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: www.pactr.org
Trial no.: PACTR201811870943127 Date of Approval: 26/11/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Implementation Research on Linking the Community Management of Acute Malnutrition and Integrated Community Case Management: A Cluster Randomized Trial in Turkana and Isiolo Counties, Kenya
Official scientific title Implementation Research on Linking the Community Management of Acute Malnutrition and Integrated Community Case Management: A Cluster Randomized Trial in Turkana and Isiolo Counties, Kenya
Brief summary describing the background and objectives of the trial An integrated approach to addressing the twin problem of disease and malnutrition would make it possible to address the presenting and underlying aspects of a child’s illness, but new evidence on the potential impact and practical experiences on integrating community-based management of acute malnutrition as part of an iCCM package is not well documented. This study, therefore, aims at investigating the effectiveness and cost-effectiveness of integrating management of acute malnutrition into iCCM. Study Design: This implementation research will be a non-inferiority cluster randomized trial, in Isiolo and Turkana, applying both quantitative and qualitative data collection methods for nutrition, iCCM and health outcomes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/11/2018
Actual trial start date
Anticipated date of last follow up 30/04/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 240
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 community units that do not receive the intervention None Four months of no intervention There is no intervention in this group. They will continue with the facility management of malnutrition 120 Historical
Experimental Group Intervention group composed of 10 community units Treatment will be given over 4 months 4 months The CHVs in this units will be trained to screen and treat malnutrition. 120
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The inclusion criteria for children under-five year is children whose parent are willing to participate in the study and are aged between 6 and 59 months and presenting with SAM, defined as either a MUAC of < 115 mm or the presence of bilateral pitting edema, without complications; or Presenting with MAM, defined as MUAC of between 115 mm and 125 mm. The CHVs who will be considered in this study are those who have been recruited and trained as CHVs by the MoH community strategy. The specific inclusion criteria for the current study: The CHVs (already recruited by MoH), should be willing to undertake and devote more of their time to the study We will exclude all those children whose parents/guardians are not willing to participate in the study or not willing to consent to have them participate in the study. CHVs who are not willing to participate and those who have discontinue their community services or move out of the study area will be excluded. Preschool Child: 2 Year-5 Year 6 Month(s) 59 Month(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 25/01/2018 AMREF Ethics and Scientific Review Committee
Ethics Committee Address
Street address City Postal code Country
Off Langata Road Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ● Cured rate ● Case-fatality rate/Death rate ● Defaulted rate ● Non-cured rate ● Average length of stay ● Average weight gain ● Coverage rate Endline after four months of treatment
Secondary Outcome ● Treatment of fever, pneumonia and diarrhea. ● Quality of care (CHVs performance and workload) Challenges and enablers in the effective integration of management of acute malnutrition into iCCM ● Cost per child recovered (from both a program and a societal perspective) ● Incremental cost-effectiveness ratio for ICCM model ● Range of costs within the sensitivity analysis After four months of the treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
AFRICAN POPULATION AND HEALTH RESEARCH CENTER MANGA CLOSE OFF KIRAWA ROAD NAIROBI 10787 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
UNICEF UN Avenue Gigiri NAIROBI 44145 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor APHRC MANGA CLOSE OFF KIRAWA ROAD NAIROBI 10787 Kenya Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
Ministry of health Research in Nutrition Division and Child health division Kenyatta Hospital Nairobi Kenya
Action Against Hunger Amboseli Road Nairobi 39900 Kenya
SAVE THE CHILDREN KENYA MATUNDU CLOSE OFF SCHOOL LANE NAIROBI 27679 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries HERMANN DONFOUET hdonfouet@aphrc.org 254722205933 Manga Close off Kirawa Road
City Postal code Country Position/Affiliation
Nairobi 10787 Kenya Associate Researcher
Role Name Email Phone Street address
Principal Investigator ELIZABETH KIMANI MURAGE ekimani@aphrc.org 254722205933 MANGA CLOSE OFF KIRAWA ROAD
City Postal code Country Position/Affiliation
NAIROBI 10787 Kenya RESEARCH SCIENTIST
Role Name Email Phone Street address
Public Enquiries ELIZABETH MWANIKI emwaniki@aphrc.org 254722205933 MANGA CLOSE OFF KIRAWA ROAD
City Postal code Country Position/Affiliation
NAIROBI 10787 Kenya RESEARCH ASSISTANT
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information