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CompletedNCT05085340MULTIPLYUpdated Jan 26, 2026

MULTIple Doses of IPTi Proposal: a Lifesaving High Yield Intervention

An observational study in Malaria, sponsored by Barcelona Institute for Global Health. Completed at 3 sites in 3 countries. Open to participants aged 10 Weeks to 18 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-26.

Sponsored by Barcelona Institute for Global Health · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
94,252
Ages
10 Weeks to 18 Months
Sex
All
01

Study 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 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.

02

Conditions studied

  • Malaria

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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
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In context

Malaria

1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.

This study's enrollment of 94,252 is above the median of 582 across 204 observational studies indexed under Malaria.

Browse Malaria studies →

Lead sponsor

Barcelona Institute for Global Health is the lead sponsor of 24 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Weeks to 18 Months
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

All infants attending their 2nd EPI contact who are eligible to receive the corresponding immunisations.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

All infants attending their 2nd EPI contact who are eligible to receive the corresponding immunisations.

Exclusion criteria

Exclusion Criteria:

Infants/children; with acute malaria; known to have sulfa allergies; who have taken SP in the past 4 weeks; who are -exposed or HIV-infected

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
94,252 participants (actual)
Patient registry
No

Interventions

  • DrugIntermittent preventive treatment of malaria in infants (IPTi) with sulfadoxine-pyrimethamine (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.

    Also known as: IPTi-SP

06

What researchers measure

Primary outcomes

  1. Proportion of children having received at least three doses of IPTi

    Time frame: Month 24

Secondary outcomes

  1. Malaria prevalence in under 2 year old children living in project districts

    Time frame: Month 24

  2. Malaria incidence in under 2 year old children living in project districts

    Time frame: Month 24

  3. Coverage of EPI routine vaccines in children living in project districts

    Time frame: Month 24

07

Study locations

3 sites
  • Fundaçao Manhiça
    Manhiça, Manhiça, Mozambique
  • College of Medicine & Allied Health Sciences (COMAHS), University of Sierra Leone
    Freetown, Sierra Leone
  • University of Lomé
    Lomé, Togo
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05085340
Lead sponsor
Barcelona Institute for Global Health
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
First posted
Oct 20, 2021
Start date
Feb 14, 2022
Primary completion
Dec 31, 2024
Completion
Oct 31, 2025
Last update
Jan 26, 2026

Study contacts

Clara Menéndez, MD, PhD
principal investigator · Barcelona Institute for Global Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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