MalariaMULTIPLYNCT05085340
MULTIple Doses of IPTi Proposal: a Lifesaving High Yield Intervention
An observational study of Malaria, run by Barcelona Institute for Global Health at 3 sites in 3 countries.
Trial summary
As efforts to control malaria are stalling, and the disease is particularly severe in children under the age of two, it is imperative for countries in sub-Saharan Africa, with areas of moderate-to-high transmissions, to implement Perennial Malaria Chemoprevention (PMC) delivered through the Expanded Program on… Read more about this study
- Who is it for?
- Ages 10 weeks to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Intermittent preventive treatment of malaria in infants (IPTi) with sulfadoxine-pyrimethamine (SP)
- Type of treatment
- Vaccines
- How many people
- 94,252 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 14 Feb 2022to 31 Oct 2025
- Phase
- Observational
- 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 10 weeks to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: All infants attending their 2nd EPI contact who are eligible to receive the corresponding immunisations.
Who may be able to join
- All infants attending their 2nd EPI contact who are eligible to receive the corresponding immunisations.
Who cannot join
- Infants/children; with acute malaria; known to have sulfa allergies; who have taken SP in the past 4 weeks; who are HIV-exposed or HIV-infected
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Sierra Leone1 site
College of Medicine & Allied Health Sciences (COMAHS), University of Sierra Leone
Freetown
Togo1 site
University of Lomé
Lomé
About this study
As efforts to control malaria are stalling, and the disease is particularly severe in children under the age of two, it is imperative for countries in sub-Saharan Africa, with areas of moderate-to-high transmissions, to implement Perennial Malaria Chemoprevention (PMC) delivered through the Expanded Program on Immunization (EPI), which is the only feasible, sustainable and cost-effective strategy to reach this high-risk group. PMC is a full therapeutic course of antimalarial medicine (with sulfadoxine-pyrimethamine, SP) delivered to infants in the context of routine immunisation services during the first two year of life.
PMC has been shown to be safe, efficacious in reducing clinical malaria, anaemia and hospital admissions, and to be highly cost-effective; for all these reasons, the World Health Organization (WHO) recommended in 2010 Intermittent Preventive Treatment for Infants (IPTi) for malaria prevention. Only one African country - Sierra Leone -put IPTi into policy and practice. Concerned with this slow adoption, WHO in 2019 recommended adaptations be urgently tested through pilots assessing impact, operational feasibility and cost effectiveness. In 2022, WHO expanded that recommendation to cover children through the age of two because of studies documenting the value in children aged 12 to 24 months. The name for this preventive treatment has consequently changed to Perennial Malaria Chemoprevention (PMC) as the updated recommendation is no longer just for infants.
MULTIPLY is the pilot implementation of PMC in selected districts in Mozambique, Sierra Leone and Togo to maximise the delivery and uptake of PMC, to achieve the full potential of this intervention. Working with the ministries of health in Mozambique, Sierra Leone and Togo, MULTIPLY will give up to 6 doses of PMC in the first two years of life. PMC will be given at health facilities and EPI mobile outreach clinics using a paediatric dispersible formulation of SP, alongside routine vaccinations and vitamin A supplementation.
Read the detailed description
The study will be conducted in 3 sub-Saharan African countries; Sierra Leone, Mozambique and Togo.
Sample size; Assuming an average population of a district/project area of 150,000 inhabitants and a percentage of U2 children of 5%, the project intervention will target approximately 45,000 U2 children in total (i.e. 7,500 children per country and per year for 2 years).
Study population; Children U2 who are eligible for IPTi in the selected MULTIPLY district of each country.
- Conditions
- Malaria
- Being tested
- Intermittent preventive treatment of malaria in infants (IPTi) with sulfadoxine-pyrimethamine (SP)
- Keywords
- IPTi, Sulfadoxine-pyrimethamine, IPTi-SP, chemoprevention, Intermittent preventive treatment of malaria in infants, children, EPI, Expanded Programme of Immunization, SSA, sub-Saharan Africa, infants, malaria
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent preventive treatment of malaria in infants (IPTi) with sulfadoxine-pyrimethamine (SP)Drug
Also called IPTi-SP
IPTi will be administered as full therapeutic courses of SP alongside routine EPI immunisations at defined intervals corresponding to vaccination schedules - usually at 10 weeks, 14 weeks, and 9 months of age - to infants living in project districts. Additional doses of IPTi will be administered at 6, 12, and 15 or 18 months of age, coinciding with vitamin A administration and measles booster immunisation. The number of doses of IPTi a child will receive will depend of the EPI schedule in the country, with a maximum of six doses in the first two years of life.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of children having received at least three doses of IPTi
Measured: Month 24
Secondary outcomes (3)
Malaria prevalence in under 2 year old children living in project districts
Measured: Month 24
Malaria incidence in under 2 year old children living in project districts
Measured: Month 24
Coverage of EPI routine vaccines in children living in project districts
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start14 Feb 2022
- Primary completion31 Dec 2024
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 94,252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barcelona Institute for Global Health
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherche pour le Developpement, Centro de Investigação em Saúde de Manhiça, Medicines for Malaria Venture, University of Lomé (UL), Togo, University of Sierra Leone
- Responsible party
- Sponsor
- Investigators
- Clara Menéndez, MD, PhD, Principal investigator, Barcelona Institute for Global Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085340
- Sponsor's protocol ID
- RIA2020S 3272
- Acronym
- MULTIPLY
- Status last verified
- Jan 2026
- First submitted
- 7 Oct 2021
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MULTIple Doses of IPTi Proposal: a Lifesaving High Yield Intervention
- ClinicalTrials.gov ID
- NCT05085340
- Acronym / sponsor ID
- MULTIPLY / RIA2020S 3272
- Conditions
- Malaria
- Keywords
- IPTi, Sulfadoxine-pyrimethamine, IPTi-SP, chemoprevention, Intermittent preventive treatment of malaria in infants, children, EPI, Expanded Programme of Immunization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94,252 participants (actual)
- Lead sponsor
- Barcelona Institute for Global HealthUniversity, hospital or other
- Collaborators
- Institut de Recherche pour le Developpement, Centro de Investigação em Saúde de Manhiça, Medicines for Malaria Venture, University of Lomé (UL), Togo, University of Sierra Leone
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 20 Oct 2021 (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.
As efforts to control malaria are stalling, and the disease is particularly severe in children under the age of two, it is imperative for countries in sub-Saharan Africa, with areas of moderate-to-high transmissions, to implement Perennial Malaria Chemoprevention (PMC) delivered through the Expanded Program on Immunization (EPI), which is the only feasible, sustainable and cost-effective strategy to reach this high-risk group. PMC is a full therapeutic course of antimalarial medicine (with sulfadoxine-pyrimethamine, SP) delivered to infants in the context of routine immunisation services during the first two year of life.
PMC has been shown to be safe, efficacious in reducing clinical malaria, anaemia and hospital admissions, and to be highly cost-effective; for all these reasons, the World Health Organization (WHO) recommended in 2010 Intermittent Preventive Treatment for Infants (IPTi) for malaria prevention. Only one African country - Sierra Leone -put IPTi into policy and practice. Concerned with this slow adoption, WHO in 2019 recommended adaptations be urgently tested through pilots assessing impact, operational feasibility and cost effectiveness. In 2022, WHO expanded that recommendation to cover children through the age of two because of studies documenting the value in children aged 12 to 24 months. The name for this preventive treatment has consequently changed to Perennial Malaria Chemoprevention (PMC) as the updated recommendation is no longer just for infants.
MULTIPLY is the pilot implementation of PMC in selected districts in Mozambique, Sierra Leone and Togo to maximise the delivery and uptake of PMC, to achieve the full potential of this intervention. Working with the ministries of health in Mozambique, Sierra Leone and Togo, MULTIPLY will give up to 6 doses of PMC in the first two years of life. PMC will be given at health facilities and EPI mobile outreach clinics using a paediatric dispersible formulation of SP, alongside routine vaccinations and vitamin A supplementation.
Detailed description
The study will be conducted in 3 sub-Saharan African countries; Sierra Leone, Mozambique and Togo.
Sample size; Assuming an average population of a district/project area of 150,000 inhabitants and a percentage of U2 children of 5%, the project intervention will target approximately 45,000 U2 children in total (i.e. 7,500 children per country and per year for 2 years).
Study population; Children U2 who are eligible for IPTi in the selected MULTIPLY district of each country.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 weeks to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All infants attending their 2nd EPI contact who are eligible to receive the corresponding immunisations.
Key inclusion criteria (1 listed)
- All infants attending their 2nd EPI contact who are eligible to receive the corresponding immunisations.
Key exclusion criteria (1 listed)
- Infants/children; with acute malaria; known to have sulfa allergies; who have taken SP in the past 4 weeks; who are HIV-exposed or HIV-infected
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 |
|---|---|---|
| Intermittent preventive treatment of malaria in infants (IPTi) with sulfadoxine-pyrimethamine (SP)Also: IPTi-SPIPTi will be administered as full therapeutic courses of SP alongside routine EPI immunisations at defined intervals corresponding to vaccination schedules - usually at 10 weeks, 14 weeks, and 9 months of age - to infants living in project districts. Additional doses of IPTi will be administered at 6, 12, and 15 or 18 months of age, coinciding with vitamin A administration and measles booster immunisation. The number of doses of IPTi a child will receive will depend of the EPI schedule in the country, with a maximum of six doses in the first two years of life. | Drug | – |
Primary outcome
Proportion of children having received at least three doses of IPTi
Time frame: Month 24
3 secondary outcomes
Malaria prevalence in under 2 year old children living in project districts
Time frame: Month 24
Malaria incidence in under 2 year old children living in project districts
Time frame: Month 24
Coverage of EPI routine vaccines in children living in project districts
Time frame: Month 24
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 26 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Clara Menéndez, MD, PhD principal investigator
Barcelona Institute for Global Health
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria, run by Barcelona Institute for Global Health at 3 sites in 3 countries.
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 1 inclusion and 1 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 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Mozambique, Sierra Leone, Togo. 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?
Proportion of children having received at least three doses of IPTi (time frame: Month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2026.