An observational study in Anemia and Malaria, sponsored by London School of Hygiene and Tropical Medicine. Completed at 1 site in Cameroon. Open to participants aged Up to 9 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by London School of Hygiene and Tropical Medicine · Observational
Among 28 studies in Anemia by London School of Hygiene and Tropical Medicine — 1 open to participants now, 1 under way, 1 of them phase 3. Anemia · London School of Hygiene and Tropical Medicine.
Among the 28 studies in Anemia by London School of Hygiene and Tropical Medicine, this one is one of 2 that started in 2023, is one of 5 observational ones, and was the 26th registered.
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
This study's enrollment of 2,138 is above the median of 270 across 368 observational studies indexed under Anemia.
Browse Anemia studies →1 of the 28 studies in Anemia by London School of Hygiene and Tropical Medicine is open now, in 3 countries. Each count lists the studies.
Of the 122 Anemia studies recruiting now, 67 (55%) set no upper age limit and 37 (30%) stop at 75 or younger; 34 take children under 18; 23 take healthy volunteers.
This study: Up to 9 Months · all sexes · healthy volunteers too.
The full table on the hub →28 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 2 started in 2023.
Median enrollment 2,941 across the 22 interventional studies, 906 across the 6 observational. Of the 25 that completed or were terminated, 0 (0%) have results posted.
London School of Hygiene and Tropical Medicine is the lead sponsor of 298 studies on the registry; 15 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 28 studies in Anemia by London School of Hygiene and Tropical Medicine, from their registry updates:
Nothing recorded among them since 2026-09-25.
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 2,080 children in the areas served by 35 health centres in Cameroon. The results of this study will allow direct evaluation of the protective efficacy of PMC on malaria incidence, severe anaemia, and malaria mortality.
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 eight doses versus five doses as standard of care in Cameroon. The design is a multi-site quantitative study of the implementation of PMC in Cameroon. The health districts of Soa and Mbankomo 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. The investigators will also extract data on malaria and anaemia cases among children receiving PMC from health facility records.
The investigators 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. Children will be screened for malnutrition by measuring their mid-upper arm circumference (MUAC). If they are determined to have either moderate (MAM) or severe acute malnutrition (SAM), treatment will consist of standard of care which can include referral to the nearest health facility with clinical management capacity or treatment on site.
Children up to 9 months of age in Soa and Mbankomo health districts of Cameroon.
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.
Exclusion Criteria:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children (aged 6-9 months) in the control arm will receive the standard of care: 5 doses of SP at EPI visits (at 10 weeks, 14 weeks, 6 months, 9 months and 15 months).
Drug: Sulfadoxine pyrimethamine
Children (aged 6-9 months) in the intervention arm with receive PMC: 8 doses of SP at EPI visits (at the same contacts as group 1 plus at 12 months, 18 months and 24 months)
Drug: Sulfadoxine pyrimethamine
Sulfadoxine-pyrimethamine paediatric formulation (250mg/12.5mg) dispersable tablets (Macleods Pharmaceuticals Ltd)
Incidence of malaria infection and clinical malaria
Incidence of: (1) malaria infection, and (2) clinical malaria in children residing in areas designated to receive PMC (intervention) versus standard care (control).
Time frame: 18 months
Incidence of severe malaria, malaria deaths, anaemia and severe anaemia
Incidence of: (1) severe malaria, (2) malaria deaths, (3) anaemia, and (4) severe anaemia in children residing in areas designated to receive PMC (intervention) versus standard care (control).
Time frame: 18 months
Malaria and anaemia incidence by delivery platform, number of doses and dose schedule
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.
Time frame: 18 months
Dose-response effects of SP on malaria and anaemia
Measure the dose-response effects of SP on incidence of: (1) malaria infection, (2) clinical malaria, (3) severe malaria, (4) anaemia, (5) severe anaemia, and (6) malaria mortality throughout the period of observation.
Time frame: 18 months
Effects of distance to health facility on malaria and anaemia
Measure the effects of distance to health facility on incidence of: (1) malaria infection, (2) clinical malaria, (3) severe malaria, (4) anaemia, (5) severe anaemia, and (6) malaria mortality throughout the period of observation.
Time frame: 18 months
Incidence of moderate, severe and overall malnutrition
Incidence of: (1) moderate, (2) severe, and (3) overall malnutrition among children residing in areas designated to receive PMC (intervention) versus standard care (control).
Time frame: 12 months
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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