Perennial Malaria Chemoprevention (PMC) in Côte d'Ivoire
Study Details
Study Description
Brief Summary
The Plus Project will assess the impact, operational feasibility, efficacy, effectiveness, and cost-effectiveness of PMC. Specifically, the impact evaluation will involve monitoring a passive cohort of all children in the study area reporting all doses of SP received and the number of confirmed cases of malaria and anaemia, as well as a prospective active cohort of children who will have seven home visits over an 18-month period. The total number of participants is expected to be approximately 1568 children in the areas served by 19 health centres in Côte d'Ivoire. The results of this study will allow direct evaluation of the protective efficacy of PMC on malaria incidence, severe anaemia, and malaria mortality.
Detailed Description
Despite impressive progress in recent years, malaria continues to impose a heavy morbidity and mortality burden. Ninety-five percent of the estimated 247 million malaria cases and 619,000 deaths worldwide in 2021 occurred in the World Health Organization (WHO) Africa Region [1]. The expansion of SP-IPTi to include children up to two years of age and additional entry points, referred to now as PMC, offers the potential to increase the impact of the intervention by delivering more protective doses of SP to an age group with a higher malaria burden. However, to support the development of national policies and international guidelines on the adoption and implementation of PMC at scale, more evidence is needed on where, when, how and under what circumstances PMC can be effective, cost-effective, acceptable, equitable and feasible.
The aim of the impact evaluation is to inform decision-making by policy makers and programme managers involved in national malaria control programmes by evaluating the protective efficacy of PMC with five doses versus zero doses as standard of care in Côte d'Ivoire. The design is a multi-site quantitative study of the implementation of PMC in Côte d'Ivoire. The health districts of Seguela and Kani were identified as the intervention and control districts, respectively, based on population size, number of Extended Programme of Immunisation (EPI) facilities, malaria incidence, EPI coverage and availability of an appropriate control population receiving standard care.
All children up to 36 months of age with parental consent will be recruited into a passive cohort. We will also extract data on malaria and anaemia cases among children receiving PMC from health facility records.
We will form and follow an active arm of the cohort in which a randomly selected subset of children in the passive cohort will be visited every three months during the study period in their homes to obtain detailed information, including details of the household, malaria risk factors, history of malaria and anaemia, health-seeking behaviour, and past EPI vaccinations. Blood will be collected for microscopy measures of parasitaemia, anaemia diagnosis by haemoglobin levels, and retrospective analysis of malaria infection (not for clinical management) by polymerase chain reaction methods. Rapid diagnostic tests will be used amongst symptomatic children to identify cases. First line antimalarial treatment will be provided to all confirmed cases.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active cohort control Children (aged 10 weeks to 6 months) in the control arm will receive the standard of care: 0 doses of SP. |
|
| Active cohort intervention Children (aged 10 weeks to 6 months) in the intervention arm with receive PMC: five doses of SP at EPI visits (10 weeks, 14 weeks, 9 months, 15 months, 18 months) |
Drug: Sulfadoxine pyrimethamine
Sulfadoxine-pyrimethamine paediatric formulation (250mg/12.5mg) dispersable tablets (Macleods Pharmaceuticals Ltd)
|
Outcome Measures
Primary Outcome Measures
- Incidence of malaria infection and clinical malaria [18 months]
Incidence of (1) malaria infection (2) clinical malaria in children residing in areas designated to receive PMC (intervention) versus standard care (control)
Secondary Outcome Measures
- Incidence of severe malaria, malaria deaths, anaemia and severe anaemia [18 months]
Incidence of (1) severe malaria (2) malaria deaths (3) anaemia (4) severe anaemia in children residing in areas designated to receive PMC (intervention) versus standard care (control)
- Malaria and anaemia incidence by delivery platform, number of doses and dose schedule [18 months]
Measure differences in incidence between children residing in areas designated to receive PMC (intervention) versus standard of care (control) based on differences in SP dose patterns by delivery platform, number of doses of SP, and the SP dose schedule
- Dose-response effects of SP on malaria and anaemia [18 months]
Estimate the dose-response and effects of SP on malaria infection, clinical malaria, severe malaria, anaemia, severe anaemia, and malaria mortality throughout the period during which children are eligible for the intervention and any changes in impact after the final administration of PMC
- Effect modification by distance to health facility [18 months]
Determine whether distance to health facilities, an indicator of access to care and PMC, is an effect modifier on the intervention.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Reside in Seguela (intervention) or Kani (control) health districts.
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Agree to take part in the census.
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Aged 10 weeks to six months at the time of enrolment.
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Parent/caregiver informed consent obtained.
Exclusion Criteria:
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Parent/caregiver refused to participate in the cohort.
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Parent/caregiver did not give informed consent.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- London School of Hygiene and Tropical Medicine
- Institut National de Santé Publique de Côte d'Ivoire
Investigators
- Principal Investigator: William Yavo, PharmD, PhD, Institut National de Santé Publique de Côte d'Ivoire
- Principal Investigator: R Matthew Chico, MPH, PhD, London School of Hygiene and Tropical Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
- PLUS-27988-CDI