MULTIple Doses of IPTi Proposal: a Lifesaving High Yield Intervention
- Conditions
- Malaria
- Registration Number
- NCT05085340
- Lead Sponsor
- Barcelona Institute for Global Health
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45000
All infants attending their 2nd EPI contact who are eligible to receive the corresponding immunisations.
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of children having received at least three doses of IPTi Month 24
- Secondary Outcome Measures
Name Time Method Malaria incidence in under 2 year old children living in project districts Month 24 Malaria prevalence in under 2 year old children living in project districts Month 24 Coverage of EPI routine vaccines in children living in project districts Month 24
Trial Locations
- Locations (3)
College of Medicine & Allied Health Sciences (COMAHS), University of Sierra Leone
🇸🇱Freetown, Sierra Leone
Fundaçao Manhiça
🇲🇿Manhiça, Mozambique
University of Lomé
🇹🇬Lomé, Togo