Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202508639314232 Date of Registration: 01/08/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Age-expanded malaria community case management in Malawi
Official scientific title Assessing the effectiveness of extending malaria community case management (mCCM) to all ages in Neno, Ntchisi and Salima, Malawi: a mixed methods study
Brief summary describing the background and objectives of the trial The burden of malaria is high in Malawi, where access to care remains a challenge. Integrated community case management (iCCM) has been shown to be effective in reducing morbidity and mortality among children less than five years of age for pneumonia, diarrhea, and malaria. Some countries, including Malawi, have expressed an interest in extending malaria community case management (mCCM). Rigorous studies to scale up mCCM for all ages are necessary prior to introducing and scaling up this strategy in high-transmission settings. Objectives: 1. To assess the effectiveness of extending mCCM to all ages for 12 months on the proportion of individuals aged two months and older with fever in the last two weeks who were tested for malaria. (Primary objective) 2. To analyze the effectiveness of extending mCCM to all ages on the proportion of children aged 2 months to <5 years, 5 to <15 years, and those aged 15+ years with febrile illness in the previous 2 weeks who: 1) sought care for that illness; 2) sought care within 24 hours; 3) were tested for malaria; and 4) were treated with an appropriate antimalarial if they tested positive for malaria. 3. To describe the effectiveness of extending mCCM to all ages on the prevalence of malaria parasitaemia among children aged 2 months to <5 years, and among children 5 to <15 years (i.e., up to and including those aged 14 years old). 4. To evaluate the effectiveness of extending mCCM to all ages on the proportion of ill-children aged 2 months to <5 years seeking care for pneumonia and diarrhea. 5. To assess the acceptability, feasibility, perceptions and experiences of extending mCCM to all ages, according to community members, HSAs, and health facility in charges. 6. To estimate costs and cost-effectiveness of the intervention.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Treatment: Other
Anticipated trial start date 01/01/2022
Actual trial start date 01/01/2022
Anticipated date of last follow up 01/04/2023
Actual Last follow-up date 01/04/2023
Anticipated target sample size (number of participants) 7200
Actual target sample size (number of participants) 7200
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Age expanded malaria community case management. 10 months Community health workers were trained and permitted to provide malaria diagnosis and treatment to individuals of all ages. Individuals with severe malaria, pregnant individuals, and individuals over five years with non-malaria illnesses covered by integrated community cases management were referred to the nearest health facility. Randomization unit was the health facility; all community health care workers associated with each included health facility were in the same arm of the trial. 3600
Control Group Standard integrated community case management 10 months Community health care workers received commodity support and refresher training on standard integrated community case management, including malaria diagnosis and treatment for individuals under five years. 3600 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria for surveys conducted at baseline (January-February 2022) and endline (January-February 2023) are: - Individuals older than 2 months from one of the 1584 households selected at random - Who spent at least 7 nights in the household during the 2 weeks prior to the survey - With an informed consent signed by the head of the household or representative - In addition, biological samples (Rapid Diagnostic Test for malaria and filter paper) will be obtained from children aged 2 months to 14 years, with written assent provided by individuals 7 to 14 years old. Inclusion criteria for the intervention (community case management of malaria): - Individuals older than 2 months living in the catchment area of one of the 15 health centers in the intervention arm - Without malaria signs of severity (WHO definition) Exclusion criteria for the intervention (community case management of malaria): - Pregnant women - Aged 2 months or less - With malaria signs of severity (WHO definition) 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Infant: 0 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 2 Month(s) 95 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/11/2021 College of Medicine Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Private Bag 360, Chichiri Blantyre 3 Blantyre NA Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of individuals two months of age or older, reporting a fever in the previous 2 weeks who were tested for malaria by a CHW or at a health facility by a health worker. Baseline in January/February 2022 and endline in January/February 2023
Secondary Outcome Proportion of children <5 years, children 5- 14 years, and those aged 15+ years with febrile illness in the previous 2 weeks who: 1) sought care for that illness; 2) were tested for malaria; and 3) were treated with an appropriate antimalarial if tested positive for malaria Baseline in January/February 2022 and endline in January/February 2023
Secondary Outcome Community-level parasite prevalence in children 2 months to 14 years (<5 and 5 – 14 years) of age as measured by malaria RDT and by serological testing using dried blood spots collected on filter paper. Baseline in January/February 2022 and endline in January/February 2023
Secondary Outcome Proportion of suspected pneumonia and diarrhea in children <5 years who sought care and who received appropriate treatment Baseline in January/February 2022 and endline in January/February 2023
Secondary Outcome Acceptability of the extension to all ages of CCM-malaria, according to community members, CHWs, and health facility providers. This will be assessed through qualitative surveys. Baseline in January/February 2022 and endline in January/February 2023
Secondary Outcome Total costs, resource needs (commodities, workload changes), the cost per patient, and the cost-effectiveness of extending community case management to all ages, as compared to the standard iCCM strategy. This will be measured by economic evaluation. Throughout the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ntchisi District NA NA Malawi
Neno District NA NA Malawi
Salima District NA NA Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
U.S. Presidents Malaria Initiative 1300 Pennsylvania Avenue NW Washington DC 20523 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Training and Research Unit of Excellence 10 Marshall Road, Mandala, P.O. Box 30538 Chichiri Blantyre 3 Malawi Established independent Malawian research institution
COLLABORATORS
Name Street address City Postal code Country
US Centers for Disease Control and Prevention 1600 Clifton Rd Atlanta 30333 United States of America
Malawi National Malaria Control Program Private Bag 65 Lilongwe Malawi
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kamija Phiri kamijaphiri@gmail.com +2651871911 P/Bag 360
City Postal code Country Position/Affiliation
Blantyre 3 Malawi Professor in Clinical Epidemiology University of Malawi College of Medicine Director TRUE
Role Name Email Phone Street address
Public Enquiries Kamija Phiri kamijaphiri@gmail.com +2651871911 P/Bag 360
City Postal code Country Position/Affiliation
Blantyre 3 Malawi Professor in Clinical Epidemiology College of Medicine Director TRUE
Role Name Email Phone Street address
Scientific Enquiries Kamija Phiri kamijaphiri@gmail.com +2651871911 P/Bag 360
City Postal code Country Position/Affiliation
Blantyre 3 Malawi Professor in Clinical Epidemiology College of Medicine Director TRUE
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary results of the trial will be shared via submission of one or more manuscripts to international peer-reviewed journals. With each manuscript, de-identified participant data necessary to reproduce study results will be shared. Informed Consent Form,Study Protocol Summary of results are uploaded with submission; plan for more detailed results will be available in peer-reviewed journal in coming months. Associated participant data will be available from the moment of manuscript publication, without time restrictions for how long it will be available. Associated participant data associated with a manuscript will be openly accessible without restrictions. Requests for additional data will need to be addressed to the study principal investigators. A summary of proposed analyses should be provided to the principal investigators who will review the request and grant access if they approve.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 28/07/2025
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 30/07/2025
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 31/07/2025 Initially listed as number of facilities enrolled rather than individuals in the survey Experimental Group, Age expanded malaria community case management., , 10 months, Community health workers were trained and permitted to provide malaria diagnosis and treatment to individuals of all ages. Individuals with severe malaria, pregnant individuals, and individuals over five years with non-malaria illnesses covered by integrated community cases management were referred to the nearest health facility. Randomization unit was the health facility; all community health care workers associated with each included health facility were in the same arm of the trial., 12, Experimental Group, Age expanded malaria community case management., , 10 months, Community health workers were trained and permitted to provide malaria diagnosis and treatment to individuals of all ages. Individuals with severe malaria, pregnant individuals, and individuals over five years with non-malaria illnesses covered by integrated community cases management were referred to the nearest health facility. Randomization unit was the health facility; all community health care workers associated with each included health facility were in the same arm of the trial., 3600,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 31/07/2025 Initially listed as number of facilities enrolled rather than individuals in the survey Control Group, Standard integrated community case management, , 10 months, Community health care workers received commodity support and refresher training on standard integrated community case management, including malaria diagnosis and treatment for individuals under five years. , 12, Active-Treatment of Control Group Control Group, Standard integrated community case management, , 10 months, Community health care workers received commodity support and refresher training on standard integrated community case management, including malaria diagnosis and treatment for individuals under five years. , 3600, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 31/07/2025 Splitting three districts to three separate lines per reviewer request Ntchisi Neno and Salima Districts, NA, NA, , Malawi Ntchisi District, NA, NA, , Malawi
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 31/07/2025 Splitting three districts to three separate lines per reviewer request Neno District, NA, NA, , Malawi
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 31/07/2025 Splitting three districts to three separate lines per reviewer request Salima District, NA, NA, , Malawi