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.: PACTR202001907367187 Date of Approval: 22/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Assessing the effectiveness of community case management of malaria (CCM-malaria) for all ages in Farafangana District, Madagascar
Official scientific title Assessing the effectiveness of community case management of malaria (CCM-malaria) for all ages in Farafangana District, Madagascar
Brief summary describing the background and objectives of the trial The burden of malaria is moderate in Madagascar, where access to care remains a challenge. Integrated community case management (iCCM) had 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 Madagascar, have expressed an interest in extending community case management of malaria (CCM-malaria). Rigorous studies to scale up CCM-malaria for all ages are necessary prior to introducing and scaling up this strategy in moderate-transmission settings. The goal of this study is to evaluate the effectiveness of extending community case management of malaria to all age groups over a 24 month period in the study areas in the district of Farafangana. For this, a cluster-randomized trial with two arms (intervention and control) will be implemented in the catchment areas of 30 health facilities (15 per arm). The control arm will implement national guidelines (CCM-malaria for children <5 years) while the intervention arm will implement an extension of CCM-malaria to all ages. The primary objective is to assess whether expanding CCM-malaria to all ages increases the proportion of people aged 2+ months with fever in the last two weeks who were tested for malaria by a community health worker (CHW) or health facility. To achieve the objectives of the study, 3 types of data collection will take place : 1) Cross-sectional household surveys (1680 households), at baseline and end line of the intervention, 2) Qualitative interviews and focus groups, and 3) Routine data abstraction from CHWs and health facilities.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) mCCM
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Malaria case management at community level
Anticipated trial start date 01/03/2020
Actual trial start date 26/10/2020
Anticipated date of last follow up 31/12/2021
Actual Last follow-up date 31/12/2021
Anticipated target sample size (number of participants) 1680
Actual target sample size (number of participants)
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 was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control arm 2 years from january 2020 to january 2022 Case management of malaria by health facilities and CHWs in line with current national recommendations (integrated community case management (iCCM) for children <5 years) 840 Historical
Experimental Group Intervention arm 2 years from january 2020 to january 2022 Case management of malaria by health facilities and community health workers in line with current national recommendations (integrated community case management for children under 5 years), with an extension of community case management of malaria to all ages 840
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria for surveys conducted at baseline (october-december 2019) and endline (october-december 2021) are: - Individuals older than 2 months from one of the 1680 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 an assentment signed for 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 (Farafangana District, Madagascar) - 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) 80 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 30/07/2019 Comite d Ethique de la Recherche Biomedicale de Madagascar
Ethics Committee Address
Street address City Postal code Country
Agmed BP8145 Antananarivo Antananarivo 8145 Madagascar
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 18/09/2019 Centers for Disease Control and Prevention Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
1600 Clifton Rd, Atlanta Atlanta 30333 United States of America
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 October-December 2019 and End line in October-December 2021
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 October-December 2019 and End line in October-December 2021
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 October-December 2019 and End line in October-December 2021
Secondary Outcome Proportion of suspected pneumonia and diarrhea in children <5 years who sought care and who received appropriate treatment Baseline in October-December 2019 and End line in October-December 2021
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. April to May 2021 in the control arm, and August to September 2021 in the intervention arm
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. Througout the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Farafangana District Not applicable Not applicable Madagascar
FUNDING SOURCES
Name of source Street address City Postal code Country
Presidents Malaria Initiative PMI. United States Agency for International Development. USAID 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 Institut Pasteur de Madagascar Ambatofotsikely Antananarivo 1274 Madagascar Malagasy private scientific establishment, not for profit and recognized of public utility. Part of the Institut Pasteur International Network
COLLABORATORS
Name Street address City Postal code Country
Centers for Disease Control and Prevention US 1600 Clifton Rd Atlanta 30333 United States of America
Plan National de Lutte contre le Paludisme Ambohidahy Antananarivo Madagascar
ONG Inter Aide Mahafasa Ouest Farafangana Madagascar
Institut de Recherche pour le Developpement 911 Avenue Agropolis Montpellier France
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Andres Garchitorena andres.garchitorena@gmail.com 00261338998024 Institut Pasteur de Madagascar, Ambatofotsikely
City Postal code Country Position/Affiliation
Antananarivo Madagascar Researcher at Institut de Recherche pour le Developpement hosted by Institut Pasteur de Madagascar
Role Name Email Phone Street address
Scientific Enquiries Aina HARIMANANA aharim@pasteur.mg 00261320213091 Institut Pasteur de Madagascar, Ambatofotsikely
City Postal code Country Position/Affiliation
Antananarivo Madagascar Researcher at Institut Pasteur de Madagascar
Role Name Email Phone Street address
Principal Investigator Laura Steinhardt iyp6@cdc.gov +2348160470159 Centers for Disease Control and Prevention
City Postal code Country Position/Affiliation
Abuja Nigeria Epidemiologist at Centers for Disease Control and Prevention
Role Name Email Phone Street address
Public Enquiries Nicole Prada nicole.prada@pasteur.mg +261326394076 Institut Pasteur Madagascar, Ampatsifotsy
City Postal code Country Position/Affiliation
Antananarivo Madagascar Research and scientific coordinator at Institut Pasteur Madagascar
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 Submission of results of the trial will be done within 2 years of completion of the study. 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 13/07/2024 10/06/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 13/07/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information