AnemiaNCT05889052
Perennial Malaria Chemoprevention (PMC) in Cameroon
An observational study of Anemia and Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in Cameroon.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 9 monthsHealthy volunteers can take part
- What is being tested?
- Sulfadoxine pyrimethamine
- Type of treatment
- Pill or oral medicine
- How many people
- 2,138 participants
- Where
- 1 siteCameroon
- Study dates
- 19 Jul 2023to 31 Dec 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 Up to 9 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children up to 9 months of age in Soa and Mbankomo health districts of Cameroon.
Who may be able to join
- Reside in Soa (intervention) or Mbankomo (control) health districts.
- Agree to take part in the census.
- Aged 6-9 months at the time of enrolment.
Who cannot join
- Parent/caregiver refused to participate in the cohort.
- Parent/caregiver did not give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact Evaluation of Intermittent Preventive Treatment of Malaria in Infants Plus (IPTi+) in Cameroon: The Plus Project
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.
Read the 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 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.
- Being tested
- Sulfadoxine pyrimethamine
- Keywords
- Malaria, Anemia, Perennial Malaria Chemoprevention (PMC), Intermittent Preventative Treatment of Infants (IPTi), Sulfadoxine-pyrimethamine (SP), chemoprevention
- Medical subject headings
- Anemia, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfadoxine pyrimethamineDrug
Sulfadoxine-pyrimethamine paediatric formulation (250mg/12.5mg) dispersable tablets (Macleods Pharmaceuticals Ltd)
| Study group | Role | What they receive |
|---|---|---|
| Active cohort control | 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). Receives: Drug: Sulfadoxine pyrimethamine | |
| Active cohort intervention | 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) Receives: Drug: Sulfadoxine pyrimethamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 18 months
Secondary outcomes (5)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start19 Jul 2023
- Primary completion28 Feb 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,138 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Fobang Institutes Centre for Health Implementation and Translational Research
- Responsible party
- Sponsor
- Investigators
- Wilfred Mbacham, ScD, Principal investigator, Fobang Institutes Centre for Health Innovation and Translational ResearchR Matthew Chico, MPH, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889052
- Sponsor's protocol ID
- PLUS-27988-CAM
- Status last verified
- Aug 2026
- First submitted
- 3 May 2023
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
WHO Malaria Report 2022, World Health Organisation
Stresman G, Lal S, Bruce J, Nji A, Serge-Brice A, Mosoff J, McGirr A, Gore-Langton G, McGuire M, Sinsai J, Lele A, Tah-Monunde M, Kouadio ZB, Anatole M, Konate-Toure A, Clarke SE, Gosling R, Mbacham WF, Yavo W, Chico RM. Effectiveness of malaria chemoprevention in the first two years of life in Cameroon and Cote d'Ivoire compared to standard of care: study protocol for a population-based prospective cohort impact evaluation study. BMC Public Health. 2024 Sep 6;24(1):2430. doi: 10.1186/s12889-024-19887-8.
PubMed 39243075
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Evaluation of Intermittent Preventive Treatment of Malaria in Infants Plus (IPTi+) in Cameroon: The Plus Project
- ClinicalTrials.gov ID
- NCT05889052
- Acronym / sponsor ID
- PLUS-27988-CAM
- Keywords
- Malaria, Anemia, Perennial Malaria Chemoprevention (PMC), Intermittent Preventative Treatment of Infants (IPTi), Sulfadoxine-pyrimethamine (SP), chemoprevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,138 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Fobang Institutes Centre for Health Implementation and Translational Research
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 5 Jun 2023 (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.
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.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active cohort control | – | Drug: Sulfadoxine pyrimethamineChildren (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). |
| Active cohort intervention | – | Drug: Sulfadoxine pyrimethamineChildren (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) |
Who may qualify
- Ages
- Up to 9 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children up to 9 months of age in Soa and Mbankomo health districts of Cameroon.
Key inclusion criteria (3 listed)
- Reside in Soa (intervention) or Mbankomo (control) health districts.
- Agree to take part in the census.
- Aged 6-9 months at the time of enrolment.
Key exclusion criteria (2 listed)
- Parent/caregiver refused to participate in the cohort.
- Parent/caregiver did not give informed consent.
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 |
|---|---|---|
| Sulfadoxine pyrimethamineSulfadoxine-pyrimethamine paediatric formulation (250mg/12.5mg) dispersable tablets (Macleods Pharmaceuticals Ltd) | Drug | Active cohort control, Active cohort intervention |
Primary outcome
Incidence of malaria infection and clinical malaria
Time frame: 18 months
Incidence of: (1) malaria infection, and (2) clinical malaria in children residing in areas designated to receive PMC (intervention) versus standard care (control).
5 secondary outcomes
Incidence of severe malaria, malaria deaths, anaemia and severe anaemia
Time frame: 18 months
Malaria and anaemia incidence by delivery platform, number of doses and dose schedule
Time frame: 18 months
Dose-response effects of SP on malaria and anaemia
Time frame: 18 months
Effects of distance to health facility on malaria and anaemia
Time frame: 18 months
Incidence of moderate, severe and overall malnutrition
Time frame: 12 months
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 8 Sep 2026.
- BackgroundWHO Malaria Report 2022, World Health Organisation
- Derived from this study: PubMed 39243075Stresman G, Lal S, Bruce J, Nji A, Serge-Brice A, Mosoff J, McGirr A, Gore-Langton G, McGuire M, Sinsai J, Lele A, Tah-Monunde M, Kouadio ZB, Anatole M, Konate-Toure A, Clarke SE, Gosling R, Mbacham WF, Yavo W, Chico RM. Effectiveness of malaria chemoprevention in the first two years of life in Cameroon and Cote d'Ivoire compared to standard of care: study protocol for a population-based prospective cohort impact evaluation study. BMC Public Health. 2024 Sep 6;24(1):2430. doi: 10.1186/s12889-024-19887-8.
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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.
Wilfred Mbacham, ScD principal investigator
Fobang Institutes Centre for Health Innovation and Translational Research
R Matthew Chico, MPH, PhD principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in Cameroon.
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 3 inclusion and 2 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 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. 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?
Incidence of malaria infection and clinical malaria (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05889052, which also lists 2 linked publications.
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 8 Sep 2026.