAp and SLD Primaquine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18,000 participants
Where
1 siteSenegal
Study dates
23 Sep 2024to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • village inaccessible during rainy season
  • village without community health worker and impossible to set up one
  • INDIVIDUAL-LEVEL: MDA with DHA-piperaquine and single low dose primaquine Inclusion
  • consent (+ assent for youth aged 12-17)
  • age >=3 months
  • in the village for >=4 days at time of MDA initiation
Show all 28Show fewer
  • not pregnant (women 15-49 years with negative pregnancy test or under contraception)
  • allergy to artemisinin combination therapy
  • pregnant women (referred for administration of IPTp) or women without pregnancy test result
  • presenting with acute disease symptoms: in case of fever or history of fever, individuals will be tested with RDT and, if positive, refered to CHW or healthpost for symptomatic malaria treatment according to national guidelines.
  • Exclusion (excluded from primaquine only, eligible for DHA-p)
  • children aged 3-6 months
  • lactating women
  • INDIVIDUAL-LEVEL: youth-targeted testing and treatment activity Inclusion
  • age 15-24 (+ assent for youth aged 15-17)
  • consent Exclusion
  • none. in case of RDT-positivity, participants will be referred for treatment according to national guidelines (recommendation of treatment in case of a positive test, irrespective of symptoms).
  • COHORT STUDY 8 villages/clusters selected for an in-depth cohort study
  • Household inclusion
  • consent of head of household
  • not planning to move out of study village
  • 50% of more members aged >=15 years agree to participate
  • Individual participant inclusion
  • household member or visitor staying longer than 1 night
  • consent (+ assent for youth aged 12-17)
  • age >=6 months
  • Individual participant exclusion
  • in another study on malaria or health

Trial locations and contacts

1 site in 1 country.

Senegal1 site

  • District de Santé de Kédougou - Kedougou Health District

    Kedougou

Other trials in Senegal

About this study

Official title: Mass Drug Administration and Targeted Control Against Carriage to Reduce Plasmodium Transmission in the Sahel - Administration de Masse d'Antipaludiques et Lutte ciblée Contre le Portage Pour REduire la Transmission de Plasmodium au Sahel

Strategies implemented since 2010 by the Senegalese National Malaria Control Program (NMCP) enabled a reduction of malaria transmission. However, malaria incidence increased again in recent years, especially in the "red zone" of Kedougou, Kolda and Tambacounda regions. Neighbouring Sahelian countries also documented an increase in malaria incidence in the same period. Current interventions include : long-lasting insecticidal nets, free diagnostic and treatment of clinical malaria, home-based case management (PECADOM), intermittent preventive treatment of pregnant women and seasonal malaria chemoprevention for children up to 10 years. These strategies, while efficient to reduce the burden of clinical malaria, do not account for individuals chronically infected with Plasmodium parasites. These carriers often remain asymptomatic and act as a reservoir for persistence during the dry season, and onwards transmission during the wet season. An observational study conducted in Kedougou in 2021 and 2022 by IRD Dakar shed light on the most affected age groups and on risk-factors associated with asymptomatic carriage.

Interventions against asymptomatic carriage could complement existing strategies and contribute to reducing malaria transmission. Mass drug administration (MDA) involves proposing a curative treatment of each member of the community, regardless of age, during a coordinated campaign. To this day, it is the only intervention available to deplete the reservoir of Plasmodium carriers, since a large proportion of asymptomatic infections remain undetectable with available field tests. A study conducted by NMCP and Iba Der Thiam University in Thiès (UIDT) in 2021 in Tambacounda showed that regular MDA campaigns during the high transmission season had a significant impact on clinical malaria incidence and on prevalence of carriage.

Read more

AMARETi project aims to evaluate an intervention to complete current control strategies. The design of this intervention combines the recent results from Kedougou and Tambacounda studies. The intervention consists of an MDA campaign at the start and at the end of the high transmission season, aiming at maximal depletion of the asymptomatic reservoir, and of age-group targeted interventions aiming to reduce chronic reinfection in individuals at highest risk of asymptomatic carriage.

The design and implementation of the intervention stem from a co-construction process with members of communities participating in the research, to maximize inclusiveness and adhesion. It aims to ensure the design of interventions that are adapted to age, gender and other factors deemed relevant by researchers and communities.

The project will evaluate if this intervention improves significantly the situation compared to current strategy in a stepped-wedge cluster-randomized controlled trial over 2 malaria high transmission seasons. If the results are conclusive, recommendations for scale-up can be made. The primary outcome will be Plasmodium falciparum infection prevalence at the end of the high transmission season. Secondary outcomes include clinical malaria incidence and malaria incidence dynamics, as well as participation, safety and acceptability.

Implementation outcomes (not detailed here) will include the assessment of implementation (CFIR's indicators), sustainability (Schell's indicators) and scalability (Coroa's indicators). These indicators use multiple dimensions stemming from qualitative and quantitative data and flexible design to understand each specific outcome (Proctor E, et al, Mental Health and Mental Health Services Research 2011).

In addition, a nested study in 10 villages will provide insights on transmission and reservoir restoration mechanisms through follow-up of a cohort and in-depth investigations.

AMARETi project will take place from 2024 to 2027 in 7 health posts and 50 villages of Kedougou department, under the leadership of the Kedougou Health District and Region authorities. The local health, administrative and community-based authorities at local and regional level are also key partners in the project, as well as local development committees and health community-based organisations. Healthpost staff and community health workers and volunteers will be essential for the operational field implementation.

Being tested
MDA with DHAp and SLD Primaquine, Targeted control (10-24 years) during the malaria high tranmission season: behaviour, Targeted control (15-24 years) during the malaria high tranmission season: test and treat
Keywords
stepped wedge, cluster randomized controlled trial, CRCT, malaria, Plasmodium falciparum, asymptomatic carriage, mass drug administration, MDA, parasite reservoir, seasonal malaria transmission, Senegal, youth-targeted, seasonal malaria chemoprevention, SMC
Medical subject headings
Malaria, Falciparum, Malaria

What participants receive

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

  • MDA with DHAp and SLD PrimaquineDrug

    MDA: 2 rounds of MDA with dihydroartemisinine-piperaquine + single low dose primaquine (PQ) administered instead of SMC round 1 and 5.

  • Targeted control (10-24 years) during the malaria high tranmission season: behaviourBehavioural

    Communication and community engagement activities by age-groups:

    • children aged 10-14 and their parents : promote early health seeking behaviour in case of symptoms
    • young adults (15-24) : promote early health seeking behaviour in case of symptoms, emphasing the importance of mild symptoms.

  • Targeted control (15-24 years) during the malaria high tranmission season: test and treatDiagnostic test

    Voluntary testing for malaria in young adults (15-24 years) using rapid diagnostic tests performed by community health workers during home visits or group testing events organized by the village youth association.

Study groups in NCT07281443
Study groupRoleWhat they receive
MDA and targeted controlExperimentalInterventions: * MDA with DHAp and SLD Primaquine * Targeted control (10-24 years) during the malaria high tranmission season: behaviour * Targeted control (15-24 years) during the malaria high tranmission season: test and treat During intervention period, villages receive 2 rounds of MDA simultaneously to SMC rounds 1 and 5. SMC-eligible children participate in MDA in replacement of round 1 and 5, but receive SMC rounds 2, 3 and 4 routinely. Youth-targeted control activities take place during the high transmission season: behavioural activies throughout and testing of asymptomatic young adults from 1 month after MDA1 to 1 month before MDA2.
Receives: Drug: MDA with DHAp and SLD Primaquine; Behavioral: Targeted control (10-24 years) during the malaria high tranmission season: behaviour; Diagnostic Test: Targeted control (15-24 years) during the malaria high tranmission season: test and treat
Routine malaria controlNo interventionControl arm will benefit from the routine malaria control strategy implemented by the Senegalese NMCP including: * universal coverage with long-lasting LLINs (renewed every 3 years); * free, community-based access to early diagnostic and treatment of malaria including active case detection activities by CHWs (DSDOM); * IPT for pregnant women using SP; * SMC for children aged 3 months to 10 years using SP+AQ, distributed door-to-door with 3-day DOTS, over 5 rounds (round 1: June; round 5: October)

What is being measured

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

  1. Plasmodium falciparum carriage reservoir at the end of the high transmission season (step 0)

    Number of participants with P. falciparum infection (measured by qPCR in cross sectional sample). Survey conducted at step 0 (baseline, year 0, no intervention). Survey takes place 4 months after SMC round 1 i.e. immediately before SMC round 5.

    Measured: 4 months after SMC round 1, baseline year 0

  2. Plasmodium falciparum carriage reservoir at the end of the high transmission season (step 1)

    Number of participants with P. falciparum infection (measured by qPCR in cross sectional sample). Surveys conducted at step 1 (year 1, intervention in 50% of clusters). Survey takes place 4 months after SMC round 1 in control villages (i.e. immediately before SMC round 5) and 4 months after MDA1 in intervention villages (i.e. immediately before MDA2).

    Measured: 4 months after MDA1/SMC round 1, year 1

  3. Plasmodium falciparum carriage reservoir at the end of the high transmission season (step 2)

    Number of participants with P. falciparum infection (measured by qPCR in cross sectional sample). Surveys conducted at step 2 (year 2). During the final step, intervention MDA3 (at the start of the wet season, replacing SMC round 1) and MDA4 (at the end of the wet season, replacing SMC round 5) take place in all clusters. Survey takes place 4 months after MDA3 in intervention villages (i.e. immediately before MDA4).

    Measured: 4 months after MDA3, year 2

  4. Odds ratio of P. falciparum infection associated with intervention/control period status

    The results of the cross sectional surveys at year 0, 1 and 2 (see outcomes 1-3) will be analysed in a multivariable multilevel logistic regression model. Explained variable : P. falciparum infection detected by qPCR. Variable of interest : intervention or control status at village level. Adjustments for individual, household, and cluster-level fixed effects. Including household, village, cluster and temporal random effects.

    Measured: 4 months after SMC round 1, years 0, 1 and 2

Secondary outcomes (12)

  1. Clinical malaria burden

    Cumulative P. falciparum clinical malaria incidence in study villages during the high transmission season (june to january) as recorded at community (CHW) and health-facility level. Comparison between intervention and control periods will evaluate burden reduction associated with intervention status.

    Measured: year 1, year 2

  2. Spatio-temporal dynamics of clinical malaria incidence

    Time-series of weekly cumulative incidence of clinical P. falciparum malaria recorded by CHW and health facilities in study villages during the high transmission season.

    Measured: year 1, year 2

  3. Mass drug administration safety (active)

    Frequency and severity of adverse events identified by active detection in a random sample of participants immediately after each MDA round.

    Measured: Day 4 after MDA start

  4. Mass drug administration safety (passive)

    Frequency and severity of adverse events recorded by passive detection at community (CHW) and health-facility level during each MDA (MDA1, 2, 3 and 4).

    Measured: Day 0 to day 7 after MDA start

  5. Plasmodium falciparum carriage reservoir at the onset of the high transmission season (step 1)

    Number of participants with P. falciparum infection (measured by qPCR in cross sectional sample). Survey conducted at step 1 (year 1, intervention in 50% of clusters). Survey takes place immediately before SMC round 1 in control villages and immediately before MDA1 in intervention villages. This period corresponds to the onset of the high transmission season (i.e. the end of the dry, low transmission season)

    Measured: immediately before MDA1/SMC round 1, year 1

  6. Plasmodium falciparum carriage reservoir at the onset of the high transmission season (step 2)

    Number of participants with P. falciparum infection (measured by qPCR in cross sectional sample). Surveys conducted at step 2 (year 2, intervention in 100% of clusters), immediately before MDA3, at the onset of the high transmission season (i.e. at the end of the dry, low transmission season)

    Measured: immediately before MDA3, year 2

  7. Plasmodium falciparum infection prevalence in 10-14 and 15-24 years

    Number of participants aged 10-14 and 15-24 years with P. falciparum infection (measured by qPCR in cross sectional sample). Surveys conducted at step 1 (year 1, intervention in 50% of clusters). Survey takes place 4 months after SMC round 1 in control villages (i.e. immediately before SMC round 5) and 4 months after MDA1 in intervention villages (i.e. immediately before MDA2). This subgroup analysis of secondary outcome 2 will enable comparison of prevalence and prevalence reduction between intervention and control periods by age-group to estimate potential effectiveness of the targeted control intervention.

    Measured: 4 months after SMC round 1 / MDA1, year 1

  8. Plasmodium falciparum infection prevalence in 10-14 and 15-24 years

    Number of participants aged 10-14 and 15-24 years with P. falciparum infection (measured by qPCR in cross sectional sample). Surveys conducted at step 2 (year 2, intervention in all clusters). Survey takes place 4 months after MDA3 (i.e. immediately before MDA4). This subgroup analysis of secondary outcome 3 will enable comparison of prevalence and prevalence reduction between intervention and control periods by age-group to estimate potential effectiveness of the targeted control intervention.

    Measured: 4 months after MDA3, year 2

  9. Intervention cost-effectiveness

    Intervention cost and cost-effectiveness ratio regarding prevalence reduction and clinical burden reduction

    Measured: year 2 and year 3

  10. Participation to MDA intervention

    Proportion of population participating to intervention relatively to total and eligible population, estimated for each MDA round (MDA1 to MDA4). 3-dose complete participation measured at the end of each MDA round, as well as incomplete participation (only 1 or 2 doses taken).

    Measured: Day 5 after MDA (MDA1 & MDA2, year 1; MDA2 & MDA3, year 2).

  11. Participation to targeted control intervention (15-24 years)

    Proportion of eligible 15-24 years old who completed at least one rapid diagnostic test during targeted control activities taking place from month 2 to month 3 after MDA1 during year 1 and from month 2 to month 3 after MDA3 during year 2.

    Measured: from month 2 to month 3 MDA1 (year 2) ; from month 2 to month 3 after MDA3 (year 2)

  12. Intervention acceptability

    Sekhon's indicators of acceptability evaluated using mixed methods (quantitative during cross-sectional surveys and qualitative) evaluated prospectively before MDA and retrospectively after MDA. Quantitative evaluation will rely on a -7 to +7 scale established combining responses to close-ended questions on the 7 dimensions of acceptability.

    Measured: after MDA, year 1

Timeline

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

  1. First posted15 Dec 2025
  2. Study start23 Sep 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Sequential
Model description
stepped-wedge cluster randomized controlled trial with three steps: step 0, observation of all clusters without intervention; step 1, intervention in 50% of clusters during a year; step 2, interventions in all clusters during a year.
Masking
None (open label)
Enrolment
18,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07281443
Sponsor's protocol ID
2024_SESSTIM_AMARETI
Other IDs
23SANIC216, ANR-23-CE35-0002
Acronym
AMARETI
Status last verified
Dec 2025
First submitted
29 Sep 2025
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing MDA with DHAp and SLD Primaquine in people with Malaria, Falciparum and Malaria, Asymptomatic Parasitaemia, run by Institut de Recherche pour le Developpement at 1 site in Senegal.

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 0 inclusion and 28 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: under way, not looking for participants, as of the sponsor's last update on 15 Dec 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 Senegal. 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?

This study is still under way. Results are not available in the source record yet.

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?

Plasmodium falciparum carriage reservoir at the end of the high transmission season (step 0) (time frame: 4 months after SMC round 1, baseline year 0). The study lists 4 primary outcomes in all. 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 NCT07281443.

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 15 Dec 2025.

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